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Sample records for adrs adverse drug

  1. 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.

  2. Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases.

    Science.gov (United States)

    Conforti, Anita; Chiamulera, Christian; Moretti, Ugo; Colcera, Sonia; Fumagalli, Guido; Leone, Roberto

    2007-01-01

    The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in other cases may be serious and life-threatening, such as rhabdomyolysis. In the last few years there has been an increasing awareness of musculoskeletal ADRs. Some recent drug safety issues dealt with serious or uncommon musculoskeletal reactions like rhabdomyolysis associated to statins and tendon rupture associated to fluoroquinolones. In this review, we firstly selected those drug classes having a significantly high percentage of musculoskeletal disorder reports in the WHO adverse drug reaction database, maintained by the Uppsala Monitoring Centre. Secondly, the different musculoskeletal ADRs were closely analyzed through the data obtained from an Italian interregional ADRs spontaneous reporting database. The findings on drugs associated to different musculoskeletal disorders, have been integrated with a review of the epidemiological data available in the literature. For the most involved drugs (HMG-CoA reductase inhibitors, fluoroquinolones, corticosteroids, bisphosphonates, retinoids) the underlying musculoskeletal ADR mechanisms were also reviewed and discussed. PMID:18690950

  3. Development of a combined system for identification and classification of adverse drug reactions: Alerts Based on ADR Causality and Severity (ABACUS).

    Science.gov (United States)

    Koh, Yvonne; Yap, Chun Wei; Li, Shu-Chuen

    2010-01-01

    Currently, adverse drug reaction (ADR) causality and severity are assessed using different systems but there is no standard method to combine the results. In this work, a combined ADR causality and severity assessment system, including an online version, was developed. Logical rules were defined to translate the score obtained from the system into three alert zones: green, amber, and red. The alert zones are useful for triaging ADR cases as they help define the seriousness of the ADR and the urgency of the responses required. This new scoring system may be useful for clinicians, investigators, and regulators seeking information on the likelihood of a drug causing an adverse reaction, and whether an adverse reaction is sufficiently dangerous for the drug to be withheld or undergo further investigation.

  4. Data mining in pharmacovigilance – to reduce Adverse Drug Effects(ADRs

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    Miral Kothari

    2013-01-01

    Full Text Available Pharmaceutical industry provides the medicines in different formats. It can be tablets, capsules, liquid or injectables. Every drug in any form may cause adverse effect varies from person to person. Before putting any drug in the market, the drugs are being tested for adverse effects on large scale. Pharacovigilance is a science which is purely related with discovery, understanding and anticipation of the Adverse Drug Effect (ADEs. Pharmaceutical experts and industries much rely on data mining algorithms or techniques to understand the huge data collected from healthcare professionals and patients and make the use of that data for further research and development of new drug. In this paper, author has tried to implement Bayesian Classification method of data mining to assist the research person in decision making

  5. Educational intervention to improve physician reporting of adverse drug reactions (ADRs in a primary care setting in complementary and alternative medicine

    Directory of Open Access Journals (Sweden)

    Ostermann Thomas

    2009-07-01

    Full Text Available Abstract Background Recent studies have shown that adverse drug reactions (ADRs are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM. Data on CAM-related ADRs, however, are sparse. Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. Methods A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results. To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI. We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P Results A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001 in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P P Conclusion The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their

  6. 171例严重药品不良反应报告分析%ADR Report Analysis of 171 Cases of Serious Adverse Drug Reactions

    Institute of Scientific and Technical Information of China (English)

    文加勇; 张万智; 唐晓霞

    2015-01-01

    目的:了解严重药品不良反应(ADR)的发生特点,为ADR监测工作提供参考。方法:提取国家ADR监测系统中2011-2013年孝感市上报的ADR严重病例报告171份,对报告来源、患者性别、药品种类、给药途径、ADR累及器官/系统等进行分析。结果:严重ADR报告率与年龄因素和性别因素有关,且儿童和老年人高于中青年人(P <0.05),女性高于男性(男女之比为1∶1.44, P <0.05);171份严重 ADR 报告中,抗感染药(78,45.62%)、维生素、营养药、调节水电解质和酸碱平衡药(37,21.64%)和中药注射剂(15,8.77%)位居前三;静脉滴注给药125例(73.09%),口服给药26例(15.20%);过敏性反应82例(47.95%),皮肤及附件损害36例(21.05%)。结论:2011-2013年孝感市严重ADR高发于女性、儿童和老年人用药、抗感染药物和静脉滴注给药,在ADR监测中应引起注意。%ABSTRACTObjective:To investigate the characteristics of serious adverse drug reactions(ADRs)so as to pro-vide a reference for ADR monitoring.Methods:The reports of 171 cases of severe ADRs submitted by Xiaogan city from 2011 to 2013 were extracted from the National Adverse Drug Reaction Monitoring System. The data was analyzed such as the source of report, patient sex, drug species, route of administration and ADR involving or-gans/systems.Results:The serious ADR reporting rate was associated with age and gender factors, serious ADRs in children and the elderly were higher than young and middle-aged people(P<0.05)and higher in women than in men(the ratio of male to female was 1∶1.44,P<0.05). In 171 cases of severe ADRs, 78 cases(45.62%) ever used anti-infective drugs, 37 cases(21.64%)used Vitamins, nutritional supplements and the drugs of regulat-ing water-electrolyte and acid-base balance, and 15 cases(8.77%)were given traditional Chinese medicine injec-tions. About 125 cases(73.09%)received intravenous

  7. Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs in selected hospitals in Nigeria

    Directory of Open Access Journals (Sweden)

    Kenneth Anene Agu

    2012-01-01

    Full Text Available Purpose: The study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following routine patient counseling and education in selected hospitals in Nigeria. Materials and Methods: From 36,459 HIV-infected patients on ART in the 36 selected hospitals, a study-specific instrument was administered to 3,650 patients in a cross-sectional study. Patients were provided counseling and education on ADRs before and after commencing ART. Factor analysis was performed using principal components extraction. Item score means above midpoint (3.7 on a 5-point scale were regarded as positive attitudes and below as negative attitudes. A chi-square test was used for inferential statistics; P3.7 which denotes positive attitudes to ADRs. Three extracted factors accounted for 73.1% of cumulative variability. All attitude items had very significant loadings of ≥0.5. Conclusion: Overall, participants reported good knowledge and positive attitudes to adverse effects of their medicines compared to what was reported previously. The patient counseling and education on drug therapy provided to patients may have contributed to these findings and are highly recommended.

  8. Gynecomastia: An ADR due to drug interaction

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    Aiman Umme

    2009-01-01

    Full Text Available Gynecomastia results from conditions that cause an imbalance of estrogenic and androgenic effects on the breast, resulting in an increased or unopposed estrogen action on breast tissue. Approximately 4 to 10% cases of gynecomastia are due to drugs. Both Digoxin and Furosemide are also reported to cause the same condition. Although, chances of gynecomastia could be more if these two drugs are coadministered, but no case report of this adverse effect is ever reported when both are prescribed concurrently. Here we report a case of gynecomastia suspected to have resulted from the coadministation of both the drugs. Probability of the adverse effect due to drug interaction was evaluated by DIPS, which suggests that the adverse drug reaction (ADR due to DI is "Possible."

  9. 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...

  10. 7690例药品不良反应报告中ADR性别差异的回顾性分析%Retrospective analysis of gender differences in ADR of 7 690 cases of reported adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    孙言才; 刘琳琳; 史天陆; 王崇薇; 张蕾; 苏丹; 姜玲

    2015-01-01

    Objective To understand certain basic characteristics of the presented gender factors during the occurrence of adverse drug reactions (ADR)in patients for the implementation of drug safety monitoring,and to provide a reference for clinical therapy. Methods National Adverse Drug Reaction Monitoring Center database of a hospital from January 2005 to December 2010 which reported 7 690 cases of ADR was collected. A retrospective analysis was performed on the 7 690 cases of ADR reports,and gender factors were analyzed and eval-uated in correlation with other indicators such as patient age,drug class,anterior drugs,drug dosage form,route of administration,involving system/ organ. Results In 7 690 cases of ADR reports,4,052 cases were male,accounting for 52. 69%,3,638 cases were female,ac-counting for 47. 31%,and the male to female ratio was 1. 11 ∶ 1. 4 years from 2007 to 2010 the proportion of males was higher than that of fe-males,and 2 years from 2005 to 2006,male lower than female. In people aged 0 to 20,over the age of 50 years,the number of ADR cases was more in male than in female,and in people aged 21 to 50,the number of ADR cases was more in female than in male. The number of ADR cases caused by drugs affecting the blood and blood-forming system,traditional Chinese medicine,vitamins,etc. ,was more in male than in female,and the number of ADR cases caused by drugs affecting allergy and immune function,cardiovascular system drugs,respirato-ry system drugs,etc. was more in female than in male. ADR cases caused by seven kinds of drugs such as oxaliplatin for injection,fluoroura-cil injection,dexamethasone sodium phosphate injection were more male than female. ADR cases caused by levofloxacin hydrochloride injec-tion,levofloxacin lactate and sodium chloride injection,injection of ceftriaxone sodium were more female than male. ADR cases caused by six kinds of formulations like application suspensions,oral solutions,powder,etc. appeared more in male than in female

  11. 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.

  12. Monitoring Adverse Drug Reactions: A Preliminary Study

    OpenAIRE

    Reynolds, J. L.

    1981-01-01

    The feasibility of family physicians functioning as monitors of adverse drug reactions (ADR) was examined over one month in ten practices. This was done as a preliminary trial, before attempting to use the 200 family physicians of the National Reporting System of the College of Family Physicians of Canada to monitor ADRs on a national basis. Both of these trials were designed to examine the feasibility of family physicians acting as prospective monitors of ADRs in newly marketed drugs and to ...

  13. 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....... These results indicate that the occurrence of ADRs in the European hospital setting-both ADRs that result in hospitalization and ADRs that occur during the hospital stay-is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information...

  14. Usefulness of drug provocation tests in children with a history of adverse drug reaction

    OpenAIRE

    Hye Ran Na; Jeong Min Lee; Jo Won Jung; Soo-Young Lee

    2011-01-01

    Purpose : There are very few reports of adverse drug reactions (ADR) and almost no study of drug provocation test (DPT) in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods : We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009). With various ...

  15. 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.

  16. Adverse reactions to new anticonvulsant drugs.

    Science.gov (United States)

    Wong, I C; Lhatoo, S D

    2000-07-01

    A lack of systematic pharmacoepidemiological studies investigating adverse drug reactions (ADRs) to anticonvulsants makes it difficult to assess accurately the incidence of anticonvulsant-related ADRs. Most of the available information in this regard stems from clinical trial experience, case reports and postmarketing surveillance, sources that are not, by any means, structured to provide precise data on adverse event epidemiology. For various ethical, statistical and logistical reasons, the organisation of structured clinical trials that are likely to provide substantial data on ADRs is extremely difficult. This review concentrates on current literature concerning serious and life-threatening ADRs. As with the older anticonvulsants, the majority of ADRs to newer anticonvulsants are CNS-related, although there are several that are apparently unique to some of these new drugs. Gabapentin has been reported to cause aggravation of seizures, movement disorders and psychiatric disturbances. Felbamate should only be prescribed under close medical supervision because of aplastic anaemia and hepatotoxicity. Lamotrigine causes hypersensitivity reactions that range from simple morbilliform rashes to multi-organ failure. Psychiatric ADRs and deterioration of seizure control have also been reported with lamotrigine treatment. Oxcarbazepine has a safety profile similar to that of carbamazepine. Hyponatraemia associated with oxcarbazepine is also a problem; however, it is less likely to cause rash than carbamazepine. Nonconvulsive status epilepticus has been reported frequently with tiagabine, although there are insufficient data at present to identify risk factors for this ADR. Topiramate frequently causes cognitive ADRs and, in addition, also appears to cause word-finding difficulties, renal calculi and bodyweight loss. Vigabatrin has been reported to cause seizure aggravation, especially in myoclonic seizures. There have been rare reports of other neurological ADRs to

  17. Predicting risk of adverse drug reactions in older adults

    OpenAIRE

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-01-01

    Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of health...

  18. ADVERSE DRUG REACTIONS: FACTORS AND ROLE OF PHARMACIST IN THEIR PREVENTION.

    Science.gov (United States)

    Bushra, Rabia; Baloch, Saba Ajaz; Jabeen, Aisha; Bano, Nusrat; Aslam, Nousheen

    2015-01-01

    Adverse drug reactions (ADRs) are the undesirable effects of drugs even when administered in daily normal doses. It has been seen that ADRs may arise even after single administration of drug(s), however, long term therapies are more prone to ADRs. Currently it has become a burning issue all around the world and connected with financial expansion owing to hospitalization. Pharmacists are the custodians of drugs especially clinical pharmacists play a vital role in preventing the risks of ADRs. This review deals with the factors leading to possible ADRs, its prevention and the role of pharmacist in management of ADRs.

  19. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

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

    2010-01-01

    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...... inpatients and outpatients. However, prevalence and incidence were much lower in the national databases. Types of reported ADRs, seriousness of ADRs and types of medicines differed substantially between studies due to differences in time periods and patient populations. Information about ADRs was mainly......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...

  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 con...... consumer for nervous system medications....

  1. Ethnic differences in adverse drug reactions to asthma medications

    DEFF Research Database (Denmark)

    Hu, Yusun; Cantarero-Arévalo, Lourdes

    2016-01-01

    BACKGROUND: Information on ethnic diversity of adverse drug reactions (ADRs) to asthma medications is rare despite evidence suggesting higher risk for African Americans when using β2-adrenergic receptor agonists. The objectives are to investigate how ethnic background was involved in ADR assessment...... and to examine the relationship between ethnic background and ADRs to asthma medications. METHODS: MEDLINE was searched until March 2014. All types of studies reporting ADRs to asthma medications involving more than one ethnic group were included. Extracted information includes study designs, ethnic backgrounds...... studies disaggregated information by ethnic background, and reports of ADRs to asthma medications in different ethnic groups were rare. We suggest that the inclusion of ADR analysis by different ethnic backgrounds is desirable....

  2. ARWAR: A network approach for predicting Adverse Drug Reactions.

    Science.gov (United States)

    Rahmani, Hossein; Weiss, Gerhard; Méndez-Lucio, Oscar; Bender, Andreas

    2016-01-01

    Predicting novel drug side-effects, or Adverse Drug Reactions (ADRs), plays an important role in the drug discovery process. Existing methods consider mainly the chemical and biological characteristics of each drug individually, thereby neglecting information hidden in the relationships among drugs. Complementary to the existing individual methods, in this paper, we propose a novel network approach for ADR prediction that is called Augmented Random-WAlk with Restarts (ARWAR). ARWAR, first, applies an existing method to build a network of highly related drugs. Then, it augments the original drug network by adding new nodes and new edges to the network and finally, it applies Random Walks with Restarts to predict novel ADRs. Empirical results show that the ARWAR method presented here outperforms the existing network approach by 20% with respect to average Fmeasure. Furthermore, ARWAR is capable of generating novel hypotheses about drugs with respect to novel and biologically meaningful ADR.

  3. Adverse Drug Reactions: Knowledge, Attitude and Practice of Pharmacy

    Directory of Open Access Journals (Sweden)

    Maryam Etminani-Isfahani

    2015-10-01

    Full Text Available Background: Adverse Drug Reactions (ADRs are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Detection and reporting of ADRs could decrease these consequences. The present study was designed to assess the Knowledge, Attitude and Practice (KAP of pharmacy students towards ADRs monitoring and reporting.Methods: A questionnaire was prepared to investigate the Knowledge, Attitude and Practice (KAP of pharmacy students regarding ADR reporting. The questionnaire consisting of 17 questions (7 questions on knowledge, 5 on attitudes and 5 on practice were given to pharmacy students randomly.Results: A total of 71 respondents participated in the study. 70% of participants had favorable general knowledge about ADRs but more than 60% of their professional knowledge was not satisfying. 60% of respondent believed that educational intervention will improve participating of health care professional in ADRs reporting. 63% of respondent observed ADRs cases but about 95% of them had never reported an ADR.Conclusion: In overall, pharmacy students have poor knowledge, attitude and practice towards ADRs reporting and pharmacovigilance. This suggests the need of suitable changes in the undergraduate teaching curriculum and additional training among the students regarding ADRs.

  4. Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands

    NARCIS (Netherlands)

    E.M. Rodenburg (Eline); B.H.Ch. Stricker (Bruno); L.E. Visser (Loes)

    2011-01-01

    textabstractAIM Adverse drug reactions (ADRs) are a major burden in health care, regularly leading to hospital admission, morbidity or death. Women tend to have a higher risk of adverse drug reactions with a 1.5 to 1.7-fold greater risk than men. Our primary aim was to study differences in ADR-relat

  5. Adverse drug reactions in the elderly

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    Dhriti K Brahma

    2013-01-01

    Full Text Available Medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population. Age-related changes in drug disposition and pharmacodynamic responses have significant clinical implications; increased use of a number of medications raises the risk that medicine-related problems may occur. The relationship between increased use of drugs including the prescription medication and elderly is well established. Majority of ADRs (80% causing admission or occurring in hospital are type A reactions. Although less common occurring in elderly, type B ADRs may sometimes cause serious toxicity. Studies have correlated the integral association between old age and increased rate of adverse drug reactions arising out of confounding association between age and polypharmacy contributed by age-related changes in pharmacodynamics and pharmacokinetics at least for some medical conditions. A drug combination may sometimes cause synergistic toxicity which is greater than the sum of the risks of toxicity of either agent used alone. But, strategies to increase opportunities for identifying ADRs and related problems have not been emphasised in current international policy responses especially in India to the increase in elderly population and chronic conditions. Careful epidemiological studies that encompass large numbers of elderly drug users are required to obtain this information as increased knowledge of the frequency and cost of adverse drug reactions is important in enabling both more rational therapeutic decisions by individual clinicians and more optimal social policy.

  6. Perception of Nigerian medical students on adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Abdullahi Rabiu Abubakar

    2015-01-01

    Full Text Available Spontaneous reporting (SPR and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs. Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV. In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring.

  7. Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment

    Directory of Open Access Journals (Sweden)

    Pierandrea Rende

    2013-01-01

    Full Text Available The use of cardiovascular drugs is related to the development of adverse drug reactions (ADRs in about 24% of the patients in the Cardiovascular Care Unit. Here, we evaluated the ADRs in patients treated with antihypertensive drugs. The study was conducted in two phases: In the first phase, we performed a retrospective study on clinical records of Clinical Divisions (i.e., Internal Medicine Operative Unit and Geriatric Operative Unit from January 1, 2012 to December 31, 2012. Moreover from January 1, 2013 to March 30, 2013 we performed a prospective study on the outpatients attending the Emergency Department (ED of the Pugliese-Ciaccio Hospital of Catanzaro, by conducting patient interviews after their informed consent was obtained. The association between a drug and ADR was evaluated using the Naranjo scale. We recorded 72 ADRs in the Clinical Divisions and six in the ED, and these were more frequent in women. Using the Naranjo score, we showed a probable association in 92% of these reactions and a possible association in 8%. The most vulnerable age group involved in ADRs was that of the elderly patients. In conclusion, our results indicate that antihypertensive drugs may be able to induce the development of ADRs, particularly in elderly women receiving multiple drug treatment. Therefore, it is important to motivate the healthcare providers to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, as also all the essential activities for optimizing patient safety.

  8. Detect adverse drug reactions for drug Pioglitazone

    OpenAIRE

    Liu, Yihui; Aickelin, Uwe

    2013-01-01

    In this study we propose a novel method to successfully detect the ADRs using feature matrix and feature selection. A feature matrix, which characterizes the medical events before patients take drugs or after patients take drugs, is created from THIN database. The feature selection method of Student's t-test is used to detect the significant features from thousands of medical events. The significant ADRs, which are corresponding to significant features, are detected. Experiments are performed...

  9. 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.

  10. Digging Up the Human Genome: Current Progress in Deciphering Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Shih-Chi Su

    2014-01-01

    Full Text Available Adverse drug reactions (ADRs are a major clinical problem. In addition to their clinical impact on human health, there is an enormous cost associated with ADRs in health care and pharmaceutical industry. Increasing studies revealed that genetic variants can determine the susceptibility of individuals to ADRs. The development of modern genomic technologies has led to a tremendous advancement of improving the drug safety and efficacy and minimizing the ADRs. This review will discuss the pharmacogenomic techniques used to unveil the determinants of ADRs and summarize the current progresses concerning the identification of biomarkers for ADRs, with a focus on genetic variants for genes encoding drug-metabolizing enzymes, drug-transporter proteins, and human leukocyte antigen (HLA. The knowledge gained from these cutting-edge findings will form the basis for better prediction and management for ADRs, ultimately making the medicine personalized.

  11. 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...... of the general type (20 %) and nervous system disorders (15 %). The largest share of serious ADRs was of the type nervous system disorders (17 % of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30 % of ADRs, antineoplastic and immunomodulating...

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

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    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

  13. Predicting risk of adverse drug reactions in older adults.

    Science.gov (United States)

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-02-01

    Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of healthcare resources. Several ADR risk tools exist but none has sufficient predictive value for clinical practice. Good clinical practice for detecting and predicting ADRs in vulnerable patients includes detailed documentation and regular review of prescribed and over-the-counter medications through standardized medication reconciliation. New medications should be prescribed cautiously with clear therapeutic goals and recognition of the impact a drug can have on multiple organ systems. Prescribers should regularly review medication efficacy and be vigilant for ADRs and their contributory risk factors. Deprescribing should occur at an individual level when drugs are no longer efficacious or beneficial or when safer alternatives exist. Inappropriate prescribing and unnecessary polypharmacy should be minimized. Comprehensive geriatric assessment and the use of explicit prescribing criteria can be useful in this regard. PMID:26834959

  14. Adverse drug reactions associated with asthma medications in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    from 1 to 22 months. The most frequently reported ADRs were exacerbation of asthma, respiratory tract infection, cough, fever and headache. Only few ADRs were rated as being serious, however a number of children dropped out of the clinical trials due to serious ADRs, and, therefore, the real number......Background Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. Objective To review published clinical trials...... on the occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. Methods We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase...

  15. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool.

    Science.gov (United States)

    Parameswaran Nair, Nibu; Chalmers, Leanne; Peterson, Gregory M; Bereznicki, Bonnie J; Castelino, Ronald L; Bereznicki, Luke R

    2016-01-01

    Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. PMID:27194906

  16. Pharmacoepidemiological characterization of drug-induced adverse reaction clusters towards understanding of their mechanisms.

    Science.gov (United States)

    Mizutani, Sayaka; Noro, Yousuke; Kotera, Masaaki; Goto, Susumu

    2014-06-01

    A big challenge in pharmacology is the understanding of the underlying mechanisms that cause drug-induced adverse reactions (ADRs), which are in some cases similar to each other regardless of different drug indications, and are in other cases different regardless of same drug indications. The FDA Adverse Event Reporting System (FAERS) provides a valuable resource for pharmacoepidemiology, the study of the uses and the effects of drugs in large human population. However, FAERS is a spontaneous reporting system that inevitably contains noise that deviates the application of conventional clustering approaches. By performing a biclustering analysis on the FAERS data we identified 163 biclusters of drug-induced adverse reactions, counting for 691 ADRs and 240 drugs in total, where the number of ADR occurrences are consistently high across the associated drugs. Medically similar ADRs are derived from several distinct indications for use in the majority (145/163=88%) of the biclusters, which enabled us to interpret the underlying mechanisms that lead to similar ADRs. Furthermore, we compared the biclusters that contain same drugs but different ADRs, finding the cases where the populations of the patients were different in terms of age, sex, and body weight. We applied a biclustering approach to catalogue the relationship between drugs and adverse reactions from a large FAERS data set, and demonstrated a systematic way to uncover the cases different drug administrations resulted in similar adverse reactions, and the same drug can cause different reactions dependent on the patients' conditions. PMID:24534381

  17. Adverse drug reactions to herbal and synthetic expectorants.

    Science.gov (United States)

    Ernst, E; Sieder, C; März, R

    1995-01-01

    Our knowledge relating to adverse drug reactions (ADRs) of phytomedicines is highly fragmentary. The aim of this study was to define the prevalence of ADRs following medication with herbal or synthetic expectorants. In a multicentre, comparative post-marketing surveillance study of more than 3000 patients with acute bronchitis, about half were treated with a herbal remedy (SinupretR) and the other half with various other expectorants. In ascending order of incidence, ADRs were noted during mono-medication of SinupretR (0.8%), Ambroxol (1.0%) and acetylcysteine (4.3%). When concomitant drugs were used, this rank order was unchanged but incidence rates were markedly increased (3.4, 6.5 and 8.2%, respectively). The most frequent ADRs were gastrointestinal symptoms. It is concluded that expectorants are associated with ADRs in roughly 1-5% of cases undergoing single drug treatment and in 3-10% when more than one medication is being used. Amongst the expectorants used in this study, the herbal preparation SinupretR is associated with the lowest incidence of ADRs.

  18. Adverse drug reactions in the paediatric population in Denmark

    DEFF Research Database (Denmark)

    Aagaard, Lise; Weber, Camilla Blicher; Hansen, Ebba Holme

    2010-01-01

    BACKGROUND: The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important n...

  19. Usefulness of drug provocation tests in children with a history of adverse drug reaction

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    Hye Ran Na

    2011-07-01

    Full Text Available Purpose : There are very few reports of adverse drug reactions (ADR and almost no study of drug provocation test (DPT in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods : We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009. With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results : There were 17 (23.9% positive DPTs results out of 71 individual DPTs, and 11 patients (68.8% from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%, Non-steroidal anti-inflammatory drugs in 4 (25%, penicillin in 3 (19%, cephalosporin in 2 (13%, and cotrimoxazole, macrolide and lactose in 1 each. Conclusion : DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.

  20. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

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    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.

  1. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    OpenAIRE

    Deepti Chopra; Rehan, Harmeet S.; Vibha Sharma; Ritu Mishra

    2016-01-01

    Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs). The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013) were studied. These reports were analyzed for various carcinoma...

  2. Quality check of spontaneous adverse drug reaction reporting forms of different countries.

    Science.gov (United States)

    Bandekar, M S; Anwikar, S R; Kshirsagar, N A

    2010-11-01

    Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.

  3. 我院251例药品不良反应报告分析%Analysis of 251 cases of adverse drug reactions in our hospital report

    Institute of Scientific and Technical Information of China (English)

    唐锦辉

    2013-01-01

      purpose: to understand adverse drug reactions in our hospital (Adverse Drug Reaction) the incidence and relevant factors, provide reference for rational drug use, avoid the occurrence of adverse drug reactions. Methods: 251 cases on our 2011 colection statistics, analysis of ADR reports. Results 251 cases ADR report total involved 16 class drugs, vein drops note is caused ADR of main to drug way (201 cases); antibiotics occurred rate Supreme (142 cases), second is proprietary Chinese medicines (28 cases), and antipyretic analgesia drug (20 cases), and anti-tumor drug (16 cases), and effect blood and hematopoietic system of drug (12 cases); clinical performance main for skin and damage (99 cases), accounted for 39.44%, digestive system of of damage (75 cases) accounted for 29.88%. Conclusion: ADR is related to many factors relevant to clinical ADR monitoring work should be strengthened to reduce or avoid the occurrence of ADR.

  4. Pattern of angiotensin-converting enzyme inhibitors induced adverse drug reactions in South Indian teaching hospital

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    Uday Venkat Mateti

    2012-01-01

    Full Text Available Background: Adverse drug reactions (ADRs occur frequently with cardiovascular drugs leading to change in therapy, increasing morbidity, and mortality. Aim: The study was conducted to evaluate the incidence of ADRs due to angiotensin-converting enzyme Inhibitors in cardiology department. Materials and Methods: A cross-sectional observational study was carried out for a period of 6 months. The data were assessed for the pattern of the ADRs with respect to patient demographics, nature of the reaction, outcome of the reactions, causality, severity, and preventability. Results: Among 692 patients, 51 (7.36% had developed 60 ADRs, and majority of cases (56.66% were in the age group of >61 years and most of them were developed in female (80%. The common ADRs observed were cough, hypotension, hyperkalemia, and acute renal failure. In 21.66% cases the dose of the suspected drug was altered and in 78.33% cases the drug was withdrawn. Considering the outcome, 93.33% of cases recovered from ADRs, whereas in 6.66% cases were continuing. Causality assessment showed that majority of ADRs was probable and were found to be moderately severe. Conclusion: Our study concludes geriatrics and female patients have higher incidence of ADRs. So early identification and management of ADRs are essential for this population.

  5. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

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    Deepti Chopra

    2016-01-01

    Full Text Available Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs. The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013 were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6% as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%. Patients treated for breast carcinoma (39.1% reported the highest incidence of ADRs. Cisplatin (19.6% was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%. Gastroenterology (40.1% was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.

  6. 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. PMID:25505588

  7. Presença de excipientes com potencial para indução de reações adversas em medicamentos comercializados no Brasil The presence of pharmaceutical excipients as possible cause of adverse drug reactions (ADR - situation in Brazil

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    Antonio Vinicios Alves da Silva

    2008-09-01

    Full Text Available Os excipientes farmacêuticos podem ser os responsáveis por inúmeras Reações Adversas a Medicamentos (RAM. O objetivo do trabalho foi identificar a presença de possíveis excipientes indutores de RAM em medicamentos comercializados no Brasil. Foram listados os 12 produtos mais vendidos no mercado brasileiro para análise. A detecção dos excipientes ocorreu a partir da consulta à composição da fórmula farmacêutica dos produtos, realizada de Agosto a Setembro/04, no Dicionário de Especialidades Farmacêuticas, sites SAC do laboratório produtor, e ficha técnica disponível no site da ANVISA. A identificação dos excipientes, possíveis causadores de RAM, foi realizada a partir de consulta à literatura. Foram identificadas 35 apresentações farmacêuticas, 26 classificadas como medicamentos de venda livre (71,4% e 15 de uso pediátrico (42,8%. Entre os excipientes identificados (n=100, nove eram possíveis causadores de RAM: metilparabeno, propilparabeno, corante amarelo tartrazina, bissulfito de sódio, benzoato de sódio, lactose, cloreto de benzalcônio, sorbitol e álcool benzílico, sendo identificados em sete apresentações de uso pediátrico (18,9% e doze de venda livre (32,4%. Os resultados demonstram a necessidade de maior atenção por parte dos profissionais de saúde, dos usuários de medicamentos e da avaliação pelos sistemas de farmacovigilância, da presença de excipientes como possíveis indutores de RAM.Pharmaceutical excipients can be responsible for many ADR. The objectives of this study were to identify the presence of possible excipients as cause of ADR in drugs commercialized in Brazil. Twelve medicines with high indices of sales in Brazil, were selected to analysis. The bibliographic research about the Pharmaceutical Preparations (PP was carried from August to September/04. The sources of information used were Pharmaceutical Specialties Dictionary, web sites and customer services from the manufacturers

  8. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college

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    Upadhyaya P

    2012-06-01

    Full Text Available Prerna Upadhyaya,1 Vikas Seth,2 Vijay V Moghe,1 Monika Sharma,1 Mushtaq Ahmed11Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan, 2Department of Pharmacology, Hind Institute of Medical Sciences, Safedabad, Barabanki, Lucknow, Uttar Pradesh, IndiaIntroduction: Poor reporting of adverse drug reactions (ADRs by doctors is a major hindrance to successful pharmacovigilance. The present study was designed to assess first-year residents’ knowledge of ADR reporting.Methods: First-year postgraduate doctors at a private medical college completed a structured questionnaire. The responses were analyzed by nonparametric methods.Results: All doctors were aware of the term “adverse drug reactions.” Fifty percent of the doctors reported being taught about ADR reporting during their undergraduate teaching, and 50% had witnessed ADRs in their internship training. Ten percent of patients suffering an ADR observed and reported by doctors required prolonged hospitalization for treatment as a result. Only 40% of interns reported the ADRs that they observed, while 60% did not report them. Twenty-eight percent reported ADRs to the head of the department, 8% to an ADR monitoring committee, and 4% to the pharmacovigilance center. Eighty-six percent of the doctors surveyed felt that a good knowledge of undergraduate clinical pharmacology therapeutics would have improved the level of ADR reporting.Conclusion: The knowledge of first-year doctors regarding ADR reporting is quite poor. There is a dire need to incorporate ADR reporting into undergraduate teaching, and to reinforce this during internships and periodically thereafter.Keywords: ADR reporting, pharmacovigilance, first-year postgraduate doctors

  9. 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.

