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Sample records for drug reaction related

  1. Adverse Drug Reactions Related to Drug Administration in Hospitalized Patients.

    Science.gov (United States)

    Gallelli, Luca; Siniscalchi, Antonio; Palleria, Caterina; Mumoli, Laura; Staltari, Orietta; Squillace, Aida; Maida, Francesca; Russo, Emilio; Gratteri, Santo; De Sarro, Giovambattista

    2017-01-01

    Drug treatment may be related to the development of adverse drug reactions (ADRs). In this paper, we evaluated the ADRs in patients admitted to Catanzaro Hospital. After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April 30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively. During the study period, we analyzed 2870 clinical records containing a total of 11,138 prescriptions, and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6 ± 1.2 days) with respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescriptions on 11,138 (27.4%) having a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) with respect to patients not experiencing ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and were treated as new diseases. Our results indicate that drug administration induces the development of ADRs also during the hospitalization, particularly in elderly women. Moreover, we also documented that ADRs in some patients are under-diagnosed, therefore, it is important to motivate healthcare to report the ADRs in order to optimize the patients' safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  2. Detection and Management of Adverse Drug Reactions Related to ...

    African Journals Online (AJOL)

    The objective of this study was to establish the detection, prevalence and management of various adverse drug reactions associated with antiretroviral drugs occurring in patients attending Comprehensive Care Centre (CCC) of Kiambu District Hospital. The study was a cross sectional survey where the patients included ...

  3. Drug Reactions

    Science.gov (United States)

    ... problem is interactions, which may occur between Two drugs, such as aspirin and blood thinners Drugs and food, such as statins and grapefruit Drugs and supplements, such as ginkgo and blood thinners ...

  4. Drug Reactions

    Science.gov (United States)

    ... Kids and Teens Pregnancy and Childbirth Women Men Seniors Your Health Resources Healthcare Management End-of-Life Issues Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & Devices Over-the- ...

  5. A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.

    Directory of Open Access Journals (Sweden)

    Rosliana Rosli

    Full Text Available Spontaneous reporting on adverse drug reactions (ADR has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification, category of ADR (according to system organ class as well as the severity of the ADR.In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%. The most common ADRs reported were from the following system organ classes: application site disorders (32.2%, skin and appendages disorders (20.6%, body as a whole general disorders (12.8% and central and peripheral nervous system disorders (11.2%. Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0% were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%. Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of

  6. Antibiotic-Related Adverse Drug Reactions at a Tertiary Care Hospital in South Korea

    Directory of Open Access Journals (Sweden)

    In Young Jung

    2017-01-01

    Full Text Available Background. Adverse drug reactions (ADRs are any unwanted/uncomfortable effects from medication resulting in physical, mental, and functional injuries. Antibiotics account for up to 40.9% of ADRs and are associated with several serious outcomes. However, few reports on ADRs have evaluated only antimicrobial agents. In this study, we investigated antibiotic-related ADRs at a tertiary care hospital in South Korea. Methods. This is a retrospective cohort study that evaluated ADRs to antibiotics that were reported at a 2400-bed tertiary care hospital in 2015. ADRs reported by physicians, pharmacists, and nurses were reviewed. Clinical information reported ADRs, type of antibiotic, causality assessment, and complications were evaluated. Results. 1,277 (62.8% patients were considered antibiotic-related ADRs based on the World Health Organization-Uppsala Monitoring Center criteria (certain, 2.2%; probable, 35.7%; and possible, 62.1%. Totally, 44 (3.4% patients experienced serious ADRs. Penicillin and quinolones were the most common drugs reported to induce ADRs (both 16.0%, followed by third-generation cephalosporins (14.9%. The most frequently experienced side effects were skin manifestations (45.1% followed by gastrointestinal disorders (32.6%. Conclusion. Penicillin and quinolones are the most common causative antibiotics for ADRs and skin manifestations were the most frequently experienced symptom.

  7. Ranking Adverse Drug Reactions With Crowdsourcing

    KAUST Repository

    Gottlieb, Assaf; Hoehndorf, Robert; Dumontier, Michel; Altman, Russ B

    2015-01-01

    Background: There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs

  8. Drug Reactions - Multiple Languages

    Science.gov (United States)

    ... PDF Drug Interactions - HIV medicines, part 6 - English MP3 Drug Interactions - HIV medicines, part 6 - 简体中文 (Chinese, Simplified (Mandarin dialect)) MP3 Drug Interactions - HIV medicines, part 6 - English MP4 ...

  9. Cutaneous adverse drug reactions

    African Journals Online (AJOL)

    CADRs).1 ... patient's management is thought to be responsible for the reaction. Some clinical ... In SJS/TEN hypotension, diarrhoea, hypothermia and confusion suggest ... and a pain management team, centred around a good core of experienced ...

  10. Drug Reactions in Oral Mucosa

    Directory of Open Access Journals (Sweden)

    Emine Derviş

    2012-12-01

    Full Text Available Both immunologic and nonimmunologic drug reactions can be seen in oral mucosa. Since considerable number of these reactions heals spontaneously without being noticed by the patients, exact frequency of the lesions is unknown. Most common lesions are xerostomia, taste disorders, mucosal ulcerations and edema. In this article, oral lesions resulting from drug intake similar to those from oral lesions of local and systemic diseases, and diagnostic problems caused by these similarities, have been reviewed.

  11. Biomarkers of adverse drug reactions.

    Science.gov (United States)

    Carr, Daniel F; Pirmohamed, Munir

    2018-02-01

    Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions. There has been significant recent progress in identifying predictive genomic biomarkers with the potential to be used in clinical settings to reduce the burden of adverse drug reactions. These have included biomarkers that can be used to alter drug dose (for example, Thiopurine methyltransferase (TPMT) and azathioprine dose) and drug choice. The latter have in particular included human leukocyte antigen (HLA) biomarkers which identify susceptibility to immune-mediated injuries to major organs such as skin, liver, and bone marrow from a variety of drugs. This review covers both the current state of the art with regard to genomic adverse drug reaction biomarkers. We also review circulating biomarkers that have the potential to be used for both diagnosis and prognosis, and have the added advantage of providing mechanistic information. In the future, we will not be relying on single biomarkers (genomic/non-genomic), but on multiple biomarker panels, integrated through the application of different omics technologies, which will provide information on predisposition, early diagnosis, prognosis, and mechanisms. Impact statement • Genetic and circulating biomarkers present significant opportunities to personalize patient therapy to minimize the risk of adverse drug reactions. ADRs are a significant heath issue

  12. Medications and Drug Allergic Reactions

    Science.gov (United States)

    American Academy of Allergy Asthma & Immunology Menu Search Main navigation Skip to content Conditions & Treatments Allergies Asthma Primary Immunodeficiency Disease Related Conditions Drug Guide Conditions Dictionary Just ...

  13. Acute renal failure secondary to drug-related crystalluria and/or drug reaction with eosinophilia and systemic symptom syndrome in a patient with metastatic lung cancer

    Directory of Open Access Journals (Sweden)

    Saime Paydas

    2017-01-01

    Full Text Available Drug reaction with eosinophilia and systemic symptoms (DRESS or drug-induced hypersensitivity is a severe adverse drug-induced reaction. Aromatic anticonvulsants, such as phenytoin, phenobarbital, and carbamazepine, and some drugs, can induce DRESS. Atypical crystalluria can be seen in patients treated with amoxycillin or some drugs and can cause acute renal failure. We describe a 66-year-old man who presented fever and rash and acute renal failure three days after starting amoxycillin. He was also using phenytoin because of cerebral metastatic lung cancer. Investigation revealed eosinophilia and atypical crystalluria. The diagnosis of DRESS syndrome was made, amoxicillin was stopped, and dose of phenytoin was reduced. No systemic corticosteroid therapy was prescribed. Symptoms began to resolve within three to four days. The aim of this paper is to highlight the importance of microscopic examination of urine in a case with acute renal failure and skin lesions to suspect DRESS syndrome.

  14. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

    Science.gov (United States)

    Ryu, JiHyeon; Lee, HeeYoung; Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

    2015-01-01

    We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.

  15. The pharmacist and adverse drug reaction reporting.

    Science.gov (United States)

    Pearson, K

    1982-08-01

    During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.

  16. Adverse ocular reactions to drugs.

    OpenAIRE

    Spiteri, M. A.; James, D. G.

    1983-01-01

    Drugs acting on various parts of the body may also affect the eye insidiously. Increased awareness of such drug toxicity by the prescribing doctor should encourage him to consider effects on the cornea, lens, retina, optic nerve and elsewhere when checking the patient's progress. The following review concerns adverse ocular effects of systemic drug administration.

  17. Derivatization reactions in the gas—liquid chromatographic analysis of drugs in biological fluids

    NARCIS (Netherlands)

    Hulshoff, A.; Lingeman, H.

    1984-01-01

    Alkylation, acylation, silylation and other derivatization reactions applied to the gas chromatographic analysis of drugs in biological matrices are reviewed. Reaction conditions are discussed in relation to reaction mechanisms. Detector-oriented labelling of drugs, and derivatization with chiral

  18. Ranking Adverse Drug Reactions With Crowdsourcing

    KAUST Repository

    Gottlieb, Assaf

    2015-03-23

    Background: There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. Objective: The intent of the study was to rank ADRs according to severity. Methods: We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. Results: There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. Conclusions: ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.

  19. Ranking adverse drug reactions with crowdsourcing.

    Science.gov (United States)

    Gottlieb, Assaf; Hoehndorf, Robert; Dumontier, Michel; Altman, Russ B

    2015-03-23

    There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. The intent of the study was to rank ADRs according to severity. We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.

  20. Synthesis and conformational analysis of new arylated-diphenylurea derivatives related to sorafenib drug via Suzuki-Miyaura cross-coupling reaction

    Science.gov (United States)

    Al-Masoudi, Najim A.; Essa, Ali Hashem; Alwaaly, Ahmed A. S.; Saeed, Bahjat A.; Langer, Peter

    2017-10-01

    Sorafenib, is a relatively new cytostatic drug approved for the treatment of renal cell and hepatocellular carcinoma. The development of new sorafenib analogues offers the possibility of generating structures of increased potency. To this end, a series of arylated-diphenylurea analogues 17-31 were synthesized via Suzuki-Miyaura coupling reaction, related to sorafenib by treatment of three diarylureas 2-4 having 3-bromo, 4-chloro and 2-iodo groups with various arylboronic acids. Conformational analysis of the new arylated urea analogues has been investigated using MOPAC 2016 of semi empirical PM7 Hamiltonian computational method. Our results showed that all compounds preferred the trans-trans conformations. Compound 17 has been selected to calculate the torsional energy profiles for rotation around the urea bonds and found to be existed predominantly in the trans-trans conformation with only very minimal fluctuation in conformation.

  1. Modeling chemical reactions for drug design.

    Science.gov (United States)

    Gasteiger, Johann

    2007-01-01

    Chemical reactions are involved at many stages of the drug design process. This starts with the analysis of biochemical pathways that are controlled by enzymes that might be downregulated in certain diseases. In the lead discovery and lead optimization process compounds have to be synthesized in order to test them for their biological activity. And finally, the metabolism of a drug has to be established. A better understanding of chemical reactions could strongly help in making the drug design process more efficient. We have developed methods for quantifying the concepts an organic chemist is using in rationalizing reaction mechanisms. These methods allow a comprehensive modeling of chemical reactivity and thus are applicable to a wide variety of chemical reactions, from gas phase reactions to biochemical pathways. They are empirical in nature and therefore allow the rapid processing of large sets of structures and reactions. We will show here how methods have been developed for the prediction of acidity values and of the regioselectivity in organic reactions, for designing the synthesis of organic molecules and of combinatorial libraries, and for furthering our understanding of enzyme-catalyzed reactions and of the metabolism of drugs.

  2. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions : an example with diuretics and non-steroidal anti-inflammatory drugs

    NARCIS (Netherlands)

    van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

    2000-01-01

    OBJECTIVE: Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable

  3. HOW ADVERSE DRUG-REACTIONS CAN PLAY A ROLE IN INNOVATIVE DRUG RESEARCH - SIMILARITIES IN ADVERSE DRUG REACTION PROFILES OF CAPTOPRIL AND PENICILLAMINE

    NARCIS (Netherlands)

    RIKKEN, F; VOS, R

    1995-01-01

    We describe how adverse drug reactions (ADRs) can play an important role in pharmaceutical research and drug development. Not only do ADRs represent the risks and drawbacks associated with drugs but they can also be related to other knowledge available in pharmaceutical and medical research. We

  4. Adverse drug reactions induced by cardiovascular drugs in outpatients

    Directory of Open Access Journals (Sweden)

    Gholami K

    2008-03-01

    Full Text Available Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs induced by this class of medicinal products seems necessary.Objectives: To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. Methods: This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. Results: The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3% patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5% and the lowest rate with Atenolol (3%. Headache was the most frequent detected ADR (23%. Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05. ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05. With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05. Conclusion: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  5. Adverse drug reactions induced by cardiovascular drugs in outpatients.

    Science.gov (United States)

    Gholami, Kheirollah; Ziaie, Shadi; Shalviri, Gloria

    2008-01-01

    Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary. To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3%) patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate with Atenolol (3%). Headache was the most frequent detected ADR (23%). Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, PPearson=0.259, P<0.05). Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  6. Reaction between drug substances and pharmaceutical excipients

    DEFF Research Database (Denmark)

    Larsen, Jesper; Cornett, Claus; Jaroszewski, Jerzy Witold

    2009-01-01

    The reactivity of citric acid towards drug substances in the solid state was examined using the beta-blocker carvedilol as a model compound. The reaction mixtures were analysed by LC-MS, the reaction products were isolated by preparative HPLC, and the structures were elucidated by microprobe NMR...... spectroscopy. Heating a mixture of solid carvedilol and solid citric acid monohydrate for 96h at 50 degrees C resulted in the formation of about 3% of a symmetrical ester as well as of a number of other reaction products in smaller amounts. Formation of the symmetrical ester was also observed at room...... temperature. At 70 degrees C, the amounts of three isomeric esters formed reached 6-8%. The minor reaction products were citric acid amides, O-acetylcarvedilol, and esters of itaconic acid....

  7. The antinociceptive effect and adverse drug reactions of oxycodone in human experimental pain in relation to genetic variations in the OPRM1 and ABCB1 genes

    DEFF Research Database (Denmark)

    Zwisler, Stine T; Enggaard, Thomas P; Noehr-Jensen, Lene

    2010-01-01

    % for the wild-type carriers, P = 0.007). C3435T: The carriers of the variant T allele generally had less adverse drug reactions on oxycodone than the carriers of the wild-type genotype. G2677T/A: The carriers of the variant T allele had a better antinociceptive effect of oxycodone than the carriers of the wild......-type genotype in the cold pressor test (25% reduction vs. 15%, P = 0.015 in the discomfort rating and 25% reduction vs. 12%, P = 0.007 in the pain time AUC) and less adverse drug reactions. The combined wild-type genotype 3435CC-2677GG was associated with less antinociceptive effect of oxycodone...

  8. [Pharmacotherapy of hyperthyreosis--adverse drug reactions].

    Science.gov (United States)

    Perger, Ludwig; Bürgi, Ulrich; Fattinger, Karin

    2011-06-01

    The antithyroid drugs mainly include thioimidazole (carbimazole, methimazole=thiamazole) and propylthiouracil. After absorption, carbimazole is rapidly metabolized to methimazole and thus switching between these two drugs should not be considered in case of side effects. Furthermore, in case of side effects, sometimes even cross reactions between thioimidazoles and propylthiouracil occur. Common and typical adverse reactions of antithyroid drugs include dose dependent hypothyroidism and thus thyroid function should be repeatedly checked while the patient is on antithyroid drugs. Furthermore, pruritus and rash may develop. In this case, one might try to switch from thioimidazoles to propylthiouracil or vice versa. Antithyroid drugs may cause mild dose dependent neutropenia or severe allergy-mediated agranulocytosis, which typically occurs during the first three months of treatment, has an incidence of 3 per 10,000 patients and cross reactivity between thioimidazoles to propylthiouracil may occur. Rarely, antithyroid drugs can cause aplastic anemia. Mainly propylthiouracil, but sometimes also methimazole may lead to an asymptomatic transient increase in liver enzymes or to severe, even lethal liver injury of cholestatic or hepatocellular pattern. Since propylthiouracil associated liver injury was observed increasingly among children and adolescent, it has been suggested to prefer thioimidazoles for these patients. Because of these potential serious adverse effects, physicians should advise patients to immediately seek medical help if they get a fever or sore throat or malaise, abdominal complaints or jaundice, respectively. Furthermore, arthralgias may develop in 1-5% of patients under both antithyroid drugs. Since arthralgias may be the first symptom of more serious immunologic side effects, it is recommended to stop the antithyroid drug in this case. Drug induced polyarthritis mainly develops during the first month of therapy, whereas ANCA-positive vasculitis is

  9. Common adverse drug reactions with psychiatric medications and ...

    African Journals Online (AJOL)

    Common adverse drug reactions with psychiatric medications and an approach to their management: Adverse drug reactions are as important in psychiatric practice as they are in any other branch of medicine.

  10. [Adverse drug reaction reporting in emergency medicine].

    Science.gov (United States)

    Milojevic, Kolia; Chassagnol, Isabelle; Brion, Nathalie; Cléro, Joël; Degrèze, Nathalie; Lambert, Yves

    2004-01-01

    A regional survey was performed between June and September 2002, to evaluate knowledge and attitudes of emergency physicians regarding adverse drug reaction (ADR) reporting in a French district. 100 questionnaires completed by physicians working in emergency departments and/or mobile intensive care units were analysed. The frequency of ADRs encountered by emergency practitioners was estimated at > or = 0.73 per year and per physician. The ADR notification rate in emergency medicine was estimated at advertising ADR reporting procedures could help to improve the notification rate in emergency medicine.

  11. Identifying Adverse Drug Events by Relational Learning.

    Science.gov (United States)

    Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael

    2012-07-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task , related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events.

  12. HLA Association with Drug-Induced Adverse Reactions

    Directory of Open Access Journals (Sweden)

    Wen-Lang Fan

    2017-01-01

    Full Text Available Adverse drug reactions (ADRs remain a common and major problem in healthcare. Severe cutaneous adverse drug reactions (SCARs, such as Stevens–Johnson syndrome (SJS/toxic epidermal necrolysis (TEN with mortality rate ranges from 10% to more than 30%, can be life threatening. A number of recent studies demonstrated that ADRs possess strong genetic predisposition. ADRs induced by several drugs have been shown to have significant associations with specific alleles of human leukocyte antigen (HLA genes. For example, hypersensitivity to abacavir, a drug used for treating of human immunodeficiency virus (HIV infection, has been proposed to be associated with allele 57:01 of HLA-B gene (terms HLA-B∗57:01. The incidences of abacavir hypersensitivity are much higher in Caucasians compared to other populations due to various allele frequencies in different ethnic populations. The antithyroid drug- (ATDs- induced agranulocytosis are strongly associated with two alleles: HLA-B∗38:02 and HLA-DRB1∗08:03. In addition, HLA-B∗15:02 allele was reported to be related to carbamazepine-induced SJS/TEN, and HLA-B∗57:01 in abacavir hypersensitivity and flucloxacillin induced drug-induced liver injury (DILI. In this review, we summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

  13. Children and ADRs (Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Napoleone Ettore

    2010-01-01

    Full Text Available Abstract Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions. The lack of reliable data in the paediatric population is associated with specific problems including: limited availability of safety data due to the lack of clinical trials in the paediatric population; under- or over-dosing in some age groups due to the lack of pharmacokinetics data or dose-finding studies; maturation, growth and development of the paediatric population susceptible to drug-induced growth and development disorders as well as to delayed ADRs not findable in adults. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Spontaneous reporting of suspected ADRs become an important means to promote reasonable warning signs. Therefore some ADRs may be known in their qualitative aspect and quantitative aspect only after successful marketing and use in the population during a "normal" use. When the drug is used in clinical practice in large unselected populations, epidemiological post-marketing studies are useful as they find their major confirmation in recalling all the events that occur during monitoring, with estimates of incidence of ADRs that can not be obtained by spontaneous reports. In these studies a significant role can be played by the Family Pediatricians with the participation to active pharmacovigilance projects.

  14. Patients’ attention to and understanding of adverse drug reaction warnings

    Directory of Open Access Journals (Sweden)

    Tresa Muir McNeal

    2010-12-01

    Full Text Available Tresa Muir McNeal1, Colleen Y Colbert1, Christian Cable1, Curtis R Mirkes1, June G Lubowinski2, John D Myers11Department of Medicine, Texas A&M University System HSC College of Medicine, Scott & White Healthcare, Temple, TX, USA; 2RD Haynes Medical Library, Scott & White Healthcare, Temple, TX, USAIntroduction: Medications are critical to the management of patient conditions, and they can have significant effects on the success or failure of medical interventions. Patient perceptions of drug warnings play an important role in medication compliance and ultimately disease management. Several factors may affect patients’ understanding of drug warnings and drug labeling, including health literacy and interactions with physicians and pharmacists.Purpose: The purpose of this article is to provide a review of the literature related to patient perceptions of drug warnings and drug labeling. Descriptive articles and studies regarding patient perceptions and knowledge of adverse drug reaction warnings were reviewed.Methods: The following databases were utilized to search the literature related to patient perceptions of drug warnings: PubMed, Academic Search Premiere, CINAHL, Medline, Psych Info, Business Source Complete, Alternative Healthwatch, Health Source (both Nursing/Academic and Consumer additions, JSTOR, and Master File Premiere. For the purpose of this review, any peer-reviewed article was eligible. Exclusionary criteria included: articles published in languages other than English, articles/studies on patient perceptions of vaccines and chemotherapy, and articles related to perceptions of medications administered in the inpatient setting. Forty-six articles were included in the review.Results: Health literacy has been shown to have a major impact on patients’ ability to understand potential adverse reactions and instructions on correct dosing of medications. Direct communication with physicians and pharmacists is one of the most important and

  15. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Aagaard, Lise; Nielsen, Lars Hougaard; Hansen, Ebba Holme

    2009-01-01

    BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...... to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). FINDINGS: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers' share of 'serious' ADRs was comparable to that of physicians (approximately 45%) but lower than...

  16. Epidemiology of adverse drug reactions in Europe

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; De Bruin, Marie L; Koopmanschap, Marc A

    2015-01-01

    Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3...... September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final...... review. The median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. Only five studies were found that assessed ADRs occurring in the outpatient setting...

  17. Identification of Carboxylate, Phosphate, and Phenoxide Functionalities in Deprotonated Molecules Related to Drug Metabolites via Ion-Molecule Reactions with water and Diethylhydroxyborane

    Science.gov (United States)

    Zhu, Hanyu; Ma, Xin; Kong, John Y.; Zhang, Minli; Kenttämaa, Hilkka I.

    2017-10-01

    Tandem mass spectrometry based on ion-molecule reactions has emerged as a powerful tool for structural elucidation of ionized analytes. However, most currently used reagents were designed to react with protonated analytes, making them suboptimal for acidic analytes that are preferentially detected in negative ion mode. In this work we demonstrate that the phenoxide, carboxylate, and phosphate functionalities can be identified in deprotonated molecules by use of a combination of two reagents, diethylmethoxyborane (DEMB) and water. A novel reagent introduction setup that allowed DEMB and water to be separately introduced into the ion trap region of the mass spectrometer was developed to facilitate fundamental studies of this reaction. A new reagent, diethylhydroxyborane (DEHB), was generated inside the ion trap by hydrolysis of DEMB on introduction of water. Most carboxylates and phenoxides formed a DEHB adduct, followed by addition of one water molecule and subsequent ethane elimination (DEHB adduct +H2O - CH3CH3) as the major product ion. Phenoxides with a hydroxy group adjacent to the deprotonation site and phosphates formed a DEHB adduct, followed by ethane elimination (DEHB adduct - CH3CH3). Deprotonated molecules with strong intramolecular hydrogen bonds or without the aforementioned functionalities, including sulfates, were unreactive toward DEHB/H2O. Reaction mechanisms were explored via isotope labeling experiments and quantum chemical calculations. The mass spectrometry method allowed the differentiation of phenoxide-, carboxylate-, phosphate-, and sulfate-containing analytes. Finally, it was successfully coupled with high-performance liquid chromatography for the analysis of a mixture containing hymecromone, a biliary spasm drug, and its three possible metabolites. [Figure not available: see fulltext.

  18. [Nursing role in reporting adverse drug reactions].

    Science.gov (United States)

    Zurita-Garaicoechea, Ana; Reis-Carvalho, Joana; Ripa-Aisa, Irantzu; Jiménez-Mendoza, Ana; Díaz-Balén, Almudena; Oroviogoicoechea, Cristina

    2015-01-01

    The spontaneous report system, in which suspected adverse drug reaction (ADR) are reported by healthcare workers, is currently one of the primary methods to prevent and discover new and serious ADR to marketed medicinal products. The collaboration of nursing professionals with this task makes it possible to improve patient safety and to reduce ADR costs. Although a total of 781 cases of ADR cases were reported in Navarra in 2011, only 7.33% were reported by nurses. The objectives werw to determine the factors that influence nurses in reporting of ADR, and second, to devise strategies which help to increase reporting. A bibliographic search for articles that included the words: reacciones adversas medicamentosas (adverse drug reactions), notificación (reporting) and enfermería (nursing) was conducted using the PubMed and Cinhal databases. A total of 107 articles were retrieved, of which 27 were selected according to inclusion and exclusion criteria. The conclusion learned by reading and analyzing the selected articles was that the factors that affect the notification depend on the attitude of the notifier, as well as personal and professional factors. The main strategies to encourage notification are education and training, motivation, and the availability of facilitating tools. The main factors that have an influence on under-notification are the lack of knowledge and motivation among professionals. To solve the problem of under-notification, the main actions and strategies to undertake are education, motivation and persistence. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  19. Adverse Cutaneous Reactions to Psychotropic Drugs: A Review

    Directory of Open Access Journals (Sweden)

    Filipa Novais

    2015-11-01

    Full Text Available Introduction: Psychotropic drugs are often implicated in cutaneous adverse drug reactions. While most of these reactions have a benign character, it is still important, however, to consider its role in the increasing stigma and treatment adherence. A small number of the cutaneous adverse drug reactions can develop into serious and potentially fatal conditions. Objectives: This article aims to review the most common cutaneous adverse drug reactions in patients taking psychotropic drugs. Methods: In this study, a search was carried out in the MEDLINE database for English language articles published , from 1999 to 2014, using as keywords: psychiatric, psychotropic, cutaneous, adverse reaction, antidepressive agents, antipsychotics, benzodiazepines, mood stabilizers, anticonvulsant, dementia. Information available from the Portuguese regulatory and supervising agency (Infarmed was also included.Results: 121 articles were found with reference to cutaneous adverse drug reactions associated with psychotropic drugs. The drugs most frequently reported as associated with such adverse effects were anticonvulsants used as mood stabilizers, followed by the antipsychotics . The antidementia drugs were rarely associated with serious cutaneous adverse reactions. Discussion and Conclusion: Cutaneous drug adverse reactions are common in psychiatric clinical practice and typically are minor in severity. The most severe reactions are most often associated with the use of mood stabilizing medications. Some of these side effects can be solved with reduction or drug discontinuation. More severe cases should be referred to a specialist in dermatology.

  20. Substantially Higher and Earlier Occurrence of Anti-Tuberculosis Drug-Related Adverse Reactions in HIV Coinfected Tuberculosis Patients: A Matched-Cohort Study.

    Science.gov (United States)

    Matono, Takashi; Nishijima, Takeshi; Teruya, Katsuji; Morino, Eriko; Takasaki, Jin; Gatanaga, Hiroyuki; Kikuchi, Yoshimi; Kaku, Mitsuo; Oka, Shinichi

    2017-11-01

    Little information exists on the frequency, severity, and timing of first-line anti-tuberculosis drug-related adverse events (TB-AEs) in HIV-tuberculosis coinfected (HIV-TB) patients in the antiretroviral therapy (ART) era. This matched-cohort study included HIV-TB patients as cases and HIV-uninfected tuberculosis (non-HIV-TB) patients as controls. Tuberculosis was culture-confirmed in both groups. Cases were matched to controls in a 1:4 ratio on age, sex, and year of diagnosis. TB-AEs were defined as Grade 2 or higher requiring drug discontinuation/regimen change. From 2003 to 2015, 94 cases and 376 controls were analyzed (95% men, 98% Asians). Standard four-drug combination therapy was initiated in 91% of cases and 89% of controls (p = 0.45). Cases had a higher frequency of TB-AE [51% (48/94) vs. 10% (39/376), p tuberculosis treatment. HIV infection was an independent risk factor for TB-AEs in the multivariate Cox analysis [adjusted HR (aHR): 6.96; 95% confidence interval: 3.93-12.3]. TB-AEs occurred more frequently in HIV-TB than in non-HIV-TB patients, and were more severe. The majority of TB-AEs occurred within 4 weeks of initiating anti-tuberculosis treatment. Because TB-AEs may delay ART initiation, careful monitoring during this period is warranted in coinfected patients.

  1. Data-driven prediction of adverse drug reactions induced by drug-drug interactions.

    Science.gov (United States)

    Liu, Ruifeng; AbdulHameed, Mohamed Diwan M; Kumar, Kamal; Yu, Xueping; Wallqvist, Anders; Reifman, Jaques

    2017-06-08

    The expanded use of multiple drugs has increased the occurrence of adverse drug reactions (ADRs) induced by drug-drug interactions (DDIs). However, such reactions are typically not observed in clinical drug-development studies because most of them focus on single-drug therapies. ADR reporting systems collect information on adverse health effects caused by both single drugs and DDIs. A major challenge is to unambiguously identify the effects caused by DDIs and to attribute them to specific drug interactions. A computational method that provides prospective predictions of potential DDI-induced ADRs will help to identify and mitigate these adverse health effects. We hypothesize that drug-protein interactions can be used as independent variables in predicting ADRs. We constructed drug pair-protein interaction profiles for ~800 drugs using drug-protein interaction information in the public domain. We then constructed statistical models to score drug pairs for their potential to induce ADRs based on drug pair-protein interaction profiles. We used extensive clinical database information to construct categorical prediction models for drug pairs that are likely to induce ADRs via synergistic DDIs and showed that model performance deteriorated only slightly, with a moderate amount of false positives and false negatives in the training samples, as evaluated by our cross-validation analysis. The cross validation calculations showed an average prediction accuracy of 89% across 1,096 ADR models that captured the deleterious effects of synergistic DDIs. Because the models rely on drug-protein interactions, we made predictions for pairwise combinations of 764 drugs that are currently on the market and for which drug-protein interaction information is available. These predictions are publicly accessible at http://avoid-db.bhsai.org . We used the predictive models to analyze broader aspects of DDI-induced ADRs, showing that ~10% of all combinations have the potential to induce ADRs

  2. Successful drug desensitization in patients with delayed-type allergic reactions to anti-tuberculosis drugs

    Directory of Open Access Journals (Sweden)

    Krittaecho Siripassorn

    2018-03-01

    Full Text Available Objective: To evaluate the outcomes of anti-tuberculosis drug desensitization. Methods: This was a retrospective study. Inclusion criteria were as follows: age >18 years, documented tuberculosis infection, a previous cutaneous allergic reaction to anti-tuberculosis drugs, and having undergone drug desensitization between January 2003 and March 2014. The definition of allergic reaction to anti-tuberculosis drugs included (1 a temporal relationship between drug use and the allergic reaction; (2 improvement in the allergic reaction after drug withdrawal; (3 recurrence of the allergic reaction after reintroduction of only the offending drug; and (4 absence of other causes. Results: A total of 19 desensitization procedures were performed. The drugs used for these procedures were isoniazid (n = 7, rifampicin (n = 6, or ethambutol (n = 6. Of note, severe allergic reactions (Stevens–Johnson syndrome (n = 4, erythema multiforme (n = 3, and drug rash with eosinophilia and systemic syndrome (n = 1 were included. All patients underwent resolution of the previous allergic reactions before desensitization. The median duration of desensitization was 18 days. The success rate was 78.9%. The allergic reactions following failed desensitization were not severe; most were maculopapular rashes. Conclusions: The desensitization protocol for anti-tuberculosis drugs was associated with a high success rate, and the individuals who failed desensitization experienced mild allergic reactions. Keywords: Desensitization, Antituberculosis, Steven-Johnson syndrome, Allergic drug reaction, Tolerance induction, Drug allergy

  3. Pharmacogenetics and Predictive Testing of Drug Hypersensitivity Reactions.

    Science.gov (United States)

    Böhm, Ruwen; Cascorbi, Ingolf

    2016-01-01

    Adverse drug reactions adverse drug reaction (ADR) occur in approximately 17% of patients. Avoiding ADR is thus mandatory from both an ethical and an economic point of view. Whereas, pharmacogenetics changes of the pharmacokinetics may contribute to the explanation of some type A reactions, strong relationships of genetic markers has also been shown for drug hypersensitivity belonging to type B reactions. We present the classifications of ADR, discuss genetic influences and focus on delayed-onset hypersensitivity reactions, i.e., drug-induced liver injury, drug-induced agranulocytosis, and severe cutaneous ADR. A guidance how to read and interpret the contingency table is provided as well as an algorithm whether and how a test for a pharmacogenetic biomarker should be conducted.

  4. Global patterns of adverse drug reactions over a decade

    DEFF Research Database (Denmark)

    Aagaard, Lise; Strandell, Johanna; Melskens, Lars

    2012-01-01

    Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. Objective: The aim of the study was to characterize ADRs reported......, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high. Results: We analysed 1¿359¿067 ADR reports including 3¿013¿074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3...

  5. Multinational experience with hypersensitivity drug reactions in Latin America.

    Science.gov (United States)

    Jares, Edgardo José; Sánchez-Borges, Mario; Cardona-Villa, Ricardo; Ensina, Luis Felipe; Arias-Cruz, Alfredo; Gómez, Maximiliano; Barayazarra, Susana; Bernstein, Jonathan A; Serrano, Carlos D; Cuello, Mabel Noemi; Morfin-Maciel, Blanca María; De Falco, Alicia; Cherrez-Ojeda, Iván

    2014-09-01

    Epidemiologic drug allergy data from Latin America are scarce, and there are no studies on specific procedures focusing on this topic in Latin America. To assess the clinical characteristics and management of hypersensitivity drug reactions in different Latin American countries. An European Network of Drug Allergy questionnaire survey was implemented in 22 allergy units in 11 Latin American countries to report on consecutive patients who presented with a suspected hypersensitivity drug reaction. Each unit used its own protocols to investigate patients. Included were 868 hypersensitivity drug reactions in 862 patients (71% of adults and elderly patients were women and 51% of children were girls, P = .0001). Children presented with less severe reactions than adults and elderly patients (P Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  6. Vertigo/dizziness as a Drugs' adverse reaction.

    Science.gov (United States)

    Chimirri, Serafina; Aiello, Rossana; Mazzitello, Carmela; Mumoli, Laura; Palleria, Caterina; Altomonte, Mariolina; Citraro, Rita; De Sarro, Giovambattista

    2013-12-01

    Vertigo, dizziness, and nausea encompass a spectrum of balance-related symptoms caused by a variety of etiologies. Balance is affected by many systems: Proprioceptive pathways and visual, cerebellar, vestibulocochlear, and vascular / vasovagal systems. Vertigo is a subtype of dizziness, in which a subject, as a result to a dysfunction of the vestibular system, improperly experiments the perception of motion. The most useful clinical subdivision is to categorize vertigo into true vertigo and pseudovertigo, whereas from a pathophysiological point of view, vertigo can be classified into central, peripheral, and psychogenic. It is not easy to identify the cause of vertigo since the patients often are not able to precisely describe their symptoms. An impressive list of drugs may cause vertigo or dizziness. The aim of the present study was to analyze the data extracted from the reporting cards of the ADRs (adverse drug reactions), received at our Pharmacovigilance Regional Center (Calabria, Italy) in 2012. In particular, the data concerning the occurrence of vertigo and dizziness, after taking certain classes of drugs, have been considered. Our results show that, among the side-effects of different classes of drugs such as anti-convulsants, anti-hypertensives, antibiotics, anti-depressants, anti-psychotics, and anti-inflammatory, also vertigo or dizziness are included. Spontaneous reports of vertigo or dizziness, as side-effect of certain drugs, received at our Pharmacovigilance Center, represented the 5% of all reports in 2012. Considering the high incidence of such an ADR for several drugs' classes, it can be speculated that under-reporting also affect vertigo and dizziness. Despite the fact that these ADRs might not represent a direct threaten for life, indirectly they can cause secondary damage to patients such as falls, fractures etc. Balance should be accurately monitored during drug use and particularly in fragile patients.

  7. Antiretroviral adverse drug reactions and their management

    African Journals Online (AJOL)

    2011-06-02

    Jun 2, 2011 ... Nevirapine and efavirenz (and etravirine) can cause a drug hypersensitivity ... HLA-B*5701 are at high risk of ABC hypersensitivity, while those with other variants .... creatinine and the patient's body weight using the modified ...

  8. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs.

    Science.gov (United States)

    van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

    2000-12-01

    Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable signalling of these possible interactions, which are often not explicitly reported, utilising reports of adverse drug reactions in data sets of SRS. As an example, the influence of concomitant use of diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) on symptoms indicating a decreased efficacy of diuretics was examined using reports received by the Netherlands Pharmacovigilance Foundation Lareb. Reports received between 1 January 1990 and 1 January 1999 of patients older than 50 years were included in the study. Cases were defined as reports with symptoms indicating a decreased efficacy of diuretics, non-cases as all other reports. Exposure categories were the use of NSAIDs or diuretics versus the use of neither of these drugs. The influence of the combined use of both drugs was examined using logistic regression analysis. The odds ratio of the statistical interaction term of the combined use of both drugs was increased [adjusted odds ratio 2.0, 95% confidence interval (CI) 1.1-3.7], which may indicate an enhanced effect of concomitant drug use. The findings illustrate that spontaneous reporting systems have a potential for signal detection and the analysis of possible drug-drug interactions. The method described may enable a more active approach in the detection of drug-drug interactions after marketing.

  9. Knowledge, Attitude and Practice of Adverse Drug Reaction ...

    African Journals Online (AJOL)

    Erah

    . Keywords: Adverse drug reactions; Knowledge, attitude and practice; Health care workers; Yellow card reporting scheme. Received: 24 August 2010. Revised accepted: 22 April 2011. *Corresponding author: E-mail: jofadare@gmail.com ...

  10. Hypersensitivity Reactions to Nonsteroidal Anti-Inflammatory Drugs: An Update

    OpenAIRE

    Sánchez-Borges, Mario; Caballero-Fonseca, Fernan; Capriles-Hulett, Arnaldo; González-Aveledo, Luis

    2010-01-01

    After beta lactam antibiotics, hypersensitivity reactions to nonsteroidal antiinflammatory drugs are the second cause of hypersensitivity to drugs. Acute manifestations affect the respiratory tract (aspirin exacerbated respiratory disease), the skin (urticaria and angioedema), or are generalized (anaphylaxis). Correct diagnosis and treatment in order to prevent unnecessary morbidity and the potential risk of death from these severe reactions, and to provide proper medical advice on future dru...

  11. Glycaemic adverse drug reactions from anti-neoplastics used in ...

    African Journals Online (AJOL)

    235625 records ... Glycaemic adverse drug reactions from anti-neoplastics used in treating pancreatic cancer. ... Based on the emphasized nine antineoplastic drugs with high hyperglycemic ADR incidence, we found: fluorouracil, sorafenib and pemetrexed with high ADR record of metabolism and nutrition disorders; ...

  12. The concept of adverse drug reaction reporting: awareness among ...

    African Journals Online (AJOL)

    Arun Kumar Agnihotri

    concept of pharmacovigilance and adverse drug reaction reporting, a section on ... ADR go undocumented worldwide8,9. ... international drug monitoring collaborating centre, ... practitioners to report all suspected ADR, the few .... more with some of the guidelines such as nurses, .... patients: a meta-analysis of prospective.

  13. Analysis of Cutaneous Adverse Drug Reactions at a Tertiary Care ...

    African Journals Online (AJOL)

    Erah

    drug reactions (ADRs) reported at Civil Hospital, Ahmedabad, India. Methods: A prospective ... cost of ADRs was calculated on the basis of hospital expenditure per patient and the amount spent by patients ... drug control mechanisms, patient education regarding self-medication and maintenance of prescription records.

  14. Bias in spontaneous reporting of adverse drug reactions in Japan.

    Directory of Open Access Journals (Sweden)

    Shinichi Matsuda

    Full Text Available Attitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs in Japan are not well known, and Japan's unique system of surveillance, called early post-marketing phase vigilance (EPPV, may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.A manufacturer's database of spontaneous ADR reports was used to extract data from individual case safety reports for 5 drugs subject to EPPV. The trend of reporting and the time lag between ADR onset and reporting to the manufacturer were examined. The following indices for ADRs occurring with each drug were calculated and analyzed to assess reporting trends: Serious:Non-serious ratio, High prominence:Low prominence ratio, and High frequency:Low frequency ratio.For all 5 drugs, the time lag between ADR onset and reporting to the manufacturer was shorter in the EPPV period than in the post-EPPV period. All drugs showed higher Serious:Non-serious ratios in the post-EPPV period. No specific patterns were observed for the High prominence:Low prominence ratio. The High frequency:Low frequency ratio for peginterferon alpha-2a and sevelamer hydrochloride decreased steadily throughout the study period.Healthcare professionals may be more likely to report serious ADRs than to report non-serious ADRs, but the effect of event prominence on reporting trends is still unclear. Factors associated with ADR reporting attitude in Japan might be different from those in other countries because of EPPV and the involvement of medical representatives in the spontaneous reporting process. Pharmacovigilance specialists should therefore be cautious when comparing data between different time periods or different countries. Further studies are needed to elucidate the underlying mechanism of spontaneous ADR reporting in Japan.

  15. Prediction of adverse drug reactions using decision tree modeling.

    Science.gov (United States)

    Hammann, F; Gutmann, H; Vogt, N; Helma, C; Drewe, J

    2010-07-01

    Drug safety is of great importance to public health. The detrimental effects of drugs not only limit their application but also cause suffering in individual patients and evoke distrust of pharmacotherapy. For the purpose of identifying drugs that could be suspected of causing adverse reactions, we present a structure-activity relationship analysis of adverse drug reactions (ADRs) in the central nervous system (CNS), liver, and kidney, and also of allergic reactions, for a broad variety of drugs (n = 507) from the Swiss drug registry. Using decision tree induction, a machine learning method, we determined the chemical, physical, and structural properties of compounds that predispose them to causing ADRs. The models had high predictive accuracies (78.9-90.2%) for allergic, renal, CNS, and hepatic ADRs. We show the feasibility of predicting complex end-organ effects using simple models that involve no expensive computations and that can be used (i) in the selection of the compound during the drug discovery stage, (ii) to understand how drugs interact with the target organ systems, and (iii) for generating alerts in postmarketing drug surveillance and pharmacovigilance.

  16. A case of adverse drug reaction induced by dispensing error.

    Science.gov (United States)

    Gallelli, L; Staltari, O; Palleria, C; Di Mizio, G; De Sarro, G; Caroleo, B

    2012-11-01

    To report about a case of acute renal failure due to absence of communication between physician and patient. A 78 year old man with human immunodeficiency virus (HIV) accessed our hospital and was brought to our attention in August 2011 for severe renal failure. Clinical history revealed that he had been taking highly active antiretroviral therapy with lamivudine/abacavir and fosamprenavir since 2006. In April 2011 due to an augmentation in creatinine plasma levels, a reduction in lamivudine dosage to 100 mg/day and the prescription of abacavir 300 mg/day became necessary. Unfortunately, the patient took both lamivudine and abacavir therefore the association of the two medications (lamivudine/abacavir) lead to asthenia and acute renal failure within a few days. This case emphasizes the importance about how physicians must pay very careful attention during drug prescription, most particularly, as far as elderly patients are concerned. In fact, communication improvement between physicians and patients can prevent increase of adverse drug reactions related to drug dispensing, with consequential reduction of costs in the healthcare system. Copyright © 2012 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  17. A perspective of nanotechnology in hypersensitivity reactions including drug allergy.

    Science.gov (United States)

    Montañez, Maria Isabel; Ruiz-Sanchez, Antonio J; Perez-Inestrosa, Ezequiel

    2010-08-01

    We provide an overview of the application of the concepts of nanoscience and nanotechnology as a novel scientific approach to the area of nanomedicine related to the domain of the immune system. Particular emphasis will be paid to studies on drug allergy reactions. Several well defined chemical structures arranged in the dimension of the nanoscale are currently being studied for biomedical purposes. By interacting with the immune system, some of these show promising applications as vaccines, diagnostic tools and activators/effectors of the immune response. Even a brief listing of some key applications of nanostructured materials shows how broad and intense this area of nanomedicine is. As a result of the development of nanoscience and nanotechnology applied to medicine, new approaches can be envisioned for problems related to the modulation of the immune response, as well as in immunodiagnosis, and to design new tools to solve related medical challenges. Nanoparticles offer unique advantages with which to exploit new properties and for materials to play a major role in new diagnostic techniques and therapies. Fullerene-C60 and multivalent functionalized gold nanoparticles of various sizes have led to new tools and opened up new ways to study and interact with the immune system. Some of the most versatile nanostructures are dendrimers. In their interaction with the immune system they can naturally occurring macromolecules, taking advantage of the fact that dendrimers can be synthesized into nanosized structures. Their multivalence can be successfully exploited in vaccines and diagnostic tests for allergic reactions.

  18. Cutaneous drug reaction case reports: from the world literature.

    Science.gov (United States)

    2003-01-01

    Skin disorders are the most common adverse reactions attributed to drugs. Any skin disorder can be imitated, induced or aggravated by drugs. To help you keep up-to-date with the very latest skin reactions occurring with both new and established drugs, this section of the journal brings you information selected from the adverse drug reaction alerting service Reactions Weekly. Reactions Weekly is the complete drug safety alerting service and summarizes information selected from over 1600 biomedical journals. This newsletter is produced by Adis International and is available in a variety of formats. Please contact your nearest Adis office for subscription details. The use of tradenames, identified by ['~'] or the use of a registered ((R)) or trade mark ( trade mark ), is for product identification purposes only and does not imply endorsement. The following case reports are selected from the very latest to be published in the world dermatology literature. Any claim of a first report has been verified by a search of AdisBase (a proprietary database of Adis International) and Medline. In addition, the World Health Organization (WHO) Adverse Drug Reactions database is also searched. This database, maintained by the Uppsala Monitoring Centre in Sweden, is the largest and most comprehensive adverse drug reaction source in the world, with information obtained from National Centers of 65 affiliate countries. Each case report is assessed for seriousness using the FDA MedWatch definition of serious (patient outcome is: death; life-threatening; hospitalization; disability; congenital anomaly; or requires intervention to prevent permanent impairment or damage).

  19. iADRs: towards online adverse drug reaction analysis.

    Science.gov (United States)

    Lin, Wen-Yang; Li, He-Yi; Du, Jhih-Wei; Feng, Wen-Yu; Lo, Chiao-Feng; Soo, Von-Wun

    2012-12-01

    Adverse Drug Reaction (ADR) is one of the most important issues in the assessment of drug safety. In fact, many adverse drug reactions are not discovered during limited pre-marketing clinical trials; instead, they are only observed after long term post-marketing surveillance of drug usage. In light of this, the detection of adverse drug reactions, as early as possible, is an important topic of research for the pharmaceutical industry. Recently, large numbers of adverse events and the development of data mining technology have motivated the development of statistical and data mining methods for the detection of ADRs. These stand-alone methods, with no integration into knowledge discovery systems, are tedious and inconvenient for users and the processes for exploration are time-consuming. This paper proposes an interactive system platform for the detection of ADRs. By integrating an ADR data warehouse and innovative data mining techniques, the proposed system not only supports OLAP style multidimensional analysis of ADRs, but also allows the interactive discovery of associations between drugs and symptoms, called a drug-ADR association rule, which can be further developed using other factors of interest to the user, such as demographic information. The experiments indicate that interesting and valuable drug-ADR association rules can be efficiently mined.

  20. Kinematic relations in heavy-ion reactions

    International Nuclear Information System (INIS)

    Gippner, P.; Kalpakchieva, R.

    1988-01-01

    The present work gives a short overview of the non-relativistic kinematics of nuclear reactions derived on the basis of the conservation laws of energy and linear momentum. Section 2 contains kinematic relations valid for two-body reactions, sections 3 makes use of these relations to describe sequential fission as a special case of reactions with three particles in the exit channel. It is the aim of this work to comprise the kinematic formulae essential for planning of experiments, data analysis and critical examination of the obtained results. (author)

  1. Drug Reaction with Eosinophilia and Systemic Symptom in a Patient with Pneumonia and Hyperthyroidism.

    Science.gov (United States)

    Jin, Hualiang; Wang, Limin; Ye, Jian

    2017-01-01

    Drug rash with eosinophilia and systemic symptoms syndrome is an idiosyncratic drug reaction characterized by fever, skin eruption, lymph node enlargement, and internal organ involvement. We report a case of a patient with pneumonia who developed clinical manifestations of fever, rash, lymphadenopathy, hypereosinophilia, and visceral involvement (renal failure and eosinophilic pneumonitis) caused by methimazole. The patient improved remarkably with drug withdrawal. A high index of clinical suspicion is emphasized to facilitate prompt diagnosis of medication-related adverse effect and its discontinuation.

  2. Role of peripheral eosinophilia in adverse cutaneous drug reactions.

    Science.gov (United States)

    Drago, F; Cogorno, L; Agnoletti, A F; Parodi, A

    2015-01-01

    The objective of this retrospective study was to verify whether peripheral eosinophilia (PE) may be a marker of severity for adverse cutaneous drug reactions (ACDR). We investigated for PE in sixty-three patients diagnosed as adverse cutaneous drug reactions. All the patients underwent blood tests at baseline visit. Only patients that showed a very likely connection between ACDR and the suspected causative drug were induced in the study. We found that 11 out of 63 patients (17%) presented PE for values ≥ 0.6 x 10(9) cells/l or for a percentage of total leukocytes ≥ 6%. These 11 patients compared to patients without eosinophilia had a longer recovery time, they showed diffuse severe cutaneous reactions and they all needed a systemic therapy compared to the 41% of patients without eosinophilia. These outcomes prompt us to believe that peripheral eosinophilia may be an index of severity for adverse cutaneous drug reactions. Therefore, we suggest physicians to always detect the presence of peripheral eosinophilia in order to not underestimate the reaction and to promptly start an appropriate therapy.

  3. Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review.

    Science.gov (United States)

    De Angelis, Alessia; Colaceci, Sofia; Giusti, Angela; Vellone, Ercole; Alvaro, Rosaria

    2016-03-01

    To describe and synthesise previous research on factors conditioning the spontaneous reporting of adverse drug reactions among nurses. Spontaneous reports of adverse drug reactions by health-care providers, are a main instrument for the continuous evaluation of the risk-benefit ratio of every drug. Under-reporting of adverse drug reactions by all health-care providers, in particular by nurses, is a major limitation to this system. An integrated review of the literature was conducted using MEDLINE, CINAHL, Embase, Scopus databases and Google Scholar. After evaluation for appropriateness related to inclusion/exclusion criteria, 16 studies were included in the final analysis and synthesis. Two factors emerged from the study: (1) intrinsic factors related to nurses' knowledge and attitudes; (2) extrinsic factors related to nurses' interaction with health-care organisations and to the relationship between nurses and physicians. Nurses' attitudes that hinder reporting include ignorance, insecurity, fear and lethargy. Nurses are not fully aware of their role in adverse drug reaction reporting. Nurses must acquire greater knowledge to implement specific skills into their daily clinical practice. To improve nurses' reporting of adverse drug reactions, it is necessary to develop management approaches that modify both intrinsic and extrinsic factors. © 2015 John Wiley & Sons Ltd.

  4. Hospitalization due to Adverse Drug Reactions and Drug Interactions before and after HAART

    Directory of Open Access Journals (Sweden)

    Michelle M Foisy

    2000-01-01

    Full Text Available OBJECTIVE: To characterize and compare the rates of adverse drug reactions (ADRs and interactions on admission in two, one-year periods: pre-highly active antiretroviral therapy (HAART (phase 1 and post-HAART (phase 2.

  5. Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

    OpenAIRE

    Castleden, C M; Pickles, H

    1988-01-01

    1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age grou...

  6. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  7. Drug reaction with eosinophilia and systemic symptoms syndrome.

    Science.gov (United States)

    Spriet, Sarah; Banks, Taylor A

    2015-01-01

    Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a potentially life-threatening adverse drug reaction. To increase awareness of the potential for recurrence in patients with a history of DRESS syndrome and provide a brief review of the clinical characteristics, diagnosis, and management of this disease process. The authors selected and reviewed salient articles on the topic and incorporated pertinent information from the patient's clinical course. A case of recurrent DRESS triggered by a structurally unrelated drug is presented, followed by discussion of the clinical characteristics, diagnosis, and management. Clinical pearls and pitfalls are emphasized for the practicing allergist, clinical immunologist, and fellow-in-training. The most important steps in the treatment of this condition are the identification and removal of the offending agent. Providers should be aware of the potential for recurrent DRESS and recognize the importance of prompt management.

  8. Toward multimodal signal detection of adverse drug reactions.

    Science.gov (United States)

    Harpaz, Rave; DuMouchel, William; Schuemie, Martijn; Bodenreider, Olivier; Friedman, Carol; Horvitz, Eric; Ripple, Anna; Sorbello, Alfred; White, Ryen W; Winnenburg, Rainer; Shah, Nigam H

    2017-12-01

    Improving mechanisms to detect adverse drug reactions (ADRs) is key to strengthening post-marketing drug safety surveillance. Signal detection is presently unimodal, relying on a single information source. Multimodal signal detection is based on jointly analyzing multiple information sources. Building on, and expanding the work done in prior studies, the aim of the article is to further research on multimodal signal detection, explore its potential benefits, and propose methods for its construction and evaluation. Four data sources are investigated; FDA's adverse event reporting system, insurance claims, the MEDLINE citation database, and the logs of major Web search engines. Published methods are used to generate and combine signals from each data source. Two distinct reference benchmarks corresponding to well-established and recently labeled ADRs respectively are used to evaluate the performance of multimodal signal detection in terms of area under the ROC curve (AUC) and lead-time-to-detection, with the latter relative to labeling revision dates. Limited to our reference benchmarks, multimodal signal detection provides AUC improvements ranging from 0.04 to 0.09 based on a widely used evaluation benchmark, and a comparative added lead-time of 7-22 months relative to labeling revision dates from a time-indexed benchmark. The results support the notion that utilizing and jointly analyzing multiple data sources may lead to improved signal detection. Given certain data and benchmark limitations, the early stage of development, and the complexity of ADRs, it is currently not possible to make definitive statements about the ultimate utility of the concept. Continued development of multimodal signal detection requires a deeper understanding the data sources used, additional benchmarks, and further research on methods to generate and synthesize signals. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Metathesis of alkanes and related reactions

    KAUST Repository

    Basset, Jean-Marie; Copé ret, Christophe; Soulivong, Daravong; Taoufik, Mostafa; Thivolle-Cazat, Jean

    2010-01-01

    , the process proceeds at relatively low temperature (ambient conditions or higher). It was discovered through the use of a silica-supported tantalum hydride, (=SiO)2TaH, a multifunctional catalyst with a single site of action. This reaction completes the story

  10. Parkinsonism caused by adverse drug reactions: a case series

    Directory of Open Access Journals (Sweden)

    Agaba Emmanuel I

    2011-03-01

    Full Text Available Abstract Introduction Parkinsonism puts a high direct cost burden on both patient and caregiver. Several reports of drug-induced parkinsonism have been published, but to the best of our knowledge, there has not been any report of quinine or halothane inducing parkinsonism. Case presentation We describe two cases of parkinsonism possibly caused by adverse drug reaction to quinine in a 29-year-old black Nigerian woman and to halothane in a 36-year-old black Hausa (Nigerian man who received it as general anaesthesia for appendicectomy in our teaching hospital. Conclusion These are two unusual cases of parkinsonism caused by adverse drug reactions to high-dose quinine and to halothane as general anaesthesia. We consider that these two cases are important in bringing this potential side-effect to the attention of both pharmacologists and primary care physicians as these are two of the most commonly used medications in our clinics. We conclude that parkinsonism should be included among the adverse drug reactions to high-dose quinine and halothane general anaesthetic.

  11. Drug reaction with eosinophilia and systemic symptoms without skin rash.

    Science.gov (United States)

    Sasidharanpillai, Sarita; Binitha, Manikoth P; Manikath, Neeraj; Janardhanan, Anisha K

    2015-01-01

    Drug reaction with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome is considered as a severe cutaneous adverse drug reaction which is most commonly precipitated by aromatic anticonvulsants, lamotrigine, dapsone, allopurinol, minocycline, and salazopyrin. Its clinical manifestations are often variable. On rare occasions, it can present with only systemic involvement without any cutaneous features. A complete drug history is of paramount importance in making an early diagnosis. We report the case of a male patient who presented with fever, lymphadenopathy, hepatosplenomegaly, and hepatitis, 2 weeks after starting salazopyrin. The presence of atypical lymphocytes in the peripheral smear was indicative of a viral infection or a hematological dyscrasia. Bone marrow examination revealed a normocellular marrow with an increase in eosinophil precursors. Investigations for the common causes for fever and hepatitis were negative. The presence of eosinophilia, the temporal relationship of the symptoms with the initiation of treatment with salazopyrin, and the marked improvement on withdrawal of the drug along with the administration of systemic corticosteroids, were features consistent with the diagnosis of DRESS. With the incidence of this condition showing a rising trend, it is important for the clinician to be aware of its variable manifestations, as a delay in diagnosis and treatment can be fatal.