  10. Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

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    M. Süsskind

    2012-01-01

    Full Text Available Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs caused by anthroposophical medicines (AMEDs in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code, causality (according to the Uppsala Monitoring Centre WHO criteria, and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6% experienced 211 ADRs (CTCAE grade 2/3 n=191, 90.5%, CTCAE grade 4/5 n=20, 9.5% of which 57 ADRs (27.0% were serious. The median age of patients with ADRs (62.1% females was 72.0 (IQR: 61.0; 80.0. Six patients (0.2% experienced six ADRs (2.8% of ADRs caused by eight suspected AMEDs, all of which were mild reactions (grade 2. Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

  11. Analysis of adverse drug reactions of atypical antipsychotic drugs in psychiatry OPD

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    Kiran G Piparva

    2011-01-01

    Full Text Available Background: Novel atypical antipsychotics are superior to conventional antipsychotics as they significantly reduce both positive and negative symptoms of schizophrenia and have lower risk of extrapyramidal symptoms (EPS. However, these drugs have separate set of adverse drug reactions (ADRs. Therefore, this study was carried out to assess these ADRs, which can have impact on long-term compliance and achieving successful treatment. Materials and Methods: A prospective study of analysis of ADR of atypical antipsychotic drugs was carried out in the psychiatry outpatient department. Patients of psychotic disorder (any age, either sex, who were prescribed atypical antipsychotic drugs, were included. Those who were prescribed conventional antipsychotics or combinations of antipsychotics were excluded from the study. Apart from spontaneously reported ADRs, a questionnaire related to the likely ADR was used and patients′ responses were recorded in the case record form. Results: Totally 93 ADRs were recorded from 84 prescriptions. Majority of the ADRs (82 out of 93 were seen with risperidone and olanzepine, as they were the commonly prescribed drugs. Weight gain, dizziness, sleep disturbance and appetite disturbance accounted for nearly 78% of the total events. With risperidone (at 4-6 mg/day and olanzepine (at 10-15 mg/day, gastrointestinal and sleep disturbance were observed in the initial (within 7 days to 2-3 months after treatment course of treatment, while EPS, fatigue, seizure, increased frequency of micturition and dizziness were observed after long-term (3-9 months use. Conclusion: The present study adds to the existing information on the prevalence of adverse effects of atypical antipsychotic drugs. Role of active surveillance in post-marketing phase is also emphasized.

  12. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    Science.gov (United States)

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

  13. Adverse drug reactions to ibuprofen: a case report

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    Khobragade Yadneshwar

    2016-02-01

    Full Text Available Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here severe distress hypersensitive reaction with ibuprofen induced hypersensitivity syndrome. Within two hours of consumption of ibuprofen patient developed severe bronchospasm, throat and laryngeal oedema leading to respiratory distress. He was treated with salbutamol, hydrocortisone, deriphylline and supportive oxygen, but did not respond and went into coma. Unlike acetaminophen, ibuprofen does not have any antidote hence managing adverse drug reactions (ADR due to ibuprofen is big challenge. Therefore understanding pathophysiology of ADR to Ibuprofen is necessary to manage the patient. Literature in the field of allergic drug reaction shows that epinephrine, a physiological antagonist of histamine is the first drug of choice for the treatment of allergic or drug induced angioedema, laryngeal oedema and bronchospasm due to its direct action on target organs. Such reactions should therefore be managed by epinephrine without loss of time. ADR due to ibuprofen could be prevented by (a avoiding unnecessary intake of drug, (b educating patients / families and public about adverse drug reactions (c surveillance and monitoring of drug reactions (d record keeping (e drug audit and (f reporting of ADR to state/central pharmacovigilance agency. We do observe doctors having misconception about adrenaline, its actions, usage and side effects especially cardio-vascular, hence are reluctant to use. But in severe violent adverse drug reaction we have to use our wisdom and judgement

  14. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation

    OpenAIRE

    Ozcan, Gulnihal; Aykac, Emel; KASAP, Yelda; Nemutlu, Nergiz T.; Sen, Ebru; Aydinkarahaliloglu, N. Demet

    2016-01-01

    Introduction 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. Objective In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. Methods We analysed ADR reports submitted to the Turkish Pharmac...

  15. Hospitalization in older patients due to adverse drug reactions –the need for a prediction tool

    OpenAIRE

    Parameswaran Nair, Nibu

    2016-01-01

    Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...

  16. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    OpenAIRE

    Parameswaran Nair N; Chalmers L; Peterson GM; Bereznicki BJ; Castelino RL; Bereznicki LR

    2016-01-01

    Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...

  17. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    Directory of Open Access Journals (Sweden)

    Het B Upadhyaya

    2015-01-01

    Full Text Available Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR. Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Gujarat (India. A total of 22 questionnaires about KAP toward ADRs and pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from our institute. We were contacted directly to postgraduate students of respective clinical department; questionnaires were distributed and taken back after 30 min. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft Excel spreadsheet. Postgraduate residents (n = 101 from different clinical departments were enrolled in the study. Average 34.83% correct and 64.08% incorrect knowledge about ADRs and pharmacovigilance and an average 90.76% students were agreed to reporting ADRs is necessary, mandatory and increased patient′s safety. Only 7.92% of postgraduate doctors were reported ADR at institute or ADR reporting center. We concluded that postgraduate students have a better attitude toward reporting ADRs, but have lack of knowledge and poor practices of ADRs. The majority of postgraduate students were felt ADR reporting and monitoring is very important, but few had ever reported ADRs because of lack of sensitization and knowledge of pharmacovigilance and ADR.

  18. 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.

  19. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    李青; 张素敏; 陈华庭; 方世平; 于星; 刘东; 施侣元; 曾繁典

    2004-01-01

    Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR

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

    Science.gov (United States)

    Machado-Alba, Jorge Enrique; Ruiz, Andrés Felipe; Machado-Duque, Manuel Enrique

    2014-12-01

    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.

  1. SCREENING OF DRUG RESISTANCE-RELATED GENES FROM HUMAN OVARIAN CANCER CELL LINE OC3/ADR BY DD-PCR

    Institute of Scientific and Technical Information of China (English)

    田方; 程国均; 周海胜; 王宏; 肖凤君

    2001-01-01

    Objective: To screen novel genes related to adriamycin (Adr) resistance from human ovarian cancer resistance cell line OC3/Adr. Methods: Multidrug resistant ovarian cancer cell line OC3/Adr was induced by intermittent treatment of the human parent cell line OC3 with high concentration Adr. The difference of gene expression was screened by using different display analysis to the acquired Adr-resistance subline OC3/Adr and its parent cell line OC3. Results: OC3/Adr cell line was obtained which was more resistance to Adr than the parent cell line OC3 with the resistance index (RI) of 15.4. The OC3/Adr cell line also showed cross-resistance to other anti-cancer drugs (VP16, CDDP,5FU ). It grew slowly and exhibited changes of cell cycle. A number of differentially expressed ESTs (Expressed Sequence Tags, ESTs) were identified at mRNA level between the OC3/Adr and OC3. Four of 18 different ESTs were sequenced. The 431/432 base pair S1 was homologous to human sperm zona pellucida binding protein, while the other two ESTs, S3 and S4, were new gene segments, which were registered to GenBank with the number of AF 117656 and AF 126507 respectively. Particularly, the expression of S2 sequence increased in all the drug-resistance cell lines and S3 sequence overexpressed in human ovarian cancer tissues as compared with benign ovarian tumors. Adr in ovarian cancer OC3/Adr is involved with changes of multiple gene expressions.

  2. Adverse Drug Reactions in HIV/AIDS Patients at a Tertiary Care Hospital in Penang, Malaysia.

    Science.gov (United States)

    Khan, Kashifullah; Khan, Amer Hayat; Sulaiman, Syed Azhar; Soo, Chow Ting; Akhtar, Ali

    2016-01-01

    In the current study we explored the occurrence of adverse drug reactions (ADRs) to antiretroviral therapy among human immune-deficiency virus (HIV)/AIDS patients. We concluded an observational retrospective study in all patients who were diagnosed with HIV infection and were receiving highly active antiviral therapy from Jan. 2007 to Dec. 2012 at Hospital Pulau Pinang, Malaysia. Patient socio-demographic details along with clinical features and susceptible ADRs were observed during the study period. Out of 743 patients, 571 (76.9%) were men, and 172 (23.1%) were women. Overall 314 (42.2%) patients experienced ADRs. A total of 425 ADRs were reported, with 311 (73.1%) occurring in men and 114 (26.8%) in women, with a significant statistical relationship (P value (P) = 0.02, OR = 1.21). Overall 239 (56.2%) ADRs were recorded among Chinese, 94 (22.1%) in Malay, and 71 (16.7%) in Indian patients, which had a statistically significant association with ADRs (P = 0.05, OR = 1.50). Out of a total 425 among ADRs, lipodystrophy was recorded in 151 (35.5%) followed by skin rashes in 80 (18.8%), anemia in 74 (17.4%), and peripheral neuropathy in 27 (6.3%) patients. These findings suggest a need of intensive monitoring of ADRs in HIV treatment centres across Malaysia.

  3. [Analysis on 315 cases of clinical adverse drug reaction/event induced by gastrodin].

    Science.gov (United States)

    Zheng, Yang-yang; Dong, Zhi; Lu, Xiao-qin; Xia, Yong-peng; Zhu, Shu-bing

    2015-05-01

    With patients' general situation, medication use, occurrence time of adverse drug reaction/event (ADR/ADE), clinical manifestations and prognosis as reference items, a retrospective study was made for 315 cases with ADR/ADE induced by Gastrodin in Chongqing from January 2008 to June 2014, in order to analyze the characteristics of ADR/ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR/ADE, 143 cases (45.4%) were males and 172 cases (54.6%) were females, most of them (74.9%) were aged above 45; 60 cases (19.0%) with ADE were caused by off-label indications and 66 cases (21.0%) with ADE were caused by over dosage; ADR/ADE cases induced by intravenous drip mainly happened within 30 min (85.5%), ADR/ADE cases induced by oral administration mainly happened within 2 h (74.4%), and all of ADR/ ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR/ADE cases were reported, which were mainly damages in gastrointestinal system, skin and its adnexa; And 61.9% of ADR/ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR/ADE induced by gastrodin, apply it in clinic with standards, pay close attention to changes of patients' situations and attach importance to the monitoring of ADR/ADE, so as to enhance the safety of medication.

  4. Adverse Drug Reaction Reports of Patients and Healthcare Professionals : How Different Are They?

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; van Puijenbroek, Eugène; van Grootheest, Adrianus

    2013-01-01

    Background: Changes in the European pharmacovigilance legislation make it possible for patients of all European member states to report concerns regarding drugs directly to the national reporting centre for adverse drug reactions (ADRs). Despite a number of studies that have been conducted on patien

  5. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands

    NARCIS (Netherlands)

    Oosterhuis, Ingrid; van Hunsel, Florence P. A. M.; van Puijenbroek, Eugene P.

    2012-01-01

    Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of

  6. Are Migraineurs at Increased Risk of Adverse Drug Responses? : A Meta-Analytic Comparison of Topiramate-Related Adverse Drug Reactions in Epilepsy and Migraine

    NARCIS (Netherlands)

    Luykx, J.; Mason, M.; Ferrari, M. D.; Carpay, J.

    2009-01-01

    To compare adverse drug reactions (ADRs) to topiramate in patients with migraine and patients with epilepsy, we systematically reviewed all published randomized controlled trials (RCTs) that compare topiramate monotherapy in epilepsy and migraine. We included four epilepsy RCTs (N = 1,179 patients;

  7. Development of an adverse drug reaction risk assessment score among hospitalized patients with chronic kidney disease.

    Directory of Open Access Journals (Sweden)

    Fatemeh Saheb Sharif-Askari

    Full Text Available BACKGROUND: Adverse drug reactions (ADRs represent a major burden on the healthcare system. Chronic kidney disease (CKD patients are particularly vulnerable to ADRs because they are usually on multiple drug regimens, have multiple comorbidities, and because of alteration in their pharmacokinetics and pharmacodynamic parameters. Therefore, one step towards reducing this burden is to identify patients who are at increased risk of an ADR. OBJECTIVE: To develop a method of identifying CKD patients who are at increased risk for experiencing ADRs during hospitalisation. MATERIALS AND METHODS: Factors associated with ADRs were identified by using demographic, clinical and laboratory variables of patients with CKD stages 3 to 5 (estimated glomerular filtration rate, 10-59 ml/min/1.73 m2 who were admitted between January 1, 2012, and December 31, 2012, to the renal unit of Dubai Hospital. An ADR risk score was developed by constructing a series of logistic regression models. The overall model performance for sequential models was evaluated using Akaike Information Criterion for goodness of fit. Odd ratios of the variables retained in the best model were used to compute the risk scores. RESULTS: Of 512 patients (mean [SD] age, 60 [16] years, 62 (12.1% experienced an ADR during their hospitalisation. An ADR risk score included age 65 years or more, female sex, conservatively managed end-stage renal disease, vascular disease, serum level of C-reactive protein more than 10 mg/L, serum level of albumin less than 3.5 g/dL, and the use of 8 medications or more during hospitalization. The C statistic, which assesses the ability of the risk score to predict ADRs, was 0.838; 95% CI, 0.784-0.892. CONCLUSION: A score using routinely available patient data can be used to identify CKD patients who are at increased risk of ADRs.

  8. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    Directory of Open Access Journals (Sweden)

    Parameswaran Nair N

    2016-05-01

    Full Text Available Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. Keywords: adverse drug reactions, hospital admission, prediction, older patients, primary care, risk factors

  9. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

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    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.

  10. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy.

    Science.gov (United States)

    Srikanth, B Akshaya; Babu, S Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar

    2012-01-01

    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. PMID:22470896

  11. 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

  12. Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006

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    de Miguel Gil

    2010-10-01

    Full Text Available Abstract Background Adverse drug reactions (ADR are a substantial cause of hospital admissions. We conducted a nationwide study to estimate the burden of hospital admissions for ADRs in Spain during a six-year period (2001-2006 along with the associated total health cost. Methods Data were obtained from the national surveillance system for hospital data (Minimum Basic Data Set maintained by the Ministry of Health and Consumer Affairs, and covering more than 95% of Spanish hospitals. From these admissions we selected all hospitalization that were code as drug-related (ICD-9-CM codes E, but intended forms of overdoses, errors in administration and therapeutics failure were excluded. The average number of hospitalizations per year, annual incidence of hospital admissions, average length of stay in the hospital, and case-fatality rate, were calculated. Results During the 2001-2006 periods, the total number of hospitalized patients with ADR diagnosis was 350,835 subjects, 1.69% of all acute hospital admissions in Spain. The estimated incidence of admissions due to ADR decreased during the period 2001-2006 (p Conclusions Approximately 1.69% of all acute hospital admissions were associated with ADRs. The rates were much higher for elderly patients. The total cost of ADR-related hospitalization to the Spanish health system is high and has increased between 2001 and 2006. ADRs are an important cause of admission, resulting in considerable use of national health system beds and a significant number of deaths.

  13. Feature Selection in Detection of Adverse Drug Reactions from the Health Improvement Network (THIN Database

    Directory of Open Access Journals (Sweden)

    Yihui Liu

    2015-02-01

    Full Text Available Adverse drug reaction (ADR is widely concerned for public health issue. ADRs are one of most common causes to withdraw some drugs from market. Prescription event monitoring (PEM is an important approach to detect the adverse drug reactions. The main problem to deal with this method is how to automatically extract the medical events or side effects from high-throughput medical events, which are collected from day to day clinical practice. In this study we propose a novel concept of feature matrix to detect the ADRs. Feature matrix, which is extracted from big medical data from The Health Improvement Network (THIN database, is created to characterize the medical events for the patients who take drugs. Feature matrix builds the foundation for the irregular and big medical data. Then feature selection methods are performed on feature matrix to detect the significant features. Finally the ADRs can be located based on the significant features. The experiments are carried out on three drugs: Atorvastatin, Alendronate, and Metoclopramide. Major side effects for each drug are detected and better performance is achieved compared to other computerized methods. The detected ADRs are based on computerized methods, further investigation is needed.

  14. Adverse drug events resulting from use of drugs with sulphonamide-containing anti-malarials and artemisinin-based ingredients: findings on incidence and household costs from three districts with routine demographic surveillance systems in rural Tanzania

    OpenAIRE

    Njau, JD; Kabanywanyi, AM; Goodman, CA; Macarthur, JR; Kapella, BK; Gimnig, JE; Kahigwa, E.; Bloland, PB; Abdulla, SM; Kachur, SP

    2013-01-01

    Background: Anti-malarial regimens containing sulphonamide or artemisinin ingredients are widely used in malaria-endemic countries. However, evidence of the incidence of adverse drug reactions (ADR) to these drugs is limited, especially in Africa, and there is a complete absence of information on the economic burden such ADR place on patients. This study aimed to document ADR incidence and associated household costs in three high malaria transmission districts in rural Tanzania covered by dem...

  15. An overview on adverse drug reactions to traditional Chinese medicines.

    Science.gov (United States)

    Chan, Kelvin; Zhang, Hongwei; Lin, Zhi-Xiu

    2015-10-01

    The safe use of Chinese materia medica (CMM) and products in traditional Chinese medicine (TCM) practice conventionally relies on correct pharmacognostic identification, good agricultural and manufacturing practices based on pharmacopoeia standards and rational/correct CMM combinations with TCM-guided clinical prescribing. These experience-based principles may not absolutely ensure safety without careful toxicological investigations when compared with development of new pharmaceutical drugs. Clinically observed toxicity reports remain as guidance for gathering toxicological evidence, though essential as pharmacovigilance, but are considered as late events for ensuring safety. The overview focuses on the following factors: global development of TCM that has affected conventional healthcare; examples of key toxic substances in CMM; reported adverse drug reactions (ADRs) consequential to taking CMM and TCM products; and proposals on rational approaches to integrate the knowledge of biomedical science and the principles of TCM practice for detecting early ADRs if both TCM products and orthodox drugs are involved. It is envisaged that good control of the quality and standards of CMM and proprietary Chinese medicines can certainly reduce the incidence of ADRs in TCM practice when these medications are used. PMID:25619530

  16. Development, implementation, and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana

    OpenAIRE

    S.M. Shareef; C. D. M. Naidu; Shrinivas R. Raikar; Y. Venkata Rao; U. Devika

    2015-01-01

    Background: Adverse drug reactions (ADR) are the fourth leading cause of mortality and a great concern in therapeutics. Pharmacovigilance is more important in India as the health care system is inadequate with poor doctor-patient ratio, high incidence of self-medication, and presence of counterfeit drugs. The present study was conducted with the aim of analyzing the pattern of ADR occurring in a rural tertiary care hospital with a newly established pharmacovigilance center and to identify the...

  17. Refill adherence and self-reported adverse drug reactions and sub-therapeutic effects : a population-based study

    OpenAIRE

    Hedna, Khedidja; Hägg, Staffan; Andersson Sundell, Karolina; Petzold, Max; Hakkarainen, Katja M

    2013-01-01

    PURPOSE: To assess refill adherence to dispensed oral long-term medications among the adult population and to investigate whether the percentages of self-reported adverse drug reactions (ADRs) and sub-therapeutic effects (STEs) differed for medications with adequate refill adherence, oversupply, and undersupply. METHOD: Survey responses on self-reported ADRs and STEs were linked to the Swedish Prescribed Drug Register in a cross-sectional population-based study. Refill adherence to antihypert...

  18. 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. PMID:22512705

  19. An adverse drug interaction of haloperidol with levodopa

    Directory of Open Access Journals (Sweden)

    Jisha M Lucca

    2015-01-01

    Full Text Available Drug interactions are known to play a significant role in the incidence of adverse drug reactions (ADRs both in the community and in hospitals. Both the newer atypical antipsychotics and their more traditional counterparts are subject to drug - drug interactions amongst themselves, with other psychotropics, and with the agents used in the treatment of various physical ailments. The most common interactions encountered in clinical practice are pharmacodynamic in nature. It is well established that antipsychotic drugs reduce the efficacy of levodopa in parkinson′s disease by blockade of dopamine receptors in the corpus striatum. The case reported here illustrates a common pharmacodynamic drug interaction of haloperidol with levodopa in a 60-year-old female patient.

  20. 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.

  1. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

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

    2015-01-01

    information is generally available for causality assessment. However, manual review of clinical notes is too time-consuming for routine use and hence there is a need for developing information technology (IT) tools for automatic screening of patient records with the purpose to detect information about......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...

  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 (donepe

  3. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Wilkes, Sarah; Grootheest, Kees van; Puijenbroek, Eugène van

    2015-01-01

    PURPOSE: This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. METHODS: This retrospective study co

  4. Reporting of adverse drug reactions by general practitioners : a questionnaire-based study in the Netherlands

    NARCIS (Netherlands)

    Passier, Anneke; ten Napel, Marije; van Grootheest, Kees; van Puijenbroek, Eugène

    2009-01-01

    BACKGROUND: There has been a gradual decline over the years in the number of spontaneous reports of potential adverse drug reactions (ADRs) from general practitioners (GPs) in the Netherlands. OBJECTIVE: To reveal aspects of knowledge, attitudes and behaviour that can stimulate GPs to submit (more)

  5. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène; Diemont, Willem; van Grootheest, Kees

    2003-01-01

    The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative

  6. Analysis of spontaneous reports of thromboembolic adverse drug reactions associated with cyproterone/ethinylestradiol

    NARCIS (Netherlands)

    Van Hunsel, F.; Van Puijenbroek, E.

    2013-01-01

    Introduction: After media attention on thromboembolic adverse drug reactions (ADRs) and the use of cyproterone/ethinylestradiol [1], the Netherlands Pharmacovigilance Centre Lareb received a high number of reports about this association, which called for a more detailed analyses. Aim: To provide an

  7. Adverse drug reaction-related hospitalisations: A nationwide study in The Netherlands

    NARCIS (Netherlands)

    C.S. van der Hooft (Cornelis); M.C.J.M. Sturkenboom (Miriam); K. van Grootheest (Kees); H.J. Kingma (Herre); B.H.Ch. Stricker (Bruno)

    2006-01-01

    textabstractBackground: The incidence of adverse drug reaction (ADR)-related hospitalisations has usually been assessed within hospitals. Because of the variability in results and methodology, it is difficult to extrapolate these results to a national level. Objectives: To evaluate the incidence and

  8. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India

    Directory of Open Access Journals (Sweden)

    Ajitha Sharma

    2015-01-01

    Full Text Available Purpose: Studies regarding pattern of adverse drug reactions (ADRs in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. Materials and Methods: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO causality assessment scale and Naranjo′s algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. Results: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%, nausea/vomiting (21.6% and febrile neutropenia (13%. Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be "probable" and 35% to be "possible," while Naranjo′s algorithm indicated that 65.6% of ADRs were "probable" and 34.4% were "possible". Modified Hartwig and Siegel scale showed most reactions (41.4% to be of "moderate level 4(a" severity, while 30.6% of reactions were of "mild level 1" severity. About 30.8% of the ADRs were "definitely preventable" according to the modified Schumock and Thornton scale. Conclusion: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.

  9. 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

  10. Risk factors of adverse drug reaction from non-steroidal anti-inflammatory drugs in Shanghai patients with arthropathy

    Institute of Scientific and Technical Information of China (English)

    Wen SHI; Yong-ming WANG; Shao-li LI; Min YAN; Duan Li; Bin-yah CHEN; Neng-neng CHENG

    2004-01-01

    AIM: The study was to screen the possible risk factors of adverse drug reaction (ADR) induced by non-steroidal anti-inflammatory drugs (NSAIDs) in Shanghai patients with arthropathy. METHODS: The subjects were randomly selected from a database of outpatients with arthropathy from 9 main hospitals in Shanghai. A door to door retrospective epidemiological survey was used to collect demographic information about the patients, both individual and familial. This included data on their medical histories, lifestyle and dietary habits, history of smoking and alcohol consumption, history of drug therapy, quality of life (QOL) prior to NSAIDs intake, history of NSAIDs therapy and its ADR events, etc. Descriptive statistical methods and univariate analysis were also used to identify possible risk factors for ADRs induced by NSAIDs. RESULTS: Of the 1002 patients surveyed, the average length of NSAIDs intake was 2 years. ADR incidence from different NSAIDs was high, in a range from 46.7 %-66.2 %.In general, the candidate risk factors for ADRs were different for each NSAID. Each of the candidate risk factors were defined and studied in order to evaluate its role in the determination of ADRs from NSAIDs. "Family history of ADRs caused by NSAIDs" was found to be a significant risk factor for the four commonly used NSAIDs:meloxicam, diclofenac, nimesulide, and nabumetone. CONCLUSION: A retrospective epidemiological survey was useful in detecting the risk factors for ADRs caused by NSAIDs. The study found that different NSAIDs might have different risk factors and that there is no single risk factor universally applicable to all NSAIDs.

  11. 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

  12. 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. PMID:25576362

  13. 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

  14. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    OpenAIRE

    Het B Upadhyaya; Vora, Mukeshkumar B.; Jatin G Nagar; Patel, Pruthvish B.

    2015-01-01

    Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR). Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP) toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Guj...

  15. Adverse Drug Reaction Reporting” Knowledge, Attitude and Practices of Community Pharmacy Dispensers in Dar es salaam, Tanzania

    OpenAIRE

    Shimwela, Grace Mng’ong’o

    2011-01-01

    Under reporting of adverse drug reactions (ADRs) by healthcare personnel is a common problem of many Pharmacovigilence programs. Lack of involvement of healthcare professionals such as pharmacists and other pharmaceutical dispensers has been cited as one of the reasons for under reporting. Pharmaceutical dispensers in the community pharmacies are in unique position by virtue of their training and profession to observe ADRs in patients, as many patients often try to avoid doctor consultation f...

  16. Knowledge, Attitude and Practices towards Pharmacovigilance and Adverse Drug Reactions in health care professional of Tertiary Care Hospital, Bhavnagar

    Directory of Open Access Journals (Sweden)

    Dr.Mukeshkumar B Vora

    2014-11-01

    Full Text Available Purpose: Adverse drug reactions (ADRs are adverse consequences of drug therapy. ADRs are representing a major concern of health systems in terms of early recognition, proper management and prevention. Under reporting of Adverse Drug Reactions (ADRs is a common problem in Pharmacovigilance programs. Poor perceptions of doctors about ADRs and risk management have contributed to high rate of ADR under-reporting in India. Underreporting has also been attributed to lack of time to doctor, misconceptions about spontaneous reporting and lack of information on how to report, where to report and a lack of availability of report forms, and also physicians' attitudes to ADRs. The objective of our study was to evaluate the knowledge, attitude and practices (KAP of health care professional towards Pharmacovigilance and adverse drug reactions in a tertiary care hospital, Bhavnagar, Gujarat, India. Methods: A cross-sectional questionnaires based study was carried out in Post graduate students and faculties of tertiary care hospital attached with Govt. Medical College, Bhavnagar, Gujarat. Post graduate students and faculties of different clinical subjects working in the tertiary care teaching hospital, Bhavnagar, Gujarat (India were enrolled and present throughout in study. 22 questionnaires about knowledge, attitude and practices towards ADRs and Pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from Pharmacology department. We were contacted directly to post graduate students and faculties of respective clinical department, questionnaires were distributed, 30 minutes time given to filled form. Any clarification and extra time was needed, provided to them. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft excel spread sheet and online statistical software. Results: In study, postgraduate residents (n=81 and faculties (n=63 from different clinical

  17. Relationship between serum acetaminophen concentration and N-acetylcysteine-induced adverse drug reactions.

    Science.gov (United States)

    Zyoud, Sa'ed H; Awang, Rahmat; Sulaiman, Syed Azhar Syed; Khan, Halilol Rahman Mohamed; Sawalha, Ansam F; Sweileh, Waleed M; Al-Jabi, Samah W

    2010-09-01

    Intravenous N-acetylcysteine is usually regarded as a safe antidote. However, during the infusion of the loading dose, different types of adverse drug reactions (ADR) may occur. The objective of this study was to investigate the relation between the incidence of different types of ADR and serum acetaminophen concentration in patients presenting to the hospital with acetaminophen overdose. This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis. Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous N-acetylcysteine and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Low serum acetaminophen concentrations were significantly associated with cutaneous anaphylactoid reactions but not other types of ADR. Low serum acetaminophen concentration was significantly associated with flushing (p acetaminophen concentrations between patients with and without the following ADR: gastrointestinal reactions (p = 0.77), respiratory reactions (p = 0.96), central nervous reactions (p = 0.82) and cardiovascular reactions (p = 0.37). In conclusion, low serum acetaminophen concentrations were associated with higher cutaneous anaphylactoid reactions. Such high serum acetaminophen concentrations may be protective against N-acetylcysteine-induced cutaneous ADR. PMID:20374238

  18. Dose-Specific Adverse Drug Reaction Identification in Electronic Patient Records: Temporal Data Mining in an Inpatient Psychiatric Population

    DEFF Research Database (Denmark)

    Eriksson, Robert; Werge, Thomas; Jensen, Lars Juhl;

    2014-01-01

    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...