  12. A Reliable Method for the Evaluation of the Anaphylactoid Reaction Caused by Injectable Drugs

    Directory of Open Access Journals (Sweden)

    Fang Wang

    2016-10-01

    Full Text Available Adverse reactions of injectable drugs usually occur at first administration and are closely associated with the dosage and speed of injection. This phenomenon is correlated with the anaphylactoid reaction. However, up to now, study methods based on antigen detection have still not gained wide acceptance and single physiological indicators cannot be utilized to differentiate anaphylactoid reactions from allergic reactions and inflammatory reactions. In this study, a reliable method for the evaluation of anaphylactoid reactions caused by injectable drugs was established by using multiple physiological indicators. We used compound 48/80, ovalbumin and endotoxin as the sensitization agents to induce anaphylactoid, allergic and inflammatory reactions. Different experimental animals (guinea pig and nude rat and different modes of administration (intramuscular, intravenous and intraperitoneal injection and different times (15 min, 30 min and 60 min were evaluated to optimize the study protocol. The results showed that the optimal way to achieve sensitization involved treating guinea pigs with the different agents by intravenous injection for 30 min. Further, seven related humoral factors including 5-HT, SC5b-9, Bb, C4d, IL-6, C3a and histamine were detected by HPLC analysis and ELISA assay to determine their expression level. The results showed that five of them, including 5-HT, SC5b-9, Bb, C4d and IL-6, displayed significant differences between anaphylactoid, allergic and inflammatory reactions, which indicated that their combination could be used to distinguish these three reactions. Then different injectable drugs were used to verify this method and the results showed that the chosen indicators exhibited good correlation with the anaphylactoid reaction which indicated that the established method was both practical and reliable. Our research provides a feasible method for the diagnosis of the serious adverse reactions caused by injectable drugs which

  13. Predicting adverse drug reaction profiles by integrating protein interaction networks with drug structures.

    Science.gov (United States)

    Huang, Liang-Chin; Wu, Xiaogang; Chen, Jake Y

    2013-01-01

    The prediction of adverse drug reactions (ADRs) has become increasingly important, due to the rising concern on serious ADRs that can cause drugs to fail to reach or stay in the market. We proposed a framework for predicting ADR profiles by integrating protein-protein interaction (PPI) networks with drug structures. We compared ADR prediction performances over 18 ADR categories through four feature groups-only drug targets, drug targets with PPI networks, drug structures, and drug targets with PPI networks plus drug structures. The results showed that the integration of PPI networks and drug structures can significantly improve the ADR prediction performance. The median AUC values for the four groups were 0.59, 0.61, 0.65, and 0.70. We used the protein features in the best two models, "Cardiac disorders" (median-AUC: 0.82) and "Psychiatric disorders" (median-AUC: 0.76), to build ADR-specific PPI networks with literature supports. For validation, we examined 30 drugs withdrawn from the U.S. market to see if our approach can predict their ADR profiles and explain why they were withdrawn. Except for three drugs having ADRs in the categories we did not predict, 25 out of 27 withdrawn drugs (92.6%) having severe ADRs were successfully predicted by our approach. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. Common allergies do not influence the prevalence of cutaneous hypersensitivity reactions to antiepileptic drugs.

    Science.gov (United States)

    Bosak, Magdalena; Porębski, Grzegorz; Słowik, Agnieszka; Turaj, Wojciech

    2017-09-01

    The aim of the study was to establish whether the presence of common allergies increases the risk of drug-related hypersensitivity reactions among patients with epilepsy treated with antiepileptic drugs (AEDs). We studied 753 patients with epilepsy seen in tertiary outpatient epilepsy clinic. We obtained data related to epilepsy type, past and ongoing treatment with AEDs, occurrence of maculopapular exanthema or more serious cutaneous adverse reactions (Stevens-Johnson syndrome - SJS) and their characteristics. We noted an occurrence of allergic reactions unrelated to treatment with AED, including rash unrelated to AED, bronchial asthma, persistent or seasonal allergic rhinitis, atopic dermatitis, rash after specific food and other allergic reactions. There were 61 cases of AED-related cutaneous hypersensitivity reaction (including 3 cases of SJS) noted in association with 2319 exposures to AEDs (2.63%) among 55 out of 753 patients (7.3%). Cutaneous hypersensitivity reaction to AED was most commonly noted after lamotrigine (12.1%), carbamazepine (5.4%) and oxcarbazepine (4.1%). Prevalence of allergic reactions unrelated to AED was similar between patients with and without AED-related cutaneous hypersensitivity reaction (rash unrelated to AED: 16.4% vs. 10.2%; bronchial asthma: 1.8% vs. 0.1%; persistent allergic rhinitis: 7.3% vs. 10.2%; seasonal allergic rhinitis: 7.3% vs. 11.7%; atopic dermatitis: 0 vs. 0.7%; rash after specific food: 5.4% vs. 6.4%; other allergic reactions: 5.4% vs. 5.2%, respectively; P>0.1 for each difference). Presence of common allergies is not a significant risk factor for AED-related cutaneous hypersensitivity reaction among patients with epilepsy. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Physician access to drug profiles to reduce adverse reactions

    Science.gov (United States)

    Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.

    1995-10-01

    Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.

  16. EXPLORING THE PATTERN OF POLYPHARMACY AND PROPORTION OF DRUG TO DRUG INTERACTIONS AND ADVERSE DRUG REACTIONS IN THE ELDERLY

    Directory of Open Access Journals (Sweden)

    Vijayashree Thyagaraj

    2017-07-01

    Full Text Available BACKGROUND The geriatric population is increasing as a result of advanced medical facilities. This population also faces a number of medical health challenges. They tend to receive multiple medications often leading to Drug-Drug Interactions (DDIs Adverse Drug Reactions (ADRs and other clinical consequences, which compromises their quality of life if not endangering it as well. There are few Indian studies focusing on this problem. Hence, this study was undertaken with the aim to assess the polypharmacy pattern, proportion of DDIs and adverse drug reactions in the geriatric population in a tertiary care hospital. MATERIALS AND METHODS This was a cross-sectional study wherein data from 201 geriatric inpatient’s prescriptions were collected. The prescriptions were assessed for demographic details such as age, gender, comorbidities and drugs prescribed. All prescriptions were evaluated for polypharmacy, DDIs and ADRs. DDIs were assessed using Micromedex software. Patients were stratified into groups and DDIs were compared between the groups, gender and also with number of drugs used. RESULTS There were 201 patients with a mean age of approximately 70 years. Polypharmacy occurred in 73.63% of them with mean number of drugs being 6.23. The number of drugs used increased significantly with age (p=0.0001. Hypertension was the most common comorbidity. Polypharmacy was strongly associated with hypertension and dyslipidaemia. A total of 129 (64.17% patients accounted for 425 potential DDIs. The most common drug involved in DDIs was aspirin. A subset analysis of ADRs showed an occurrence of 50.68% with 10.81% being definitely avoidable. CONCLUSION Elderly individuals are at increased risk of being on polypharmacy. This comes with the risk of several potential DDIs, which in turn may lead to adverse drug reactions, which results in morbidity. Doctors involved in the care of the elderly should be aware of these facts and exercise caution while adding any

  17. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region......%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR...

  18. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

    Directory of Open Access Journals (Sweden)

    Aliasghar Farazi

    2014-01-01

    Full Text Available Background. Antituberculosis multidrug regimens have been associated with increased incidence of adverse drug reactions (ADRs. This study aimed to determine the incidence and associated factors of ADRs due to antituberculosis therapy. Methods. This is a retrospective cross-sectional study on tuberculosis patients who were treated in tuberculosis clinics in Markazi province in Iran. The information contained in the medical files was extracted and entered into the questionnaire. Data was descriptively analyzed by using statistical package for social sciences (SPSS 18. Results. A total of 940 TB patients of 1240 patients’ medical records available in 10 medical offices were included in this study. Of the 563 ADRs found in this study, 82.4% were considered minor reactions and 17.6% were major reactions. No death from antituberculosis ADR was observed. We found that the risk of major ADRs was higher in females (P  value=0.0241, age >50 y (P  value=0.0223, coinfection with HIV (P  value=0.0323, smoking (P  value=0.002, retreatment TB (P  value=0.0203, and comorbidities (P  value=0.0005. Conclusions. This study showed that severe side effects of anti-TB drugs are common in patients who have risk factors of ADRs and they should be followed up by close monitoring.

  19. Spontaneous adverse drug reaction reporting in rural districts of Mozambique.

    Science.gov (United States)

    Sevene, Esperança; Mariano, Alda; Mehta, Ushma; Machai, Maria; Dodoo, Alexander; Vilardell, David; Patel, Sam; Barnes, Karen; Carné, Xavier

    2008-01-01

    The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and their performance under any circumstance is difficult to predict given the known shortage of human, financial and technical resources. Nevertheless, the importance of such systems in all countries is not in doubt, and research to identify problems, with the aim of offering pragmatic solutions, is urgently needed. To examine the impact of training and monitoring of healthcare workers, making supervisory visits and the availability of telecommunication and transport facilities on the implementation of a pharmacovigilance system in Mozambique. This was a descriptive study enumerating the lessons learnt and challenges faced in implementing a spontaneous reporting system in two rural districts of Mozambique - Namaacha and Matutuíne - where remote location, poor telecommunication services and a low level of education of health professionals are ongoing challenges. A 'yellow card' system for spontaneous reporting of adverse drug reactions (ADRs) was instituted following training of health workers in the selected districts. Thirty-five health professionals (3 medical doctors, 2 technicians, 24 nurses, 4 basic healthcare agents and 2 pharmacy agents) in these districts were trained to diagnose, treat and report ADRs to all medicines using a standardized yellow card system. There were routine site visits to identify and clarify any problems in filling in and sending the forms. One focal person was identified in each district to facilitate communication between the health professionals and the National Pharmacovigilance Unit (NPU). The report form was assessed for quality and causality. The availability of telecommunications and transport was assessed. Fourteen months after

  20. Desensitization in delayed drug hypersensitivity reactions -- an EAACI position paper of the Drug Allergy Interest Group.

    Science.gov (United States)

    Scherer, K; Brockow, K; Aberer, W; Gooi, J H C; Demoly, P; Romano, A; Schnyder, B; Whitaker, P; Cernadas, J S R; Bircher, A J

    2013-07-01

    Drug hypersensitivity may deprive patients of drug therapy, and occasionally no effective alternative treatment is available. Successful desensitization has been well documented in delayed drug hypersensitivity reactions. In certain situations, such as sulfonamide hypersensitivity in HIV-positive patients or hypersensitivity to antibiotics in patients with cystic fibrosis, published success rates reach 80%, and this procedure appears helpful for the patient management. A state of clinical tolerance may be achieved by the administration of increasing doses of the previously offending drug. However, in most cases, a pre-existent sensitization has not been proven by positive skin tests. Successful re-administration may have occurred in nonsensitized patients. A better understanding of the underlying mechanisms of desensitization is needed. Currently, desensitization in delayed hypersensitivity reactions is restricted to mild, uncomplicated exanthems and fixed drug eruptions. The published success rates vary depending on clinical manifestations, drugs, and applied protocols. Slower protocols tend to be more effective than rush protocols; however, underreporting of unsuccessful procedures is very probable. The decision to desensitize a patient must always be made on an individual basis, balancing risks and benefits. This paper reviews the literature and presents the expert experience of the Drug Hypersensitivity Interest Group of the European Academy of Allergy and Clinical Immunology. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  1. Pharmacogenetics of drug-induced arrhythmias : a feasibility study using spontaneous adverse drug reactions reporting data

    NARCIS (Netherlands)

    De Bruin, Marie L; van Puijenbroek, Eugene P; Bracke, Madelon; Hoes, Arno W; Leufkens, Hubert G M

    PURPOSE: The bottleneck in pharmacogenetic research on rare adverse drug reactions (ADR) is retrieval of patients. Spontaneous reports of ADRs may form a useful source of patients. We investigated the feasibility of a pharmacogenetic study, in which cases were selected from the database of a

  2. Metathesis of alkanes and related reactions

    KAUST Repository

    Basset, Jean-Marie

    2010-02-16

    (Figure Presented) The transformation of alkanes remains a difficult challenge because of the relative inertness of the C-H and C-C bonds. The rewards for asserting synthetic control over unfunctionalized, saturated hydrocarbons are considerable, however, because converting short alkanes into longer chain analogues is usually a value-adding process. Alkane metathesis is a novel catalytic and direct transformation of two molecules of a given alkane into its lower and higher homologues; moreover, the process proceeds at relatively low temperature (ambient conditions or higher). It was discovered through the use of a silica-supported tantalum hydride, (=SiO)2TaH, a multifunctional catalyst with a single site of action. This reaction completes the story of the metathesis reactions discovered over the past 40 years: olefin metathesis, alkyne metathesis, and ene-yne cyclizations. In this Account, we examine the fundamental mechanistic aspects of alkane metathesis as well as the novel reactions that have been derived from its study. The silica-supported tantalum hydride catalyst was developed as the result of systematic and meticulous studies of the interaction between oxide supports and organometallic complexes, a field of study denoted surface organometallic chemistry (SOMC). A careful examination of this surface-supported tantalum hydride led to the later discovery of aluminasupported tungsten hydride, W(H)3/Al 2O3, which proved to be an even better catalyst for alkane metathesis. Supported tantalum and tungsten hydrides are highly unsaturated, electron-deficient species that are very reactive toward the C-H and C-C bonds of alkanes. They show a great versatility in various other reactions, such as cross-metathesis between methane and alkanes, cross-metathesis between toluene and ethane, or even methane nonoxidative coupling. Moreover, tungsten hydride exhibits a specific ability in the transformation of isobutane into 2,3-dimethylbutane as well as in the metathesis of

  3. Metathesis of alkanes and related reactions.

    Science.gov (United States)

    Basset, Jean-Marie; Copéret, Christophe; Soulivong, Daravong; Taoufik, Mostafa; Cazat, Jean Thivolle

    2010-02-16

    The transformation of alkanes remains a difficult challenge because of the relative inertness of the C-H and C-C bonds. The rewards for asserting synthetic control over unfunctionalized, saturated hydrocarbons are considerable, however, because converting short alkanes into longer chain analogues is usually a value-adding process. Alkane metathesis is a novel catalytic and direct transformation of two molecules of a given alkane into its lower and higher homologues; moreover, the process proceeds at relatively low temperature (ambient conditions or higher). It was discovered through the use of a silica-supported tantalum hydride, ([triple bond]SiO)(2)TaH, a multifunctional catalyst with a single site of action. This reaction completes the story of the metathesis reactions discovered over the past 40 years: olefin metathesis, alkyne metathesis, and ene-yne cyclizations. In this Account, we examine the fundamental mechanistic aspects of alkane metathesis as well as the novel reactions that have been derived from its study. The silica-supported tantalum hydride catalyst was developed as the result of systematic and meticulous studies of the interaction between oxide supports and organometallic complexes, a field of study denoted surface organometallic chemistry (SOMC). A careful examination of this surface-supported tantalum hydride led to the later discovery of alumina-supported tungsten hydride, W(H)(3)/Al(2)O(3), which proved to be an even better catalyst for alkane metathesis. Supported tantalum and tungsten hydrides are highly unsaturated, electron-deficient species that are very reactive toward the C-H and C-C bonds of alkanes. They show a great versatility in various other reactions, such as cross-metathesis between methane and alkanes, cross-metathesis between toluene and ethane, or even methane nonoxidative coupling. Moreover, tungsten hydride exhibits a specific ability in the transformation of isobutane into 2,3-dimethylbutane as well as in the metathesis

  4. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

    2010-01-01

    AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...

  5. Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review.

    Science.gov (United States)

    Rodrigues, Maria Cristina Soares; Oliveira, Cesar de

    2016-09-01

    to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. identificar e sintetizar estudos que examinam as interações medicamentosas (IM) e reações adversas a medicamentos (RAM) em idosos polimedicados. revisão integrativa de estudos publicados de janeiro de 2008 a dezembro de 2013, de acordo com critérios de inclusão e exclusão, nas bases de dados eletrônicas MEDLINE e EMBASE. foram analisados 47 estudos de texto completo, incluindo 14,624,492 idosos (≥ 60 anos): 24 (51,1%) sobre RAM, 14 (29,8%) sobre IM e 9 estudos (19,1%) que investigaram tanto IM como RAM. Encontramos uma variedade de desenhos metodológicos. Os estudos revisados reforçaram que a polifarmácia é um processo multifatorial, e os preditores e a prescrição inadequada estão associados a

  6. A PROSPECTIVE, OBSERVATIONAL STUDY OF ADVERSE REACTIONS TO DRUG REGIME FOR MULTI-DRUG RESISTANT PULMONARY TUBERCULOSIS IN CENTRAL INDIA.

    Directory of Open Access Journals (Sweden)

    Dr. Rohan C. Hire

    2014-09-01

    Full Text Available Abstract Objective: 1 To assess the adverse drug reactions of second line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR TB in central India on the basis of causality, severity and avoidability scales. 2 To study the relationship of type of MDR TB (primary or secondary and presence of diabetes mellitus (DM with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug resistant tuberculosis patients enrolled for DOTS‑Plus regimen at TB and Chest Disease Department from January to December 2012. They were followed for 9 months thereafter and encountered adverse drug reactions (ADRs were noted along with the time of sputum conversion. The data were analysed by Chi-square or Fisher’s exact test and unpaired student’s‘t’ test. Results: Total 64 ADRs were reported in 55 patients out of total 110 patients (n = 110. As per the Naranjo causality assessment of ADRs, 7 patients had “definite” causal relation, 45 had “probable” causal relation and 3 had “possible” causal relation with drugs of DOTS Plus regime. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being “Definitely avoidable”, 26 “Possibly avoidable”, 23 “Not avoidable” and 3 “unevaluable”. . Mean sputum smear conversion time is significantly higher in patients with secondary type than that of primary type of MDR TB (p = 0.0001 and in patients with DM than those without DM (p <0.0001. Conclusion: ADRs were common in patients of MDR TB on DOTs-Plus drug regime. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regime compared to DOTS regime in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and

  7. Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

    Directory of Open Access Journals (Sweden)

    Marília Berlofa Visacri

    2014-04-01

    Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

  8. Neuroimaging for drug addiction and related behaviors

    International Nuclear Information System (INIS)

    Parvaz, M.A.; Alia-Klein, N.; Woicik, P.A.; Volkow, N.D.; Goldstein, R.Z.

    2011-01-01

    In this review, we highlight the role of neuroimaging techniques in studying the emotional and cognitive-behavioral components of the addiction syndrome by focusing on the neural substrates subserving them. The phenomenology of drug addiction can be characterized by a recurrent pattern of subjective experiences that includes drug intoxication, craving, bingeing, and withdrawal with the cycle culminating in a persistent preoccupation with obtaining, consuming, and recovering from the drug. In the past two decades, imaging studies of drug addiction have demonstrated deficits in brain circuits related to reward and impulsivity. The current review focuses on studies employing positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and electroencephalography (EEG) to investigate these behaviors in drug-addicted human populations. We begin with a brief account of drug addiction followed by a technical account of each of these imaging modalities. We then discuss how these techniques have uniquely contributed to a deeper understanding of addictive behaviors.

  9. Neuroimaging for drug addiction and related behaviors

    Energy Technology Data Exchange (ETDEWEB)

    Parvaz M. A.; Parvaz, M.A.; Alia-Klein, N.; Woicik,P.A.; Volkow, N.D.; Goldstein, R.Z.

    2011-10-01

    In this review, we highlight the role of neuroimaging techniques in studying the emotional and cognitive-behavioral components of the addiction syndrome by focusing on the neural substrates subserving them. The phenomenology of drug addiction can be characterized by a recurrent pattern of subjective experiences that includes drug intoxication, craving, bingeing, and withdrawal with the cycle culminating in a persistent preoccupation with obtaining, consuming, and recovering from the drug. In the past two decades, imaging studies of drug addiction have demonstrated deficits in brain circuits related to reward and impulsivity. The current review focuses on studies employing positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and electroencephalography (EEG) to investigate these behaviors in drug-addicted human populations. We begin with a brief account of drug addiction followed by a technical account of each of these imaging modalities. We then discuss how these techniques have uniquely contributed to a deeper understanding of addictive behaviors.

  10. Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

    Science.gov (United States)

    Castleden, C M; Pickles, H

    1988-10-01

    1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age.

  11. The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety

    International Nuclear Information System (INIS)

    Boyd, Ian W.

    2002-01-01

    The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin

  12. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    Medical product information contains information about efficacy and safety for marketed pharmaceuticals. Three studies have compared safety labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions (ADRs......). The rapid increase in use of medications for treatment of ADHD symptoms has created concern due to lack of information about effects from long-term use. The aim of this study was to compare ADR information in product information (PI)/summary of product characteristics (SPC) for oral formulations...... of atomoxetine, methylphenidate and modafinil marketed by the same pharmaceutical companies in Australia, Denmark and the United States. Discrepancies in listed ADRs were defined as types of ADRs (system organ class) not listed in all countries. For ADRs where discrepancies were detected, we extracted...

  13. Adverse drug reactions from psychotropic medicines in the paediatric population

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba H

    2010-01-01

    of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise...... ADRs reported for psychotropic medicines in the Danish paediatric population over a decade. FINDINGS: All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age...... and gender of the child, suspected medicine and type of reported ADR. A total of 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious. Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported...

  14. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise

    2015-01-01

    and labeling status. Findings: A total of 207 patients were included in the study leading to the identification of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible. 15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with sitagliptin......Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood....... Methods: For observed adverse events (AEs) we extracted time to onset, outcome, and suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type of ADR (system organ class), seriousness...

  15. Radiation-protective drugs and their reaction mechanisms

    International Nuclear Information System (INIS)

    Livesey, J.C.; Reed, D.J.; Adamson, L.F.

    1985-01-01

    The objective of this book is to provide the reader with a concise review of radioprotective drugs and their reaction mechanisms. The first chapter reviews the effect of radiation on biological systems at the atomic, molecular, and subcellular levels. The second chapter discusses endogenous factors that influence radioresistance. Chapter 3 presents the main theme of the book, chemical radioprotection and its mechanisms, and examines the basis of natural radioprotection and how it may be affected by exogenous chemicals. Chapter 4, the Therapy of Radiation Damage, is a very brief general discussion that only touches on some of the experimental approaches to therapy. Chapter 5 contains recommendations for future research. The two appendices list research in progress in the United States and some radioprotective compounds of possible investigational interest. Also included is a brief discussion of structure-activity relationships

  16. Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review.

    Science.gov (United States)

    Pisano, Umberto; Deosaran, Jordanna; Leslie, Stephen J; Rushworth, Gordon F; Stewart, Derek; Ford, Ian; Watson, Angus J M

    2016-03-01

    Nicorandil is a popular anti-anginal drug in Europe and Japan. Apart from some common adverse drug reactions (ADR), its safety is satisfactory. Several reports have suggested a link between nicorandil, gastrointestinal (GI) ulceration and fistulas. The review aims to critically appraise, synthesize and present the available evidence of all known GI ADR per anatomical location. The study complied with the PRISMA statement. Literature and pharmacovigilance databases were used to provide rate and/or calculate parameters (median age, median dose, history of symptoms, length of therapy and healing time after withdrawal of the drug). Differences in distribution of quantitative variables were analyzed via Mann-Whitney test. Correlation between quantitative variables was assessed with a Spearman's correlation coefficient. A p value <0.05 was significant. Oral ulcerations occur in 0.2% of the subjects, anal ulcerations are present between 0.07% and 0.37% of patients. Oral and distal GI involvements are the most common ADR (28-29% and 27-31% of all GI ADR, respectively). The hepatobiliary system, the pancreas and salivary glands are not affected by nicorandil exposure. The time to develop oral ulcerations is 74 weeks among people on <30 mg/day compared to only 7.5 weeks in individuals on higher regimens (p = 0.47). There is a significant correlation between dose and ulcer healing time (Spearman's 0.525, p < 0.001). Ulcerative disease is a very commonly reported GI ADR. A delayed ulcerative tendency supports the hypothesis of an ulcerogenic metabolite. Nicorandil seems to act as a cause of the ulcerations, but appears to also work in synergy with other promoting factors. Whether the action of the metabolites relies on a specific mechanism or a simple chemical ulceration is still to be established.

  17. Biotransformation and bioactivation reactions of alicyclic amines in drug molecules.

    Science.gov (United States)

    Bolleddula, Jayaprakasam; DeMent, Kevin; Driscoll, James P; Worboys, Philip; Brassil, Patrick J; Bourdet, David L

    2014-08-01

    Aliphatic nitrogen heterocycles such as piperazine, piperidine, pyrrolidine, morpholine, aziridine, azetidine, and azepane are well known building blocks in drug design and important core structures in approved drug therapies. These core units have been targets for metabolic attack by P450s and other drug metabolizing enzymes such as aldehyde oxidase and monoamine oxidase (MAOs). The electron rich nitrogen and/or α-carbons are often major sites of metabolism of alicyclic amines. The most common biotransformations include N-oxidation, N-conjugation, oxidative N-dealkylation, ring oxidation, and ring opening. In some instances, the metabolic pathways generate electrophilic reactive intermediates and cause bioactivation. However, potential bioactivation related adverse events can be attenuated by structural modifications. Hence it is important to understand the biotransformation pathways to design stable drug candidates that are devoid of metabolic liabilities early in the discovery stage. The current review provides a comprehensive summary of biotransformation and bioactivation pathways of aliphatic nitrogen containing heterocycles and strategies to mitigate metabolic liabilities.

  18. A Review of Adverse Cutaneous Drug Reactions Resulting from the Use of Interferon and Ribavirin

    Directory of Open Access Journals (Sweden)

    Nisha Mistry

    2009-01-01

    Full Text Available Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions.

  19. Erythema multiforme-like eruption from a slimming drug preparation cutaneous adverse drug reaction

    Directory of Open Access Journals (Sweden)

    Linda Tognetti

    2011-01-01

    Full Text Available We report a case of a 34-year-old woman presenting with an erythema multiforme (EM-like eruption. Lesions developed after a 12-day treatment with a slimming drug preparation (food integrator with thermogenic activity and a herbal remedy (pilosella tincture. Serological investigations excluded viral or bacterial infections. Patch testing with galenic preparations of both drugs demonstrated sensitization to the slimming drug preparation. According to literature reports and immune-chemical properties, those components that are likely to have triggered the skin eruption are clorazepate dipotassium and theobromine. Their interaction with other two constituents such as pseudoephedrine hydrochloride and dehydrocholic acid may have caused the adverse reaction by means of a summation effect. There are no reports specifically about EM caused by a slimming drug preparation and no studies have identified thermogenic pills as cause of EM/EM-like eruption. Weight-loss compounds in slimming preparations should be kept in mind as a possible cause of drug-induced EM-like eruption.

  20. Adverse drug reaction monitoring of newer oral anti diabetic drugs – a pharmacovigilance perspective

    Directory of Open Access Journals (Sweden)

    Ankita Bhattacharjee

    2016-04-01

    Full Text Available Objective: To monitor and evaluate adverse drug reactions (ADRs of newer oral anti-diabetic drugs in type II diabetics by spontaneous/solicited ADR monitoring.Material and methods: Two hundred and thirty two diabetic patients on newer oral antidiabetic drugs were evaluated prospectively in a cross-sectional study over a period of eighteen months. All patients were followed up for ADRs which were evaluated for incidence, frequency, severity and causality. ADR severity was graded according to University of Virginia Health System Adverse Drug Reaction Reporting program criteria and causality assessment was done using WHO-UMC scale.Results: 190 out of 232 patients (42 patients lost to follow up were evaluated. ADRs were observed in 34 cases (17.9%. Most common ADRs were gastrointestinal (44.2% followed by musculoskeletal (17.6%, metabolic (14.7%, infections (5.9% and others (17.6%. The maximal frequency of ADRs was seen with sitagliptin (6.4% followed by vildagliptin(3.8%, saxagliptin(2.7%, saroglitazar(2.1%, linagliptin(1.6%, canagliflozin(1.6%. 25(73.5%, 8(23.5% and 1(3% ADRs were mild, moderate and severe respectively. 24(70% ADRs were classified as possible, 9(27% probable and 1(3% unlikely on causality assessment. Conclusion: Newer oral antidiabetic drugs like gliptins and SGLT-2 inhibitors have potential to cause ADRs. Gastro-intestinal, musculoskeletal, metabolic were most common ADRs. Active pharmacovigilance should be carried out for risk identification and management. 

  1. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Mechanism to preserve phrenic nerve function during photosensitization reaction: drug uptake and photosensitization reaction effect on electric propagation

    Science.gov (United States)

    Takahashi, Haruka; Hamada, Risa; Ogawa, Emiyu; Arai, Tsunenori

    2018-02-01

    To study a mechanism of phrenic nerve preservation phenomena during a photosensitization reaction, we investigated an uptake of talaporfin sodium and photosensitization reaction effect on an electric propagation. Right phrenic nerve was completely preserved after superior vena cava isolations using the photosensitization reaction in canine animal experiments, in spite of adjacent myocardium was electrically blocked. We predicted that low drug uptake and/or low photosensitization reaction effect on the nerve might be a mechanism of that phenomena. To investigate uptake to various nerve tissue, a healthy extracted crayfish ventral nerve cord and an extracted porcine phrenic nerve were immersed in 20 μg/ml talaporfin sodium solution for 0-240 min. The mean talaporfin sodium fluorescence brightness increased depending on the immersion time. This brightness saturated around the immersion time of 120 min. We found that talaporfin sodium uptake inside the perineurium which directly related to the electric propagation function was lower than that of outside in the porcine phrenic nerve. To investigate photosensitization reaction effect on electric propagation, the crayfish nerve was immersed into the same solution for 15 min and irradiated by a 663 nm laser light with 120 mW/cm2. Since we found the action potential disappeared when the irradiation time was 25-65 s, we consider that the crayfish nerve does not tolerant to the photosensitization reaction on electric propagation function at atmospheric pressure. From these results, we think that the low uptake of talaporfin sodium inside the perineurium and low oxygen partial pressure of nerve might be the possible mechanism to preserve phrenic nerve in vivo.

  3. Chemical reaction vector embeddings: towards predicting drug metabolism in the human gut microbiome.

    Science.gov (United States)

    Mallory, Emily K; Acharya, Ambika; Rensi, Stefano E; Turnbaugh, Peter J; Bright, Roselie A; Altman, Russ B

    2018-01-01

    Bacteria in the human gut have the ability to activate, inactivate, and reactivate drugs with both intended and unintended effects. For example, the drug digoxin is reduced to the inactive metabolite dihydrodigoxin by the gut Actinobacterium E. lenta, and patients colonized with high levels of drug metabolizing strains may have limited response to the drug. Understanding the complete space of drugs that are metabolized by the human gut microbiome is critical for predicting bacteria-drug relationships and their effects on individual patient response. Discovery and validation of drug metabolism via bacterial enzymes has yielded >50 drugs after nearly a century of experimental research. However, there are limited computational tools for screening drugs for potential metabolism by the gut microbiome. We developed a pipeline for comparing and characterizing chemical transformations using continuous vector representations of molecular structure learned using unsupervised representation learning. We applied this pipeline to chemical reaction data from MetaCyc to characterize the utility of vector representations for chemical reaction transformations. After clustering molecular and reaction vectors, we performed enrichment analyses and queries to characterize the space. We detected enriched enzyme names, Gene Ontology terms, and Enzyme Consortium (EC) classes within reaction clusters. In addition, we queried reactions against drug-metabolite transformations known to be metabolized by the human gut microbiome. The top results for these known drug transformations contained similar substructure modifications to the original drug pair. This work enables high throughput screening of drugs and their resulting metabolites against chemical reactions common to gut bacteria.

  4. Adverse drug reactions monitoring of psychotropic drugs: a tertiary care centre study

    Directory of Open Access Journals (Sweden)

    Hemendra Singh

    2017-06-01

    Full Text Available Background: Many new psychotropic drugs/ agents have been developed and found to be effective in the treatment of psychiatric disorders. However, these drugs also exhibit adverse drug reactions (ADRs which may affect compliance in psychiatric patients. Hence the present study was aimed at monitoring and assessing ADRs caused by psychotropic drugs. Methods: A hospital based prospective observational study was carried out in the psychiatry outpatient department of a tertiary care teaching hospital for the duration of six months. Two hundred and two patients were included in the study and ADRs were documented using a predesigned data collection form. The causality assessment was carried out as per the criteria of both the World Health Organization- Uppsala Monitoring Centre (WHO-UMC and Naranjo scale. Severity and predictability assessment of ADRs were also performed. Results: A total of 106 ADRs were observed during the study period with majority of them occurring in 25-35 years of age group (40.56%. Weight gain (18.86% followed by sedation (16.03% and insomnia (11.32% were found to be the commonest ADRs. Risperidone (19.8% and escitalopram (12.3% were the drugs responsible for majority of the ADRs. Causality assessment showed that most of ADRs were possible and probable. 94.33% of ADRs were found to be mild and 89% of them were predictable. Conclusion: A wide range of ADRs affecting central nervous and metabolic systems were reported with psychotropic drugs. The study findings necessitate the need for an active pharmacovigilance programme for the safe and effective use of psychotropics.

  5. Clinical experience of adverse drug reaction in gadolinium-DTPA enhancement of MRI

    International Nuclear Information System (INIS)

    Kim, Mi Hyae; Hong, Ju Hee; Lee, Yeon Su; Cha, Kyung Soo; Chang, Suk Il; Lee, Young Chul; Kim, Yeong Soo

    1992-01-01

    Gadopentetate dimenglumine(Gd-DTPA) has low toxicity and good tolerance and it is said that the observed adverse drug reaction of Gd-DTPA is compatible to those of iodinated nonionic contrast media. The overall incidence of adverse drug reaction of Gd-DTPA is even lower than those of iodinated nonionic contrast media. Then, the possibility of potential adverse drug reaction of these contrast media is not fully known and recently, many authors have a growing interest in this point. We have taken 2501 cases of MRI and executed 1467 case of Gd-DTPA enhancement scanning(58.7%) and experienced 12 cases of adverse drug reaction(11 cases: mild reaction, 1 case: severs anaphylactic shock) and the overall incidence of our adverse drug reaction of Gd-DTPA was 0.8%. In conclusion, the adverse drug reaction of Gd-DTPA is not rare and the severe adverse drug reaction of Gd-DTPA may occur. So, the possibility of adverse drug reaction after Gd-DTPA injection should always be kept in mind, especially when the patient has a history of reaction to contrast material, allergy(particularly asthma) and cardiac disease. For the safe use of Gd-DTPA, well trained personnel and nearby emergent care facilities should be available

  6. [Drug surveillance and adverse reactions to drugs. The literature and importance of historical data].

    Science.gov (United States)

    Mariani, L; Minora, T; Ventresca, G P

    1996-12-01

    The authors highlight the essential role of pharmacovigilance and the need for a simple, efficient and low-cost system of adverse reaction (AR) reporting which could cover the whole population and all marketed drugs, and suggest that the only one presently viable is based on spontaneous reporting. To support their proposal the authors provide a definition of AR and of the different monitoring system, and list as many drugs as possible to find in the literature that have been associated with a specific AR, together with the active molecule, the therapeutic indication, the features of the AR and the regulatory actions (withdrawal from the market, restriction of use). Moreover, by describing the "history" behind some of these drugs the authors highlight the contribution that pharmacovigilance and spontaneous reporting have had to the development of regulations for approval and marketing of new drugs. It is also highlighted how some of these unexpected events (thalidomide, DES) have had a significant and important contribution to pharmacological and toxicological knowledge.

  7. Association between ABCG2 and SLCO1B1 polymorphisms and adverse drug reactions to regorafenib: a preliminary study
.

    Science.gov (United States)

    Maeda, Akimitsu; Ando, Hitoshi; Ura, Takashi; Komori, Azusa; Hasegawa, Ayako; Taniguchi, Hiroya; Kadowaki, Shigenori; Muro, Kei; Tajika, Masahiro; Kobara, Makiko; Matsuzaki, Masahide; Hashimoto, Naoya; Maeda, Mieko; Kojima, Yasushi; Aoki, Masahiro; Kondo, Eisaku; Mizutani, Akiyoshi; Fujimura, Akio

    2017-05-01

    Due to the occurrence of severe adverse drug reactions to regorafenib, a drug used in cancer therapy, the identification of a predictive marker(s) is needed to increase the therapeutic applicability of this compound. We therefore investigated whether polymorphisms in the ABCG2 and SLCO1B genes are associated with adverse drug reactions to regorafenib. For these analyses, 37 Japanese cancer patients were treated with regorafenib, genotyped for polymorphisms in ABCG2 and SLCO1B, and evaluated for drug-related adverse drug reactions. There was no association between the ABCG2 421C>A variant and adverse drug reactions to regorafenib. After treatment, the incidences of increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as well as increased total bilirubin (grade ≥ 2) were 8%, 4%, and 12%, and 42%, 25%, and 25% among SLCO1B1*1b carriers and non-carriers, respectively. There were no significant associations between elevated ALT and bilirubin and the SLCO1B1*1b allele. However, there were significantly lower incidences of increased AST (8% vs. 42%) and anemia (16% vs. 50%) in SLCO1B1*1b carriers than in non-carriers. The absence of SLCO1B1*1b allele appears to be associated with the development of adverse drug reactions to regorafenib; however, further studies involving larger test groups and other populations are needed to confirm these findings.
.

  8. [Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

    Science.gov (United States)

    Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

    2018-01-01

    The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

  9. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

    Directory of Open Access Journals (Sweden)

    Moore N

    2015-07-01

    Full Text Available Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. Keywords: adverse effects, nonsteroidal anti-inflammatory drugs, gastrointestinal, cardiovascular, renal

  10. Adverse reactions to antituberculosis drugs in Manguinhos, Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Glauciene Santana Damasceno

    2013-01-01

    Full Text Available OBJECTIVES: This study aimed to characterize and estimate the frequency of adverse reactions to antituberculosis drugs in the population treated at the Centro de Saúde Escola Germano Sinval Faria, a primary health care clinic in Manguinhos, Rio de Janeiro City, and to explore the relationship between adverse drug reactions and some of the patients' demographic and health characteristics. METHODS: This descriptive study was conducted via patient record review of incident cases between 2004 and 2008. RESULTS: Of the 176 patients studied, 41.5% developed one or more adverse reactions to antituberculosis drugs, totaling 126 occurrences. The rate of adverse reactions to antituberculosis drugs was higher among women, patients aged 50 years or older, those with four or more comorbidities, and those who used five or more drugs. Of the total reactions, 71.4% were mild. The organ systems most affected were as follows: the gastrointestinal tract (29.4%, the skin and appendages (21.4%, and the central and peripheral nervous systems (14.3%. Of the patients who experienced adverse reactions to antituberculosis drugs, 65.8% received no drug treatment for their adverse reactions, and 4.1% had one of the antituberculosis drugs suspended because of adverse reactions. "Probable reactions" (75% predominated over "possible reactions" (24%. In the study sample, 64.3% of the reactions occurred during the first two months of treatment, and most (92.6% of the reactions were ascribed to the combination of rifampicin + isoniazid + pyrazinamide (Regimen I. A high dropout rate from tuberculosis treatment (24.4% was also observed. CONCLUSION: This study suggests a high rate of adverse reactions to antituberculosis drugs.

  11. Nuclear halo and its related reactions

    International Nuclear Information System (INIS)

    Zhang Huanqiao

    2005-01-01

    In order to search proton halo, the reaction cross sections of 27,28 P, 29 S and the corresponding isotones on Si target were measured at intermediate energies. The measured reaction cross sections of the N=12 and 13 isotones show an abrupt increase at Z=15. The experimental results for the isotones with Z=14 as well as 28 P can be well described by the modified Glauber theory of the optical limit approach. The enhancement of the reaction cross sections for 28 P could be explained in the modified Glauber theory with an enlarged core. Theoretical analysis with the modified Glauber theory of the optical limit and few-body approaches underpredicted the experimental data of 27 P. Our theoretical analysis shows that an enlarged core together with proton halo is probably the mechanism responsible for the enhancement of the cross sections for the reaction of 27 P+ 28 Si. In addition, we find from the experimental results that 29 S may have a moderate proton halo structure. Except the nuclei near or at drop-lines, halo may appear in the excited states of stable nuclei. By means of the asymptotic normalization coefficients (ANC's) extracted from transfer reactions of 11 B(d, p) 12 B, 12 C(d, p) 13 C, and H( 6 He, n) 6 Li, we have verified that the second ( Jπ = 2 - ) and third (Jπ = 1 - ) excited states in 12 B and the first (Jπ =1/2 + ) excited state in 13 C are the neutron halo states, while the second excited state (3.56 MeV, Jπ = 0 + ) in 6 Li is a proton-neutron halo state. We have proposed a procedure to extract the probability for valence particle being out of the binding potential from the measured nuclear asymptotic normalization coefficients. With this procedure, available data regarding the nuclear halo candidates are systematically analyzed and a number of halo nuclei are confirmed. Based on these results we have got a much relaxed condition for nuclear halo occurrence. Furthermore, we have presented the scaling laws for the dimensionless quantity 2 >/R 2 of

  12. Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review 1

    Science.gov (United States)

    Rodrigues, Maria Cristina Soares; de Oliveira, Cesar

    2016-01-01

    ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. PMID:27598380

  13. The validation of an invitro colonic motility assay as a biomarker for gastrointestinal adverse drug reactions

    International Nuclear Information System (INIS)

    Keating, Christopher; Martinez, Vicente; Ewart, Lorna; Gibbons, Stephen; Grundy, Luke; Valentin, Jean-Pierre; Grundy, David

    2010-01-01

    Motility-related gastrointestinal adverse drug reactions (GADRs), such as constipation and diarrhea, are some of the most frequently reported adverse events associated with the clinical development of new chemical entities, and for marketed drugs. However, biomarkers capable of detecting such GADRs are lacking. Here, we describe an in vitro assay developed to detect and quantify changes in intestinal motility as a surrogate biomarker for constipation/diarrhea-type GADRs. In vitro recordings of intraluminal pressure were used to monitor the presence of colonic peristaltic motor complexes (CPMCs) in mouse colonic segments. CPMC frequency, contractile and total mechanical activity were assessed. To validate the assay, two experimental protocols were conducted. Initially, five drugs with known gastrointestinal effects were tested to determine optimal parameters describing excitation and inhibition as markers for disturbances in colonic motility. This was followed by a 'blinded' evaluation of nine drugs associated with or without clinically identified constipation/diarrhea-type GADRs. Concentration-response relationships were determined for these drugs and the effects were compared with their maximal free therapeutic plasma concentration in humans. The assay detected stimulatory and inhibitory responses, likely correlating to the occurrence of diarrhea or constipation. Concentration-related effects were identified and potential mechanisms of action were inferred for several drugs. Based on the results from the fourteen drugs assessed, the sensitivity of the assay was calculated at 90%, with a specificity of 75% and predictive capacity of 86%. These results support the potential use of this assay in screening for motility-related GADRs during early discovery phase, safety pharmacology assessment.

  14. Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports

    Science.gov (United States)

    Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M.; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

    2013-01-01

    Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health. PMID:24347986

  15. Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports.

    Science.gov (United States)

    Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

    2013-12-01

    Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.

  16. A continuous GRASP to determine the relationship between drugs and adverse reactions

    International Nuclear Information System (INIS)

    Hirsch, Michael J.; Meneses, Claudio N.; Pardalos, Panos M.; Ragle, Michelle; Resende, Mauricio G. C.

    2007-01-01

    Adverse drag reactions (ADRs) are estimated to be one of the leading causes of death. Many national and international agencies have set up databases of ADR reports for the express purpose of determining the relationship between drugs and adverse reactions that they cause. We formulate the drug-reaction relationship problem as a continuous optimization problem and utilize C-GRASP, a new continuous global optimization heuristic, to approximately determine the relationship between drugs and adverse reactions. Our approach is compared against others in the literature and is shown to find better solutions

  17. Optimization of the THP-1 activation assay to detect pharmaceuticals with potential to cause immune mediated drug reactions.

    Science.gov (United States)

    Corti, Daniele; Galbiati, Valentina; Gatti, Nicolò; Marinovich, Marina; Galli, Corrado L; Corsini, Emanuela

    2015-10-01

    Despite important impacts of systemic hypersensitivity induced by pharmaceuticals, for such endpoint no reliable preclinical approaches are available. We previously established an in vitro test to identify contact and respiratory allergens based on interleukin-8 (IL-8) production in THP-1 cells. Here, we challenged it for identification of pharmaceuticals associated with systemic hypersensitivity reactions, with the idea that drug sensitizers share common mechanisms of cell activation. Cells were exposed to drugs associated with systemic hypersensitivity reactions (streptozotocin, sulfamethoxazole, neomycin, probenecid, clonidine, procainamide, ofloxacin, methyl salicylate), while metformin was used as negative drug. Differently to chemicals, drugs tested were well tolerated, except clonidine and probenecid, with no signs of cytotoxicity up to 1-2mg/ml. THP-1 activation assay was adjusted, and conditions, that allow identification of all sensitizing drugs tested, were established. Next, using streptozotocin and selective inhibitors of PKC-β and p38 MAPK, two pathways involved in chemical allergen-induced cell activation, we tested the hypothesis that similar pathways were also involved in drug-induced IL-8 production and CD86 upregulation. Results indicated that drugs and chemical allergens share similar activation pathways. Finally, we made a structure-activity hypothesis related to hypersensitivity reactions, trying to individuate structural requisite that can be involved in immune mediated adverse reactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. [Trends in drug-induced liver injury based on reports of adverse reactions to PMDA in Japan].

    Science.gov (United States)

    Sudo, Chie; Maekawa, Keiko; Segawa, Katsunori; Hanatani, Tadaaki; Sai, Kimie; Saito, Yoshiro

    2012-01-01

    Reports on drug-related adverse reactions from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated under the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety measures. Although association between the medicine and the adverse event has not been clearly evaluated, and an incidence may be redundantly reported, this information would be useful to roughly grasp the current status of drug-related adverse reactions. In the present study, we analyzed the incidence of drug-induced liver injury by screening the open-source data publicized by the homepage of Pharmaceutical and Medical Devices Agency from 2005 to 2011 fiscal years. Major drug-classes suspected to cause general drug-induced liver injury were antineoplastics, anti-inflammatory agents/common cold drugs, chemotherapeutics including antituberculous drugs, antidiabetics, antiulcers and antiepileptics. In addition, reported cases for fulminant hepatitis were also summarized. We found that antituberculous isoniazid and antineoplastic tegafur-uracil were the top two suspected drugs. These results might deepen understanding of current situations for the drug-induced liver injury in Japan.

  19. A study on adverse drug reactions in a tertiary care hospital of ...

    African Journals Online (AJOL)

    Acne (46) was commonly reported reaction. Topical steroids, betamethasone sodium phosphate and clobetasol were reported to induce maximum number of reactions (59). Skin (227, 66.9%) was commonly affected organ system. Most of the adverse drug reactions were possible (240, 94.1%) and mild (222, 87%) in nature.

  20. Aligning Metabolic Pathways Exploiting Binary Relation of Reactions.

    Directory of Open Access Journals (Sweden)

    Yiran Huang

    Full Text Available Metabolic pathway alignment has been widely used to find one-to-one and/or one-to-many reaction mappings to identify the alternative pathways that have similar functions through different sets of reactions, which has important applications in reconstructing phylogeny and understanding metabolic functions. The existing alignment methods exhaustively search reaction sets, which may become infeasible for large pathways. To address this problem, we present an effective alignment method for accurately extracting reaction mappings between two metabolic pathways. We show that connected relation between reactions can be formalized as binary relation of reactions in metabolic pathways, and the multiplications of zero-one matrices for binary relations of reactions can be accomplished in finite steps. By utilizing the multiplications of zero-one matrices for binary relation of reactions, we efficiently obtain reaction sets in a small number of steps without exhaustive search, and accurately uncover biologically relevant reaction mappings. Furthermore, we introduce a measure of topological similarity of nodes (reactions by comparing the structural similarity of the k-neighborhood subgraphs of the nodes in aligning metabolic pathways. We employ this similarity metric to improve the accuracy of the alignments. The experimental results on the KEGG database show that when compared with other state-of-the-art methods, in most cases, our method obtains better performance in the node correctness and edge correctness, and the number of the edges of the largest common connected subgraph for one-to-one reaction mappings, and the number of correct one-to-many reaction mappings. Our method is scalable in finding more reaction mappings with better biological relevance in large metabolic pathways.

  1. A study on adverse drug reactions in a tertiary care hospital of ...

    African Journals Online (AJOL)

    Ratan J. Lihite

    2016-06-27

    Jun 27, 2016 ... Patients of all age and either sex were included. Adverse drug ... adverse drug reactions in majority of the patients. The commonly .... ten prescription drugs were excluded. .... Pneumonia with respiratory distress, Vision problem, Knee pain, .... back of spontaneous reporting system i.e. underreporting. Thus ...

  2. Filtering big data from social media--Building an early warning system for adverse drug reactions.

    Science.gov (United States)

    Yang, Ming; Kiang, Melody; Shang, Wei

    2015-04-01

    Adverse drug reactions (ADRs) are believed to be a leading cause of death in the world. Pharmacovigilance systems are aimed at early detection of ADRs. With the popularity of social media, Web forums and discussion boards become important sources of data for consumers to share their drug use experience, as a result may provide useful information on drugs and their adverse reactions. In this study, we propose an automated ADR related posts filtering mechanism using text classification methods. In real-life settings, ADR related messages are highly distributed in social media, while non-ADR related messages are unspecific and topically diverse. It is expensive to manually label a large amount of ADR related messages (positive examples) and non-ADR related messages (negative examples) to train classification systems. To mitigate this challenge, we examine the use of a partially supervised learning classification method to automate the process. We propose a novel pharmacovigilance system leveraging a Latent Dirichlet Allocation modeling module and a partially supervised classification approach. We select drugs with more than 500 threads of discussion, and collect all the original posts and comments of these drugs using an automatic Web spidering program as the text corpus. Various classifiers were trained by varying the number of positive examples and the number of topics. The trained classifiers were applied to 3000 posts published over 60 days. Top-ranked posts from each classifier were pooled and the resulting set of 300 posts was reviewed by a domain expert to evaluate the classifiers. Compare to the alternative approaches using supervised learning methods and three general purpose partially supervised learning methods, our approach performs significantly better in terms of precision, recall, and the F measure (the harmonic mean of precision and recall), based on a computational experiment using online discussion threads from Medhelp. Our design provides

  3. Reaction thresholds in doubly special relativity

    International Nuclear Information System (INIS)

    Heyman, Daniel; Major, Seth; Hinteleitner, Franz

    2004-01-01

    Two theories of special relativity with an additional invariant scale, 'doubly special relativity', are tested with calculations of particle process kinematics. Using the Judes-Visser modified conservation laws, thresholds are studied in both theories. In contrast with some linear approximations, which allow for particle processes forbidden in special relativity, both the Amelino-Camelia and Magueijo-Smolin frameworks allow no additional processes. To first order, the Amelino-Camelia framework thresholds are lowered and the Magueijo-Smolin framework thresholds may be raised or lowered

  4. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia.

    Science.gov (United States)

    Aziz, Zoriah; Siang, Tan Ching; Badarudin, Nurul Suhaida

    2007-02-01

    Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood. To identify factors, which would predict physicians' failure to send ADR reports. Face-to-face interview using a structured questionnaire involving physicians working at the University of Malaya Medical Centre, Malaysia. About a third of the physicians in the Centre participated. Sixty-five of the 415 approached refused to participate. A high proportion of the respondents (81.4%) indicated that they had suspected an ADR but did not report it, while about 40% of the respondents were not aware of the existence of the national reporting system in Malaysia. Logistic regression modelling identified the variable 'ADR considered to be too trivial or too well known to report' as the strongest predictor of not reporting, followed by physicians' category and uncertainty that the reaction had been definitely caused by a drug. Important predictor variables, which limit physicians from reporting ADR in Malaysia, were related to uncertainty of types of reaction to report, lack of awareness about the existence, function and purpose of national ADR reporting. The findings could be useful for planning strategies to improve the reporting rate.

  5. Relating Derived Relations as a Model of Analogical Reasoning: Reaction Times and Event-Related Potentials

    Science.gov (United States)

    Barnes-Holmes, Dermot; Regan, Donal; Barnes-Holmes, Yvonne; Commins, Sean; Walsh, Derek; Stewart, Ian; Smeets, Paul M.; Whelan, Robert; Dymond, Simon

    2005-01-01

    The current study aimed to test a Relational Frame Theory (RFT) model of analogical reasoning based on the relating of derived same and derived difference relations. Experiment 1 recorded reaction time measures of similar-similar (e.g., "apple is to orange as dog is to cat") versus different-different (e.g., "he is to his brother as…

  6. Drug related problems with Antiparkinsonian agents: consumer Internet reports versus published data.

    Science.gov (United States)

    Schröder, Sabrina; Zöllner, York Francis; Schaefer, Marion

    2007-10-01

    There is currently a lack of detailed information concerning drug related problems in the outpatient treatment of Parkinson's disease. Problems associated with drug treatment communicated anonymously in Parkinson's disease online forums were therefore retrospectively searched and documented for 1 year. Based on postings concerning 12 drugs for the treatment of Parkinson's disease, a total of 238 drug related problems were identified and categorised using the Problem Intervention Documentation (PI-Doc). Of these, 153 were adverse drug reactions. Adverse drug reactions associated with the skin were relatively common, but central effects such as cognitive or psychiatric changes, effects on the sleep/waking system and other problems like headache and dizziness accounted for the highest percentage of adverse events. A comparison with data from scientific literature revealed a number of differences. This means that an analysis of online forums detected a number of drug related problems that were otherwise largely invisible. These were mainly associated with the qualitative aspects of treatment such as medication handling, dosage and individual problems concerning adverse events. In addition, the described method of identifying and classifying drug related problems in Internet forums may also be seen as a contribution to the international discussion about consumer reports and pharmacovigilance. The information about adverse drug reactions given by Internet users can be seen as a valuable adjunct to clinical trial data and as being very timely with regard to the event itself. Online forums may be considered as a suitable source of observational information to complement data from randomised clinical trials.

  7. Lower alert rates by clustering of related drug interaction alerts

    NARCIS (Netherlands)

    Heringa, M.; Siderius, Hidde; Schreudering, A.; De Smet, Peter Agm; Bouvy, M.L.

    OBJECTIVE: We aimed to investigate to what extent clustering of related drug interaction alerts (drug-drug and drug-disease interaction alerts) would decrease the alert rate in clinical decision support systems (CDSSs). METHODS: We conducted a retrospective analysis of drug interaction alerts

  8. Therapeutic potential of cannabis-related drugs.

    Science.gov (United States)

    Alexander, Stephen P H

    2016-01-04

    In this review, I will consider the dual nature of Cannabis and cannabinoids. The duality arises from the potential and actuality of cannabinoids in the laboratory and clinic and the 'abuse' of Cannabis outside the clinic. The therapeutic areas currently best associated with exploitation of Cannabis-related medicines include pain, epilepsy, feeding disorders, multiple sclerosis and glaucoma. As with every other medicinal drug of course, the 'trick' will be to maximise the benefit and minimise the cost. After millennia of proximity and exploitation of the Cannabis plant, we are still playing catch up with an understanding of its potential influence for medicinal benefit. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Drug-related acute renal failure in hospitalised patients

    Directory of Open Access Journals (Sweden)

    Lujan Iavecchia

    2015-11-01

    Conclusions: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality.

  10. Cutaneous adverse drug reactions seen at a university hospital department of dermatology

    DEFF Research Database (Denmark)

    Borch, Jakob E; Andersen, Klaus E; Bindslev-Jensen, Carsten

    2006-01-01

    Patients with suspected cutaneous adverse drug reactions are often referred to allergy clinics or departments of dermatology for evaluation. These patients are selected compared with patients identified in prospective and cross-sectional studies of hospital populations. This explains the observed...... variation in prevalence of specific reactions and of eliciting drugs. This study investigated the prevalence of cutaneous adverse drug reactions in a university hospital department of dermatology that is specially focused on allergy. An 8-month survey was carried out during the period April-December 2003...

  11. Precision-cut mouse liver slices as an ex vivo model to study the mechanism of inflammatory stress-related idiosyncratic drug-induced liver injury

    NARCIS (Netherlands)

    Hadi, Mackenzie; Chen, Y.; Starokozhko, Viktoriia; Merema, Maja; Groothuis, Genoveva

    2012-01-01

    Idiosyncratic drug reactions (IDRs) can be defined as adverse drug reactions that occur in a small minority of the patients taking clinically-relevant doses and do not involve the known pharmacological effects of the drug. IDR related to hepatotoxicity or idiosyncratic drug-induced liver injury

  12. Stevens-Johnson syndrome and toxic epidermal necrolysis: an update on pharmacogenetics studies in drug-induced severe skin reaction.

    Science.gov (United States)

    Rufini, Sara; Ciccacci, Cinzia; Politi, Cristina; Giardina, Emiliano; Novelli, Giuseppe; Borgiani, Paola

    2015-11-01

    Stevens-Johnson syndrome and toxic epidermal necrolysis are severe, life-threatening drug reactions involving skin and membranes mucous, which are associated with significant morbidity and mortality and triggered, especially by drug exposure. Different studies have demonstrated that drug response is a multifactorial character and that the interindividual variability in this response depends on both environmental and genetic factors. The last ones have a relevant significance. In fact, the identification of new specific genetic markers involved in the response to drugs, will be of great utility to establish a more personalized therapeutic approach and to prevent the appearance of these adverse reactions. In this review, we summarize recent progresses in the Pharmacogenetics studies related to Stevens-Johnson syndrome/toxic epidermal necrolysis reporting the major genetic factors identified in the last years as associated with the disease and highlighting the use of some of these genomic variants in the clinical practice.