  19. Effects of autophagy on multidrug resistance of drug resistant LoVo/Adr cells of colon carcinoma

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    Qiang MA

    2013-11-01

    Full Text Available Objective To observe the effects of autophagy on multidrug resistance (MDR of drug resistant LoVo/Adr cells of colon carcinoma. Methods The formation of autophagosomes was monitored with transmission electron microscopy, and autophagy rate was measured with the aid of MDC staining and flow cytometry. IC50 value of adriamycin (ADR on colon carcinoma cells was detected by MTT assay. The mRNA level of MDR1 gene was measured by RT-PCR, and P-gp protein expression was detected by Western blotting. Results The sporadic autophagosomes or green epoptic dots were found to distribute in LoVo/Adr cells with an autophagy rate of 3.1%±0.5%. A large number of autophagosomes were seen after being treated with ADR or rapamycin (RAPA with the autophagy rates of 33.6%±5.1% and 45.2%±6.1%, respectively (P<0.05. After being treated with ADR combining RAPA, autophagosomes appeared abundantly with an autophagy rate of 76.2%±7.4%, which was significantly higher than that when treated with ADR or RAPA alone (P<0.05. The IC50 value of LoVo/Adr cells on ADR was 3.05±0.52mg/L, which decreased to 1.12±0.21mg/L after being treated with RAPA (P<0.01. RAPA could reverse MDR with a reversal ratio of 2.26. High expression of mRNA and protein of MDR1 gene were observed in LoVo/Adr cells. When treated with RAPA, the expression of MDR1 mRNA decreased from 1.42±0.31 to 0.54±0.20 (P<0.05, and the expression of P-gp protein also decreased significantly from 0.67±0.14 to 0.15±0.08 (P<0.01. Conclusion MDR LoVo/Adr cell shows a low autophagic activity, and RAPA can reverse MDR by increasing autophagy activity. The reversal path might be related with the increase of cell autophagic death and the decrease in MDR1 gene expression in LoVo/Adr cells. DOI: 10.11855/j.issn.0577-7402.2013.11.007

  20. Adverse effects of antihypertensive drugs.

    Science.gov (United States)

    Husserl, F E; Messerli, F H

    1981-09-01

    Early essential hypertension is asymptomatic and should remain so throughout treatment. In view of the increasing number of available antihypertensive agents, clinicians need to become familiar with the potential side effects of these drugs. By placing more emphasis on non-pharmacological treatment (sodium restriction, weight loss, exercise) and thoroughly evaluating each case in particular, the pharmacological regimen can be optimally tailored to the patient's needs. Potential side effects should be predicted and can often be avoided; if they become clinically significant they should be rapidly recognised and corrected. These side effects can be easily remembered in most instances, as they fall into 3 broad categories: (a) those caused by an exaggerated therapeutic effect; (b) those due to a non-therapeutic pharmacological effect; and (c) those caused by a non-therapeutic, non-pharmacological effect probably representing idiosyncratic reactions. This review focuses mainly on adverse effects of the second and third kind. Each group of drugs in general shares the common side effects of the first two categories, while each individual drug has its own idiosyncratic side effects.

  1. Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh

    Science.gov (United States)

    Amin, Mohammad Nurul; Khan, Tahir Mehmood; Dewan, Syed Masudur Rahman; Islam, Mohammad Safiqul; Moghal, Mizanur Rahman

    2016-01-01

    Objectives To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh. Method A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh. Results The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were ‘I do not know how to report (Relative Importance Index (RII)=0.998)’, ‘reporting forms are not available (0.996)’, ‘I am not motivated to report (0.997)’ and ‘Unavailability of professional environment to discuss about ADR (RII=0.939)’. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731). Conclusions The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings. PMID:27489151

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

    Directory of Open Access Journals (Sweden)

    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

  3. Pharmacogenomics and adverse drug reactions in children

    OpenAIRE

    Rieder, Michael J; Carleton, Bruce

    2014-01-01

    Adverse drug reactions are a common and important complication of drug therapy in children. Over the past decade it has become increasingly apparent that genetically controlled variations in drug disposition and response are important determinants of adverse events for many important adverse events associated with drug therapy in children. While this research has been difficult to conduct over the past decade technical and ethical evolution has greatly facilitated the ability of investigators...

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

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    Caterina Palleria

    2013-01-01

    Full Text Available 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.

  5. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study

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    Akram Ahmad

    2013-01-01

    Full Text Available Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists′ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.. The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists

  6. Respiratory paradoxical adverse drug reactions associated with acetylcysteine and carbocysteine systemic use in paediatric patients: a national survey.

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    Pauline Mallet

    Full Text Available OBJECTIVE: To report pediatric cases of paradoxical respiratory adverse drug reactions (ADRs after exposure to oral mucolytic drugs (carbocysteine, acetylcysteine that led to the withdrawal of licenses for these drugs for infants in France and then Italy. DESIGN: The study followed the recommendations of the European guidelines of pharmacovigilance for medicines used in the paediatric population. SETTING: Cases voluntarily reported by physicians from 1989 to 2008 were identified in the national French pharmacovigilance public database and in drug company databases. PATIENTS: The definition of paradoxical respiratory ADRs was based on the literature. Exposure to mucolytic drugs was arbitrarily defined as having received mucolytic drugs for at least 2 days (>200 mg and at least until the day before the first signs of the suspected ADR. RESULTS: The non-exclusive paradoxical respiratory ADRs reported in 59 paediatric patients (median age 5 months, range 3 weeks to 34 months, 98% younger than 2 years old were increased bronchorrhea or mucus vomiting (n = 27, worsening of respiratory distress during respiratory tract infection (n = 35, dyspnoea (n = 18, cough aggravation or prolongation (n = 11, and bronchospasm (n = 1. Fifty-one (86% children required hospitalization or extended hospitalization because of the ADR; one patient died of pulmonary oedema after mucus vomiting. CONCLUSION: Parents, physicians, pharmacists, and drug regulatory agencies should know that the benefit risk ratio of mucolytic drugs is at least null and most probably negative in infants according to available evidence.

  7. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil: comparison of product information for oral formulations in Australia, Denmark and the United States.

    Science.gov (United States)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-07-01

    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 information about study design (clinical trials, spontaneous report). Discrepancies in ADR labelling for the medications were found across the three countries. A total of 75 ADR categories were listed for atomoxetine and 80% of these were listed in all three countries. For methylphenidate, totally 101 ADR categories and for modafinil 115 ADR categories were listed. For both substances approximately 60% of listed ADRs were found in all three countries. Discrepancies were primarily detected for ADRs information based on clinical trials. For methylphenidate, many ADRs labelled in Australia and Denmark were not mentioned in PIs issued in the United States. In conclusion, information about possible ADRs associated with the use of a specific product should be made available worldwide, as the prescriber information about medicines' safety profile should not depend on the country in which the medication is licensed. PMID:23914751

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

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    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.

  9. 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)

    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

  10. 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.

  11. Designing a national combined reporting form for adverse drug reactions and medication errors.

    Science.gov (United States)

    Tanti, A; Serracino-Inglott, A; Borg, J J

    2015-06-09

    The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

  12. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital

    OpenAIRE

    Nishita H. Darji; Shilpa Jadav; Chintan Doshi; Rutvij Hedamba; Rusva Mistry; Hiren Trivedi

    2016-01-01

    Background: Use of drugs itself may result into illness and death due to their adverse effects. In India 10-20% of inpatients developed adverse drug reactions. Most of these problems can be overcome by undertaking hospital based intensive monitoring. Objective of this study was to estimate the incidence and document the spectrum of ADRs in studied patients in terms of causality, severity, frequency, type and preventability. A prospective, observational, single centre study conducted among the...

  13. Prevalence of Adverse Drug Reactions in CAD STEMI Patients Treated in the Cardiac Intensive Care Unit at the Public Hospital in Bandung, Indonesia.

    Science.gov (United States)

    Amalia, Lia; Anggadireja, Kusnandar; Aprami, Toni M; Septiani, Vina

    2016-01-01

    Adverse drug reactions (ADRs) are associated with morbidity, mortality, and can contribute to increased healthcare costs. This study was conducted to identify the occurence, types, and management of ADRs, as well as analyze the causal relationship, severity, and preventability of ADRs. The study was observational analysis with concurrent data collection from patients with Coronary Artery Disease-ST segment Elevation Myocardial Infarction (CAD-STEMI) treated in the Cardiac Intensive Care Unit (CICU) at a hospital in Bandung Indonesia, during the period of December 2013 to March 2014. The occurence of identified ADRs was assessed using the probability scale of Naranjo, while the severity by the scale of Hartwig and their preventability was evaluated using the scale of Schumock-Thornton. 49 ADRs were identified in 29 patients. Organ systems most affected by the ADRs were the cardiovascular and body electrolyte, each accounting for 20.41%. The hematology and gastrointestinal systems each contributed 18.37% to ADR occurrences. The causal relationship was mostly classified as "probable," accounting for 69.39%. With regard to severity, most ADRs were classified as "moderate" at level 3, contributing to 53.06% of the occurence. In terms of preventability, most of the ADRs fell into the "non-preventable" category (79.59%). The most widely applied ADRs management was administration of an antidote or other treatments (40.82%). Further analysis revealed that the average number of drug types and duration of hospitalization significantly affected the presence of ADRs. Taken together, most patients with CAD STEMI treated in the CICU of the studied hospital experienced non-preventable ADRs and were treated with antidote or other treatments. PMID:27110507

  14. Pattern of Adverse Drug Reactions in Children Attending the Department of Pediatrics in a Tertiary Care Center: A Prospective Observational Study

    Science.gov (United States)

    Digra, Kishour Kumar; Pandita, Aakash; Saini, GS; Bharti, Rajni

    2015-01-01

    AIM To study the pattern of various adverse drug reactions (ADRs) occurring in children attending the Department of Pediatrics, SMGS Hospital, Jammu over 1 year. SUBJECTS AND METHODS This was a prospective study, with study population of patients attending Department of Pediatrics over a period of 1 year. A structured format was used to enroll the participants. A pilot study was conducted to test the suitability of the format and feasibility of the study. The study was carried out to review various pattern of ADRs by using the Naranjo probability scale, and severity was assessed by using the Hartwig severity scale. ADRs were classified according to the classification used by the Adverse Drug Reaction Monitoring Center, Central Drugs Standard Control Organization, New Delhi, India. RESULTS In the present study, 104 patients were found to have developed acute drug reactions. Among these, 83.6% were type B, 14.42% type A, and 1.92% were type U. Furthermore, 25.96% ADRs were due to anticonvulsants, followed by antibiotics (22.11%), antipyretics (11.53%), vaccination (8.65%), steroids (6.73%), decongestants (5.67%), snake antivenom and antiemetics (3.84%), and fluids, insulin, and antacids (1.92%). The patients’ dermatological system was involved in 67.30%, followed by the central nervous system (CNS) in 11.53% patients. Renal system was involved in 6.73% patients. Cardiac, musculoskeletal, metabolic, and other systems were involved in 4.80%, 3.84%, 2.88%, and 0.96%, respectively. According to the Hartwig severity scale of ADRs, 64.4% patients had moderate ADRs, 29.8% patients had severe ADRs, and 5.76% had mild ADRs. In the present study, 64.4% patients expressed moderate severity, whereas 29.8% expressed high severity and 5.76% expressed mild ADRs. CONCLUSION ADRs were seen in 71% of the patients between 1 and 5 years of age, 26% in the age group of 5–10 years, and 3% were more than 10 years old. Anticonvulsants (25.96%) and antibiotics (22.11%) were responsible

  15. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène P; Bate, Andrew; Leufkens, Hubert G M; Lindquist, Marie; Orre, Roland; Egberts, Antoine C G

    2002-01-01

    PURPOSE: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways

  16. 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

    OpenAIRE

    Endalkachew Admassie; Tesfahun Melese; Woldeselassie Mequanent; Wubshet Hailu; B Akshaya Srikanth

    2013-01-01

    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...

  17. Do no harm - But first we need to know more: The case of adverse drug reactions with antiepileptic drugs

    Directory of Open Access Journals (Sweden)

    Gagandeep Singh

    2011-01-01

    Full Text Available An adverse drug reaction (ADR is defined by the World Health Organization as a noxious, unintended, and undesired drug effect, when used for therapeutic purposes in humans. ADRs to anti-epileptic drugs (AEDs significantly impact the quality of life of people with epilepsy and account for a little less than half of all recorded treatment failures with AEDs. Hence prevention and early recognition of ADRs constitute an important aspect of management of epilepsy. Recent developments have improved our ability to predict and hence potentially prevent the occurrence of some of the serious ADRs to AEDs. One example is the potential prediction of the risk of severe cutaneous hypersensitivity reactions including Stevens Johnson syndrome and toxic epidermal necrolysis by testing for expression of HLA BFNx011502 allele in people of Asian origin who are prescribed carbamazepine. The association between HLA BFNx011502 expression and carbamazepine skin reactions has been documented in India but the role of HLA testing in Indian populations needs to be clarified in larger studies across different ethnic groups within the country.

  18. 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

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    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.

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

    Science.gov (United States)

    Mugoša, Snežana; Djordjević, Nataša; Djukanović, Nina; Protić, Dragana; Bukumirić, Zoran; Radosavljević, Ivan; Bošković, Aneta; Todorović, Zoran

    2016-01-01

    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 (Phospitalization, CYP2D6 poor metabolizer phenotype, and the concomitant use of other CYP2D6-metabolizing drugs. Therefore, in hospitalized patients with polypharmacy CYP2D6 genotyping might be useful in detecting those at risk of ADRs.

  20. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim

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    Supratim Datta

    2015-01-01

    Full Text Available Aim: Spontaneous voluntary adverse drug reaction (ADR reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC Gangtok, Sikkim. Knowledge, perception, attitude, and awareness of health professionals are determinants of reporting practices. This questionnaire study aims at evaluating these indicators in the teaching hospital attached to the Medical Institute and find out methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in the Medical, Surgical and Pathology Departments of the Teaching Hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 h. Data obtained from filled questionnaires were thereby analyzed. Results: The overall correct response rate to the knowledge-based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that the difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an AMC affiliated to the hospital, and 87% of the respondents admitted that they were not sending filled ADR forms to the AMC. Conclusions: The study indicates that the respondents have an average knowledge and positive attitude toward ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and attitude toward pharmacovigilance and ADR reporting.

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

    Institute of Scientific and Technical Information of China (English)

    Zuzana Zelinkova; Evelien Bultman; Lauran Vogelaar; Cheima Bouziane; Ernst J Kuipers; C Janneke van der Woude

    2012-01-01

    AIM: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 dinic of a referral hospital were identified through the electronic diagnosis registration system.The electronic medical records of IBD patients were reviewed and the files of those patients who have used immune suppressive therapy for IBD,i.e.,thiopurines,methotrexate,cyclosporine,tacrolimus and anti-tumor necrosis factor agents (anti-TNF); infliximab (IFX),adalimumab (ADA) and/or certolizumab,were further analyzed.The reported ADR to immune suppressive drugs were noted.The general definition of ADR used in clinical practice comprised the occurrence of the ADR in the temporal relationship with its disappearance upon discontinuation of the medication.Patients for whom the required information on drug use and ADR was not available in the electronic medical record and patients with only one registered contact and no further followup at the outpatient clinic were excluded.The difference in the incidence and type of ADR between male and female IBD patients were analyzed statistically by x2 test.RESULTS:In total,1009 IBD patients were identified in the electronic diagnosis registration system.Out of these 1009 patients,843 patients were eligible for further analysis.There were 386 males (46%),mean age 42 years (range:16-87 years) with a mean duration of the disease of 14 years (range:0-54 years); 578 patients with Crohn's disease,244 with ulcerative colitis and 21 with unclassified colitis.Seventy percent (586 pts) of patients used any kind of immune suppressive agents at a certain point of the disease course,the majority of the patients (546 pts,65%) used thiopurines,176 pts (21%) methotrexate,46 pts (5%) cyclosporine and one patient tacrolimus.One third (240pts,28%) of patients were treated with anti-TNF,the majority of patients (227 pts,27%) used IFX,99 (12

  2. Standardizing adverse drug event reporting data

    OpenAIRE

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a sta...

  3. 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.

  4. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

    Directory of Open Access Journals (Sweden)

    Yamamoto M

    2015-01-01

    Full Text Available Michiko Yamamoto,1 Kiyoshi Kubota,2 Mitsuhiro Okazaki,3 Akira Dobashi,3 Masayuki Hashiguchi,4 Hirohisa Doi,1 Machi Suka,5 Mayumi Mochizuki4 1Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan; 3Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan; 4Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan; 5Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan Background: Patients have been allowed to report adverse drug reactions (ADRs directly to the government in some countries, which would contribute to pharmacovigilance.Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.Methods: Patients who submitted online ADR reports were contacted to respond to an ADR reporting questionnaire; only consenting reporters were included. Subjects with multiple responses were excluded from analysis. The questionnaire consisted of both closed and open questions. Questionnaire responses were examined using Pearson’s chi-squared test.Results: A total of 220 web-based ADR reports were collected from January to December 2011; questionnaires were sent to 190 reporters, excluding those who gave multiple reports and those that refused to be contacted. Responses were obtained from 94 individuals (effective response rate: 49.5%. The median respondent age was 46.0 years. Sixty-three respondents found out about this pilot study on the Internet (67.0%. The numbers of respondents claiming that they had difficulty recalling the time/date of ADR occurrence were 16 patient

  5. 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. PMID:24955289

  6. A curated and standardized adverse drug event resource to accelerate drug safety research.

    Science.gov (United States)

    Banda, Juan M; Evans, Lee; Vanguri, Rami S; Tatonetti, Nicholas P; Ryan, Patrick B; Shah, Nigam H

    2016-01-01

    Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies. PMID:27193236

  7. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD medications in the pediatric population: a qualitative review of empirical studies

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2011-12-01

    Full Text Available Lise Aagaard1-3, Ebba Holme Hansen1-31Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark; 2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark; 3Danish Pharmacovigilance Research Project (DANPREP, Copenhagen, DenmarkBackground: To review empirical studies of adverse drug reactions (ADRs reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD symptoms in the pediatric population.Methods: PubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.Results: The review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA. The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.Conclusion: Reported ADRs from use of

  8. Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models.

    Science.gov (United States)

    Stevenson, Jennifer M; Williams, Josceline L; Burnham, Thomas G; Prevost, A Toby; Schiff, Rebekah; Erskine, S David; Davies, J Graham

    2014-01-01

    Adverse drug reaction (ADR) risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012) to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with practical design and good performance. Only then can implementation and impact be assessed with the aim of generating a model of high enough quality to be considered for use in clinical care to prioritize older people at high risk of suffering an ADR.

  9. Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

    Science.gov (United States)

    Sato, Izumi; Akazawa, Manabu

    2013-01-01

    Background The concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities. Objective This study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR) in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications. Methods Using a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs) and 95% confidence intervals (CIs) were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings. Results Of 61,661 elderly Japanese patients (men, 41.8%; 75 years or older, 35.1%) registered in the database, 2491 patients (4.0%) experienced a total of 3144 ADR events during the study period. The rate of ADR per 10,000 person-days was 2.0 for the monotherapy group, 5.1 for

  10. 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

  11. REVERSAL EFFECTS OF MIFEPRISTONE ON MULTIDRUG RESISTANCE(MDR) IN DRUG-RESISTANT BREAST CANCER CELL LINE MCF7/ADR IN VITRO AND IN VIVO

    Institute of Scientific and Technical Information of China (English)

    李大强; 潘丽华; 邵志敏

    2004-01-01

    Objective: To explore the reversal effect of mifepristone on multidrug resistance (MDR) in drug-resistant human breast cancer cell line MCF7/ADR and its mechanisms. Methods: Expression of MDR1 and MDR-associated protein(MRP) mRNA in MCF7/ADR cells was detected using reverse transcription- polymerase chain reaction(RT-PCR). Western blotting was used to assay the protein levels of P-glycoprotein (P-gp) and MRP. Intracellular rhodamine 123 retention and [3H]vincristine (VCR) accumulation were measured by flow cytometry and liquid scintillation counter, respectively. MTT reduction assay was used to determine the sensitivity of cells to the anticancer agent, adriamycin (ADR). Additionally, a MCF7/ADR cell xenograft model was established to assess the reversal effect of mifeprisone on MDR in MCF7/ADR cells in vivo. Results: Miferpristone dose-dependently down- regulated the expression of MDR1 and MRP mRNA in MCF7/ADR cells, accompanied by a significant decrease in the protein levels of P-gp and MRP. After exposure to 5, 10, and 20 μmol/L mifepristone, MCF7/ADR cells showed a 3.87-, 5.81-, and 7.40-fold increase in the accumulation of intracellular VCR(a known substrate of MRP), and a 2.14-, 4.39-, and 5.53-fold increase in the retention of intracellular rhodamine 123(an indicator of P-gp function), respectively. MTT analysis showed that the sensitivity of MCF7/ADR cells to ADR was enhanced by 7.23-, 13.62-, and 20.96-fold after incubation with mifepristone as above-mentioned doses for 96 h. In vivo, mifepristone effectively restored the chemosensitivity of MCF7/ADR cells to ADR. After 8 weeks of administration with ADR(2 mg·kg-1·d-1) alone or in combination with mifepristone(50 mg·kg-1·d-1), the growth inhibitory rate of xenografted tumors in nude mice was 8.08% and 37.25%, respectively. Conclusion: Mifepristone exerts potent reversal effects on MDR in MCF7/ADR cells in vitro and in vivo through down- regulation of MDR1/P-gp and MRP expression and inhibition of P

  12. Analysis of adverse drug reactions:on 93 cases report%药品不良反应93例分析

    Institute of Scientific and Technical Information of China (English)

    罗卿春

    2016-01-01

    目的:了解我院药品不良反应发生的特点及其引发的相关因素,为临床安全、合理用药提供依据。方法对该院2014年度收集上报的93例 ADR 报告进行回顾性分析。结果 ADR 93例,男性高于女性,50岁以上人群所占比例高于其他年龄段;引起 ADR 的因素以抗菌药物使用最高,占56.99%,其中又以β-内酰胺类居首,24例,占45.28%;损害器官、系统以皮肤及附件为主,引发 ADR 类型以一般药品不良反应为主,占94.62%。结论药品不良反应的发生与年龄、联合用药等因素有关,应加强 ADR 监测和报告工作,指导临床合理用药,减少药品不良反应的发生。%Objective To investigate the characteristics and the predisposing factors of adverse drug reactions(ADR) occurred in our hospital,the safety and rational use of drugs may be provided. Methods Analyzed 93 cases of ADRs,collected from a retrospective survey,in our hospital in 2014. Results Among 93 cases of ADRs,the male was more than the female in the ratio,proportion of people over the age of 50 was higher than other age groups;The incidence of ADR cases was mainly in-duced by the antimicrobial drugs,accounted for 56. 99% ,among which the cases that caused by β-lactamase antibiotics were acounted for the most(24cases,45. 28% );system-organ damages were common in skin and appendixes,the conventional ADR was most in the predisposing types of ADRs,accounting for 94. 62% . Conclusion Occurrence rate of ADR relates to the dis-tribution of patient age and approach of using drug. We should strengthen the monitoring and reporting work,in order to promote the rational drug use,and reduce ADRs.

  13. Analysis on 70 Cases of Serious Adverse Drug Reactions%70例严重药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张利国; 周颖; 张琼丹; 曾永兰

    2013-01-01

    Objective To understand the situation of serious adverse drug reactions ( ADR ) occurred in hospital for promoting the clinical medication safety. Methods The case reports of serious ADR during 2009-2011 were performed the retrospective analysis. Results ADR involving drugs were 6 categories 38 varieties,dominated by anticancer drugs,followed by antimicrobial drugs. The administration route was mainly intravenous infusion, accounting for 80% . The manifestations of ADR were dominated by leukopenia. Conclusion The awareness of rational drug use should be enhanced to avoid severe ADR and reduce the medical disputes.%目的 了解医院严重药品不良反应(ADR)发生情况,促进临床用药安全.方法 对2009年至2011年70例严重药品不良反应报告进行回顾性分析.结果 不良反应涉及药品6大类38种,以抗肿瘤药物为主,其次是抗微生物药物;给药途径以静脉滴注为主,占80%;不良反应表现主要以白细胞减少为主.结论 增强合理用药意识,避免严重ADR发生,减少医疗纠纷.

  14. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    Science.gov (United States)

    Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe

    2014-01-01

    Objective The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. Conclusion ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. PMID

  15. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria

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    Kenneth A Agu

    2013-01-01

    Full Text Available Aim: This study evaluated the suspected adverse drug reactions (ADR reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV positive patients receiving antiretroviral therapy (ART in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5% were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1-35.5 years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD of 1.5 (± 0.8 ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0% peripheral neuropathy, (11.4% skin rash, (10.1% pruritus and (6.5% dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05 unlike gender. Anaemia was associated with Zidovudine (AZT/ Lamivudine (3TC /Nevirapine (NEV regimen [Odds ratio, OR = 6.4 (3.0-13.8; P < 0.0001], and peripheral neuropathy with Stavudine (d4T/3TC/NEV regimen [OR = 8.7 (5.8-30.0, P < 0.0001] and Tenofovir (TDF/Emtricitabine (FTC/Efavirenz (EFV regimen [OR = 2.1 (1.0-4.1, P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3-6.6, P = 0.0056] and 45-59years [OR = 1.9 (1.3-2.7, P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9-349.6, P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS [OR = 50.2 (0.9-562.1, P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to

  16. 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...... direct encountering and questioning with drug users. METHOD: Pharmacy students undertaking internship in a community pharmacy were approached. Thirteen students from nine community pharmacies participated in the project as data collectors. Prior to the study students attended an educational seminar...... focusing on ADR detection and reporting in general. Ibuprofen was chosen as the drug of study. Pharmacy students approached recurrent drug users purchasing the drug. Participating users were asked about experienced ADRs linked to ibuprofen use. Reported ADRs were collected and analysed. RESULTS: Hundred...

  17. PROSPECTIVE OBSERVATIONAL, NON-RANDOMIZED, PARALLEL SEQUENCE STUDY FOR ASSESSMENT OF ADVERSE DRUG REACTIONS DUE TO CHEMOTHERAPEUTIC TREATMENT IN DIFFERENT TYPES OF CANCER PATIENTS

    Directory of Open Access Journals (Sweden)

    Mrugank B.P. * and Hareesha R.P.

    2013-01-01

    Full Text Available Objective: To assess incidence, causality, severity, predictability and preventability of adverse drug reactions (ADRs in hospitalised oncology patients.Materials and Methods: A prospective observational, non-randomized, parallel sequence study was conducted at Dr B. Borooah Cancer Institute (BBCI after getting an approval from human ethical committee. Patients hospitalised at BBCI from Aug 2010 to June 2011 were interviewed about symptoms related to their drug therapy. Patient medical records were also reviewed for data collection.Results: Total 663 patients associated with hospitalizations were interviewed. 899 ADRs were identified in total 410 (61.84% patients detected with ADRs. Most of all ADRs were moderate, predictable and not preventable. The most common ADRs were leucopenia, weakness, anorexia, alopecia, vomiting, diarrhoea, nausea, abdominal pain, fatigue, and anaemia in this study.Conclusions: For definite conclusion study should be repeated. Strict drug analyzing and in vivo study is also required if feasible.Key message: The process of defining and concluding about ADRs should be continuous and ongoing to keep a record of newly marketed drugs and medicinal products.

  18. Identification of possible adverse drug reactions in clinical notes:the case of glucose-lowering medicines

    OpenAIRE

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise; Jensen, Lars Juhl; Brunak, Søren; Krag, Malene Hammer; Rossing, Peter; Almdal, Thomas; Andersen, Henrik Ullits; Hansen, Ebba Holme

    2015-01-01

    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-glucose lowering medicines" (A10BD), "dipeptidyl peptidase-4 (DDP-4) inhibitors" (A10BH), and "other blood glucose lowering medicines" (A10BX). Specifically, we aimed to describe the potential of clinical notes ...

  19. 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

    2016-01-01

    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 Ce

  20. Psychiatric Adverse Effects of Dermatological Drugs

    Directory of Open Access Journals (Sweden)

    Mine Özmen

    2010-07-01

    Full Text Available Dermatological drugs, mostly corticosteroids and isotretinoin, cause different psychiatric adverse effects. During steroid therapy, a wide range of psychiatric conditions, from minor clinical symptoms like insomnia and anxiety to serious psychiatric syndromes like psychosis and delirium might be seen. In medical literature, a causal connection is usually suggested between “isotretinoin”, which is used for treatment of acne vulgaris and depression and suicide attempts. However, there are no statistically significant double-blind randomized studies that support this connection. Clinicians must know patient’s psychiatric history before using any dermatological treatment known as causing psychiatric adverse effects, and psychiatric consultation should be established whenever necessary.

  1. 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

  2. Adverse reactions following mass drug administration with diethylcarbamazine in lymphatic filariasis endemic areas in the Northeast of Brazil

    Directory of Open Access Journals (Sweden)

    Ana Wládia Lima

    2012-12-01

    Full Text Available INTRODUCTION: The Global Programme to Eliminate Lymphatic Filariasis was launched with the goal of eliminating this disease via the annual mass drug administration (MDA of a single dose of antifilarial drugs. Adverse drug reactions following MDA are a major factor of poor treatment adherence in several countries. This study assessed the occurrence of adverse drug reactions (ADRs following the first round of mass treatment in two communities treated with different dosages of diethylcarbamazine (DEC in the City of Recife, Brazil. METHODS: Population-based cross-sectional surveys were conducted in a random sample of the population living in both communities (Areas I and II. The dose of DEC recommended by the WHO (6mg/kg was calculated based on the individual's weight-for-age. In Area II, weight differences between the genders were also considered when determining dosage. Data were obtained through interviews conducted in the first 12 to 48h and on the 5th day after MDA during household visits. RESULTS: A total of 487 and 365 individuals were interviewed in Areas I and II, respectively. The prevalence of ADRs in Area I (23.6; 95%CI: 19.1-29.5 was higher than in Area II (16.2; 95%CI:11.9-21.5(p=0.0078. The prevalence of ADRs among females was higher than in males in Area I (p=0.0021. In Area II, no significant difference between the genders was observed (p=0.1840. Age was not associated with ADRs in either area. CONCLUSIONS: Adjusting MDA dosage schedules according to weight-for-age and sex may be may contribute to reduce the occurrence of adverse drug reactions in the population.

  3. 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. Obj

  4. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India

    Directory of Open Access Journals (Sweden)

    Farhan Ahmad Khan

    2013-10-01

    Full Text Available Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs. This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs. Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively. Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45% followed by 61-80 age (37.29% and least from >80 yr (3.24%. But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%. The most commonly prescribed antibacterials were β-Lactams (64.61%. Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B. Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients. [Int J Basic Clin Pharmacol 2013; 2(5.000: 548-553

  5. Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

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    Katja Marja Hakkarainen

    Full Text Available PURPOSE: Adverse drug events (ADEs are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs and sub-therapeutic effects (STEs. METHODS: In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥ 18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18-44, 45-64, or ≥65 years were compared. RESULTS: Of 7099 respondents (response rate 51.0%, ADEs were reported by 19.4% (95% confidence interval, 18.5-20.3%, and the prevalence did not differ by age group (p>0.05. The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2-8.4%, 7.6% (7.0-8.2% and 8.1% (7.5-8.7%, respectively. The prevalence of self-reported drug dependence was 2.2% (1.9-2.6%, and drug intoxications 0.2% (0.1-0.3%. The respondents considered 19.2% (14.8-23.6% of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar. CONCLUSIONS: One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs from

  6. Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz

    Science.gov (United States)

    Abah, Isaac Okoh; Akanbi, Maxwell; Abah, Mercy Enuwa; Finangwai, Amos Istifanus; Dady, Christy W; Falang, Kakjing Dadul; Ebonyi, Augustine Odoh; Okopi, Joseph Anejo; Agbaji, Oche Ochai; Sagay, Altiene Solomon; Okonkwo, Prosper; Idoko, John A; Kanki, Phyllis J

    2015-01-01

    Introduction Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART). Methods This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. Results A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. Conclusion Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up. PMID:26405676

  7. Cutaneous adverse drug reactions caused by antituberculosis drugs.

    Science.gov (United States)

    Rezakovic, Saida; Pastar, Zrinjka; Kostovic, Kresimir

    2014-01-01

    Multidrug antituberculosis regimen is associated with diverse clinical patterns of cutaneous adverse drug reactions (CADR), ranging from mild and moderate such as pruritus, maculopapular exanthems, lichenoid eruptions, fixed drug eruptions and urticaria to severe and even life threatening ones like acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These adverse reactions to antituberculosis drugs are commonly observed adverse events. This is of particular importance for high HIV prevalence settings and developing countries where tuberculosis is common infection resulting in higher occurrence rate of these reactions. There is still significant heterogenity in definition and classification of CADR, as well as diversity in treatment modalities following adverse reactions and rechallenge management. The aim of this review is to discuss clinical presentation, occurrence of CADR caused by antituberculosis drugs, to identify risk factors for intolerance of the standard therapy as well as to draw attention to importance of multi-disciplinary approach, early detection, prompt diagnosis and in time management of antituberculosis drugs associated CADR. CADR can cause significant treatment interruption and alteration, resulting in increased risk of treatment failure, drug resistance, relapses and increased risk of complications including even lethal outcome. Finally, it can be concluded that it is of great importance to identify the best possible treatment and preventive regimens in order to enable continuity of the antituberculosis therapy to the full extent. PMID:25039910

  8. Pharmacogenetics of idiosyncratic adverse drug reactions.

    Science.gov (United States)

    Pirmohamed, Munir

    2010-01-01

    Idiosyncratic adverse drug reactions are unpredictable and thought to have an underlying genetic etiology. With the completion of the human genome and HapMap projects, together with the rapid advances in genotyping technologies, we have unprecedented capabilities in identifying genetic predisposing factors for these relatively rare, but serious, reactions. The main roadblock to this is the lack of sufficient numbers of well-characterized samples from patients with such reactions. This is now beginning to be solved through the formation of international consortia, including developing novel ways of identifying and recruiting patients affected by these reactions, both prospectively and retrospectively. This has been led by the research on abacavir hypersensitivity - its association with HLA-B*5701 forms the gold standard of how we need to identify associations and implement them in clinical practice. Strong genetic predisposing factors have also been identified for hypersensitivity reactions such as are associated with carbamazepine, allopurinol, flucloxacillin, and statin-induced myopathy. However, for most other idiosyncratic adverse drug reactions, the genetic effect sizes have been low to moderate, although this may partly be due to the fact that only small numbers have been investigated and limited genotyping strategies have been utilized. It may also indicate that genetic predisposition will be dependent on multiple genes, with complex interactions with environmental factors. Irrespective of the strength of the genetic associations identified with individual idiosyncratic adverse drug reactions, it is important to undertake functional investigations to provide insights into the mechanism(s) of how the drug interacts with the gene variant to lead to a phenotype, which can take a multitude of clinical forms with variable severity. Such investigations will be essential in preventing the burden caused by idiosyncratic reactions, both in healthcare and in industry

  9. Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

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    Sato I

    2013-06-01

    Full Text Available Izumi Sato,1 Manabu Akazawa21Department of Epidemiology and Statistics, Graduate School of Medicine, The University of Tokyo Tokyo, Japan; 2Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, JapanBackground: The concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities.Objective: This study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications.Methods: Using a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs and 95% confidence intervals (CIs were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings.Results: Of 61,661 elderly

  10. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

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    Perrone V

    2014-12-01

    Full Text Available Valentina Perrone,1,* Valentino Conti,2,* Mauro Venegoni,2 Stefania Scotto,2 Luca Degli Esposti,3 Diego Sangiorgi,3 Lucia Prestini,4 Sonia Radice,1 Emilio Clementi,5,6 Giuseppe Vighi,2,4 1Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 2Regional Centre for Pharmacovigilance, Lombardy, Milan, Italy; 3CliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy; 4Unit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca’Granda Hospital, Milan, Italy; 5Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 6Scientific Institute, IRCCS Eugenio Medea, Lecco, Italy *These authors contributed equally to the work Objective: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs reported in emergency departments (EDs and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal

  11. Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models

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    Stevenson JM

    2014-09-01

    Full Text Available Jennifer M Stevenson,1,2 Josceline L Williams,1,2 Thomas G Burnham,2 A Toby Prevost,3 Rebekah Schiff,4 S David Erskine,2 J Graham Davies1 1Institute of Pharmaceutical Sciences, King’s College London, London, UK; 2Pharmacy Department, St Thomas’ Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 3Department of Primary Care and Public Health Sciences, King’s College London, London, UK; 4Department of Ageing and Health, Guy’s and St Thomas’ NHS Foundation Trust, London, UK Abstract: Adverse drug reaction (ADR risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012 to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with

  12. Serum tryptase levels in adverse drug reactions.

    Science.gov (United States)

    Ordoqui, E; Zubeldia, J M; Aranzábal, A; Rubio, M; Herrero, T; Tornero, P; Rodríguez, V M; Prieto, A; Baeza, M L

    1997-11-01

    We evaluated the usefulness of individual tryptase levels and variations after adverse drug reactions in 64 patients. Our aim was to find a tool for the diagnosis of drug allergy. Thirty-seven subjects were confirmed to have drug allergy, 12 had nonsteroidal anti-inflammatory drug (NSAID) reactions, five had negative controlled drug challenges (NAAR), and 10 had symptoms after placebo intake (PLA). Serum tryptase levels greatly increased after anaphylactic shocks (2242%) and anaphylaxis (710.5%). Patients with allergic urticaria and those with idiosyncratic responses to acetylsalicylic acid (ASA) exhibited a small increase in serum tryptase (49.5% and 38.2%, respectively). In the other two groups (NAAR and PLA), no variation in this serum protease was observed. The time of appearance of the serum tryptase peak differed considerably among patients with similar clinical reactions (from 30 min to 6 h) and was independent of the latent period, severity of symptoms, or the amount of tryptase released. We conclude that serum tryptase determinations are helpful in the diagnosis of anaphylactic shock and anaphylaxis, but serial measurements may be needed to confirm mast-cell participation in milder reactions.

  13. Adverse Drug Reactions Reported in Our Hospital: Analysis of 560 Cases%我院560例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张夏华; 吴广通; 石玉岚; 米丽

    2009-01-01

    To probe into the status quo and characteristics of the adverse drug reactions (ADR) occurred in our hospital. METHODS: A total of 560 ADR cases collected in our hospital from 2004 to 2008 were analyzed statistically in respect of patients' age and sex, drug varieties, route of administration and clinical manifestation, etc. RESULTS: Of all the ADR cases reported in our hospital, 51.8% were induced by anti-infective drugs vs. 10.7% by traditional Chinese medicines; 51.8% manifested as lesions of skin and its appendants, but none of them died. CONCLUSION: Clinical importance should be attached to the monitoring of ADR, the indications of the anti-infective drugs and traditional Chinese medicines should be strictly followed in order to decrease the incidence of ADR.%目的:了解我院药品不良反应(ADR)的发生情况及特点.方法:将我院2004~2008年收集的ADR报告560例,按患者性别、年龄、涉及药品种类、给药途径、临床表现等进行统计、分析.结果:在我院上报的ADR中,抗感染药引发的ADR占51.8%,中药制剂占10.7%;ADR类型以皮肤及其附件损伤最常见,占51.8%,无死亡病例报道.结论:临床应加强ADR监测工作,尤其要严格把握抗感染药及中成药的使用指征,减少ADR的发生.

  14. Transfer of p14ARF gene in drug-resistant human breast cancer MCF-7/Adr cells inhibits proliferation and reduces doxorubicin resistance

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Objective: To elucidate the effect of p14ARF gene on multidrug-resistant tumor cells. Methods: We transferred a p14ARF cDNA into p53-mutated MCF-7/Adr human breast cancer cells. Results: In this report we demonstrated for the first time that p14ARF expression was able to greatly inhibit the MCF-7/Adr cell proliferation. Furthermore, p14ARF expression resulted in decreases in MDR1 mRNA and P-glycoprotein production, which linked with the reducing resistance of MCF-7/Adr cells to doxorubicin. Conclusion: These results imply that drug resistance might be effectively reversed with the wild-type p14ARF expression in human breast cancer cells.

  15. 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

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    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

  16. 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.

    2015-01-01

    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

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

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    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

  18. Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

    Science.gov (United States)

    Umar, Muhammad Tukur; Bello, Shaibu Oricha; Chika, Aminu; Oche, Oche Mansur

    2016-01-01

    Objective: Objective of this study was to assess the attitude of nurses and pharmacists towards adverse drug reactions (ADRs) reporting. Methods: The questionnaire was designed based on extended “Inman seven deadly sins.” Two hundred and seventy-two respondents were selected by stratified sampling technique. The questionnaires were delivered to the respondents at their places of practice. The data generated were analyzed by Sigma XL Software Inc. Findings: There was no statistically significant relationship between demographic profiles and reporting attitude except for qualification. On extended “Inman seven deadly sins” awareness of reporting protocol and nearby center for ADRs reporting were low 27.3 and 7.5%, respectively. However, respondents’ score on components of attitude of ADRs reporting is generally encouraging. On comparative basis, no statistical significance exists between pharmacists and nurses. Conclusion: The study showed that attitude of respondents towards ADRs reporting is good. However, there is a need for targeted health education intervention among these cadres of health-care professionals, especially on aspects of awareness of reporting protocol and reporting center.

  19. Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”

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    Dobashi A

    2016-04-01

    Full Text Available Akira Dobashi,1 Kaori Kurata,1 Mitsuhiro Okazaki,2,3 Mari Nishizawa4 1Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Hachioji, Tokyo, 2Faculty of Health Sciences, Health Innovation and Technology Center, Hokkaido University, Hokkaido, 3Cross Care Field Co., Ltd., 4Yakuju Corporation, Tokyo, Japan Purpose: Spontaneous inquiries about the development of adverse drug reactions (ADRs to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”. Our aim was to clarify the characteristics related to people’s descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry. Methods: Fifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term “Fukusayō” (ADR in Japanese that were posted from July 2004 to June 2009 were extracted from the site. Results: Among 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s. Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525. Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine. Conclusion: Our examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms

  20. Colombian ADRs: Why so few?

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    Maximiliano González

    2011-12-01

    Full Text Available We address the question of why Colombian companies have had such a limited presence in the American Depositary Receipts (ADRs market. Traditional explanations state that weak investor protection and the degree of economic and financial development in Colombia increase the cost of entry in the ADR market. However, in the case of Colombia these explanations do not suffice because in these respects Colombia is no different from other Latin American countries. Using a theoretical model, we show that additional factors such as drug trafficking and armed conflict better explain why Colombian firms have moved away from the ADRs market

  1. 560例黄芪注射液不良反应/事件文献分析%Literature Analysis on 560 Cases of Adverse Drug Reactions/Events of Astragalus Injection

    Institute of Scientific and Technical Information of China (English)

    王月; 郭利平; 商洪才; 胡晶; 付姝菲

    2011-01-01

    目的 探讨黄芪注射液所致不良反应(ADR)或不良事件(AE)发生情况及其相关因素.方法 检索中国期刊全文数据库、中文科技期刊全文数据库及中国生物医学文献数据库1995年1月~2010年5月关于黄芪注射液的临床研究及ADR报告.纳入文献共2690篇,提取分析纳入文献中ADR/AE病例原患疾病、黄芪注射液用药剂量、溶媒及配伍用药情况.ADR/AE病例的性别、年龄及有无过敏史情况,ADR/AE出现时间、类型、处理及转归等.结果 2604篇临床研究中有132篇共报道448例ADR/AE病例;86篇ADR报告共包括112例ADR/AE病例.ADR/AE病例总体多发生于40~69岁年龄段;ADR报告的ADR/AE主要集中于全身反应(发热、过敏性休克),临床研究的ADR/AE最多见于消化系统(恶心);84.46%的ADR/AE病例严重程度为Ⅲ~Ⅳ级,无死亡病例;ADR/AE病例原患疾病最主要为心肌炎和心功能衰竭;13例(11.61%)ADR/AE病例有过敏史;黄芪注射液ADR/AE病例所用溶媒主要为5%葡萄糖液、10%葡萄糖液和生理盐水,共107例(19.10%)ADR/AE病例为黄芪注射液和其他药物配伍使用;首次用药者ADR/AE病例占总ADR/AE的66.96%.结论 黄芪注射液ADR/AE的发生是由多因素导致,临床使用须以说明书为参照,辨证使用,严格掌握用药禁忌,使用前询问过敏史,慎重选用溶媒,做好全程监控及随访.%Objective To analyze the adverse drug reactions (ADR) or adverse events (AE) of Astragalus Injection and their related factors.Methods All the clinical studies and adverse reaction reports on the Astragalus Injection from January 1995 to May 2010 in the CNKI, VIP, and CBM database were retrieved and totally 2 690 papers were enrolled for analysis.The information of the ADR/AE cases such as the original diseases, dosage, and compatibility of the Astragalus Injection; the age, gender and allergic history of patients; the happening time, type, treatment, and prognosis of the ADR/AE was

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba H

    2010-01-01

    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...

  3. 748例β-内酰胺类抗菌药物不良反应分析%Analysis on 748 Cases of β-lactam Antibiotics Drug Adverse Reaction

    Institute of Scientific and Technical Information of China (English)

    张树强; 邢蓉; 王群; 师佩兰; 谢冬梅; 许健

    2011-01-01

    目的 了解蚌埠地区β-内酰胺类抗菌药物致药品不良反应(ADR)的发生情况.方法 对2010年1~12月蚌埠地区上报的748例β-内酰胺类抗菌药物ADR病例报告,按性别、年龄、给药途径、药品类别、ADR累及系统-器官及临床表现等进行统计、分析.结果 ADR涉及的β-内酰胺类抗菌药物共26种,ADR发生频次以阿莫西林居首位,其次为头孢氨苄和头孢拉啶;主要的ADR类型为皮肤及其附件损害,占47.48%;1例严重ADR.结论 应规范β-内酰胺类抗菌药物的临床应用,以减少ADR的发生率.%Objective To investigate the situation of β- lactam antibiotics drug adverse reactions in Bengbu region. Method According to gender, age, administration route, drug category, organs or systems, clinical manifestations Involved with ADR, and so on, 748 cases of β-lactam antibiotics drag adverse reactions in Bengbu region reported from Jan 2010 to Dec 2010 were analyzed. Results 26 β-lactam antibiotics drugs were involved with ADR. As to the ADR frequence, the highest was related to amoxicillin, and then were related to cephalexin and cephradine. The major organ-system damage involved in ADR was skin and appendages disorders, which accounted for 47.48% of the total, and a serious ADR occurred. Conclusion Clinical appliance of β-lactam antibiotics drug should be standardized to reduce the ADR incidence.

  4. 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.

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

    International Nuclear Information System (INIS)

    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

  6. 碘对比剂的不良反应分析%Analysis the adverse drug reaction of iodine contrast agent

    Institute of Scientific and Technical Information of China (English)

    谢升阳

    2013-01-01

    Adopt a retrospective study method,66 cases adverse drugs reaction (ADR) of iodine contrast agent in Zhejiang Traditional Chinese Medical Hospital from 2009 to 2012 were analyzed.ADR of iodine contrast agent have variety of clinical manifestations.The most common is skin allergy,skin allergy have 46 cases(69.70%),11 cases (16.67%)occur in digestive system.%用回顾性研究方法,对本院2009~2012年收集的66例碘对比剂的药物不良反应(ADR)进行归纳分析.碘对比剂ADR的临床表现多种多样,以皮肤过敏最常见,皮肤过敏共46例(占69.70%),消化系统11例(占16.67%).

  7. Association between thiopurine S-methyltransferase polymorphisms and thiopurine-induced adverse drug reactions in patients with inflammatory bowel disease: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yue-Ping Liu

    Full Text Available Thiopurine drugs are well established treatments in the management of inflammatory bowel disease (IBD, but their use is limited by significant adverse drug reactions (ADRs. Thiopurine S-methyltransferase (TPMT is an important enzyme involved in thiopurine metabolism. Several clinical guidelines recommend determining TPMT genotype or phenotype before initiating thiopurine therapy. Although several studies have investigated the association between TPMT polymorphisms and thiopurine-induced ADRs, the results are inconsistent. The purpose of this study is to evaluate whether there is an association between TPMT polymorphisms and thiopurine-induced ADRs using meta-analysis.We explored PubMed, Web of Science and Embase for articles on TPMT polymorphisms and thiopurine-induced ADRs. Studies that compared TPMT polymorphisms with-ADRs and without-ADRs in IBD patients were included. Relevant outcome data from all the included articles were extracted and the pooled odds ratio (OR with corresponding 95% confidence intervals were calculated using Revman 5.3 software.Fourteen published studies, with a total of 2,206 IBD patients, which investigated associations between TPMT polymorphisms and thiopurine-induced ADRs were included this meta-analysis. Our meta-analysis demonstrated that TPMT polymorphisms were significantly associated with thiopurine-induced overall ADRs and bone marrow toxicity; pooled ORs were 3.36 (95%CI: 1.82-6.19 and 6.67 (95%CI: 3.88-11.47, respectively. TPMT polymorphisms were not associated with the development of other ADRs including hepatotoxicity, pancreatitis, gastric intolerance, flu-like symptoms and skin reactions; the corresponding pooled ORs were 1.27 (95%CI: 0.60-2.71, 0.97 (95%CI: 0.38-2.48, 1.82 (95%CI: 0.93-3.53, 1.28 (95%CI: 0.47-3.46 and 2.32 (95%CI: 0.86-6.25, respectively.Our meta-analysis demonstrated an association of TPMT polymorphisms with overall thiopurine-induced ADRs and bone marrow toxicity, but not with

  8. 药物不良反应的遗传药理学研究进展%Research advances in pharmacogenetics and adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    陈旺青; 张伟

    2011-01-01

    药物不良反应(adverse drug reactions,ADRs)目前已成为危害人类健康的重要公共卫生问题,不仅损害国民健康而且对社会经济造成难以估量的损失,因而如何合理用药避免药物不良反应具有重要意义.导致药物不良反应的原因众多,如药物、环境、机体、用药和其他因素等.随着人类基因组计划的完成和药物遗传靶标的不断发现,药物不良反应的遗传因素已成为研究药物不良反应的一个全新领域.本文主要阐述遗传因素与药物不良反应的关系.%Adverse drug reactions (ADRs) have become an important public health issue that hazards to human health, which has caused immeasurable losses to national health and economics, so it is of great significance to explore how to use drugs rationally. Many factors lead to ADRs, such as those from drugs, environments, organisms, drug administration and others. With the development of human genome project and the continuing discoveries of genetic targets, the studying of genetic factors in ADRs has become a new field. This paper described the various genetic factors impacting ADRs.

  9. 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.

  10. 莫西沙星的严重不良反应及其防范%Severe Adverse Drug Reactions Induced by Moxifloxacin and Their Prevention

    Institute of Scientific and Technical Information of China (English)

    陈晨钟; 史道华

    2011-01-01

    目的:提示临床高度关注莫西沙星的不良反应.方法:检索我院不良反应监测系统,对其中莫西沙星产生的3例严重不良反应报告进行分析.结果:3例莫西沙星严重不良反应中,暴发性肝衰竭1例,经抢救无效死亡;过敏性休克2例,经抢救未产生严重后果.结论:临床应重视莫西沙星严重不良反应的危害性.%OBJECTIVE: To prompt the adverse drug reactions (ADR) of moxifloxacin should be paid high attention to clinic.METHODS: Retrieved from ADR reporting and monitoring system of our hospital, 3 serious ADR cases induced by moxifloxacin were analyzed. RESULTS: Among 3 serious ADR cases induced by moxifloxacin, one case developed fulminant hepatic failure leading to death after rescue, and other 2 patients with anaphylactic shock was recovered without severe consequence after rescue.CONCLUSION:Great importance should be attached to ADR induced by moxifloxacin in the clinic.

  11. Rough-set-based ADR signaling from spontaneous reporting data with missing values.

    Science.gov (United States)

    Lin, Wen-Yang; Lan, Lin; Huang, Feng-Hsiung; Wang, Min-Hsien

    2015-12-01

    Spontaneous reporting systems of adverse drug events have been widely established in many countries to collect as could as possible all adverse drug events to facilitate the detection of suspected ADR signals via some statistical or data mining methods. Unfortunately, due to privacy concern or other reasons, the reporters sometimes may omit consciously some attributes, causing many missing values existing in the reporting database. Most of research work on ADR detection or methods applied in practice simply adopted listwise deletion to eliminate all data with missing values. Very little work has noticed the possibility and examined the effect of including the missing data in the process of ADR detection. This paper represents our endeavor towards the exploration of this question. We aim at inspecting the feasibility of applying rough set theory to the ADR detection problem. Based on the concept of utilizing characteristic set based approximation to measure the strength of ADR signals, we propose twelve different rough set based measuring methods and show only six of them are feasible for the purpose. Experimental results conducted on the FARES database show that our rough-set-based approach exhibits similar capability in timeline warning of suspicious ADR signals as traditional method with missing deletion, and sometimes can yield noteworthy measures earlier than the traditional method.

  12. Cutaneous adverse drug reactions in dogs treated with antiepileptic drugs

    Directory of Open Access Journals (Sweden)

    Tina eKoch

    2016-04-01

    Full Text Available Epilepsy is one of the most common neurologic disorders in dogs and life-long treatment with antiepileptic drugs (AED is frequently required. Adverse events of antiepileptic drugs targeting the skin are only rarely reported in veterinary medicine and the true incidence and spectrum of cutaneous reactions in epileptic dogs remains unknown. In this study we hypothesized that cutaneous reactions commonly occur in epileptic dogs and are related to AED treatment. A retrospective case review of 185 dogs treated for epilepsy identified 20.0% with simultaneous appearance of dermatologic signs. In a subsequent prospective case investigation (n=137 we identified newly appearing or distinct worsening of skin lesions following initiation of antiepileptic drug therapy in 10.9% of dogs treated for epilepsy (95% CI 6.8- 17.7%. Cutaneous lesions were classified as probably drug-induced in 40.0% of these cases. Patch-testing and intradermal testing was further investigated as potential diagnostic methods to confirm antiepileptic drug hypersensitivity. They were of high specificity but sensitivity and positive predictive value appeared inappropriate to recommend their routine use in clinical practice.

  13. Ci4SeR--curation interface for semantic resources--evaluation with adverse drug reactions.

    Science.gov (United States)

    Souvignet, Julien; Asfari, Hadyl; Declerck, Gunnar; Lardon, Jérémy; Trombert-Paviot, Béatrice; Jaulent, Marie-Christine; Bousquet, Cédric

    2014-01-01

    Evaluation and validation have become a crucial problem for the development of semantic resources. We developed Ci4SeR, a Graphical User Interface to optimize the curation work (not taking into account structural aspects), suitable for any type of resource with lightweight description logic. We tested it on OntoADR, an ontology of adverse drug reactions. A single curator has reviewed 326 terms (1020 axioms) in an estimated time of 120 hours (2.71 concepts and 8.5 axioms reviewed per hour) and added 1874 new axioms (15.6 axioms per hour). Compared with previous manual endeavours, the interface allows increasing the speed-rate of reviewed concepts by 68% and axiom addition by 486%. A wider use of Ci4SeR would help semantic resources curation and improve completeness of knowledge modelling.

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    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...... not mentioned in PIs issued in the United States. In conclusion, information about possible ADRs associated with the use of a specific product should be made available worldwide, as the prescriber information about medicines' safety profile should not depend on the country in which the medication is licensed....... categories and for modafinil 115 ADR categories were listed. For both substances approximately 60% of listed ADRs were found in all three countries. Discrepancies were primarily detected for ADRs information based on clinical trials. For methylphenidate, many ADRs labelled in Australia and Denmark were...

  15. Global patterns of adverse drug reactions over a decade

    DEFF Research Database (Denmark)

    Aagaard, Lise; Strandell, Johanna; Melskens, Lars;

    2012-01-01

    , 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...

  16. Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

    OpenAIRE

    2011-01-01

    BackgroundThiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs.MethodsType 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: ...

  17. 我院129例喹诺酮类抗菌药物致不良反应报告分析%Analysis of 129 Cases of Adverse Drug Reactions Induced by Quinolones

    Institute of Scientific and Technical Information of China (English)

    金伟华; 王晓蕙; 陈华; 谭永红

    2011-01-01

    目的:探讨喹诺酮类药物致不良反应(ADR)的特点,为其临床合理应用提供参考.方法:收集2004年1月-2011年1月我院应用喹诺酮类抗菌药物致ADR的临床资料,进行总结、分析.结果:我院共报告129例喹诺酮类致ADR,涉及8个药品种类,左氧氟沙星最多,发生86例,占66.67%;从受损系统或器官看,皮肤及附件最多,发生49例,占37.98%.结论:临床应重视合理使用喹诺酮类抗菌药物,杜绝或减少ADR的重复发生.%OBJECTIVE: To explore the characteristics of adverse drug reactions (ADR) induced by quinolones and to provide reference for rational drug use in the clinic. METHODS: Clinical information of ADR induced by quinolones collected from our hospital during Jan. 2004-Jan. 2011 were analyzed and summarized. RESULTS: 129 ADR cases induced by quinolones in our hospital involved 8 drug categories. Main type of ADR-inducing drugs was levofloxacin (86 cases, accounting for 66.67% ). In respective of injured system and site, lesion of skin and its appendants occupied great proportion and appeared in 49 cases, accounting for 37.98%. CONCLUSION: To use quinolones rationally and great importance should be attached to the adverse consequences of its ADR.

  18. Adaptation and validation of an adverse drug reaction preventability score for bleeding due to vitamin K antagonists.

    Science.gov (United States)

    Liabeuf, Sophie; Masmoudi, Kamel; Scailteux, Lucie-Marie; Moragny, Julien; Masson, Henri; Brnet-Dufour, Valérie; Andrejak, Michel; Gras-Champel, Valérie

    2016-09-01

    Although drug therapy is inherently associated with the risk of adverse drug reactions (ADRs), some of these events are preventable. The estimated proportion of preventable ADRs varies from one study or clinical context to another. Bleeding caused by antithrombotic agents (and particularly vitamin K antagonists, VKAs) constitutes one of the most frequent causes of ADR-related hospitalization.Hence, the objective of the present study was to adapt and validate an ADR preventability score for bleeding due to VKAs and evaluate the preventability of bleeding in 906 consecutive hospitalized, VKA-treated adult patients with a risk of major bleeding (defined as an international normalized ratio ≥5) over a 2-year period. A specific preventability scale for VKA-associated bleeding was developed by adapting a published tool.Overall, 241 of the 906 patients in the study experienced at least 1 VKA-associated bleeding event. The scale's reliability was tested by 2 different evaluators. The inter-rater reliability (evaluated by calculation of Cohen's kappa) ranged from "good" to "excellent." Lastly, the validated scale was used to assess the preventability of the VKA-associated bleeding. We estimated that bleeding was preventable or potentially preventable in 109 of the 241 affected patients (45.2%).We have developed a useful, reliable tool for evaluating the preventability of VKA-associated bleeding. Application of the scale in a prospective study revealed that a high proportion of VKA-associated bleeding events in hospitalized, at-risk adult patients were preventable or potentially preventable. PMID:27684801

  19. Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

    Science.gov (United States)

    Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

    2016-01-01

    Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

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

    Directory of Open Access Journals (Sweden)

    JiHyeon Ryu

    Full Text Available 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 < 0.001, and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001. Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001 but not among 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 < 0.001.We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health

  1. 环丙沙星致不良反应46例文献分析%Literature Analysis of 46 Cases of Adverse Drug Reaction Induced by Ciprofloxacin

    Institute of Scientific and Technical Information of China (English)

    杨月琴; 韩志云

    2012-01-01

    OBJECTIVE: To discuss the characteristics and rules of ciprofloxacin-induced adverse drug reactions (ADR), and to provide reference for rational drug use in the clinic. METHODS: Retrieved from CNKI database, literatures about ciprofloxacin-induced ADR were collected and analyzed statistically. RESULTS: Ciprofloxacin can cause many types of ADR, the main ADR was systemic damage (27 cases, accounting for 58.70%), it can also cause rare symptom, including cardiac arrest. The male was higher than the female; ADR can be caused by intravenous infusion and oral administration, ADR induced by intravenous administration mostly occurred 1~20 min and oral administration in 1~6 h; ADR prognosis was satisfactory. CONCLUSION: Ciprofloxacin can cause a variety of ADR, so we should pay attention to its clinical applications and safety.%目的:探讨环丙沙星致不良反应(ADR)发生的规律及特点,为临床合理用药提供参考.[方法]:通过中国知网数据库(CNKI)检索有关环丙沙星ADR的文献,并进行统计、分析及评价.[结果]:环丙沙星可引起多种类型ADR,以全身性损害为主(27例,占58.70%),亦可引起心脏骤停等罕见ADR;其ADR发生率男性较女性稍高;静脉滴注和口服给药均可能发生ADR,静脉滴注给药多在用药1~20 min内发生,而口服给药多在用药1~6h内发生;ADR预后均较好.[结论]:环丙沙星可引起多种ADR,临床应用须高度重视其安全性.

  2. Promoting adverse drug reaction reporting: comparison of different approaches

    Directory of Open Access Journals (Sweden)

    Inês Ribeiro-Vaz

    2016-01-01

    Full Text Available ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each, followed by first educational approach (265 reports, 20.31 €/report and by the hyperlink approach (136 reports, 15.59 €/report. Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs. Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report, followed by first educational approach (38.79 €/report. CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

  3. Mechanism study of PEGylated polyester and β-cyclodextrin integrated micelles on drug resistance reversal in MRP1-overexpressed HL60/ADR cells.

    Science.gov (United States)

    Ji, Qian; Qiu, Liyan

    2016-08-01

    Chemotherapy is one of the main strategies for cancer treatment, but its effective application is seriously limited by the development of drug resistance. In this study, we designed micellar vectors for doxorubicin based on amphiphilic copolymers sequentially linking β-cyclodextrin (β-CD), polylacticacid (PLA) or polycaprolactone (PCL) block, and polyethylene glycol (PEG) block to overcome drug resistance in human acute myeloid leukemia cells (HL60/ADR) overexpressing multidrug resistance protein 1 (MRP1). The significant enhancement in cytotoxicity and inhibited HL60/ADR tumor growth in mouse was achieved. More importantly, several analyses were performed to understand the interactions between various polymers and MRP1 at the cellular level. The results showed that the polymers did not show remarkable correlation of MRP1 gene and protein expression, but could decrease intracellular ATP, mitochondrial membrane potential and glutathione levels, which was greatly dependent on the molecular structure of polymers. In conclusion, these novel micelles can be considered as a kind of promising drug delivery system for tumor therapy to reverse drug resistance related to MRP1 overexpression. PMID:27088190

  4. The Survey of Healthcare Professionals on Cognition Degree for Adverse Drug Reaction in Jiayuguan%对嘉峪关市医务人员药品不良反应认知度的调查与研究

    Institute of Scientific and Technical Information of China (English)

    郝军祥; 严疏; 刘光斌; 刘效栓; 杨东瑞; 张莉; 李润军; 刘虎

    2011-01-01

    目的 了解嘉峪关市各级医院医务人员对药品不良反应(ADR)认知度,为开展ADR监测工作提供参考依据.方法 采用调查问卷的形式,对嘉峪关市不同级别医院的医务人员进行抽样调查.结果 医务人员对ADR概念、严重ADR的范畴、引发ADR药品类别等相关知识认知度具有显著性差异(P <0.05);不同职业者对药品不良反应知识的认知度差异具有显著性(P <0.05),其中药学人员的认知度最高,管理人员认知度最低.结论 应加强有关ADR知识的宣传与培训,提高医务人员对ADR的认知度,提升其在ADR监测工作中的自觉性.%Objective To investigate the cognition degree on adverse drug reactions(ADR) among healthcare professionals as to improve and promote the ADR reporting and monitoring.Methods A questionnaire survey was conducted among the healthcare professionals of different level hospitals and cliniques in Jiayuguan.Results The healthcare professionals' knowledge was difference on ADR concept, ADR happening scope,(P <0.05); cognition degree on adverse drug reaction was significant difference between different profession(P<0.05), where in the recognition degree of pharmacy staff was the highest, managers had the lowest awareness.Conclusion Both propaganda and education should be strengthened to improve the cognition degree about ADR during the healthcare professionals and to elevate their consciousness in the ADR monitoring.