  13. Potentially inappropriate prescribing and the risk of adverse drug reactions in critically ill older adults

    Directory of Open Access Journals (Sweden)

    Galli TB

    2016-12-01

    Full Text Available Background: Potentially inappropriate medication (PIM use in the elderly is associated with increased risk of adverse drug reactions (ADRs, but there is limited information regarding PIM use in the intensive care unit (ICU setting. Objective: The aim of the study is to describe the prevalence and factors associated with the use of PIM and the occurrence of PIM-related adverse reactions in the critically ill elderly. Methods: This study enrolled all critically ill older adults (60 years or more admitted to medical or cardiovascular ICUs between January and December 2013, in a large tertiary teaching hospital. For all patients, clinical pharmacists listed the medications given during the ICU stay and data on drugs were analyzed using 2012 Beers Criteria, to identify the prevalence of PIM. For each identified PIM the medical records were analyzed to evaluate factors associated with its use. The frequency of ADRs and, the causal relationship between PIM and the ADRs identified were also evaluated through review of medical records. Results: According to 2012 Beers Criteria, 98.2% of elderly patients used at least one PIM (n=599, of which 24.8% were newly started in the ICUs. In 29.6% of PIMs, there was a clinical circumstance that justified their prescription. The number of PIMs was associated with ICU length of stay and total number of medications. There was at least one ADR identified in 17.8% of patients; more than 40% were attributed to PIM, but there was no statistical association. Conclusions: There is a high prevalence of PIM used in acutely ill older people, but they do not seem to be the major cause of adverse drug reactions in this population. Although many PIMs had a clinical circumstance that led to their prescription during the course of ICU hospitalization, many were still present upon hospital discharge. Therefore, prescription of PIMs should be minimized to improve the safety of elderly patients.

  14. Adverse drug reactions to CT contrast media in south Korea: Incidence and risk factors

    International Nuclear Information System (INIS)

    Bae, Kyung Soo; Jeon, Kyung Nyeo; Moon, Jin Il; Choi, Bo Hwa; Baek, Hye Jin; Cho, Soo Buem; Lee, Sang Min; Ha, Ji Young; Choi, Dae Seob; Cho, Jae Min; Na, Jae Beom

    2016-01-01

    To evaluate the incidence, severity, and risk factors of adverse drug reactions (ADR) to intravenous administration of nonionic iodinated contrast media in computed tomography (CT), and to determine the recurrence rate after premedication in patients with a previous history of ADR. We prospectively recorded all ADR to intravenous CT contrast media in 32313 consecutive outpatients (54572 cases) who underwent contrast enhanced CT examinations. Clinical report forms and electronic medical records were reviewed to search for the incidence of ADR, treatment, and clinical outcome of patients. The risk factors of ADR to CT contrast media (age, sex, history of previous ADR, season) were evaluated using statistical analysis. Of the 54572 cases, a total of 191 (0.35%) had adverse reactions. Of the 191 cases, 157 (82%) were categorized as mild reactions, 29 (15%) were moderate, and 5 (3%) were severe. A total of 165 (86.4%) cases had acute adverse reactions (which occurred within 1 hour after administration), while 26 (13.6%) had delayed adverse reactions (occurred 1 hour after the administration). The rate of ADR was significantly higher in females [relative risk (RR) = 2.05, 95% confidence interval (CI) 1.53-2.75], patients under the age of 60 years (RR = 1.45, 95% CI 1.07-1.98), patients with a history of previous ADR (RR = 6.51, 95% CI 3.13-13.57), and in the spring season (RR = 1.44, 95% CI 1.07-1.95). The recurrence rate after premedication in patients with previous ADR to CT contrast media was 3.2% (8/247). No deaths occurred that were attributed to the contrast media. The incidence of ADR to nonionic CT contrast media was 0.35%; most of which were mild reactions. Risk factors for ADR included female gender, an age of under 60 years, a history of previous ADR, and spring season

  15. Adverse drug reactions to CT contrast media in south Korea: Incidence and risk factors

    Energy Technology Data Exchange (ETDEWEB)

    Bae, Kyung Soo; Jeon, Kyung Nyeo; Moon, Jin Il; Choi, Bo Hwa; Baek, Hye Jin; Cho, Soo Buem [Dept. of Radiology, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon (Korea, Republic of); Lee, Sang Min; Ha, Ji Young; Choi, Dae Seob; Cho, Jae Min; Na, Jae Beom [Dept. of Radiology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju (Korea, Republic of)

    2016-07-15

    To evaluate the incidence, severity, and risk factors of adverse drug reactions (ADR) to intravenous administration of nonionic iodinated contrast media in computed tomography (CT), and to determine the recurrence rate after premedication in patients with a previous history of ADR. We prospectively recorded all ADR to intravenous CT contrast media in 32313 consecutive outpatients (54572 cases) who underwent contrast enhanced CT examinations. Clinical report forms and electronic medical records were reviewed to search for the incidence of ADR, treatment, and clinical outcome of patients. The risk factors of ADR to CT contrast media (age, sex, history of previous ADR, season) were evaluated using statistical analysis. Of the 54572 cases, a total of 191 (0.35%) had adverse reactions. Of the 191 cases, 157 (82%) were categorized as mild reactions, 29 (15%) were moderate, and 5 (3%) were severe. A total of 165 (86.4%) cases had acute adverse reactions (which occurred within 1 hour after administration), while 26 (13.6%) had delayed adverse reactions (occurred 1 hour after the administration). The rate of ADR was significantly higher in females [relative risk (RR) = 2.05, 95% confidence interval (CI) 1.53-2.75], patients under the age of 60 years (RR = 1.45, 95% CI 1.07-1.98), patients with a history of previous ADR (RR = 6.51, 95% CI 3.13-13.57), and in the spring season (RR = 1.44, 95% CI 1.07-1.95). The recurrence rate after premedication in patients with previous ADR to CT contrast media was 3.2% (8/247). No deaths occurred that were attributed to the contrast media. The incidence of ADR to nonionic CT contrast media was 0.35%; most of which were mild reactions. Risk factors for ADR included female gender, an age of under 60 years, a history of previous ADR, and spring season.

  16. Adverse drug reactions of angiotensin converting enzyme inhibitors : towards precision medicine

    NARCIS (Netherlands)

    Mahmoud Pour, S.H.

    2016-01-01

    Worldwide, millions of patients with cardiovascular diseases are treated with angiotensin converting enzyme inhibitors (ACEIs) according to the international treatment guidelines. Although this class of medications is generally well tolerated, adverse drug reactions (ADRs) may prevent their use in

  17. MONITORING POTENTIAL DRUG INTERACTIONS AND REACTIONS VIA NETWORK ANALYSIS OF INSTAGRAM USER TIMELINES.

    Science.gov (United States)

    Correia, Rion Brattig; Li, Lang; Rocha, Luis M

    2016-01-01

    Much recent research aims to identify evidence for Drug-Drug Interactions (DDI) and Adverse Drug reactions (ADR) from the biomedical scientific literature. In addition to this "Bibliome", the universe of social media provides a very promising source of large-scale data that can help identify DDI and ADR in ways that have not been hitherto possible. Given the large number of users, analysis of social media data may be useful to identify under-reported, population-level pathology associated with DDI, thus further contributing to improvements in population health. Moreover, tapping into this data allows us to infer drug interactions with natural products-including cannabis-which constitute an array of DDI very poorly explored by biomedical research thus far. Our goal is to determine the potential of Instagram for public health monitoring and surveillance for DDI, ADR, and behavioral pathology at large. Most social media analysis focuses on Twitter and Facebook, but Instagram is an increasingly important platform, especially among teens, with unrestricted access of public posts, high availability of posts with geolocation coordinates, and images to supplement textual analysis. Using drug, symptom, and natural product dictionaries for identification of the various types of DDI and ADR evidence, we have collected close to 7000 user timelines spanning from October 2010 to June 2015.We report on 1) the development of a monitoring tool to easily observe user-level timelines associated with drug and symptom terms of interest, and 2) population-level behavior via the analysis of co-occurrence networks computed from user timelines at three different scales: monthly, weekly, and daily occurrences. Analysis of these networks further reveals 3) drug and symptom direct and indirect associations with greater support in user timelines, as well as 4) clusters of symptoms and drugs revealed by the collective behavior of the observed population. This demonstrates that Instagram

  18. MONITORING POTENTIAL DRUG INTERACTIONS AND REACTIONS VIA NETWORK ANALYSIS OF INSTAGRAM USER TIMELINES

    Science.gov (United States)

    CORREIA, RION BRATTIG; LI, LANG; ROCHA, LUIS M.

    2015-01-01

    Much recent research aims to identify evidence for Drug-Drug Interactions (DDI) and Adverse Drug reactions (ADR) from the biomedical scientific literature. In addition to this “Bibliome”, the universe of social media provides a very promising source of large-scale data that can help identify DDI and ADR in ways that have not been hitherto possible. Given the large number of users, analysis of social media data may be useful to identify under-reported, population-level pathology associated with DDI, thus further contributing to improvements in population health. Moreover, tapping into this data allows us to infer drug interactions with natural products—including cannabis—which constitute an array of DDI very poorly explored by biomedical research thus far. Our goal is to determine the potential of Instagram for public health monitoring and surveillance for DDI, ADR, and behavioral pathology at large. Most social media analysis focuses on Twitter and Facebook, but Instagram is an increasingly important platform, especially among teens, with unrestricted access of public posts, high availability of posts with geolocation coordinates, and images to supplement textual analysis. Using drug, symptom, and natural product dictionaries for identification of the various types of DDI and ADR evidence, we have collected close to 7000 user timelines spanning from October 2010 to June 2015. We report on 1) the development of a monitoring tool to easily observe user-level timelines associated with drug and symptom terms of interest, and 2) population-level behavior via the analysis of co-occurrence networks computed from user timelines at three different scales: monthly, weekly, and daily occurrences. Analysis of these networks further reveals 3) drug and symptom direct and indirect associations with greater support in user timelines, as well as 4) clusters of symptoms and drugs revealed by the collective behavior of the observed population. This demonstrates that

  19. Adverse reactions analysis and prevention of antiseptic drug in the obstetrics and gynecology nursing.

    Science.gov (United States)

    Wang, Yongli; Bo, Qing; Zhang, Ying; He, Jing

    2018-05-01

    Antimicrobial agents are widely used in gynecologic inflammation and surgical period, so as to cure some infectious diseases, reduce the chance of surgical incision infection, but at the same time, there are many adverse reactions. The use of nursing interventions in obstetrics and gynecology can significantly reduce the adverse drug reactions in the treatment. The results showed that the incidence of adverse reactions in the observation group was 8.8%, while that in the control group was 15.6%. The incidence of adverse reactions in the observation group was significantly lower than that in the control group (P<0.05). The results showed that the nursing intervention in obstetrics and gynecology could reduce the adverse drug reactions. In a word, the nursing intervention of obstetrics and gynecology can greatly reduce the adverse reaction of antibiotics and has certain application value. It is worth popularizing in clinical practice.

  20. The prevalence of acute cutaneous drug reactions in a Scandinavian University hospital

    DEFF Research Database (Denmark)

    Borch, Jacob Eli; Andersen, Klaus Ejner; Bindslev-Jensen, Carsten

    2006-01-01

    2 weeks' duration. Patients were examined clinically and offered investigation for possible drug allergy, including blood tests, and skin tests when appropriate. Subsequent drug challenge tests were performed in selected cases. Finally, the history and test results were evaluated to determine......To investigate the epidemiology of acute cutaneous adverse drug reactions, a cross-sectional study was designed with four visits, equally distributed over one year, to all clinical departments of a large university hospital in order to find patients with possible drug-induced exanthema of less than...... the imputability of each drug as the possible culprit. In a cohort of 11,371 in- and out-patients, 131 were referred for evaluation. Twenty-nine cases of acute cutaneous drug reactions were identified, giving a prevalence of 0.33% in in-patients, 0.14% in out-patients, and 0.25% overall. Twenty-five percent...

  1. Incidence of cutaneous adverse drug reactions among medical inpatients of Sultanah Aminah Hospital Johor Bahru.

    Science.gov (United States)

    Latha, S; Choon, S E

    2017-06-01

    Cutaneous adverse drug reactions (cADRs) are common. There are only few studies on the incidence of cADRs in Malaysia. To determine the incidence, clinical features and risk factors of cADRs among hospitalized patients. A prospective study was conducted among medical inpatients from July to December 2014. A total of 43 cADRs were seen among 11 017 inpatients, yielding an incidence rate of 0.4%. cADR accounted for hospitalization in 26 patients. Previous history of cADR was present in 14 patients, with 50% exposed to the same drug taken previously. Potentially lifethreatening severe cutaneous adverse reactions (SCAR), namely drug reaction with eosinophilia and systemic symptoms (DRESS: 14 cases) and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN: 6 cases) comprise almost 50% of cADRs. The commonest culprit drug group was antibiotics (37.2%), followed by anticonvulsants (18.6%). Cotrimoxazole, phenytoin and rifampicin were the main causative drugs for DRESS. Anticonvulsants were most frequently implicated in SJS/TEN (66.7%). Most cases had "probable" causality relationship with suspected drug (69.8%). The majority of cases were of moderate severity (65.1%), while 18.6% had severe reaction with 1 death recorded. Most cases were not preventable (76.7%). Older age (> 60 years) and mucosal involvement were significantly associated with a more severe reaction. The incidence of cADRs was 0.4%, with most cases classified as moderate severity and not preventable. The commonest reaction pattern was DRESS, while the main culprit drug group was antibiotics. Older age and mucosal membrane involvement predicts a severe drug reaction.

  2. Radiology of adverse reactions to drugs and toxic hazards

    International Nuclear Information System (INIS)

    Ansell, G.

    1989-01-01

    The book reviews the contribution offered by radiological methods to detection of lesions, confirmation of tentative diagnoses, and differentiation of lesions. The radiological methods discussed cover the conventional roentgenology as well as computed tomography, ultrasonography, scintiscanning, and NMR tomography, which are the useful tools for the very important task, to detect and define the manifestations of adverse reactions and toxic hazards, in order to commence treatment in time. (orig.) With 154 figs [de

  3. Reactions of inorganic free radicals with liver protecting drugs

    International Nuclear Information System (INIS)

    Gyoergy, I.; Foeldiak, G.; Blazovics, A.; Feher, J.

    1990-01-01

    Liver protecting drugs, silibinin, a flavonolignane, and the dihydroquinoline derivatives, CH 402 and MTDQ-DA, were shown to inhibit processes in which enzymatically or non-enzymatically generated free radicals were involved. Inorganic free radicals (N 3 , (SCN) 2 - , OH, Trp, CO 2 - , O 2 - ) produced by pulse radiolysis readily react with the compounds, which transform into exceptionally long-lived, unreactive transients. Time evolution of the UV and visible spectra indicate that oxidising radicals form a phenoxyl type radical from silibinin, while OH forms an adduct by attacking, simultaneously, at various sites of the molecule. Superoxide radicals reduce silibinin and oxidise CH 402 and MTDQ-DA. It is concluded that the drugs might exhibit antioxidant behavior in living systems. (author)

  4. Unpredictable drug reaction in a child with Cornelia de Lange syndrome.

    Science.gov (United States)

    Stevic, Marija; Milojevic, Irina; Bokun, Zlatko; Simic, Dusica

    2015-02-01

    Preoperative use of midazolam sedation is mandatory during induction of anesthesia in noncooperative and hyperactive children to prevent possible obstacles. Unusual drug reactions rarely occur in patients undergoing anesthesia or in intensive care unit. This report describes an unpredictable drug reaction after a routine midazolam premedication in a patient with no history of allergy. There has been no literature data yet to show that midazolam can provoke respiratory problems in patients with Cornelia de Lange Syndrome. In our opinion midazolam should be avoided in patients with Cornelia de Lange Syndrome, which we enforced after first unpredictable reaction.

  5. Relationship among reaction rate, release rate and efficiency of nanomachine-based targeted drug delivery.

    Science.gov (United States)

    Zhao, Qingying; Li, Min; Luo, Jun

    2017-12-04

    In nanomachine applications towards targeted drug delivery, drug molecules released by nanomachines propagate and chemically react with tumor cells in aqueous environment. If the nanomachines release drug molecules faster than the tumor cells react, it will result in loss and waste of drug molecules. It is a potential issue associated with the relationship among reaction rate, release rate and efficiency. This paper aims to investigate the relationship among reaction rate, release rate and efficiency based on two drug reception models. We expect to pave a way for designing a control method of drug release. We adopted two analytical methods that one is drug reception process based on collision with tumors and another is based on Michaelis Menten enzymatic kinetics. To evaluate the analytical formulations, we used the well-known simulation framework N3Sim to establish simulations. The analytical results of the relationship among reaction rate, release rate and efficiency is obtained, which match well with the numerical simulation results in a 3-D environment. Based upon two drug reception models, the results of this paper would be beneficial for designing a control method of nanomahine-based drug release.

  6. Cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia.

    Science.gov (United States)

    Ding, Wen Yi; Lee, Chew Kek; Choon, Siew Eng

    2010-07-01

    Adverse drug reactions are most commonly cutaneous in nature. Patterns of cutaneous adverse drug reactions (ADRs) and their causative drugs vary among the different populations previously studied. Our aim is to determine the clinical pattern of drug eruptions and the common drugs implicated, particularly in severe cutaneous ADRs in our population. This study was done by analyzing the database established for all adverse cutaneous drug reactions seen from January 2001 until December 2008. A total of 281 cutaneous ADRs were seen in 280 patients. The most common reaction pattern was maculopapular eruption (111 cases, 39.5%) followed by Stevens-Johnson Syndrome (SJS: 79 cases, 28.1%), drug reaction with eosinophilia and systemic symptoms (DRESS: 19 cases, 6.8%), toxic epidermal necrolysis (TEN: 16 cases, 5.7 %), urticaria/angioedema (15 cases, 5.3%) and fixed drug eruptions (15 cases, 5.3%). Antibiotics (38.8%) and anticonvulsants (23.8%) accounted for 62.6% of the 281 cutaneous ADRs seen. Allopurinol was implicated in 39 (13.9%), carbamazepine in 29 (10.3%), phenytoin in 27 (9.6%) and cotrimoxazole in 26 (9.3%) cases. Carbamazepine, allopurinol and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 24.0%, 18.8% and 12.5% respectively of the 96 cases seen whereas DRESS was mainly caused by allopurinol (10 cases, 52.6%) and phenytoin (3 cases, 15.8%). The reaction patterns and drugs causing cutaneous ADRs in our population are similar to those seen in other countries although we have a much higher proportion of severe cutaneous ADRs probably due to referral bias, different prescribing habit and a higher prevalence of HLA-B*1502 and HLA-B*5801 which are genetic markers for carbamazepine-induced SJS/TEN and allopurinol-induced SJS/TEN/DRESS respectively. The most common reaction pattern seen in our study population was maculopapular eruptions. Antibiotics, anticonvulsants and NSAIDs were the most frequently implicated drug groups. Carbamazepine

  7. Drug-related mortality in Denmark 1970-93

    DEFF Research Database (Denmark)

    Juel, K; Helweg-Larsen, K

    1999-01-01

    We analysed drug-related mortality in Denmark with respect to secular trends, gender, and regional variations, for the period 1970-93, for all deaths from poisoning and among drug addicts. The study was based on the Register of Causes of Death in Denmark and included 6,229 drug-related deaths...

  8. Pattern of adverse drug reactions reported by the community pharmacists in Nepal

    Directory of Open Access Journals (Sweden)

    Palaian S

    2010-09-01

    Full Text Available The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61 KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4 maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males were reported. Antibiotics/ antibacterials caused 42% (n=37 of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20, followed by generalized edema [8.6 % (n=10]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49 of the cases. Over two third (69% of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4% were of ‘mild (level 2’ type. Nearly two third [64.7 % (n=46] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen

  9. Pharmacist intervention in drug-related problems for patients with ...

    African Journals Online (AJOL)

    Trop J Pharm Res, October 2016; 15(10): 2275. Tropical Journal of ... medication errors in irrational drug use, while patient adherence ..... Drug-related problems identified from geriatric medication safety ... Ann. Pharmacother. 2005; 39:1423-.

  10. Detection of Adverse Reaction to Drugs in Elderly Patients through Predictive Modeling

    Directory of Open Access Journals (Sweden)

    Rafael San-Miguel Carrasco

    2016-03-01

    Full Text Available Geriatrics Medicine constitutes a clinical research field in which data analytics, particularly predictive modeling, can deliver compelling, reliable and long-lasting benefits, as well as non-intuitive clinical insights and net new knowledge. The research work described in this paper leverages predictive modeling to uncover new insights related to adverse reaction to drugs in elderly patients. The differentiation factor that sets this research exercise apart from traditional clinical research is the fact that it was not designed by formulating a particular hypothesis to be validated. Instead, it was data-centric, with data being mined to discover relationships or correlations among variables. Regression techniques were systematically applied to data through multiple iterations and under different configurations. The obtained results after the process was completed are explained and discussed next.

  11. Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

    Science.gov (United States)

    Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

    2013-01-01

    Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

  12. A reaction limited in vivo dissolution model for the study of drug absorption: Towards a new paradigm for the biopharmaceutic classification of drugs.

    Science.gov (United States)

    Macheras, Panos; Iliadis, Athanassios; Melagraki, Georgia

    2018-05-30

    The aim of this work is to develop a gastrointestinal (GI) drug absorption model based on a reaction limited model of dissolution and consider its impact on the biopharmaceutic classification of drugs. Estimates for the fraction of dose absorbed as a function of dose, solubility, reaction/dissolution rate constant and the stoichiometry of drug-GI fluids reaction/dissolution were derived by numerical solution of the model equations. The undissolved drug dose and the reaction/dissolution rate constant drive the dissolution rate and determine the extent of absorption when high-constant drug permeability throughout the gastrointestinal tract is assumed. Dose is an important element of drug-GI fluids reaction/dissolution while solubility exclusively acts as an upper limit for drug concentrations in the lumen. The 3D plots of fraction of dose absorbed as a function of dose and reaction/dissolution rate constant for highly soluble and low soluble drugs for different "stoichiometries" (0.7, 1.0, 2.0) of the drug-reaction/dissolution with the GI fluids revealed that high extent of absorption was found assuming high drug- reaction/dissolution rate constant and high drug solubility. The model equations were used to simulate in vivo supersaturation and precipitation phenomena. The model developed provides the theoretical basis for the interpretation of the extent of drug's absorption on the basis of the parameters associated with the drug-GI fluids reaction/dissolution. A new paradigm emerges for the biopharmaceutic classification of drugs, namely, a model independent biopharmaceutic classification scheme of four drug categories based on either the fulfillment or not of the current dissolution criteria and the high or low % drug metabolism. Copyright © 2018. Published by Elsevier B.V.

  13. Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.

    Science.gov (United States)

    Awodele, Olufunsho; Ibrahim, Ali; Orhii, Paul

    2016-03-16

    Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals. A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17. Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia. More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.

  14. E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.

    Science.gov (United States)

    Neubert, Antje; Dormann, Harald; Prokosch, Hans-Ulrich; Bürkle, Thomas; Rascher, Wolfgang; Sojer, Reinhold; Brune, Kay; Criegee-Rieck, Manfred

    2013-09-01

    Computer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity. A computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients. A total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively. This study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

  15. Retrospective clinical analysis of adverse drug reactions associated ...

    African Journals Online (AJOL)

    Rentia van Graan

    Pty) Ltd and Informa UK Limited ... aimed to identify, classify and analyse the prevalence of ART-related ADRs. ... HIV, are at an increased risk of experiencing ADRs that can be ... Ethics approval was granted by the Human Research Ethics.

  16. The social construction of drug-related death.

    Science.gov (United States)

    Cruts

    2000-12-01

    This article invites you to a social constructionist view on the issue of drug-related death. Social constructionism is often misunderstood for denying plain facts. It sure is a fact that there are deadly doses of legal and illegal substances. In this sense it is a truism that drugs kill people. Nonetheless, it is argued that reducing the causes of death to a certain drug as the essential underlying cause of death is a social construction. A case is discussed to demonstrate that a drug-related death can just as well be seen as a free-market death. Free markets kill people at least as much as drugs do. It is argued that drug-related death is a social construction, because attributing a death to a drug is based on unfalsifiable counterfactual thinking. Counterfactual thoughts about what the world would look like if there were no drugs, are seen as expressing one's view of life.

  17. Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

    Science.gov (United States)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G M; Dheda, Mukesh; Haaijer-Ruskamp, Flora M; Taxis, Katja; Mol, Peter G M

    2015-06-01

    Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.' © 2015 John Wiley & Sons Ltd.

  18. Automatic mimicry reactions as related to differences in emotional empathy.

    Science.gov (United States)

    Sonnby-Borgström, Marianne

    2002-12-01

    The hypotheses of this investigation were derived by conceiving of automatic mimicking as a component of emotional empathy. Differences between subjects high and low in emotional empathy were investigated. The parameters compared were facial mimicry reactions, as represented by electromyographic (EMG) activity when subjects were exposed to pictures of angry or happy faces, and the degree of correspondence between subjects' facial EMG reactions and their self-reported feelings. The comparisons were made at different stimulus exposure times in order to elicit reactions at different levels of information processing. The high-empathy subjects were found to have a higher degree of mimicking behavior than the low-empathy subjects, a difference that emerged at short exposure times (17-40 ms) that represented automatic reactions. The low-empathy subjects tended already at short exposure times (17-40 ms) to show inverse zygomaticus muscle reactions, namely "smiling" when exposed to an angry face. The high-empathy group was characterized by a significantly higher correspondence between facial expressions and self-reported feelings. No differences were found between the high- and low-empathy subjects in their verbally reported feelings when presented a happy or an angry face. Thus, the differences between the groups in emotional empathy appeared to be related to differences in automatic somatic reactions to facial stimuli rather than to differences in their conscious interpretation of the emotional situation.

  19. Reaction mixtures formed by nitrite and selected sulfa-drugs showed mutagenicity in acidic medium

    Directory of Open Access Journals (Sweden)

    Claudia Trossero

    2009-01-01

    Full Text Available Nitrite, which is present in preserved meat and can be produced in the oral cavity by reduction of nitrate taken from vegetables, could react in stomach with nitrosatable drugs, giving genotoxic-carcinogenic N-nitroso compounds (NOC. The mutagenicity of reaction mixtures formed by sodium nitrite and selected sulfa-drugs (sulfathiazole, HST; phtalylsulfathiazole, PhST; complex Co(II-sulfathiazole, Co(II-ST in acidic medium was evaluated using the Salmonella typhimurium reverse mutation assay (Ames test, with TA98 and TA 100 strains. The reactions were carried out at room temperature, with a mole ratio [nitrite]/[sulfa-drug] > 1. The three reaction mixtures showed mutagenic effects in the considered range.

  20. Mining adverse drug reactions from online healthcare forums using hidden Markov model.

    Science.gov (United States)

    Sampathkumar, Hariprasad; Chen, Xue-wen; Luo, Bo

    2014-10-23

    Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. Current post-marketing drug surveillance methods, which are based purely on voluntary spontaneous reports, are unable to provide the early indications necessary to prevent the occurrence of such injuries or fatalities. The objective of this research is to extract reports of adverse drug side-effects from messages in online healthcare forums and use them as early indicators to assist in post-marketing drug surveillance. We treat the task of extracting adverse side-effects of drugs from healthcare forum messages as a sequence labeling problem and present a Hidden Markov Model(HMM) based Text Mining system that can be used to classify a message as containing drug side-effect information and then extract the adverse side-effect mentions from it. A manually annotated dataset from http://www.medications.com is used in the training and validation of the HMM based Text Mining system. A 10-fold cross-validation on the manually annotated dataset yielded on average an F-Score of 0.76 from the HMM Classifier, in comparison to 0.575 from the Baseline classifier. Without the Plain Text Filter component as a part of the Text Processing module, the F-Score of the HMM Classifier was reduced to 0.378 on average, while absence of the HTML Filter component was found to have no impact. Reducing the Drug names dictionary size by half, on average reduced the F-Score of the HMM Classifier to 0.359, while a similar reduction to the side-effects dictionary yielded an F-Score of 0.651 on average. Adverse side-effects mined from http://www.medications.com and http://www.steadyhealth.com were found to match the Adverse Drug Reactions on the Drug Package Labels of several drugs. In addition, some novel adverse side-effects, which can be potential Adverse Drug Reactions, were also

  1. Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2016-07-01

    We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals over time. We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines. We assessed the levels of evidence on which withdrawals were based using the Oxford Center for Evidence Based Medicine Levels of Evidence. Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide. Anecdotal reports were cited as evidence for withdrawal in 30 (75%) and deaths occurred in 27 (68%). Hepatic, cardiac, and nervous system toxicity accounted for over 60% of withdrawals. In 28 cases, the first withdrawal was initiated by the manufacturer. The median interval between the first report of an adverse drug reaction that led to withdrawal and the first withdrawal was 1 year (range 0-43 years). Worldwide withdrawals occurred within 1 year after the first withdrawal in any country. In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time. However, there are inconsistencies in current withdrawal procedures when adverse drug reactions are suspected. A uniform method for establishing worldwide withdrawal of approved medicinal products when adverse drug reactions are suspected should be developed, to facilitate global withdrawals. Rapid synthesis of the evidence on harms should be a priority when serious adverse reactions are suspected.

  2. Drug desensitization in the management of hypersensitivity reactions to monoclonal antibodies and chemotherapy.

    Science.gov (United States)

    Mezzano, Veronica; Giavina-Bianchi, Pedro; Picard, Matthieu; Caiado, Joana; Castells, Mariana

    2014-04-01

    Hypersensitivity reactions to monoclonal antibodies and chemotherapy, which may vary in severity from mild to life-threatening, can lead to their discontinuation and replacement by alternative agents that are often less effective, more toxic, and/or more expensive. Drug desensitization has emerged as the best treatment modality capable of allowing re-introduction of the hypersensitivity reaction-inducing medication in highly sensitized patients in need of first line therapies. In recent years, the availability of new anti-neoplastic drugs and therapeutic monoclonal antibodies has increased, as has the potential for hypersensitivity reactions. Development of desensitization protocols for these new medications requires a careful assessment of the potential risks and benefits. The purposes of this review are to provide an overview of the presentation of hypersensitivity reactions amenable to desensitization and to increase awareness of the indications for and outcomes of desensitization protocols. Rapid drug desensitization has proven to be a safe and effective way of administering first line therapy to patients with hypersensitivity reactions, providing an extremely powerful treatment modality for patients for whom alternative drugs are deemed unacceptable. Rapid drug desensitization protocols should be administered only by highly trained allergists and nurses who have experience in determining which reactions are amenable to desensitization, and can identify high risk patients and provide them with appropriate care. Efforts should be made to increase awareness of the remarkable safety and efficacy of rapid drug desensitization among non-allergists, especially in the fields of oncology and rheumatology, so as to favor its universal application. Development of desensitization units to provide state-of-the-art care is possible only through coordinated teamwork.

  3. Full-course drug challenge test in the diagnosis of delayed allergic reactions to penicillin.

    Science.gov (United States)

    Borch, Jakob E; Bindslev-Jensen, Carsten

    2011-01-01

    Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy. To improve sensitivity of the diagnostic work-up in diagnosing penicillin allergics with histories of allergic reactions on day 2 or later in the course of penicillin treatment. A full-course DCT was added to the current protocol if specific IgE, skin tests and DCT were all negative in patients who had a nonimmediate reaction to penicillin treatment. Sixteen patients with a history of an immediate reaction to penicillin treatment underwent testing with negative outcomes. Fifty percent of patients undergoing full-course DCT experienced a cutaneous adverse drug reaction. None of the controls reacted (p = 0.001). The mean time of reaction was 6 days. Penicillin V accounted for most reactions. Urticaria was the most frequent clinical reaction observed. Full-course DCT offers an improvement of sensitivity and predictive values of the diagnostic work-up of allergic reactions to penicillin occurring on day 2 of penicillin treatment or later. Copyright © 2011 S. Karger AG, Basel.

  4. Vertigo/dizziness as a Drugs? adverse reaction

    OpenAIRE

    Chimirri, Serafina; Aiello, Rossana; Mazzitello, Carmela; Mumoli, Laura; Palleria, Caterina; Altomonte, Mariolina; Citraro, Rita; De Sarro, Giovambattista

    2013-01-01

    Introduction: Vertigo, dizziness, and nausea encompass a spectrum of balance-related symptoms caused by a variety of etiologies. Balance is affected by many systems: Proprioceptive pathways and visual, cerebellar, vestibulocochlear, and vascular / vasovagal systems. Vertigo is a subtype of dizziness, in which a subject, as a result to a dysfunction of the vestibular system, improperly experiments the perception of motion. The most useful clinical subdivision is to categorize vertigo into true...

  5. Reaction time in relation to duration of heroin abuse

    Directory of Open Access Journals (Sweden)

    Martinović-Mitrović Slađana

    2011-01-01

    Full Text Available Introduction. Consequences of heroin abuse include organic damage of cerebral structures. The level of impairments is in a direct and positive relation with the length of heroin abuse. Objective. The aim of this research was the evaluation of the reaction time with heroin addicts with different length of substance abuse. Methods. Research method: 90 examinees were divided into three groups with relation to the length of heroin abuse. Data collection included a questionnaire referring to socio-demographic and addictive characteristics. A specially designed programme was used for the evaluation of reaction time to audio/ visual signal. Results. In relation to the reaction time as overall model, the difference between examinees with different length of heroin abuse can be found on the marginal level of significance (F=1.69; df=12; p=0.07. In visual modality, with the increase of length of heroin abuse leads to a significant prolongation of simple (the first visual sign: F=3.29; df=2; p=0.04 and choice reaction time (the second visual sign: F=4.97; df=2; p=0.00; the third visual sign: F=3.08; df=2; p=0.05. Longer heroin consumption also leads to the prolongation of the simple (the first auditory task: F=3.41; df=2; p=0.04 and the complex auditory reaction time (the second auditory task: F=5.67; df=2; p=0.01; the third auditory task: F=6.42; df=2; p=0.00. Conclusion. Heroin abuse leads to the prolongation of both simple and choice reaction time in visual as well as auditory modality. The average daily dose of opiates was the most important predictor of the abovementioned cognitive dysfunction.

  6. [High activity antiretroviral therapy change associated to adverse drug reactions in a specialized center in Venezuela].

    Science.gov (United States)

    Subiela, José D; Dapena, Elida

    2016-03-01

    Adverse drug reactions (ADRs) represent the first cause of change of the first-line highly active antiretroviral therapy (HAART) regimen, therefore, they constitute the main limiting factor in the long-term follow up of HIV patients in treatment. A retrospective study was carried out in a specialized center in Lara State, Venezuela, including 99 patients over 18 years of age who had change of first-line HAART regimen due to ADRs, between 2010 and 2013. The aims of this research were to describe the sociodemographic and clinical variables, frequency of ADRs related to change of HAART, duration of the first-line HAART regimen, to determine the drugs associated with ARVs and to identify the risk factors. The ADRs constituted 47.5% of all causes of change of first-line HAART regimen, the median duration was 1.08±0.28 years. The most frequent ADRs were anemia (34.3%), hypersensitivity reactions (20.2%) and gastrointestinal intolerance (13.1%). The most frequent ARV regimen type was the protease inhibitors-based regimen (59.6%), but zidovudine was the ARV most linked to ADRs (41.4%). The regression analysis showed increased risk of ADRs in singles and students in the univariate analysis and heterosexuals and homosexuals in multivariate analysis; and decreased risk in active workers. The present work shows the high prevalence of ADRs in the studied population and represents the first case-based study that describes the pharmacoepidemiology of a cohort of HIV-positive patients treated in Venezuela.

  7. Reações alérgicas a medicamentos Allergic drug reactions

    Directory of Open Access Journals (Sweden)

    Aparecida T. Nagao-Dias

    2004-08-01

    , por meio de ações de farmacovigilância, bem como a identificação dos possíveis mecanismos imunológicos envolvidos através de testes laboratoriais, história e avaliação clínica detalhadas.OBJECTIVE: This review addresses the most recent published literature regarding drug allergy, in order to provide physicians with a background for a better understanding of this problem of great relevance for public health. SOURCES OF DATA: The sources of data for obtaining the original and review articles published in the last 10 years were MEDLINE, Pubmed and Lilacs. The articles chosen for this review relate drug allergy to immunological mechanisms, epidemiology, clinical and laboratory evaluation, skin lesions, clinical management, and re-exposure to the drug. SUMMARY OF THE FINDINGS: Allergic reactions represent one third of adverse drug reactions. They are considered rare but with high morbimortality. Gell & Coombs' definition has been useful for classifying some types of drug allergic reactions; however, some still remain without classification because of poor knowledge of the mechanisms involved. The existence of T cell subpopulations with diverse characteristics reveals the complexity of the subject and, at the same time, elucidates several questions raised about it. It was recently postulated a new concept of chemically inert drug presentation to T cells, restricted to the major histocompatibility complex, but in a non-covalent and labile way. In clinical practice, without adequate laboratory tests, it is difficult to correlate clinical symptoms and immunological mechanisms. In vitro and in vivo skin tests have been employed in cases of suspected drug allergy reaction. However, there are very few commercially available reagents. CONCLUSIONS: Drug allergy constitutes an important problem in adverse drug reactions because of its potential of morbidity and mortality. It is necessary to emphasize the relevance of pharmacovigilance during treatment of patients, as

  8. Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

    Science.gov (United States)

    Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

    2015-04-01

    Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

  9. Cases of Adverse Reaction to Psychotropic Drugs and Possible Association with Pharmacogenetics

    Directory of Open Access Journals (Sweden)

    Irina Piatkov

    2012-10-01

    Full Text Available Thousands of samples for pharmacogenetic tests have been analysed in our laboratory since its establishment. In this article we describe some of the most interesting cases of CYP poor metabolisers associated with adverse reactions to psychotropic drugs. Prevention of disease/illness, including Adverse Drug Reaction (ADR, is an aim of modern medicine. Scientific data supports the fact that evaluation of drug toxicology includes several factors, one of which is genetic variations in pharmacodynamics and pharmacokinetics of drug pathways. These variations are only a part of toxicity evaluation, however, even if it would help to prevent only a small percentage of patients from suffering adverse drug reactions, especially life threatening ADRs, pharmacogenetic testing should play a significant role in any modern psychopharmacologic practice. Medical practitioners should also consider the use of other medications or alternative dosing strategies for drugs in patients identified as altered metabolisers. This will promise not only better and safer treatments for patients, but also potentially lowering overall healthcare costs.

  10. Patch testing in non-immediate cutaneous adverse drug reactions: value of extemporaneous patch tests.

    Science.gov (United States)

    Assier, Haudrey; Valeyrie-Allanore, Laurence; Gener, Gwendeline; Verlinde Carvalh, Muriel; Chosidow, Olivier; Wolkenstein, Pierre

    2017-11-01

    Patch testing following a standardized protocol is reliable for identifying the culprit drug in cutaneous adverse drug reactions (CADRs). However, these patch tests (PTs) require pharmaceutical material and staff, which are not always easily available. To evaluate an extemporaneous PT method in CADRs. We retrospectively analysed data for all patients referred to our department between March 2009 and June 2013 for patch testing after a non-immediate CADR. The patients who supplied their own suspected drugs were tested both with extemporaneous PTs and with conventional PTs. Extemporaneous PTs involved a nurse crushing and diluting the drug in pet. in a ratio of approximately one-third to two-thirds. Standardized PTs were performed according to guidelines, with commercial drugs diluted to 30% or with active ingredients diluted to 10%. We analysed the data for the two PT methods in terms of the number of positive test reactions, drugs tested, and type of CADR for patients in whom the two PT methods were used. In total, 75 of 156 patients underwent the two PT procedures, including 91 double tests. Overall, 21 tests gave positive reactions with the two methods, and 69 other tests gave negative results with the two methods. Our series yielded results similar to those of published series concerning the types of CADR and the drugs responsible. Our results suggest that, for CADRs, if a patient supplies a suspected drug but if the pharmaceutical material and staff are not available for conventional PTs, extemporaneous PTs performed by the nurse with the commercial drug used by the patient can be useful and reliable. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Risk factors for adverse drug reactions in pediatric inpatients: A cohort study.

    Science.gov (United States)

    Andrade, Paulo Henrique Santos; Lobo, Iza Maria Fraga; da Silva, Wellington Barros

    2017-01-01

    The present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients. A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0-14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used. A total of 173 children (208 admissions) and 66 ADR classified as "definite" and "probable" were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19-5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21-20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08-6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40-10.56) were identified risk factors for ADR. We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.

  12. Risk factors for adverse drug reactions in pediatric inpatients: A cohort study.

    Directory of Open Access Journals (Sweden)

    Paulo Henrique Santos Andrade

    Full Text Available The present study aims to identify the risk factors for adverse drug reactions (ADR in pediatric inpatients.A prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0-14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used.A total of 173 children (208 admissions and 66 ADR classified as "definite" and "probable" were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%. In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR 2.44; 95% confidence interval (CI 1.19-5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21-20.54, antibacterial for systemic use (HR 2.75; 95% CI 1.08-6.98 and antiepileptic drugs (HR 3.84; 95% CI 1.40-10.56 were identified risk factors for ADR.We identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.

  13. The socioeconomic impact of drug-related crimes in Chile.

    Science.gov (United States)

    Fernández, Matías

    2012-11-01

    Illegal drug use and trafficking are closely connected to crime. This article estimates the socioeconomic impact of this connection in Chile. Goldstein's tripartite model was applied quantifying drug-crime connections and then using those estimates to measure the socioeconomic impact of drug-related crimes. This was estimated in terms of both the monetary cost of law enforcement, and lost productivity due to incarceration. This socioeconomic impact can be divided into: (a) the direct costs arising from infractions to Chile's Drug Law, and the indirect costs originated by crimes linked only partially to drug consumption and trafficking; (b) is measured in productivity losses, as well as in costs to the three branches of Chile's criminal justice system (police, judiciary, and prisons); and (c) is attributed to the three illicit drugs most prevalent in Chile: cannabis, cocaine hydrochloride (CH) and cocaine base paste (CBP). The socioeconomic impact of Chile's drug-crime relationship in 2006 is estimated to be USD 268 million. Out of this amount, 36% is spent on national Drug Law enforcement, and the remaining 64% comes from the connection of drug use and trafficking with non-Drug-Law-related crimes. The police bear the largest share of drug enforcement costs (32%), followed by penitentiaries (25%). Productivity losses due to incarceration for drug-related crimes represent 29% of the total impact. 53% of the costs are attributable to CBP, 29% to CH, and the remaining 18% to cannabis. The impact of CBP is greater when indirect costs are taken into account, although direct costs are primarily associated with CH. The majority of costs is attributed to the trafficking and consumption of CBP, a drug with a relatively low prevalence. Based on the results, this study suggests reviewing drug enforcement policies to differentiate them according to the social and individual harm caused by each drug. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Relating derived relations as a model of analogical reasoning: reaction times and event-related potentials.

    Science.gov (United States)

    Barnes-Holmes, Dermot; Regan, Donal; Barnes-Holmes, Yvonne; Commins, Sean; Walsh, Derek; Stewart, Ian; Smeets, Paul M; Whelan, Robert; Dymond, Simon

    2005-11-01

    The current study aimed to test a Relational Frame Theory (RFT) model of analogical reasoning based on the relating of derived same and derived difference relations. Experiment 1 recorded reaction time measures of similar-similar (e.g., "apple is to orange as dog is to cat") versus different-different (e.g., "he is to his brother as chalk is to cheese") derived relational responding, in both speed-contingent and speed-noncontingent conditions. Experiment 2 examined the event-related potentials (ERPs) associated with these two response patterns. Both experiments showed similar-similar responding to be significantly faster than different-different responding. Experiment 2 revealed significant differences between the waveforms of the two response patterns in the left-hemispheric prefrontal regions; different-different waveforms were significantly more negative than similar-similar waveforms. The behavioral and neurophysiological data support the RFT prediction that, all things being equal, similar-similar responding is relationally "simpler" than, and functionally distinct from, different-different analogical responding. The ERP data were fully consistent with findings in the neurocognitive literature on analogy. These findings strengthen the validity of the RFT model of analogical reasoning and supplement the behavior-analytic approach to analogy based on the relating of derived relations.

  15. Ultrasound-mediated drug delivery by gas bubbles generated from a chemical reaction.

    Science.gov (United States)

    Lee, Sungmun; Al-Kaabi, Leena; Mawart, Aurélie; Khandoker, Ahsan; Alsafar, Habiba; Jelinek, Herbert F; Khalaf, Kinda; Park, Ji-Ho; Kim, Yeu-Chun

    2018-02-01

    Highly echogenic and ultrasound-responsive microbubbles such as nitrogen and perfluorocarbons have been exploited as ultrasound-mediated drug carriers. Here, we propose an innovative method for drug delivery using microbubbles generated from a chemical reaction. In a novel drug delivery system, luminol encapsulated in folate-conjugated bovine serum albumin nanoparticles (Fol-BSAN) can generate nitrogen gas (N 2 ) by chemical reaction when it reacts with hydrogen peroxide (H 2 O 2 ), one of reactive oxygen species (ROS). ROS plays an important role in the initiation and progression of cancer and elevated ROS have been observed in cancer cells both in vitro and in vivo. High-intensity focussed ultrasound (HIFU) is used to burst the N 2 microbubbles, causing site-specific delivery of anticancer drugs such as methotrexate. In this research, the drug delivery system was optimised by using water-soluble luminol and Mobil Composition of Matter-41 (MCM-41), a mesoporous material, so that the delivery system was sensitive to micromolar concentrations of H 2 O 2 . HIFU increased the drug release from Fol-BSAN by 52.9 ± 2.9% in 10 minutes. The cytotoxicity of methotrexate was enhanced when methotrexate is delivered to MDA-MB-231, a metastatic human breast cancer cell line, using Fol-BSAN with HIFU. We anticipate numerous applications of chemically generated microbubbles for ultrasound-mediated drug delivery.

  16. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  17. Perceived antecedents of emotional reactions in inter-ethnic relations.

    Science.gov (United States)

    Dijker, A J; Koomen, W; van den Heuvel, H; Frijda, N H

    1996-06-01

    It is argued that the aspects of intergroup relations that potentially can arouse emotions in the perceiver are likely to become central and motivationally relevant elements of group stereotypes. Asking participants to report on the perceived antecedents of their emotional reactions to in-group and out-group members should therefore be an especially useful method to reveal the content of stereotypes. Native Dutch participants reported both the frequencies with which different emotions were felt in different intergroup relations and the perceived causes of these emotions. Analysis of self-reported antecedents of emotional reactions revealed that (a) despite a general in-group favourability bias, both the in-group and the two out-groups employed arouse different kinds of negative and positive emotions; and (b) differences in emotional reactions to the two out-groups are related to salient differences in perceived antecedents between these groups. Theoretical and practical implications of the present emphasis on the cognitive foundation of emotion in intergroup relations are discussed.

  18. A cross-sectional study of cutaneous drug reactions in a private ...

    African Journals Online (AJOL)

    2011-07-20

    Jul 20, 2011 ... in a private dental college and government medical ... Materials and Methods: The study was carried out in the department of Oral and Maxillofacial surgery in a Private dental ... maculopapular rash, all other skin reactions were observed more ... status of lesions on withdrawal of drug, associated mucosal.

  19. Adverse drug reactions in older patients during hospitalisation: are they predictable?

    LENUS (Irish Health Repository)

    O'Connor, Marie N

    2012-11-01

    adverse drug reactions (ADRs) are a major cause of morbidity and healthcare utilisation in older people. The GerontoNet ADR risk score aims to identify older people at risk of ADRs during hospitalisation. We aimed to assess the clinical applicability of this score and identify other variables that predict ADRs in hospitalised older people.

  20. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European...... consumer for nervous system medications....

  1. Sex-dimorphic adverse drug reactions to immune suppressive agents in inflammatory bowel disease

    NARCIS (Netherlands)

    Z. Zelinkova (Zuzana); E. Bultman (Evelien); L. Vogelaar (Lauran); C. Bouziane (Cheima); E.J. Kuipers (Ernst); C.J. van der Woude (Janneke)

    2012-01-01

    textabstractAIM: To analyze sex differences in adverse drug reactions (ADR) to the immune suppressive medication in inflammatory bowel disease (IBD) patients. METHODS: All IBD patients attending the IBD outpatient clinic of a referral hospital were identifed through the electronic diagnosis

  2. A dataset of 200 structured product labels annotated for adverse drug reactions.

    Science.gov (United States)

    Demner-Fushman, Dina; Shooshan, Sonya E; Rodriguez, Laritza; Aronson, Alan R; Lang, Francois; Rogers, Willie; Roberts, Kirk; Tonning, Joseph

    2018-01-30

    Adverse drug reactions (ADRs), unintended and sometimes dangerous effects that a drug may have, are one of the leading causes of morbidity and mortality during medical care. To date, there is no structured machine-readable authoritative source of known ADRs. The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA). We present the curation process and the structure of the publicly available database SPL-ADR-200db containing 5,098 distinct ADRs. The database is available at https://bionlp.nlm.nih.gov/tac2017adversereactions/; the code for preparing and validating the data is available at https://github.com/lhncbc/fda-ars.

  3. DL-ADR: a novel deep learning model for classifying genomic variants into adverse drug reactions.

    Science.gov (United States)

    Liang, Zhaohui; Huang, Jimmy Xiangji; Zeng, Xing; Zhang, Gang

    2016-08-10

    Genomic variations are associated with the metabolism and the occurrence of adverse reactions of many therapeutic agents. The polymorphisms on over 2000 locations of cytochrome P450 enzymes (CYP) due to many factors such as ethnicity, mutations, and inheritance attribute to the diversity of response and side effects of various drugs. The associations of the single nucleotide polymorphisms (SNPs), the internal pharmacokinetic patterns and the vulnerability of specific adverse reactions become one of the research interests of pharmacogenomics. The conventional genomewide association studies (GWAS) mainly focuses on the relation of single or multiple SNPs to a specific risk factors which are a one-to-many relation. However, there are no robust methods to establish a many-to-many network which can combine the direct and indirect associations between multiple SNPs and a serial of events (e.g. adverse reactions, metabolic patterns, prognostic factors etc.). In this paper, we present a novel deep learning model based on generative stochastic networks and hidden Markov chain to classify the observed samples with SNPs on five loci of two genes (CYP2D6 and CYP1A2) respectively to the vulnerable population of 14 types of adverse reactions. A supervised deep learning model is proposed in this study. The revised generative stochastic networks (GSN) model with transited by the hidden Markov chain is used. The data of the training set are collected from clinical observation. The training set is composed of 83 observations of blood samples with the genotypes respectively on CYP2D6*2, *10, *14 and CYP1A2*1C, *1 F. The samples are genotyped by the polymerase chain reaction (PCR) method. A hidden Markov chain is used as the transition operator to simulate the probabilistic distribution. The model can perform learning at lower cost compared to the conventional maximal likelihood method because the transition distribution is conditional on the previous state of the hidden Markov

  4. Monitoring of Adverse Drug Reactions Associated with Antihypertensive Medicines at a University Teaching Hospital in New Delhi

    Directory of Open Access Journals (Sweden)

    Fowad Khurshid

    2012-09-01

    Full Text Available Aim To monitor the adverse drug reactions (ADRs caused by antihypertensive medicines prescribed in a university teaching hospital.Methods:he present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO, Government of India.Results:A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29 % than males, 7 (3.64 %. Combination therapy was associated with more number of adverse drug reactions (66.7 % as against monotherapy (33.3 %. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7, followed by diuretics (n = 5, and beta- blockers (n = 4. Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7, followed by torasemide (n = 3. Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8 % followed by musculo-skeletal complaints (23.8 % and gastro-intestinal disorders (14.3 %. Conclusions:The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.

  5. Drug-related death in Denmark in 2007

    DEFF Research Database (Denmark)

    Simonsen, Kirsten Wiese; Hansen, A. Carsten; Rollmann, Dorte

    2011-01-01

    INTRODUCTION: We investigated fatal poisonings among drug addicts in 2007. The cause of death, abuse pattern and geographic differences are presented. MATERIAL AND METHODS: All drug-related deaths examined at the three forensic medicine institutes in Denmark in 2007 were evaluated. RESULTS...... drug use was common. Heroin/morphine, cocaine, amphetamine, cannabis, methadone, benzodiazepines and alcohol were included in the poly-drug use. CONCLUSION: This investigation shows stabilization in the number of fatal poisonings in drug addicts. Geographic differences were observed. Methadone...

  6. Adverse drug reaction prediction using scores produced by large-scale drug-protein target docking on high-performance computing machines.

    Science.gov (United States)

    LaBute, Montiago X; Zhang, Xiaohua; Lenderman, Jason; Bennion, Brian J; Wong, Sergio E; Lightstone, Felice C

    2014-01-01

    Late-stage or post-market identification of adverse drug reactions (ADRs) is a significant public health issue and a source of major economic liability for drug development. Thus, reliable in silico screening of drug candidates for possible ADRs would be advantageous. In this work, we introduce a computational approach that predicts ADRs by combining the results of molecular docking and leverages known ADR information from DrugBank and SIDER. We employed a recently parallelized version of AutoDock Vina (VinaLC) to dock 906 small molecule drugs to a virtual panel of 409 DrugBank protein targets. L1-regularized logistic regression models were trained on the resulting docking scores of a 560 compound subset from the initial 906 compounds to predict 85 side effects, grouped into 10 ADR phenotype groups. Only 21% (87 out of 409) of the drug-protein binding features involve known targets of the drug subset, providing a significant probe of off-target effects. As a control, associations of this drug subset with the 555 annotated targets of these compounds, as reported in DrugBank, were used as features to train a separate group of models. The Vina off-target models and the DrugBank on-target models yielded comparable median area-under-the-receiver-operating-characteristic-curves (AUCs) during 10-fold cross-validation (0.60-0.69 and 0.61-0.74, respectively). Evidence was found in the PubMed literature to support several putative ADR-protein associations identified by our analysis. Among them, several associations between neoplasm-related ADRs and known tumor suppressor and tumor invasiveness marker proteins were found. A dual role for interstitial collagenase in both neoplasms and aneurysm formation was also identified. These associations all involve off-target proteins and could not have been found using available drug/on-target interaction data. This study illustrates a path forward to comprehensive ADR virtual screening that can potentially scale with increasing number

  7. Adverse drug reaction prediction using scores produced by large-scale drug-protein target docking on high-performance computing machines.

    Directory of Open Access Journals (Sweden)

    Montiago X LaBute

    Full Text Available Late-stage or post-market identification of adverse drug reactions (ADRs is a significant public health issue and a source of major economic liability for drug development. Thus, reliable in silico screening of drug candidates for possible ADRs would be advantageous. In this work, we introduce a computational approach that predicts ADRs by combining the results of molecular docking and leverages known ADR information from DrugBank and SIDER. We employed a recently parallelized version of AutoDock Vina (VinaLC to dock 906 small molecule drugs to a virtual panel of 409 DrugBank protein targets. L1-regularized logistic regression models were trained on the resulting docking scores of a 560 compound subset from the initial 906 compounds to predict 85 side effects, grouped into 10 ADR phenotype groups. Only 21% (87 out of 409 of the drug-protein binding features involve known targets of the drug subset, providing a significant probe of off-target effects. As a control, associations of this drug subset with the 555 annotated targets of these compounds, as reported in DrugBank, were used as features to train a separate group of models. The Vina off-target models and the DrugBank on-target models yielded comparable median area-under-the-receiver-operating-characteristic-curves (AUCs during 10-fold cross-validation (0.60-0.69 and 0.61-0.74, respectively. Evidence was found in the PubMed literature to support several putative ADR-protein associations identified by our analysis. Among them, several associations between neoplasm-related ADRs and known tumor suppressor and tumor invasiveness marker proteins were found. A dual role for interstitial collagenase in both neoplasms and aneurysm formation was also identified. These associations all involve off-target proteins and could not have been found using available drug/on-target interaction data. This study illustrates a path forward to comprehensive ADR virtual screening that can potentially scale with

  8. The Impact of Herbal Drug Use on Adverse Drug Reaction Profiles of Patients on Antiretroviral Therapy in Zimbabwe

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    Tinashe Mudzviti

    2012-01-01

    Full Text Available Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART. Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2% of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%, Bidens pilosa (66.0%, Eucalyptus globulus (52.3%, Moringa oleifera (44.1%, Lippia javanica (36.3%, and Peltoforum africanum (34.3%. Two indigenous herbs, Musakavakadzi (OR=0.25; 95% CI 0.076–0.828 and Peltoforum africanum (OR=0.495; 95% CI 0.292–0.839 reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles.

  9. Factors Associated with the Reporting of Adverse Drug Reactions by Health Workers in Nnewi Nigeria

    Science.gov (United States)

    Ezeuko, Amaka Y.; Ebenebe, Uzo E.; Nnebue, Chinomnso C; Ugoji, John O.