  5. 老年患者药物不良反应分析%Analysis of adverse drug reaction in elderly

    Institute of Scientific and Technical Information of China (English)

    潘祺琦; 罗璨

    2015-01-01

    目的:分析老年患者药物不良反应(ADR)发生的特点,以利于临床上提高监测和应对。方法回顾性地分析国家药品不良反应监测中心数据库收集的南京医科大学第一附属医院2012年1月至2014年11月>65岁的老年患者的ADR报告。结果共收集212例次老年患者ADR报告(占总体ADR的21.3%),其中男性91例次,女性121例次,平均年龄(75.25±6.43)岁;91例次发生于门急诊(42.9%),114例次发生于住院非ICU(53.78%);涉及药品98种,主要为抗感染药物(30.66%),其次为中枢神经系统药物(26.42%);用药途径主要是静脉滴注(86.32%);ADR所累及的器官或系统损害主要是全身性损害(23.10%),其次是皮肤及其附件损害(19.49%),主要表现为过敏样反应、皮疹。结论本研究反映了我院老年患者发生ADR的主要风险药物、给药途径、临床表现等,应重点关注应用高风险药物的人群,用药过程中密切监测。对门急诊、院外老年患者的用药安全及口服药物的安全性也应加以重视。由于存在漏报现象,本研究的报告率仅能从一定程度上反映老年患者ADR的发生情况,应进一步重视和加强老年患者ADR的监测上报工作。%Objective To analyze the features of adverse drug reaction (ADR) in the elderly (>65 years old) in order to improve its surveillance and coping strategies. Methods All ADR reports in the elderly patients from the First Affiliated Hospital, Nanjing Medical University during the years of 2012 to 2014 in the National Center for ADR Monitoring Database were collected and retrospectively analyzed. Results There were 212 ADR reports in the elderly patients (accounting for 21.3% of the total ADR reports). They were 91 males and 121 females, at an average age of (75.25±6.43)years. Ninety-one ADRs (42.9%) occurred in the outpatient or emergency department, and 114 reports occurred in the non

  6. A Survey of Adverse Drug Reactions in Family Practice

    OpenAIRE

    Reynolds, J. L.

    1984-01-01

    In this study, 232 Canadian family physicians recorded suspected adverse drug reactions (SADRs) in their practices for five months. Patients' age and sex, the drug(s) implicated, type of reaction and any disability were recorded on a card and sent to a central coordinating office each week. The number of SADRs in clinical practice seems to be small. An estimated 300,000 patients were involved in the study, and a total of 314 suspected adverse drug reactions in 314 patients were reported. A pr...

  7. The SIDER database of drugs and side effects

    DEFF Research Database (Denmark)

    Kuhn, Michael; Letunic, Ivica; Jensen, Lars Juhl;

    2016-01-01

    Unwanted side effects of drugs are a burden on patients and a severe impediment in the development of new drugs. At the same time, adverse drug reactions (ADRs) recorded during clinical trials are an important source of human phenotypic data. It is therefore essential to combine data on drugs......, targets and side effects into a more complete picture of the therapeutic mechanism of actions of drugs and the ways in which they cause adverse reactions. To this end, we have created the SIDER ('Side Effect Resource', http://sideeffects.embl.de) database of drugs and ADRs. The current release, SIDER 4......, contains data on 1430 drugs, 5880 ADRs and 140 064 drug-ADR pairs, which is an increase of 40% compared to the previous version. For more fine-grained analyses, we extracted the frequency with which side effects occur from the package inserts. This information is available for 39% of drug-ADR pairs, 19...

  8. The impact of glutathione S-transferase genotype and phenotype on the adverse drug reactions to azathioprine in patients with inflammatory bowel diseases.

    Science.gov (United States)

    Liu, Hui; Ding, Liang; Zhang, Fangbin; Zhang, Yu; Gao, Xiang; Hu, Pinjin; Bi, Huichang; Huang, Min

    2015-10-01

    Azathioprine (AZA) is a thiopurine prodrug which is widely used in patients with inflammatory bowel disease (IBD). However, the use is limited in one-third of patients because of adverse drug reactions (ADRs) or a lack of clinical response. It has been considered that the polymorphic enzyme thiopurine S-methyltransferase (TPMT) plays an important role in the in vivo process of AZA and the occurrence of its myelotoxicity. Glutathione S-transferase (GST) mutation is another pharmacogenetic polymorphism which is probably involved in AZA metabolism and tolerance. The aim of this study was to investigate the association among GST polymorphism, enzyme activity and AZA-related ADRs in Chinese Han patients with IBD. We found that the patients who became neutropenic had a significantly higher GSTs activity when compared with of the patients who did not develop ADRs (analysis of variance, P GST activity constituted a pharmacogenetic high risk group for leucopenia during AZA treatment. GST-P1 Ile105/Ile105 genotype appeared to be a promising marker indicating predisposition to AZA-related ADRs. PMID:26432087

  9. The Review of the Adverse Drug Reaction Using Ibuprofen Suspension%布洛芬混悬液不良反应回顾

    Institute of Scientific and Technical Information of China (English)

    万雪琴; 张华锋

    2011-01-01

    总结布洛芬混悬液出现的不良反应,以"布洛芬"为关键词,检索2000~2010年CNKI中国期刊全文数据库、维普中文数据库中4篇布洛芬混悬液不良反应捆首S例,及我院1例不良反应报道进行总结分析.布洛芬混悬液不良反应主要涉及消化系统、血液系统、神经系统、皮肤及其附件等.提示临床中儿童应注意安全使用布洛芬混悬液,以避免不良反应的发生.%This article introduces the occurrenc and distribution of adverse drug reactions(ADR) induced by Ibuprofen Suspension, With "Ibuprofen" as key word, literatures were retrieved from CNKI and CQVIP from Jan. 2000 to Jun. 2010. 4 literatures including 5 cases were analyzed statistically, and another case happened in our hospital Main clinical manifestation of ADR cases were digestive system, Blood system, Nervous system, lesion of skin and its appendants.We should strengthen to monitor the ADR of Ibuprofen Suspension and ensure rational and standardized use of children, avoid or reduce the occurrence of severe ADR.

  10. Adverse drug reactions in self-medication

    OpenAIRE

    Smuseva O.N.; Solovkina Yu.V.

    2012-01-01

    The research goal is to study the actual problem of self-medication. The Association of the European Self-Medication Industry (AESGP) considers the term «responsible self-medication». The key characteristic is that the patients are responsible for their health. The article presents cases of self-medication thoroughly analyzed in Volgograd Regional Centre of Drug Safety Monitoring. Some of them may be considered as unfavourable and even lethal. Therefore it should be mentioned that there is on...

  11. A smart tumor targeting peptide-drug conjugate, pHLIP-SS-DOX: synthesis and cellular uptake on MCF-7 and MCF-7/Adr cells.

    Science.gov (United States)

    Song, Qin; Chuan, Xingxing; Chen, Binlong; He, Bing; Zhang, Hua; Dai, Wenbing; Wang, Xueqing; Zhang, Qiang

    2016-06-01

    Doxorubicin (DOX) is a potent anticancer drug for the treatment of tumors, but the poor specificity and multi-drug resistance (MDR) on tumor cells have restricted its application. Here, a pH and reduction-responsive peptide-drug conjugate (PDC), pHLIP-SS-DOX, was synthesized to overcome these drawbacks. pH low insertion peptide (pHLIP) is a cell penetrating peptide (CPP) with pH-dependent transmembrane ability. And because of the unique cell membrane insertion pattern, it might reverse the MDR. The cellular uptake study showed that on both drug-sensitive MCF-7 and drug-resistant MCF-7/Adr cells, pHLIP-SS-DOX obviously facilitated the uptake of DOX at pH 6.0 and the uptake level on MCF-7/Adr cells was similar with that on MCF-7 cells, indicating that pHLIP-SS-DOX had the ability to target acidic tumor cells and reverse MDR. In vitro cytotoxicity study mediated by GSH-OEt demonstrated that the cytotoxic effect of pHLIP-SS-DOX was reduction responsive, with obvious cytotoxicity at pH 6.0; while it had poor cytotoxicity at pH 7.4, no matter with or without GSH-OEt pretreatment. This illustrated that pHLIP could deliver DOX into tumor cells with acidic microenvironment specifically and could not deliver drugs into normal cells with neutral microenvironment. In summary, pHLIP-SS-DOX is a promising strategy to target drugs to tumors and provides a possibility to overcome MDR.

  12. Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

    OpenAIRE

    Bennett, Charles L.; Starko, Karen M.; Thomsen, Henrik S; Cowper, Shawn; Sartor, Oliver; Macdougall, Iain C.; Qureshi, Zaina P; Bookstaver, P. Brandon; Miller, April D; Norris, LeAnn B.; Xirasagar, Sudha; Trenery, Alyssa; Lopez, Isaac; Kahn, Adam; Murday, Alanna

    2012-01-01

    Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye’s syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who...

  13. Hospitalizations Due to Adverse Drug Events in the Elderly—A Retrospective Register Study

    Science.gov (United States)

    Laatikainen, Outi; Sneck, Sami; Bloigu, Risto; Lahtinen, Minna; Lauri, Timo; Turpeinen, Miia

    2016-01-01

    Adverse drug events (ADEs) are more likely to affect geriatric patients due to physiological changes occurring with aging. Even though this is an internationally recognized problem, similar research data in Finland is still lacking. The aim of this study was to determine the number of geriatric medication-related hospitalizations in the Finnish patient population and to discover the potential means of recognizing patients particularly at risk of ADEs. The study was conducted retrospectively from the 2014 emergency department patient records in Oulu University Hospital. A total number of 290 admissions were screened for ADEs, adverse drug reactions (ADRs) and drug-drug interactions (DDIs) by a multi-disciplinary research team. Customized Naranjo scale was used as a control method. All admissions were categorized into “probable,” “possible,” or “doubtful” by both assessment methods. In total, 23.1% of admissions were categorized as “probably” or “possibly” medication-related. Vertigo, falling, and fractures formed the largest group of ADEs. The most common ADEs were related to medicines from N class of the ATC-code system. Age, sex, residence, or specialty did not increase the risk for medication-related admission significantly (min p = 0.077). Polypharmacy was, however, found to increase the risk (OR 3.3; 95% CI, 1.5–6.9; p = 0.01). In conclusion, screening patients for specific demographics or symptoms would not significantly improve the recognition of ADEs. In addition, as ADE detection today is largely based on voluntary reporting systems and retrospective manual tracking of errors, it is evident that more effective methods for ADE detection are needed in the future. PMID:27761112

  14. Epidemiology and prevention of adverse drug reactions in the elderly

    Institute of Scientific and Technical Information of China (English)

    Lexin WANG

    2005-01-01

    Many studies have demonstrated a correlation between increasing age and adverse drug reactions. This increased risk is related to aged-related changes in pharmacokinetics and pharmacodynamics. In addition, chronic illnesses such as congestive heart failure, coronary artery disease and hypertension are more prevalent in the elderly who also have an increased risk of diabetes, arthritis and cancer. Consequently elderly patients are often treated with multiple medications, which may cause drug interactions and adverse drug reactions. Adequate undergraduate training in clinical pharmacology and continued professional development in evidence-based therapeutics will undoubtedly reduce inappropriate prescribing and improve the quality of medications. Good communications between physicians and patients are also critically important in avoidance or prevention of adverse drug reactions in the elderly.

  15. Automatic Identification of Messages Related to Adverse Drug Reactions from Online User Reviews using Feature-based Classification.

    Directory of Open Access Journals (Sweden)

    Jingfang Liu

    2014-11-01

    Full Text Available User-generated medical messages on Internet contain extensive information related to adverse drug reactions (ADRs and are known as valuable resources for post-marketing drug surveillance. The aim of this study was to find an effective method to identify messages related to ADRs automatically from online user reviews.We conducted experiments on online user reviews using different feature set and different classification technique. Firstly, the messages from three communities, allergy community, schizophrenia community and pain management community, were collected, the 3000 messages were annotated. Secondly, the N-gram-based features set and medical domain-specific features set were generated. Thirdly, three classification techniques, SVM, C4.5 and Naïve Bayes, were used to perform classification tasks separately. Finally, we evaluated the performance of different method using different feature set and different classification technique by comparing the metrics including accuracy and F-measure.In terms of accuracy, the accuracy of SVM classifier was higher than 0.8, the accuracy of C4.5 classifier or Naïve Bayes classifier was lower than 0.8; meanwhile, the combination feature sets including n-gram-based feature set and domain-specific feature set consistently outperformed single feature set. In terms of F-measure, the highest F-measure is 0.895 which was achieved by using combination feature sets and a SVM classifier. In all, we can get the best classification performance by using combination feature sets and SVM classifier.By using combination feature sets and SVM classifier, we can get an effective method to identify messages related to ADRs automatically from online user reviews.

  16. Characterization of Schizophrenia Adverse Drug Interactions through a Network Approach and Drug Classification

    Directory of Open Access Journals (Sweden)

    Jingchun Sun

    2013-01-01

    Full Text Available Antipsychotic drugs are medications commonly for schizophrenia (SCZ treatment, which include two groups: typical and atypical. SCZ patients have multiple comorbidities, and the coadministration of drugs is quite common. This may result in adverse drug-drug interactions, which are events that occur when the effect of a drug is altered by the coadministration of another drug. Therefore, it is important to provide a comprehensive view of these interactions for further coadministration improvement. Here, we extracted SCZ drugs and their adverse drug interactions from the DrugBank and compiled a SCZ-specific adverse drug interaction network. This network included 28 SCZ drugs, 241 non-SCZs, and 991 interactions. By integrating the Anatomical Therapeutic Chemical (ATC classification with the network analysis, we characterized those interactions. Our results indicated that SCZ drugs tended to have more adverse drug interactions than other drugs. Furthermore, SCZ typical drugs had significant interactions with drugs of the “alimentary tract and metabolism” category while SCZ atypical drugs had significant interactions with drugs of the categories “nervous system” and “antiinfectives for systemic uses.” This study is the first to characterize the adverse drug interactions in the course of SCZ treatment and might provide useful information for the future SCZ treatment.

  17. Administrative Data Repository (ADR)

    Data.gov (United States)

    Department of Veterans Affairs — The Administrative Data Repository (ADR) was established to provide support for the administrative data elements relative to multiple categories of a person entity...

  18. Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance

    OpenAIRE

    S. Malhotra; Karan, R; P. Pandhi; S. Jain

    2001-01-01

    BACKGROUND—Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed.
METHODS—A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, conse...

  19. 114例儿童药品不良反应报告分析%Analysis of 114 Pediatric Adverse Drug Reaction Reports in Our Hospital

    Institute of Scientific and Technical Information of China (English)

    李榕; 陈崇泽

    2011-01-01

    Objective:To investigate the adverse drug reactions that occurred in children. Methods: The ages, sex, drug usage, main manifestation, time of occurrence and level of severity of ADR were analyzed in 114 cases of children aged from 2 month to 15 years old. Results: Among 114 cases, 78 patients were male, 36 patients were female. There were fifty three drugs involved. Antibiotics held the first position (42. 11%) and the next was Chinese Anti-inffectives (25. 44%). The main manifestation of ADR was rash, anaphylactoid reaction and somnolence. The main route of administration was intravenous drip. Conclusions: Monitoring of ADR in children should be strengthened in order to ensure the safety of drug usage.%目的:了解儿童发生药品不良反应(ADR)的情况.方法:按患者的年龄、性别、用药情况及ADR的主要表现、发生时间、严重程度等进行统计分析.结果:114例ADR报告中,男78例,女36例,涉及药品53种,主要为抗感染药物(42.11%),其次为中药抗感染药物(25.44%).ADR主要表现是皮疹,其次是过敏样反应、嗜睡.主要给药途径是静脉滴注.结论:应加强对儿童ADR的监测工作,以保证用药安全.

  20. 鲑鱼降钙素致不良反应的文献分析%A Literature Analysis of Adverse Drug Reactions Induced by Salmon Calcitonin

    Institute of Scientific and Technical Information of China (English)

    苏娜; 吴逢波; 徐珽

    2013-01-01

    Objective To study the characteristics and the general pattern of the adverse drug reaction (ADR) induced by salmon calcitonin. Methods ADR induced by salmon calcitonin reported in domestic medical journals during January 1994 to March 2012 were retrieved from CNKI and WanFang databases. Classification and statistical analysis were carried out according to patients' age, gender, route of administration, dosage, time of the occurrence of ADR, clinical symptoms, allergic history, treatment and recovery. Results Fifteen ADR cases involved the integumentary system , cardiovascular system, digestive system, nervous system and allergic reaction, with advanced age group and women showing the highest incidence. Conclusion Salmon calcitonin should be used with caution in the clinic for it may induce ADR.%目的 总结鲑鱼降钙素致不良反应的一般规律和特点.方法 检索中国期刊全文数据库(CNKI)、万方数据库(WanFang)1994年1月-2012年3月鲑鱼降钙素所致不良反应的个案报道,按患者年龄、性别、给药途径、用药剂量、不良反应发生时间、临床表现症状、有无过敏史、治疗与转归等进行分类统计分析.结果 15例不良反应包括皮肤系统、心血管系统、消化系统、神经系统和超敏反应,高年龄段和女性发生率较高.结论 临床上应重视鲑鱼降钙素可致不良反应,坚持合理用药.

  1. Awareness of adverse drug reactions in third M.B.B.S students practicing self-medication

    Directory of Open Access Journals (Sweden)

    Shreyas R. Burute

    2016-02-01

    Conclusions: Considering the wide range of drugs consumed, the numbers of ADRs mentioned were few and their spectrum limited indicating scope for improvement. [Int J Basic Clin Pharmacol 2016; 5(1.000: 196-201

  2. Study of prescription pattern and adverse drug reactions in patients with cervical cancer in tertiary care teaching institute

    Directory of Open Access Journals (Sweden)

    Ankita Sunilrao Jire

    2016-08-01

    Conclusions: Among patients with CA cervix, cisplatin was most commonly prescribed drug. Nausea was most common ADR which is of and lsquo;mild level 1' severity. [Int J Basic Clin Pharmacol 2016; 5(4.000: 1594-1597

  3. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

    Directory of Open Access Journals (Sweden)

    Ghosh S

    2006-01-01

    Full Text Available The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the adverse drug reactions were also studied. Adverse drug reactions were also assessed for causality, using Naranjo′s scale, severity, and preventability, using Hartwig et al. scale. Adverse drug reaction attributes to 77% of the hospital visit. Incidence of reported cutaneous adverse drug reactions, were 2.85%. Majority of the adverse drug reactions (96% were of type B. Antibiotics (30%, were the common class of drugs, causing a cutaneous adverse drug reactions. Maximum number of adverse drug reactions were due to Acetaminophen, Amoxicillin, antitubercular drugs, and Phenytoin. Most of the adverse drug reactions were managed by withdrawal of drug (81%, and 58% patients were recovered from the reaction. Naranjos scale classifies, 29 as probable, 21 as possible, and 3 as definite adverse drug reactions. Most of the adverse drug reactions were of moderate severity, however 13 adverse drug reactions were severe. All the adverse drug reactions were probably preventable on extreme caution.

  4. Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

    DEFF Research Database (Denmark)

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse...

  5. 碘造影剂不良反应文献的系统评价%Systematic evaluation of literatures regarding the adverse drug reactions to iodine contrast media

    Institute of Scientific and Technical Information of China (English)

    马祖文; 许良; 朱瑾

    2014-01-01

    目的:了解碘造影剂不良反应的发生率及其相关因素,探索药品上市后不良反应再评价的方法。方法收集、整理、分析有关碘造影剂的不良反应的临床研究、不良反应监测及案例报道,包括个案和经典案例分析。结果本研究纳入9012例碘造影剂不良反应(ADR);原发疾病为循环系统的患者、老年患者及有其他药物过敏史的患者更容易发生ADR ;ADR多发生在30 min内;根据发表资料尚无法鉴别ADR。结论当前的证据表明,碘造影剂的ADR高,临床使用应密切关注,防止给患者带来不必要的伤害。%Objective To find out the occurrence rate of adverse drug reaction (ADR) following iodine-contrast media and to under-stand the relative factors causing ADR ,to preliminarily explore the methods for re-evaluation of the drug after marketing .Method The literature was classified into 3 categorise ,i .e .synchronous clinical study ,ADR monitoring and medical records analysis ,as well as individual or typical case reports .Results Totally 9 012 cases were included in this review .Although we are unable to an-swer the question weather the incidence of adverse drug reaction (ADR) induced by iodine-contrast media due to the absence of to-tal amount of production and market information ,it was estimated based on the limited data that the possibility of ADR should be high .The review showed that the ADR was easier to occur in 30 min after injecting into the older and the one who had circulation system disease or drug allergy .Conclusion Current evidence shows that iodine-contrast media has a high risk of ADR .We should pay close attention to the application of iodine-contrast media to prevent unnecessary harmness .

  6. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  7. Mining for adverse drug events with formal concept analysis

    CERN Document Server

    Estacio-Moreno, Alexander; Bousquet, Cédric

    2009-01-01

    The pharmacovigilance databases consist of several case reports involving drugs and adverse events (AEs). Some methods are applied consistently to highlight all signals, i.e. all statistically significant associations between a drug and an AE. These methods are appropriate for verification of more complex relationships involving one or several drug(s) and AE(s) (e.g; syndromes or interactions) but do not address the identification of them. We propose a method for the extraction of these relationships based on Formal Concept Analysis (FCA) associated with disproportionality measures. This method identifies all sets of drugs and AEs which are potential signals, syndromes or interactions. Compared to a previous experience of disproportionality analysis without FCA, the addition of FCA was more efficient for identifying false positives related to concomitant drugs.

  8. Influence of the Calmodulin Antagonist EBB on Cyclin B1 and Cdc2-p34 in Human Drug-resistant Breast Cancer MCF-7/ADR Cells

    Institute of Scientific and Technical Information of China (English)

    Xu Shi; Huifang Zhu; Yanhong Cheng; Linglin Zou; Dongsheng Xiong; Yuan Zhou; Ming Yang; Dongmei Fan; Xiaohua Dai; Chunzheng Yang

    2008-01-01

    OBJECTIVE To investigate the influence of O-(4-ethoxyl-butyl)-berbamine (EBB) on the expression of cyclin B1 and cdc2-p34 in the human drug-resistant breast cancer MCF-7/ADR cell line.METHODS The MTT assay was used to assess the cytotoxicity of EBB. Different levels of EBB were added to different cell lines at series of time points solely or combined with doxorubicin (DOX)to detect the effect on the expression of cyclinB1 and cdc2-p34 by Western blots, cdc2-p34 tyrosine phosphorylation was detected by immunoprecipitation. In addition, apoptosis and cytoplastic Ca2+concentrations were systematically examined by laser scanning confocal microscopy (LSCM).RESULTS EBB showed little inhibitory activity on human umbilical vein endothelial cells (ECV304), whereas EBB inhibited cell growth (IC50 range, 4.55~15.74 μmol/L) in a variety of sensitive and drug-resistance cell lines. EBB also down-regulated the expression of cyclin B1 and cdc2-p34 in a concentration and time dependent manner, which was an important reason for the G2/M phase arrest. EBB was shown to induce apoptosis of MCF-7/ADR cells while increasing the level of cytoplastic Ca2+.CONCLUSION The low cytotoxicity of EBB suggests it may be useful as a rational reversal agent. The effect of EBB on cell cycle arrest and related proteins, apoptosis, and cytoplastic Ca2+ concentration may be involved in reversing multidrug resistance.

  9. Adverse Drug Event Prevention: 2014 Action Plan Conference.

    Science.gov (United States)

    Ducoffe, Aaron R; Baehr, Avi; Peña, Juliet C; Rider, Briana B; Yang, Sandra; Hu, Dale J

    2016-09-01

    Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.

  10. Analysis of intravenous infusion adverse drug reation reports%静脉输液不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    徐德洲

    2011-01-01

    Objective To analyze the characteristics and laws of intravenous infusion adverse drug reaction (ADR) reports of out-patient/emergency on 83 cases in our hospital and to provide the reference of rational use of drugs and safe transfusion. Methods A statistical analysis was conducted based on 83 cases of drug intravenous infusion ADR which were reported from January 2009 to February 2011. Results In the 83 cases, women were 44 cases(53.0% ) and elderly patients were 40 cases(48.2% ). The top three drugs of ADR incidence were antimicrobial drugs (54.2%), traditional Chinese medicine injection( 19.3% )and adjuvant therapies and plasma substitute (10.8%). The mainly involving organs were skin, accessories, digestive and nervous system. Conclusions We should pay attention to intravenous infusion ADR of out-patient/emergency. Management of monitoring should be strengthened to ensure safety of drug use.%目的 分析静脉输液药物不良反应(ADR)的发生特点和规律,为临床合理用药、安全输液提供参考。方法 对2009年1月至2011年2月门诊和急诊上报的83例静脉输液ADR报告进行分类统计分析。结果 发生静脉输液ADR的83例患者中,女性[44例(53.0%)]和老年患者[40例(48.2%)]较多见;发生率在前3位的药物依次为抗微生物药[45例(54.2%)]、中药注射剂[16例(19.3%)]和血制品及血浆代用品[9例(10.8%)];主要累及器官为皮肤及附件、消化系统及神经系统等。结论 需重视门急诊静脉输液ADR,加强监测,指导临床合理用药,减少和避免静脉输液ADR的发生,保障用药安全。

  11. Analysis of Association between Adverse Drug Reactions Induced by Cardiovascular and Cerebrovascular Drugs and Patients%心脑血管用药不良反应与用药人群间的关联关系分析

    Institute of Scientific and Technical Information of China (English)

    冯变玲; 魏芬; 杨世民; 赵君; 雷祎; 覃蓝

    2011-01-01

    目的 分析药品不良反应与用药人群的性别、年龄间潜在的关联关系,为心脑血管类疾病用药的安全、合理、有效提供参考.方法 根据江苏省药品不良反应监测中心2004-2009年收集的9 640份心脑血管疾病用药不良反应报告数据,运用数据挖掘技术中广义规则归纳法(GRI)的关联规则算法对数据进行分析.从年龄、性别支持度,不同不良反应现象与不同年龄段间关联关系的置信度以及不同不良反应现象与不同性别间关联关系的置信度进行分析,得出相关结果.结果与结论 药品不良反应主要发生在2个年龄段,一是50~59岁年龄段,不良反应主要为咳嗽和头晕;二是60~69岁年龄段,不良反应主要为头晕和恶心.药品不良反应在男性身上发生的频次较女性多;个别不良反应有较明显的性别偏向.%OBJECTIVE: To explore potential correlation of adverse drug reaction (ADR) with patient's gender and age, and to provide the best evidence for medical staff to making decision to ensure that security of drug use for cardiovascular and cerebro-vascular diseases and improve therapeutic efficacy. METHODS: 9 640 ADR reports on drug use for cardiovascular and cerebrovas-cular diseases were collected from Jiangsu Province Adverse Drug Reaction Monitoring Centre during 2004 - 2009. GRI association rules algorithm of data mining technology was used for data analysis. RESULTS: During 2004-2009, data was analyzed from support of age and gender, confidence level of association of different ADR phenomena with different age groups and confidence level of association of different ADR phenomenon with gender. Related results were obtained. CONCLUSION: The ADR mainly occurred in two age groups, 50~59 age group and ADR included coughing and dizziness; 60~69 age group and ADR included dizziness and nausea. ADR occurred in more male than female; individual ADR were more obvious gender bias, such as cough mainly in

  12. [Analysis on the common causes for traditional Chinese medicinal injection induced adverse reactions and the preventive countermeasures].

    Science.gov (United States)

    Wu, Guo-lin; Zhang, Li; Yu, Guo-you

    2008-12-01

    As a new dosage form, TCM injection is commonly used in clinical practice. But the increasing events of adverse drug reactions (ADRs) could even seriously endanger patients' lives. The causes of TCM injection inducing ADRs might be the unstable quality of preparation; the irrational clinical use and operation; the sensitive physique of patient and the change of patients' primary illness, etc. For preventing the occurrence of ADRs, based on guaranteeing the stable quality of product, putting stress on accurate usages and normalized operations in clinical practice, enhancing the monitor on ADRs and the precautionary awareness in medical units are very important. PMID:19317176

  13. 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.

  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. Heat Switches for ADRs

    Science.gov (United States)

    DiPirro, M. J.; Shirron, P. J.

    2014-01-01

    Heat switches are key elements in the cyclic operation of Adiabatic Demagnetization Refrigerators (ADRs). Several of the types of heat switches that have been used for ADRs are described in this paper. Key elements in selection and design of these switches include not only ON/OFF switching ratio, but also method of actuation, size, weight, and structural soundness. Some of the trade-off are detailed in this paper.

  16. Report on Adverse Drug Reactions Induced by Pediatric Intravenous Transfusion and Nursing Countermeasures%小儿静脉用药引发的药品不良反应报告及护理对策

    Institute of Scientific and Technical Information of China (English)

    党玉梅; 汪友兰; 张会娥

    2016-01-01

    OBJECTIVE:To investigate the adverse drug reactions ( ADR ) induced by pediatric intravenous transfusion and nursing countermeasures .METHODS:The clinical manifestation form of 125 cases of ADR induced by pediatric intravenous transfusion admitted into Xiaogan Municipal Central Hospital ( hereinafter referred to as “our hospital”) from Mar.2013 to Mar.2015 were analyzed, and the related nursing countermeasures were discussed . RESULTS:Of the 125 ADR cases, the primary disease was respiratory disease .The highest incidence of ADR was anti-infection drugs, and digestive system was the main involved organs and (or) systems.The clinical manifestations of ADR cases induced by pediatric intravenous transfusion were closely associated with the categories of drugs and pediatric individual differences , the medical and nursing staff were suppose to strengthen the observation and nursing measures.CONCLUSIONS: The incidence of ADR cases induced by pediatric intravenous transfusion is relatively high.It is necessary for the clinic to attach more importance to this aspect and take the nursing measures during the whole process of administration , so as to reduce the incidence of ADR .%目的:了解小儿静脉用药引发的常见不良反应(adverse drug reaction,ADR)及护理措施。方法:分析孝感市中心医院(以下简称“我院”)2013年3月—2015年3月125例小儿静脉用药引发的ADR临床表现形式,探讨护理对策。结果:在发生ADR的125例患儿中,主要原发性疾病为呼吸系统疾病,ADR发生率最高的药品为抗感染药,主要累及器官和(或)系统为消化系统。小儿静脉用药ADR的发生及其临床表现形式与药物的种类、儿童个体差异密切相关,要求医、护人员加强观察,并做好护理措施。结论:儿童在进行药物静脉用药时容易发生 ADR,需引起临床重视,采取给药前、给药中以及给药后全程护理措施,以降低ADR的发生率。

  17. Effect of TSA on the drug-resistance reversion in SGC7901/ADR%曲古霉素A对SGC7901/ADR细胞系耐药逆转机制的研究

    Institute of Scientific and Technical Information of China (English)

    王丹; 孙红坤; 唐青; 杨晓丹; 乔文

    2013-01-01

    目的 观察组蛋白去乙酰酶抑制剂曲古霉素A(trichostain,TSA)对体外培养胃癌耐药细胞SGC7901/ADR是否具有逆转耐药的作用,并对其作用机制进行探讨. 方法 ①MTT法计算出胃癌耐药细胞SGC7901/ADR的耐药倍数及TSA作用后的逆转倍数.②分空白组、1.5 nmol/L TSA组和12 nmol/L TSA组,依次作用48 h和72 h,用流式细胞仪检测胃癌耐药细胞内阿霉素(adriacin,ADR)浓度.RT-PCR法检测耐药细胞内MDR1(multidrug resistance)基因表达. 结果 TSA对胃癌耐药细胞SGC7901/ADR有明显逆转作用,MTT法计算出SG C7901/ADR细胞的耐药倍数是29.51倍,TSA作用后逆转倍数约为1.95倍,流式细胞仪检测TSA作用后胃癌耐药细胞内阿霉素浓度明显增加,且呈时间剂量依赖性,RT-PCR法检测TSA作用后耐药细胞内MDR1基因表达明显降低. 结论 TSA对胃癌耐药细胞SGC7901/ADR具有明显逆转作用,可能是通过下调MDR1的表达,增加细胞内ADR浓度实现的.%Objective To investigate the reversal effect of trichostain A (TSA) , a histone deacetylase inhibitor, in the gastric cancer in vitro,and to explore its mechanism. Methods ①MTT assay was used to calculate the drug-resistance index of the SGC7901/ADR and the reversion drug-resistance index after giving TSA. ②The cells were divided into blank group, 1. 5 nmol/L TSA group, and 12 nmol/L TSA group. The cells were treated respectively for 48 h and 72 h. Then the flow cytometer was used to detect the adriacin (ADR) density in the SGC7901/ADR. RT-PCR was employed to detect the MDR1 gene expression in the SGC7901. Results TSA exerted obvious reversion effects on the SGC7901/ADR. The drug-resistance index obtained by MTT method was 29.51 ,and the reversion drug-resistance index after giving TSA was 1.95. Flow cytometry results showed that the adriacin density in the SGC7901/ADR obviously increased after giving TSA in a time- and dose-dependent manner. RT-PCR results showed that the MDR1 gene

  18. CONCEPT OF DRUG INTERACTION

    OpenAIRE

    Singh Nidhi

    2012-01-01

    Drug interaction is an increasingly important cause of adverse reactions (ADR), and is the modification of the effect of one drug (object) by the prior or concomitant administration of another drug (precipitant drug). Drug interaction may either enhance or diminish the intended effect of one or both drugs. For example severe haemorrhage may occur if warfarin and salicylates (asprin) are combined. Precipitant drugs modify the object drug's absorption, distribution, metabolism, excretion or act...

  19. EDITORIAL ADVERSE DRUG REACTIONS: A MULTIFORM PATHOLOGY RESPONSABILITY OF MANY

    Directory of Open Access Journals (Sweden)

    Joan-Ramon Laporte

    2009-09-01

    Full Text Available Possibly still are health professionals that when hearing about adverse drug reactions only think in cutaneous rash, blood dyscrasias, anaphylactic shock and congenital malformations. The mentioned adverse effects are real, but relatively infrequent. Furthermore, are unexpected, not related with the pharmacological mechanism of action, unpredictable and dose independent. These adverse drug reactions are like a therapeutic lottery, depending on «luck».However, when the pharmacological pathology resulting in medical care is analyzed, the perspective is very different. For instance, the predominant adverse drug reactions in emergency wards are those related with the pharmacological mechanism of action: severe hemorrhage due to anticoagulant and antiplatelet drugs; renal insufficiency and hyperkalemia by inhibitors of the renin-angiotensin axis; hyponatremia, fells and fractures by SSRI antidepressants, digitalis intoxication… These are relatively common pathologies, expectable, dose-related, and favored by patient comorbidity, preventable in many cases if the dose would have carefully individualized, if the patient complied better with the instructions (in case the patient understood the information or if a more carefully clinical surveillance were performed.A review of the literature reminds us other pathologies attended in other assistance levels, for example:- Breast cancer attributable to the hormone replacement therapy (HRT: three to four additional cases per 1.000 women treated during 5 years, this is translated in thousands of additional cases of breast cancer according to the sales data of these products between the years 1993 to 2003. Moreover, it was irresponsibly promoted for the prevention of cardiovascular events, dementia, and as the source of eternal youth without proven efficacy at that time (no evidence of efficacy exist today.- Non-steroidal anti-inflammatory drugs (NSAIDs - especially celecoxib and diclofenac -increase the

  20. Analysis of 155 reports of ADR Induced by Quinolones%155例喹诺酮类药品不良反应分析

    Institute of Scientific and Technical Information of China (English)

    钟晗; 刘晓琰; 崔敏; 苏颖杰

    2013-01-01

    目的 研究喹诺酮类药物在临床治疗中发生的不良反应(ADR)情况,寻找应对该类药物ADR的临床策略.方法 采用回顾性研究方法,对我院2004~2011年上报的喹诺酮类药物ADR进行系统分析.结果 155例ADR报表中涉及9种喹诺酮类药物,左氧氟沙星ADR例次最多(105例次).主要不良反应表现为过敏反应(40.4%)和消化系统症状(27.1%).结论 对喹诺酮类药物的临床应用需加强监测,促进合理用药.%Objective To determine adverse drug reaction (ADR) occurrence associated with quinolones in clinical practices. Methods 155 reports of quinolones-induced ADR from 2010 to 2011 were analyzed. Results Nine drugs of quinolones were involved in 155 ADR reports, among which levofloxacin resulted in ADR most frequently(105 cases). The ADRs manifestations mainly covered allergies(40.4%) and digestive system disease symptoms(27.1%). Conclusion It is necessary to monitor clinical application of quinolones, therefore promote rational use of drug.

  1. Using Rich Data on Comorbidities in Case-Control Study Design with Electronic Health Record Data Improves Control of Confounding in the Detection of Adverse Drug Reactions

    Science.gov (United States)

    Chase, Herbert

    2016-01-01

    Recent research has suggested that the case-control study design, unlike the self-controlled study design, performs poorly in controlling confounding in the detection of adverse drug reactions (ADRs) from administrative claims and electronic health record (EHR) data, resulting in biased estimates of the causal effects of drugs on health outcomes of interest (HOI) and inaccurate confidence intervals. Here we show that using rich data on comorbidities and automatic variable selection strategies for selecting confounders can better control confounding within a case-control study design and provide a more solid basis for inference regarding the causal effects of drugs on HOIs. Four HOIs are examined: acute kidney injury, acute liver injury, acute myocardial infarction and gastrointestinal ulcer hospitalization. For each of these HOIs we use a previously published reference set of positive and negative control drugs to evaluate the performance of our methods. Our methods have AUCs that are often substantially higher than the AUCs of a baseline method that only uses demographic characteristics for confounding control. Our methods also give confidence intervals for causal effect parameters that cover the expected no effect value substantially more often than this baseline method. The case-control study design, unlike the self-controlled study design, can be used in the fairly typical setting of EHR databases without longitudinal information on patients. With our variable selection method, these databases can be more effectively used for the detection of ADRs. PMID:27716785

  2. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals : A simulation study

    NARCIS (Netherlands)

    Vermeer, Niels S.; Ebbers, Hans C.; Straus, Sabine M J M; Leufkens, Hubert G M; Egberts, Toine C G; De Bruin, Marie L.

    2016-01-01

    Background and Objective: The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge between products containing the same active substance. In spontaneous adverse drug reaction (ADR) re

  3. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl;

    2014-01-01

    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...... 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...

  4. 抗癫痫药物等引发药疹与人类白细胞抗原基因的相关性研究%Drug-induced cADR and polymorphism of HLA genes:A correlational study

    Institute of Scientific and Technical Information of China (English)

    吴培培; 李奕; 杨飞; 乔海灵; 杨静

    2013-01-01

    目的 探讨抗癫痫药物等引发药疹与HLA基因多态性的相关性,以期为药疹的预防和治疗提供依据.方法 收集48例药疹患者,采用PCR-SSP方法检测HLA-B*1502、HLA-A*0206、HLA-A*3101、HLA-A*1101、HLA-B*5901、HLA-Cw*0704、HLA-Cw*0801、HLA-DRB1*1202等8个等位基因.采用RT-PCR检测HLA-B*1502基因阳性者中mRNA表达水平.结果 药物引发的药疹可能与HLA-B*1502、HLA-Cw*0801、HLA-A*0206和HLA-Cw*0704等位基因相关(P<0.05);其中抗癫痫药物引发的重症药疹与HLA-B*1502等位基因的相关性最强(P<0.01);且抗癫痫药物引发的重症药疹HLA-B*1502 mRNA的表达水平明显高于耐受组及对照组(P<0.01).结论 抗癫痫药物引发的重症药疹与HLA-B*1502等位基因密切相关.HLA-B*1502mRNA表达水平可以作为预测抗癫痫药物诱发重症药疹的重要指标.%Aim To explore the association between cutaneous adverse drug reactions( Cadr ) and HLA genetic polymorphisms in patients with drug eruption, in order to provide basis for guarding and treating drug e-ruptions. Methods Forty-eight patients with drug-induced Cadr were enrolled to detect HLA-B * 1502, HLA-A * 0206, HLA-A * 3101, HLA-A * 1101, HLA-B* 5901, HLA-Cw* 0704, HLA-Cw* 0801, HLA-DRB1 * 1202 alleles by polymerase chain reaction with sequence specific primers( PCR-SSP ). The changes of HLA-B * 1502 Mrna level were detected by relative fluorescence quantitative PCR( RT-PCR ). Results HLA-B* 1502, HLA-Cw* 0801, HLA-A* 0206 and HLA-Cw * 0704 alleles might be associated with drug-induced cADR ( P < 0. 05 ). Of which, HLA-B * 1502 allele showed the highest relative risk for bullous drug cADR with SJS/TEN ( P < 0. 01 ). Compared with control and AED-tolerant group respectively, the levels of HLA-B * 1502 mRNA in AED-induced SJS/TEN group indicated a marked increase ( P < 0. 01 ). Conclusions HLA-B * 1502 allele is strongly associated with AED-induced SJS/TEN. Detection of HLA-B* 1502 mRNA level can be the important

  5. 三氧化二砷逆转人胃癌细胞SGC7901/ADR耐药性的作用机制%Reversal mechanism of arsenic trioxide in the drug resistance of human gastric cancer cell line SGC7901/ADR

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Objective: To investigate the reversal effect of arsenic trioxide (As2O3) on the multidrug resistance of human gastric tumor SGC7901/ADR cell line to adriamycin (ADM) and its reversal mechanisms. Methods: The non-cytotoxic concentration of As2O3 and the sensitivity of SGC7901/ADR cells to ADM were detected by MTT assay. The drug concentration and P-gp function of SGC7901/ADR cells were measured with flow cytometry (FCM), and the impacts of As2O3 on the GST-π and TopoⅡ expressions of SGC7901/ADR cells were analyzed by immunohistochemical method. Results: As2O3 at 0.4 to 0.8 μmol/Lconcentrations were not significantly cytotoxic to SGC7901/ADR cells. As2O3 at 0.8 μmol/L could improve the sensitivity of SGC7901/ADR cells to ADM via inhibiting P-gp function, down-regulating GST-π expression and increasing the intracellular accumulation of ADM in SGC7901/ADR cells. Conclusion: As2O3 can reverse partly the drug-resistance of SGC7901/ADR cells to ADM, which may be related with inhibiting the P-gp function and down-regulating GST-π expression.

  6. 135例氟喹诺酮类抗菌药物致不良反应%135 Cases of Adverse Drug Reactions Induced by Fluoroquinolones Antibiotics

    Institute of Scientific and Technical Information of China (English)

    张益钦; 谢根英; 辜雅莉; 吴小红

    2016-01-01

    OBJECTIVE: To investigate the occurrence of adverse drug reactions ( ADR ) induced by fluoroquinolones antibiotics in clinic , so as to provide some tips for the clinic to attach more importance to the adverse drug reactions and promote the rational drug use .METHODS: ADR cases induced by fluoroquinolones antibiotics received by ADR monitoring center of Xiamen Haicang Hospital during 2012-2015 were statistically analyzed . RESULTS:Of the 135 cases, 36 cases were ≥60 years old, accounting for 26.67%; including three kinds of fluoroquinolones antibiotics , and moxifloxacin dominated the first place , followed by levofloxacin and ciprofloxacin . 73 cases were induced by oral administration , and 62 cases were induced by intravenous administration .The main manifestations of ADR induced by fluoroquinolones antibiotics were central nervous system symptoms , followed by gastrointestinal symptoms and anaphylactic reactions , etc..CONCLUSIONS: The incidence of ADR induced by fluoroquinolones antibiotics is relatively high , the clinic should strictly apply fluoroquinolones antibiotics according to the information of usage and dosage , contraindications, matters need attention, ADR, drug combination and medication of special crowd .Meanwhile , the clinic should closely observe the changes of patients'conditions , timely withdrawal drugs and give symptomatic treatment to the patients , so as to improve the rationality of drug use .%目的:了解氟喹诺酮类抗菌药物在临床应用中的不良反应发生情况,提醒临床警惕该类药物的不良反应,促进合理用药。方法:对厦门市海沧医院2012—2015年药品不良反应监测中心收到的氟喹诺酮类抗菌药物所致的不良反应进行整理和分析。结果:135例发生药品不良反应的患者中,≥60岁36例,占26.67%;涉及3种氟喹诺酮类抗菌药物,主要为莫西沙星,其次为左氧氟沙星,再次为环丙沙星;口服给药73例,静脉给药62

  7. Analysis of 109 Reports of Adverse Drug Reaction of Cefoperazone Sodium and Sulbactam Sodium for Injection%109例头孢哌酮钠舒巴坦钠不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    刘宪军; 付娜

    2014-01-01

    Objective To investigate relevant factors of the adverse drug reaction induced by cefoperazone sodium and sulbactam sodium for injection to provide scientific reference for the safe and rational drug use in clinic. Methods 109 ADR reports of cefoperazone sodium and sulbactam sodium for injection collected by Beijing Center for ADR Monitoring from January 2010 to October 2010 were statistically analyzed retrospectively. Results The clinical manifestations of ADR involved skins and appendages damage, blood system damage, digestive system damage, hepatobiliary system damage and generalized lesion. Most ADR cases occurred in 30 minutes after medication, and drug combination maybe cause serious adverse reactions. Conclusion The ADR induced by cefoperazone sodium and sulbactam sodium for injection is associated with its chemical structure, individual diathesis, different diet, drug combination and so on. In order to avoid the occurrence of ADR induced by cefoporazone sodium and sulbactam sodium for injection, the drug must be used rationally and the patient should be intensively warded.%目的:探讨头孢哌酮钠舒巴坦钠致不良反应发生的相关因素,为临床安全合理用药提供参考。方法采用回顾性研究方法,对2012年1月~2012年10月北京市药品不良反应监测中心收集的109例注射用头孢哌酮钠舒巴坦钠不良反应报告进行统计分析。结果头孢哌酮钠舒巴坦钠致不良反应累及系统-器官主要为皮肤及其附件、血液系统、胃肠系统、肝胆系统及全身性损害。多数不良反应出现在用药后30 min 内,且以联合用药出现不良反应的症状较重。结论头孢哌酮钠舒巴坦钠致不良反应与其化学结构、患者个体体质、饮食、联合用药等有关。加强注射用头孢哌酮钠舒巴坦钠的合理使用及用药监护,可以避免或减少不良反应的发生。

  8. Pharmacogenomics and Global Precision Medicine in the Context of Adverse Drug Reactions: Top 10 Opportunities and Challenges for the Next Decade

    Science.gov (United States)

    Alessandrini, Marco; Chaudhry, Mamoonah; Dodgen, Tyren M.

    2016-01-01

    Abstract In a move indicative of the enthusiastic support of precision medicine, the U.S. President Barack Obama announced the Precision Medicine Initiative in January 2015. The global precision medicine ecosystem is, thus, receiving generous support from the United States ($215 million), and numerous other governments have followed suit. In the context of precision medicine, drug treatment and prediction of its outcomes have been important for nearly six decades in the field of pharmacogenomics. The field offers an elegant solution for minimizing the effects and occurrence of adverse drug reactions (ADRs). The Clinical Pharmacogenetics Implementation Consortium (CPIC) plays an important role in this context, and it aims at specifically guiding the translation of clinically relevant and evidence-based pharmacogenomics research. In this forward-looking analysis, we make particular reference to several of the CPIC guidelines and their role in guiding the treatment of highly relevant diseases, namely cardiovascular disease, major depressive disorder, cancer, and human immunodeficiency virus, with a view to predicting and managing ADRs. In addition, we provide a list of the top 10 crosscutting opportunities and challenges facing the fields of precision medicine and pharmacogenomics, which have broad applicability independent of the drug class involved. Many of these opportunities and challenges pertain to infrastructure, study design, policy, and science culture in the early 21st century. Ultimately, rational pharmacogenomics study design and the acquisition of comprehensive phenotypic data that proportionately match the genomics data should be an imperative as we move forward toward global precision medicine. PMID:27643672

  9. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    OpenAIRE

    Fabiana Rossi Varallo; Helaine Carneiro Capucho; Cleópatra da Silva Planeta; Patrícia de Carvalho Mastroianni

    2014-01-01

    OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to Decemb...

  10. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

    OpenAIRE

    Ghosh S; Acharya Leelavathi; Rao Padma

    2006-01-01

    The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the advers...

  11. Safety learning from drugs of the same class

    DEFF Research Database (Denmark)

    Stefansdottir, G; Knol, M J; Arnardottir, A H;

    2012-01-01

    This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs......) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were......, a longer time interval between entry into the market by the two drugs, and an earlier date of ADR. Although there appears to be some degree of safety learning from same-class drugs, there is still room for improvement, possibly by increasing proactive risk management....

  12. Variation of adverse drug reaction profile of platinum-based chemotherapy with body mass index in patients with solid tumors: An observational study

    Directory of Open Access Journals (Sweden)

    Dattatreyo Chatterjee

    2014-01-01

    Full Text Available Objectives: Toxicity of cancer chemotherapy may be affected by nutritional status of patients which is reflected in the body mass index (BMI. We sought to assess whether the adverse drug reaction (ADR profile of platinum-based chemotherapy varies with BMI status. Materials and Methods: Adult patients of either sex, suffering from a solid tumor (lung, head and neck, ovary, gall bladder, stomach, colon and started on platinum-based chemotherapy as initial treatment were included. BMI at chemotherapy commencement was obtained from medical records. Events were recorded and graded as per Eastern Co-operative Oncology Group Common Toxicity Criteria-patients′ complaints; clinically evident signs and laboratory reports were considered. Frequencies of individual adverse events were compared between low BMI (<18.5 kg/m 2 and satisfactory BMI groups. Similar comparisons were done for events with grades 2 or 3 severities. Results: A total of 50 patients were observed over a 3-month period of whom 17 (34% belonged to the low BMI group. Nausea, vomiting, diarrhea, stomatitis, anemia, alopecia, tinnitus and paresthesia were the commonly observed ADRs. The frequencies of anemia (P = 0.152 and vomiting (P = 0.140 and severity of grades of nausea (P = 0.066, anemia (P = 0.120 and paresthesia (P = 0.128 showed a higher trend in the low BMI group though differences were not statistically significant. The frequencies of tinnitus (P = 0.021 and paresthesia overall (P = 0.036 were significantly higher in the low BMI group. Conclusion: ADR profile of primary platinum-based chemotherapy appears to be partly influenced by BMI. This suggests the importance of maintaining adequate nutrition in patients and the need for greater vigilance in those with low BMI.

  13. Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    and type of reporter. The unit of analysis was one ADR. Results We located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85 % of reported ADRs were serious including six fatal cases. In total, 57 % of ADRs were reported for boys. One quarter of all...

  14. Inappropriate prescribing and adverse drug events in older people

    Directory of Open Access Journals (Sweden)

    Gallagher Paul F

    2009-01-01

    Full Text Available Abstract Inappropriate prescribing (IP in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs, morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  15. Inappropriate prescribing and adverse drug events in older people.

    LENUS (Irish Health Repository)

    Hamilton, Hilary J

    2009-01-01

    Inappropriate prescribing (IP) in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs), morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  16. Prospective Observational Study of Adverse Drug Reactions of Anticancer Drugs Used in Cancer Treatment in a Tertiary Care Hospital

    OpenAIRE

    V. K. Saini; Sewal, R. K.; Ahmad, Yusra; B Medhi

    2015-01-01

    Adverse drug reactions associated with the use of anticancer drugs are a worldwide problem and cannot be ignored. Adverse drug reactions can range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to observe the suspected adverse drug reactions of cancer chemotherapy in patients aged >18 years having cancer attending Postgraduate Institute of Medical Education and Research, Chandigarh. During the study period, 101 patients of breast cancer and ...

  17. Discussion on adverse reactions monitoring modes of drug manufacturers under new measures for administration of adverse drug reaction report and monitoring%《药品不良反应报告和监测管理办法》下药品生产企业不良反应监测工作模式探讨

    Institute of Scientific and Technical Information of China (English)

    杨延音; 董志; 夏永鹏

    2012-01-01

    Objective: To discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring. Method: Work modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains. Result and Conclusion: As there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.%目的:探讨药品生产企业在《药品不良反应报告和监测管理办法》(新《办法》)下顺利开展ADR监测工作的模式.方法:通过对新《办法》解读、现状及制约因素分析,探索生产企业ADR监测工作开展模式.结果与结论:生产企业在短期内一步到位完全按照新《办法》要求开展ADR监测工作与现状跨度较大,可以通过一“平台”四“拓展”的模式,分块逐步突破,开展ADR监测工作,最终完全达到新《办法》的要求,履行主体地位的责任和使命.

  18. Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

    OpenAIRE

    Jeetu, G; G. Anusha

    2010-01-01

    Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The ...

  19. Market segmentation: Venezuelan ADRs

    Directory of Open Access Journals (Sweden)

    Urbi Garay

    2012-12-01

    Full Text Available The control on foreign exchange imposed by Venezuela in 2003 constitute a natural experiment that allows researchers to observe the effects of exchange controls on stock market segmentation. This paper provides empirical evidence that although the Venezuelan capital market as a whole was highly segmented before the controls were imposed, the shares in the firm CANTV were, through their American Depositary Receipts (ADRs, partially integrated with the global market. Following the imposition of the exchange controls this integration was lost. Research also documents the spectacular and apparently contradictory rise experienced by the Caracas Stock Exchange during the serious economic crisis of 2003. It is argued that, as it happened in Argentina in 2002, the rise in share prices occurred because the depreciation of the Bolívar in the parallel currency market increased the local price of the stocks that had associated ADRs, which were negotiated in dollars.

  20. Toxic epidermal necrolysis: a severe cutaneous adverse drug reaction

    Directory of Open Access Journals (Sweden)

    K. N. Chidananda

    2015-02-01

    Full Text Available Toxic epidermal necrolysis (TEN is a rare but serious is a rare but potentially life-threatening condition. It is primarily a cutaneous reaction to various precipitating agents, characterized by wide spread erythema and detachment of the epidermis from the dermis. Among the various cutaneous adverse drug reactions, TEN occupy a primary place in terms of mortality. In TEN large sheets of skin are lost from the body surface, thereby decreasing the protecting function of the skin, which results in complications. Usually, TEN is self-limited in absence of complications. If complicated by sepsis, there will be increased chances of mortality. The main treatment would be cessation of the causative drug and early admission of the patient for supportive care and minimizing the occurrence of complications. The present articles reviews the etiology, pathophysiology, differential diagnosis and treatment protocol, with a case of TEN occurrence in a child of 4 years age after consuming phenytoin syrup for febrile convulsions. [Int J Basic Clin Pharmacol 2015; 4(1.000: 1-5

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

    Directory of Open Access Journals (Sweden)

    Eckstrand Julie

    2010-02-01

    Full Text Available Abstract Background Despite the high frequency with which adverse drug events (ADEs occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA. Methods A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described. Results A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1% were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157, 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note. Conclusions Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist

  3. Retrospective Analysis of Adverse Drug Reaction of Ibuprofen%布洛芬不良反应回顾性分析

    Institute of Scientific and Technical Information of China (English)

    吴朝霞

    2014-01-01

    目的:通过分析布洛芬所致药物不良反应(ADR)的一般规律和药物流行病学特点,为临床合理安全使用提供参考。方法:以“布洛芬”、“不良反应”关键词检索中国期刊全文数据库(CNKI)和中文科技期刊数据库(VIP)1996-2012年中文期刊,收集布洛芬所致ADR案例,对其ADR信息进行回顾性分析。结果:布洛芬所致ADR在各年龄组段均有分布且临床表现复杂多样涉及多器官、多系统,应警惕其引发严重ADR。结论:应注重患者个体差异,规范用药,提高患者用药依从性,强化药物治疗监测,以确保用药安全。%Objective:To analyze the general rules of the adverse drug reactions induced by ibuprofen and the pharmacoepidemiology features so as to provide a reference for rational and safe application of ibuprofen in clinical practice. Methods: ADR cases induced by ibuprofen were retrieved through key words searching and database review of CNKI and VIP from 1996 to 2012. The ADR information was retrospectively analyzed using statistical method. Results:The ADRs induced by ibuprofen presented in all age groups and the clinical manifestations were many and complex involving multiple organs and systems, therefore precautions should be made for the occurrence of serious ADRs. Conclusion: In order to ensure safe medication attention should be paid to the individual difference of patients and the standardization of drug application, in addition, medication compliance of patients should be improved and the therapeutic drug monitoring be strengthened.

  4. Reason analysis of 98 cases of adverse drug reactions in our hospital in 2010%我院2010年度98例药物不良反应原因分析

    Institute of Scientific and Technical Information of China (English)

    陈俊涛; 邢亚丽; 刘文化

    2011-01-01

    目的:对我院98例药物不良反应(ADR)情况及特点进行分析,促进临床合理用药.方法:采用回顾性分类统计,对98例报告中涉及的年龄、性别、临床表现、给药途径、给药剂量、使用方法、配液环境、输液器材等进行整理分析.结果:药物使用不规范引起74例,配液环境引起反应6例,输液器(留置针)引起反应4例,患者体质引起反应14例.结论:提高医护人员综合素质、临床药师加强监管,对减少ADR的发生、促进合理用药具有重要性.%Objective: To analyze the conditions and characteristics of 98 cases of adverse drug reactions (ADR) in our hospital and promote clinical rational drug use. Methods: The retrospective classified statistics was used to settle and analyze age, sex, clinical manifestation, route of administration, dosage, usage, preparation environment, transfusion equipments in 98 cases. Results: Irregular drug use caused 74 cases of ADR, preparation environment caused 6 cases, transfusion e -quipments (remaining needle) caused 4 cases and physique of patients caused 14 cases. Conclusion: To improve the overall quality of health care workers and strengthen supervision over clinical pharmacists are important to reduce the inci -dence of ADR and promote rational drug use.

  5. Association between SLCO1B1 -521T>C and -388A>G polymorphisms and risk of statin-induced adverse drug reactions: A meta-analysis.

    Science.gov (United States)

    Jiang, Jiajia; Tang, Qing; Feng, Jing; Dai, Rong; Wang, Yang; Yang, Yuan; Tang, Xiaojun; Deng, Changkai; Zeng, Huan; Zhao, Yong; Zhang, Fan

    2016-01-01

    An increasing number of studies have investigated the association between SLCO1B1 -521T>C and -388A>G polymorphisms and the risk of statin-induced adverse drug reactions (ADRs), but the results have been inconsistent. This meta-analysis was performed to gain more insight into the relationship. PubMed, Embase, Cochrane Library and Web of Science were searched for relevant articles published before March 5th, 2015. The quality of included studies was evaluated by the Newcastle-Ottawa Quality scale. Pooled effect estimates (odds ratios [ORs] or hazard ratios [HRs) and corresponding 95 % confidence intervals (CIs) were calculated to assess the association in overall and subgroup analyses for various genetic models. Begg's rank correlation test and Egger's linear regression test were used to examine the publication bias. A total of nine cohort and four case-control studies involving 11, 246 statin users, of whom 2, 355 developing ADRs were included in the analysis. Combined analysis revealed a significant association between the SLCO1B1-521T>C polymorphism and increased risk for ADRs caused by various statins, but the synthesis heterogeneity was generally large (dominant model: pooled effect estimate = 1.85, 95 % CI 1.20-2.85, P = 0.005; I (2) = 80.70 %, Pheterogeneity G polymorphism and ADRs caused by various statins (dominant model: pooled effect estimate = 0.94, 95 % CI 0.79-1.13, P = 0.526; I (2) = 40.10 %, Pheterogeneity = 0.196). The meta-analysis suggests that SLCO1B1 -521T>C polymorphism may be a risk factor for statin-induced ADRs, especially in simvastatin therapy. Conversely, there may be no significant association for -388A>G polymorphism. PMID:27606156

  6. 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 si

  7. 基于 HIS 的药品不良反应快速上报与智能搜索系统研究与应用%Research and Application of Adverse Drug Reaction Rapid Reporting and Intelligent Searching System Based on HIS

    Institute of Scientific and Technical Information of China (English)

    邓剑雄; 王玲; 陈文戈; 舒婷; 张业象

    2015-01-01

    solved under reporting, misinformation, delay reporting and other issues of adverse drug reactions, achieved rapid reporting and intelligent searching functions, improved the hospital's ADR reporting rate and the reporter's initiative, and let the adverse drug reaction monitoring mode turn from the traditional"passive" to the "active". Conclusion The ADR rapid reporting and intelligent searching system effectively enhances the capacity of drug post-marketing surveillance, and greatly improves the rational drug use in medical institutions, and it is of significant importance to strengthen drug safety monitoring and evaluation in our country.

  8. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-03-01

    Full Text Available OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%, fatigue (12.3%, and chest pain (9.0%. Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

  9. Core Concepts Involving Adverse Psychotropic Drug Effects: Assessment, Implications, and Management.

    Science.gov (United States)

    Goldberg, Joseph F; Ernst, Carrie L

    2016-09-01

    Adverse effects from psychiatric drugs can profoundly influence treatment adherence and outcomes. Good care involves addressing adverse effects no differently than any other component of treatment. Knowledge about adverse effect assessment and management fosters a proper context that helps clinicians not sacrifice a drug's potential therapeutic benefits because of greater concerns about its tolerability. This article provides an overview of basic concepts related to the assessment and management of suspected adverse effects from psychotropic drugs. Key points are discussed regarding clinical, pharmacogenetic, pharmacokinetic, and pharmacodynamic risk factors for treatment-emergent adverse effects, alongside recommendations for their systematic assessment. PMID:27514295

  10. Revisión sistemática de los estudios de evaluación del coste de las reacciones adversas a medicamentos Systematic review of studies assessing the cost of adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Antonio Vallano Ferraz

    2012-06-01

    Full Text Available Objetivos: Las reacciones adversas a medicamentos (RAM son un problema sanitario relevante. El objetivo fue revisar los estudios publicados que han analizado los costes de las RAM en cualquier ámbito asistencial. Métodos: Se realizó una búsqueda de artículos publicados en bases bibliográficas (1970-2010. Se identificaron 28 estudios y se seleccionaron 16 que incluyeron casos de RAM según la definición de la Organización Mundial de la Salud. Se revisó la información relacionada con las características del diseño de los estudios, los tipos de costes analizados y los resultados descritos. Resultados: Las características del diseño y de las poblaciones incluidas en los estudios fueron heterogéneas. Sólo en dos se definió explícitamente la perspectiva del estudio. Sólo cinco estudios compararon los casos de los pacientes con RAM con controles apareados sin RAM. Todos los estudios analizaron los costes directos sanitarios, pero ninguno los costes indirectos o intangibles. En 14 estudios se analizaron los costes de los días de hospitalización. El porcentaje medio (DE de RAM fue de 3,04% (2,3 [mediana 2,4%, mínimo 0,70% y máximo 26,1%]. La mediana de días de hospitalización de los pacientes con RAM fue de 8,8 días (intervalo de 0,15 a 19,2 días. Los sistemas de contabilidad y los costes monetarios fueron muy variables. Conclusión: Los estudios sobre los costes de las RAM tienen diseños heterogéneos, han evaluado los costes directos sanitarios hospitalarios y sus resultados indican que las RAM generan costes significativos. Son necesarios estudios sobre los costes de las RAM realizados con una metodología adecuada.Objective: Adverse drug reactions (ADRs are an important healthcare problem. The objective of this study was to review published articles analyzing the cost of ADRs in any healthcare setting. Method: We conducted a search of articles published on the cost of ADRs in the bibliographic databases from 1970 to 2010

  11. Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting.