    2015-01-01

    Background: Under-reporting of adverse drug reactions (ADRs) by the prescribers is a common public health problem. Monitoring of factors that influence ADR reporting will reduce risks associated with drug use; improve patients care, safety and treatment outcome. The aim of this study was to determine the factors associated with the reporting of ADRs by health workers in Nnewi Nigeria. Methods: A cross-sectional study of 372 health workers in different health facilities in Nnewi North Local Government Area of Anambra state, selected using multistage sampling technique was done. Data collection employed pretested, self-administered structured questionnaires. Data were analyzed using Statistical Package for Social Sciences version 17. Tests of statistical significance were carried out using Chi-square tests for proportions. A P < 0.05 was considered significant. Results: Out of the 372 respondents studied, 255 (68.5%) were females, and 117 (31.5%) were males. The modal age range (37.6%) was 31–40 years. Factors related by the respondents to influence ADR reporting include: Unavailability of electronic reporting (83.6%), unavailability of reporting forms (66.4%) and ignorance (58.2%). The difference among medical practitioners who related unavailability of electronic reporting process as obstacle to ADR reporting was not significant (P = 0.18). Conclusions: The study results revealed the factors associated with the reporting of ADRs among health workers in Nnewi Nigeria. It is desirable to initiate electronic reporting process, training programs on ADR reporting and make reporting forms/guidelines available to relevant health workers. PMID:25949775

  10. DRUG REACTION WITH HERBAL SUPPLEMENT: A POSSIBLE CASE OF DRUG INDUCED LUPUS ERYTHEMATOSUS

    Directory of Open Access Journals (Sweden)

    AZIZ NA

    2010-01-01

    Full Text Available A 24-year-old lady presented with four days history of fever, non-pruritic rash, ankle pain and swelling. She had consumed herbal supplement five days before the onset of symptoms. Examinations revealed erythematous maculo-papular lesions of varying sizes on sun exposed areas. Patient was suspected to have Drug Induced Lupus Erythematosus (DILE and subsequently symptoms subsided rapidly on withholding the herbal medication.

  11. Adverse drug reaction and toxicity caused by commonly used antimicrobials in canine practice

    Directory of Open Access Journals (Sweden)

    K. Arunvikram

    2014-05-01

    Full Text Available An adverse drug reaction (ADR is a serious concern for practicing veterinarians and other health professionals, and refers to an unintended, undesired and unexpected response to a drug that negatively affects the patient's health. It may be iatrogenic or genetically induced, and may result in death of the affected animal. The ADRs are often complicated and unexpected due to myriad clinical symptoms and multiple mechanisms of drug-host interaction. Toxicity due to commonly used drugs is not uncommon when they are used injudiciously or for a prolonged period. Licosamides, exclusively prescribed against anaerobic pyoderma, often ends with diarrhoea and vomiting in canines. Treatment with Penicillin and β-lactam antibiotics induces onset of pemphigious vulgare, drug allergy or hypersensitivity. Chloroamphenicol and aminoglycosides causes Gray's baby syndrome and ototoxicity in puppies, respectively. Aminoglycosides are very often associated with nephrotoxicity, ototoxicity and neuromuscular blockage. Injudicious use of fluroquinones induces the onset of arthropathy in pups at the weight bearing joints. The most effective therapeutic measure in managing ADR is to treat the causative mediators, followed by supportive and symptomatic treatment. So, in this prospective review, we attempt to bring forth the commonly occurring adverse drug reactions, their classification, underlying mechanism, epidemiology, treatment and management as gleaned from the literature available till date and the different clinical cases observed by the authors.

  12. THE PROSPECTIVE OBSERVATIONAL STUDY ON CUTANEOUS ADVERSE DRUG REACTIONS TO CHEMOTHERAPY

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    Prakash Mani

    2016-07-01

    Full Text Available INTRODUCTION There are a wide spectrum of adverse cutaneous drug reactions (ACDRs varying from transient maculopapular rash to fatal toxic epidermal necrolysis (TEN. With the advent of newer and targeted therapy in the field of dermatology, the pattern of cutaneous adverse drug eruptions and the drugs responsible for them keep changing every year. Hence, this study was undertaken to ascertain the clinical spectrum of ACDRs and the causative drugs, in a tertiary care centre in South India. MATERIALS AND METHODS This study was a prospective, observational study conducted in Department of Medical Oncology, Government Rajaji Hospital, Madurai Medical College, Madurai during the period of March 2015 - August 2015 (6 months. Severity of the reaction was assessed using CTCAE (Common Terminology Criteria for Adverse Events scale version 4.1. Causality of the drug was assessed using Naranjo Causality Assessment Scale. The scale was calculated first for the regimen and then for individual drugs separately. The adverse events with score of 6 or more (probable and definite adverse events were taken for the study. RESULTS AND CONCLUSION The overall incidence of ACDRs found in this study was 85%. Alopecia was the commonest ACDR occurring in 51.6% of patients. Nail pigmentation and supravenous pigmentation were the next common ACDRs, recorded in 35% and 16% of patients respectively. Imatinib caused generalised hypopigmentation in 40% of patients. Bleomycin induced, flagellate erythema and pigmentation in 17% of patients and stomatitis was seen in 11% of patients. Acneiform eruptions were recorded with erlotinib and gefitinib therapy. Supravenous pigmentation was common with 5-fluorouracil and docetaxel, occurring in 53% & 48% respectively. Newer targeted therapies like EGFR (Epidermal growth factor receptor inhibitors recorded low incidence of ACDRs like alopecia as against conventional antineoplastic agents. The cancer chemotherapeutic drugs are associated

  13. Severe idiosyncratic drug reactions with epidermal necrolysis: A 5-year study

    Directory of Open Access Journals (Sweden)

    I O Fadeyibi

    2011-01-01

    Full Text Available Introduction: Idiosyncratic drug reactions (IDRs are unexpected responses to a drug. The spectrums of severe cutaneous reactions include Stevens-Johnson Syndrome (SJS, SJS/Lyell Syndrome and Toxic Epidermal Necrolysis (TEN. The conditions are associated with high mortality. This study was designed to determine the causal agents, patterns of presentations, review the management and make recommendations to reduce the incidence and mortality of this class of drug reactions. Materials and Methods: A retrospective study was made of patients seen with IDR in the Lagos State University Teaching Hospital, LASUTH, between January, 2004 and December, 2008. They were cases admitted with bullous skin eruptions with associated systemic symptoms. Results: Sixty-seven patients were seen, with 45 (67.2% satisfying the inclusion criteria. Fifteen males and 30 females were involved, giving a male to female (M:F ratio of 1:2. Their ages ranged from 7 to 79 years (mean, 40.02 ± 17.89 years. Peak incidences occurred among the 20-24 and 30-34 year age groups. The causal agents were antibiotics (48.89%, sulphonamides (24.44%, herbal preparations (17.78% and artemisinin drugs (8.89%. Conclusions: The age groups with the peak incidence are the most likely to indulge more in drug abuse in environments with poor drug control. Diagnosis of SJS, SJS/TEN and TEN were missed in many patients at first contact due to the progressive nature of the conditions. Patients needed reviews at regular intervals when IDR was suspected. Health education to prevent drug abuse is important and herbal preparations should be scientifically studied to determine the efficacy and side-effects.

  14. Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2018-01-01

    Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index. We included licensed analgesics that were withdrawn after marketing because of adverse reactions between 1950 and March 2017. We excluded herbal products, non-human medicines, and non-prescription medicines. We used the Oxford Centre for Evidence Based Medicine criteria to document the levels of evidence, and chi-squared tests to compare withdrawal patterns across geographical regions. Expert opinion: Pharmacovigilance systems in low-resource settings should be strengthened. Greater co-ordination across regulatory authorities in assessing and interpreting the benefit-harm balance of new analgesics should be encouraged. Future reporting of harms in clinical trials of analgesics should follow standardized guidelines.

  15. Extent of poly-pharmacy, occurrence and associated factors of drug-drug interaction and potential adverse drug reactions in Gondar Teaching Referral Hospital, North West Ethiopia

    Directory of Open Access Journals (Sweden)

    Endalkachew Admassie

    2013-01-01

    Full Text Available The aim of this study was to assess the extent of poly-pharmacy, occurrence, and associated factors for the occurrence of drug-drug interaction (DDI and potential adverse drug reaction (ADR in Gondar University Teaching Referral Hospital. Institutional-based retrospective cross-sectional study. This study was conducted on prescriptions of both in and out-patients for a period of 3 months at Gondar University Hospital. Both bivariate analysis and multivariate logistic regression were used to identify risk factors for the occurrence of DDI and possible ADRs. All the statistical calculations were performed using SPSS; software. A total of 12,334 prescriptions were dispensed during the study period of which, 2,180 prescriptions were containing two or more drugs per prescription. A total of 21,210 drugs were prescribed and the average number of drugs per prescription was 1.72. Occurrences of DDI of all categories (Major, Moderate, and Minor were analyzed and DDI were detected in 711 (32.6% prescriptions. Sex was not found to be a risk factor for the occurrence of DDI and ADR, while age and number of medications per prescription were found to be significant risk factors for the occurrence of DDI and ADR. The mean number of drugs per prescription was 1.72 and hence with regard to the WHO limit of drugs per prescription, Gondar hospital was able to maintain the limit and prescriptions containing multiple drugs supposed to be taken systemically. Numbers of drugs per prescription as well as older age were found to be predisposing factors for the occurrence of DDI and potential ADRs while sex was not a risk factor.

  16. Drug-related acute renal failure in hospitalised patients.

    Science.gov (United States)

    Iavecchia, Lujan; Cereza García, Gloria; Sabaté Gallego, Mònica; Vidal Guitart, Xavier; Ramos Terrades, Natalia; de la Torre, Judith; Segarra Medrano, Alfons; Agustí Escasany, Antònia

    2015-01-01

    The information available on the incidence and the characteristics of patients with acute renal failure (ARF) related to drugs is scarce. To estimate the incidence of drug-related ARF in hospitalised patients and to compare their characteristics with those of patients with ARF due to other causes. We selected a prospective cohort of patients with ARF during hospital admission (July 2010-July 2011). Information on patients' demographics, medical antecedents, ARF risk factors, ARF severity according to the RIFLE classification and hospital drug administration was collected. We analysed the relationship of drugs with the ARF episodes using Spanish Pharmacovigilance System methods and algorithm. A total of 194 cases had an episode of hospital-acquired ARF. The median age of patients was 72 years [IQR 20]; 60% were men. The ARF incidence during hospitalization was 9.6 per 1,000 admissions. According to the RIFLE classification, a risk of kidney damage or kidney injury was present in 77.8% of cases. In 105 (54.1%) cases, ARF was drug-related; the drugs most frequently involved were diuretics, agents acting on the renin-angiotensin system, immunosuppressants, β-blocking agents, calcium channel blockers, contrast media and non-steroid anti-inflammatory drugs. Patients with drug-related ARF had more multi-morbidity, fewer ARF risk factors and lower mortality. Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality. Copyright © 2015 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  17. Adverse drug reaction profile of anti-snake venom in a rural tertiary care teaching hospital

    Science.gov (United States)

    Deshpande, Rushikesh Prabhakar; Motghare, Vijay Motiram; Padwal, Sudhir Laxman; Pore, Rakesh Ramkrishna; Bhamare, Chetanraj Ghanshyam; Deshmukh, Vinod Shivaji; Pise, Harshal Nutan

    2013-01-01

    Objectives The study was carried out with the aim of evaluation of the adverse drug reaction profile of anti-snake venom serum (ASV) in a rural tertiary care hospital. Methods An observational study was conducted in SRTR Medical College, Ambajogai, Maharashtra, India. A total number of 296 indoor case papers of snake bite from February to September 2011 and June to August 2012 were retrieved from the record section and the antivenom reactions were assessed. In addition, basic epidemiological data and prescribing practices of ASV were also analyzed. Results Vasculotoxic snake bites were more common (50.61%) than neuroparalytic ones (22.56%). Mild envenomation was the commonest presentation. A total of 92 (56.10%) patients who received ASV suffered from antivenom reactions. The most common nature of reaction was chills, rigors (69.56%) followed by nausea and vomiting (34.8%). 10-15% patients suffered from moderate to severe reactions like hypotension and sudden respiratory arrest. We did not find any dose response relationship of ASV to risk of reactions (odds ratio 0.37). Intradermal sensitivity test was performed in about 72% cases. Conclusion Our study showed a higher incidence of reactions to ASV at our institute. PMID:24396245

  18. Rapid drug desensitization for hypersensitivity reactions to chemotherapy and monoclonal antibodies in the 21st century.

    Science.gov (United States)

    Castells Guitart, M C

    2014-01-01

    The frequency of hypersensitivity reactions (HSR) to drugs has risen in the last 10 years owing to increased exposure to better and more allergenic medications including monoclonal antibodies. HSRs prevent patients from using their first-line therapy, leading to decreased quality of life and life expectancy. Although premedication with antihistamines, leukotriene blockers, and corticosteroids can protect against mild-to-moderate HSR, none of these medications has provided protection against anaphylaxis. Rapid drug desensitization is a treatment option for patients with HSR to their first-line medication that protects against anaphylaxis.Although the mechanisms of drug desensitization are not completely understood, in vitro mast cell models of IgE antigen desensitization have led to the design of safe and effective in vivo protocols aimed at protecting highly sensitized patients from hypersensitivity reactions and anaphylaxis. This review provides an insight into the mechanisms of IgE/mast cell desensitization, the principles and practice of drug desensitization, and an overview of the different desensitization protocols and their safety and efficacy profiles. Drug desensitization should only be performed by allergists, trained nurses, and experienced pharmacists, since this high-risk procedure involves reintroducing allergenic medication to highly sensitized patients, with the consequent potential for severe or fatal HSRs.

  19. Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001 : special report

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    R. Gehring

    2001-07-01

    Full Text Available The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

  20. Reações cutâneas desencadeadas por drogas Skin reactions to drugs

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    Maria Regina Cavariani Silvares

    2008-06-01

    Full Text Available FUNDAMENTOS: Drogas podem desencadear reações adversas. As manifestações cutâneas são as mais comuns. OBJETIVO: Analisar as farmacodermias e relacionar as drogas envolvidas e os tipos de reações cutâneas mais freqüentes. MÉTODOS: Estudo retrospectivo e descritivo. Avaliados pacientes com diagnóstico inicial de farmacodermia internados na Enfermaria de Dermatologia, no período de janeiro de 1999 a junho de 2004. Incluídos no estudo os pacientes que confirmaram o diagnóstico de farmacodermia, com base em critérios clínicos e histopatológicos, após a análise dos prontuários. RESULTADOS: Tiveram diagnóstico inicial de farmacodermia 121 pacientes. Incluídos 43 pacientes, dos quais 51,2% eram do sexo feminino, e 86% da raça branca. Destes, 48,8% faziam uso de apenas uma medicação, sendo o grupo dos antibióticos o mais utilizado (20,9% e o principal responsável pela farmacodermia(33,3%. O segundo grupo de drogas mais envolvido foi o dos antiinflamatórios (16,7%, seguido pelo dos anticonvulsivantes (13%, e analgésicos/antipiréticos (13%. A forma clínica da erupção cutânea foi exantema maculopapular em 41,9% dos pacientes, eritrodermia em 25,6% e urticária em 23,3%. CONCLUSÃO: O exantema maculopapular foi a principal forma de reação cutânea desencadeada por drogas, e os antibióticos, os medicamentos que mais freqüentemente desencadearam essas reações.BACKGROUND: Drugs may trigger adverse reactions and skin manifestations are the most frequent ones. OBJECTIVE: To assess drug reactions and report the drugs involved and the most frequent types of skin reactions. METHODS: A retrospective and descriptive study. Data of inpatients at the Dermatology Ward with initial diagnosis of adverse drug reactions were evaluated from January 1999 to June 2004. Patients with confirmed diagnosis were included in the study based on clinical and histopathological criteria, after analysis of medical charts. RESULTS: Initial diagnosis

  1. On quark model relations for hypercharge-exchange reactions

    International Nuclear Information System (INIS)

    Kluyver, J.C.; Blokzijl, R.; Massaro, G.G.G.; Wolters, G.F.; Grossmann, P.; Lamb, P.R.; Wells, J.

    1978-01-01

    Peripheral two-body reactions of the type K - p → M 0 + Λ, Σ 0 or Σ 0 (1385) are considered. Predictions based on the additive quark model and SU(6) baryon wave functions are tested against data on cross sections and polarisations for given momentum transfer. Data obtained in a high statistics experiment at 4.2 GeV/c K - momentum, as well as data from a large variety of other experiments are used. Highly significant violations of these predictions are observed in the data. These violations are shown to occur in a systematic fashion, according to which SU(6) must be relaxed, but the amplitude structure implied by additivity would remain valid. As an application an amplitude analysis for natural parity exchange reactions with M 0 = π, phi and rho respectively is performed, which determines a relative phase, which cannot be obtained in model-independent analysis. Also reactions with M 0 = delta or B are considered, and some implications for coupling constants are discussed. (Auth.)

  2. Study of adverse drug reactions in out-patient departments of a teaching hospital

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    Zinnat Ara Begum

    2012-06-01

    Full Text Available The study conducted in the Medicine and Skin outpatient departments of Dhaka Medical College, Dhaka revealed 19 cases (7 males, 12 females of adverse drug reactions (ADR out of 160 patients. 31.58% ADRs were of mild type, 42.1% were of moderate and 26.32% were of severe in nature. Gastrointestinal complications were the most frequent adverse effect (56%. Antimicrobial drugs were the most common cause of ADR (42.86% followed by NSAIDs (33.33%. This study is a preliminary study for getting information on the pattern of ADRs in Bangladesh needing further studies.

  3. Pharmacist intervention in drug-related problems for patients with ...

    African Journals Online (AJOL)

    Purpose: To investigate the role of the community pharmacist in identifying, preventing and resolving drug related problems (DRPs) encountered by patients, with particular emphasis on cardiovascular drugs in community pharmacies in Northern Cyprus, Turkey. Methods: A prospective observational study for the ...

  4. Characteristics of potential drug-related problems among oncology patients

    NARCIS (Netherlands)

    Bulsink, Arjan; Imholz, Alex L. T.; Brouwers, Jacobus R. B. J.; Jansman, Frank G. A.

    Background Oncology patients are more at risk for drug related problems because of treatment with (combinations of) anticancer drugs, as they have a higher risk for organ failure or altered metabolism with progression of their disease. Objective The aim of this study was to characterize and to

  5. Enhancing communication about paediatric medicines: lessons from a qualitative study of parents' experiences of their child's suspected adverse drug reaction.

    Science.gov (United States)

    Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L; Turner, Mark A; Young, Bridget

    2012-01-01

    There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for linking children

  6. Enhancing communication about paediatric medicines: lessons from a qualitative study of parents' experiences of their child's suspected adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Janine Arnott

    Full Text Available There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines.To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction.Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions. Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method.Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction.Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for

  7. Enhancing Communication about Paediatric Medicines: Lessons from a Qualitative Study of Parents' Experiences of Their Child's Suspected Adverse Drug Reaction

    Science.gov (United States)

    Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J.; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L.

    2012-01-01

    Background There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. Objective To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Methods Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Results Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Conclusion Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and

  8. Comparison of TiO2 photocatalysis, electrochemically assisted Fenton reaction and direct electrochemistry for simulation of phase I metabolism reactions of drugs

    NARCIS (Netherlands)

    Ruokolainen, Miina; Gül, Turan; Permentier, Hjalmar; Sikanen, Tiina; Kostiainen, Risto; Kotiaho, Tapio

    2016-01-01

    The feasibility of titanium dioxide (TiO2) photocatalysis, electrochemically assisted Fenton reaction (EC-Fenton) and direct electrochemical oxidation (EC) for simulation of phase I metabolism of drugs was studied by comparing the reaction products of buspirone, promazine, testosterone and

  9. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university

    Directory of Open Access Journals (Sweden)

    Johnson Segun Showande

    2013-01-01

    Full Text Available Adverse drug reaction (ADR is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0% had heard about pharmacovigilance at symposiums, 7(10.1% during clinical clerkship program and 18(26.1% from media jingles. Twenty nine (42.0% agreed that pharmacovigilance was in their curriculum, however only 16(23.2% could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had

  10. Contextualization of drug-mediator relations using evidence networks.

    Science.gov (United States)

    Tran, Hai Joey; Speyer, Gil; Kiefer, Jeff; Kim, Seungchan

    2017-05-31

    Genomic analysis of drug response can provide unique insights into therapies that can be used to match the "right drug to the right patient." However, the process of discovering such therapeutic insights using genomic data is not straightforward and represents an area of active investigation. EDDY (Evaluation of Differential DependencY), a statistical test to detect differential statistical dependencies, is one method that leverages genomic data to identify differential genetic dependencies. EDDY has been used in conjunction with the Cancer Therapeutics Response Portal (CTRP), a dataset with drug-response measurements for more than 400 small molecules, and RNAseq data of cell lines in the Cancer Cell Line Encyclopedia (CCLE) to find potential drug-mediator pairs. Mediators were identified as genes that showed significant change in genetic statistical dependencies within annotated pathways between drug sensitive and drug non-sensitive cell lines, and the results are presented as a public web-portal (EDDY-CTRP). However, the interpretability of drug-mediator pairs currently hinders further exploration of these potentially valuable results. In this study, we address this challenge by constructing evidence networks built with protein and drug interactions from the STITCH and STRING interaction databases. STITCH and STRING are sister databases that catalog known and predicted drug-protein interactions and protein-protein interactions, respectively. Using these two databases, we have developed a method to construct evidence networks to "explain" the relation between a drug and a mediator.  RESULTS: We applied this approach to drug-mediator relations discovered in EDDY-CTRP analysis and identified evidence networks for ~70% of drug-mediator pairs where most mediators were not known direct targets for the drug. Constructed evidence networks enable researchers to contextualize the drug-mediator pair with current research and knowledge. Using evidence networks, we were

  11. Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

    Science.gov (United States)

    Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

    2015-07-10

    The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

  12. STUDIES OF ADVERSE DRUG REACTION PROFILE OF ANTISNAKE VENOM AT DISTRICT GENERAL HOSPITAL

    OpenAIRE

    Mulchand Shende *, Sneha Gawali , Kanchan Bhongade , Vivek Bhuskade , Abhijit Nandgaonkar

    2017-01-01

    Snake bite is a common predominant problem of the rural and periurban areas, neglected and frequently devastating environmental and occupational disease, especially in rural areas of tropical developing countries. This study aimed to investigate of the adverse drug reaction profile of anti-snake venom (ASV) in a district general hospital. An observational study was conducted in hospital for six months. A total number of 142 indoor case papers of snake bite from October 2016 to April 2017 were...

  13. Fenton-like reaction: a possible way to efficiently remove illicit drugs and pharmaceuticals from wastewater.

    Science.gov (United States)

    Mackuľak, Tomáš; Mosný, Michal; Grabic, Roman; Golovko, Oksana; Koba, Olga; Birošová, Lucia

    2015-03-01

    We analyzed 13 psychoactive pharmaceuticals, illicit drugs and their metabolites in wastewater treatment plant influent and effluent and the possibility of their degradation by biological and chemical processes. Tramadol (413-853 ng/L) and methamphetamine (460-682 ng/L) were the most concentrated compounds in the wastewater in winter and summer, respectively. A significant decrease in the concentration of tramadol in wastewater was measured during the summer. The lowest efficiency was observed for tramadol, venlafaxine, citalopram and oxazepam (∼ 10%) and the highest efficiency was observed for amphetamine and THC-COOH (∼ 80%). The efficiency of compound degradation via the Fenton reaction, a modified Fenton reaction and different degradation (by algae, wood-rotting fungi and enzymes at influent versus effluent) was determined. The Fenton reaction and its modification were efficient at eliminating these substances in comparison with the tested biological processes. Copyright © 2015 Elsevier B.V. All rights reserved.

  14. Regulatory Notes on Impact of Excipients on Drug Products and the Maillard Reaction.

    Science.gov (United States)

    Chowdhury, Dipak K; Sarker, Haripada; Schwartz, Paul

    2018-02-01

    In general, it is an important criterion that excipients remain inert throughout the shelf life of the formulated pharmaceutical product. However, depending on the functionality in chemical structure of active drug and excipients, they may undergo interaction. The well-known Maillard reaction occurs between a primary amine with lactose at high temperature to produce brown pigments. The reactivity of Maillard reaction may vary depending on the concentration as well as other conditions. Commercially, there are products where the active pharmaceutical ingredient is a primary amine and contains less than 75% lactose along with inactive excipients. This product does not show Maillard reaction during its shelf life of around 2 years at ambient conditions. However, when the same type of product contains more than 95 % lactose as an excipient, then there is a possibility of interactions though it is not visible in the initial year. Therefore, this regulatory note discusses involvement of different factors of a known drug-excipient interactions with case studies and provides an overview on how the concentration of lactose in the pharmaceutical product is important in addition to temperature and moisture in Maillard reaction.

  15. Adverse drug reactions associated with the use of disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Jorge Enrique Machado-Alba

    2014-12-01

    Full Text Available This study describes the adverse drug reactions (ADRs and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART. A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years; these patients were from a cohort of 1 364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9. The cohort was mostly female (366, 87.4% and had a mean age of 52.7 years (± 13.1. The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively. The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.

  16. Herbal medicine use and linked suspected adverse drug reactions in a prospective cohort of Ugandan inpatients.

    Science.gov (United States)

    Kiguba, Ronald; Ononge, Sam; Karamagi, Charles; Bird, Sheila M

    2016-05-26

    Clinical history-taking can be employed as a standardized approach to elucidate the use of herbal medicines and their linked suspected adverse drug reactions (ADRs) among hospitalized patients. We sought to identify herbal medicines nominated by Ugandan inpatients; compare nomination rates by ward and gender; confirm the herbs' known pharmacological properties from published literature; and identify ADRs linked to pre-admission use of herbal medicines. Prospective cohort of consented adult inpatients designed to assess medication use and ADRs on one gynaecological and three medical wards of 1790-bed Mulago National Referral Hospital. Baseline and follow-up data were obtained on patients' characteristics, including pre-admission use of herbal medicines. Fourteen percent (26/191) of females in Gynaecology nominated at least one specific herbal medicine compared with 20 % (114/571) of inpatients on medical wards [20 % (69/343) of females; 20 % (45/228) of males]. Frequent nominations were Persea americana (30), Mumbwa/multiple-herb clay rods (23), Aloe barbadensis (22), Beta vulgaris (12), Vernonia amygdalina (11), Commelina africana (7), Bidens pilosa (7), Hoslundia opposita (6), Mangifera indica (4), and Dicliptera laxata (4). Four inpatients experienced 10 suspected ADRs linked to pre-admission herbal medicine use including Commelina africana (4), multiple-herb-mumbwa (1), or unspecified local-herbs (5): three ADR-cases were abortion-related and one kidney-related. The named herbal medicines and their nomination rates generally differed by specialized ward, probably guided by local folklore knowledge of their use. Clinical elicitation from inpatients can generate valuable safety data on herbal medicine use. However, larger routine studies might increase the utility of our method to assess herbal medicine use and detect herb-linked ADRs. Future studies should take testable samples of ADR-implicated herbal medicines for further analysis.

  17. Factors associated with drug-related harms related to policing in Tijuana, Mexico

    Science.gov (United States)

    2011-01-01

    Objective To assess factors associated with drug-related harms related to policing among injection drug users (IDUs) in Tijuana, Mexico. Methods IDUs who were over 18 years old and had injected drugs within the last six months were recruited via respondent-driven sampling and underwent questionnaires and testing for HIV (human immunodeficiency virus), syphilis and TB (tuberculosis). Random effects logistic regression was used to simultaneously model factors associated with five drug-related harms related to policing practices in the prior six months (i.e., police led them to rush injections; affected where they bought drugs; affected locations where they used drugs; feared that police will interfere with their drug use; receptive syringe sharing). Results Of 727 IDUs, 85% were male; median age was 38 years. Within the last 6 months, 231 (32%) of IDUs reported that police had led them to rush injections, affected where they bought or used drugs or were very afraid police would interfere with their drug use, or shared syringes. Factors independently associated with drug-related harms related to policing within the last six months included: recent arrest, homelessness, higher frequencies of drug injection, use of methamphetamine, using the local needle exchange program and perceiving a decrease in the purity of at least one drug. Conclusions IDUs who experienced drug-related harms related to policing were those who were most affected by other micro and macro influences in the physical risk environment. Police education programs are needed to ensure that policing practices do not exacerbate risky behaviors or discourage protective behaviors such as needle exchange program use, which undermines the right to health for people who inject drugs. PMID:21477299

  18. Factors associated with drug-related harms related to policing in Tijuana, Mexico

    Directory of Open Access Journals (Sweden)

    Patterson Thomas L

    2011-04-01

    Full Text Available Abstract Objective To assess factors associated with drug-related harms related to policing among injection drug users (IDUs in Tijuana, Mexico. Methods IDUs who were over 18 years old and had injected drugs within the last six months were recruited via respondent-driven sampling and underwent questionnaires and testing for HIV (human immunodeficiency virus, syphilis and TB (tuberculosis. Random effects logistic regression was used to simultaneously model factors associated with five drug-related harms related to policing practices in the prior six months (i.e., police led them to rush injections; affected where they bought drugs; affected locations where they used drugs; feared that police will interfere with their drug use; receptive syringe sharing. Results Of 727 IDUs, 85% were male; median age was 38 years. Within the last 6 months, 231 (32% of IDUs reported that police had led them to rush injections, affected where they bought or used drugs or were very afraid police would interfere with their drug use, or shared syringes. Factors independently associated with drug-related harms related to policing within the last six months included: recent arrest, homelessness, higher frequencies of drug injection, use of methamphetamine, using the local needle exchange program and perceiving a decrease in the purity of at least one drug. Conclusions IDUs who experienced drug-related harms related to policing were those who were most affected by other micro and macro influences in the physical risk environment. Police education programs are needed to ensure that policing practices do not exacerbate risky behaviors or discourage protective behaviors such as needle exchange program use, which undermines the right to health for people who inject drugs.

  19. Do candidate reactions relate to job performance or affect criterion-related validity? A multistudy investigation of relations among reactions, selection test scores, and job performance.

    Science.gov (United States)

    McCarthy, Julie M; Van Iddekinge, Chad H; Lievens, Filip; Kung, Mei-Chuan; Sinar, Evan F; Campion, Michael A

    2013-09-01

    Considerable evidence suggests that how candidates react to selection procedures can affect their test performance and their attitudes toward the hiring organization (e.g., recommending the firm to others). However, very few studies of candidate reactions have examined one of the outcomes organizations care most about: job performance. We attempt to address this gap by developing and testing a conceptual framework that delineates whether and how candidate reactions might influence job performance. We accomplish this objective using data from 4 studies (total N = 6,480), 6 selection procedures (personality tests, job knowledge tests, cognitive ability tests, work samples, situational judgment tests, and a selection inventory), 5 key candidate reactions (anxiety, motivation, belief in tests, self-efficacy, and procedural justice), 2 contexts (industry and education), 3 continents (North America, South America, and Europe), 2 study designs (predictive and concurrent), and 4 occupational areas (medical, sales, customer service, and technological). Consistent with previous research, candidate reactions were related to test scores, and test scores were related to job performance. Further, there was some evidence that reactions affected performance indirectly through their influence on test scores. Finally, in no cases did candidate reactions affect the prediction of job performance by increasing or decreasing the criterion-related validity of test scores. Implications of these findings and avenues for future research are discussed. PsycINFO Database Record (c) 2013 APA, all rights reserved

  20. Electrical characterization of copper related defect reactions in silicon

    Energy Technology Data Exchange (ETDEWEB)

    Heiser, T. [Centre National de la Recherche Scientifique, 67 - Strasbourg (France). Lab. PHASE; Istratov, A.A.; Flink, C.; Weber, E.R. [Department of Material Science and Mineral Engineering, University of California at Berkeley, 577 Evans Hall, Berkeley, CA 94720 (United States)

    1999-02-12

    Defect reactions involving interstitial copper impurities (Cu{sub i}) in silicon are reviewed. The influence of the Coulomb interaction between positively charged copper and negatively charged defects, such as acceptor states of transition metals and lattice defects, on the complex formation rate is discussed in detail. The diffusivity of interstitial copper and the dissociation kinetics of copper-acceptor pairs are studied using the recently introduced transient ion drift (TID) method. TID results reveal that most interstitial copper impurities remain dissolved immediately after the quench and form pairs with shallow acceptors. It is shown that in moderately and heavily doped silicon the diffusivity of copper is trap limited, while in low B-doped silicon the interstitial copper-acceptor pairing is weak enough to allow the assessment of the copper intrinsic diffusion coefficient. The intrinsic diffusion barrier is estimated to be 0.18{+-}0.01 eV. It is concluded that the Coulomb potential used in previous publications underestimated considerably the acceptor-copper interaction. In light of these results, a general discussion on Cu related defect reactions is given. (orig.) 44 refs.

  1. Accelerant-related burns and drug abuse: Challenging combination.

    Science.gov (United States)

    Leung, Leslie T F; Papp, Anthony

    2018-05-01

    Accelerants are flammable substances that may cause explosion when added to existing fires. The relationships between drug abuse and accelerant-related burns are not well elucidated in the literature. Of these burns, a portion is related to drug manufacturing, which have been shown to be associated with increased burn complications. 1) To evaluate the demographics and clinical outcomes of accelerant-related burns in a Provincial Burn Centre. 2) To compare the clinical outcomes with a control group of non-accelerant related burns. 3) To analyze a subgroup of patients with history of drug abuse and drug manufacturing. Retrospective case control study. Patient data associated with accelerant-related burns from 2009 to 2014 were obtained from the British Columbia Burn Registry. These patients were compared with a control group of non-accelerant related burns. Clinical outcomes that were evaluated include inhalational injury, ICU length of stay, ventilator support, surgeries needed, and burn complications. Chi-square test was used to evaluate categorical data and Student's t-test was used to evaluate mean quantitative data with the p value set at 0.05. A logistic regression model was used to evaluate factors affecting burn complications. Accelerant-related burns represented 28.2% of all burn admissions (N=532) from 2009 to 2014. The accelerant group had higher percentage of patients with history of drug abuse and was associated with higher TBSA burns, ventilator support, ICU stay and pneumonia rates compared to the non-accelerant group. Within the accelerant group, there was no difference in clinical outcomes amongst people with or without history of drug abuse. Four cases were associated with methamphetamine manufacturing, all of which underwent ICU stay and ventilator support. Accelerant-related burns cause significant burden to the burn center. A significant proportion of these patients have history of drug abuse. Copyright © 2017 Elsevier Ltd and ISBI. All rights

  2. Adverse Drug Reactions Reported With Cholinesterase Inhibitors : An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

    NARCIS (Netherlands)

    Kroeger, Edeltraut; Mouls, Marie; Wilchesky, Machelle; Berkers, Mieke; Carmichael, Pierre-Hugues; van Marum, Rob; Souverein, Patrick; Egberts, Toine; Laroche, Marie-Laure

    2015-01-01

    Background: No worldwide pharmacovigilance study evaluating the spectrum of adverse drug reactions (ADRs) induced by cholinesterase inhibitors (ChEI) in Alzheimer's disease has been conducted since their emergence on the market. Objective: To describe ChEI related ADRs in Alzheimer's disease

  3. Adverse Drug Reactions Reported With Cholinesterase Inhibitors: An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

    NARCIS (Netherlands)

    Kroger, E.; Mouls, M.; Wilchesky, M.; Berkers, M.; Carmichael, P.H.; van Marum, R.J.; Souverein, P.; Egberts, T.; Laroche, M.L.

    2015-01-01

    Background: No worldwide pharmacovigilance study evaluating the spectrum of adverse drug reactions (ADRs) induced by cholinesterase inhibitors (ChEI) in Alzheimer’s disease has been conducted since their emergence on the market. Objective: To describe ChEI related ADRs in Alzheimer’s disease

  4. The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life : A Retrospective Cross-Sectional Study in the Netherlands

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Taxis, Katja; van Puijenbroek, Eugène

    INTRODUCTION: There is little information as to what extent adverse drug reactions (ADRs) influence patients' health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance

  5. Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective : a prospective, observational cohort study in the Netherlands

    NARCIS (Netherlands)

    de Jong, Loek; Härmark, Linda; van Puijenbroek, Eugène

    2016-01-01

    PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

  6. Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands

    NARCIS (Netherlands)

    Jong, L.A.W.; Harmark, L.; Puijenbroek, E. van

    2016-01-01

    PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

  7. CONTEMPORARY ISSUES RELATED TO ILLICIT DRUG TRAFFICKING AND CONSUMPTION TARGETING THE NATIONAL SECURITY OF ROMANIA

    Directory of Open Access Journals (Sweden)

    Bogdan MARINESCU

    2018-05-01

    Full Text Available A serious social problem is drug use, which is very widespread all over the world. Drugs are a terrible problem whose seriousness becomes more visible every day. Problems caused by drug abuse and illegal trafficking are among the most serious problems faced by the world today but also threatening future generations. After the First World War, drugs began to be consumed on a large scale. Up to the end of the 30s, they were legal. Their marketing over time has led to enormous profits outlaw, making drugs an invaluable source for the black market. Scourge illicit drug trafficking from South America and the Middle East comprised the whole the planet. Governments have begun to allocate more resources to the fight against drugs, but the processes were slow because the problem was very complex. The impact was very high among young people who out of curiosity, terrible or solidarity with the entourage, have begun to consume. The Romanian society was caught by surprise by this drug scourge, coming out so very serious problems both in justice and in the medical world. Weak reactions and untrained authorities have favored the phenomenon of drug abuse that has come to be devastating. Drug use is a high-risk activity. Optimism and illusion of maintaining self-control is also dangerous because it affects reasoning. The drug consumer becomes not only an unfortunate person, but also a social problem. Changes made by traffickers are evident in street-related lawsuits: thefts, arsonists, assassinations. We are all affected in some way by drug trafficking. The extent of the problem current narcotics outweighs the concerns of the police forces and the medical world, constituting a threat to the economic and social order of the world.

  8. State and Community Responses to Drug-related Violence in Mexico

    International Development Research Centre (IDRC) Digital Library (Canada)

    Violent conflict related to drug trafficking in Mexico has had a profound impact on the ... mostly due to illegal drug trafficking and the government's response to it, ... security forces and drug traffickers or in executions related to the drug trade.

  9. Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database

    DEFF Research Database (Denmark)

    Jakobsen, Klaus D.; Wallach-Kildemoes, Helle; Bruhn, Christina H.

    2017-01-01

    Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...... and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported......, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns....

  10. Deaths from acute drug reactions in Galician (Spain Prisons (2001-2010

    Directory of Open Access Journals (Sweden)

    D. Miguel-Arias

    Full Text Available Introduction and objectives: drug use is associated with multiple complications with an increase in morbidity, with death by acute drugs reactions (ADR being the most serious. A large percentage of the prison population has problems associated with drug additions, and substance abuse is also a common internal problem of penal institutions, despite their control measures. The goal of this study is to analyse the prevalence of ADR in penitentiaries, deceased sociodemographic characteristics as well as the circumstances in which they are produced. Material and methods: All deaths by ADR between 2001-2010 in Galicia are studied, in particular, those deaths that took place inside prisons. Results: In the whole sample (n=510 male (90.6%, single (46.1% with an average age of 35.8 and with a prevalent factor of long experience in drug abuse. Thirty seven of them died in Penal/Correctional Institutions, representing 7.3% of the total sample. The characteristics of this population subtype were similar to the total sample (average age: 34.7 years; 89.2% were males but we found significant differences regarding the substances detected. Discussion: ADR is the most frequent cause of death among drug addict convicts in prisons. The pattern of the detected substances in the toxicological analysis as well as the socio-demographic characteristics can help to establish a higher risk profile and preventive measures.

  11. Predicting and detecting adverse drug reactions in old age: challenges and opportunities.

    Science.gov (United States)

    Mangoni, Arduino A

    2012-05-01

    Increased, often inappropriate, drug exposure, pharmacokinetic and pharmacodynamic changes, reduced homeostatic reserve and frailty increase the risk of adverse drug reactions (ADRs) in the older population, thereby imposing a significant public health burden. Predicting and diagnosing ADRs in old age presents significant challenges for the clinician, even when specific risk scoring systems are available. The picture is further compounded by the potential adverse impact of several drugs on more 'global' health indicators, for example, physical function and independence, and the fragmentation of care (e.g., increased number of treating doctors and care transitions) experienced by older patients during their clinical journey. The current knowledge of drug safety in old age is also curtailed by the lack of efficacy and safety data from pre-marketing studies. Moreover, little consideration is given to individual patients' experiences and reporting of specific ADRs, particularly in the presence of cognitive impairment. Pending additional data on these issues, the close review and monitoring of individual patients' drug prescribing, clinical status and biochemical parameters remain essential to predict and detect ADRs in old age. Recently developed strategies, for example, medication reconciliation and trigger tool methodology, have the potential for ADRs risk mitigation in this population. However, more information is required on their efficacy and applicability in different healthcare settings.

  12. Drug-related stigma and access to care among people who inject drugs in Vietnam.

    Science.gov (United States)

    Lan, Chiao-Wen; Lin, Chunqing; Thanh, Duong Cong; Li, Li

    2018-03-01

    There are considerable challenges faced by people with a history of injecting drug use (PWID) in Vietnam, including drug-related stigma and lack of access to healthcare. Seeking and utilising healthcare, as well as harm reduction programs for PWID, are often hampered by drug-related stigma. This study aimed to examine the impacts of drug-related stigma on access to care and utilisation of harm reduction programs among PWID in Vietnam. A cross-sectional study was conducted in two provinces in Vietnam, Phú Thọ and Vinh Phúc. The study participants completed the survey by using Audio Computer-Assisted Self-Interview between late 2014 and early 2015. Linear multiple regression models and logistic regression models were used to assess the relationship among drug-related stigma, access to care and utilisation of harm reduction programs, including methadone maintenance treatment (MMT) and needle exchange programs (NEP). A total of 900 PWID participated in this study. Drug-related stigma was significantly associated with lower level of access to care, but not with utilisation of MMT or NEP. Older age was positively associated with higher levels of access to care. Levels of education were positively correlated with access to care, as well as utilisation of MMT and NEP. This study underscores the need for future interventions to reduce drug-related stigma in society and in health-care settings to improve PWID's utilisation of care services. Special attention should be paid to younger PWID and those with lower levels of education. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  13. A New Zealand platform to enable genetic investigation of adverse drug reactions.

    Science.gov (United States)

    Maggo, Simran Ds; Chua, Eng Wee; Chin, Paul; Cree, Simone; Pearson, John; Doogue, Matthew; Kennedy, Martin A

    2017-12-01

    A multitude of factors can affect drug response in individuals. It is now well established that variations in genes, especially those coding for drug metabolising enzymes, can alter the pharmacokinetic and/or pharmacodynamic profile of a drug, impacting on efficacy and often resulting in drug-induced toxicity. The UDRUGS study is an initiative from the Carney Centre for Pharmacogenomics to biobank DNA and store associated clinical data from patients who have suffered rare and/or serious adverse drug reactions (ADRs). The aim is to provide a genetic explanation of drug-induced ADRs using methods ranging from Sanger sequencing to whole exome and whole genome sequencing. Participants for the UDRUGS study are recruited from various sources, mainly via referral through clinicians working in Canterbury District Health Board, but also from district health boards across New Zealand. Participants have also self-referred to us from word-of-mouth communication between participants. We have recruited various ADRs across most drug classes. Where possible, we have conducted genetic analyses in single or a cohort of cases to identify known and novel genetic association(s) to offer an explanation to why the ADR occurred. Any genetic results relevant to the ADR are communicated back to the referring clinician and/or participant. In conclusion, we have developed a programme for studying the genetic basis of severe, rare or unusual ADR cases resulting from pharmacological treatment. Genomic analyses could eventually identify most genetic variants that predispose to ADRs, enabling a priori detection of such variants with high throughput DNA tests.

  14. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

  15. Consequences of the exclusion of known adverse drug reactions in a spontaneous reporting system on the possibility to detect unknown drug/ADR combinations

    NARCIS (Netherlands)

    Borgsteede, Sander; Van Puijenbroek, Eugene; Van Grootheest, Kees

    Background: The Reporting Odds Ratio (ROR) is one of the expressions to analyse disproportionallity of adverse drug reactions (ADRs) in a spontaneous reporting system. The ROR is defined as the extent to which the association between a suspected drug and ADR stands out against the background

  16. Drug-related celebrity deaths: A cross-sectional study.

    Science.gov (United States)

    Just, Johannes M; Bleckwenn, Markus; Schnakenberg, Rieke; Skatulla, Philipp; Weckbecker, Klaus

    2016-12-09

    Celebrities are at risk for premature mortality as well as drug-related death. Despite being a vulnerable patient group, celebrities influence people's health behaviours through biological, psychological and social processes. Therefore, celebrity endorsement of the topic could be one way to challenge the current "opioid endemic". Our aim was to better understand the factors surrounding drug-related celebrity deaths by investigating the incidence as well as substances used between 1970 and 2015 using a cross-sectional study design. We searched public databases for drug-related celebrity deaths between 1970 and 2015. They were categorized for sex, profession, age at death, year of death and substances involved. The main outcome measures are descriptive values including number of drug deaths per year and substances involved. Secondary outcome measures are analytical questions to examine whether and which factors influence age at death and year of death (e.g. type of substance use disorder). We identified 220 celebrities who died a drug-related death with a clear indication of involved substances between 1970 and 2015. The average age at death was 38.6 years; 75% were male. Most celebrities died between the age of 25 and 40. The number of drug-related deaths increased in the 21st century, with a significant increase in the use of prescription opioids. Deaths involving prescription opioids and heroin were associated with a significantly lower mean age at death compared to deaths where these substances were not involved. Compared to the 20th century, the total number of celebrities who died from a drug-related death in the 21st century increased, possibly due to an increased involvement of prescription opioids. Negative effects on individual health decisions of celebrity's followers could be the result.

  17. Drug reaction with eosinophilia and systemic symptoms syndrome in a patient taking phenytoin and levetiracetam: a case report

    Directory of Open Access Journals (Sweden)

    Hall David Jeffrey

    2013-01-01

    Full Text Available Abstract Introduction Drug reaction with eosinophilia and systemic symptoms syndrome is a potentially life-threatening hypersensitivity reaction with rash, fever, and internal organ involvement, often hepatitis, occurring most commonly two to eight weeks after initiation of a medication. The present case is an example of severe and potentially life-threatening hepatitis as a manifestation of drug reaction with eosinophilia and systemic symptoms syndrome. Case presentation We report a case of anti-epileptic-induced drug reaction with eosinophilia and systemic symptoms syndrome in an 18-year-old African-American man who presented with a five-day history of rash, periorbital and upper extremity edema, hepatitis and fever. Laboratory findings revealed an atypical lymphocytosis, eosinophilia, and elevated serum transaminases. No drug allergies were reported at the time of presentation, but phenytoin and levetiracetam therapy had been initiated five weeks prior to hospital admission for new-onset seizures. Both medications were discontinued on hospital admission, and after three days of high-dose corticosteroid therapy the patient experienced resolution of both his symptoms and laboratory markers of inflammation. Conclusion Given the significant mortality attributed to drug reaction with eosinophilia and systemic symptoms syndrome, medical personnel should be aware of the potential for this severe hypersensitivity reaction and should ensure close follow-up and offer anticipatory guidance when beginning any new medication, particularly anti-epileptic therapy. Early recognition of drug reaction with eosinophilia and systemic symptoms syndrome and initiation of appropriate therapy are imperative in limiting morbidity.

  18. Valproic acid-induced hyperammonemic encephalopathy - a potentially fatal adverse drug reaction.

    Science.gov (United States)

    Sousa, Carla

    2013-12-01

    A patient with an early diagnosed epilepsy Valproic acid is one of the most widely used antiepileptic drugs. Hyperammonemic encephalopathy is a rare, but potentially fatal, adverse drug reaction to valproic acid. A patient with an early diagnosed epilepsy, treated with valproic acid, experienced an altered mental state after 10 days of treatment. Valproic acid serum levels were within limits, hepatic function tests were normal but ammonia levels were above the normal range. Valproic acid was stopped and the hyperammonemic encephalopathy was treated with lactulose 15 ml twice daily, metronidazole 250 mg four times daily and L-carnitine 1 g twice daily. Monitoring liver function and ammonia levels should be recommended in patients taking valproic acid. The constraints of the pharmaceutical market had to be taken into consideration and limited the pharmacological options for this patient's treatment. Idiosyncratic symptomatic hyperammonemic encephalopathy is completely reversible, but can induce coma and even death, if not timely detected. Clinical pharmacists can help detecting adverse drug reactions and provide evidence based information for the treatment.

  19. Advances in allergic skin disease, anaphylaxis, and hypersensitivity reactions to foods, drugs, and insects in 2009.

    Science.gov (United States)

    Sicherer, Scott H; Leung, Donald Y M

    2010-01-01

    This review highlights some of the research advances in anaphylaxis and hypersensitivity reactions to foods, drugs, and insects, as well as advances in allergic skin disease that were reported in the Journal in 2009. Among key epidemiologic observations, several westernized countries report that more than 1% of children have peanut allergy, and there is some evidence that environmental exposure to peanut is a risk factor. The role of regulatory T cells, complement, platelet-activating factor, and effector cells in the development and expression of food allergy were explored in several murine models and human studies. Delayed anaphylaxis to mammalian meats appears to be related to IgE binding to the carbohydrate moiety galactose-alpha-1,3-galactose, which also has implications for hypersensitivity to murine mAb therapeutics containing this oligosaccharide. Oral immunotherapy studies continue to show promise for the treatment of food allergy, but determining whether the treatment causes tolerance (cure) or temporary desensitization remains to be explored. Increased baseline serum tryptase levels might inform the risk of venom anaphylaxis and might indicate a risk for mast cell disorders in persons who have experienced such episodes. Reduced structural and immune barrier function contribute to local and systemic allergen sensitization in patients with atopic dermatitis, as well as increased propensity of skin infections in these patients. The use of increased doses of nonsedating antihistamines and potential usefulness of omalizumab for chronic urticaria was highlighted. These exciting advances reported in the Journal can improve patient care today and provide insights on how we can improve the diagnosis and treatment of these allergic diseases in the future. Copyright 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  20. Your brain on drugs: imaging of drug-related changes in the central nervous system.

    Science.gov (United States)

    Tamrazi, Benita; Almast, Jeevak

    2012-01-01

    Drug abuse is a substantial problem in society today and is associated with significant morbidity and mortality. Various drugs are associated with serious complications affecting the brain, and it is critical to recognize the imaging findings of these complications to provide prompt medical management. The central nervous system (CNS) is a target organ for drugs of abuse as well as specific prescribed medications. Drugs of abuse affecting the CNS include cocaine, heroin, alcohol, amphetamines, toluene, and cannabis. Prescribed medications or medical therapies that can affect the CNS include immunosuppressants, antiepileptics, nitrous oxide, and total parenteral nutrition. The CNS complications of these drugs include neurovascular complications, encephalopathy, atrophy, infection, changes in the corpus callosum, and other miscellaneous changes. Imaging abnormalities indicative of these complications can be appreciated at both magnetic resonance (MR) imaging and computed tomography (CT). It is critical for radiologists to recognize complications related to drugs of abuse as well as iatrogenic effects of various medications. Therefore, diagnostic imaging modalities such as MR imaging and CT can play a pivotal role in the recognition and timely management of drug-related complications in the CNS.

  1. Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Rafaniello, Concetta; Mascolo, Annamaria; Cimmaruta, Daniela; Scavone, Cristina; Fiorentino, Sonia; Grassi, Enrico; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2016-12-01

    The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

  2. A systematic investigation of computation models for predicting Adverse Drug Reactions (ADRs.

    Directory of Open Access Journals (Sweden)

    Qifan Kuang

    Full Text Available Early and accurate identification of adverse drug reactions (ADRs is critically important for drug development and clinical safety. Computer-aided prediction of ADRs has attracted increasing attention in recent years, and many computational models have been proposed. However, because of the lack of systematic analysis and comparison of the different computational models, there remain limitations in designing more effective algorithms and selecting more useful features. There is therefore an urgent need to review and analyze previous computation models to obtain general conclusions that can provide useful guidance to construct more effective computational models to predict ADRs.In the current study, the main work is to compare and analyze the performance of existing computational methods to predict ADRs, by implementing and evaluating additional algorithms that have been earlier used for predicting drug targets. Our results indicated that topological and intrinsic features were complementary to an extent and the Jaccard coefficient had an important and general effect on the prediction of drug-ADR associations. By comparing the structure of each algorithm, final formulas of these algorithms were all converted to linear model in form, based on this finding we propose a new algorithm called the general weighted profile method and it yielded the best overall performance among the algorithms investigated in this paper.Several meaningful conclusions and useful findings regarding the prediction of ADRs are provided for selecting optimal features and algorithms.

  3. A systematic investigation of computation models for predicting Adverse Drug Reactions (ADRs).

    Science.gov (United States)

    Kuang, Qifan; Wang, MinQi; Li, Rong; Dong, YongCheng; Li, Yizhou; Li, Menglong

    2014-01-01

    Early and accurate identification of adverse drug reactions (ADRs) is critically important for drug development and clinical safety. Computer-aided prediction of ADRs has attracted increasing attention in recent years, and many computational models have been proposed. However, because of the lack of systematic analysis and comparison of the different computational models, there remain limitations in designing more effective algorithms and selecting more useful features. There is therefore an urgent need to review and analyze previous computation models to obtain general conclusions that can provide useful guidance to construct more effective computational models to predict ADRs. In the current study, the main work is to compare and analyze the performance of existing computational methods to predict ADRs, by implementing and evaluating additional algorithms that have been earlier used for predicting drug targets. Our results indicated that topological and intrinsic features were complementary to an extent and the Jaccard coefficient had an important and general effect on the prediction of drug-ADR associations. By comparing the structure of each algorithm, final formulas of these algorithms were all converted to linear model in form, based on this finding we propose a new algorithm called the general weighted profile method and it yielded the best overall performance among the algorithms investigated in this paper. Several meaningful conclusions and useful findings regarding the prediction of ADRs are provided for selecting optimal features and algorithms.

  4. A web-based quantitative signal detection system on adverse drug reaction in China.

    Science.gov (United States)

    Li, Chanjuan; Xia, Jielai; Deng, Jianxiong; Chen, Wenge; Wang, Suzhen; Jiang, Jing; Chen, Guanquan

    2009-07-01

    To establish a web-based quantitative signal detection system for adverse drug reactions (ADRs) based on spontaneous reporting to the Guangdong province drug-monitoring database in China. Using Microsoft Visual Basic and Active Server Pages programming languages and SQL Server 2000, a web-based system with three software modules was programmed to perform data preparation and association detection, and to generate reports. Information component (IC), the internationally recognized measure of disproportionality for quantitative signal detection, was integrated into the system, and its capacity for signal detection was tested with ADR reports collected from 1 January 2002 to 30 June 2007 in Guangdong. A total of 2,496 associations including known signals were mined from the test database. Signals (e.g., cefradine-induced hematuria) were found early by using the IC analysis. In addition, 291 drug-ADR associations were alerted for the first time in the second quarter of 2007. The system can be used for the detection of significant associations from the Guangdong drug-monitoring database and could be an extremely useful adjunct to the expert assessment of very large numbers of spontaneously reported ADRs for the first time in China.

  5. Drug-related problems and pharmacy interventions in community practice

    DEFF Research Database (Denmark)

    Westerlund, Tommy; Almarsdóttir, Anna Birna; Melander, Arne

    1999-01-01

    Objectives. (1) To document types and number of drug-related problems identified by community pharmacy personnel in Sweden; (2) to determine relationships among the types and number of problems identified and the gender, age and number of prescribed drugs in patients; and (3) to document the inte......Objectives. (1) To document types and number of drug-related problems identified by community pharmacy personnel in Sweden; (2) to determine relationships among the types and number of problems identified and the gender, age and number of prescribed drugs in patients; and (3) to document...... the interventions made by pharmacy personnel with patients and prescribers. Method. Random samples of pharmacists, prescriptionists and pharmacy technicians were drawn nationwide in Sweden; 144 (63 per cent) of the employees fulfilling the inclusion criteria agreed to take part. The participants documented drug......-related problems, interventions and patient variables on a data collection form, and tallied the number of patients they served on another form. Setting. One hundred and sixteen community pharmacies and 12 outpatient hospital pharmacies. Key findings. One problem or more was identified among 2.5 per cent...