    Directory of Open Access Journals (Sweden)

    Nora Anderson

    Full Text Available Annually, adverse drug reactions result in more than 2,000,000 hospitalizations and rank among the top 10 causes of death in the United States. Consequently, there is a need to continuously monitor and to improve the safety assessment of marketed drugs. Nonetheless, pharmacovigilance practice frequently lacks causality assessment. Here, we report the case of flupirtine, a centrally acting non-opioid analgesic. We re-evaluated the plausibility and causality of 226 unselected, spontaneously reported hepatobiliary adverse drug reactions according to the adapted Bradford-Hill criteria, CIOMS score and WHO-UMC scales. Thorough re-evaluation showed that only about 20% of the reported cases were probable or likely for flupirtine treatment, suggesting an incidence of flupirtine-related liver injury of 1∶100,000 when estimated prescription data are considered, or 0.8 in 10,000 on the basis of all 226 reported adverse drug reactions. Neither daily or cumulative dose nor duration of treatment correlated with markers of liver injury. In the majority of cases (151/226, an average of 3 co-medications with drugs known for their liver liability was observed that may well be causative for adverse drug reactions, but were reported under a suspected flupirtine ADR. Our study highlights the need to improve the quality and standards of ADR reporting. This should be done with utmost care taking into account contributing factors such as concomitant medications including over-the-counter drugs, the medical history and current health conditions, in order to avoid unjustified flagging and drug warnings that may erroneously cause uncertainty among healthcare professionals and patients, and may eventually lead to unjustified safety signals of useful drugs with a reasonable risk to benefit ratio.

  12. Prevention and Management of Adverse Reactions Induced by Iodinated Contrast Media.

    Science.gov (United States)

    Wu, Yi Wei; Leow, Kheng Song; Zhu, Yujin; Tan, Cher Heng

    2016-04-01

    Iodinated radiocontrast media (IRCM) is widely used in current clinical practice. Although IRCM is generally safe, serious adverse drug reactions (ADRs) may still occur. IRCM-induced ADRs may be subdivided into chemotoxic and hypersensitivity reactions. Several factors have been shown to be associated with an increased risk of ADRs, including previous contrast media reactions, history of asthma and allergic disease, etc. Contrast media with lower osmolality is generally recommended for at-risk patients to prevent ADRs. Current premedication prophylaxis in at-risk patients may reduce the risk of ADRs. However, there is still a lack of consensus on the prophylactic role of premedication. Contrast-induced nephropathy (CIN) is another component of IRCM-related ADRs. Hydration remains the mainstay of CIN prophylaxis in at-risk patients. Despite several preventive measures, ADRs may still occur. Treatment strategies for potential contrast reactions are also summarised in this article. This article summarises the pathophysiology, epidemiology and risk factors of ADRs with emphasis on prevention and treatment strategies. This will allow readers to understand the rationale behind appropriate patient preparation for diagnostic imaging involving IRCM. PMID:27292007

  13. [Adverse or toxic effects of drugs in medical practice: a one-year follow-up].

    Science.gov (United States)

    Grange, J C

    1990-01-01

    In order to analyse the response of pharmaceutical companies to adverse drug reaction reports, 37 suspected side effects were sent by mail to the 30 companies concerned. The time period involved was 1 year and corresponded to a total of 3341 consultations in general practice. Companies answered in 29 cases (78.3%), sent 21 reply forms and returned 3 evaluations of adverse drugs reactions to the reporting doctor. The high percentage of adverse drug reactions (1.07 per one hundred consultations), the doctor's work-load and poor feed-back lead one to reflect on the usefulness of systematic adverse drug reaction reporting by general practitioners. PMID:2399517

  14. Ziconotide: new drug. Limited analgesic efficacy, too many adverse effects.

    Science.gov (United States)

    2008-10-01

    (1) When oral morphine does not relieve severe pain and when there is no specific treatment for the underlying cause, the first option is to try subcutaneous or intravenous administration. If this standard treatment fails or is poorly tolerated, intrathecal injection is usually preferred as the direct route to the central nervous system. However, one-quarter to one-half of patients still do not achieve adequate pain relief, and adverse effects are relatively frequent; (2) Ziconotide is not an opiate and is not related to the usual classes of drugs that interfere with nervous transmission in the posterior horn of the spinal cord. Marketing authorization has been granted for "severe, chronic pain in patients who require intrathecal analgesia". The Summary of Product Characteristics (SPC) recommends continuous infusion via an intrathecal catheter connected to a pump; (3) Clinical evaluation of ziconotide does not include any trials versus morphine in patients with nociceptive pain, or any trials versus tricyclic or antiepileptic drugs in patients with neurogenic pain; (4) In a trial in 220 patients in whom systemic morphine had failed, the mean pain score on a 100-mm visual analogue scale was 69.8 mm after three weeks on ziconotide, compared to 75.8 mm with placebo. This difference, although statistically significant, is clinically irrelevant. The proportion of "responders" (reduction of at least 30% in the initial pain score) was respectively 16.1% and 12.0% (no statistically significant difference); (5) The two other placebo-controlled trials included 112 patients with pain linked to cancer or HIV infection, and 257 patients with non-cancer pain. After a titration phase lasting 5 to 6 days, a combined analysis of the two trials showed that the mean pain score was 48.8 mm with ziconotide and 68.4 mm with placebo (statistically significant difference). However, many patients did not complete the titration phase. Efficacy also appeared to differ according to the type

  15. A study of adverse events associated with the use of Immunosuppressive agents in kidney transplanted Patients

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    Sharma Love

    2012-09-01

    Full Text Available Introduction: Kidney transplantation provides a l i f e saving treatment for patients wi th End Stage Renal Disease (ESRD. But total success after transplantation is hugely dependent on proper course of immunosuppressive therapy. The rationale behind this study was to monitor, analyse, and evaluate the AEs and ADRs associated with immunosuppressive drugs and to document the pharmacotherapeutic actions taken for its management. Methodology: The study was Retrospective and medical data of all patients (as per inclusion/exclusion criteria admitted during the Study Period was analysed. Results: A total of 95 patients were enrolled in the study and incidence rate of patient affected due to ADR was found to be 75.78 % and overall 352 AEs were documented. Causality and Severity assessment of ADRs were done which showed Probabale (47, and Moderate (47 respectively. Out of 84 ADRs, 80 ADRs were Not preventable. Furthermore significant relation was observed (p<0.005 among various factors, drugs and suspected ADRs. Conclusion: The results of this study show that immunosuppressive drugs may cause serious and frequent adverse effects. So, special monitoring and regular follow up of patients are required to minimise the risk and frequency of these adverse effects.

  16. Pharmaco-epidemiology of Sumatriptan : cardiovascular adverse reactions to a new antimigrainous drug

    NARCIS (Netherlands)

    J.P. Ottervanger (Jan Paul)

    1996-01-01

    textabstractThe rationale to study a potential adverse reaction of a specific drug mainly depends on three questions: 1) how serious is the adverse reaction? 2) what is the incidence of the adverse reaction among users of the dlUg?, and 3) what is the frequency of consumption of the specific dlUg in

  17. Adverse events of modern antifungal drugs during treatment of invasive fungal infections

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    N. V. Dmitrieva

    2013-01-01

    Full Text Available Characteristics of adverse events of modern antimycotics by organ systems and comparative frequency between different medicines and their groups are presented. The examples of incompatibility of antifungal drugs with other pharmacological groups are discussed. Records of adverse events and drug compatibility will allow the practitioner to prevent and timely cure possible complications, should they arise.

  18. 湖北民族学院附属民大医院药品不良反应相关因素分析%Related Factors of Adverse Drug Reactions in Hubei University for Nationalities Affiliated Minda Hospital

    Institute of Scientific and Technical Information of China (English)

    李红玲; 庄红玲; 谭娜; 郭淑敏; 覃正碧

    2015-01-01

    OBJECTIVE:To analyze the related factors of the adverse drug reactions ( ADRs) in Hubei University for Nationalities Affiliated Minda Hospital so as to probe into the characteristics of the ADRs for clinical reference of safe medication.METHODS:A total of 75 ADR cases reported from January 2012 to October 2014 in this hospital were analyzed with regard to patients'age, drug type, routes of administration, ADR-involved organs or systems, and medication information and outcomes of the new and severe ADR cases.RESULTS: The ADRs occurred in different age group, and induced mostly by intravenously administered drugs, by anti-infective drugs and traditional Chinese medicine injections, and manifested mostly by the damage of skin and its appendages.The new and serious ADR occurred more often in patients with a history of allergy and in thosev treated with combination of multiple drugs. CONCLUSION:To avoid the risk of medication and reduce the occurrence of ADR in this hospital, it is important to attach great importance to the special population including the infants and elderly and those with hypersensitivity, reduce the ratio of intravenous administration, avoid excessive use of antimicrobial drugs and regulate the use of traditional Chinese medicine injections.%目的:通过对湖北民族学院附属民大医院上报的药品不良反应( ADR)及相关因素进行分析,了解药品不良反应发生特点,为临床安全用药提供依据。方法:收集该院2012年1月至2014年10月上报的200例ADR报告,对发生ADR的患者年龄、药品类别、用药途径、发生部位以及新发严重ADR的用药信息及转归等情况进行汇总统计分析。结果:ADR可涉及任意年龄阶段,静脉给药方式是引起ADR的主要途径,涉及药物以抗感染药物、中药注射剂为主,临床表现以皮肤及其附件损害的表现多见。新发严重ADR多发生在有过敏史的患者,且联合用药品种较多。结论:关

  19. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    Directory of Open Access Journals (Sweden)

    Bero Lisa

    2010-11-01

    Full Text Available Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62% reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  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. Analysis of adverse reaction reports of penicillin drugs%青霉素类药物不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张兵; 冯变玲; 赵晓红; 吉天天

    2013-01-01

    目的比较注射与口服青霉素类药物不良反应的差别。方法采用回顾性分析方法对2007~2012年江苏省不良反应中心收集到的青霉素类药品的不良反应报告进行分析。结果江苏省注射用青霉素的不良反应数为6082例,占92.98%;口服青霉素的不良反应数为454例,占6.94%。注射用青霉素有新的严重的不良反应2例。注射用青霉素不良反应病例经治疗后有9例死亡病例,3例病人留下后遗症;口服青霉素的不良反应经治疗后均痊愈或好转。结论口服青霉素类药物不良反应数量少,且严重程度低,经治疗后无死亡或留下后遗症的病例。%Objective Compare with injection penicillin drugs and oral penicillin drugs for ADR .Method The adverse reaction re-ports of penicillin drugs collected by Jiangsu adverse reaction center from 2007 to 2012 were analyzed retrospectively .Result The case number of adverse reactions of injection penicillin was 6 082 ,accounting for 92 .98% ;Oral penicillin adverse reactions num-ber was 454 cases ,accounting for 6 .94% ;The injection penicillin drugs had new serious adverse reactions in 2 cases ;After the treatment of injection penicillin adverse reaction ,9 cases were die and 3 cases left sequela ;On the other hand ,the cases of oral penicillin adverse reactions were recoveried or better after treatment .Conclusion For the adverse drug reactions of oral penicillin , the quantity was less and the serious degree was low and no death or sequela was reported after treatment .

  2. 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

    2016-01-01

    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. PMID:26990265

  3. Pilot study on developing a decision support tool for guiding re-administration of chemotherapeutic agent after a serious adverse drug reaction

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    Chew Lita

    2011-07-01

    Full Text Available Abstract Background Currently, there are no standard guidelines for recommending re-administration of a chemotherapeutic drug to a patient after a serious adverse drug reaction (ADR incident. The decision on whether to rechallenge the patient is based on the experience of the clinician and is highly subjective. Thus the aim of this study is to develop a decision support tool to assist clinicians in this decision making process. Methods The inclusion criteria for patients in this study are: (1 had chemotherapy at National Cancer Centre Singapore between 2004 to 2009, (2 suffered from serious ADRs, and (3 were rechallenged. A total of 46 patients fulfilled the inclusion criteria. A genetic algorithm attribute selection method was used to identify clinical predictors for patients' rechallenge status. A Naïve Bayes model was then developed using 35 patients and externally validated using 11 patients. Results Eight patient attributes (age, chemotherapeutic drug, albumin level, red blood cell level, platelet level, abnormal white blood cell level, abnormal alkaline phosphatase level and abnormal alanine aminotransferase level were identified as clinical predictors for rechallenge status of patients. The Naïve Bayes model had an AUC of 0.767 and was found to be useful for assisting clinical decision making after clinicians had identified a group of patients for rechallenge. A platform independent version and an online version of the model is available to facilitate independent validation of the model. Conclusion Due to the limited size of the validation set, a more extensive validation of the model is necessary before it can be adopted for routine clinical use. Once validated, the model can be used to assist clinicians in deciding whether to rechallenge patients by determining if their initial assessment of rechallenge status of patients is accurate.

  4. Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

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    Ogunwande Isiaka A

    2011-08-01

    Full Text Available Abstract Background Adverse drug reactions (ADRs contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria. Methods Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP and four Patent and Proprietary Medicine Stores (PPMS in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period. Results and Discussion A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases; of this number, purchases of sulphadoxine-pyrimethamine (SP and chloroquine (CQ were highest (39.3 and 25.2% respectiuvely. Other anti-malarials purchased were artesunate monotherapy (AS - 16.1%, artemether-lumefantrine (AL 10.0%, amodiaquine (AQ - 6.6%, quinine (QNN - 1.9%, halofantrine (HF - 0.2% and proguanil (PR - 0.2%. CQ was the cheapest (USD 0.3 and halofantrine the most expensive (USD 7.7. AL was 15.6 times ($4.68 more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1 after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%. Conclusion The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource

  5. 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.

  6. Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

    2014-11-01

    Disease-modifying antirheumatic drugs (DMARDs) and biological agents are critical in preventing the severe complications of rheumatoid arthritis (RA). However, the outcome of treatment with these drugs in RA patients is quite variable and unpredictable. Drug-metabolizing enzymes (dihydrofolate reductase, cytochrome P450 enzymes, N-acetyltransferases, etc.), drug transporters (ATP-binding cassette transporters), and drug targets (tumor necrosis factor-α receptors) are coded for by variant alleles. These gene polymorphisms may influence the pharmacokinetics, pharmacodynamics, and side effects of medicines. The cause for differences in efficacy and adverse drug reactions may be genetic variation in drug metabolism among individuals. Polymorphisms in drug transporter genes may change the distribution and excretion of medicines, and the sensitivity of the targets to drugs is strongly influenced by genetic variations. In this article, we review the genetic polymorphisms that affect the efficacy of DMARDs or the occurrence of adverse drug reactions associated with DMARDs in RA.

  7. Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

    2014-11-01

    Disease-modifying antirheumatic drugs (DMARDs) and biological agents are critical in preventing the severe complications of rheumatoid arthritis (RA). However, the outcome of treatment with these drugs in RA patients is quite variable and unpredictable. Drug-metabolizing enzymes (dihydrofolate reductase, cytochrome P450 enzymes, N-acetyltransferases, etc.), drug transporters (ATP-binding cassette transporters), and drug targets (tumor necrosis factor-α receptors) are coded for by variant alleles. These gene polymorphisms may influence the pharmacokinetics, pharmacodynamics, and side effects of medicines. The cause for differences in efficacy and adverse drug reactions may be genetic variation in drug metabolism among individuals. Polymorphisms in drug transporter genes may change the distribution and excretion of medicines, and the sensitivity of the targets to drugs is strongly influenced by genetic variations. In this article, we review the genetic polymorphisms that affect the efficacy of DMARDs or the occurrence of adverse drug reactions associated with DMARDs in RA. PMID:25144752

  8. 我国药品不良反应报告质量评估现状的分析与思考%Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China

    Institute of Scientific and Technical Information of China (English)

    刘巍; 李馨龄; 程刚; 沈璐; 董铎; 刘翠丽; 王亚丽

    2014-01-01

    s:Objective To review the progress of the evaluation for the quality of the adverse drug reactions (ADR) in China. Methods Progress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. Results By the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitor-ing. Conclusion The quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods.%目的:分析药品不良反应报告质量评估工作的现状。方法对目前国内药品不良反应个案报告表质量和药品不良反应数据库整体质量评估工作的历史和现状进行回顾和总结。结果对每份个案报告表质量的评估能发现报告表填写、评价审核中存在的细节问题,而药品不良反应数据库整体质量评估则能发现监测工作在方法、导向以及趋势等方面相对宏观的问题。二者互为补充,对推动监测工作健康发展具有积极作用。结论药品不良反应报告质量提高工作是药品不良反应监测工作的重要内容,亟待建立针对药品不良反应个案报告表和药品不良反应数据库建立科学、可操作的评估体系和方法。

  9. Adverse drug reactions to ibuprofen: a case report

    OpenAIRE

    Khobragade Yadneshwar; Khobragade Sujata

    2016-01-01

    Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here sever...

  10. Is it Safe? Adverse drug effects and cardiac arrhythmias

    OpenAIRE

    Varkevisser, R.

    2014-01-01

    The potentially life-threatening polymorphic ventricular arrhythmia Torsade de Pointes (TdP) generally occurs in the setting of delayed ventricular repolarization, as reflected on the ECG by a prolonged QT interval. A growing number of drugs are associated with QT prolongation and/or TdP, as a result, development of promising new drugs has been aborted, and already marketed drugs have received severe restrictions or have been withdrawn. To address this cardiac safety issue, international guid...

  11. Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

    NARCIS (Netherlands)

    Orten-Luiten, van A.C.B.; Janse, A.; Dhonukshe-Rutten, R.A.M.; Witkamp, R.F.

    2016-01-01

    Purpose: Adverse drug reactions as well as vitamin D deficiency are issues of public health concern in older people. However, relatively little is known about the impact of drug use on vitamin D status. Our primary aim is to explore associations between drug use and vitamin D status in older peop

  12. Caffeic Acid Phenethyl Ester: A Review of Its Antioxidant Activity, Protective Effects against Ischemia-reperfusion Injury and Drug Adverse Reactions.

    Science.gov (United States)

    Tolba, Mai F; Omar, Hany A; Azab, Samar S; Khalifa, Amani E; Abdel-Naim, Ashraf B; Abdel-Rahman, Sherif Z

    2016-10-01

    Propolis, a honey bee product, has been used in folk medicine for centuries for the treatment of abscesses, canker sores and for wound healing. Caffeic acid phenethyl ester (CAPE) is one of the most extensively investigated active components of propolis which possess many biological activities, including antibacterial, antiviral, antioxidant, anti-inflammatory, and anti-cancer effects. CAPE is a polyphenolic compound characterized by potent antioxidant and cytoprotective activities and protective effects against ischemia-reperfusion (I/R)-induced injury in multiple tissues such as brain, retina, heart, skeletal muscles, testis, ovaries, intestine, colon, and liver. Furthermore, several studies indicated the protective effects of CAPE against chemotherapy-induced adverse drug reactions (ADRs) including several antibiotics (streptomycin, vancomycin, isoniazid, ethambutol) and chemotherapeutic agents (mitomycin, doxorubicin, cisplatin, methotrexate). Due to the broad spectrum of pharmacological activities of CAPE, this review makes a special focus on the recently published data about CAPE antioxidant activity as well as its protective effects against I/R-induced injury and many adverse drug reactions. PMID:25365228

  13. Optimising the retrieval of information on adverse drug effects.

    Science.gov (United States)

    Golder, Su

    2013-12-01

    Pharmaceutical interventions have brought about many benefits to health, improving the population's well-being and life expectancy. However, these interventions are not without potential harmful side-effects and yet searching for the evidence on adverse effects is challenging. This article summarises a PhD whose main aim was to develop a better understanding of the implications of using different sources and approaches to identifying relevant data on adverse effects. The author is Su Golder, who has recently completed her PhD at the University of York and who has already published several articles on specific aspects of her research, including this journal. This article is the first in the Dissertations into Practice series to report on a PhD study, and it summarises her research in a way which emphasises the implications for practice.

  14. Analysis of the Reports of Adverse Drug Reactions Induced by PEG-interferon Alfa-2a Injection%聚乙二醇干扰素α-2a注射液不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    韩丹; 代菲; 储文功

    2013-01-01

    目的:探讨聚乙二醇干扰素α-2a注射液不良反应发生的特点及相关因素,为临床安全用药提供参考.方法:收集某省药品不良反应监测中心2004~2011年自发呈报系统上报的1 606例聚乙二醇干扰素α-2a注射液的不良反应(ADR)报告,对ADR所涉及的患者年龄、性别,以及ADR年份、类型、结果、临床表现等进行统计分析.结果:1606例报告中,男883例,女723例,30 ~60岁患者最多(72.6%);发生严重不良反应243例,新的严重ADR 86例;临床表现以血液系统损害为主占59.95%,其次为肝胆系统损害占10.76%.结论:临床在运用聚乙二醇干扰素α-2a治疗丙肝的过程中,应密切观察其ADR,制定周密的护理计划,积极干预和防治,以有效减少和防止ADR发生.%To probe into the characteristics of adverse drug reactions (ADR) caused by PEG-interferon alfa-2a injection to provide some rational clinical guidance. Methods: 1606 reports of adverse reactions caused by PEG-interferon alfa-2a injection were collected from January 2004 to December 2011 and statistically analyzed in respect of patients'sex and age, involved type, years, result, clinical manifestations, etc. Results:883 of the 1606 cases were male cases,723 were female cases, and 72. 6% were the adults at the age of 30 to 60.The incidence rate of severe ADR were 243 cases, and new and severe ADR were 86 cases. The blood system was the main lesion in ADR cases (59.95%) , and the second was liver and gall system(10.76%). Conclusion: The corresponding adverse reactions should be closely observed during the clinical use of PEG-interferon alfa-2a in the treatment of hepatitis C. The occurrence of adverse reactions could be effectively reduced and prevented by making a careful nursing plan and conducting an active intervention and control.

  15. Colombian ADRs: Why so few?

    OpenAIRE

    Maximiliano González; Alexander Guzmán; María Andrea Trujillo

    2009-01-01

    We address the question of why Colombian companies have had such a limited presence in the American Depositary Receipts (ADRs) market. Traditional explanations state that weak investor protection and the degree of economic and financial development in Colombia increase the cost of entry in the ADR market. However, in the case of Colombia these explanations do not suffice because in these respects Colombia is no different from other Latin American countries. Using a theoretical model, we sh...

  16. 中药注射剂不良反应103例回顾性分析%An retrospective analysis of adverse drug reaction in 103 cases of traditional Chinese medicine injection

    Institute of Scientific and Technical Information of China (English)

    易智勇

    2014-01-01

    目的:探讨中药注射剂不良反应( ADR)发生的规律及特点,为安全合理使用中药注射剂提供参考。方法对安徽省淮南新华医疗集团新华医院2010年1月至2013年12月663例ADR报告进行归纳整理,其中103例中药注射剂ADR报告,按患者年龄、性别、给药途径、报告来源、评价、临床表现、ADR涉及系统/器官等方面进行统计、分析。结果103例ADR报告中,共涉及26种药品,均为静脉给药方式,有90例(87.37%)发生在用药30 min 以内,男女性别比例为60:43,60岁以上老年患者 ADR 发生率最高(54.37%),以皮肤及附件损害为主(35例,33.98%),灯盏花素ADR例数最多(15例,14.56%)。结论应坚持开展中药注射剂ADR监测与上市后再评价,规范、合理使用中药注射剂,保障用药安全。%Objective To understand the rules and characteristics of adverse drug reaction ( ADR) in Xinhua Hospital of Xinhua Medical Group ( Huainan City Anhui Province )′s traditional Chinese medicine ( TCM) injection ca-ses,and to provide reference for rational and safety usage of TCM injection .Methods Reorganization was preformed on 663 cases of ADR report from January 2010 to November 2013 in this hospital .We selected 103 cases of TCM in-jection′s ADR reports,and made statistics and analysis according to patients′age,sex,drug source,report source,eval-uation,clinical features,system and organ ADR involved,etc.Results 103 cases of ADR reports involved in 26 kinds of drugs.All of them were vein medication .87.37%of the above cases were happened in 30 minutes with gender ratio of 60:43.54.36%were old patients over 60 with the highest incidence rate .33.98%were skin and appendages dis-orders.14.56%were Breviscapine ADR reports which was the most one .Conclusion It must insist on monitoring ADR of TCM injection and re-evaluation of market products ,to use TCM injection normative and rational ,and

  17. Analysis on the adverse drug reaction signal and its impact factors induced by oral hypoglycemic agents%口服抗糖尿病药物不良反应信号及其相关因素分析

    Institute of Scientific and Technical Information of China (English)

    柯俊; 汤文璐; 薛浩; 庞露微

    2012-01-01

    目的 研究口服抗糖尿病药物不良反应特征,并提供相应临床合理用药的依据.方法 通过上海市不良反应监测中心收集2006至2010年有关口服抗糖尿病药物不良反应的数据,使用描述性统计,logistic回归模型及不相称性,对不良反应发生的特征、风险因子和相关因素进行分析.结果 共获得812例口服抗糖尿病药物的不良反应报告.结果显示老年人和女性占不良反应发生的多数;不良反应级别以一般为主;2009至2010年间作为药品说明书中未记载的新的不良反应有上升的趋势;双胍类及磺酰脲类(SU)不良反应最为突出;logistic回归模型显示女性、日服用药频次多、单一用药是胃肠道不良反应的危险因素.体质量是皮肤损害的危险因素,联合用药、患者年龄大是SU致低血糖的危险因素.不相称性研究同时也得到一些口服抗糖尿病药物致不良反应的信号.结论 口服抗糖尿病药物不良反应累及系统器官广泛,像性别、年龄、体质量、用药频次、是否联合用药都会在一定程度上影响不良反应的发生.故口服抗糖尿病药物在临床使用时应加强不良反应监测,重视和控制其风险因子,以期更合理安全地用药.%AIM To study the feature and regularity of adverse drug reaction (ADR) induced by oral hypoglycemic agents (OHAs) and provide reasonable advice for clinical use.METHODS By collecting ADR reports of OHAs from database of Shanghai ADR spontaneous reporting system from 2006 to 2010,we made through analysis on the character and risk factors of ADR induced by OHAs using descriptive statistics and logistic regression model,and also applied disproportional measures on data mining of ADR signal and its relevant factors.RESULTS A total of 812 ADR reports induced by OHAs were included in this study.The results indicated that the senior and female patients were mostly concerned,and mainly marked as moderately injured

  18. Nonsteroidal Anti-Inflammatory Drugs: Adverse Effects and Their Prevention

    NARCIS (Netherlands)

    Vonkeman, Harald E.; Laar, van de Mart A.F.J.

    2010-01-01

    Objectives: To discuss nonsteroidal anti-inflammatory drugs (NSAIDs), their history, development, mode of action, toxicities, strategies for the prevention of toxicity, and future developments. - Methods: Medline search for articles published up to 2007, using the keywords acetylsalicylic acid, asp

  19. 某基层医院中老年人药品不良反应特点及合理用药建议%Characteristics of Adverse Drug Reactions in Middle Aged and Elderly People and Suggestions for Rational Drug Use

    Institute of Scientific and Technical Information of China (English)

    陈宗清

    2015-01-01

    Objective To understand the clinical characteristics of adverse drug reactions ( ADR ) to offer reference for clinical rational drug use in future. Methods The clinical data of 1260 inpatients in the internal medicine department of our hospital from March. 2012 to May. 2013 were collected, in which 726 cases aged more than 49 years were selected as the research subjects. The general informa-tion, disease course, length of hospital stay, liver or renal function, ADR history, clinical manifestations, etc. were statistically ana-lyzed. Results There were 138 cases of ADR with the ADR occurrence rate of 19. 01% and the case-times rate of 21. 90%; the mild and moderate ADR was predominant, which accounted for 80. 43%. ADR occurred in 10 categories of drugs, which were mainly antimicrobial agents, accounted for 30. 19%, followed by the circulatory system drugs, accounted for 19. 50%, digestive system drugs was the third, accounted for 11. 32% ; the intravenous drip or intravenous injection were the main administration mode causing ADR ( 69. 18% );skin, digestive and nervous systems were the main ADR involving parts;91. 30% of cases were cured after actively symp-tomatic treatment. The single factor chi-square analysis found that females, the patients aged over 60 years old, with abnormal liver or renal function, past history of ADR, and the diseases more than 3 kinds were more likely to happen ADR, there were statistically signif-icant differences ( P< 0. 05 or P< 0. 01 ) . Conclusion The middle aged and elderly people have the higher occurrence rate of ADR. Recognizing the patients with susceptibility to ADR on admission and by combining the clinical characteristics of ADR can increase the rate of rational drug use, thus reduce the occurrence rate of ADR.%目的:了解中老年人发生药品不良反应(ADR)的临床特点,为临床合理用药提供借鉴。方法收集2012年3月至2013年5月期间医院内科病房1260例患者

  20. Adverse drug reactions and organ damage: The liver.

    Science.gov (United States)

    Licata, Anna

    2016-03-01

    Drug-induced liver injury (DILI) is among the most challenging acute or chronic liver conditions to be handled by physicians. Despite its low incidence in the general population, DILI is a frequent cause of acute liver failure. As such, the possibility of DILI should be considered in all patients who present with acute liver damage, independent of any known pre-existing liver disease. DILI can be classified as intrinsic/dose-dependent (e.g., acetaminophen toxicity) or idiosyncratic/dose-independent, with the latter form being relatively uncommon. Amoxicillin-clavulanate is the antimicrobial that is most frequently associated with idiosyncratic DILI. Large, ongoing, prospective studies in western countries have reported other drugs associated with DILI, including nonsteroidal anti-inflammatory drugs, statins, and herbal and dietary supplements. An important safety issue, DILI is one of the most frequently cited reasons for cessation of drug development during or after preclinical studies and for withdrawal of a drug from the market. This review summarizes the epidemiology, risk factors, commonly implicated drugs, clinical features, and diagnosis of DILI, with the aim of aiding physicians in the management of this debated problem. Old and new biomarkers for DILI and pharmacogenetic studies are also described. PMID:26827101

  1. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    OpenAIRE

    Brown, S.L.; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to ...

  2. Drug-induced cerebellar ataxia: a systematic review

    NARCIS (Netherlands)

    Gaalen, J. van; Kerstens, F.G.; Maas, R.P.P.W.M.; Harmark, L.; Warrenburg, B.P.C. van de

    2014-01-01

    BACKGROUND AND OBJECTIVES: Cerebellar ataxia can be induced by a large number of drugs. We here conducted a systemic review of the drugs that can lead to cerebellar ataxia as an adverse drug reaction (ADR). METHODS: We performed a systematic literature search in Pubmed (1966 to January 2014) and EMB

  3. Literature Analysis of 61 Cases of Adverse Drug Reaction Induced by Troxerutin%61例曲克芦丁制剂不良反应的文献分析

    Institute of Scientific and Technical Information of China (English)

    冯亚楠; 刘欣欣; 李永辉; 郭瑞锋; 吕骏轻

    2015-01-01

    Objective To explore the causes and regularity of the adverse reactions (ADRs) of troxerutin , in order to provide the scientific references for safe drug use in clinic. Methods 61 cases of the ADRs of troxerutin reported in domestic literature were analyzed. Results Among 61 cases of the ADRs of troxerutin, more than 80% occurred in the age group above 45 years and 55.7% happened after the drug was taken beyond indications showed in the instructions. Futhermore, among 57 cases accepting intravenous drop infusion, 68% used glucose injection as solvent, and the ADRs of the solvent were more risky than that of other solvents. In addition, 22% occurred when troxerutin was used combining with other drugs in the same infusion bottle. 77% happened within 30 minutes after the drug was taken. Finally, the main ADRs were anaphylactic and anaphylactoid reactions. Conclusion Medical staff should well know instructions of the drugs, use it in accordance with the indications and doses labeled in the instructions strictly, and be cautious of drug combination. Furthermore, it is prohibited to use the drug combining with other drugs in the same infusion bottle. Meanwhile, the drug should be used under strict monitoring to reduce the damage caused by ADRs to a minimum.Pharmaceutical manufacturers should strengthen researches on preparation quality control and safety of troxerutin, so as to revise and improve the instructions on safety of the drugs.%目的:探讨曲克芦丁制剂不良反应的发生原因与规律,为临床安全用药提供参考。方法对国内文献报道的61例曲克芦丁制剂不良反应病例进行统计和分析。结果61例不良反应病例中,80%以上为45岁以上中老年人,55.7%存在超说明书适应证用药;57例静脉途径给药的病例报告中,68%以葡萄糖注射液为溶媒,不良反应发生风险高于其他溶媒;22%存在同瓶配伍输注现象,易发生不良反应;77%不良反应出现在用药30 min 内

  4. 沉默Ko70基因逆转人乳腺癌耐药细胞MCF-7/ADR耐药性%Silence Ko70 gene inverted MCF7/ADR drug resistence to cisplatin

    Institute of Scientific and Technical Information of China (English)

    葛亮; 佟倜; 李欣蓉; 崔雪玲; 陈芳芳

    2013-01-01

    目的 探讨沉默Ko70基因对耐表阿霉素人乳腺癌细胞MCF-7/ADR耐药逆转作用.方法 以脂质体包裹的SiRNA-Ko70转染细胞,RT-PCR验证KO70沉默效率.CCK8试剂盒测定细胞增殖活性,通过Caspase-3分光光度法、Annexin Ⅴ-PI染色检测细胞凋亡.结果 SiRNA-KO70转染组Ko70-mRNA表达明显下降,细胞对表阿霉素的敏感性明显增加,药物半数致死浓度(IC50)由34.38±6.75 μg/ml降低为13.06±2.62 μg/ml,耐药指数(RI)由8.26减至3.14.以表阿霉素5 μg/ml的培养液培养细胞24 h,SiRNA-Ko70转染组(12 pmol)与阴性对照组及空白对照组相比,caspase-3活性明显增高;凋亡细胞数明显增多.结论 SiRNA-Ko70通过下调Ko70的表达,逆转耐表阿霉素人乳腺癌细胞MCF-7/ADR对表阿霉素的耐药性,降低凋亡域值,从而增强了人乳腺癌细胞对表阿霉素的敏感性.%Objective To explore whether silence Ko70 protein can reverse the resistance of the cpirubicin-rcsistant human breast cancer cell MCF-7/ADR to cpirubicin. Methods Transfcctcd SiRNA-Ko70 into MCF7/ADR via liposomc, RT-PCR validated the silent efficiency of Ko70. CCK8 kit to determine the cells proliferation activity, Anncxin V-PI staining and Caspasc-3 kit to detect cells apoptosis. Results SiRNA-Ko70 transfection decreased Ko70-mRNA expression significantly and increased the sensitivity of MCF7/ADR to cpirubicin, drug median lethal Concentration (IC50) decreased from 34. 38 + 6. 75 μg/ml to 13. 06 i 2. 62 μg/ml,rcsistantindcx (RI) decreased from 8. 26 to 3. 14. caspasc-3 activity and the number of apoptotic cells of SiRNA-Ko70 transfection group (12 pmol) increased significantly compared with the negative control group and blank control group after cultured with 5 μg/ml cpirubicin for 24 hours. Conclusion Down regulation of Ko70 could reverse drug resistance to cpirubicin in human breast cancer cell MCF-7/ADR, reduce apoptosis domain value of MCF-7/ADR and enhance sensitivity of the human breast cancer

  5. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  6. Adverse Selection and the Challenges to Stand-Alone Prescription Drug Insurance

    OpenAIRE

    Mark V. Pauly; Yuhui Zeng

    2003-01-01

    This paper investigates a possible predictor of adverse selection problems in unsubsidized stand-alone' prescription drug insurance: the persistence of an individual's high spending over multiple years. Using MEDSTAT claims data and data from the Medicare Survey of Current Beneficiaries, we find that persistence is much higher for outpatient drug expenses than for other categories of medical expenses. We then use these estimates to develop a simple and intuitive model of adverse selection in ...

  7. The Effects of Pharmaceutical Marketing and Promotion on Adverse Drug Events and Regulation

    OpenAIRE

    Guy David; Sara Markowitz; Seth Richards

    2009-01-01

    This paper analyzes the relationship between postmarketing promotional activity and reporting of adverse drug events by modeling the interaction between a welfare maximizing regulator (the FDA) and a profit maximizing firm. In our analysis demand is sensitive to both promotion and regulatory interventions. Promotion-driven market expansions enhance profitability yet may involve the risk that the drug would be prescribed inappropriately, leading to adverse regulatory actions against the firm. ...

  8. Adverse drug reactions: 'six rights' to ensure best practice for children.

    Science.gov (United States)

    Kanneh, Agnes

    2011-06-01

    In the second of a two-part article on adverse drug reactions Agnes Kanneh describes the six 'rights' of the recipient of a drug. These are: that the right person should receive the right drug, in the right dose, at the right time within the right intervals, via the right route, followed by the right (correct) documentation. The author argues that the observance of these 'rights' by children's nurses ensures the best pharmacotherapeutic practice, thus a robust practical safeguard in adverse drug reactions and threats to the good reputation of the nursing profession.

  9. Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

    OpenAIRE

    Orten-Luiten, van, A.C.B.; A. Janse; R. A. M. Dhonukshe-Rutten; Witkamp, R F

    2016-01-01

    Purpose Adverse drug reactions as well as vitamin D deficiency are issues of public health concern in older people. However, relatively little is known about the impact of drug use on vitamin D status. Our primary aim is to explore associations between drug use and vitamin D status in older people. Furthermore, prevalences of drug use and vitamin D deficiency are estimated. Methods In a population of 873 community-dwelling Dutch geriatric outpatients, we explored the cross-sectional relations...

  10. The associations between idiosyncratic adverse drug reactions and HLA alleles and their underlying mechanism%遗传异质性药物毒副作用与HLA基因关联及分子机制研究进展

    Institute of Scientific and Technical Information of China (English)

    王青; 梅虎; 张亚兰; 潘显超; 谭文; 晁丽

    2013-01-01

    随着高通量基因测序技术的发展,全基因组关联分析(genome-wide association study,GWAS)被越来越多地应用到遗传异质性药物毒副作用(adverse drug reactions,ADRs)研究中.越来越多的研究发现:遗传异质性ADRs与人类白细胞抗原(human leukocyte antigen,HLA)密切相关,如阿巴卡韦(abacavir)与HLA-B*5701、别嘌醇(allopurinol)与HLA-B*5801、卡马西平(carbamazepine)与HLA-B*1502等基因关联.针对上述基因关联现象,相继提出半抗原理论、危险因子理论、“P-I”理论以及最新提出的自身免疫机制.本文就遗传异质性ADRs与HLA基因关联及其机制研究的最新进展进行了详细综述.%With the advent of Twenty-First century,more and more genome-wide association studies (GWAS)showed that idiosyncratic adverse drug reactions (ADRs) were closely related with human leukocyte antigen (HLA) alleles,such as the associations of abacavir-HLA-B*5701,allopurinol-HLA-B*5801,and carbamazepineHLA-B*1502,etc.To explore the mechanisms of these idiosyncratic drug reactions,hapten hypothesis,danger signal hypothesis,pharmacological interaction (P-I) concept and autoimmune mechanism are proposed.In this paper,recent GWAS studies on the HLA-mediated adverse drug reactions and underlying mechanism are reviewed in detail.

  11. Is it Safe? Adverse drug effects and cardiac arrhythmias

    NARCIS (Netherlands)

    Varkevisser, R.

    2014-01-01

    The potentially life-threatening polymorphic ventricular arrhythmia Torsade de Pointes (TdP) generally occurs in the setting of delayed ventricular repolarization, as reflected on the ECG by a prolonged QT interval. A growing number of drugs are associated with QT prolongation and/or TdP, as a resul

  12. 729例临床药品不良反应报告分析%Analysis on 729 Cases of Clinical Adverse Drug Reactions

    Institute of Scientific and Technical Information of China (English)

    于海燕; 何粤红; 胥小叶

    2016-01-01

    Objective: To analyze the clinical adverse drug reactions ( ADR ) , and provide guidances for clinical rational drug use.Methods:729 cases of ADR collected which were monitored by the national ADR system in our hospital during the year between 2010 and 2015.And then the effective statistics,analysis and evaluation works were done with data.Results:In the 729 patients, there was 45 cases whose age were less than 18 years old, 207 cases were the age of 19 to 30 years old, 237 cases were the age of 31 to 45, 168 cases were the age of 46 to 60, 65 cases were the age of 61 to 80, and 7 cases were the age more than 80 years old;Meditation meth-ods for 701 cases were oral medicine, 19 cases were intramuscular injection, 6 cases were intravenous injection, 2 cases were venous in-jection, 1 case subcutaneous injection.29 kinds of medicines were involved, among which there were 41 gauges.And there were 7 organs or systems involved, among which the nervous system damage was 520 cases, digestive system damage was 103 cases, cardiovascular sys-tem damage was 61 cases, endocrine system damage was 18 cases, immune system damage was 12 cases, blood system damage was 11 cases, urinary system damage was 4 cases.The improved outcome of adverse reactions was 571 cases (78.33%), the recovery outcome was 158 cases(21.67%).Conclusion:The incidence of ADR in our hospital was the highest during the age of 31 to 45(32.51%) , the method of adverse reaction was mainly the oral medicine, the adverse reactions were given priority with the nervous system damage.And the risperdal was reported the most ADR.ADR monitoring and reporting should be strengthened to promote the rational use of drugs of the clinical.%目的:分析临床药品不良反应( ADR)的情况,为临床合理用药提供指导。方法:对我院2010~2015年收集上报至国家药品不良反应监测系统的729例有效报告进行统计、分析、评价。结果:729例ADR报告中,患者年龄≤18岁45

  13. 44例聚明胶肽注射液不良反应的文献分析%Literature Analysis of 44 Cases of Adverse Drug Reactions Induced by Polygeline Injection

    Institute of Scientific and Technical Information of China (English)

    陈海涛; 张临宏; 昝旺

    2015-01-01

    Objective Through analyzing adverse drug reaction cases of polygeline injection to explore the regularity and cause of adverse drug reactions, provide reference for clinical rational drug use. Methods By retrieving CNKI database and Wanfang database, 44 cases of polygeline injection ADRs reported from 26 literatures were analyzed. Results Most of the ADRs are immediate response type, 91% cases happened within 30 mins, which involv multiple systems and organs including systemic lesions(62.50%) and cardiovascular lesions(10.94%). Allergic shock and severe anaphylactoid reactions are more obvious. At the same time, new ADRs are found in 44 cases. Conclusion More at tention should be paid to the ADRs of polygeline injection and the monitoring of medication should also be strengthened to ensure the safe medication.%目的:通过对聚明胶肽注射液致不良反应文献的病例进行分析,探讨其引起不良反应的规律和原因,为临床合理用药提供参考。方法检索中国期刊全文数据库和万方数据库所载的聚明胶肽不良反应文献,对26篇目标文献所报道的44例病例报告进行统计分析。结果聚明胶肽注射液所致不良反应多数为速发型,91%的个案发生在30 min内;聚明胶肽致不良反应累及多个系统-器官,其中以全身性损害(62.50%)和心血管系统损害(10.94%)为主,过敏性休克和严重过敏样反应突出,同时也有新的不良反应出现。结论临床应重视聚明胶肽注射液的不良反应,加强用药监测,确保用药安全。

  14. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    Science.gov (United States)

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  15. 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...

  16. 喹诺酮类药物的严重不良反应及合理应用%Serious ADRs of Quinolones and TheirRational Use

    Institute of Scientific and Technical Information of China (English)

    付铁梅; 田丽娟

    2011-01-01

    目的 促进喹诺酮类药物的合理使用,减少药品不良反应和耐药性的发生.方法 通过查阅文献等,对喹诺酮类药物的严重不良反应及产生原因进行分析,并提出合理使用的对策建议.结果 与结论随着喹诺酮类药物临床使用量不断增加,其严重药品不良反应的发生也越来越多.临床用药,一定要增强合理用药意识,确保患者用药安全有效.%Objective To promote the rational use of quinolones to reduce serious adverse drug reactions (ADRs) and occurrence of resistance to qmnolones. Methods The literature review was conducted to analyze the serious ADRs of quinolones and their causes, and the countermeasures of their rational use were proposed. Results and Conclusion As the clinical use of quinolones increasing, serious ADRs occur more and more, Both doctors and patients should enhance Erie awareness of rational use of quinolones to reduce the serious ADRs and ensure lhe safe and effective drug use m patients.

  17. Shielded ADR Magnets For Space Applications Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The Phase II program will concentrate on manufacturing of qualified low-current, light-weight, 10K ADR magnets for space application. Shielded ADR solenoidal...

  18. Adverse Health Consequences of Performance-Enhancing Drugs: An Endocrine Society Scientific Statement

    OpenAIRE

    Pope, Harrison G.; Wood, Ruth I.; Rogol, Alan; Nyberg, Fred; Bowers, Larry; Bhasin, Shalender

    2013-01-01

    Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated....

  19. Using text-mining techniques in electronic patient records to identify ADRs from medicine use

    DEFF Research Database (Denmark)

    Warrer, Pernille; Hansen, Ebba Holme; Jensen, Lars Juhl;

    2012-01-01

    This literature review included studies that use text-mining techniques in narrative documents stored in electronic patient records (EPRs) to investigate ADRs. We searched PubMed, Embase, Web of Science and International Pharmaceutical Abstracts without restrictions from origin until July 2011. We...... and populations, various types of ADRs were identified and thus we could not make comparisons across studies. The review underscores the feasibility and potential of text mining to investigate narrative documents in EPRs for ADRs. However, more empirical studies are needed to evaluate whether text mining of EPRs...... included empirically based studies on text mining of electronic patient records (EPRs) that focused on detecting ADRs, excluding those that investigated adverse events not related to medicine use. We extracted information on study populations, EPR data sources, frequencies and types of the identified ADRs...

  20. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  1. Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

    Science.gov (United States)

    Bender, Ralf; Beckmann, Lars; Lange, Stefan

    2016-07-01

    The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd. PMID:26928768

  2. Pattern of adverse reactions of antipsychotics in a tertiary care hospital

    OpenAIRE

    Meenakshy T. Viswanathan; Asha Sisupalan; Vidhukumar Karunakaran

    2016-01-01

    Background: This study was undertaken to analyse the pattern of adverse drug reactions (ADR) of antipsychotics among patients attending the psychiatry outpatient department of a tertiary care centre. Methods: Patients attending the psychiatry outpatient department who have been on treatment with one or more antipsychotics for more than 6 weeks were included in the study. Details about the prescription given in the previous appointment were collected. Various adverse effects associated with...

  3. Can the genotype or phenotype of two polymorphic drug metabolising cytochrome P450-enzymes identify oral lichenoid drug eruptions?

    DEFF Research Database (Denmark)

    Kragelund, Camilla; Hansen, Claus; Reibel, Jesper;

    2010-01-01

    Lichenoid drug eruptions (LDE) in the oral cavity are adverse drug reactions (ADR) that are impossible to differentiate from oral lichen planus (OLP) as no phenotypic criteria exist. Impaired function of polymorphic cytochrome 450-enzymes (CYPs) may cause increased plasma concentration of some...

  4. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Sharminder Kaur

    2011-01-01

    Conclusion : Development of ADR in one of every five cardiac patient points toward a grave situation, but a higher incidence of Type A reactions in cardiology department means that these can be avoided.

  5. Analysis of 748 cases of quinolone adverse drug reaction in Suzhou city of 2013%2013年宿州市748例喹喏酮类药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    郭秀秀

    2014-01-01

    目的:研究影响喹诺酮类药物不良反应的因素,以期减少药物不良反应。方法:收集宿州市2013年喹诺酮类合成抗菌药物不良反应报表进行汇总分析。结果:748例喹诺酮类药物不良反应报表以左氧氟沙星引起的不良反应最多(68.14%)。不良反应涉及器官或系统最主要表现在胃肠系统(42.80%)、皮肤(30.64%)、中枢及外周神经系统(5.73%)。结论:应加强喹诺酮类药物的临床监测,提高合理用药的安全性。%Objective Study on the influence factors of adverse drug reactions of quinolones, in order to reduce the occurrence of adverse drug reaction.Methods Collected and analyzed the reports of Quinolones synthetic antibacterial drug adverse reactions in Suzhou city of 2013.Results Levofloxacin induced adverse reaction is most(68.14%)in 748 cases of ADR reports .The adverse drug reactions involving organs or systems mainly reflected in the gastrointestinal system (42.80%), skin (30.64%), the central and peripheral nervous system (5.73%).Conclusion We should strengthen the clinical monitoring of quinolones, to improve security of rational use of drug.

  6. Pharmacovigilance for antiretroviral drugs in Africa, lessons from a study in Abidjan, Cote d’Ivoire

    Science.gov (United States)

    Jaquet, Antoine; Djima, Mariam Mama; Coffie, Patrick; Kacou, Henri Die; Eholie, Serge P.; Messou, Eugene; Minga, Albert; Guehi, Calixte; Yavo, Jean Claude; Bissagnene, Emmanuel; Dabis, Francois; Ekouevi, Didier K.

    2011-01-01

    Background While antiretroviral treatment (ART)-related adverse drug reactions (ADR) are documented in industrialized countries, there is no pre-existing surveillance system dedicated to ADR monitoring in most African countries. We assessed knowledge towards pharmacovigilance among ART prescribers and available capacity of HIV clinics to conduct ADR monitoring in Abidjan, Côte d’Ivoire. Methods A questionnaire was administered to ART prescribers, to assess their knowledge towards the occurrence of ADRs. A retrospective ADR survey was also conducted, based on a data query of treatment modification/interruptions in three HIV clinics. Clinical monitors went back to medical charts to review and validate the reasons of the treatment modification/interruptions. Results Of the 81 ART prescribers interviewed, 25 (31%) declared not grading ADRs and 12 (14.8%) declared notifying ADRs to the national regulatory authorities. Among 5,252 adult ART-treated patients who attended the participating clinics in 2008, 599 treatment modifications were identified. Reasons for treatment modification/interruptions identified in the electronic database were documented in the medical charts in 554 (92.5%) cases, ADR accounting for 273 (45.5%) cases. Toxicity related to ART was graded in only 58 (21%) cases in the medical charts. Discussion This study describes challenges limiting the implementation of reliable pharmacovigilance activities in HIV clinics in Côte d’Ivoire. The lack of knowledge of ART prescribers concerning ADR grading does not support the spontaneous reporting of ADRs. Using treatment modification/interruptions for ADR monitoring appears feasible but improvements are needed to respond to key questions related to drug toxicities in the context of ART scale up in Africa. PMID:21735508

  7. Adverse Drug Reaction Mining in Pharmacovigilance data using Formal Concept Analysis

    OpenAIRE

    Villerd, Jean; Toussaint, Yannick; Lillo Le-Louët, Agnès

    2010-01-01

    International audience In this paper we discuss the problem of extracting and evaluating associations between drugs and adverse effects in pharmacovigilance data. Approaches proposed by the medical informatics community for mining one drug - one effect pairs perform an exhaustive search strategy that precludes from mining high-order associations. Some specificities of pharmacovigilance data prevent from applying pattern mining approaches proposed by the data mining community for similar pr...

  8. Results of serum drug concentration of Digoxin and adverse reactions analysis%219例地高辛血药浓度监测结果及不良反应分析

    Institute of Scientific and Technical Information of China (English)

    傅海媛

    2016-01-01

    Objective To summarize the results of serum drug concentration of digoxin in the hospital for clinical rational use . Methods Serum concentration of digoxin(219 cases)was determined by access immunoassay system and the results were statisti‐cally analyzed .Results there were 7 cases drug adverse reactions(ADR)with the serum drug concentration in the therapeutic win‐dow (0 .5‐2ng/mL) ,meanwhile ,9 cases ADR with the serum drug concentration higher than the maximun effective concentration (>2 .0ng/mL) .Conclusion Timely and effective monitoring of digoxin serum concentration should be established ,to individualize the treatment programs ,ensure the efficacy and reduce the occurrence of adverse reactions .%目的:对本院2015年1~9月地高辛血药浓度监测结果进行回顾性分析,为临床合理用药提供参考。方法采用全自动免疫分析仪对219例口服地高辛患者进行血药浓度的检测,并对监测结果及药品不良反应(ADR )进行统计、分析。结果地高辛血药浓度在0.5‐2.0ng/mL有153例(1.03±0.31ng/mL),发生7例不良反应;<0.5ng/mL有30例(0.3±0.13ng/mL);>2.0 ng/mL有36例(3.06±0.78 ng/mL),共9例不良反应。结论及时有效的监测地高辛血药浓度,实行个体化治疗,降低不良反应发生率。

  9. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    Science.gov (United States)

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. PMID:26291578

  10. Review of the rational use and adverse reactions to human serum albumin in the People’s Republic of China

    Directory of Open Access Journals (Sweden)

    Zhou T

    2013-11-01

    Full Text Available Ting Zhou, Saihua Lu, Xiufeng Liu, Ye Zhang, Feng XuDepartment of Clinical Pharmacology, Fengxian Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of ChinaAbstract: Human serum albumin (HSA is an ideal natural colloid that has been widely used in clinical practice for supplemental albumin or as a plasma substitute during therapeutic plasma exchanges to redress hypoproteinemia. However, a paucity of well-designed clinical trials, a lack of a clear cut survival benefit, and frequent case reports of adverse drug reaction (ADR make the use of HSA controversial. This study aims to review and to comment on the reported ADRs of HSA in People's Republic of China, so as to provide the basis for rational HSA use in clinical settings. Data on the ADR case reports from HSA administration between January 1990 and December 2012 available from the China National Knowledge Infrastructure (CNKI database, Wanfang data (WF, and Chinese Biomedical Literature (CBM were reviewed. The reasons for using HSA, the types of ADRs, the causality of ADRs and the rationality for HSA administration were extracted and analyzed. In total, 61 cases of ADR reports were identified of which the primary disease of patients using HSA was malignant tumor (34.42%. The primary ADR was anaphylaxis (59.02%. Of the 61 cases, 30 were caused by irrational use of HSA. The most common irrational use was off-label use (56.67%, followed by inappropriate infusion rate. Therefore, we conclude that to avoid the occurrence of ADRs, guidelines for using HSA are needed to guarantee its rational use and HSA should be used strictly according to these guidelines. In addition, medical staff, including clinical pharmacists and nurses, should pay more attention to the patients who inject HSA to ensure its safe use in the clinic.Keywords: HSA, off-label use, ADR, plasma substitute, albumin, hypoproteinemia

  11. Impact of censoring on estimates of adverse drug effects: A simulation study

    NARCIS (Netherlands)

    Groenwold, Rolf H.; Van Staa, Tjeerd P.; De Boer, Anthonius; Klungel, Olaf H.

    2013-01-01

    Background: The results from studies on adverse drug effects in electronic health care databases may vary due to multiple reasons, one of them being differences in (left and right) censoring mechanisms between databases. Such censoring mechanisms can be features of the database and are therefore har

  12. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... then at annual intervals. The applicant shall submit each quarterly report within 30 days of the close... annual report within 60 days of the anniversary date of approval of the application. Upon written notice... § 314.80 Postmarketing reporting of adverse drug experiences. (a) Definitions. The following...

  13. Adverse effects of the antimalaria drug, mefloquine: due to primary liver damage with secondary thyroid involvement?

    Directory of Open Access Journals (Sweden)

    Herxheimer Andrew

    2002-03-01

    Full Text Available Abstract Background Mefloquine is a clinically important antimalaria drug, which is often not well tolerated. We critically reviewed 516 published case reports of mefloquine adverse effects, to clarify the phenomenology of the harms associated with mefloquine, and to make recommendations for safer prescribing. Presentation We postulate that many of the adverse effects of mefloquine are a post-hepatic syndrome caused by primary liver damage. In some users we believe that symptomatic thyroid disturbance occurs, either independently or as a secondary consequence of the hepatocellular injury. The mefloquine syndrome presents in a variety of ways including headache, gastrointestinal disturbances, nervousness, fatigue, disorders of sleep, mood, memory and concentration, and occasionally frank psychosis. Previous liver or thyroid disease, and concurrent insults to the liver (such as from alcohol, dehydration, an oral contraceptive pill, recreational drugs, and other liver-damaging drugs may be related to the development of severe or prolonged adverse reactions to mefloquine. Implications We believe that people with active liver or thyroid disease should not take mefloquine, whereas those with fully resolved neuropsychiatric illness may do so safely. Mefloquine users should avoid alcohol, recreational drugs, hormonal contraception and co-medications known to cause liver damage or thyroid damage. With these caveats, we believe that mefloquine may be safely prescribed in pregnancy, and also to occupational groups who carry out safety-critical tasks. Testing Mefloquine's adverse effects need to be investigated through a multicentre cohort study, with small controlled studies testing specific elements of the hypothesis.

  14. Drug-induced progressive multifocal leukoencephalopathy

    DEFF Research Database (Denmark)

    Vermeer, N S; Straus, S M J M; Mantel-Teeuwisse, A K;

    2015-01-01

    Progressive multifocal leukoencephalopathy (PML) has been identified as a serious adverse drug reaction (ADR) of several immunomodulatory biologicals. In this study, we contrasted the reporting patterns of PML for two biologicals for which the risk was identified at different points in their life...

  15. Evaluation of a procedure to assess the adverse effects of illicit drugs.

    Science.gov (United States)

    van Amsterdam, J G C; Best, W; Opperhuizen, A; de Wolff, F A

    2004-02-01

    The assessment procedure of new synthetic illicit drugs that are not documented in the UN treaty on psychotropic drugs was evaluated using a modified Electre model. Drugs were evaluated by an expert panel via the open Delphi approach, where the written score was discussed on 16 items, covering medical, health, legal, and criminalistic issues of the drugs. After this face-to-face discussion the drugs were scored again. Taking the assessment of ketamine as an example, it appeared that each expert used its own scale to score, and that policymakers do not score deviant from experts trained in the medical-biological field. Of the five drugs evaluated by the panel, p-methoxy-metamphetamine (PMMA), gamma-hydroxybutyric acid (GHB), and 4-methylthio-amphetamine (MTA) were assessed as more adverse than ketamine and psilocine and psilocybine-containing mushrooms. Whereas some experts slightly adjusted during the assessment procedure their opinion on ketamine and PMMA, the opinion on mushrooms was not affected by the discussion held between the two scoring rounds. All experts rank the five drugs in a similar way on the adverse effect scale i.e., concordance scale of the Electre model, indicating unanimity in the expert panel with respect to the risk classification of these abused drugs. PMID:14746774

  16. Analysis of ADR Reports in A Hospital from 2014 to 2015%某院2014-2015年药品不良反应分析

    Institute of Scientific and Technical Information of China (English)

    鞠凤阁

    2015-01-01

    Objective To investigate the characteristics of adverse drug reaction (ADR) cases in our hospital and to promote rational clinical use of drugs. Methods A total of 141 ADR reports were collected from A hospital from 2014 to 2015 and analyzed statistically. Results Most of the ADR cases (90.35%) were related to the intravenous route, 44.73% of the ADR cases were caused by antibiotics. ADR involving organs were mostly skin, Chills and fever. Conclusion Clinical monitouing of ADR should be strengthened by regulating the application of antimicrobial drugs and improving the use of traditional Chinese medicine injection in order to reduce the incidence of ADR.%目的:通过对某院2014—2015年所上报的114份药品不良反应进行分析,了解某院药品不良反应的整体质量,促进药品不良反应监测的进一步完善,为临床安全、合理用药提供参考。方法按照国家ADR监测中心制定的标准,对某院2014—2015年的114例ADR报告进行汇总、分类,并进行回顾性分析。结果 ADR涉及11类药、39个品种,抗感染药居各类药品种数的首位(占44.73%),其次是中成药和血液系统药品;静脉用药引发的ADR占90.35%;ADR主要为过敏反应和寒战高热。结论临床应重视ADR的报告和监测工作,以减少或避免ADR的发生,促进临床合理用药。

  17. Adverse effects of antiretroviral treatment at a tertiary care hospital in India: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Sweta V. Vaghani

    2013-06-01

    Full Text Available Background: Data on adverse drug reactions (ADRs related to antiretroviral (ARV use in public health practice are few indicating the need for antiretroviral therapy (ART safety surveillance in clinical care. Methods: 143 patients on ART were studied prospectively over a period of two years. All patients were asked to visit the clinic if they developed any symptoms or on a monthly basis. They were screened clinically and investigated suitably for any ADRs. Results: 143 HIV positive patients were analyzed. At least one ADR was seen in 87 (60.83% subjects. The most common ADR observed was peripheral neuropathy in 54 (37.76% patients, followed by lipodystrophy (13.98%, anemia (10.48% and hyperlipidemia (6.29%. Patients with peripheral neuropathy and lipodystrophy were mainly on stavudine based regimes, while patient with anemia and hyperlipidemia were on zidovudine based regimes. Conclusions: In spite of high ADRs, highly active antiretroviral therapy (HAART is the only answer to HIV/AIDS. To optimize adherence and thus, efficacy of ART, clinicians must focus on preventing adverse effects whenever possible, and distinguish those that are self-limited from those that are potentially serious. [Int J Res Med Sci 2013; 1(3.000: 230-232

  18. 青蒿素对乳腺癌多药耐药MCF-7/ADR细胞的逆转作用%Reversal of Drug Resistance in Multidrug-resistant MCF-7/ADR Cells of Breast Cancer by Artemisinin

    Institute of Scientific and Technical Information of China (English)

    余和平; 崔乐; 潘跃进

    2011-01-01

    Objective To investigate the application of Artemisinin in multidrug resistance of breast cancer. Methods The effects of Artemisinin combined with adriamycin on growth and proliferation of MCF-7/ADR cells were observed by using MTT assay. The expression levels of P-gp in MCF-7/ADR cells treated with Artemisinin plus adriamycin were detected by flow cytometry. Results Artemisinin of 10,20 and 40 μmol/L could induce reversal of drug resistance with the reversal index being 1.53,1.90 and 3.62 times respectively. The positive expression rate of P-gp on the surface of MCF-7/ADR cells treated with Artemisinin(0,10,20 and 40 μmol/L