  6. OCCUPATION AND MORTALITY RELATED TO ALCOHOL DRUGS AND SEXUAL HABITS

    Science.gov (United States)

    Coggon, David; Harris, E. Clare; Brown, Terry; Rice, Simon; Palmer, Keith T

    2011-01-01

    AIms To identify opportunities for targeted prevention, we explored differences in occupational mortality from diseases and injuries related to alcohol consumption, sexual habits and drug abuse. Methods Using data on all deaths among men and women aged 16-74 years in England and Wales during 1991-2000, we derived age- and social class-standardised proportional mortality ratios (PMRs) by occupation for cause of death categories defined a priori as potentially related to alcohol consumption, sexual habits or drug abuse. Results The highest mortality from alcohol-related diseases and injuries was observed in publicans and bar staff (both sexes), and in male caterers, cooks and kitchen porters, and seafarers. Male seafarers had significantly elevated PMRs for cirrhosis (179), “other alcohol-related diseases” (275), cancers of the liver (155), oral cavity (275) and pharynx (267), and injury by fall on the stairs (187). PMRs for HIV/AIDS were particularly high in tailors and dressmakers (918, 95%CI 369-1890, in men; 804, 95%CI 219-2060, in women) and male hairdressers (918, 95%CI 717-1160). Most jobs with high mortality from HIV/AIDS also had more deaths than expected from viral hepatitis. Of seven jobs with significantly high PMRs for both drug dependence and accidental poisoning by drugs, four were in the construction industry (male painters and decorators, bricklayers and masons, plasterers, and roofers and glaziers). Conclusions Our findings highlight major differences between occupations in mortality from diseases and injuries caused by alcohol, sexual habits and drug abuse. Priorities for preventive action include alcohol-related disorders in male seafarers and drug abuse in construction workers. PMID:20407041

  7. Occupation and mortality related to alcohol, drugs and sexual habits.

    Science.gov (United States)

    Coggon, D; Harris, E C; Brown, T; Rice, S; Palmer, K T

    2010-08-01

    To identify opportunities for targeted prevention, we explored differences in occupational mortality from diseases and injuries related to alcohol consumption, sexual habits and drug abuse. Using data on all deaths among men and women aged 16-74 years in England and Wales during 1991-2000, we derived age- and social class-standardized proportional mortality ratios (PMRs) by occupation for cause of death categories defined a priori as potentially related to alcohol consumption, sexual habits or drug abuse. The highest mortality from alcohol-related diseases and injuries was observed in publicans and bar staff (both sexes) and in male caterers, cooks and kitchen porters and seafarers. Male seafarers had significantly elevated PMRs for cirrhosis (179), 'other alcohol-related diseases' (275), cancers of the liver (155), oral cavity (275) and pharynx (267) and injury by fall on the stairs (187). PMRs for human immunodeficiency virus infection (HIV)/acquired immunodeficiency syndrome (AIDS) were particularly high in tailors and dressmakers (918, 95% CI: 369-1890, in men; 804, 95% CI: 219-2060, in women) and male hairdressers (918, 95% CI: 717-1160). Most jobs with high mortality from HIV/AIDS also had more deaths than expected from viral hepatitis. Of seven jobs with significantly high PMRs for both drug dependence and accidental poisoning by drugs, four were in the construction industry (male painters and decorators, bricklayers and masons, plasterers, and roofers and glaziers). Our findings highlight major differences between occupations in mortality from diseases and injuries caused by alcohol, sexual habits and drug abuse. Priorities for preventive action include alcohol-related disorders in male seafarers and drug abuse in construction workers.

  8. Beyond the drug-terror nexus: drug trafficking and state-crime relations in Central Asia.

    Science.gov (United States)

    De Danieli, Filippo

    2014-11-01

    In the wake of collapse of the Soviet Union, Central Asia has transformed into a key hub along the Afghan opiates trafficking routes. Around 30 percent of the heroin manufactured in Afghanistan is estimated to be smuggled through Central Asian republics in its way to booming drug markets in Russia and Eastern Europe. Building upon available evidence and extensive fieldwork research, the article seeks to confute mainstream analyses which emphasize connections between criminal and terrorist networks. The focus is on conducive factors for the establishment of drug routes in Central Asia, the characteristics of drug related networks, and the nature of political-criminal relations across the region. It is argued that in all five Central Asia republics strategic partnerships have formed between drug traffickers and state actors around the exploitation of drug rents and that mafias' influence on politics is stronger in Tajikistan and Kyrgyzstan, the region's poorest countries. By moving the focus from narco-terror to the state-crime connections, the article provides a critical insight into political economy issues surrounding a complex and multifaceted phenomenon such as the drug trade. Copyright © 2014. Published by Elsevier B.V.

  9. Zolpidem prescribing and adverse drug reactions in hospitalized general medicine patients at a Veterans Affairs hospital.

    Science.gov (United States)

    Mahoney, Jane E; Webb, Melissa J; Gray, Shelly L

    2004-03-01

    Zolpidem is prescribed for sleep disruption in hospitalized patients, but data on the incidence of adverse drug reactions (ADRs) are based largely on outpatient studies. Thus, the incidence of ADRs in hospitalized patients may be much higher. The goal of this study was to describe prescribing patterns of zolpidem for hospitalized medical patients aged 50 years, the incidence of ADRs possibly and probably associated with its use, and the factors associated with central nervous system (CNS) ADRs. This case series was conducted in 4 general medicine wards at a Veterans Affairs hospital and was a consecutive sample of patients aged 50 years who were hospitalized between 1993 and 1997 and received zolpidem as a hypnotic during hospitalization, but had not received it in the previous 3 months. Chart review was conducted by 2 evaluators. Data extracted from the medical records included admission demographic characteristics, medications, comorbidities, and levels of function in performing basic and instrumental activities of daily living. The main outcome measure was ADRs possibly or probably related to zolpidem use. The association between zolpidem and the occurrence of CNS ADRs (eg, confusion, dizziness, daytime somnolence) was analyzed separately. The review included 119 medical patients aged > or =50 years who had newly received zolpidem for sleep disruption during hospitalization. The median age of the population was 70 years; 86 (72.3%) patients were aged 65 years. The initial zolpidem dose was 5 mg in 42 patients (35.3%) and 10 mg in 77 patients (64.7%). Twenty-three patients had a respective 16 and 10 ADRs possibly and probably related to zolpidem use (19.3% incidence). Of a total of 26 ADRs, 21 (80.8%) were CNS ADRs, occurring with both zolpidem 5 mg (10.8% of users) and 10 mg (18.3% of users). On univariate analyses, the only factor significantly associated with a CNS ADR was functional impairment at baseline (P = 0.003). Zolpidem was discontinued in 38.8% of

  10. Betalactam antibiotics affect human dendritic cells maturation through MAPK/NF-kB systems. Role in allergic reactions to drugs

    International Nuclear Information System (INIS)

    Lopez, Soledad; Gomez, Enrique; Torres, Maria J.; Pozo, David; Fernandez, Tahia D.; Ariza, Adriana; Sanz, Maria L.; Blanca, Miguel; Mayorga, Cristobalina

    2015-01-01

    The mechanisms leading to drug allergy in predisposed patients, especially those related to T-cell-mediated drug hypersensitivity, are not well understood. A key event in allergic reactions to drugs is the maturation process undergone by dendritic cells (DCs). Although amoxicillin (AX) has been reported to interact and maturate DCs from patients with AX-induced delayed-type hypersensitivity, the cell signaling pathways related to AX-mediated DC maturation have not been elucidated. We sought to determine the role of the MAPK and NF-κΒ pathways on AX-induced DC maturation and functional status. For that purpose, in monocyte-derived-DCs from AX-delayed allergic patients and tolerant subjects, we analyzed the activation pattern of p38MAPK, JNK, and ERK signaling and the NF-κB, maturation markers as well as endocytosis and allostimulatory capacities driven by AX-stimulated-DCs. Our data reveal that AX induces an increase in the phosphorylation levels of the three MAPKsand activated NF-κB in DCs from allergic patients. Moreover, the inhibition of these pathways prevents the up-regulation of surface molecules induced by AX. Additionally, we observed that the allostimulatory capacity and the endocytosis down-regulation in AX-stimulated-DCs from allergic patients depend on JNK and NF-κB activities. Taken together, our data shed light for the first time on the main signaling pathways involved in DC maturation from AX-delayed allergic patient. - Highlights: • The cell signaling pathways related to drug-mediated DC maturation were tested. • Amoxicillin induces activation of MAPK and NF-κB in DCs from allergic patients. • The inhibition of these pathways prevents the up-regulation of DC surface molecules. • Their allostimulatory and endocytosis capacities depend on JNK and NF-κB activities. • The low involvement of p38-MAPK could be the cause of an incomplete DC maturation.

  11. Betalactam antibiotics affect human dendritic cells maturation through MAPK/NF-kB systems. Role in allergic reactions to drugs

    Energy Technology Data Exchange (ETDEWEB)

    Lopez, Soledad [CABIMER-Andalusian Center for Molecular Biology and Regenerative Medicine, Seville (Spain); Department of Medical Biochemistry, Molecular Biology and Immunology, The University of Seville Medical School, Seville (Spain); Gomez, Enrique [Research Laboratory, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain); Torres, Maria J. [Allergy Service, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain); Pozo, David [CABIMER-Andalusian Center for Molecular Biology and Regenerative Medicine, Seville (Spain); Department of Medical Biochemistry, Molecular Biology and Immunology, The University of Seville Medical School, Seville (Spain); Fernandez, Tahia D.; Ariza, Adriana [Research Laboratory, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain); Sanz, Maria L. [Department of Allergology and Clinical Immunology, University Clinic of Navarra, Pamplona (Spain); Blanca, Miguel [Allergy Service, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain); Mayorga, Cristobalina, E-mail: lina.mayorga@ibima.eu [Research Laboratory, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain); Allergy Service, IBIMA-Regional University Hospital of Malaga, UMA, Málaga (Spain)

    2015-11-01

    The mechanisms leading to drug allergy in predisposed patients, especially those related to T-cell-mediated drug hypersensitivity, are not well understood. A key event in allergic reactions to drugs is the maturation process undergone by dendritic cells (DCs). Although amoxicillin (AX) has been reported to interact and maturate DCs from patients with AX-induced delayed-type hypersensitivity, the cell signaling pathways related to AX-mediated DC maturation have not been elucidated. We sought to determine the role of the MAPK and NF-κΒ pathways on AX-induced DC maturation and functional status. For that purpose, in monocyte-derived-DCs from AX-delayed allergic patients and tolerant subjects, we analyzed the activation pattern of p38MAPK, JNK, and ERK signaling and the NF-κB, maturation markers as well as endocytosis and allostimulatory capacities driven by AX-stimulated-DCs. Our data reveal that AX induces an increase in the phosphorylation levels of the three MAPKsand activated NF-κB in DCs from allergic patients. Moreover, the inhibition of these pathways prevents the up-regulation of surface molecules induced by AX. Additionally, we observed that the allostimulatory capacity and the endocytosis down-regulation in AX-stimulated-DCs from allergic patients depend on JNK and NF-κB activities. Taken together, our data shed light for the first time on the main signaling pathways involved in DC maturation from AX-delayed allergic patient. - Highlights: • The cell signaling pathways related to drug-mediated DC maturation were tested. • Amoxicillin induces activation of MAPK and NF-κB in DCs from allergic patients. • The inhibition of these pathways prevents the up-regulation of DC surface molecules. • Their allostimulatory and endocytosis capacities depend on JNK and NF-κB activities. • The low involvement of p38-MAPK could be the cause of an incomplete DC maturation.

  12. Cutaneous adverse drug reactions in a tertiary care teaching hospital in India: An intensive monitoring study

    Directory of Open Access Journals (Sweden)

    Sejal Thakkar

    2017-01-01

    Full Text Available Background: The epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs. Aim: The aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population. Methodology: Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs. Results: A total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39–0.53. The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%, urticaria (21.64%, and fixed drug eruptions (FDEs (18.13%. Antimicrobials (35.18% and nonsteroidal anti-inflammatory drugs (NSAIDs were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05–0.11, 0.04% (95% CI: 0.02–0.06, and 0.003% (95% CI: 0.000–0.001, respectively. Conclusion: Ethnic characteristics should be considered while interpreting incidence from the international studies. The

  13. Quantitative prediction of drug side effects based on drug-related features.

    Science.gov (United States)

    Niu, Yanqing; Zhang, Wen

    2017-09-01

    Unexpected side effects of drugs are great concern in the drug development, and the identification of side effects is an important task. Recently, machine learning methods are proposed to predict the presence or absence of interested side effects for drugs, but it is difficult to make the accurate prediction for all of them. In this paper, we transform side effect profiles of drugs as their quantitative scores, by summing up their side effects with weights. The quantitative scores may measure the dangers of drugs, and thus help to compare the risk of different drugs. Here, we attempt to predict quantitative scores of drugs, namely the quantitative prediction. Specifically, we explore a variety of drug-related features and evaluate their discriminative powers for the quantitative prediction. Then, we consider several feature combination strategies (direct combination, average scoring ensemble combination) to integrate three informative features: chemical substructures, targets, and treatment indications. Finally, the average scoring ensemble model which produces the better performances is used as the final quantitative prediction model. Since weights for side effects are empirical values, we randomly generate different weights in the simulation experiments. The experimental results show that the quantitative method is robust to different weights, and produces satisfying results. Although other state-of-the-art methods cannot make the quantitative prediction directly, the prediction results can be transformed as the quantitative scores. By indirect comparison, the proposed method produces much better results than benchmark methods in the quantitative prediction. In conclusion, the proposed method is promising for the quantitative prediction of side effects, which may work cooperatively with existing state-of-the-art methods to reveal dangers of drugs.

  14. The Diels-Alder reaction: A powerful tool for the design of drug delivery systems and biomaterials.

    Science.gov (United States)

    Gregoritza, Manuel; Brandl, Ferdinand P

    2015-11-01

    Click reactions have the potential to greatly facilitate the development of drug delivery systems and biomaterials. These reactions proceed under mild conditions, give high yields, and form only inoffensive by-products. The Diels-Alder cycloaddition is one of the click reactions that do not require any metal catalyst; it is one of the most useful reactions in synthetic organic chemistry and material design. Herein, we highlight possible applications of the Diels-Alder reaction in pharmaceutics and biomedical engineering. Particular focus is placed on the synthesis of polymers and dendrimers for drug delivery, the preparation of functionalized surfaces, bioconjugation techniques, and applications of the Diels-Alder reaction in nanotechnology. Moreover, applications of the reaction for the preparation of hydrogels for drug delivery and tissue engineering are reviewed. A general introduction to the Diels-Alder reaction is presented, along with a discussion of potential pitfalls and challenges. At the end of the article, we provide a set of tools that may facilitate the application of the Diels-Alder reaction to solve important pharmaceutical or biomedical problems. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. a survey on drug related problems in cervical cancer patients

    African Journals Online (AJOL)

    userpc

    Cisplatin/5FU/paclitaxel. 6. 9.23. 6. Seizure. Cisplatin. 2. 3.08. 7. Loss of hair. Cisplatin/5FU/Paclitaxel. 3. 4.62. 8. Nephrotoxicity. Cisplatin. 3. 4.62. 9. Hypotension. Paclitaxel. 3. 4.62. TOTAL. 65. 100. Table 3: Relationship between cervical cancer patients' factors and DRPs. Patients Factor. Drug Related Problems (DRPs).

  16. Drug-related problems in patients with osteoporosis

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    Ilić Darko

    2016-01-01

    Full Text Available Background/Aim. Drug-related problems are especially frequent among patients suffering from non-communicable diseases, like osteoporosis, leading to suboptimal treatment response. The aim of this study was to identify drug-related problems in patients with osteoporosis. Methods. This cross-sectional prospective study was conducted in January 2014 on outpatients with osteoporosis from three health facilities in Belgrade, Serbia. The patients included in the study were older than 50 years, and they were offered an anonymous questionnaire with open-ended questions. Results. There were 355 study participants, 329 (92.7% females and 26 (7.3% males. The patients who experienced at least one osteoporotic fracture (n = 208 were significantly less adherent to the therapy, less engaged in sports and regular physical activities, and more prone to nutrition with inadequate intake of calcium and vitamin D than patients without fractures (n = 147. Conclusion. The effectiveness of osteoporosis treatment is decreased by several drug-related problems encountered by both physicians and patients. However, the majority of the drug-related problems could be greatly influenced by appropriate educational programs. [Projekat Ministarstva nauke Republike Srbije, br. 175007

  17. Pharmacists' Intervention to Reduce Drug Related Problems in HIV ...

    African Journals Online (AJOL)

    Despite advances in the use of highly active antiretroviral therapy (HAART) in the management of HIV/AIDS, drug-related problems (DRPs) still remain an issue, particularly in developing countries. This study evaluated the incidence of DRPs among HIV/AIDS patients in a HIV/AIDS care centre in southern Nigeria and the ...

  18. Do Geriatric Conditions Increase Risk of Adverse Drug Reactions in Ambulatory Elders? Results From the VA GEM Drug Study

    Science.gov (United States)

    Hanlon, Joseph T.; Sloane, Richard J.; Boscardin, W. John; Schmader, Kenneth E.

    2011-01-01

    Background. Many clinicians prescribe cautiously to older adults with common geriatric conditions for fear of causing adverse drug reactions (ADRs). However, little is known about the association between these conditions and risk of ADRs. Methods. Using data from the VA Geriatric Evaluation and Management Drug Study, we determined any, preventable, and serious ADRs in 808 elders for 12 months after hospital discharge using a validated process involving patient self-report and chart review adjudicated by two health care professionals. Eight common geriatric conditions (activities of daily living, dementia, incontinence, falls, difficulty ambulating, malnourishment, depression, and prolonged bed rest) were evaluated at study baseline through self-report and structured assessments. We used Poisson regression to model the relationship between these geriatric conditions and ADRs. Results. Participants had a mean of 2.9 ± 1.2 geriatric conditions. Over the 12-month follow-up period, 497 ADRs occurred in 269 participants, including 187 ADRs considered preventable and 127 considered severe. On multivariable analyses, participants with dependency in one or more activities of daily living were less likely to suffer ADRs than those who were fully independent (incidence rate ratio: 0.78, 95% confidence interval = 0.62–1.00). None of the other seven geriatric conditions assessed were associated with ADR risk. Results were similar for preventable and serious ADRs, although participants with a history of falls were more likely to develop serious ADRs (incidence rate ratio: 1.49, 95% confidence interval = 1.00–2.21). Conclusions. Many geriatric conditions were not associated with risk of ADRs. Although it is prudent to prescribe judiciously in patients with these conditions, excessive caution may not be warranted. PMID:21321003

  19. Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Bondon-Guitton, Emmanuelle; Mourgues, Thibaut; Rousseau, Vanessa; Cousty, Sarah; Cottin, Judith; Drablier, Guillaume; Micallef, Joëlle; Montastruc, Jean-Louis

    2017-09-01

    Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database. Among 523,808 reports of adverse drug reactions, we identified 454 reports of gingival bleeding (0.09%). Most of them were "serious" (58.4%) and occurred in females (54.6%). The frequency of gingival bleeding increased with age. The most frequently "suspected" drugs were antithrombotics (67.8%), particularly fluindione. Other drugs frequently involved were furosemide followed by paracetamol, amiodarone, amoxicillin, paroxetine, ketoprofen, zolpidem, enalapril and ramipril. Thirty-nine reports involved a drug-drug interaction with antithrombotics, mainly with anti-infectives. Gingival bleeding can be an adverse drug reaction, often "serious" and rarely fatal. Patients older than 50 years and women are particularly at risk. Among drugs known to increase the risk of gingival bleeding, the most frequently involved were fluindione, furosemide, paracetamol, amiodarone, amoxicillin, paroxetine or ketoprofen. We also identified signal for drugs not usually known to be involved in bleeding, like zolpidem, enalapril or ramipril. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Severe adverse drug reaction following Crotalidae Polyvalent Immune Fab (Ovine) administration for copperhead snakebite.

    Science.gov (United States)

    Lepak, Maryjoy R; Bochenek, Samantha H; Bush, Sean P

    2015-01-01

    To present the case of a severe anaphylactic/anaphylactoid reaction to Crotalidae Polyvalent Immune Fab (Ovine) in a patient bitten by a copperhead snake. A 68-year-old man presented with progressive envenomation after receiving a copperhead snakebite on each hand. Crotalinae Fab antivenom was administered. While the initial and only dose was partially infusing, the patient developed an adverse drug reaction (ADR) of urticaria and hypotension, which resolved with cessation of the infusion, recurred with resumption of the infusion, and ultimately was completed with supportive care. An additional episode of hypotension, urticaria, and angioedema occurred shortly after antivenom therapy completion. Epinephrine was administered, resolving the reaction with complete patient recovery. The event received a Naranjo score of 10, indicating a definite ADR. Treating copperhead snakebites with antivenom is a matter of debate. Concern over adverse events and cost induce some physicians to manage copperhead bites without antivenom because they are generally milder in severity. As demonstrated in this case, severe ADR can occur with Crotalinae Fab antivenom, and its efficacy for copperhead envenoming needs to be better established via placebo-controlled, randomized trials. © The Author(s) 2014.

  1. Adverse drug reactions due to antipsychotics and sedative-hypnotics in the elderly

    Directory of Open Access Journals (Sweden)

    Natasha S Kate

    2015-01-01

    Full Text Available Psychotropic drugs are commonly used to manage mental and behavioral problems in geriatric patients. This is, however, accompanied by the risk of developing adverse drug reactions (ADRs, impacting the safety with which the drug can be used. In this article, we provide an overview of the factors associated with the ADRs due to psychotropic medication in the elderly, and the ADRs associated with the use of antipsychotics and sedative-hypnotics in the geriatric population. For this, literature searches were conducted through MEDLINE, PubMed, and Google Scholar using keyword terms: Geriatric, elderly, safety, adverse events, ADRs, antipsychotic, names of individual antipsychotics, benzodiazepine, sedative, hypnotic, zolpidem, zaleplon, zopiclone. Research data indicate that antipsychotics are associated with an increased risk of metabolic syndrome, thromboembolism, cerebrovascular and cardiac events, pneumonia, fractures, and increased mortality. Among antipsychotics, aripiprazole seems to have fewer ADRs while other antipsychotics (typical and atypicals have reports of troublesome side effect profiles. Sedative-hypnotics are associated with a risk of falls, fractures, cognitive impairment, and may increase the risk of developing dementia with long-term use. The risk of these complications is present with both benzodiazepines and medications such as zolpidem and zopiclone.

  2. An epidemiological and clinical analysis of cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia

    Directory of Open Access Journals (Sweden)

    Siew-Eng Choon

    2012-01-01

    Full Text Available Background: The prevalence, clinical patterns, and causative drugs of cutaneous adverse drug reactions (cADR vary among the different populations previously studied. Aim: To determine the prevalence, the clinical patterns of drug eruptions, and the common drugs implicated, particularly in severe cADR such as Stevens-Johnson Syndrome/Toxic epidermal necrolysis (SJS/TEN and drug rash with eosinophilia and systemic symptoms (DRESS in our population. Methods: We analyzed the database established for all cADR seen by the department of Dermatology from January 2001 till December 2010. Results: A total of 362 cADR were seen among 42 170 new clinic attendees, yielding an incidence rate of 0.86%. The most common reaction pattern seen was maculopapular eruption (153 cases followed by SJS/TEN (110 cases and DRESS (34 cases. Antibiotics was the most commonly implicated drug group (146 cases followed by anticonvulsants (81 cases and antigout drugs (50 cases. The most frequently implicated drug was allopurinol (50 cases. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 21.8%, 20.9%, and 12.7%, respectively, of the 110 cases seen, whereas DRESS was mainly caused by allopurinol (15 cases. Mortality rates for TEN, SJS, and DRESS were 28.6%, 2.2%, and 5.9%, respectively Conclusions: The low rate of cADR with a high proportion of severe reactions observed in this study was probably due to referral bias. Otherwise, the reaction patterns and drugs causing cADR in our population were similar to those seen in other countries. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN in our population.

  3. An epidemiological and clinical analysis of cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia.

    Science.gov (United States)

    Choon, Siew-Eng; Lai, Nai-Ming

    2012-01-01

    The prevalence, clinical patterns, and causative drugs of cutaneous adverse drug reactions (cADR) vary among the different populations previously studied. To determine the prevalence, the clinical patterns of drug eruptions, and the common drugs implicated, particularly in severe cADR such as Stevens-Johnson Syndrome/Toxic epidermal necrolysis (SJS/TEN) and drug rash with eosinophilia and systemic symptoms (DRESS) in our population. We analyzed the database established for all cADR seen by the department of Dermatology from January 2001 till December 2010. A total of 362 cADR were seen among 42 170 new clinic attendees, yielding an incidence rate of 0.86%. The most common reaction pattern seen was maculopapular eruption (153 cases) followed by SJS/TEN (110 cases) and DRESS (34 cases). Antibiotics was the most commonly implicated drug group (146 cases) followed by anticonvulsants (81 cases) and antigout drugs (50 cases). The most frequently implicated drug was allopurinol (50 cases). Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 21.8%, 20.9%, and 12.7%, respectively, of the 110 cases seen, whereas DRESS was mainly caused by allopurinol (15 cases). Mortality rates for TEN, SJS, and DRESS were 28.6%, 2.2%, and 5.9%, respectively. The low rate of cADR with a high proportion of severe reactions observed in this study was probably due to referral bias. Otherwise, the reaction patterns and drugs causing cADR in our population were similar to those seen in other countries. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN in our population.

  4. Relationship between drug interactions and drug-related negative clinical outcomes in two community pharmacies

    Directory of Open Access Journals (Sweden)

    Gonzalo M

    2009-03-01

    Full Text Available Drug interactions may represent an iatrogenic risk that should be controlled in community pharmacies at the dispensing level. Aim: We analyzed the association between potential drug-drug interactions (DDIs and negative clinical outcomes.Methods: We used dispensing data from two community pharmacies: instances where drug dispensing was associated with a potential DDI and a comparison group of randomized dispensing operations with no potential DDI. In cases where potential DDIs were detected, we analyzed the underlying negative clinical outcomes. Age and gender data were included in the analysis.Results: During the study period, we registered 417 potential DDIs. The proportion of women and age were higher in the study group than in the comparison group. The average potential DDIs per patient was 1.31 (SD=0.72. The Consejo General de Colegios Oficiales de Farmacéuticos (CGCOF database did not produce an alert in 2.4% of the cases. Over-the-counter medication use was observed in 5% of the potential DDI cases. The drugs most frequently involved in potential DDIs were acenocoumarol, calcium salts, hydrochlorothiazide, and alendronic acid, whereas the most predominant potential DDIs were calcium salts and bisphosphonates, oral antidiabetics and thiazide diuretics, antidiabetics and glucose, and oral anticoagulant and paracetamol. The existence of a drug-related negative clinical outcome was observed only in 0.96% of the potential DDI cases (50% safety cases and 50% effectiveness cases. Conclusions: Only a small proportion of the detected potential DDIs lead to medication negative outcomes. Considering the drug-related negative clinical outcomes encountered, tighter control would be recommended in potential DDIs with NSAIDs or benzodiazepines.

  5. Adverse Drug Reactions Causing Admission to Medical Wards: A Cross-Sectional Survey at 4 Hospitals in South Africa.

    Science.gov (United States)

    Mouton, Johannes P; Njuguna, Christine; Kramer, Nicole; Stewart, Annemie; Mehta, Ushma; Blockman, Marc; Fortuin-De Smidt, Melony; De Waal, Reneé; Parrish, Andy G; Wilson, Douglas P K; Igumbor, Ehimario U; Aynalem, Getahun; Dheda, Mukesh; Maartens, Gary; Cohen, Karen

    2016-05-01

    Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions.We prospectively followed patients admitted to 4 hospitals' medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission.There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34-65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06-2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09-1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07-1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17-3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable.In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect South Africa's high HIV

  6. An analysis of serious adverse drug reactions at a tertiary care teaching hospital

    Directory of Open Access Journals (Sweden)

    Kinjal Prajapati

    2016-01-01

    Full Text Available Objective: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs such as clinical presentation, causality, severity, and preventability occurring in a hospital setting. Materials and Methods: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC criteria. A retrospective analysis was carried out for clinical presentation, causality (as per the WHO-UMC scale and Naranjo′s algorithm, severity (Hartwig and Siegel scale, and preventability (Schumock and Thornton criteria. Results: Out of 2977 ADRs reported, 375 were serious in nature. The most common clinical presentation involved was skin and appendageal disorders (71, 18.9%. The common causal drug group was antitubercular (129, 34.4% followed by antiretroviral (76, 20.3% agents. The criteria for the majority of serious ADRs were intervention to prevent permanent impairment or damage (164, 43.7% followed by hospitalization (158, 42.1%. Majority of the serious ADRs were continuing (191, 50.9% at the time of reporting, few recovered (101, 26.9%, and two were fatal. The majority of serious ADRs were categorized as possible (182, 48.8% followed by probable (173, 46.1% in nature. Conclusion: Antitubercular, antiretroviral, and antimicrobial drugs were the most common causal drug groups for serious ADRs. This calls for robust ADR monitoring system and education of patients and prescribers for identification and effective management.

  7. Days lost due to disability of diclofenac-induced adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Thomas D

    2012-03-01

    Full Text Available Disability Adjusted Life Years (DALY is a widely used measure to quantify the burden of diseases or illness. DALYs for a disease is calculated as the sum of the Years of Life Lost (YLL due to premature mortality in the population and the equivalent healthy Years Lost due to Disability (YLD. The only difference from the YLD and Days Lost due to Disability (DLD calculation is that instead of considering the duration of Adverse Drug Reaction (ADR in years, it is calculated in days. Objective: DLD was measured for diclofenac tablets to prepare the ADR profile.Methods: The study was done on the patients (18-65 years old attending the community pharmacy at Kasaragod district, South India, with prescription of diclofenac tablets. Patients reported ADRs on their next visit to the pharmacy or they had called to the provided phone number and reported it. Disability Weight (DW was calculated in an analogue scale from 0-1. Zero represent complete health and 1 represent death or equivalent condition. DW was multiplied with occurrence and duration of ADRs in days.Results: About 943 patients received diclofenac tablets in 1000 prescriptions were successfully followed up for possible, probable and definite ADRs. A total of 561 reactions reported in 2010 for diclofenac tablet in the study population. There were 34 different types of ADRs under 12 physiological systems/organs. Most common reactions were on gastrointestinal (GI system (48%, followed by skin (14%, Central Nervous System (10%, renal (7%, and cardiovascular (7%. Abdominal pain, cramps or flatulence was the highest occurring GI ADR (107, followed by 43 rashes, 42 nausea/vomiting, 37 indigestion, 34 peptic ulcers, 31 edema etc. DLD for peptic ulcer was considerably high (0.078 per 1000 of the study population on diclofenac. The most damaging ADR were peptic ulcer with or without perforation, followed by rash 0.036 DLD and edema 0.027 DLD. There was considerable DLD by acute renal failure (0.012 Steven

  8. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  9. Adverse drug reactions in children reported by European consumers from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    Background Information about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children. Objective To characterize ADRs in children reported by consumers in Europe from 2007 to 2011...... agents for 23 % and sex hormones for 13 %. Conclusion Only few paediatric ADR consumer reports were found in EudraVigilance. Many of these ADRs were serious, and fatal cases were reported, however also nonserious reports were present. The findings indicate that consumer reports may be of value....... Methods We analysed ADRs reported to the European ADR database, EudraVigilance (EV) for individuals from birth to 17 years. Data were characterized with respect to age and sex of the child, type of ADR (system organ class and preferred term), seriousness and suspected medicines (anatomical therapeutic...

  10. A prediction model-based algorithm for computer-assisted database screening of adverse drug reactions in the Netherlands.

    Science.gov (United States)

    Scholl, Joep H G; van Hunsel, Florence P A M; Hak, Eelko; van Puijenbroek, Eugène P

    2018-02-01

    The statistical screening of pharmacovigilance databases containing spontaneously reported adverse drug reactions (ADRs) is mainly based on disproportionality analysis. The aim of this study was to improve the efficiency of full database screening using a prediction model-based approach. A logistic regression-based prediction model containing 5 candidate predictors was developed and internally validated using the Summary of Product Characteristics as the gold standard for the outcome. All drug-ADR associations, with the exception of those related to vaccines, with a minimum of 3 reports formed the training data for the model. Performance was based on the area under the receiver operating characteristic curve (AUC). Results were compared with the current method of database screening based on the number of previously analyzed associations. A total of 25 026 unique drug-ADR associations formed the training data for the model. The final model contained all 5 candidate predictors (number of reports, disproportionality, reports from healthcare professionals, reports from marketing authorization holders, Naranjo score). The AUC for the full model was 0.740 (95% CI; 0.734-0.747). The internal validity was good based on the calibration curve and bootstrapping analysis (AUC after bootstrapping = 0.739). Compared with the old method, the AUC increased from 0.649 to 0.740, and the proportion of potential signals increased by approximately 50% (from 12.3% to 19.4%). A prediction model-based approach can be a useful tool to create priority-based listings for signal detection in databases consisting of spontaneous ADRs. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

  11. Pharmacy Student Facilitation of Reporting of Adverse Drug Reactions in a Hospital.

    Science.gov (United States)

    Wentzell, Jason; Nguyen, Tiffany; Bui, Stephanie; MacDonald, Erika

    2017-01-01

    Health Canada relies on health professionals to voluntarily report adverse reactions to the Canada Vigilance Program. Current rates of reporting adverse drug reactions (ADRs) are inadequate to detect important safety issues. To assess the impact of pharmacy student facilitation of ADR reporting by pharmacists at a tertiary care teaching hospital in Canada. The intervention of interest, implemented at one campus of the hospital, was facilitation of ADR reporting by pharmacy students. The students received training on how to submit ADR reports and presented information sessions on the topic to hospital pharmacists; the pharmacists were then encouraged to report ADRs to a designated student for formal reporting. Frequency of reporting by pharmacists at the intervention campus was compared with reporting at a control campus of the same hospital. Data were collected prospectively over a 6-month pilot period, starting in April 2015. During the pilot period, 27 ADR reports were submitted at the intervention campus, and 3 reports at the control campus. All student participants strongly agreed that they would recommend that responsibility for submitting ADR reports to the Canada Vigilance Program remain with pharmacy students during future rotations. Availability of a pharmacy student to facilitate reporting of ADRs may increase the frequency of ADR reporting and could alleviate pharmacist workload; this activity is also a potentially valuable learning experience for students.

  12. Advances in allergic skin disease, anaphylaxis, and hypersensitivity reactions to foods, drugs, and insects.

    Science.gov (United States)

    Sicherer, Scott H; Leung, Donald Y M

    2006-07-01

    This review highlights some of the research advances in anaphylaxis; hypersensitivity reactions to foods, drugs, and insects; and allergic skin disease that were reported primarily in the Journal in 2005. Although studies documented deficiencies in community management of anaphylaxis, guidelines and National Institutes of Health summary reports provide direction toward improved research and education. At least 9% of young children "outgrow" a tree nut allergy. Advances in food allergy diagnosis include reports of probability of reactions to peanut at various peanut-specific IgE concentrations and skin test response size and the utility of evaluating IgE binding to specific epitopes. Future food allergy treatments might include selection of "less allergenic" fruit cultivars, genetic silencing of major allergens, and treatment of allergic patients with Chinese herbal remedies. Osteopontin might be a useful biomarker for success of venom immunotherapy. Progress in our understanding of the immunology of atopic dermatitis and autoimmune urticaria has also been made. These observations will likely contribute toward optimizing management of these common allergic disorders.

  13. Adverse reactions among patients being treated for multi-drug resistant tuberculosis at Abbassia Chest Hospital

    Directory of Open Access Journals (Sweden)

    Mohammad A. Tag El Din

    2015-10-01

    Conclusions: There is a relation between both tobacco smoking and drug addiction, and MDR TB. The most common type of resistance is acquired resistance because of lack of adherence to treatment or inappropriate treatment. The most common co-morbidities associated with MDR TB are diabetes and chronic obstructive lung diseases. The most important predictors of patients’ outcome are sputum conversion, number of previous TB treatment and presence of co-morbidities.

  14. Direct costs of managing adverse drug reactions during rifampicin-resistant tuberculosis treatment in South Africa.

    Science.gov (United States)

    Schnippel, K; Firnhaber, C; Berhanu, R; Page-Shipp, L; Sinanovic, E

    2018-04-01

    To estimate the provider costs of managing adverse drug reactions (ADRs) to standard long-course treatment for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) according to South African guidelines. We parameterised a published Markov health state model for MDR/RR-TB with guidelines-based, bottom-up public-sector provider costing of ADR management. Frequency of ADR occurrence was extracted from the literature. Costs were estimated over 10 years, discounted 3% annually and tested using probabilistic sensitivity analysis. On average, guidelines-based costing of moderate ADRs weighted by the frequency of occurrence was US$135.76 (standard deviation [SD] US$17.18) and the cost of serious ADRs was US$521.29 (SD US$55.99). We estimated that the incremental costs of ADR management were US$380.17 annually per patient initiating MDR/RR-TB treatment. The incremental costs of ADR management for the public health sector in South Africa was US$4.76 million, 8.3% of the estimated cohort costs of MDR/RR-TB treatment ($57.55 million) for the 2015 cohort of 12 527 patients. Management of multiple ADRs and serious ADRs, which are common during the first 6 months of standard, long-course MDR/RR-TB treatment, substantially increases provider treatment costs. These results need to be taken into account when comparing regimen costs, and highlight the urgent need to identify drug regimens with improved safety profiles.

  15. Hybrid Semantic Analysis for Mapping Adverse Drug Reaction Mentions in Tweets to Medical Terminology.

    Science.gov (United States)

    Emadzadeh, Ehsan; Sarker, Abeed; Nikfarjam, Azadeh; Gonzalez, Graciela

    2017-01-01

    Social networks, such as Twitter, have become important sources for active monitoring of user-reported adverse drug reactions (ADRs). Automatic extraction of ADR information can be crucial for healthcare providers, drug manufacturers, and consumers. However, because of the non-standard nature of social media language, automatically extracted ADR mentions need to be mapped to standard forms before they can be used by operational pharmacovigilance systems. We propose a modular natural language processing pipeline for mapping (normalizing) colloquial mentions of ADRs to their corresponding standardized identifiers. We seek to accomplish this task and enable customization of the pipeline so that distinct unlabeled free text resources can be incorporated to use the system for other normalization tasks. Our approach, which we call Hybrid Semantic Analysis (HSA), sequentially employs rule-based and semantic matching algorithms for mapping user-generated mentions to concept IDs in the Unified Medical Language System vocabulary. The semantic matching component of HSA is adaptive in nature and uses a regression model to combine various measures of semantic relatedness and resources to optimize normalization performance on the selected data source. On a publicly available corpus, our normalization method achieves 0.502 recall and 0.823 precision (F-measure: 0.624). Our proposed method outperforms a baseline based on latent semantic analysis and another that uses MetaMap.

  16. Advances in allergic skin disease, anaphylaxis, and hypersensitivity reactions to foods, drugs, and insects in 2011.

    Science.gov (United States)

    Sicherer, Scott H; Leung, Donald Y M

    2012-01-01

    This review highlights some of the research advances in anaphylaxis; hypersensitivity reactions to foods, drugs, and insects; and allergic skin diseases that were reported in the Journal in 2011. Food allergy appears to be increasing in prevalence and carries a strong economic burden. Risk factors can include dietary ones, such as deficiency of vitamin D and timing of complementary foods, and genetic factors, such as filaggrin loss-of-function mutations. Novel mechanisms underlying food allergy include the role of invariant natural killer T cells and influences of dietary components, such as isoflavones. Among numerous preclinical and clinical treatment studies, promising observations include the efficacy of sublingual and oral immunotherapy, a Chinese herbal remedy showing promising in vitro results, the potential immunotherapeutic effects of having children ingest foods with baked-in milk if they tolerate it, and the use of anti-IgE with or without concomitant immunotherapy. Studies of allergic skin diseases, anaphylaxis, and hypersensitivity to drugs and insect venom are elucidating cellular mechanisms, improved diagnostics, and potential targets for future treatment. The role of skin barrier abnormalities, as well as the modulatory effects of the innate and adaptive immune responses, are major areas of investigation. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  17. [Adverse reactions to drugs reported by the primary care physicians of Andalusia. Analysis of underreporting].

    Science.gov (United States)

    Torelló Iserte, J; Castillo Ferrando, J R; Laínez, M M; García Morillas, M; Arias González, A

    1994-04-15

    To discover the sort of adverse reactions to medication (ARM) notified by Primary Care doctors and identify the under-notification of those cases having special clinical-epidemiological interest. Retrospective study in which 2,597 ARM corresponding to 1,467 Yellow Cards (YC) were analysed. These were notified by Primary Care doctors to the Centro Andaluz de Farmacovigilancia (Andalusian Drug-watch centre) during the period from 1/6/90 to 31/12/92. To assess the seriousness of the ARM, their terminological classification and imputability, the criteria used in the WHO's international "Yellow Card" programme of spontaneous notification were followed. 77.2% of all notifications were from Primary Care, of which 7.4% were of special interest due to their serious or novel character. However an undernotification of serious and well-known ARM was detected, such as digestive haemorrhages (1.07/10(6) inhibitants per year), anaphylactic shock (0.34/10(6) inhab/year), agranulocytosis (0.23/10(6) inhab/year) and aplastic anaemia (0.05/10(6) inhab/year), among others. Most of the main under-notified ARM are generated in the community but treated in hospital Casualty departments. Therefore it would be useful to develop specific Drug-watch programmes in the hospitals themselves.

  18. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Kejian, E-mail: kejian.wang.bio@gmail.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Weng, Zuquan [Japan National Institute of Occupational Safety and Health, Kawasaki (Japan); Sun, Liya [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Sun, Jiazhi; Zhou, Shu-Feng [Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL (United States); He, Lin, E-mail: helin@Bio-X.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China)

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.

  19. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    International Nuclear Information System (INIS)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-01-01

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development

  20. Factors affecting the development of adverse drug reactions to β-blockers in hospitalized cardiac patient population

    Directory of Open Access Journals (Sweden)

    Mugoša S

    2016-08-01

    Full Text Available Snežana Mugoša,1,2 Nataša Djordjević,3 Nina Djukanović,4 Dragana Protić,5 Zoran Bukumirić,6 Ivan Radosavljević,7 Aneta Bošković,8 Zoran Todorović5,9 1Department of Pharmacotherapy, Faculty of Pharmacy, University of Montenegro, 2Clinical Trial Department, Agency for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro; 3Department of Pharmacology and Toxicology, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, 4High Medical School “Milutin Milanković”, Belgrade, 5Department of Pharmacology, Clinical Pharmacology and Toxicology, 6Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, 7Department of Surgery, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia; 8Clinic for Heart Diseases, Clinical Centre of Montenegro, Podgorica, Montenegro; 9Department of Clinical Immunology and Allergy, Medical Center “Bežanijska kosa”, Belgrade, Serbia Abstract: The aim of the present study was to undertake a study on the prevalence of cytochrome P450 2D6 (CYP2D6 poor metabolizer alleles (*3, *4, *5, and *6 on a Montenegrin population and its impact on developing adverse drug reactions (ADRs of β-blockers in a hospitalized cardiac patient population. A prospective study was conducted in the Cardiology Center of the Clinical Center of Montenegro and included 138 patients who had received any β-blocker in their therapy. ADRs were collected using a specially designed questionnaire, based on the symptom list and any signs that could point to eventual ADRs. Data from patients’ medical charts, laboratory tests, and other available parameters were observed and combined with the data from the questionnaire. ADRs to β-blockers were observed in 15 (10.9% patients. There was a statistically significant difference in the frequency of ADRs in relation to genetically determined enzymatic activity (P<0.001, with ADRs’ occurrence significantly

  1. Severe cutaneous drug reactions in Guinean children: a monocentric retrospective study of 35 cases

    Directory of Open Access Journals (Sweden)

    Thierno Mamadou Tounkara

    2018-04-01

    Full Text Available Background: Data on Severe cutaneous drug reactions (CADRs are not common among in sub-Saharan Africa children. The purpose of this study was to document the clinical, etiological and evolutionary aspects of Severe CDRs in children hospitalized at the dermatology department of university hospitals of Conakry. Material and Methods: Retrospective study, conducted from 1 January 2000 to 31 December 2014. Were included all children aged 0-17 years hospitalized for severe CARDs. The data collected were Socio-demographic, clinical, para-clinical and evolution variables. The data was entered and analyzed using the Excel 8.0 software. Results: During a study period, 4437 patients of all ages was hospitalized in dermatology department. 35 patients were included with an average age of 11.3 years and a sex ratio of 1.5. The main clinical patterns were: Stevens Johnson syndrome 37.14% (13/35 Lyell syndrome 25.71 % and generalized bullous fixed eruption 22.85%. The drug was identified as 32 patients (91.42%: Sulfadoxine–Pyriméthamine 40.62%, cotrimoxazole 21.85%, nevirapin 12.5%, ampicillin 6.25%, traditional Pharmacopoeia 6.25% and griseofulin 3.12%. It was taken following self-medication in 14 patients, including a parental initiative in 9 patients. 7 patients had a history of drug allergy and 4 were HIV positive. We recorded 5 deaths. Conclusion: Our study confirms the rarity of severe CADRs in children. The importance of the sulfadoxine-pyrimethamine in the occurrence of severe CADRs in children is the particularity of our series.

  2. Sex and age related differences in postmyelographic adverse reactions

    International Nuclear Information System (INIS)

    Maly, P.

    1989-01-01

    Differences in frequency of postmyelographic adverse reactions were analyzed with respect to sex and age in a prospective study including 1026 patients injected with metrizamide and 739 injected with iohexol. Regardless of the type of contrast medium or myelography, all types of adverse reactions were 1.4-3.8 times as frequent in women as in men. Most of the differences were statistically significant. Headache was more frequent, while vomiting and dizziness were less frequent in both women and men aged 26-50 years compared with those over 50 years of age. Dizziness and increased low back pain were consistently reported spontaneously by the patients less frequently than emerged via formal interview. The large differences between the sexes suggest that further research on contrast media toxicity would be best performed with separation of the data by gender. (orig.)

  3. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

    Science.gov (United States)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Pharmacodynamic genetic polymorphisms affect adverse drug reactions of haloperidol in patients with alcohol-use disorder

    Directory of Open Access Journals (Sweden)

    Zastrozhin MS

    2017-07-01

    Full Text Available Mikhail Sergeevich Zastrozhin,1,2 Vadim Markovich Brodyansky,3 Valentin Yurievich Skryabin,4 Elena Anatolievna Grishina,5 Dmitry Vladimirovich Ivashchenko,5 Kristina Anatolievna Ryzhikova,5 Ludmila Mikhaylovna Savchenko,1 Alexander Olegovich Kibitov,3 Evgeny Alekseevich Bryun,1,4 Dmitry Alekseevich Sychev6 1Department of Addictology, Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia; 2Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Center for the Prevention of Dependent Behavior, Moscow, Russia; 3Federal Medical Research Centre of Psychiatry and Addictology, Laboratory of Molecular Genetics, Moscow, Russia; 4Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Department of Addictology, Moscow, Russia; 5Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Research Centre, Moscow, Russia; 6Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Department of Clinical Pharmacology and Therapy, Moscow, Russia Background: Antipsychotic action of haloperidol is due to blockade of D2 receptors in the mesolimbic dopamine pathway, while the adverse drug reactions are associated with striatal D2 receptor blockade. Contradictory data concerning the effects of genetic polymorphisms of genes encoding these receptors and associated structures (catechol-O-methyltransferase [COMT], glycine transporter and gene encoding the density of D2 receptors on the neuronal membrane are described.Objective: The objectives of this study were to evaluate the correlation between DRD2, SLC6A3 (DAT and COMT genetic polymorphisms and to investigate their effect on the development of adverse drug reactions in patients with alcohol-use disorder who received haloperidol.Patients and methods: The study

  5. Alcohol- and drug-related absenteeism: a costly problem.

    Science.gov (United States)

    Roche, Ann; Pidd, Ken; Kostadinov, Victoria

    2016-06-01

    Absenteeism related to alcohol and other drug (AOD) use can place a substantial burden on businesses and society. This study estimated the cost of AOD-related absenteeism in Australia using a nationally representative dataset. A secondary analysis of the 2013 National Drug Strategy Household Survey (n=12,196) was undertaken. Two measures of AOD-related absenteeism were used: participants' self-reported absence due to AOD use (M1); and the mean difference in absence due to any illness/injury for AOD users compared to abstainers (M2). Both figures were multiplied by $267.70 (average day's wage in 2013 plus 20% on-costs) to estimate associated costs. M1 resulted in an estimation of 2.5 million days lost annually due to AOD use, at a cost of more than $680 million. M2 resulted in an estimation of almost 11.5 million days lost, at a cost of $3 billion. AOD-related absenteeism represents a significant and preventable impost upon Australian businesses. Workplaces should implement evidence-based interventions to promote healthy employee behaviour and reduce AOD-related absenteeism. © 2015 Public Health Association of Australia.

  6. Teledermatologist expert skin advice: A unique model of care for managing skin disorders and adverse drug reactions in hepatitis C patients.

    Science.gov (United States)

    Charlston, Samuel; Siller, Gregory

    2018-03-23

    To conduct an audit of teledermatologist expert skin advice, a store and forward tele-dermatological service, to determine its effectiveness and user satisfaction in managing cutaneous adverse drug reactions in patients with hepatitis C, and to demonstrate a unique collaborative model of care for patients receiving specialised drug therapy. A retrospective analysis of data on teledermatologist expert skin advice referrals from January 2014 to December 2015 was performed. The primary outcomes assessed included number of referrals, referral locations, diagnoses, response times, quality of clinical information provided and user satisfaction ratings. Altogether 43 consultations from 29 referring sites were received from Australian metropolitan and rural settings. Of the patients, 43 were diagnosed with an adverse drug reaction related to the use of either telaprevir or simeprevir. The average time taken for the dermatologist to reply electronically with a final diagnosis and management plan was 1 h 57 min. As many as 26% of referrals required additional photos to establish a diagnosis due to poor-quality images or insufficient detail. Altogether 18 clinicians completed the customer satisfaction survey, all of whom rated teledermatologist expert skin advice nine or above on a scale of one to 10. Teledermatologist expert skin advice was regarded by clinicians as a valuable patient care service. The platform is a novel modality that supports patients undergoing specialised treatments at risk of cutaneous adverse drug reaction. © 2018 The Australasian College of Dermatologists.

  7. Preparation of ionic-crosslinked chitosan-based gel beads and effect of reaction conditions on drug release behaviors.

    Science.gov (United States)

    Chen, Shilan; Liu, Mingzhu; Jin, Shuping; Wang, Bin

    2008-02-12

    Drug-loaded chitosan (CS) beads were prepared under simple and mild condition using trisodium citrate as ionic crosslinker. The beads were further coated with poly(methacrylic acid) (PMAA) by dipping the beads in PMAA aqueous solution. The surface and cross-section morphology of these beads were observed by scanning electron microscopy and the observation showed that the coating beads had core-shell structure. In vitro release of model drug from these beads obtained under different reaction conditions was investigated in buffer medium (pH 1.8). The results showed that the rapid drug release was restrained by PMAA coating and the optimum conditions for preparing CS-based drug-loaded beads were decided through the effect of reaction conditions on the drug release behaviors. In addition, the drug release mechanism of CS-based drug-loaded beads was analyzed by Peppa's potential equation. According to this study, the ionic-crosslinked CS beads coated by PMAA could serve as suitable candidate for drug site-specific carrier in stomach.

  8. Scientometrics of drug discovery efforts: pain-related molecular targets

    Directory of Open Access Journals (Sweden)

    Kissin I

    2015-07-01

    Full Text Available Igor KissinDepartment of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USAAbstract: The aim of this study was to make a scientometric assessment of drug discovery efforts centered on pain-related molecular targets. The following scientometric indices were used: the popularity index, representing the share of articles (or patents on a specific topic among all articles (or patents on pain over the same 5-year period; the index of change, representing the change in the number of articles (or patents on a topic from one 5-year period to the next; the index of expectations, representing the ratio of the number of all types of articles on a topic in the top 20 journals relative to the number of articles in all (>5,000 biomedical journals covered by PubMed over a 5-year period; the total number of articles representing Phase I–III trials of investigational drugs over a 5-year period; and the trial balance index, a ratio of Phase I–II publications to Phase III publications. Articles (PubMed database and patents (US Patent and Trademark Office database on 17 topics related to pain mechanisms were assessed during six 5-year periods from 1984 to 2013. During the most recent 5-year period (2009–2013, seven of 17 topics have demonstrated high research activity (purinergic receptors, serotonin, transient receptor potential channels, cytokines, gamma aminobutyric acid, glutamate, and protein kinases. However, even with these seven topics, the index of expectations decreased or did not change compared with the 2004–2008 period. In addition, publications representing Phase I–III trials of investigational drugs (2009–2013 did not indicate great enthusiasm on the part of the pharmaceutical industry regarding drugs specifically designed for treatment of pain. A promising development related to the new tool of molecular targeting, ie, monoclonal antibodies, for pain treatment has not

  9. Neural Correlates of Drug-Related Attentional Bias in Heroin Dependence

    Directory of Open Access Journals (Sweden)

    Qinglin Zhao

    2018-01-01

    Full Text Available The attention of drug-dependent persons tends to be captured by stimuli associated with drug consumption. This involuntary cognitive process is considered as attentional bias (AB. AB has been hypothesized to have causal effects on drug abuse and drug relapse, but its underlying neural mechanisms are still unclear. This study investigated the neural basis of AB in abstinent heroin addicts (AHAs, combining event-related potential (ERP analysis and source localization techniques. Electroencephalography data were collected in 21 abstinent heroin addicts and 24 age- and gender-matched healthy controls (HCs during a dot-probe task. In the task, a pair of drug-related image and neutral image was presented randomly in left and right side of the cross fixation, followed by a dot probe replacing one of the images. Behaviorally, AHAs had shorter reaction times (RTs for the congruent condition compared to the incongruent condition, whereas this was not the case in the HCs. This finding demonstrated the presence of AB towards drug cues in AHAs. Furthermore, the image-evoked ERPs in AHAs had significant shorter P1 latency compared to HCs, as well as larger N1, N2, and P2 amplitude, suggesting that drug-related stimuli might capture attention early and overall require more attentional resources in AHAs. The target-related P3 had significantly shorter latency and lower amplitude in the congruent than incongruent condition in AHAs compared to HCs. Moreover, source localization of ERP components revealed increased activity for AHAs as compared to HCs in the dorsal posterior cingulate cortex (dPCC, superior parietal lobule and inferior frontal gyrus (IFG for image-elicited responses, and decreased activity in the occipital and the medial parietal lobes for target-elicited responses. Overall, the results of our study confirmed that AHAs may exhibit AB in drug-related contexts, and suggested that the bias might be related to an abnormal neural activity, both in

  10. [Sleep disorders and impaired sleep as adverse drug reactions of psychotropic drugs: an evaluation of data of summaries of product characteristics].

    Science.gov (United States)

    Gahr, Maximilian; Connemann, Bernhard J; Zeiss, René; Fröhlich, Albrecht

    2018-03-02

     Psychopharmacotherapy is essential in the treatment of many mental disorders. Adverse drug reactions (ADR) have impact on compliance and tolerability. Sleep disorders or impaired sleep may occur as ADRs of psychopharmacotherapy. Sleep disorders are associated with an increased risk for physical and mental illness and may impair cognition, impulse control, emotion regulation and mood. Objective of the following study was the systematic presentation of type and risk of sleep disorders/impairments of sleep of frequently prescribed psychotropic drugs.  Psychotropic agents that are most frequently prescribed in Germany were identified by using the Arzneiverordnungs-Report 2016. Summaries of product characteristics (SmPC) of corresponding original products were analyzed regarding presence and frequency of sleep disorders/impairments of sleep according to the International Classification of Sleep Disorders 3 (ICSD-3).  N = 64 SmPCs were analyzed. In most of the analyzed SmPCs, at least one sleep disorder (50/64; 78 %) was listed. At least one SmPC with a corresponding ADR was found in the categories insomnia (52 %), parasomnias (33 %), and sleep-related movement disorders (20 %); sleep-related breathing disorders (6 %) and central disorders of hypersomnolence (5 %) were rarely listed; circadian rhythm sleep-wake disorder was not found. The SmPCs of the four most frequently prescribed agents (citalopram > venlafaxine > mirtazapine > sertraline) listed insomnia as an ADR. Nearly all analysed hypnotics (except chloral hydrate) were associated with nightmares.  Most of the psychotropic agents frequently prescribed in Germany may induce sleep disorders/impairments of sleep. The four most frequently prescribed agents were antidepressants and all of the corresponding SmPCs listed insomnia as a possible ADR. Sleep disorders should be taken seriously as possible ADRs of psychopharmacotherapy. © Georg Thieme Verlag KG Stuttgart · New York.

  11. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

    ... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

  12. Reaction

    African Journals Online (AJOL)

    abp

    19 oct. 2017 ... Reaction to Mohamed Said Nakhli et al. concerning the article: "When the axillary block remains the only alternative in a 5 year old child". .... Bertini L1, Savoia G, De Nicola A, Ivani G, Gravino E, Albani A et al ... 2010;7(2):101-.

  13. [Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward].

    Science.gov (United States)

    Tribiño, Gabriel; Maldonado, Carlos; Segura, Omar; Díaz, Jorge

    2006-03-01

    Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. Intensive follow-ups for a cohort of patients were conducted for a five month period in order to detect ADRs; different ways to classify them, according to literature, were considered as well. Information was collected using the INVIMA reporting format, and causal probability was evaluated with the Naranjo algorithm. Direct costs were calculated from the perspective of payer, based on the following costs: additional hospital stay, medications, paraclinical tests, additional procedures, patient displacement to intermediate or intensive care units, and other costs. Of 836 patients admitted to the service, 268 adverse drug reactions were detected in 208 patients (incidence proportion 25.1%, occurence rate 0.32). About the ADRs found, 74.3% were classified as probable, 92.5% were type A, and 81.3% were moderate. The body system most often affected was the circulatory system (33.9%). Drugs acting on the blood were most frequently those ones associated with adverse reactions (37.6%). The costs resulting from medical care of adverse drug reactions varied from COL dollar 93,633,422 (USD dollar 35,014.92) to COL dollar 122,155,406 (USD dollar 45,680.94), according to insurance type, during the study period. Adverse drug reactions have a significant negative health and financial impact on patient welfare. Because of the substantial resources required for their medical care and the significant proportion of preventable adverse reactions, active programs of institutional pharmacovigilance are highly recommended.

  14. ADVERSE DRUG REACTIONS DUE TO ANTITUBERCULAR DRUGS DURING THE INITIAL PHASE OF THERAPY IN HOSPITALISED PATIENTS FOR TUBERCULOSIS IN SRI KRISHNA MEDICAL COLLEGE, MUZAFFARPUR, BIHAR

    Directory of Open Access Journals (Sweden)

    Manish Ranjan Shrivastava

    2017-03-01

    Full Text Available BACKGROUND To improve patient care and safety in relation to the use of medicines and providing early warnings regarding ADR and the risk groups associated with its development, which might affect the success of the programme. It will thus support the safe and more effective use of medicine. MATERIALS AND METHODS A prospective study done from Indoor Patient Department (IPD Medicine and IPD Tuberculosis and Chest (including DOTS and DOTS Plus Centre in Sri Krishna Medical College and Hospital (SKMCH, Muzaffarpur, Bihar, from April 2015 to June 2016. Total of 500 patients included in the study and reviewed for at least first 2 months of initiation of treatment. Naranjo adverse drug reaction probability scale and Hartwig’s severity assessment scale were utilised for determination of probability and severity of ADR, respectively. RESULTS 500 patients included in study were analysed. ADR was found in 60 patients (incidence of ADR12%, mostly presented within first 30 days of initiation of treatment and mostly it is due to multidrug treatment and the most common drugs responsible were isoniazid, then rifampicin and pyrazinamide, which were more common in female patients (36 as compared to male patients (24, most cases were mild and had probable relationship. Most cases recovered spontaneously while some required symptomatic and very few required specific treatment. The most common ADR noted was hepatobiliary (increased in liver enzyme (54.69%.95% of cases showing ADR were between 31.2 to 56.8 years of age and between 26.47 to 76.87 kg weight. CONCLUSION In our study, incidences of ADR of antitubercular drug was around 12% and hepatobiliary manifestations in the form of raised liver enzymes is the most common manifestation. The most common drug responsible is isoniazid. ADRs are more common in females and in rural population with mean age 44 years and mean weight of 51.67 kg and mostly noticed within 30 days of initiation of treatment. Most of the

  15. Evaluation of Internet Social Networks using Net scoring Tool: A Case Study in Adverse Drug Reaction Mining.

    Science.gov (United States)

    Katsahian, Sandrine; Simond Moreau, Erica; Leprovost, Damien; Lardon, Jeremy; Bousquet, Cedric; Kerdelhué, Gaétan; Abdellaoui, Redhouane; Texier, Nathalie; Burgun, Anita; Boussadi, Abdelali; Faviez, Carole

    2015-01-01

    Suspected adverse drug reactions (ADR) reported by patients through social media can be a complementary tool to already existing ADRs signal detection processes. However, several studies have shown that the quality of medical information published online varies drastically whatever the health topic addressed. The aim of this study is to use an existing rating tool on a set of social network web sites in order to assess the capabilities of these tools to guide experts for selecting the most adapted social network web site to mine ADRs. First, we reviewed and rated 132 Internet forums and social networks according to three major criteria: the number of visits, the notoriety of the forum and the number of messages posted in relation with health and drug therapy. Second, the pharmacist reviewed the topic-oriented message boards with a small number of drug names to ensure that they were not off topic. Six experts have been chosen to assess the selected internet forums using a French scoring tool: Net scoring. Three different scores and the agreement between experts according to each set of scores using weighted kappa pooled using mean have been computed. Three internet forums were chosen at the end of the selection step. Some criteria get high score (scores 3-4) no matter the website evaluated like accessibility (45-46) or design (34-36), at the opposite some criteria always have bad scores like quantitative (40-42) and ethical aspect (43-44), hyperlinks actualization (30-33). Kappa were positives but very small which corresponds to a weak agreement between experts. The personal opinion of the expert seems to have a major impact, undermining the relevance of the criterion. Our future work is to collect results given by this evaluation grid and proposes a new scoring tool for Internet social networks assessment.

  16. The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

    Science.gov (United States)

    Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

    2017-07-01

    Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

  17. Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

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    Protić D

    2016-02-01

    Full Text Available Dragana Protić,1 Nada Vujasinović-Stupar,2 Zoran Bukumirić,3 Slavica Pavlov-Dolijanović,4 Snežana Baltić,5 Slavica Mutavdžin,6 Ljiljana Markovic-Denić,7 Marija Zdravković,8 Zoran Todorović1 1Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 2Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 3Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 4Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5Department 5, Institute of Rheumatology, Belgrade, Serbia; 6Institute of Physiology “Rihard Burjan”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 8Department of Cardiology, Medical Center “Bežanijska kosa”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia Background: Adverse drug reactions (ADRs have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods: Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261 completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results: Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found

  18. Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia.

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    Sales, Ibrahim; Aljadhey, Hisham; Albogami, Yasser; Mahmoud, Mansour A

    2017-09-01

    Purpose: To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. Method: A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study. Results: A total of 204 questionnaires were collected with a response rate of 68%. Twenty-three percent could correctly define ADRs. Only 13(15.7%) of responders were familiar with the term "Pharmacovigilance" and only 78.6% were aware about the Saudi Pharmacovigilance Center. Sixty-seventy percent indicated that their physicians or pharmacists don't actively encourage them to report ADRs that may occur when they take their medications. The majority of responders (73.2%) believed that the medical team, rather than consumers, should report ADRs. When asked why patients do not report ADRs, 19.1(48.5%) believed that patients do not know whether the ADR is from the medication or not, 18.1(46.1%) stated that the reason was because patients don't know about the Pharmacovigilance Center, 16(40.7%) think that patients don't know about the importance of ADRs reporting, and 14(36.3%) responded that patients probably don't know how to report ADRs. Conclusion: The general public in Saudi Arabia are not aware about ADRs reporting and the pharmacovigilance system. The Saudi Food and Drug Authorities (FDA) need to put more efforts to increasing public awareness about the importance of ADRs reporting process and the importance of pharmacovigilance system in promoting patient safety.

  19. Treatments that generate higher number of adverse drug reactions and their symptoms

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    Lucía Fernández-López

    2015-12-01

    Full Text Available Objectives: Adverse drug reactions (ADRs are an important cause of morbidity and mortality worldwide and generate high health costs. Therefore, the aims of this study were to determine the treatments which produce more ADRs in general population and the main symptoms they generate. Methods: An observational, cross-sectional study consisting in performing a self-rated questionnaire was carried out. 510 patients were asked about the treatments, illnesses and ADRs, they had suffered from. Results: 26.7% of patients had suffered from some ADR. Classifying patients according to the type of prescribed treatment and studying the number of ADR that they had, we obtained significant differences (p ≤ 0.05 for treatments against arthrosis, anemia and nervous disorders (anxiety, depression, insomnia. Moreover, determining absolute frequencies of these ADRs appearance in each treatment, higher frequencies were again for drugs against arthrosis (22.6% of patients treated for arthrosis suffered some ADR, anemia (14.28%, nerve disorders (13.44% and also asthma (16%. Regarding the symptoms produced by ADRs, the most frequent were gastrointestinal (60% of patients who suffered an ADR, had gastrointestinal symptoms and nervous alterations (dizziness, headache, sleep disturbances etc (24.6%. Conclusion: Therapeutic groups which produce more commonly ADRs are those for arthrosis, anemia, nervous disorders and asthma. In addition, symptoms which are generated more frequently are gastrointestinal and nervous problems. This is in accordance with the usual side effects of mentioned treatments. Health professionals should be informed about it, so that they would be more alert about a possible emergence of an ADR in these treatments. They also could provide enough information to empower patients and thus, they probably could detect ADR events. This would facilitate ADR detection and would avoid serious consequences generated to both patients' health and health economics.

  20. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria

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    Kazeem Adeola Oshikoya

    Full Text Available CONTEXT AND OBJECTIVES: Adverse drug reactions (ADRs may cause prolonged hospital admissions with high treatment costs. The burden of ADRs in children has never been evaluated in Nigeria. The incidence of pediatric ADRs and the estimated cost of treatment over an 18-month period were determined in this study. DESIGN AND SETTING: Prospective observational study on children admitted to the pediatric wards of the Lagos State University Teaching Hospital (LASUTH in Nigeria, between July 2006 and December 2007. METHODS: Each patient was assessed for ADRs throughout admission. Medical and non-medical costs to the hospital and patient were estimated for each ADR by reviewing the medical and pharmacy bills, medical charts and diagnostic request forms and by interviewing the parents. Cost estimates were performed in 2007 naira (Nigeria currency from the perspectives of the hospital (government, service users (patients and society (bearers of the total costs attributable to treating ADRs. The total estimated cost was expressed in 2007 United States dollars (USD. RESULTS: Two thousand and four children were admitted during the study; 12 (0.6% were admitted because of ADRs and 23 (1.2% developed ADR(s during admission. Forty ADRs were suspected in these 35 patients and involved 53 medicines. Antibiotics (50% were the most suspected medicines. Approximately 1.83 million naira (USD 15,466.60 was expended to manage all the patients admitted due to ADRs. CONCLUSIONS: Treating pediatric ADRs was very expensive. Pediatric drug use policies in Nigeria need to be reviewed so as to discourage self-medication, polypharmacy prescription and sales of prescription medicines without prescription.

  1. Cutaneous adverse drug reactions: clinical pattern and causative agents--a 6 year series from Chandigarh, India.

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    Sharma V

    2001-04-01

    Full Text Available AIM: To study the different clinical spectrum of cutaneous adverse drug reactions (ADR and to determine the causative drugs. MATERIALS & METHODS: A prospective, hospital based study was carried out over a period of 6 years recording various cutaneous ADR. RESULTS: A total of 500 patients with cutaneous ADR were enrolled in the study. The most common types of cutaneous ADR patterns were maculopapular rash (34.6%, fixed drug eruption (FDE (30% and urticaria (14%. The drugs most often incriminated for the various cutaneous ADR were antimicrobials (42.6%, anticonvulsants (22.2% and NSAIDs (18%. Anticonvulsants were implicated in 41.6% of maculopapular rashes. Sulfonamides accounted for 43.3% and NSAIDs for 30.7% of FDE. Urticaria was caused mainly by NSAIDs(24.3% and penicillins(20%. Anticonvulsants were responsible for 43.8% of life-threatening toxic epidermal necrolysis and Stevens Johnson syndrome. CONCLUSIONS: The clinical pattern and drugs causing cutaneous ADR are similar to those observed in other countries except for minor variations. Cutaneous ADR patterns and the drugs causing various reactions are changing every year, which may be due to the emergence of newer molecules and changing trends in the use of drugs.

  2. College students' behavioral reactions upon witnessing relational peer aggression.

    Science.gov (United States)

    You, Ji-In; Bellmore, Amy

    2014-01-01

    With a sample of 228 college students (82.5% females) from the Midwestern United States, individual factors that contribute to emerging adults' behavioral responses when witnessing relational aggression among their peers were explored. The experience of witnessing relational aggression was found to be systematically associated with college students' behavioral responses to relational aggression through two social cognitive processes: normative beliefs about relational aggression and susceptibility to peer influence. The experience of witnessing relational aggression was associated with defending behavior through normative beliefs about relational aggression and both assisting and reinforcing behavior through normative beliefs about relational aggression and susceptibility to peer influence. The experience of witnessing relational aggression was also associated with onlooking behavior through normative beliefs about relational aggression. The findings indicate that exposure to relational aggression as a witness may influence witness responses because of the way such exposure may shape specific social cognitions. The potential for using the study findings for promoting effective witness interventions among college students is discussed. © 2014 Wiley Periodicals, Inc.

  3. Exploring off-targets and off-systems for adverse drug reactions via chemical-protein interactome--clozapine-induced agranulocytosis as a case study.

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    Lun Yang

    2011-03-01

    Full Text Available In the era of personalized medical practice, understanding the genetic basis of patient-specific adverse drug reaction (ADR is a major challenge. Clozapine provides effective treatments for schizophrenia but its usage is limited because of life-threatening agranulocytosis. A recent high impact study showed the necessity of moving clozapine to a first line drug, thus identifying the biomarkers for drug-induced agranulocytosis has become important. Here we report a methodology termed as antithesis chemical-protein interactome (CPI, which utilizes the docking method to mimic the differences in the drug-protein interactions across a panel of human proteins. Using this method, we identified HSPA1A, a known susceptibility gene for CIA, to be the off-target of clozapine. Furthermore, the mRNA expression of HSPA1A-related genes (off-target associated systems was also found to be differentially expressed in clozapine treated leukemia cell line. Apart from identifying the CIA causal genes we identified several novel candidate genes which could be responsible for agranulocytosis. Proteins related to reactive oxygen clearance system, such as oxidoreductases and glutathione metabolite enzymes, were significantly enriched in the antithesis CPI. This methodology conducted a multi-dimensional analysis of drugs' perturbation to the biological system, investigating both the off-targets and the associated off-systems to explore the molecular basis of an adverse event or the new uses for old drugs.

  4. Adverse drug reaction reports for cardiometabolic drugs from sub Sahara Africa: A study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew F.; Juhlin, Kristina; Star, Kristina; Haaijer-Ruskamp, Flora M.; Michael, Kidane; Taxis, Katja; Mol, Peter G. M.

    2014-01-01

    Background: Many pharmacovigilance centers have been established in Sub Sahara Africa (SSA) in recent years. Their focus has been on ADRs to drugs for communicable diseases. Little is known about ADRs caused by drugs for cardiometabolic diseases, although its burden is increasing rapidly in SSA.

  5. Drug Reaction, Eosinophilia and Systemic Symptoms (DRESS) syndrome secondary to allopurinol with early lymphadenopathy and symptom relapse.

    Science.gov (United States)

    Turney, Rhiannon; Skittrall, Jordan Peter; Donovan, Joseph; Agranoff, Daniel

    2015-10-05

    Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a rare condition with a mortality rate of up to 10%. Herein, we describe a case of DRESS syndrome secondary to allopurinol and which may have been precipitated by amoxicillin, the diagnostic challenge it represented and the successful treatment of the condition with corticosteroids. 2015 BMJ Publishing Group Ltd.

  6. Clinical coding of prospectively identified paediatric adverse drug reactions--a retrospective review of patient records.

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    Bellis, Jennifer R; Kirkham, Jamie J; Nunn, Anthony J; Pirmohamed, Munir

    2014-12-17

    National Health Service (NHS) hospitals in the UK use a system of coding for patient episodes. The coding system used is the International Classification of Disease (ICD-10). There are ICD-10 codes which may be associated with adverse drug reactions (ADRs) and there is a possibility of using these codes for ADR surveillance. This study aimed to determine whether ADRs prospectively identified in children admitted to a paediatric hospital were coded appropriately using ICD-10. The electronic admission abstract for each patient with at least one ADR was reviewed. A record was made of whether the ADR(s) had been coded using ICD-10. Of 241 ADRs, 76 (31.5%) were coded using at least one ICD-10 ADR code. Of the oncology ADRs, 70/115 (61%) were coded using an ICD-10 ADR code compared with 6/126 (4.8%) non-oncology ADRs (difference in proportions 56%, 95% CI 46.2% to 65.8%; p codes as a single means of detection. Data derived from administrative healthcare databases are not reliable for identifying ADRs by themselves, but may complement other methods of detection.

  7. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional.

    Science.gov (United States)

    Herdeiro, María T; Polonia, Jorge; Gestal-Otero, Juan J; Figueiras, Adolfo

    2004-11-01

    The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.

  8. Reporting patterns of adverse drug reactions over recent years in China: analysis from publications.

    Science.gov (United States)

    Guo, Xiao-jing; Ye, Xiao-fei; Wang, Xing-xing; Wang, Jing; Shi, Wen-tao; Gao, Qing-bin; Zhang, Tian-yi; Xu, Jin-fang; Zhu, Tian-tian; He, Jia

    2015-02-01

    The goal of this study was to clarify the reporting patterns of self-reported adverse drug reactions (ADRs) in China. A variety of sources were searched, including the official website of China FDA, the national center for ADR monitoring center, publications from PubMed, and so on. We retrieved the relevant information and made descriptive and comparative analysis from the year 2009 to 2013. The ADR reporting numbers were 638,996, 692,904, 852,799, 1,200,000 and 1,317,000 from 2009 to 2013, respectively. Healthcare professionals contributed significantly, and their proportion always exceeded 80% before 2012. The average report per million inhabitants has increased from 479 to 983 from 2009 to 2013. However, the proportion of new or serious report was always below 25%. The reports mainly concern anti-infective agents and traditional Chinese medicine (TCM), especially TCM injection. The proportion of ADR reports in geriatric patients has increased for 4 consecutive years. ADR report numbers and reporting rates in China are on the rise. However, the proportion of new or serious reports as well as the proportion of reports contributed by consumers and pharmaceutical companies are still quite low. More attention should be paid to the elderly, anti-infective agents and TCM, especially TCM injections.

  9. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting

    Science.gov (United States)

    Green, Christopher F; Mottram, David R; Rowe, Philip H; Pirmohamed, Munir

    2001-01-01

    Aims To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of adverse drug reaction (ADR) reporting. Methods A postal questionnaire survey of 600 randomly selected hospital pharmacists was conducted. Results The response rate was 53.7% (n = 322). A total of 217 Yellow Cards had been submitted to the CSM/MCA by 78 (25.6%) of those responding. Half of those responding felt that ADR reporting should be compulsory and over three-quarters felt it was a professional obligation. However, almost half were unclear as to what should be reported, while the time available in clinical practice and time taken to complete forms were deemed to be major deterrents to reporting. Pharmacists were not dissuaded from reporting by the need to consult a medical colleague or by the absence of a fee. Education and training had a significant influence on pharmacists' participation in the Yellow Card Scheme. Conclusions Pharmacists have a reasonable knowledge and are supportive of the Yellow Card spontaneous ADR reporting scheme. However, education and training will be important in maintaining and increasing ADR reports from pharmacists. PMID:11167664

  10. A 3-armed randomized controlled trial of nurses' continuing education meetings on adverse drug reactions.

    Science.gov (United States)

    Sarayani, Amir; Naderi-Behdani, Fahimeh; Hadavand, Naser; Javadi, Mohammadreza; Farsad, Fariborz; Hadjibabaie, Molouk; Gholami, Kheirollah

    2015-01-01

    Nurses' insufficient knowledge of adverse drug reactions is reported as a barrier to spontaneous reporting. Therefore, CE meetings could be utilized to enhance nurses' competencies. In a 3-armed randomized controlled trial, 496 nurses, working in a tertiary medical center, were randomly allocated to a didactic lecture, brainstorming workshop, or the control group (delayed education). Similar instructors (2 clinical pharmacists) prepared and delivered the educational content to all 3 groups. Outcomes were declarative/procedural knowledge (primary outcome), participation rate, and satisfaction. Knowledge was evaluated using a validated researcher-made questionnaire in 3 time points: immediately before, immediately after, and 3 months after each session. Participants' satisfaction was assessed immediately after each meeting via a standard tool. Data were analyzed using appropriate parametric and nonparametric tests. Rate of participation was 37.7% for the lecture group and 47.5% for the workshop group. The workshop participants were significantly more satisfied in comparison with the lecture group (p techniques. © 2015 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

  11. Nurses' reporting of suspect adverse drug reactions: a mixed-methods study

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    Alessia De Angelis

    2015-12-01

    Full Text Available OBJECTIVE: To assess nurses' knowledge, attitudes and practices (KAP towards spontaneous adverse drug reactions (ADRs reporting. METHODS: The mixed-method study was conducted following a quanti-qualitative sequential approach: a survey (using a KAP questionnaire followed by a focus group was performed. RESULTS: In the quantitative findings, responders (570 hospital nurses declared that they were unaware of the pharmacovigilance system (58.1%, n = 331; where to find the reporting form (63.5%, n = 362; how fill it in (71.6%, n = 408; to whom and how to send it (65.8%, n = 375. Only 11.1% (n = 63 reported ADRs. The qualitative phase supported the quantitative findings and provided new information about other factors that condition ADR reporting: misinterpretation of the meaning of "reporting", unawareness of nurses' autonomy in ADR reporting and fear of consequences after ADR reporting. CONCLUSION: Nurses are not fully aware of their role in ADR reporting. We recommend educational interventions and management changes.

  12. [Do pediatricians identify adverse drug reactions even when they do not report them?

    Science.gov (United States)

    Morales-Ríos, Olga; Jasso-Gutiérrez, Luis; Garduño-Espinosa, Juan; Olivar-López, Víctor; Muñoz-Hernández, Onofre

    Spontaneous notification depends on the ability of pediatricians to identify adverse drug reactions (ADRs) along with their habit of reporting these incidents. During the years 2008 and 2009, the frequency of reports of ADRs to the Electronic Program of Pharmacovigilance (SISFAR) in the Hospital Infantil of Mexico Federico Gomez (HIMFG) was low (0.44% and 0.20%, respectively). Because of the above, the ability of pediatricians from the Emergency Department (ED) to identify ADRs using the clinical chart review was evaluated in 2010 in this study. A descriptive, observational, cross-sectional retrospective study was conducted in the ED from March 1 to August 31. ADRs were classified and quantified as "ADRs identified by pediatricians" when there was evidence in the clinical chart that pediatricians associated a clinical sign, symptom and laboratory value with an ADR. The numbers of notifications reported in SISFAR were quantified. Descriptive analysis was done using SPSS v.18. Considering patients who were admitted to the ED, the frequency of ADRs was 21.8%. The frequency of ADRs identified by physicians in clinical charts was 86%. The pharmacist detected 14% of ADRs. The frequency of ADRs reported by physicians was 6.1%. Although identification of ADRs in the clinical charts by pediatricians was high, it is possible that some ADRs were undetected. Because underreporting was very high, it is necessary to take actions to improve the reporting process. Copyright © 2015. Publicado por Masson Doyma México S.A.

  13. The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.

    Science.gov (United States)

    Carnovale, Carla; Brusadelli, Tatiana; Zuccotti, GianVincenzo; Beretta, Silvia; Sullo, Maria Giuseppa; Capuano, Annalisa; Rossi, Francesco; Moschini, Martina; Mugelli, Alessandro; Vannacci, Alfredo; Laterza, Marcella; Clementi, Emilio; Radice, Sonia

    2014-09-01

    To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use. We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization. The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.

  14. Phenotyping and Visualizing Infusion-Related Reactions for Breast Cancer Patients

    Science.gov (United States)

    Sun, Deyu; Sarda, Gopal; Skube, Steven J.; Blaes, Anne H.; Khairat, Saif; Melton, Genevieve B.; Zhang, Rui

    2018-01-01

    Infusion-related reactions (IRRs) are typical adverse events for breast cancer patients. Detecting IRRs and visualizing their occurance associated with the drug treatment would potentially assist clinicians to improve patient safety and help researchers model IRRs and analyze their risk factors. We developed and evaluated a phenotyping algorithm to detect IRRs for breast cancer patients. We also designed a visualization prototype to render IRR patients’ medications, lab tests and vital signs over time. By comparing with the 42 randomly selected doses that are manually labeled by a domain expert, the sensitivity, positive predictive value, specificity, and negative predictive value of the algorithms are 69%, 60%, 79%, and 85%, respectively. Using the algorithm, an incidence of 6.4% of patients and 1.8% of doses for docetaxel, 8.7% and 3.2% for doxorubicin, 10.4% and 1.2% for paclitaxel, 16.1% and 1.1% for trastuzumab were identified retrospectively. The incidences estimated are consistent with related studies. PMID:29295166

  15. Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway.

    Science.gov (United States)

    Fog, Amura Francesca; Kvalvaag, Gunnar; Engedal, Knut; Straand, Jørund

    2017-12-01

    We describe the drug-related problems (DRPs) identified during medication reviews (MRs) and the changes in drug utilization after MRs at nursing homes in Oslo, Norway. We explored predictors for the observed changes. Observational before-after study. Forty-one nursing homes. MRs performed by multidisciplinary teams during November 2011 to February 2014. In all, 2465 long-term care patients. DRPs identified by explicit criteria (STOPP/START and NORGEP) and drug-drug interaction database; interventions to resolve DRPs; drug use changes after MR. A total of 6158 DRPs were identified, an average of 2.6 DRPs/patient, 2.0 for regular and 0.6 for pro re nata (prn) drugs. Of these patients, 17.3% had no DRPs. The remaining 82.7% of the patients had on average 3.0 DRPs/patient. Use of unnecessary drugs (43.5%), excess dosing (12.5%) and lack of monitoring of the drug use (11%) were the most frequent DRPs. Opioids and psychotropic drugs were involved in 34.4% of all DRPs. The mean number of drugs decreased after the MR from 6.8 to 6.3 for regular drugs and from 3.0 to 2.6 for prn drugs. Patients with DRPs experienced a decrease of 1.1 drugs after MR (0.5 for regular and 0.6 for prn drugs). The reduction was most pronounced for the regular use of antipsychotics, antidepressants, hypnotics/sedatives, diuretics, antithrombotic agents, antacid drugs; and for prn use of anxiolytics, opioids, hypnotics/sedatives, metoclopramide and NSAIDs. The medication review resulted in less drug use, especially opioids and psychotropic drugs.

  16. Drug-related perinatal damage from the pathological point of view

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    Daniela Fanni

    2014-06-01

    Full Text Available Drug dosage in the perinatal period represents a continuous challenge for the neonatologist because of interindividual variability of drug metabolism. The human liver plays a central role in the uptake, transport, metabolism and excretion of the vast majority of xenobiotics and drugs. The protein products of human CYP3A account for the largest portion of CYP450 proteins in human liver. At least 50% of currently used drugs in neonatal intensive care units (NICUs are substrates of CYP3A4 including antibiotics, antivirals, antifungals, immunomodulators, benzodiazepines, proton pump inhibitors, steroid hormones and acetaminophen. The variable CYP3A4 and CYP3A7 expression recently reported in neonatal liver suggests the existence of a marked interindividual variability in drug metabolism during the intrauterine and neonatal lives and, as a consequence, the need of an individualized tailored therapeutic approach in NICUs. The increased risk for adverse effects reported for some drugs in neonates could be related to pharmacokinetic peculiarities of the newborn liver. The fetal and neonatal liver in infants undergoing drug-induced liver injury (DILI is always characterized by the overlapping between developmental and pathological changes, the differential diagnosis between these changes representing often a challenge for the pathologist. Data here reported clearly evidence the peculiarity of the histological examination of the newborn liver, as compared to the adult liver. In conclusion, the role of the pathologist in the interpretation of liver reactions to drugs may be relevant, only when supported by the dialogue with neonatologists. A deep knowledge of the events taking place during liver development at different gestational ages is necessary for a dedicated neonatal pathologist, in order to avoid misinterpretation of the histological changes related to liver development, giving them a pathological significance. Proceedings of the International

  17. Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

    Science.gov (United States)

    Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-10-01

    The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting

  18. Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

    Science.gov (United States)

    Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-01-01

    Aim: The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). Methodology: A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Results: Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. Conclusion: The GPs and CPs were aware about the importance and benefits

  19. EVALUASI DRUG RELATED PROBLEMS PADA PASIEN GERIATRI DENGAN HIPERTENSI DISERTAI VERTIGO DI RS PANTI RINI YOGYAKARTA AGUSTUS 2013

    Directory of Open Access Journals (Sweden)

    Kresensiana Yosriani

    2016-04-01

    Full Text Available Abstract : This study aimed to evaluate Drug Related Problems (DRPs among hypertensive geriatric patients with vertigo co morbid at Panti Rini Hospital Yogyakarta. This is a non-experimental research descriptive evaluative design using a retrospective medical record data. Collected data including patient's identity; initial, final, and complication diagnosis; cardiovascular system drugs and antivertigo, laboratory data. The inclusion criteria were ≥ 60 years with an initial diagnosis of hypertension with vertigo co morbid, used a diuretic drug, and had creatinine test result. Data were analyzed case by case using selected literatur. There were 20 cases found. Result of the study showed that 100% of patients used antihypertensive as the cardiovascular system drugs and 80% patients used antivertigo as nervous system drugs. There were 18 cases of DRPs found related to the use of antihypertensive and antivertigo. 1 case of dosage too low, 8 cases of adverse drug reaction, and 9 cases of dosege too high. Keywords : hypertension with vertigo co morbid, geriatrics, Drug Related Problems

  20. Swedish high-school pupils’ attitudes towards drugs in relation to drug usage, impulsiveness and other risk factors

    Directory of Open Access Journals (Sweden)

    Fariba Mousavi

    2014-06-01

    Full Text Available Background. Illicit drug use influences people’s lives and elicits unwanted behaviour. Current research shows that there is an increase in young people’s drug use in Sweden. The aim was to investigate Swedish high-school pupils’ attitudes, impulsiveness and gender differences linked to drug use. Risk and protective factors relative to drug use were also a focus of interest.Method. High school pupils (n = 146 aged 17–21 years, responded to the Adolescent Health and Development Inventory, Barratt Impulsiveness Scale and Knowledge, and the Attitudes and Beliefs. Direct logistic, multiple regression analyses, and Multivariate Analysis of Variance were used to analyze the data.Results. Positive Attitudes towards drugs were predicted by risk factors (odds ratio = 37.31 and gender (odds ratio = .32. Risk factors (odds ratio = 46.89, positive attitudes towards drugs (odds ratio = 4.63, and impulsiveness (odds ratio = 1.11 predicted drug usage. Risk factors dimensions Family, Friends and Individual Characteristic were positively related to impulsiveness among drug users. Moreover, although boys reported using drugs to a greater extent, girls expressed more positive attitude towards drugs and even reported more impulsiveness than boys.Conclusion. This study reinforces the notion that research ought to focus on gender differences relative to pro-drug attitudes along with testing for differences in the predictors of girls’ and boys’ delinquency and impulsiveness. Positive attitudes towards drugs among adolescents seem to be part of a vicious circle including risk factors, such as friendly drug environments (e.g., friends who use drugs and unsupportive family environments, individual characteristics, and impulsiveness.

  1. Severe Osteomalacia Related to Long-Term Intravenous Drug Abuse

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    Leslie Gamache MD

    2014-09-01

    Full Text Available Objective . We present the clinical, biochemical, and imaging findings of a woman with vitamin D deficiency and severe osteomalacia related to intravenous heroin addiction. Results . A 54-year-old woman with a medical history significant for long-standing heroin abuse presented with complaints of bone pain, muscle cramping, and a left hip ulcer. She had been bed bound for approximately 1 year secondary to pain of uncertain etiology, and her husband was bringing her both food and drugs. She was admitted to the hospital for debridement of a right ischial ulcer. Further workup revealed osteomyelitis of the left hip and severe vitamin D deficiency. Radiologic evaluation demonstrated diffuse osteopenia with pseudofractures, as well as true fractures. Conclusion . This is the first case reported in the English literature of advanced osteomalacia resulting from a debilitating narcotic dependency. Vitamin D deficiency should be considered in patients with poor nutrition and prolonged sunlight deprivation from any cause.

  2. Factors related to alcohol and drug consumption in Swedish widows.

    Science.gov (United States)

    Grimby, Agneta; Johansson, Asa K

    2009-01-01

    The use of alcohol and medications among Swedish widows was analyzed in relation to various background variables. In Total, 1053 widows (640 widows younger than 65 years and 413 widows older than 65 years) answered the questionnaire. Many reported increased fatigue and sleeping problems. Around one-third of the widows reported drinking alcohol for relief of grief and inadequate support. Association existed between grief and increased intake of sedatives and sleeping pills, and between grief and drinking for relief of grief, as well as increase in intake of sedatives. In widows older than 65 years, perception of bad health, negative outlook for the future, and insufficient support seemed to increase the risk of more sedatives and sleeping pills. Negative outlook for the future also tended to lead to a heightened risk for increased intake of alcohol. There seems to be remaining health problems a long time after bereavement, and counseling may be needed especially when drugs and alcohol are extensively used.

  3. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure

    DEFF Research Database (Denmark)

    Krintel, Sophine B; Grunert, Veit Peter; Hetland, Merete L

    2013-01-01

    To investigate the frequency of anti-infliximab antibodies in patients with RA and the associations with adverse drug reactions and treatment failure.......To investigate the frequency of anti-infliximab antibodies in patients with RA and the associations with adverse drug reactions and treatment failure....

  4. Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students.

    Science.gov (United States)

    Tripathi, Raakhi Kaliprasad; Jalgaonkar, Sharmila Vinayak; Sarkate, Pankaj V; Rege, Nirmala Narayan

    2016-10-01

    Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. The module consisted of (a) e-mailing an ADR narrative and online filling of the "suspected ADR reporting form" (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012-2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013-2014. The evaluation consisted of recording the number of students responding and the scores achieved. A total of 171 students in 2012-2013 batch and 179 in 2013-2014 batch participated. In the 2012-2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013-2014 batch, the number ( n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

  5. Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

    Science.gov (United States)

    Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

    2017-07-01

    Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  6. The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting

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    Tarik Catic

    2016-04-01

    Full Text Available Introduction: Adverse drug reactions (ADRs are threat to the patient’s safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina.Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014.Results: The response rate was 73% (44 of 60 and 93% (148 of 160 among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate.Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field.

  7. 13-year overview of serious adverse drug reactions following subcutaneous specific immunotherapy with a chemically modified allergen preparation.

    Science.gov (United States)

    Distler, Andreas; Pappelendam, Debbie

    The Paul-Ehrlich-Institut (PEI) published an analysis of reports of adverse drug reactions (ADRs) in 2001 with test and therapy allergens from the period from 1991 to 2000. Possible risk factors were evaluated for the ADR reports classified as "serious". During the analyzed period, modified semi-depot preparations (allergoids) induced between 0.01 % and 0.0005 % serious systemic reactions, i. e. one serious ADR occurred in 10,000 to 200,000 injections. No information was provided regarding the respective incidences in relation to the individual companies or preparations. Within the scope of a 13-year analysis (2001-2013), the serious ADRs were analysed at HAL for the allergoid preparations PURETHAL® Pollen and Mites. As in the analysis of PEI, the frequency of serious ADRs was based on the estimated number of administered injections. A total of 46 cases with serious ADRs were received. In 26 % of the cases, a serious ADR occurred during initial treatment after the first injection. In 82.6 % of the cases, the serious ADR occurred within the 30-minute observation period in the practice. Adrenaline was administered as emergency treatment in seven cases. Hospitalisations were initiated by the treating physician or by patients themselves in 45 cases. The duration of the hospital stay varied from a few hours up to three days for further monitoring. Serious ADRs occurred in 11 cases with mites and in 35 cases with pollen. If it is assumed that there are six injections in each vial, this yields an incidence of 0.00061 % (1 : 164,000). The frequency with mites (0.00093 %) was slightly higher than with pollen (0.00055 %). The allergoid preparations (pollen and mite allergens) showed a very low risk of serious ADRs, which was close to the lower level of incidence of 0.0005 % for allergoid preparations published by the PEI.

  8. The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses' reporting.

    Science.gov (United States)

    Karlsson, Sofia A; Jacobsson, Ingela; Boman, Marit Danell; Hakkarainen, Katja M; Lövborg, Henrik; Hägg, Staffan; Jönsson, Anna K

    2015-05-01

    In March 2007, a legislative amendment was issued in Sweden compelling nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. The aims of this study were to describe the status of ADR reporting, before and after the implementation of the legislative changes, and to describe the general characteristics of suspected ADRs reported by nurses. The Swedish pharmacovigilance system during the study period constituted six regional centres responsible for the handling of all spontaneous ADR reports within their region. In this study, we identified all individual ADR reports from 2005 and 2010, analysed in depth the ADR reports from two regional centres and collated information about the reporter and the nature of the reported ADR. From the two regional centres, a total of 898 and 1074 reports were submitted in 2005 and 2010 respectively. Nurses submitted 31% (275 reports) of the reports in 2005 and 24% (260 reports) in 2010. Nurses' reporting of serious ADRs was 3% (seven reports) in 2005 and 7% (17 reports) in 2010 with reporting of unlabelled ADRs at 4% (11 reports) in 2005 and 17% (45 reports) in 2010. Most of the serious and/or unlabelled reactions were related to vaccine administration (14 reports in 2005 and 36 reports in 2010). The overall ADR reporting by nurses did not appear to increase after the change in reporting legislation. The proportion of serious and/or unlabelled ADRs reported by nurses did however appear to increase during the same period. Taken together, our data suggests that further pro-active measures should be considered in order to involve nurses in the reporting of suspected ADRs.

  9. Risk factors and mortality among patients with severe muco-cutaneous drug reactions

    DEFF Research Database (Denmark)

    Crüger, Anne-Mette Torp; Kaur-Knudsen, Diljit; Zachariae, Claus

    2015-01-01

    with TEN, whereas SJS was associated with a broad spectrum of drugs. EM was related mainly to viral infections, predominantly herpes (30.6%); 38.2% of the causes of EM remained unknown. Patients with TEN had the highest mortality; i.e. 60% in the course of the ten-year study period: adjusted hazard ratio...... tertiary dermatological departments during a ten-year period. RESULTS: In a total of 192 cases (77.4%), the primary diagnosis of EM (66.5%), SJS (62.2%) and TEN (100%) was confirmed, whereas the remaining cases (22.6%) were diagnosed differently. Antibiotics and allopurinol were predominantly associated...... (HR) = 11.2 (95% confidence interval (CI): 3.65-34.35); p 2.60 (95% CI: 1.10-6.16); p = 0.030; however, this did not remain statistically significant after adjustment...

  10. Comparison of TiO2 photocatalysis, electrochemically assisted Fenton reaction and direct electrochemistry for simulation of phase I metabolism reactions of drugs.

    Science.gov (United States)

    Ruokolainen, Miina; Gul, Turan; Permentier, Hjalmar; Sikanen, Tiina; Kostiainen, Risto; Kotiaho, Tapio

    2016-02-15

    The feasibility of titanium dioxide (TiO2) photocatalysis, electrochemically assisted Fenton reaction (EC-Fenton) and direct electrochemical oxidation (EC) for simulation of phase I metabolism of drugs was studied by comparing the reaction products of buspirone, promazine, testosterone and 7-ethoxycoumarin with phase I metabolites of the same compounds produced in vitro by human liver microsomes (HLM). Reaction products were analysed by UHPLC-MS. TiO2 photocatalysis simulated the in vitro phase I metabolism in HLM more comprehensively than did EC-Fenton or EC. Even though TiO2 photocatalysis, EC-Fenton and EC do not allow comprehensive prediction of phase I metabolism, all three methods produce several important metabolites without the need for demanding purification steps to remove the biological matrix. Importantly, TiO2 photocatalysis produces aliphatic and aromatic hydroxylation products where direct EC fails. Furthermore, TiO2 photocatalysis is an extremely rapid, simple and inexpensive way to generate oxidation products in a clean matrix and the reaction can be simply initiated and quenched by switching the UV lamp on/off. Copyright © 2015 Elsevier B.V. All rights reserved.

  11. A Systems Dynamic Model for Drug Abuse and Drug-Related Crime in the Western Cape Province of South Africa

    Directory of Open Access Journals (Sweden)

    Farai Nyabadza

    2017-01-01

    Full Text Available The complex problem of drug abuse and drug-related crimes in communities in the Western Cape province cannot be studied in isolation but through the system they are embedded in. In this paper, a theoretical model to evaluate the syndemic of substance abuse and drug-related crimes within the Western Cape province of South Africa is constructed and explored. The dynamics of drug abuse and drug-related crimes within the Western Cape are simulated using STELLA software. The simulation results are consistent with the data from SACENDU and CrimeStats SA, highlighting the usefulness of such a model in designing and planning interventions to combat substance abuse and its related problems.

  12. Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

    Science.gov (United States)

    O'Callaghan, J; Griffin, B T; Morris, J M; Bermingham, Margaret

    2018-06-01

    In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

  13. Drug Reaction with Eosinophilia and Systemic Symptom (DRESS) induced by carbamazepine: a case report and literature review

    Science.gov (United States)

    EL Omairi, Nissrine; Abourazzak, Sanae; Chaouki, Sanae; Atmani, Samir; Hida, Moustapha

    2014-01-01

    Drug-induced hypersensitivity or Drug Reaction with Eosinophilia and Systemic Symptom (DRESS) is a severe adverse drug-induced reaction. Diagnosing DRESS is challenging due to the diversity of cutaneous eruption and organs involved. Most of the aromatic anticonvulsants, such as phenytoin, phenobarbital, and carbamazepine, can induce DRESS. Culprit drug withdrawal and corticosteroids constituted the mainstay of DRESS treatment. We describe a 6 year-old boy who presented fever and rash 4 weeks after starting carbamazepine. Investigation revealed leukocytosis, atypical lymphocytosis, and elevated serum transaminases. The diagnosis of DREES syndrome was made, Carbamazepine was stopped and replaced initially by Clobazam and by Valproic acid after discharge, no systemic corticotherapy was prescribed. Symptoms began to resolve within two weeks, and by one month later her laboratory values had returned to normal. The aim of this work is to raise awareness general practitioner and pediatricians to suspect Dress syndrome in patients who present with unusual complaints and skin findings after starting any antiepileptic drug. PMID:25360193

  14. Adverse Drug Reaction reports for cardiometabolic drugs from sub-Saharan Africa : a study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G. M.; Dheda, Mukesh; Haaijer-Ruskamp, Flora M.; Taxis, Katja; Mol, Peter G. M.

    OBJECTIVE: Identifying key features of cardiometabolic ADR reports in sub Saharan Africa (SSA) compared with reports from the rest of the world (RoW). METHODS: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from

  15. 76 FR 41434 - Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for...

    Science.gov (United States)

    2011-07-14

    .... FDA-2011-N-0446] Removal of Certain Requirements Related to the Prescription Drug Marketing Act... Food and Drug Administration (FDA) is proposing to remove a section of the Prescription Drug Marketing... prior sale, purchase, or trade of such drug,'' starting with the manufacturer, and that the identifying...

  16. To address surface reaction network complexity using scaling relations machine learning and DFT calculations

    International Nuclear Information System (INIS)

    Ulissi, Zachary W.; Medford, Andrew J.; Bligaard, Thomas; Nørskov, Jens K.

    2017-01-01

    Surface reaction networks involving hydrocarbons exhibit enormous complexity with thousands of species and reactions for all but the very simplest of chemistries. We present a framework for optimization under uncertainty for heterogeneous catalysis reaction networks using surrogate models that are trained on the fly. The surrogate model is constructed by teaching a Gaussian process adsorption energies based on group additivity fingerprints, combined with transition-state scaling relations and a simple classifier for determining the rate-limiting step. The surrogate model is iteratively used to predict the most important reaction step to be calculated explicitly with computationally demanding electronic structure theory. Applying these methods to the reaction of syngas on rhodium(111), we identify the most likely reaction mechanism. Lastly, propagating uncertainty throughout this process yields the likelihood that the final mechanism is complete given measurements on only a subset of the entire network and uncertainty in the underlying density functional theory calculations.

  17. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    Energy Technology Data Exchange (ETDEWEB)

    Pan, Jian-Bo [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Nan; Pan, Wen; Hong, Ru [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Wang, Hao [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Zhi-Liang, E-mail: appo@xmu.edu.cn [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China)

    2014-01-01

    Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified.

  18. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    International Nuclear Information System (INIS)

    Pan, Jian-Bo; Ji, Nan; Pan, Wen; Hong, Ru; Wang, Hao; Ji, Zhi-Liang

    2014-01-01

    Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified

  19. Admissions through the emergency department due to drug-related problems

    International Nuclear Information System (INIS)

    Yosef H Al-Olah; Khalifa M Al Thiab

    2010-01-01

    Hospital admissions due to drug-related problems (DRPs) have been studied internationally, but local data are limited. Therefore, we undertook a prospective, observational study of all admissions through the emergency department (ED) at a tertiary referral hospital in Saudi Arabia to determine the incidence of admissions through the ED due to DRPs, types of DRPs, length of stay (LOS) in the hospital after ED admissions due to DRPs, and assessment of preventability of admissions due to DRPs.All admissions through the ED over a period of 28 consecutive days were evaluated to determine if they were due to definite or possible DRPs. Data was collected on a daily basis for each admission over the previous 24 hours. Each incident was assessed by three investigators Of 557 patients admitted through the ED, 82 (14.7%) admissions were due to DRP (53 definite, 29 possible). The most common types of DRP were failure to receive medication in 25 cases (47.2%), an adverse drug reaction in 13 cases (24.5%), and drug overdose in 6 cases (11.3%). In the definite DRP group, 83.0% were definitely preventable, 3.8% were possibly preventable and 13.2% were definitely non-preventable.DRPs are a serious and costly issue facing health care professionals and health care systems. Most admissions due to DRPs are avoidable (Author).

  20. Methodological framework to identify possible adverse drug reactions using population-based administrative data [v1; ref status: indexed, http://f1000r.es/3ys

    Directory of Open Access Journals (Sweden)

    Brian Sauer

    2014-10-01

    Full Text Available Purpose: We present a framework for detecting possible adverse drug reactions (ADRs using the Utah Medicaid administrative data. We examined four classes of ADRs associated with treatment of dementia by acetylcholinesterase inhibitors (AChEIs: known reactions (gastrointestinal, psychological disturbances, potential reactions (respiratory disturbance, novel reactions (hepatic, hematological disturbances, and death. Methods: Our cohort design linked drug utilization data to medical claims from Utah Medicaid recipients. We restricted the analysis to 50 years-old and older beneficiaries diagnosed with dementia-related diseases. We compared patients treated with AChEI to patients untreated with anti-dementia medication therapy. We attempted to remove confounding by establishing propensity-score-matched cohorts for each outcome investigated; we then evaluated the effects of drug treatment by conditional multivariable Cox-proportional-hazard regression. Acute and transient effects were evaluated by a crossover design using conditional logistic regression. Results: Propensity-matched analysis of expected reactions revealed that AChEI treatment was associated with gastrointestinal episodes (Hazard Ratio [HR]: 2.02; 95%CI: 1.28-3.2, but not psychological episodes, respiratory disturbance, or death. Among the unexpected reactions, the risk of hematological episodes was higher (HR: 2.32; 95%CI: 1.47-3.6 in patients exposed to AChEI. AChEI exposure was not associated with an increase in hepatic episodes. We also noted a trend, identified in the case-crossover design, toward increase odds of experiencing acute hematological events during AChEI exposure (Odds Ratio: 3.0; 95% CI: 0.97 - 9.3. Conclusions: We observed an expected association between AChEIs treatment and gastrointestinal disturbances and detected a signal of possible hematological ADR after treatment with AChEIs in this pilot study. Using this analytic framework may raise awareness of potential

  1. Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Maša Amrain

    2014-09-01

    Full Text Available Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87% completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH. Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4% of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

  2. 77 FR 12997 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Representatives at VA Facilities

    Science.gov (United States)

    2012-03-05

    ...,'' ``promotional materials,'' ``patient education materials,'' and ``individual departments.'' We disagree with the... supply, or therapeutic indication be submitted to a specific approval authority. With respect to... and associated materials regarding (1) a drug, drug-related supply, or new therapeutic indication for...

  3. Vulnerability to drug-related infections and co-infections among injecting drug users in Budapest, Hungary

    Science.gov (United States)

    Neaigus, Alan; Ujhelyi, Eszter

    2009-01-01

    Background: Drug-related infectious diseases are among the major health consequences of drug use, and any existing drug-related infection may predispose injecting drug users (IDUs) to other infections. Methods: We assessed among IDUs in Budapest, Hungary the prevalence of and vulnerability to selected drug-related infections and co-infections. The sample consisted of 186 participants recruited between October 2005 and December 2006. Results: We found 0% HIV, 37% HCV, 24% HAV, and 14% past HBV infection. Infections with Herpes 1 or 2, tuberculosis, Chlamydia, syphilis, and gonorrhoea were 79%, 12%, 7%, 4%, and 0%, respectively. Co-infection with HAV/HCV was 12%, HBV/HCV 9%, HAV/HBV 7%, and HAV/HBV/HCV 4%. Those over age 30, the ethnic Roma, and the homeless were more likely to have any hepatitis and a higher number of drug-related infections. Amphetamine injectors were more likely to have a higher number of drug-related infections and those who travelled within Hungary were more likely to have any STI. However, those who worked at least part time and those who were in treatment were less likely to have drug-related infections. Conclusions: These results highlight the need of interventions in Hungary to reach and focus on marginalized (Roma or homeless) IDUs and address not only injecting and sex risk, but also hygienic living and injecting conditions. Furthermore, structural interventions to increase social integration (working or being in treatment) may improve welfare and decrease drug use and infection risk tied to drug use/injection among disadvantaged, marginalized, mostly minority populations. PMID:19224936

  4. Dose-specific adverse drug reaction identification in electronic patient records: temporal data mining in an inpatient psychiatric population.

    Science.gov (United States)

    Eriksson, Robert; Werge, Thomas; Jensen, Lars Juhl; Brunak, Søren

    2014-04-01

    Data collected for medical, filing and administrative purposes in electronic patient records (EPRs) represent a rich source of individualised clinical data, which has great potential for improved detection of patients experiencing adverse drug reactions (ADRs), across all approved drugs and across all indication areas. The aim of this study was to take advantage of techniques for temporal data mining of EPRs in order to detect ADRs in a patient- and dose-specific manner. We used a psychiatric hospital's EPR system to investigate undesired drug effects. Within one workflow the method identified patient-specific adverse events (AEs) and links these to specific drugs and dosages in a temporal manner, based on integration of text mining results and structured data. The structured data contained precise information on drug identity, dosage and strength. When applying the method to the 3,394 patients in the cohort, we identified AEs linked with a drug in 2,402 patients (70.8 %). Of the 43,528 patient-specific drug substances prescribed, 14,736 (33.9 %) were linked with AEs. From these links we identified multiple ADRs (p patient population, larger doses were prescribed to sedated patients than non-sedated patients; five antipsychotics [corrected] exhibited a significant difference (p<0.05). Finally, we present two cases (p < 0.05) identified by the workflow. The method identified the potentially fatal AE QT prolongation caused by methadone, and a non-described likely ADR between levomepromazine and nightmares found among the hundreds of identified novel links between drugs and AEs (p < 0.05). The developed method can be used to extract dose-dependent ADR information from already collected EPR data. Large-scale AE extraction from EPRs may complement or even replace current drug safety monitoring methods in the future, reducing or eliminating manual reporting and enabling much faster ADR detection.

  5. Relative mobility of 1-H atoms of carbohydrates in heterogeneous isotope exchange reactions

    International Nuclear Information System (INIS)

    Akulov, G.P.; Snetkova, E.V.; Kayumov, V.G.; Kaminskii, Yu.L.

    1988-01-01

    The method of competitive reactions was used to determine the relative mobilities of the 1-H atoms of carbohydrates in reactions of heterogeneous isotope exchange, using various reference standards, catalysts, and buffer systems. On the basis of the results obtained, the investigated carbohydrates are ranged in a series of decreasing mobility of the hydrogen atoms exchanged in heterogeneous isotope exchange reactions. It was demonstrated that the mobility of the 1-H atoms is related to the concentration of the acyclic forms of the carbohydrates

  6. Potential drug-drug interactions in a Brazilian teaching hospital: age-related differences?

    Directory of Open Access Journals (Sweden)

    Daniela Oliveira Melo

    2016-07-01

    Full Text Available This study proposes to measure frequency and to characterize the profile of potential drug interactions (pDDI in a general medicine ward of a teaching hospital. Data about identification and clinical status of patients were extracted from medical records between March to August 2006. The occurrence of pDDI was analyzed using the database monographs Micromedex® DrugReax® System. From 5,336 prescriptions with two or more drugs, 3,097 (58.0% contained pDDI. The frequency of major and well document pDDI was 26.5%. Among 647 patients, 432 (66.8% were exposed to at least one pDDI and 283 (43.7% to major pDDI. The multivariate analysis identified that factors related to higher rates of major pDDI were the same age (p< 0.0001, length of stay (p< 0.0001, prevalence of hypertension [OR=3.42 (p< 0.0001] and diabetes mellitus [OR=2.1 (p< 0.0001], cardiovascular diseases (p< 0.0001 and the number of prescribed drugs (Spearman’s correlation=0.640622, p< 0.0001. Between major pDDI, the main risk was hemorrhage (50.3%, the most frequent major pDDI involved combination of anticoagulants and antiplatelet drugs. Among moderate pDDI, 3,866 (90.8% involved medicines for the treatment of chronic non-communicable diseases, mainly hypertension. In HU-USP, the profile of pDDI was similar among adults and elderly (the most frequent pDDI and major pDDI were same, the difference was only the frequency in either group. The efforts of the clinical pharmacists should be directed to elderly patients with cardiovascular compromise, mainly in use of anticoagulants and antiplatelet drugs. Furthermore, hospital managers should increase the integration between levels of health care to promote safety patient after discharge.Keywords: Drug interactions. Aged. Internal Medicine. Hospitals, University. RESUMOInterações medicamentosas potenciais em um hospital escolar brasileiro: diferenças relacionadas à idade?O estudo tem por objetivo descrever o perfil de intera

  7. Increasing insect reactions in Alaska: is this related to changing climate?

    Science.gov (United States)

    Demain, Jeffrey G; Gessner, Bradford D; McLaughlin, Joseph B; Sikes, Derek S; Foote, J Timothy

    2009-01-01

    In 2006, Fairbanks, AK, reported its first cases of fatal anaphylaxis as a result of Hymenoptera stings concurrent with an increase in insect reactions observed throughout the state. This study was designed to determine whether Alaska medical visits for insect reactions have increased. We conducted a retrospective review of three independent patient databases in Alaska to identify trends of patients seeking medical care for adverse reactions after insect-related events. For each database, an insect reaction was defined as a claim for the International Classification of Diseases, Ninth Edition (ICD-9), codes E9053, E906.4, and 989.5. Increases in insect reactions in each region were compared with temperature changes in the same region. Each database revealed a statistically significant trend in patients seeking care for insect reactions. Fairbanks Memorial Hospital Emergency Department reported a fourfold increase in patients in 2006 compared with previous years (1992-2005). The Allergy, Asthma, and Immunology Center of Alaska reported a threefold increase in patients from 1999 to 2002 to 2003 to 2007. A retrospective review of the Alaska Medicaid database from 1999 to 2006 showed increases in medical claims for insect reactions among all regions, with the largest percentage of increases occurring in the most northern areas. Increases in insect reactions in Alaska have occurred after increases in annual and winter temperatures, and these findings may be causally related.

  8. Supramolecular hydrogel formation between chitosan and hydroxypropyl β-cyclodextrin via Diels-Alder reaction and its drug delivery.

    Science.gov (United States)

    Zhang, Mengke; Wang, Jinpeng; Jin, Zhengyu

    2018-07-15

    Chitosan-cyclodextrin hydrogel (CFCD) was prepared via Diels-Alder reaction between furfural functionalized chitosan (CF) and N-maleoyl alanine functionalized hydroxypropyl β-cyclodextrin (HPCD-AMI) in aqueous media without any catalyst or initiator. The CF and HPCD-AMI were confirmed by Fourier transform infrared spectroscopy and 1 H nuclear magnetic resonance spectroscopy. The resultant CFCD hydrogel was characterized in terms of thermal peripteries, microstructure, rheology behavior, and swelling capacity. The rheology analysis found that the storage modulus G' ranged from 1pa to 1200pa as the degree of furfural substitute on chitosan increased from 2.6% to 28.3%, indicating the hydrogel strength can be tuned readily by reaction stoichiometry. The swelling behaviors proved that CFCD hydrogel was pH-responsive with low swelling capacity, which would be preferable for drug delivery. Drug adsorption analysis showed the introduction of cyclodextrin into CFCD hydrogels promoted drug adsorption capacity. In addition, methyl orange cumulative release in PBS buffer was only 48.85% after 24h, suggesting CFCD hydrogel had good sustained release capacity on the loaded drug. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Combination of Deep Recurrent Neural Networks and Conditional Random Fields for Extracting Adverse Drug Reactions from User Reviews.

    Science.gov (United States)

    Tutubalina, Elena; Nikolenko, Sergey

    2017-01-01

    Adverse drug reactions (ADRs) are an essential part of the analysis of drug use, measuring drug use benefits, and making policy decisions. Traditional channels for identifying ADRs are reliable but very slow and only produce a small amount of data. Text reviews, either on specialized web sites or in general-purpose social networks, may lead to a data source of unprecedented size, but identifying ADRs in free-form text is a challenging natural language processing problem. In this work, we propose a novel model for this problem, uniting recurrent neural architectures and conditional random fields. We evaluate our model with a comprehensive experimental study, showing improvements over state-of-the-art methods of ADR extraction.

  10. Combination of Deep Recurrent Neural Networks and Conditional Random Fields for Extracting Adverse Drug Reactions from User Reviews

    Directory of Open Access Journals (Sweden)

    Elena Tutubalina

    2017-01-01

    Full Text Available Adverse drug reactions (ADRs are an essential part of the analysis of drug use, measuring drug use benefits, and making policy decisions. Traditional channels for identifying ADRs are reliable but very slow and only produce a small amount of data. Text reviews, either on specialized web sites or in general-purpose social networks, may lead to a data source of unprecedented size, but identifying ADRs in free-form text is a challenging natural language processing problem. In this work, we propose a novel model for this problem, uniting recurrent neural architectures and conditional random fields. We evaluate our model with a comprehensive experimental study, showing improvements over state-of-the-art methods of ADR extraction.

  11. The difference between the perception of absolute and relative motion: A reaction time study

    NARCIS (Netherlands)

    J.B.J. Smeets (Jeroen); E. Brenner (Eli)

    1994-01-01

    textabstractWe used a reaction-time paradigm to examine the extent to which motion detection depends on relative motion. In the absence of relative motion, the responses could be described by a simple model based on the detection of a fixed change in position. If relative motion was present, the

  12. RIGHT MEDICATION RELATED TO DRUG CENTRALIZED IN RSUD SIDOARJO

    Directory of Open Access Journals (Sweden)

    Aprilia Aprilia

    2017-02-01

    Full Text Available Introduction. Centralized drug is a management of the entire drug which is entirely done by nurses to administration to patients. Right medication is the process of right drug administration which is done by nurses based on 6 rights of medication, and wary of side effects. The purpose of this study was to analyze the corelation between centralized drug, team leadership, and nurse`s knowledge with right medication among nurses. Methods.The design of the study was descriptive corelational with cross-sectional approach. The population was inpatient nurses in RSUD Sidoarjo. Total sample was 114 respondents was selected by purposive sampling. The independent variables in this study: centralized drug, team leadership, and nurse`s knowledge. The dependent variable was right medication. Data were collected by using questionnares for independent variables and dependent variable. Data were analyzed by using Binary Logistic Regression with degree of significance α>0,05. Results. Binary Logistic Regression test showed non significance level between centralized drug with right medication (P=0.501, team leadership with right medication (P=0.874, and nurses`s knowledge with right medication (P=0.243. Discussion. This study concluded centralized drug, team leadership, and nurse`s knowledge were good. But, there are nurses that have negative value at right medication, however right medication in RSUD Sidoarjo has majority positive value. Keywords: centralized drug, right medication

  13. [Substance-abuse related emergencies--illegal drugs, part I].

    Science.gov (United States)

    Kinn, Michael; Holzbach, Rüdiger; Pajonk, Frank-Gerald Bernhard

    2008-11-01

    For the first time since the year 2000 the number of death due to substance abuse of illegal drugs has increased in Germany in 2007 (+8 % compared to 2006). Emergency situations due to drug abuse are frequent, particular in big cities. They may be, however, difficult to diagnose and/or treat for an emergency physician on scene because of a lack of diagnostic tools, the local and personal surroundings, and the unknown number and nature of drugs. Many drug intoxications must be considered suicidal. On the other hand, drug intoxications may mask (other) life-threatening conditions. Emergency situations due to withdrawal offer the possibility to motivate patients to take advantage of specialist-guided abstinence programs.

  14. Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.

    Science.gov (United States)

    Nikfarjam, Azadeh; Sarker, Abeed; O'Connor, Karen; Ginn, Rachel; Gonzalez, Graciela

    2015-05-01

    Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words' semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  15. Full-course drug challenge test in the diagnosis of delayed allergic reactions to penicillin

    DEFF Research Database (Denmark)

    Borch, Jakob E; Bindslev-Jensen, Carsten

    2011-01-01

    Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy.......Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy....

  16. Nuclear attitudes and reactions: associations with depression, drug use, and quality of life

    Energy Technology Data Exchange (ETDEWEB)

    Newcomb, M.D.

    1986-05-01

    For 40 years the world has lived with the threat of nuclear war and, recently, with the possibility of nuclear power plant accidents. Although virtually every generation must confront various national or international crises, the threat of nuclear war is unprecedented in its destructive potential. This study is an attempt to assess attitudes and amount of distress associated with the ever-present threat of nuclear war and the possibility of accidents at nuclear power plants. The Nuclear Attitudes Questionnaire (NAQ) consists of 15 items and was administered to 722 young adults who have grown up in the nuclear age. The items were found to reflect four latent factors of nuclear concern, nuclear support, fear of the future, and nuclear denial, all of which in turn represent a second-order construct of nuclear anxiety. Women reported significantly more nuclear concern, less nuclear support, more fear of the future, and less nuclear denial than did men. In latent-variable models, nuclear anxiety was found to be significantly associated with less purpose in life, less life satisfaction, more powerlessness, more depression, and more drug use. It is concluded that the threat of nuclear war and accidents is significantly related to psychological distress and may disturb normal maturational development.

  17. Mortality due to acute adverse drug reactions in Galicia: 1997-2011.

    Science.gov (United States)

    Miguel-Arias, Domingo; Pereiro Gómez, César; Bermejo Barrera, Ana M; López de Abajo Rodríguez, Benito; Sobrido Prieto, María

    2016-03-02

    The aim of this research is to study all people who died in the Autonomous Community of Galicia from acute death after drugconsumption (ADR) in which there was judicial intervention during the period from 1997 to 2011, according to inclusion and exclusión criteria established by the National Drug Plan for the entire national territory. Sociodemographic and clinical characteristics of deceased subjects were studied, in order to identify key risk factors and/or vulnerable populations.A total of 805 deaths were recorded. The distribution by provinces and municipalities corresponds to the areas of greatest population, incidence of consumption and proximity to the coast. The average age of these patients was 34.34 years, with a gradual increase over years. Most of them were male (91.2%) and single (47.7). 43.5% of the deceased habitually used the parenteral route of administration and 36.4% had positive HIV serology. The most frequently-detected substances corresponded to opiates (heroin: 61.3%, methadone: 35.6%), followed by cocaine (53.7%), although the most common pattern was that of poly-consumption. ADR mortality figures remain relatively stable throughout the study period. The predominant pattern is that of males, opiates and a long history of consumption.

  18. [Characteristics of local human skeleton reactions to microgravity and drug treatment of osteoporosis in clinic].

    Science.gov (United States)

    Oganov, V S; Skripnikova, I A; Novikov, V E; Bakulin, A V; Kabitskaia, O E; Murashko, L M

    2011-01-01

    Analysis of the results of long-term investigations of bones in cosmonauts flown on the orbital station MIR and International space station (n = 80) was performed. Theoretically predicted (evolutionary predefined) change in mass of different skeleton bones was found to correlate (r = 0.904) with position relatively the Earth's gravity vector. Vector dependence of bone loss ensues from local specificity of expression of bone metabolism genes which reflects mechanic prehistory of skeleton structures in the evolution of Homo erectus. Genetic polymorphism is accountable for high individual variability of bone loss attested by the dependence of bone loss rate on polymorphism of certain bone metabolism markers. Parameters of one and the other orbital vehicle did not modulate individual-specific stability of the bone loss ratio in different segments of the skeleton. This fact is considered as a phenotype fingerprint of local metabolism in the form of a locus-unique spatial structure of distribution of noncollagenous proteins responsible for position regulation of endosteal metabolism. Drug treatment of osteoporosis (n = 107) evidences that recovery rate depends on bone location; the most likely reason is different effectiveness of local osteotrophic intervention into areas of bustling resorption.

  19. Nuclear attitudes and reactions: associations with depression, drug use, and quality of life

    International Nuclear Information System (INIS)

    Newcomb, M.D.

    1986-01-01

    For 40 years the world has lived with the threat of nuclear war and, recently, with the possibility of nuclear power plant accidents. Although virtually every generation must confront various national or international crises, the threat of nuclear war is unprecedented in its destructive potential. This study is an attempt to assess attitudes and amount of distress associated with the ever-present threat of nuclear war and the possibility of accidents at nuclear power plants. The Nuclear Attitudes Questionnaire (NAQ) consists of 15 items and was administered to 722 young adults who have grown up in the nuclear age. The items were found to reflect four latent factors of nuclear concern, nuclear support, fear of the future, and nuclear denial, all of which in turn represent a second-order construct of nuclear anxiety. Women reported significantly more nuclear concern, less nuclear support, more fear of the future, and less nuclear denial than did men. In latent-variable models, nuclear anxiety was found to be significantly associated with less purpose in life, less life satisfaction, more powerlessness, more depression, and more drug use. It is concluded that the threat of nuclear war and accidents is significantly related to psychological distress and may disturb normal maturational development

  20. Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

    Directory of Open Access Journals (Sweden)

    Lense Temesgen Gurmesa

    2016-01-01

    Full Text Available Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%, 56 (42.1%, and 13 (9.8% health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.

  1. Recurrence Relations for the Equilibrium Means of Distributions Arising in Chemical Reactions

    Directory of Open Access Journals (Sweden)

    E.K. Elsheikh

    1997-12-01

    Full Text Available In this paper we derive recurrence relations that describe how the equilibrium mean of the number molecules of a reactant varies with each of the parameters defining the initial state for four basic reversible chemical reactions. In essence, the relations provide a rationale for updating the equilibrium mean following the addition (or removal of a molecule of one of the types involved in the reaction, there being a relation for each type. With a new parameterization introduced for each reaction, the relations provide a convenient means of evaluating the means, variances and other important moments without any need to work out the underlying distributions. As an application, the relations are used to numerically assess-approximate expressions for the means and variances.

  2. Is There a Potential of Misuse for Quetiapine?: Literature Review and Analysis of the European Medicines Agency/European Medicines Agency Adverse Drug Reactions' Database.

    Science.gov (United States)

    Chiappini, Stefania; Schifano, Fabrizio

    2018-02-01

    A recent years' increase in both prescribing and availability of second-generation antipsychotics (SGAs) has been observed. According to the literature, typically made up by case studies/series, quetiapine seems to be the most commonly misused SGA, with both intranasal and intravenous intake modalities having been described. Another SGA that has been anecdotally reported to be misused is olanzapine. For these molecules, both a previous history of drug misuse and being an inmate have been described as factors associated with misuse. Hence, while providing here an updated literature review of the topic, we aimed at assessing all cases of quetiapine misuse/abuse/dependence/withdrawal as reported to the European Medicines Agency's EudraVigilance (EV) database; this was carried out in comparison with the reference drug olanzapine. All spontaneous, European Medicines Agency database reports relating to both quetiapine (2005-2016) and olanzapine (2004-2016) misuse/abuse/dependence/withdrawal issues were retrieved, and a descriptive analysis was performed. From the EV database, 18,112 (8.64% of 209,571) and 4178 (7.58% of 55,100) adverse drug reaction reports of misuse/abuse/dependence/withdrawal were associated with quetiapine and olanzapine, respectively. The resulting proportional reporting ratio values suggested that the misuse/abuse-, dependence-, and withdrawal-related adverse drug reactions were more frequently reported for quetiapine (1.07, 1.01, and 5.25, respectively) in comparison with olanzapine. Despite data collection limitations, present EV data may suggest that, at least in comparison with olanzapine, quetiapine misuse may be a cause for concern.

  3. Drug allergies

    Science.gov (United States)

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The first time ...

  4. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation.

    Science.gov (United States)

    Ozcan, Gulnihal; Aykac, Emel; Kasap, Yelda; Nemutlu, Nergiz T; Sen, Ebru; Aydinkarahaliloglu, N Demet

    2016-03-01

    In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.

  5. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

  6. Factors related to drug approvals : predictors of outcome?

    NARCIS (Netherlands)

    Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Bert

    2017-01-01

    There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters':

  7. Analysis of π+p→π0(eta)Δ++ and related reactions

    International Nuclear Information System (INIS)

    Saleem, Mohammad; Fazal-e-Aleem; Rafique, Muhammad

    1984-01-01

    The differential and integrated cross sections and density matrix elements for the reactions π + p→ π 0 (eta)Δ ++ and the reactions π - p→π - Δ + , K + p→K 0 Δ ++ and K - n→K-bar 0 Δ - which are related to them by SU(2) and SU(3) are fitted by using a simple Regge pole model with phenomenological residue functions. (author)

  8. [Illicit drug use and the critical perspectives of drug users' relatives and acquaintances in Northern Rio de Janeiro City, Brazil].

    Science.gov (United States)

    Loyola, Cristina Maria Douat; Brands, Bruna; Adlaf, Edward; Giesbrecht, Norman; Simich, Laura; Wright, Maria da Gloria Miotto

    2009-01-01

    This article presents the partial results of a multicenter, cross-temporal study, which was performed using multiple methods, and involved seven Latin-American countries and Canada. The results presented refer to the city center of Rio de Janeiro (n=108). The central question of the study was: 'How do illicit drug users' relatives and acquaintances describe protective and risk factors, prevention initiatives, treatment services, laws and policies regarding illicit drugs?' The quantitative data was collected using an instrument containing closed questions. In total, 108 young adults (18 years of age or older) were interviewed, who stated being affected by the drug although they were not users. For 104 interviewees (96%), negligence is the family dynamics that causes the greatest exposure to drugs, and 106 (98%) consider that parent support is what offers the greatest protection. Policies, the police and the criminal system have neither reduced drug use nor do they protect users.

  9. Emotional Reactions to Deviance in Groups: The Relation between Number of Angry Reactions, Felt Rejection, and Conformity

    Directory of Open Access Journals (Sweden)

    Marc W. Heerdink

    2015-06-01

    Full Text Available How many members of a group need to express their anger in order to influence a deviant group member's behavior? In two studies, we examine whether an increase in number of angry group members affects the extent to which a deviant individual feels rejected, and we investigate downstream effects on conformity. We show that each additional angry reaction linearly increases the extent to which a deviant individual feels rejected, and that this relation is independent of the total number of majority members (Study 1. This felt rejection is then shown to lead to anti-conformity unless two conditions are met: (1 the deviant is motivated to seek reacceptance in the group, and (2 conformity is instrumental in gaining reacceptance because it is observable by the majority (Study 2. These findings show that angry reactions are likely to trigger anti-conformity in a deviant, but they are also consistent with a motivational account of conformity, in which conformity is strategic behavior aimed at gaining reacceptance from the group.

  10. Emotional reactions to deviance in groups: the relation between number of angry reactions, felt rejection, and conformity.

    Science.gov (United States)

    Heerdink, Marc W; van Kleef, Gerben A; Homan, Astrid C; Fischer, Agneta H

    2015-01-01

    How many members of a group need to express their anger in order to influence a deviant group member's behavior? In two studies, we examine whether an increase in number of angry group members affects the extent to which a deviant individual feels rejected, and we investigate downstream effects on conformity. We show that each additional angry reaction linearly increases the extent to which a deviant individual feels rejected, and that this relation is independent of the total number of majority members (Study 1). This felt rejection is then shown to lead to anti-conformity unless two conditions are met: (1) the deviant is motivated to seek reacceptance in the group, and (2) conformity is instrumental in gaining reacceptance because it is observable by the majority (Study 2). These findings show that angry reactions are likely to trigger anti-conformity in a deviant, but they are also consistent with a motivational account of conformity, in which conformity is strategic behavior aimed at gaining reacceptance from the group.

  11. Relative state, social comparison reactions, and the behavioral constellation of deprivation.

    Science.gov (United States)

    Novakowski, Dallas; Mishra, Sandeep

    2017-01-01

    Pepper & Nettle compellingly synthesize evidence indicating that temporal discounting is a functional, adaptive response to deprivation. In this commentary, we underscore the importance of the psychology of relative state, which is an index of relative competitive (dis)advantage. We then highlight two proximate emotional social comparison reactions linked with relative state - personal relative deprivation and envy - that may play an important role in the deprivation-discounting link.

  12. Me, Myself, Fairness, and I: On the Self-Related Aspects of Fairness Reactions

    NARCIS (Netherlands)

    Loseman, A.

    2011-01-01

    The current dissertation focuses on the psychology of justice as a self-related process. Six experiments within three justice domains are reported in which specific self-related aspects and their influence on fairness reactions are investigated. The construction of one’s self-image (i.e., the

  13. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... a larger amount of the drug substance than what is intended to be delivered to the patient. This... patient, but also to others, including family members, caregivers, children, and pets. For example...

  14. Prospective observational study of adverse drug reactions to diclofenac in children

    Science.gov (United States)

    Standing, Joseph F; Ooi, Kuan; Keady, Simon; Howard, Richard F; Savage, Imogen; Wong, Ian C K

    2009-01-01

    AIM The aim of this study was to investigate the type of common (occurring in >1% of patients) adverse reactions caused by diclofenac when given to children for acute pain. METHODS A prospective observational study was undertaken on paediatric surgical patents aged ≤12 years at Great Ormond Street and University College London Hospitals. All adverse events were recorded, and causality assessment used to judge the likelihood of them being due to diclofenac. Prospective recruitment meant not all patients were prescribed diclofenac, allowing an analysis of utilization. Causality of all serious adverse events was reviewed by an expert panel. RESULTS Children prescribed diclofenac were significantly older, and stayed in hospital for shorter periods than those who were not. Diclofenac was not avoided in asthmatic patients. Data on 380 children showed they suffer similar types of nonserious adverse reactions to adults. The incidence (95% confidence interval) of rash was 0.8% (0.016, 2.3); minor central nervous system disturbance 0.5% (0.06, 1.9); rectal irritation with suppositories 0.3% (0.009, 1.9); and diarrhoea 0.3% (0.007, 1.5). No serious adverse event was judged to be caused by diclofenac, meaning the incidence of serious adverse reactions to diclofenac in children is Children given diclofenac for acute pain appeared to suffer similar types of adverse reactions to adults; the incidence of serious adverse reaction is <0.8%. PMID:19694745

  15. Atomoxetine effects on attentional bias to drug-related cues in cocaine dependent individuals

    NARCIS (Netherlands)

    Passamonti, L. (Luca); M. Luijten (Maartje); Ziauddeen, H.; I. Coyle-Gilchrist (Ian); Rittman, T.; Brain, S.A.E.; Regenthal, R.; I.H.A. Franken (Ingmar); Sahakian, B.J.; Bullmore, E.T.; Robbins, T.W.; Ersche, K.D.

    2017-01-01

    textabstractRationale: Biased attention towards drug-related cues and reduced inhibitory control over the regulation of drug-intake characterize drug addiction. The noradrenaline system has been critically implicated in both attentional and response inhibitory processes and is directly affected by

  16. NAGD regimen for the coma of drug-related overdose.

    Science.gov (United States)

    Rappolt, R T; Gay, G R; Decker, W J; Inaba, D S

    1980-07-01

    A specific arousal therapy with NAGD (Naloxone, Activated Charcoal, Glucagon, Doxapram) is outlined for victims of drug overdose in comatose and semi-comatose states. Several direct benefits accrue if early awakening or lightening of such patients is safely accomplished. There are: 1) elimination of need for prolonged intubation or tracheostomy; 2) patient's ability to tell which drug(s) were taken; 3) excessively frantic and vigorous supportive treatment is obviated; and 4) the overall hospital stay is shortened. The NAGD regimen has been found to effectively, safely, and predictably reverse coma. Therapy consists of: naloxone 0.8 mg to 1.6 mg intravenously; large-bore orogastric tube instillation of 100 gm to 120 gm activated charcoal slurry; glucagon 1 mg to 2 mg intravenously; and, in selected cases, doxapram 1 mg/kg to 2 mg/kg intravenously.

  17. How to ascertain drug related deaths during clinical trials ?

    Science.gov (United States)

    Lele, R D

    2013-10-01

    Recent guidelines by the Drug Controller General of India require extra care by Investigators & Sponsors of Clinical Trials in India. The author, an eminent member & Chairman of various Independent Ethics Committees in Mumbai, proposes various concrete solutions for adherence to these guidelines. Insurance cover to the subjects, use of Internet databanks for drug interactions, active involvement by the pharmacologists in Ethics Committee, review of data from animal studies, being amongst them. In case of death due to trial, autopsies, or at least verbal autopsies, are essential in the interest of Science and Law. More importantly Anticipation and prevention of ADEs can be done by exclusion of subjects from trials by using newer technologies like cDNA in microarrays to determine several polygenic quantitative trait loci (QTLs) and tests for Single Nucleotide Polymorphisms (SNPs). Drug manufacturers must provide prototypes of Affymetrix chips to clinicians and bear the cost in their own enlightened self-interest.

  18. Parental reactions to children's negative emotions: prospective relations to Chinese children's psychological adjustment.

    Science.gov (United States)

    Tao, Annie; Zhou, Qing; Wang, Yun

    2010-04-01

    The prospective relations between five types of parental reactions to children's negative emotions (PRCNE) and children's psychological adjustment (behavioral problems and social competence) were examined in a two-wave longitudinal study of 425 school-age children in China. Parents (mostly mothers) reported their own PRCNE. Parents, teachers, and children or peers reported on children's adjustment. Parental punitive reactions positively predicted externalizing problems (controlling for baseline), whereas emotion- and problem-focused reactions were negatively related to internalizing problems. Parental minimizing and encouragement of emotion expression were unrelated to adjustment. Concurrent relations were found between PRCNE and parents' authoritative and authoritarian parenting dimensions. However, PRCNE did not uniquely predict adjustment controlling for global parenting dimensions. The findings have implications for cultural adaptation of parent-focused interventions for families of Chinese origin. 2010 APA, all rights reserved

  19. Mental health and family relations among people who inject drugs and their family members in Vietnam.

    Science.gov (United States)

    Li, Li; Tuan, Nguyen Anh; Liang, Li-Jung; Lin, Chunqing; Farmer, Shu C; Flore, Martin

    2013-11-01

    This article explores the association of people who inject drugs and their family members in terms of mental health and family relations. The objective was to understand the family context and its impact on people who inject drugs in a family-oriented culture in Vietnam. Cross-sectional assessment data were gathered from 83 people who inject drugs and 83 of their family members recruited from four communes in Phú Thọ province, Vietnam. Depressive symptoms and family relations were measured for both people who inject drugs and family members. Internalized shame and drug-using behavior were reported by people who inject drugs, and caregiver burden was reported by family members. We found that higher level of drug using behavior of people who inject drugs was significantly associated with higher depressive symptoms and lower family relations reported by themselves as well as their family members. Family relations reported by people who inject drugs and their family members were positively correlated. The findings highlight the need for interventions that address psychological distress and the related challenges faced by family members of people who inject drugs. The article has policy implication which concludes with an argument for developing strategies that enhance the role of families in supporting behavioral change among people who inject drugs. Copyright © 2013 Elsevier B.V. All rights reserved.

  20. [Use of illicit drugs and critical perspectives of drug users' relatives and acquaintances in Northern Rio de Janeiro City, Brazil].

    Science.gov (United States)

    Vargens, Octavio Muniz da Costa; Brands, Bruna; Adlaf, Edward; Giesbrecht, Norman; Simich, Laura; Wright, Maria da Gloria Miotto

    2009-01-01

    This article presents the partial results of a multicenter, qualitative study, which involved seven Latin-American countries and Canada. The results presented refer to Northern Rio de Janeiro (city), Brazil. The objective of the study was to describe the perspective of relatives/acquaintances of illicit drug users about protective and risk factors, prevention initiatives, treatment services, and legal aspects regarding illicit drugs. Interviews were performed with 99 individuals, who reported being affected by their relationship with an illicit drug user (relative or acquaintance), approaching their perspectives regarding the key-domains. Most participants were women (73.7%); relatives who used drugs were mostly men (78.2%); the most consumed drug was marijuana (77.8%). The highlighted protective factor was having recreational-sports activities in the community (88.9%), and the risk factor was curiosity for trying something new (94.4%). The main treatment services were Church Groups (51.5%), and participants stated that laws should be more punitive (82.8%). In conclusion, this information is essential to fight against drug use/abuse, showing that there is a need for actions that consider different perspectives at different levels.

  1. Analysis of Adverse Reaction of Analgesics, Antipyretics and Non-Steroidal Anti-Inflammatory Drugs Prescribed by Physicians of Health Care Facilities in Podilskyi Region during 2015

    OpenAIRE

    Stepaniuk, N. H.; Hladkykh, F. V.; Basarab, O. V.

    2016-01-01

    The problem of medicines rational use exists all over the world. It concerns particularly analgesics, antipyretics and non-steroidal anti-inflammatory drugs (NSAIDs). In Ukraine the side effects caused by non-steroidal antiphlogistics rank the second place according to the prevalence among all registered cases.The objective of the research was to analyze adverse drug reaction report forms concerning adverse reactions caused by the use of NSAIDs, analgesics, antipyretics, and were submitted du...

  2. Establishing MALDI-TOF as Versatile Drug Discovery Readout to Dissect the PTP1B Enzymatic Reaction.

    Science.gov (United States)

    Winter, Martin; Bretschneider, Tom; Kleiner, Carola; Ries, Robert; Hehn, Jörg P; Redemann, Norbert; Luippold, Andreas H; Bischoff, Daniel; Büttner, Frank H

    2018-07-01

    Label-free, mass spectrometric (MS) detection is an emerging technology in the field of drug discovery. Unbiased deciphering of enzymatic reactions is a proficient advantage over conventional label-based readouts suffering from compound interference and intricate generation of tailored signal mediators. Significant evolvements of matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) MS, as well as associated liquid handling instrumentation, triggered extensive efforts in the drug discovery community to integrate the comprehensive MS readout into the high-throughput screening (HTS) portfolio. Providing speed, sensitivity, and accuracy comparable to those of conventional, label-based readouts, combined with merits of MS-based technologies, such as label-free parallelized measurement of multiple physiological components, emphasizes the advantages of MALDI-TOF for HTS approaches. Here we describe the assay development for the identification of protein tyrosine phosphatase 1B (PTP1B) inhibitors. In the context of this precious drug target, MALDI-TOF was integrated into the HTS environment and cross-compared with the well-established AlphaScreen technology. We demonstrate robust and accurate IC 50 determination with high accordance to data generated by AlphaScreen. Additionally, a tailored MALDI-TOF assay was developed to monitor compound-dependent, irreversible modification of the active cysteine of PTP1B. Overall, the presented data proves the promising perspective for the integration of MALDI-TOF into drug discovery campaigns.

  3. Long term adverse drug reaction to Efavirenz in a HIV infected ...

    African Journals Online (AJOL)

    There is only one published case of serious adverse reaction to Efavirenz in an adolescent after long-term use. The case of a male HIV Positive Nigerian patient aged 13 years. He presented with five-day history of Difficulty sleeping, abnormal dreams, inability to concentrate, restlessness, irrational behavior and long-term ...

  4. Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program

    Directory of Open Access Journals (Sweden)

    Rahul Vasudev

    2016-01-01

    Full Text Available Aims: In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program. Materials and Methods: All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied for a period of 1 year. Any transfusion-related adverse event was worked up in accordance with guidelines laid down by the Directorate General of Health Services (DGHS and departmental standard operating procedures. Results: During the study period from November 1, 2011 to October 31, 2012, 45812 components were issued [30939 WB/PRBC; 12704 fresh frozen plasma (FFP; 2169 platelets]. Risk estimation per 1000 units of red cells (WB/PRBC transfused was estimated to be: 0.8 for febrile nonhemolytic transfusion reaction (FNHTR, 0.7 for allergic reaction, 0.19 for acute hemolytic transfusion reaction (AcHTR, 0.002 for anaphylactoid reactions, 0.1 for bacterial sepsis, and 0.06 for hypervolemia and hypocalcemia. 0.09 is the risk for delayed transfusion reaction and 0.03 is the risk for transfusion-related acute lung injury (TRALI. Risk estimate per 1,000 units of platelets transfused was estimated to be 1.38 for FNHTR, 1.18 for allergic reaction, and 1 in case of bacterial sepsis. Risk estimation per 1,000 units of FFP was estimated to be 0.15 for FNHTR and 0.2 for allergic reactions. Conclusions: Factors such as clerical checks at various levels, improvement in blood storage conditions outside blood banks, leukodepletion, better inventory management, careful donor screening, bedside monitoring of transfusion, and documentation of adverse events may decrease transfusion-related adverse events. Better coordination between transfusion specialists and various clinical

  5. Adverse drug reactions of haloperidol used in critically ill children for the treatment of delirium

    NARCIS (Netherlands)

    Spaans, E.; Slooff, V.; Van Puijenbroek, E.; Jessurun, N.; De Hoog, M.; Tibboel, D.; De Wildt, S.

    BACKGROUND: As delirium in critically ill children is increasingly recognized, more children are treated with the antipsychotic drug haloperidol. However, little is known about its safety in this context. The objective of this study was to investigate the incidence and nature of adverse events

  6. Pharmacy student driven detection of adverse drug reactions in the community pharmacy setting

    DEFF Research Database (Denmark)

    Christensen, Søren Troels; Søndergaard, Birthe; Honoré, Per Hartvig

    2011-01-01

    of pharmacists in ADR reporting, although varies significantly among countries. Pharmacists in community pharmacies are in a unique position for detection of experienced ADRs by the drug users. The study reports from a study on community pharmacy internship students' proactive role in ADR detection through...

  7. Adverse drug reactions to tocolytic treatment for preterm labour: Prospective cohort study

    NARCIS (Netherlands)

    R. de Heus (Roel); B.W.J. Mol (Ben); J.J.H.M. Erwich; H.P. van Geijn (Herman); W.J. Gyselaers (Wilfried); M. Hanssens (Myriam); L. Harmark (Linda); C.D. van Holsbeke (Caroline); J.J. Duvekot (Hans); F. Famschobben; H. Wolf (Hans Uwe); G.H. Visser (Gerhard Henk)

    2009-01-01

    textabstractObjective To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. Design Prospective cohort study. Setting 28 hospitals in the Netherlands and Belgium. Participants 1920

  8. Harm reduction and knowledge exchange-a qualitative analysis of drug-related Internet discussion forums.

    Science.gov (United States)

    Soussan, Christophe; Kjellgren, Anette

    2014-09-08

    Novel psychoactive substances (NPS) are continuously and increasingly appearing on the international drug market. Global Internet forums are a publicly available reality where users anonymously discuss and share information about NPS. The aim of this study was to explore and characterize the discussions about NPS on international Internet forums. The most post-frequent NPS discussions were collected from three "leading edge" international Internet forums. A total of 13,082 posts from 60 threads of discussion were systematically examined and interpreted to reveal recurring topics and patterns. Each thread was coded with emerging topics and supporting quotations from the data set. Eventually, codes with coherent meaning were arranged into 51 broader categories of abstraction, which were combined into four overarching themes. Four themes emerged during the analysis: (1) uncovering the substance facts, (2) dosage and administration, (3) subjectively experienced effects, and (4) support and safety. The first theme dealt primarily with substance identification, pharmacology, and assessed not only purity but also legal status and acquisition. The second theme focused on administration techniques, dose recommendations, technical talk about equipment, and preferred settings for drug use. The third theme involved a multitude of self-reported experiences, in which many different aspects of intoxication were depicted in great detail. The users emphasized both positive and negative experiences. The last theme incorporated the efforts of the communities to prevent and minimize harm by sharing information about potential risks of the harmful effects or contraindications of a substance. Also, online support and guidance were given to intoxicated persons who experienced bad or fearful reactions. The findings showed that the discussions were characterized by a social process in which users supported each other and exchanged an extensive and cumulative amount of knowledge about NPS

  9. Socializing in an open drug scene: the relationship between access to private space and drug-related street disorder.

    Science.gov (United States)

    Debeck, Kora; Wood, Evan; Qi, Jiezhi; Fu, Eric; McArthur, Doug; Montaner, Julio; Kerr, Thomas

    2012-01-01

    Limited attention has been given to the potential role that the structure of housing available to people who are entrenched in street-based drug scenes may play in influencing the amount of time injection drug users (IDU) spend on public streets. We sought to examine the relationship between time spent socializing in Vancouver's drug scene and access to private space. Using multivariate logistic regression we evaluated factors associated with socializing (three+ hours each day) in Vancouver's open drug scene among a prospective cohort of IDU. We also assessed attitudes towards relocating socializing activities if greater access to private indoor space was provided. Among our sample of 1114 IDU, 43% fit our criteria for socializing in the open drug scene. In multivariate analysis, having limited access to private space was independently associated with socializing (adjusted odds ratio: 1.80, 95% confidence interval: 1.28-2.55). In further analysis, 65% of 'socializers' reported positive attitudes towards relocating socializing if they had greater access to private space. These findings suggest that providing IDU with greater access to private indoor space may reduce one component of drug-related street disorder. Low-threshold supportive housing based on the 'housing first' model that include safeguards to manage behaviors associated with illicit drug use appear to offer important opportunities to create the types of private spaces that could support a reduction in street disorder. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  10. How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

    Science.gov (United States)

    Fleuranceau-Morel, P

    2002-01-01

    It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated

  11. Factors related to drug approvals: predictors of outcome?

    Science.gov (United States)

    Liberti, Lawrence; Breckenridge, Alasdair; Hoekman, Jarno; McAuslane, Neil; Stolk, Pieter; Leufkens, Hubert

    2017-06-01

    There is growing interest in characterising factors associated with positive regulatory outcomes for drug marketing authorisations. We assessed empirical studies published over the past 15 years seeking to identify predictive factors. Factors were classified to one of four 'factor clusters': evidentiary support; product or indication characteristics; company experience or strategy; social and regulatory factors. We observed a heterogeneous mix of technical factors (e.g., study designs, clinical evidence of efficacy) and less studied social factors (e.g., company-regulator interactions). We confirmed factors known to be of relevance to drug approval decisions (imperative) and a cohort of less understood (compensatory) social factors. Having robust supportive clinical evidence, addressing rare or serious illness, following scientific advice and prior company experience were associated with positive outcomes, which illustrated the multifactorial nature of regulatory decision making and factors need to be considered holistically while having varying, context-dependent importance. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. U.S. Drug Policy: Shaping Relations With Latin America

    Science.gov (United States)

    2014-06-01

    90  Figure 12.  Management levels within Colombian wheel network. ...................................91  x THIS PAGE... environmental and community damage in Latin America, citing coca eradication programs that have an adverse effect on community ecosystems. The effects of U.S...favor of drug policy change but endorse arbitrary or minuscule legislation that would not pose a great political risk to their careers. MacCoun and

  13. Drug-related police encounters across the globe: How do they compare?

    Science.gov (United States)

    Hughes, Caitlin E; Barratt, Monica J; Ferris, Jason A; Maier, Larissa J; Winstock, Adam R

    2018-06-01

    Drug law enforcement subsumes the majority of drug policy expenditure across the globe. Fuelled by knowledge that much of this investment is ineffective or counter-productive there have been increasing calls for cross-national comparisons to identify where policing approaches differ and what types of approaches may be more effective. Yet, to date cross-national comparison of drug law enforcement has proven a methodologically hazardous affair. Using a new drug policing module added to the 2017 Global Drug Survey, this study seeks to provide the first cross-national comparison of the incidence, nature and intensity of illicit drug-related police encounters amongst people who use drugs. The Global Drug Survey was administered in late 2016. Across 26 countries including Australia, Germany, Italy, Mexico, Switzerland, the UK and the USA a total of 45,942 people who had recently used drugs completed the drug policing module. Key variables assessed included the incidence and frequency of drug-related police encounters in the last 12 months that involved: a) being stopped and searched; b) encountering a drug detection dog; c) being given a caution or warning; d) being charged and arrested; and e) paying a bribe. Multi-level models were used to control for pre-existing national differences in drug use prevalence and non-drug specific policing (including the total number of police personnel in each country). Drug-related police encounters were most commonly reported in Italy and Scotland. Conversely, police encounters were most likely to lead to arrest in Norway, Finland and Sweden. The type and locations of encounters further differed across countries, with for example stop and search most reported in Greece and Colombia, and encounters with drug detection dogs most reported in Scotland, Italy, UK and Australia. Multi-level models showed that the incidence of reported policing encounters continued to differ significantly across countries after controlling for pre

  14. Interaction of Avelox with Bovine Serum Albumin and Effect of the Coexistent Drugs on the Reaction

    Directory of Open Access Journals (Sweden)

    Baosheng Liu

    2012-01-01

    Full Text Available The interaction between Avelox and bovine serum albumin (BSA was investigated at different temperatures by fluorescence spectroscopy. Results showed that Avelox could quench the intrinsic fluorescence of BSA strongly, and the quenching mechanism was a static quenching process with Förester spectroscopy energy transfer. The electrostatic force played an important role on the conjugation reaction between BSA and Avelox. The order of magnitude of binding constants (Ka was 104, and the number of binding site (n in the binary system was approximately equal to 1. The binding distance (r was less than 3 nm and the primary binding site for Avelox was located in subdomain IIA of BSA. Synchronous fluorescence spectra clearly revealed that the microenvironment of amino acid residues and the conformation of BSA were changed during the binding reaction. In addition, the effect of some antibiotics on the binding constant of Avelox with BSA was also studied.

  15. Following Drug Uptake and Reactions inside Escherichia coli Cells by Raman Microspectroscopy

    Science.gov (United States)

    2015-01-01

    Raman microspectroscopy combined with Raman difference spectroscopy reveals the details of chemical reactions within bacterial cells. The method provides direct quantitative data on penetration of druglike molecules into Escherichia coli cells in situ along with the details of drug–target reactions. With this label-free technique, clavulanic acid and tazobactam can be observed as they penetrate into E. coli cells and subsequently inhibit β-lactamase enzymes produced within these cells. When E. coli cells contain a β-lactamase that forms a stable complex with an inhibitor, the Raman signature of the known enamine acyl–enzyme complex is detected. From Raman intensities it is facile to measure semiquantitatively the number of clavulanic acid molecules taken up by the lactamase-free cells during growth. PMID:24901294

  16. Drug-related decrease in neuropsychological functions of abstinent drug users

    NARCIS (Netherlands)

    van Holst, Ruth Janke; Schilt, Thelma

    2011-01-01

    This article reviews neuropsychological performance in frequent users of cocaine, (meth)amphetamines, ecstasy, opiates, alcohol, and cannabis. We searched the scientific literature published in the last five years, focusing on studies that required at least 2 weeks of abstinence from drug use, and

  17. A smart hydrogel-based time bomb triggers drug release mediated by pH-jump reaction

    Directory of Open Access Journals (Sweden)

    Prapatsorn Techawanitchai, Naokazu Idota, Koichiro Uto, Mitsuhiro Ebara and Takao Aoyagi

    2012-01-01

    Full Text Available We demonstrate a timed explosive drug release from smart pH-responsive hydrogels by utilizing a phototriggered spatial pH-jump reaction. A photoinitiated proton-releasing reaction of o-nitrobenzaldehyde (o-NBA was integrated into poly(N-isopropylacrylamide-co-2-carboxyisopropylacrylamide (P(NIPAAm-co-CIPAAm hydrogels. o-NBA-hydrogels demonstrated the rapid release of protons upon UV irradiation, allowing the pH inside the gel to decrease to below the pKa value of P(NIPAAm-co-CIPAAm. The generated protons diffused gradually toward the non-illuminated area, and the diffusion kinetics could be controlled by adjusting the UV irradiation time and intensity. After irradiation, we observed the enhanced release of entrapped L-3,4-dihydroxyphenylalanine (DOPA from the gels, which was driven by the dissociation of DOPA from CIPAAm. Local UV irradiation also triggered the release of DOPA from the non-illuminated area in the gel via the diffusion of protons. Conventional systems can activate only the illuminated region, and their response is discontinuous when the light is turned off. The ability of the proposed pH-jump system to permit gradual activation via proton diffusion may be beneficial for the design of predictive and programmable devices for drug delivery.

  18. Age-related accumulation of Maillard reaction products in human articular cartilage collagen

    NARCIS (Netherlands)

    Verzijl, N.; Degroot, J.; Oldehinkel, E.; Bank, R. A.; Thorpe, S. R.; Baynes, J. W.; Bayliss, M. T.; Bijlsma, J. W.; Lafeber, F. P.; TeKoppele, J. M.

    2000-01-01

    Non-enzymic modification of tissue proteins by reducing sugars, the so-called Maillard reaction, is a prominent feature of aging. In articular cartilage, relatively high levels of the advanced glycation end product (AGE) pentosidine accumulate with age. Higher pentosidine levels have been associated

  19. Cerebral activation related to implicit sequence learning in a Double Serial Reaction Time task

    NARCIS (Netherlands)

    van der Graaf, FHCE; Maguire, RP; Leenders, KL; de Jong, BM

    2006-01-01

    Using functional magnetic resonance imaging (fMRI), we examined the distribution of cerebral activations related to implicitly learning a series of fixed stimulus-response combinations. In a novel - bimanual - variant of the Serial Reaction Time task (SRT), simultaneous finger movements of the two

  20. Integrative relational machine-learning for understanding drug side-effect profiles.

    Science.gov (United States)

    Bresso, Emmanuel; Grisoni, Renaud; Marchetti, Gino; Karaboga, Arnaud Sinan; Souchet, Michel; Devignes, Marie-Dominique; Smaïl-Tabbone, Malika

    2013-06-26

    Drug side effects represent a common reason for stopping drug development during clinical trials. Improving our ability to understand drug side effects is necessary to reduce attrition rates during drug development as well as the risk of discovering novel side effects in available drugs. Today, most investigations deal with isolated side effects and overlook possible redundancy and their frequent co-occurrence. In this work, drug annotations are collected from SIDER and DrugBank databases. Terms describing individual side effects reported in SIDER are clustered with a semantic similarity measure into term clusters (TCs). Maximal frequent itemsets are extracted from the resulting drug x TC binary table, leading to the identification of what we call side-effect profiles (SEPs). A SEP is defined as the longest combination of TCs which are shared by a significant number of drugs. Frequent SEPs are explored on the basis of integrated drug and target descriptors using two machine learning methods: decision-trees and inductive-logic programming. Although both methods yield explicit models, inductive-logic programming method performs relational learning and is able to exploit not only drug properties but also background knowledge. Learning efficiency is evaluated by cross-validation and direct testing with new molecules. Comparison of the two machine-learning methods shows that the inductive-logic-programming method displays a greater sensitivity than decision trees and successfully exploit background knowledge such as functional annotations and pathways of drug targets, thereby producing rich and expressive rules. All models and theories are available on a dedicated web site. Side effect profiles covering significant number of drugs have been extracted from a drug ×side-effect association table. Integration of background knowledge concerning both chemical and biological spaces has been combined with a relational learning method for discovering rules which explicitly

  1. Evaluation of cutaneous drug reactions in patients visiting out patient departments of Indira Gandhi Government Medical College and Hospital (IGGMC and H, Nagpur

    Directory of Open Access Journals (Sweden)

    Sachin Hiware

    2013-01-01

    Full Text Available Objectives: To detect cutaneous drug reactions through spontaneous reporting system in IGGMCand H, Nagpur and analyze them using standard assessment scales. Materials and Methods: An observational, prospective study was performed in patients attending dermatology OPD of IGGMC and H, Nagpur from 1 st June 05 to 31 st May 09. Patients were examined for cutaneous drug reactions (CDRs by spontaneous Adverse Drug Reaction reporting system. Results: Among 2693 total ADRs reported, 872 (33.04% were CDRs. Antimicrobials (55.5% were the main drugs involved followed by NSAIDs (18.56% and steroids (12.61%. Maculopapular rash (37.73% followed by fixed drug eruption (17.2% and urticaria (14.56% were the most frequently observed CDRs. The common drugs causing CDRs were cotrimoxazole (20.41%, topical steroids (betamethasone, ibuprofen (7.91%, ampicillin (6.54%, diclofenac (4.7% and iron dextran (3.44%. Conclusion : It was observed that commonly used drugs like antibiotics and NSAIDs lead to maximum number of CDRs. Hence strict vigilance is required while using them. This study provides a database of ADRs due to common drugs, which will help clinicians in safe use of these drugs.

  2. [Analysis of drug-related problems in a tertiary university hospital in Barcelona (Spain)].

    Science.gov (United States)

    Ferrández, Olivia; Casañ, Borja; Grau, Santiago; Louro, Javier; Salas, Esther; Castells, Xavier; Sala, Maria

    2018-05-07

    To describe drug-related problems identified in hospitalized patients and to assess physicians' acceptance rate of pharmacists' recommendations. Retrospective observational study that included all drug-related problems detected in hospitalized patients during 2014-2015. Statistical analysis included a descriptive analysis of the data and a multivariate logistic regression to evaluate the association between pharmacists' recommendation acceptance rate and the variable of interest. During the study period 4587 drug-related problems were identified in 44,870 hospitalized patients. Main drug-related problems were prescription errors due to incorrect use of the computerized physician order entry (18.1%), inappropriate drug-drug combination (13.3%) and dose adjustment by renal and/or hepatic function (11.5%). Acceptance rate of pharmacist therapy advice in evaluable cases was 81.0%. Medical versus surgical admitting department, specific types of intervention (addition of a new drug, drug discontinuation and correction of a prescription error) and oral communication of the recommendation were associated with a higher acceptance rate. The results of this study allow areas to be identified on which to implement optimization strategies. These include training courses for physicians on the computerized physician order entry, on drugs that need dose adjustment with renal impairment, and on relevant drug interactions. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. Interaction in the Research Interview and Drug-Related Disclosures among Respondents.

    Science.gov (United States)

    Myers, Vincent

    1979-01-01

    Interviewers and respondents judged interview interactions during a survey of drug-related sentiments. Pronounced variability in interviewer-respondent judgements occurred in unanticipated ways related to gender, role, and ethnicity of participants. Positive interaction yielded different respondent cognitions and reports of illicit drug ingestion…

  4. State and Community Responses to Drug-related Violence in Mexico

    International Development Research Centre (IDRC) Digital Library (Canada)

    Extrants. Études. State and community responses to drug-related violence in Mexico. Rapports. Respuestas estatales y comunitarias a la violencia asociada al narcotráfico en México : informe técnico. Rapports. State and community responses to drug-related violence in Mexico ...

  5. Susceptibility Testing by Polymerase Chain Reaction DNA Quantitation: A Method to Measure Drug Resistance of Human Immunodeficiency Virus Type 1 Isolates

    Science.gov (United States)

    Eron, Joseph J.; Gorczyca, Paul; Kaplan, Joan C.; D'Aquila, Richard T.

    1992-04-01

    Polymerase chain reaction (PCR) DNA quantitation (PDQ) susceptibility testing rapidly and directly measures nucleoside sensitivity of human immunodeficiency virus type 1 (HIV-1) isolates. PCR is used to quantitate the amount of HIV-1 DNA synthesized after in vitro infection of peripheral blood mononuclear cells. The relative amounts of HIV-1 DNA in cell lysates from cultures maintained at different drug concentrations reflect drug inhibition of virus replication. The results of PDQ susceptibility testing of 2- or 3-day cultures are supported by assays measuring HIV-1 p24 antigen production in supernatants of 7- or 10-day cultures. DNA sequence analyses to identify mutations in the reverse transcriptase gene that cause resistance to 3'-azido-3'-deoxythymidine also support the PDQ results. With the PDQ method, both infectivity titration and susceptibility testing can be performed on supernatants from primary cultures of peripheral blood mononuclear cells. PDQ susceptibility testing should facilitate epidemiologic studies of the clinical significance of drug-resistant HIV-1 isolates.

  6. Drug-related problems identified in medication reviews by Australian pharmacists

    DEFF Research Database (Denmark)

    Stafford, Andrew C; Tenni, Peter C; Peterson, Gregory M

    2009-01-01

    OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study was to exam......OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study....... These reviews had been self-selected by pharmacists and submitted as part of the reaccreditation process to the primary body responsible for accrediting Australian pharmacists to perform medication reviews. The drug-related problems identified in each review were classified by type and drugs involved. MAIN...... OUTCOME MEASURE: The number and nature of drug-related problems identified in pharmacist-conducted medication reviews. RESULTS: There were 1,038 drug-related problems identified in 234 medication reviews (mean 4.6 (+/-2.2) problems per review). The number of problems was higher (4.9 +/- 2.0 vs. 3.9 +/- 2...

  7. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

    Science.gov (United States)

    Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

    2015-02-01

    The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

  8. OntoADR a semantic resource describing adverse drug reactions to support searching, coding, and information retrieval.

    Science.gov (United States)

    Souvignet, Julien; Declerck, Gunnar; Asfari, Hadyl; Jaulent, Marie-Christine; Bousquet, Cédric

    2016-10-01

    Efficient searching and coding in databases that use terminological resources requires that they support efficient data retrieval. The Medical Dictionary for Regulatory Activities (MedDRA) is a reference terminology for several countries and organizations to code adverse drug reactions (ADRs) for pharmacovigilance. Ontologies that are available in the medical domain provide several advantages such as reasoning to improve data retrieval. The field of pharmacovigilance does not yet benefit from a fully operational ontology to formally represent the MedDRA terms. Our objective was to build a semantic resource based on formal description logic to improve MedDRA term retrieval and aid the generation of on-demand custom groupings by appropriately and efficiently selecting terms: OntoADR. The method consists of the following steps: (1) mapping between MedDRA terms and SNOMED-CT, (2) generation of semantic definitions using semi-automatic methods, (3) storage of the resource and (4) manual curation by pharmacovigilance experts. We built a semantic resource for ADRs enabling a new type of semantics-based term search. OntoADR adds new search capabilities relative to previous approaches, overcoming the usual limitations of computation using lightweight description logic, such as the intractability of unions or negation queries, bringing it closer to user needs. Our automated approach for defining MedDRA terms enabled the association of at least one defining relationship with 67% of preferred terms. The curation work performed on our sample showed an error level of 14% for this automated approach. We tested OntoADR in practice, which allowed us to build custom groupings for several medical topics of interest. The methods we describe in this article could be adapted and extended to other terminologies which do not benefit from a formal semantic representation, thus enabling better data retrieval performance. Our custom groupings of MedDRA terms were used while performing signal

  9. The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

    Directory of Open Access Journals (Sweden)

    Elham Azhdari

    2013-02-01

    Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

  10. Nitric oxide-related drug targets in headache

    DEFF Research Database (Denmark)

    Olesen, Jes

    2010-01-01

    SUMMARY: Nitric oxide (NO) is a very important molecule in the regulation of cerebral and extra cerebral cranial blood flow and arterial diameters. It is also involved in nociceptive processing. Glyceryl trinitrate (GTN), a pro-drug for NO, causes headache in normal volunteers and a so-called del......SUMMARY: Nitric oxide (NO) is a very important molecule in the regulation of cerebral and extra cerebral cranial blood flow and arterial diameters. It is also involved in nociceptive processing. Glyceryl trinitrate (GTN), a pro-drug for NO, causes headache in normal volunteers and a so......-called delayed headache that fulfils criteria for migraine without aura in migraine sufferers. Blockade of nitric oxide synthases (NOS) by L-nitromonomethylarginine effectively treats attacks of migraine without aura. Similar results have been obtained for chronic the tension-type headache and cluster headache....... Inhibition of the breakdown of cyclic guanylate phosphate (cGMP) also provokes migraine in sufferers, indicating that cGMP is the effector of NO-induced migraine. Similar evidence suggests an important role of NO in the tension-type headache and cluster headache. These very strong data from human...

  11. Graphic and Arousing? Emotional and Cognitive Reactions to Tobacco Graphic Health Warnings and Associated Quit-Related Outcomes Among Low SEP Population Groups.

    Science.gov (United States)

    Bekalu, Mesfin Awoke; Ramanadhan, Shoba; Bigman, Cabral A; Nagler, Rebekah H; Viswanath, Kasisomayajula

    2018-02-01

    Research on graphic health warnings (GHWs) indicates that beyond changing cognitions about the health effects of smoking, GHWs evoke emotional reactions that can influence quit-related outcomes. Emotions can be classified based on valence (positive or negative) and arousal (calm or excited). However, although considerable research has examined the differential effectiveness of positive versus negative GHW-evoked emotions, research investigating the role of arousal activation in quit-related behaviors is scarce. This study examined associations between quit-related outcomes (intention and attempt to quit) and GHWs-evoked negative emotions classified as high and low in arousal activation as well as cognitive reactions among smokers of low socioeconomic position (SEP). It also examined whether perceived health risks of smoking moderate the relationship between emotional and cognitive reactions to GHWs and quit-related outcomes. Data were collected from low SEP smokers in three Massachusetts communities. Participants were screened and randomized to view one of the nine GHWs initially proposed for use by the U.S. Food and Drug Administration (FDA) and answered pre- and post-exposure questions. Results showed that GHW-evoked negative emotions high in arousal activation and cognitive reactions were both significantly associated with intention to quit during immediate post-test, controlling for age, warning label difference, and prior quit intention. However, these associations did not hold for quit attempts at follow-up. Perceived health risks of smoking moderated the association between cognitive reactions to GHWs and quit attempts at follow-up. The findings suggest that not all negative emotions evoked by GHWs are effective. Negative emotions high in arousal activation may be more effective in influencing quit-related behavioral intentions in low SEP groups. Additionally, unlike emotional reactions, cognitive reactions to GHWs may have effects that last relatively

  12. Investigation of Frequency of Leftover Drugs at Home and Related Factors

    Directory of Open Access Journals (Sweden)

    Muharrem Ucar

    2009-04-01

    Full Text Available AIM: The purpose of this survey was to investigate the frequency of leftover drugs at homes and related factors regarding this problem. METHOD: This descriptive study was performed among 692 non-medical personnel servicing at two military bases in December 2006. Data were collected by using a questionnaire, which had been developed by the investigators. Frequencies and percents were used as descriptive statistics. Chi-square test was used to compare the frequencies of leftover drugs according to certain variables. RESULTS: Of the total participants 78,8% were males, 72,8% aged between 18 to 39, and 29,6% were unmarried. The findings revealed that 61,3% of the participants had leftover drugs at their homes. Participants living with together 2 to 4 family members had higher frequencies of leftover drugs at homes. When we looked at the frequencies of leftover drugs according to drug use behaviors; the frequency of leftover drug was determined higher among those who stated; the recipe was not explained sufficiently, he did not use drugs as directed, he kept drugs until due time when did not use all of the drugs, he kept drugs in a box or bag, he visited a health center in order to have a recipe (p<0,05. CONCLUSION: It was determined leftover drugs were kept at nearly two third of the participants’ homes. Regarding incompleteness of treatment, the intoxication risk for children, and drug waste, this frequency of drug leftover was high, and all responsible professions in the chain of rationale drug use particularly physicians should be awaked on this issue. The use of drugs in a recipe should be explained to patients clearly. [TAF Prev Med Bull 2009; 8(2.000: 113-118

  13. Relation of expansion due to alkali silica reaction to the degree of reaction measured by SEM image analysis

    International Nuclear Information System (INIS)

    Haha, M. Ben; Gallucci, E.; Guidoum, A.; Scrivener, K.L.

    2007-01-01

    Scanning Electron Microscopy Image Analysis (SEM-IA) was used to quantify the degree of alkali silica reaction in affected microbars, mortar and concrete prisms. It was found that the degree of reaction gave a unique correlation with the macroscopic expansion for three different aggregates, stored at three temperatures and with two levels of alkali. The relationships found for the concretes and the mortars overlap when normalised by the aggregate content. This relationship seems to be linear up to a critical reaction degree which coincides with crack initiation within the reactive aggregates

  14. Work-related injuries in a state trauma registry: relationship between industry and drug screening.

    Science.gov (United States)

    Bunn, Terry L; Slavova, Svetla; Bernard, Andrew C

    2014-08-01

    Work-related injuries exert a great financial and economic burden on the US population. The study objectives were to identify the industries and occupations associated with worker injuries and to determine the predictors for injured worker drug screening in trauma centers. Work-related injury cases were selected using three criteria (expected payer source of workers' compensation, industry-related e-codes, and work-related indicator) from the Kentucky Trauma Registry data set for years 2008 to 2012. Descriptive analyses and multiple logistic regression were performed on the work-related injury cases. The "other services" and construction industry sectors accounted for the highest number of work-related cases. Drugs were detected in 55% of all drug-screened work-related trauma cases. Higher percentages of injured workers tested positive for drugs in the natural resources and mining, transportation and public utilities, and construction industries. In comparison, higher percentages of injured workers in the other services as well as transportation and public utilities industries were drug screened. Treatment at Level I trauma centers and Glasgow Coma Scale (GCS) scores indicating a coma or severe brain injury were both significant independent predictors for being screened for drugs; industry was not a significant predictor for being drug screened. The injured worker was more likely to be drug screened if the worker had a greater than mild injury, regardless of whether the worker was an interfacility transfer. These findings indicate that there may be elevated drug use or abuse in natural resources and mining, transportation and public utilities, as well as construction industry workers; improved identification of the specific drug types in positive drug screen results of injured workers is needed to better target prevention efforts. Epidemiologic study, level III.

  15. Reacciones adversas a medicamentos como causa de abandono del tratamiento farmacológico en hipertensos Adverse reactions to drugs as leaving drug therapy cause in hypertensive persons

    Directory of Open Access Journals (Sweden)

    Ana Julia García Milián

    2009-03-01

    , Gramma, Santiago de Cuba, and Ciego de Avila provinces. Survey was the method of information collection. RESULTS: more used anti-hypertensive drugs were Captopril, Hydrochlorothiazide, and Atenolol and the first one with a 31,9 %, the drug with higher percentage of non-fulfillment and the cause of an adverse event. Fulfillment was higher in patients younger aged than 30. Second place within causes of adverse reactions, with the 16,9 % for leave treatment was for cough, skin reactions, and weakness. CONCLUSIONS: Adverse reactions are located within the more frequent causes of leaving anti-hypertensive treatment and Captopril and Hydrochlorothiazide those with the greatest frequency of leaving. Most of adverse reactions mentioned are considered as minor.

  16. Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS

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    He Ping

    2010-05-01

    Full Text Available Abstract Background More than 1 million tuberculosis (TB patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS in China every year. Adverse reactions (ADRs induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Methods/Design Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA. Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI, a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis. Discussion ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy.

  17. Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)

    Science.gov (United States)

    2010-01-01

    Background More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Methods/Design Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA). Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI), a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis. Discussion ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy. PMID:20492672

  18. Drugs Related to Oropharyngeal Dysphagia in Older People.

    Science.gov (United States)

    Miarons, Marta; Campins, Lluís; Palomera, Elisabet; Serra-Prat, Mateu; Cabré, Mateu; Rofes, Laia

    2016-10-01

    Scientific evidence on the impact of medication on the physiology of swallowing is scarce and mainly based on clinical case reports. To evaluate the association between oropharyngeal dysphagia (OD) and chronic exposure to medication in older patients admitted to the acute geriatric unit (AGU) of a secondary hospital, we performed a retrospective cross-sectional study of 966 patients admitted to an AGU from 2008 to 2011. We reviewed (a) diagnosis of OD (assessed with the volume-viscosity swallow test, V- VST); (b) chronic patient medication classified by anatomical, therapeutic, chemical codes; and (c) demographic and clinical data. A univariate analysis was performed to determine which medications were associated with OD. A multivariate analysis adjusting for confounding clinical factors was performed to identify which of those medications were independently associated with OD. The age of patients included was 85.3 ± 6.37 years and 59.4 % were women. A total of 41.9 % presented OD. We found a possible protective effect of beta blocking agents on OD after the multivariate analysis (OR 0.54, 95 % CI 0.35-0.85). None of the categories of drugs was associated with an altered swallowing function after adjusting for confounding variables. The present study is the first one to widely investigate the association between drugs and OD, increasing understanding of their association. The role of beta blockers in OD needs to be further studied as their potentially beneficial effects on the swallowing function in older patients could help to prevent complications.

  19. Physical and relational aggression as predictors of drug use: gender differences among high school students.

    Science.gov (United States)

    Skara, Silvana; Pokhrel, Pallav; Weiner, Michelle D; Sun, Ping; Dent, Clyde W; Sussman, Steve

    2008-12-01

    The present study investigated the longitudinal relationships between physical and relational aggression and later drug use, as moderated by gender. Self-reported data were gathered from 2064 high school students at pretest and 1-year post-test to test the hypotheses that (1) males would engage in more physical aggression than females, whereas females would engage in more relational aggression than males; and (2) physical aggression would be a stronger drug use predictor for males and relational aggression a stronger predictor for females. Results indicated that males reported engaging in more physical aggression than females at baseline; however, females and males reported engaging in similar rates of relational aggression. After controlling for relational aggression, baseline drug use, and demographic variables, physical aggression at baseline was found to predict alcohol use 1-year later for males but not for females. After controlling for physical aggression, baseline drug use, and demographic variables, relational aggression was found to predict cigarette use and marijuana use for females but not for males. However, relational aggression was found to predict later alcohol and hard drug equally across gender. These findings suggest that both physical and relational aggression are predictive of subsequent drug use and have important implications for violence and drug use prevention intervention efforts.

  20. Standard-based comprehensive detection of adverse drug reaction signals from nursing statements and laboratory results in electronic health records.

    Science.gov (United States)

    Lee, Suehyun; Choi, Jiyeob; Kim, Hun-Sung; Kim, Grace Juyun; Lee, Kye Hwa; Park, Chan Hee; Han, Jongsoo; Yoon, Dukyong; Park, Man Young; Park, Rae Woong; Kang, Hye-Ryun; Kim, Ju Han

    2017-07-01

    We propose 2 Medical Dictionary for Regulatory Activities-enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)-based pharmacovigilance method, called CLEAR. Adverse drug reaction (ADR) signals from 117 laboratory abnormalities and 1357 standard nursing statements for all precautionary drugs ( n   = 101) were comprehensively detected and validated against SIDER (Side Effect Resource) by MetaLAB and MetaNurse against 11 817 and 76 457 drug-ADR pairs, respectively. We demonstrate that MetaLAB (area under the curve, AUC = 0.61 ± 0.18) outperformed CLEAR (AUC = 0.55 ± 0.06) when we applied the same 470 drug-event pairs as the gold standard, as in our previous research. Receiver operating characteristic curves for 101 precautionary terms in the Medical Dictionary for Regulatory Activities Preferred Terms were obtained for MetaLAB and MetaNurse (0.69 ± 0.11; 0.62 ± 0.07), which complemented each other in terms of ADR signal coverage. Novel ADR signals discovered by MetaLAB and MetaNurse were successfully validated against spontaneous reports in the US Food and Drug Administration Adverse Event Reporting System database. The present study demonstrates the symbiosis of laboratory test results and nursing statements for ADR signal detection in terms of their system organ class coverage and performance profiles. Systematic discovery and evaluation of the wide spectrum of ADR signals using standard-based observational electronic health record data across many institutions will affect drug development and use, as well as postmarketing surveillance and regulation. © The Author 2017. Published by Oxford University Press on behalf of the American

  1. Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia.

    Science.gov (United States)

    Elkalmi, Ramadan; Hassali, Mohamed Azmi; Al-Lela, Omar Qutaiba; Jawad Awadh, Ammar Ihsan; Al-Shami, Abdul Kareem; Jamshed, Shazia Qasim

    2013-07-01

    The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system. An anonymous, self-administered questionnaire (15 items) was designed. The questionnaire was subjected to face validity and content validity. The reliability coefficient was found to be 0.71. This study recruited proportionately large convenience sample of the general public in Penang. Interviews using a structured questionnaire were conducted over a week period in August 2009. The recommended sample size was calculated to be 368. Three hundred thirty-four responses were received. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179). When asked about the sources of their medication majority of them reported medical doctor (85.6%), whereas small number (34.7%) reported community pharmacists as sources of medications. Three-quarter of the respondents (77.2%) get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%). More than half of the respondents (65.6%, n = 219) reported unawareness about the existence of ADR center set up by the Ministry of Health. Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases.

  2. Adverse drug reactions reporting : Knowledge and opinion of general public in Penang, Malaysia

    Directory of Open Access Journals (Sweden)

    Ramadan Elkalmi

    2013-01-01

    Full Text Available Objective: The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system. Methods: An anonymous, self-administered questionnaire (15 items was designed. The questionnaire was subjected to face validity and content validity. The reliability coefficient was found to be 0.71. This study recruited proportionately large convenience sample of the general public in Penang. Interviews using a structured questionnaire were conducted over a week period in August 2009. The recommended sample size was calculated to be 368. Results: Three hundred thirty-four responses were received. Slightly more than half of the respondents were in the age group of 18-25 years (53.6%; n = 179. When asked about the sources of their medication majority of them reported medical doctor (85.6%, whereas small number (34.7% reported community pharmacists as sources of medications. Three-quarter of the respondents (77.2% get their information about the side-effects of drugs from physicians, followed by pharmacist (44.6%. More than half of the respondents (65.6%, n = 219 reported unawareness about the existence of ADR center set up by the Ministry of Health. Conclusion: Respondents reflected inadequate knowledge on ADR reporting. This needs to be corrected as the trend of future pharmacovigilance is toward the patient. Moreover, the new trend seems to be more appropriate as the patient is the group of the people who are directly affected from the ADR of a particular drug and not the health-care providers. Furthermore, the patient will be informed about the economic implications of not reporting ADR. It is recommended that government agencies, like MADRAC needs to find ways to increase patient- reported ADR cases.

  3. Mathematical model to analyze the dissolution behavior of metastable crystals or amorphous drug accompanied with a solid-liquid interface reaction.

    Science.gov (United States)

    Hirai, Daiki; Iwao, Yasunori; Kimura, Shin-Ichiro; Noguchi, Shuji; Itai, Shigeru

    2017-04-30

    Metastable crystals and the amorphous state of poorly water-soluble drugs in solid dispersions (SDs), are subject to a solid-liquid interface reaction upon exposure to a solvent. The dissolution behavior during the solid-liquid interface reaction often shows that the concentration of drugs is supersaturated, with a high initial drug concentration compared with the solubility of stable crystals but finally approaching the latter solubility with time. However, a method for measuring the precipitation rate of stable crystals and/or the potential solubility of metastable crystals or amorphous drugs has not been established. In this study, a novel mathematical model that can represent the dissolution behavior of the solid-liquid interface reaction for metastable crystals or amorphous drug was developed and its validity was evaluated. The theory for this model was based on the Noyes-Whitney equation and assumes that the precipitation of stable crystals at the solid-liquid interface occurs through a first-order reaction. Moreover, two models were developed, one assuming that the surface area of the drug remains constant because of the presence of excess drug in the bulk and the other that the surface area changes in time-dependency because of agglomeration of the drug. SDs of Ibuprofen (IB)/polyvinylpyrrolidone (PVP) were prepared and their dissolution behaviors under non-sink conditions were fitted by the models to evaluate improvements in solubility. The model assuming time-dependent surface area showed good agreement with experimental values. Furthermore, by applying the model to the dissolution profile, parameters such as the precipitation rate and the potential solubility of the amorphous drug were successfully calculated. In addition, it was shown that the improvement in solubility with supersaturation was able to be evaluated quantitatively using this model. Therefore, this mathematical model would be a useful tool to quantitatively determine the supersaturation

  4. Linear relations in microbial reaction systems: a general overview of their origin, form, and use.

    Science.gov (United States)

    Noorman, H J; Heijnen, J J; Ch A M Luyben, K

    1991-09-01

    In microbial reaction systems, there are a number of linear relations among net conversion rates. These can be very useful in the analysis of experimental data. This article provides a general approach for the formation and application of the linear relations. Two type of system descriptions, one considering the biomass as a black box and the other based on metabolic pathways, are encountered. These are defined in a linear vector and matrix algebra framework. A correct a priori description can be obtained by three useful tests: the independency, consistency, and observability tests. The independency are different. The black box approach provides only conservations relations. They are derived from element, electrical charge, energy, and Gibbs energy balances. The metabolic approach provides, in addition to the conservation relations, metabolic and reaction relations. These result from component, energy, and Gibbs energy balances. Thus it is more attractive to use the metabolic description than the black box approach. A number of different types of linear relations given in the literature are reviewed. They are classified according to the different categories that result from the black box or the metabolic system description. Validation of hypotheses related to metabolic pathways can be supported by experimental validation of the linear metabolic relations. However, definite proof from biochemical evidence remains indispensable.

  5. Drug abuse-related accidents leading to emergency department visits at two medical centers

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    Isaac Chun-Jen Chen

    2012-05-01

    Conclusion: Although the prevalence of drug abuse-related accidents was low, and only three patient deaths were reported in this study, many patients presented to the EDs with severe effects and later required hospitalization. Better and timely management of such patients will help to minimize the adverse health impacts associated with drug abuse. Governmental agencies and all healthcare professionals should also work together to fight against the surging trend of drug abuse in Taiwan.

  6. Understanding drug-related mortality in released prisoners: a review of national coronial records

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    Andrews Jessica Y

    2012-04-01

    Full Text Available Abstract Background The prisoner population is characterised by a high burden of disease and social disadvantage, and ex-prisoners are at increased risk of death following release. Much of the excess mortality can be attributed to an increased risk of unnatural death, particularly from drug overdose; however, relatively few studies have investigated the circumstances surrounding drug-related deaths among released prisoners. This study aimed to explore and compare the circumstances of death for those who died from accidental drug-related causes to those who died from all other reportable causes. Methods A nationwide search of the Australian National Coroners Information System (NCIS was conducted to identify reportable deaths among ex-prisoners from 2000 to 2007. Using a structured coding form, NCIS records for these cases were interrogated to explore causes and circumstances of death. Results Coronial records for 388 deceased ex-prisoners were identified. Almost half of these deaths were a result of accidental drug-related causes (45%. The majority of accidental drug-related deaths occurred in a home environment, and poly-substance use at or around the time of death was common, recorded in 72% of drug-related deaths. Ex-prisoners who died of accidental drug-related causes were on average younger and less likely to be Indigenous, born in Australia, married, or living alone at or around the time of death, compared with those who died from all other reportable causes. Evidence of mental illness or self-harm was less common among accidental drug-related deaths, whereas evidence of previous drug overdose, injecting drug use, history of heroin use and history of drug withdrawal in the previous six months were more common. Conclusions Drug-related deaths are common among ex-prisoners and often occur in a home (vs. public setting. They are often associated with use of multiple substances at or around the time of death, risky drug-use patterns, and even

  7. Drug abuse-related accidents leading to emergency department visits at two medical centers.

    Science.gov (United States)

    Chen, Isaac Chun-Jen; Hung, Dong-Zong; Hsu, Chi-Ho; Wu, Ming-Ling; Deng, Jou-Fang; Chang, Chin-Yu; Shih, Hsin-Chin; Liu, Chen-Chi; Wang, Chien-Ying; Wen, Yi-Szu; Wu, Jackson Jer-Kan; Huang, Mu-Shun; Yang, Chen-Chang

    2012-05-01

    Drug abuse is becoming more prevalent in Taiwan, as evidenced by increasing reports of drug trafficking and drug abuse-related criminal activity, and the wide use of more contemporary illicit drugs. Consequently, drug abuse-related accidents are also expected to occur with greater frequency. However, no study has yet specifically evaluated the prevalence, pattern, and outcomes of drug abuse-related accidents among patients visiting emergency departments (EDs) in Taiwan. We conducted an ambidirectional study with patients who visited the EDs of Taipei Veterans General Hospital (TVGH) and China Medical University Hospital (CMUH) due to drug abuse-related accidents from January 2007 through September 2009. Information on the patients' baseline characteristics and clinical outcomes was collected and analyzed. During the study period, a total of 166 patients visited the EDs of one of the two study hospitals due to drug abuse-related accidents. This yielded a prevalence of drug abuse of 0.1% among all patients visiting the ED due to accident and/or trauma. Fifty-six out of the 166 patients visited the ED at TVGH, most patients being between 21 and 40 years old. Opioids (41.1%) were the drugs most commonly abused by the patients, followed by benzodiazepines (32.1%). More than two-thirds of the patients (n=38, 67.9%) required hospitalization, and three patients died (5.4%). In contrast, 110 patients with drug abuse-related accidents visited the ED at CMUH during the study period. Most of these subjects had abused benzodiazepines (69.1%), were between 21 and 40 years old, and were female. Fewer than one-fifth of the patients (n=19, 17.3%) required hospitalization, with no deaths reported. There were significant between-hospital differences in terms of patient gender, drugs of choice, injury mechanisms, method and time of the ED visit, triage levels, and need for hospitalization. Although the prevalence of drug abuse-related accidents was low, and only three patient deaths

  8. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  9. Diagnosis-based and external cause-based criteria to identify adverse drug reactions in hospital ICD-coded data: application to an Australia population-based study

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    Wei Du

    2017-04-01

    Full Text Available Objectives: External cause International Classification of Diseases (ICD codes are commonly used to ascertain adverse drug reactions (ADRs related to hospitalisation. We quantified ascertainment of ADR-related hospitalisation using external cause codes and additional ICD-based hospital diagnosis codes. Methods: We reviewed the scientific literature to identify different ICD-based criteria for ADR-related hospitalisations, developed algorithms to capture ADRs based on candidate hospital ICD-10 diagnoses and external cause codes (Y40–Y59, and incorporated previously published causality ratings estimating the probability that a specific diagnosis was ADR related. We applied the algorithms to the NSW Admitted Patient Data Collection records of 45 and Up Study participants (2011–2013. Results: Of 493 442 hospitalisations among 267 153 study participants during 2011–2013, 18.8% (n = 92 953 had hospital diagnosis codes that were potentially ADR related; 1.1% (n = 5305 had high/very high–probability ADR-related diagnosis codes (causality ratings: A1 and A2; and 2.0% (n = 10 039 had ADR-related external cause codes. Overall, 2.2% (n = 11 082 of cases were classified as including an ADR-based hospitalisation on either external cause codes or high/very high–probability ADR-related diagnosis codes. Hence, adding high/very high–probability ADR-related hospitalisation codes to standard external cause codes alone (Y40–Y59 increased the number of hospitalisations classified as having an ADR-related diagnosis by 10.4%. Only 6.7% of cases with high-probability ADR-related mental symptoms were captured by external cause codes. Conclusion: Selective use of high-probability ADR-related hospital diagnosis codes in addition to external cause codes yielded a modest increase in hospitalised ADR incidence, which is of potential clinical significance. Clinically validated combinations of diagnosis codes could potentially further enhance capture.

  10. Induced tolerance to nebulized colistin after severe reaction to the drug.

    Science.gov (United States)

    Domínguez-Ortega, J; Manteiga, E; Abad-Schilling, C; Juretzcke, M A; Sánchez-Rubio, J; Kindelan, C

    2007-01-01

    Daily nebulized colistin therapy has been used as maintenance therapy for patients with chronic Pseudomonas aeruginosa infection and in treatment protocols aimed at eradicating early P aeruginosa infection. Colistin-induced nephrotoxicity and mild neurotoxic effects have been described but hypersensitivity reactions are rare. However, bronchial constriction has been reported associated with the inhalation of the antibiotic. We report the case of a 63-year-old man who had been diagnosed with bronchiectasis and bronchopleural fistula and who developed severe bronchospasm when using nebulized colistin. A skin prick test (80 mg/mL) with colistin was performed and was negative. An intradermal test was not performed due to its possible irritant effect. As our patient suffered from a tobramycin-resistant P aeruginosa infection, we started a procedure to induce tolerance to 80 mg colistin (8 mg, 16 mg, 24 mg, 32 mg, 40 mg, 80 mg) nebulized in 30-minutes-intervals. No changes in forced expiratory volume in 1 second values were observed and the patient continues on treatment twice daily after the tolerance induction with no new episodes of bronchospasm. We report the first successful procedure to induce tolerance to colistin after escalating doses of inhaled colistin.

  11. Less travelled roads in clinical immunology and allergy: drug reactions and the environmental influence.

    Science.gov (United States)

    Selmi, Carlo; Crotti, Chiara; Meroni, Pier Luigi

    2013-08-01

    Allergy and clinical immunology are examples of areas of knowledge in which working hypotheses are dominant over mechanistic understanding. As such, sometimes scientific efforts follow major streams and overlook some epidemiologically prevalent conditions that thus become underestimated by the research community. For this reason, we welcome the present issue of Clinical Reviews in Allergy and Immunology that is dedicated to uncommon themes in clinical immunology and allergy. First, comprehensive discussions are provided for allergy phenomena of large potential impact in clinical practice such as reactions to cephalosporins or aspirin-induced asthma and in everyday life such as allergies to food additives or legumes. Further, the issue addresses other uncommon themes such as urticaria and angioedema, cercarial dermatitis, or late-onset inflammation to soft tissue fillers. Last, there will be discussion on transversal issues such as olfactory defects in autoimmunity, interleukin 1 beta pathway, and the search for new serological markers in chronic inflammation. As a result, we are convinced that this issue will be of help to clinicians involved in internal medicine as well as to allergists and clinical immunologists. More importantly, we are convinced that these discussions will be of interest also to basic scientists for the numerous translational implications.

  12. Clinical Manifestations of an Anti-Drug Antibody Response: Autoimmune Reactions.

    Science.gov (United States)

    Swanson, Steven J

    2014-12-01

    Antibodies can be generated against a therapeutic protein upon administration to human subjects. When the therapeutic protein closely mimics one of the subject's endogenous proteins, those antibodies might bind to the endogenous protein in addition to the therapeutic protein. This scenario results when tolerance to the endogenous protein is broken. The consequences of breaking tolerance include an autoimmune response where antibodies are generated against the endogenous protein. These autoantibodies could have significant clinical relevance depending on several factors, including the redundancy of action of the endogenous protein as well as the concentration, binding affinity, and neutralizing potential of the antibodies. The consequences of a therapeutic-protein-induced autoimmune reaction can be challenging to manage as the stimulus for further perpetuation of the immune response can shift from the therapeutic protein to the endogenous protein. The potential for inducing an autoimmune response is one of the reasons that the immune response to a therapeutic protein should be monitored if it persists through the end of the study.

  13. Formation of carbonato and hydroxo complexes in the reaction of platinum anticancer drugs with carbonate.

    Science.gov (United States)

    Di Pasqua, Anthony J; Centerwall, Corey R; Kerwood, Deborah J; Dabrowiak, James C

    2009-02-02

    The second-generation Pt(II) anticancer drug carboplatin is here shown to react with carbonate, which is present in blood, interstitial fluid, cytosol, and culture medium, to produce platinum-carbonato and -hydroxo complexes. Using [(1)H-(15)N] HSQC NMR and (15)N-labeled carboplatin, we observe that cis-[Pt(CBDCA-O)(OH)(NH(3))(2)](-), cis-[Pt(OH)(2)(NH(3))(2)], cis-[Pt(CO(3))(OH)(NH(3))(2)](-), and what may be cis-[Pt(CO(3))(NH(3))(2)] are produced when 1 is allowed to react in 23.8 mM carbonate buffer. When (15)N-labeled carboplatin is allowed to react in 0.5 M carbonate buffer, these platinum species, as well as other hydroxo and carbonato species, some of which may be dinuclear complexes, are produced. Furthermore, we show that the carbonato species cis-[Pt(CO(3))(OH)(NH(3))(2)](-) is also produced when cisplatin is allowed to react in carbonate buffer. The study outlines the conditions under which carboplatin and cisplatin form carbonato and aqua/hydroxo species in carbonate media.

  14. Spectrophotometric Determination of Rifampicin in Bulk Drug and Pharmaceutical Formulations Based on Redox and Complexation Reactions

    Science.gov (United States)

    Swamy, N.; Basavaiah, K.

    2017-09-01

    Two spectrophotometric methods were developed and validated for the determination of rifampicin (RIF) in bulk form, formulations, and spiked human urine. The first method is based on the reduction of the Folin-Ciocalteu (FC) reagent by RIF to form a blue colored chromogen with λmax at 760 nm (the FCR method). In the second method, iron(III) is reduced by RIF in a neutral medium, and the resulting iron(II) is complexed with ferricyanide to form a Prussian blue peaking at 750 nm (the FFC method). Under optimum conditions, Beer's law enabled the determination of the drug in the concentration ranges 1-35 and 2.5-50 μg/mL with apparent molar absorptivities of 2.72 × 104 and 1.63×104 L/(mol × cm) for the FCR and FFC methods, respectively. The Sandell sensitivity, limits of detection (LOD), and quantification (LOQ) values were also reported for both methods. The precision of the methods, with % RSD of human urine without interference from endogenous substances. A statistical analysis indicated that there was no significant difference between the results obtained by the developed methods and the official method.

  15. Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

    Science.gov (United States)

    Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo

    2017-10-01

    Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison.

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    Ann-Kathrin Oehme

    Full Text Available BACKGROUND: In recent years, efforts have been made to improve paediatric drug therapy. The aim of this research was to investigate any changes regarding the frequency and nature of adverse drug reactions (ADRs in hospitalized children in one paediatric general medical ward over a 9-year period. METHODOLOGY: Two prospective observational cohort studies were conducted at a large University hospital in Germany in 1999 and 2008, respectively. Children aged 0-18 years admitted to the study ward during the study periods were included. ADRs were identified using intensive chart review. Uni- and multivariable regression has been used for data analysis. RESULTS: A total of 520 patients (574 admissions were included [1999: n = 144 (167; 2008: n = 376 (407]. Patients received a total of 2053 drugs [median 3, interquartile range (IQR 2-5]. 19% of patients did not receive any medication. Median length of stay was 4 days (IQR 3-7; range 1-190 days with a significantly longer length of stay in 1999. The overall ADR incidence was 13.1% (95% CI, 9.8-16.3 varying significantly between the two study cohorts [1999: 21.9%, 95% CI, 14.7-29.0; 2008: 9.2%, 95% CI, 5.9-12.5 (p<0.001]. Antibacterials and corticosteroids for systemic use caused most of the ADRs in both cohorts (1999; 2008. Exposure to systemic antibacterials decreased from 62.9% to 43.5% whereas exposure to analgesics and anti-inflammatory drugs increased from 17.4% to 45.2%, respectively. The use of high risk drugs decreased from 75% to 62.2%. In 1999, 45.7% and in 2008 96.2% of ADRs were identified by treating clinicians (p<0.001. CONCLUSIONS: Between 1999 and 2008, the incidence of ADRs decreased significantly. Improved treatment strategies and an increased awareness of ADRs by physicians are most likely to be the cause for this positive development. Nevertheless further research on ADRs particularly in primary care and the establishment of prospective pharmacovigilance systems are still

  17. Interstitial lung disease caused by TS-1: a case of long-term drug retention as a fatal adverse reaction.

    Science.gov (United States)

    Park, Joong-Min; Hwang, In Gyu; Suh, Suk-Won; Chi, Kyong-Choun

    2011-12-01

    TS-1 is an oral anti-cancer agent for gastric cancer with a high response rate and low toxicity. We report a case of long-term drug retention of TS-1 causing interstitial lung disease (ILD) as a fatal adverse reaction. A 65-year-old woman underwent a total gastrectomy with pathologic confirmation of gastric adenocarcinoma. She received 6 cycles of TS-1 and low-dose cisplatin for post-operative adjuvant chemotherapy followed by single-agent maintenance therapy with TS-1. After 8 months, the patient complained of a productive cough with sputum and mild dyspnea. A pulmonary evaluation revealed diffuse ILD in the lung fields, bilaterally. In spite of discontinuing chemotherapy and the administration of corticosteroids, the pulmonary symptoms did not improve, and the patient died of pulmonary failure. TS-1-induced ILD can be caused by long-term drug retention that alters the lung parenchyma irreversibly, the outcome of which can be life-threatening. Pulmonary evaluation for early detection of disease is recommended.

  18. Associations of Religiousness with 12-Month Prevalence of Drug Use and Drug-Related Sex

    Science.gov (United States)

    Toussaint, Loren

    2009-01-01

    The purpose of the present study was to examine the hypothesis that religious affiliation, attendance at religious services, and religious importance would be negatively associated with substance use and sexual behavior related to substance use. An additional hypothesis was tested to determine if age-related differences in the magnitude of these…

  19. Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan

    Directory of Open Access Journals (Sweden)

    Zaka Un Nisa

    2018-05-01

    Full Text Available Adverse Drug Reactions (ADRs underreporting is a great challenge to pharmacovigilance. Healthcare professionals should consider ADR reporting as their professional obligation because the effective system of ADR reporting is important to improve patient care and safety. This study was designed to assess the knowledge, attitude, practice and factors associated with ADR reporting by healthcare professionals (physicians and pharmacists in secondary and tertiary hospitals of Islamabad. A pretested questionnaire comprising of 27 questions (knowledge 12, attitude 4, practice 9 and factors influencing ADR reporting 2 was administered to 384 physicians and pharmacists in public and private hospitals. Respondents were evaluated for their knowledge, attitude and practice related to ADR reporting. Additionally, the factors which encourage and discourage respondents to report ADRs were also determined. The data was analysed by using SPSS statistical software. Among 384 respondents, 367 provided responses to questionnaire, giving a response rate of 95.5%. The mean age was 28.3 (SD = 6.7. Most of the respondents indicated poor ADR reporting knowledge (83.1%. The majority of respondents (78.2% presented a positive attitude towards ADR reporting and only a few (12.3% hospitals have good ADR reporting practice. The seriousness of ADR, unusualness of reaction, new drug involvement and confidence in the diagnosis of ADR are the factors which encourage respondents to report ADR whereas lack of knowledge regarding where and how to report ADR, lack of access to ADR reporting form, managing patient is more important than reporting ADR legal liability issues were the major factors which discourage respondents to report ADR. The study reveals poor knowledge and practice regarding ADR reporting. However, most of the respondents have shown a positive attitude towards ADR reporting. There is a serious need for educational training as well as sincere and sustained

  20. Age-related patterns of drug use initiation among polydrug using regular psychostimulant users.

    Science.gov (United States)

    Darke, Shane; Kaye, Sharlene; Torok, Michelle

    2012-09-01

    To determine age-related patterns of drug use initiation, drug sequencing and treatment entry among regular psychostimulant users. Cross-sectional study of 269 regular psychostimulant users, administered a structured interview examining onset of use for major licit and illicit drugs. The mean age at first intoxication was not associated with age or gender. In contrast, younger age was associated with earlier ages of onset for all of the illicit drug classes. Each additional year of age was associated with a 4 month increase in onset age for methamphetamine, and 3 months for heroin. By the age of 17, those born prior to 1961 had, on average, used only tobacco and alcohol, whereas those born between 1986 and 1990 had used nine different drug classes. The period between initial use and the transition to regular use, however, was stable. Age was also negatively correlated with both age at initial injection and regular injecting. Onset sequences, however, remained stable. Consistent with the age-related patterns of drug use, each additional year of age associated with a 0.47 year increase in the age at first treatment. While the age at first intoxication appeared stable, the trajectory through illicit drug use was substantially truncated. The data indicate that, at least among those who progress to regular illicit drug use, younger users are likely to be exposed to far broader polydrug use in their teens than has previously been the case. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  1. A new look at lipid-membrane structure in relation to drug research

    DEFF Research Database (Denmark)

    Mouritsen, Ole G.; Jørgensen, Kent

    1998-01-01

    Lipid-bilayer membranes are key objects in drug research in relation to (i) interaction of drugs with membrane-bound receptors, (ii) drug targeting, penetration, and permeation of cell membranes, and (iii) use of liposomes in micro-encapsulation technologies for drug delivery. Rational design...... of new drugs and drug-delivery systems therefore requries insight into the physical properties of lipid-bilayer membranes. This mini-review provides a perspective on the current view of lipid-bilayer structure and dynamics based on information obtained from a variety of recent experimental...... and theoretical studies. Special attention is paid to trans-bilayer structure, lateral molecular organization of the lipid bilayer, lipid-mediated protein assembly, and lipid-bilayer permeability. It is argued that lipids play a major role in lipid membrane-organization and functionality....

  2. Alcohol and drugs in relation to sexual offending

    NARCIS (Netherlands)

    Kraanen, F.L.; Emmelkamp, P.M.G.; Sanders, T.

    2017-01-01

    There has been a significant increase in the focus on sex offending in recent years. This has occurred in both the academic and the public spheres. In attempting to understand sexual offending, this collection recognizes two different discourses that currently operate in relation to sex crime. At

  3. A STUDY ON ADVERSE DRUG REACTIONS INVOLVING CENTRAL NERVOUS SYSTEM, ITS SEVERITY AND CAUSALITY ASSESSMENT IN PEDIATRIC PATIENTS ADMITTED TO A TERTIARY CARE HOSPITAL

    Directory of Open Access Journals (Sweden)

    Arati

    2015-09-01

    Full Text Available A retrospective study was conducted in Department of pediatrics SCB Medical College and SVPPGIP for a period of 2 years i.e. September 2012 to August 2014 . All the patients from birth to 14 years admitted to the pediatric ward in this study were under ADR surveillance. Patients admitted to our hospital with adverse drug reaction o r patients developing adverse drug reaction in our hospital were studied; only those cases where the central nervous system was involved were taken in our study. The cases were compiled and the causality of offending drugs was found using WHO - UMC causality assessment score. The severity of drug reaction in every case was determined by using HARTWIG’s severity scoring scale. Total 350 Adverse reactions were reported in this period with prevalence rate of 2.04% i.e. 20 out of 1000 children faced ADR due to dr ugs, with annual incidence rate of 0.9% and 1.14% over two years. Out of total 350 cases dermatological system was most commonly involved i.e. 207 cases (59.14%. This is followed by involvement of central nervous system 46 number of cases (13.14%. The GI system was involved in 34 cases i.e. (9.71%. Life threatening reactions like anaphylaxis, angioedema and shock like immediate life threatening ADRs were reported in 16 cases. Our study group was the patient in whom the ADR involved the CNS. Out of 46 suc h cases, there were 25 female and 21 male. Various reaction due to drug were encephalopathy , eps, febrile seizure, tremor, head reeling, ototoxicity, persistant cry, pseudotumor cerebri, psychosis, seizure, status epilepticus, toxic amblyopia, tremor, atax ia etc. The most common CNS manifestation was Extra pyramidal side effects (EPS involving 21% of cases. The most common Drug causing CNS manifestation was ATT (HRZE causing blindness, Eps, psychosis , toxic amblyopia blindness etc.

  4. Trends in licit and illicit drug-related deaths in Florida from 2001 to 2012.

    Science.gov (United States)

    Lee, Dayong; Delcher, Chris; Maldonado-Molina, Mildred M; Bazydlo, Lindsay A L; Thogmartin, Jon R; Goldberger, Bruce A

    2014-12-01

    Florida, the epicenter of the recent prescription drug epidemic in the United States, maintains a statewide drug mortality surveillance system. We evaluated yearly profiles, demographic characteristics, and correlation between drug trends to understand the factors influencing drug-induced mortality. All drug-related deaths reported to the Florida Medical Examiners Commission during 2001-2012 were included (n=92,596). A death was considered "drug-related" if at least one drug was identified in the decedent. Depending on its contribution to death, a drug could be listed as a causative agent or merely present, but not both. Rate of drug-caused deaths was 8.0 per 100,000 population in 2001, increasing to 17.0 in 2010 and then decreasing to 13.9 in 2012. Benzodiazepines had the highest mortality rate in 2010, although drugs. Opioid-caused mortality rate also peaked in 2010 and started to decline (-28%) in 2010-2012. The heroin-caused mortality rates were negatively correlated with opioids and benzodiazepines (ρ's ≥ -0.670; P≤0.034). Ethanol- and cocaine-mortality rates stabilized to 3.0-3.1 and 2.8-3.0 per 100,000 over 2009-2012, respectively. Amphetamines, zolpidem, and inhalants-caused deaths were on the rise with rates of ≤0.6 per 100,000. Overall declines in benzodiazepine- and opioid-caused deaths in 2011-2012 may have been related to Florida's attempts to regulate prescription drug abuse. This period, however, was also marked by a rise in heroin-caused mortality, which may reflect growing use of heroin as an alternative. Increases in amphetamines, zolpidem, and inhalants-induced mortality are an additional public health concern. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Inappropriate prescribing and prescribing omissions among drug-related problems using STOPP-START criteria

    NARCIS (Netherlands)

    Verdoorn, M.A.; Kwint, H.-F.; Faber, A.; L. Bouvy, M.

    2013-01-01

    Background and objectives: Medication review has been suggested as a way to prevent drug related problems (DRPs). Screening tools have been formulated to identify potentially inappropriate medicines (PIMs) and potential prescribing omissions (PPOs) respectively called Screening Tool of Older

  6. Reaction time inconsistency in a spatial stroop task: age-related differences through childhood and adulthood.

    Science.gov (United States)

    Williams, Benjamin R; Strauss, Esther H; Hultsch, David F; Hunter, Michael A

    2007-07-01

    Age-related differences in inconsistency of reaction time (RT) across the life span were examined on a task with differing levels of demand on executive control. A total of 546 participants, aged 5 to 76 years, completed a spatial Stroop task that permitted observations under three conditions (congruent, incongruent, and neutral) according to the correspondence between the required response (based on stimulus direction) and stimulus location. An interference effect was observed across all ages. Analyses of neutral condition data replicated previous research demonstrating RT inconsistency follows a U-shaped developmental curve across the life span. The relationship between age and inconsistency, however, depended on condition: inconsistency in the congruent condition was higher than inconsistency in both the neutral and incongruent conditions across middle-aged groups. Reaction time inconsistency may reflect processing efficiency that is maximal in young adulthood and may also be sensitive to fluctuations in performance that reflect momentarily highly efficient responding.

  7. 3-12 Detection and Management of Adverse Drug React

    African Journals Online (AJOL)

    MINA SAN

    Detection and Management of Adverse Drug Reactions Related to Antiretroviral Drugs among. HIV/AIDS Patients in Kiambu ... of various adverse drug reactions associated with antiretroviral drugs occurring in patients attending Comprehensive Care .... educational level, perception of ADRs, knowledge of ADRs, detection ...

  8. Providing care to relatives with mental illness: reactions and distress among primary informal caregivers.

    Science.gov (United States)

    Chang, Sherilyn; Zhang, Yunjue; Jeyagurunathan, Anitha; Lau, Ying Wen; Sagayadevan, Vathsala; Chong, Siow Ann; Subramaniam, Mythily

    2016-03-25

    The responsibility of caring for relatives with mental illness often falls on the family members. It has been reported that the reactions to or consequences of providing care are what rendered the role of a caregiver challenging and hence a source of distress. This present study thus aimed to identify socio-demographic correlates of caregiving experiences using the Caregiver Reaction Assessment (CRA) and to examine the associations between reactions to caregiving and psychological distress. A total of 350 caregivers with relatives seeking outpatient care at a tertiary psychiatric hospital were recruited for this study. Distress among caregivers was assessed using the Patient Health Questionnaire (PHQ-9). The CRA was administered to measure reactions from caregiving in four domains including impact on schedule and health (ISH), impact on finance (IF), lack of family support (LFS) and caregiver esteem (CE). Participants also completed a questionnaire that asked for their socio-demographic information. Multivariable linear regression analysis was first used with domains of CRA as outcome variables and socio-demographic variables as predictors in the models. The next set of multivariable linear regression analysis tested for the association between CRA domains and distress with CRA domain scores as outcome variables and PHQ-9 score as predictor, controlling for socio-demographic variables. Socio-demographic correlates of CRA domains identified were age, education, employment, income and ethnicity. Domain scores of CRA were significantly associated with PHQ-9 score even after controlling for socio-demographic variables. A higher distress score was associated with greater impact felt in the domain of ISH (β = 0.080, P social care support in these domains may help to address caregiver distress.

  9. A reaction-diffusion model for market fluctuations - A relation between price change and traded volumes

    Science.gov (United States)

    Yuvan, Steven; Bier, Martin

    2018-02-01

    Two decades ago Bak et al. (1997) [3] proposed a reaction-diffusion model to describe market fluctuations. In the model buyers and sellers diffuse from opposite ends of a 1D interval that represents a price range. Trades occur when buyers and sellers meet. We show analytically and numerically that the model well reproduces the square-root relation between traded volumes and price changes that is observed in real-life markets. The result is remarkable as this relation has commonly been explained in terms of more elaborate trader strategies. We furthermore explain why the square-root relation is robust under model modifications and we show how real-life bond market data exhibit the square-root relation.

  10. Labelled drug-related public expenditure in relation to gross domestic product (GDP) in Europe: a luxury good?

    LENUS (Irish Health Repository)

    Prieto, Luis

    2010-01-01

    "Labelled drug-related public expenditure" is the direct expenditure explicitly labelled as related to illicit drugs by the general government of the state. As part of the reporting exercise corresponding to 2005, the European Monitoring Centre for Drugs and Drug Addiction\\'s network of national focal points set up in the 27 European Union (EU) Member States, Norway, and the candidates countries to the EU, were requested to identify labelled drug-related public expenditure, at the country level. This was reported by 10 countries categorised according to the functions of government, amounting to a total of EUR 2.17 billion. Overall, the highest proportion of this total came within the government functions of Health (66%), and Public Order and Safety (POS) (20%). By country, the average share of GDP was 0.023% for Health, and 0.013% for POS. However, these shares varied considerably across countries, ranging from 0.00033% in Slovakia, up to 0.053% of GDP in Ireland in the case of Health, and from 0.003% in Portugal, to 0.02% in the UK, in the case of POS; almost a 161-fold difference between the highest and the lowest countries for Health, and a 6-fold difference for POS. Why do Ireland and the UK spend so much in Health and POS, or Slovakia and Portugal so little, in GDP terms? To respond to this question and to make a comprehensive assessment of drug-related public expenditure across countries, this study compared Health and POS spending and GDP in the 10 reporting countries. Results found suggest GDP to be a major determinant of the Health and POS drug-related public expenditures of a country. Labelled drug-related public expenditure showed a positive association with the GDP across the countries considered: r = 0.81 in the case of Health, and r = 0.91 for POS. The percentage change in Health and POS expenditures due to a one percent increase in GDP (the income elasticity of demand) was estimated to be 1.78% and 1.23% respectively. Being highly income elastic

  11. Study of deaths related to drug abuse in France and Europe.

    Science.gov (United States)

    Ingold, F R

    1986-01-01

    A study of deaths related to drug abuse, based on information available in France and Europe, shows that data on such deaths are divergent and difficult to compare between countries because the definition of "death related to drug abuse" may vary from country to country. For this reason, the author attaches little importance to the use of such data as an indirect indicator for assessing the incidence and prevalence of drug abuse. The author carried out an in-depth study of 99 deaths of this type recorded by the police in the Paris area in 1983, which showed that 80 per cent of the cases involved heroin that had been injected intravenously. An analysis of the biographical background of persons who had died as a result of drug abuse revealed that, in addition to severe drug intoxication, the length of drug abuse and psychopathological disorders, a number of so-called "risk situations" were important factors contributing to their deaths. The risk situations included use of heroin for a long period of time, recent discontinuation of heroin use, regular and intensive use of psychotropic substances and alcohol, and injection of drugs in public places where there was no way of testing the drugs beforehand.

  12. Drug-drug Interactions of Statins Potentially Leading to Muscle-Related Side Effects in Hospitalized Patients.

    Science.gov (United States)

    Bucsa, Camelia; Farcas, Andreea; Leucuta, D; Mogosan, Cristina; Bojita, M; Dumitrascu, D L

    2015-01-01

    The associations of drugs that may interact with the statins resulting in elevated serum concentration of the statins are an important risk factor for statin induced muscle disorders. We aimed to determine the prevalence of these associations in all hospitalized patients that had been prescribed statins before/during hospitalization and to find out how often they are associated with muscle-related side effects. This prospective, non-interventional study performed in two internal medicine departments included patients with statin therapy before/during hospitalization. Data on each patient demographic characteristics, co-morbidities and treatment was collected from medical charts and interviews. We evaluated patients' therapy for the targeted associations using Thomson Micromedex Drug Interactions checker and we ranked the identified drug-drug interactions (DDIs) accordingly. Each patient with statin treatment before admission was additionally interviewed in order to identify muscular symptoms. In 109 patients on statin treatment we found 35 potential (p) DDIs of statins in 30 (27.5%) patients, most of which were in the therapy before admission (27 pDDIs). The pDDIs were moderate (20 pDDIs) and major (15 pDDIs). Of the total number of pDDIs, 24 were targeting the muscular system. The drugs most frequently involved in the statins' pDDIs were amiodarone and fenofibrate. Two of the patients with pDDIs reported muscle pain, both having additional risk factors for statin induced muscular effects. The prevalence of statins' pDDIs was high in our study, mostly in the therapy before admission, with only a small number of pDDIs resulting in clinical outcome.

  13. Iron based superconductors and related compounds synthesized by solid state metathesis and high temperature reactions

    International Nuclear Information System (INIS)

    Frankovsky, Rainer

    2013-01-01

    The results of this thesis can be divided into three major topics, which can also be seen as different approaches of solid state chemistry to reveal interesting features of known and unknown compounds and to develop alternative synthesis routes. Firstly, known compounds with related structural motifs to the superconducting iron-arsenides were investigated regarding their structural and physical properties. In case of La 3 Pd 4 Ge 4 the influence of Fe doping on the properties was studied, whereas in the series ZrMAs (M=Ti,V) the physical properties have not yet been reported at all and were investigated for the first time. Secondly, an alternative synthesis route has been developed for the synthesis of superconducting LaFeAsO 1-x F x . This solid state metathesis reaction distinctly increased the quality of the samples compared to conventionally prepared products. Furthermore, the reaction pathway was investigated and clarified, which helps to understand the processes during high temperature solid state metathesis reactions in general. Thirdly, this alternative synthesis route was expanded to other systems and new compounds like co-substituted LaFe 1-x Mn x AsO 1-y F y were prepared and thoroughly investigated. This led to a complex study of the interplay of magnetism, electronic and structural conditions and the occurrence of superconducting properties. The investigation and understanding of such complex coherences will probably be decisive for the further understanding of the superconducting mechanism in iron based superconductors.

  14. Becoming the denigrated other: Group relations perspectives on initial reactions to a bipolar disorder diagnosis

    Directory of Open Access Journals (Sweden)

    Susan G. Goldberg

    2012-09-01

    Full Text Available The initial reactions to a bipolar disorder diagnosis of research participants in a small, qualitative study consisted of astonishment, dread of being mad, and extremely negative associations. All had prior mental health diagnoses, including episodes of severe depression (all but one and alcoholism (one. All participants reported mental health histories prediagnosis and most had spent years contending with mental health labels, medications, symptoms, and hospitalizations. In addition, most participants were highly educated health professionals, quite familiar with the behaviors that the medical system considered to comprise bipolar disorder. Their negative associations to the initial bipolar disorder diagnosis, therefore, appeared inconsistent with their mental health histories and professional knowledge. This article contextualizes these initial reactions of shock and distress and proposes interpretations of these findings from societal and psychodynamic group relations perspectives. The participants’ initial negative reactions are conceptualized as involving the terror of being transported from the group of normal people into the group of mad or crazy people, i.e., people with mental illnesses, who may constitute a societal denigrated other.

  15. Consumer attitudes and factors related to prescription switching decisions in multitier copayment drug benefit plans.

    Science.gov (United States)

    Ganther-Urmie, Julie M; Nair, Kavita V; Valuck, Robert; McCollum, Marianne; Lewis, Sonya J; Turpin, Robin S

    2004-03-01

    To examine patient attitudes related to formulary medications and medication-related decision making in multitier copayment prescription drug plans. A cross-sectional retrospective analysis. Data were collected via mail survey from a random sample of 25,008 members of a managed care organization. The selected members were enrolled in a variety of 2- and 3-tier copayment plans and were taking prescription medication to treat 1 or more of 5 chronic disease states. Most respondents did not believe that formulary drugs were safer or more effective than nonformulary drugs, but 39.7% thought that formulary drugs were relatively less expensive. Most respondents appeared willing to consider switching from a nonformulary drug to a formulary drug with a lower copayment. The percent of respondents who reported they would be very unlikely or unlikely to switch was only 15.3% for a new prescription and 24.2% for a refill prescription. Medication efficacy and physician opinion were important factors in plan members' switching decisions. Cost was an important factor for some members, but older plan members were less likely to report that cost was important. Multitier plan members generally believed that drugs are placed on the formulary for reasons of cost rather than safety or efficacy. Most plan members were receptive to switching from a nonformulary to a formulary medication, but financial incentives alone may not convince some plan members to make the switch.

  16. Low body weight and type of protease inhibitor predict discontinuation and treatment-limiting adverse drug reactions among HIV-infected patients starting a protease inhibitor regimen: consistent results from a randomized trial and an observational cohort

    DEFF Research Database (Denmark)

    Kirk, O; Gerstoft, J; Pedersen, C

    2001-01-01

    OBJECTIVES: To assess predictors for discontinuation and treatment-limiting adverse drug reactions (TLADR) among patients starting their first protease inhibitor (PI). METHODS: Data on patients starting a PI regimen (indinavir, ritonavir, ritonavir/saquinavir and saquinavir hard gel) in a randomi......OBJECTIVES: To assess predictors for discontinuation and treatment-limiting adverse drug reactions (TLADR) among patients starting their first protease inhibitor (PI). METHODS: Data on patients starting a PI regimen (indinavir, ritonavir, ritonavir/saquinavir and saquinavir hard gel....... Low body weight and initiation of ritonavir relative to other PIs were associated with an increased risk of TLADRs. Very consistent results were found in a randomized trial and an observational cohort....

  17. Literature Analysis of Adverse Drug Reactions Induced by Bupivacaine Injection%布比卡因注射液致不良反应文献分析

    Institute of Scientific and Technical Information of China (English)

    黄迪; 陈勇; 窦元元

    2014-01-01

    目的:分析布比卡因注射液致药品不良反应的特点和规律,为临床合理用药提供参考。方法:以“布比卡因”、“不良反应”等关键词检索中国期刊全文数据库、维普资讯网和万方数据库文献,共检索2000~2013年布比卡因注射液致不良反应病例56例,对报告进行统计与分析。结果:布比卡因注射液所致不良反应可发生于各个年龄段,多在用药10 min内发生。其不良反应可累及多个系统和器官,主要表现为心血管系统损害、中枢神经系统、呼吸系统和全身性损害等。结论:布比卡因注射液所致不良反应多在短时间内发生,应加强临床用药监测,防范不良反应的发生。目前,国内说明书存在不良反应信息提示不足的情况,建议相关部门对说明书进行修改和完善。%Objective:To analyze the characteristics and regularity of adverse drug reactions ( ADRs) induced by bupivacaine injec-tion and provide basis for clinical rational drug use.Methods: With "Bupivacaine","adverse drug reaction"as keywords, retrieved literatures from CNKI,CQVIP and Wanfang database in 2000 to 2013,232 cases of ADR by bupivacaine injection were statistically ana-lyzed.Results:The ADRs induced by bupivacaine injection could occur at all ages with a higher incidence of within 10 minutes after administration.ADR involved multiple systems and organs.The main clinical manifestation represented as cardiovascular system (28.10%),central nervous system(26.64%), respiratory system(14.60%) and systemic damage(11.31%),there may be serious death.Conclusion:ADR induced by bupivacaine injection occured mostly in a short period of time.The clinical application should be monitored closely to prevent the occurrence of adverse reactions.The domestic drug package inserts are lack of warnings for ADR infor-mation.It is suggested that related administration departments should revise and improve the drug package

  18. Iodinated Contrast Media and the Alleged "Iodine Allergy": An Inexact Diagnosis Leading to Inferior Radiologic Management and Adverse Drug Reactions.

    Science.gov (United States)

    Böhm, Ingrid; Nairz, Knud; Morelli, John N; Keller, Patricia Silva Hasembank; Heverhagen, Johannes T

    2017-04-01

    Purpose  To test the hypothesis that the incomplete diagnosis "iodine allergy" is a possibly dangerous concept for patients under routine radiologic conditions. Materials and Methods  300 patients with a history of an "iodine allergy" were retrospectively screened and compared with two age-, sex-, and procedure-matched groups of patients either diagnosed with a nonspecific "iodine contrast medium (ICM) allergy" or an allergy to a specific ICM agent. For all groups, the clinical symptoms of the most recent past adverse drug reaction (ADR), prophylactic actions taken for subsequent imaging, and ultimate outcome were recorded and analyzed. Results  The diagnosis "iodine allergy" was not otherwise specified in 84.3 % patients. For this group, in most cases, the symptoms of the previous ADRs were not documented. In contrast, the type of ADR was undocumented in only a minority of patients in the comparison groups. In the group of patients with an "iodine allergy" the percentage of unenhanced CT scans was greater than within the other two groups (36.7 % vs. 28.7 %/18.6 %). ADRs following prophylactic measures were only observed in the "iodine allergy" group (OR of 9.24 95 % CI 1.16 - 73.45; p contrast media containing covalently bound iodine.. · There is a clear correlation between the exactness of the diagnosis - from the alleged "iodine allergy" to "contrast media allergy" to naming the exact culprit CM - and the quality of documentation of the symptoms.. · Management of patients diagnosed with "iodine allergy" was associated with uncertainty leading to unenhanced scans and sometimes unnecessary prophylactic actions.. · The term "iodine allergy" should be omitted, because it is potentially dangerous and can decrease the quality of radiology exams.. Citation Format · Böhm Ingrid, Nairz Knud, Morelli John N et al. Iodinated Contrast Media and the Alleged "Iodine Allergy": An Inexact Diagnosis Leading to Inferior Radiologic Management and

  19. Reaction of the residents to nuclear related policies: in a risk perception perspective

    International Nuclear Information System (INIS)

    Cho, S. K.

    2001-01-01

    In general, most of the nuclear related policies are discussed at governmental level. Siting nuclear related facilities policies is the state as this. The government, as the single decision-maker, tends to decide all procedures from policy drafting, decision making to implementation. That is to say, the government has been opting for DAD(Decide-Announce-Defend) measure. This resulted in many forms of discord because the government overlooked the importance of sufficient communication with resident or the public. However, the precondition for promoting nuclear related policies is public acceptance. Meanwhile, the public including resident fully understand the necessity of nuclear facilities but do not agree with the idea of having them in their residential area. Therefore, the research focuses on identifying the affecting factors toward reaction of the resident derived from previous studies. It also aims to lay the foundation for devising effective communication strategies between the government and the public. The result of case study, it was found that these factors-trust, participation and compensative-have interacted to affect resident's reaction. Ultimately, the government must recognize the residents as decision-maker so as to gain the PA(Public Acceptance). It also necessary to create better decision making processes by substantial participation, reasonable compensation and trust are essential first steps toward improving the situation

  20. Risk Evaluation of Endoscopic Retrograde Cholangiopancreatography-Related Contrast Media Allergic-Like Reaction: A Single Centre Experience

    Directory of Open Access Journals (Sweden)

    Félix Trottier-Tellier

    2018-01-01

    Full Text Available Background and Aims. Few cases of endoscopic retrograde cholangiopancreatography- (ERCP- related contrast media (CM adverse reactions have been reported in the current literature. There is a lack of standardisation in practice regarding premedication prophylaxis for at-risk patients undergoing ERCP and there are few data to guide the practitioners. Our goal is to evaluate the risk of CM adverse reaction in a group of patients with a past history of allergic-like reaction to iodine product undergoing ERCP. Methods. A retrospective chart review study was performed of patients who underwent ERCP at our single centre from January 2010 to December 2015. Results. 2295 ERCPs were performed among 1766 patients. No anaphylactoid or severe adverse reaction occurred. One (0.04% ERCP-related CM benign reaction was reported in a patient known for penicillin allergy. Among 127 ERCPs performed on patients with a prior adverse reaction to iodine, 121 procedures were done without and 6 with a premedication prophylaxis. In both groups, no ERCP-related CM reaction occurred. Conclusions. To our knowledge, we report the largest cohort of iodine allergic patients undergoing ERCP ever published. These results suggest that ERCP-related CM adverse reactions are very rare even among patients at risk for CM reaction.

  1. Work-related post-traumatic stress reactions: the hidden dimension.

    Science.gov (United States)

    Lawson, B Z

    1987-01-01

    A variety of occupational health hazards can cause employees to experience feelings of victimization and to develop work-related post-traumatic stress responses. The author presents assessment guidelines developed in work with people suffering from toxic exposures to help identify factors that can place employees at high risk for such stress responses. These guidelines can be adapted to evaluate employee reactions to any type of occupational injury. Clinicians also need to move beyond individual treatment approaches to address workplace and policy interventions.

  2. The direct oxidative diene cyclization and related reactions in natural product synthesis

    Directory of Open Access Journals (Sweden)

    Juliane Adrian

    2016-09-01

    Full Text Available The direct oxidative cyclization of 1,5-dienes is a valuable synthetic method for the (diastereoselective preparation of substituted tetrahydrofurans. Closely related reactions start from 5,6-dihydroxy or 5-hydroxyalkenes to generate similar products in a mechanistically analogous manner. After a brief overview on the history of this group of transformations and a survey on mechanistic and stereochemical aspects, this review article provides a summary on applications in natural product synthesis. Moreover, current limitations and future directions in this area of chemistry are discussed.

  3. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    B Akshaya Srikanth

    2012-01-01

    Full Text Available To estimate the incidence of adverse drug reactions (ADRs in Human immune deficiency virus (HIV patients on highly active antiretroviral therapy (HAART. To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%. The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52% was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm 3 with comorbid conditions.

  4. The timing of drug funding announcements relative to elections: a case study involving dementia medications.

    Directory of Open Access Journals (Sweden)

    Sudeep S Gill

    Full Text Available Following initial regulatory approval of prescription drugs, many factors may influence insurers and health systems when they decide whether to add these drugs to their formularies. The role of political pressures on drug funding announcements has received relatively little attention, and elections represent an especially powerful form of political pressure. We examined the temporal relationship between decisions to add one class of drugs to publicly funded formularies in Canada's ten provinces and elections in these jurisdictions.Dates of provincial formulary listings for cholinesterase inhibitors, which are drugs used to treat Alzheimer's disease and related dementias, were compared to the dates of provincial elections. Medical journal articles, media reports, and proceedings from provincial legislatures were reviewed to assemble information on the chronology of events. We tested whether there was a statistically significant increase in the probability of drug funding announcements within the 60-day intervals preceding provincial elections.Decisions to fund the cholinesterase inhibitors were made over a nine-year span from 1999 to 2007 in the ten provinces. In four of ten provinces, the drugs were added to formularies in a time period closely preceding a provincial election (P = 0.032; funding announcements in these provinces were made between 2 and 47 days prior to elections. Statements made in provincial legislatures highlight the key role of political pressures in these funding announcements.Impending elections appeared to affect the timing of drug funding announcements in this case study. Despite an established structure for evidence-based decision-making, drug funding remains a complex process open to influence from many sources. Awareness of such influences is critical to maintain effective drug policy and public health decision-making.

  5. The timing of drug funding announcements relative to elections: a case study involving dementia medications.

    Science.gov (United States)

    Gill, Sudeep S; Gupta, Neeraj; Bell, Chaim M; Rochon, Paula A; Austin, Peter C; Laupacis, Andreas

    2013-01-01

    Following initial regulatory approval of prescription drugs, many factors may influence insurers and health systems when they decide whether to add these drugs to their formularies. The role of political pressures on drug funding announcements has received relatively little attention, and elections represent an especially powerful form of political pressure. We examined the temporal relationship between decisions to add one class of drugs to publicly funded formularies in Canada's ten provinces and elections in these jurisdictions. Dates of provincial formulary listings for cholinesterase inhibitors, which are drugs used to treat Alzheimer's disease and related dementias, were compared to the dates of provincial elections. Medical journal articles, media reports, and proceedings from provincial legislatures were reviewed to assemble information on the chronology of events. We tested whether there was a statistically significant increase in the probability of drug funding announcements within the 60-day intervals preceding provincial elections. Decisions to fund the cholinesterase inhibitors were made over a nine-year span from 1999 to 2007 in the ten provinces. In four of ten provinces, the drugs were added to formularies in a time period closely preceding a provincial election (P = 0.032); funding announcements in these provinces were made between 2 and 47 days prior to elections. Statements made in provincial legislatures highlight the key role of political pressures in these funding announcements. Impending elections appeared to affect the timing of drug funding announcements in this case study. Despite an established structure for evidence-based decision-making, drug funding remains a complex process open to influence from many sources. Awareness of such influences is critical to maintain effective drug policy and public health decision-making.

  6. Association between lithium serum level, mood state, and patient-reported adverse drug reactions during long-term lithium treatment : a naturalistic follow-up study

    NARCIS (Netherlands)

    Wilting, Ingeborg; Heerdink, Eibert R.; Mersch, Peter-Paul A.; den Boer, Johannes A.; Egberts, Antoine C. G.; Nolen, Willem A.

    To assess the association between mood state and the prevalence and the severity of lithium adverse drug reactions (ADRs). A 26-year follow-up study was conducted among patients >= 18 years treated at the outpatient lithium clinic of the University Medical Center Groningen, The Netherlands, between

  7. 49 CFR 40.13 - How do DOT drug and alcohol tests relate to non-DOT tests?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false How do DOT drug and alcohol tests relate to non... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibil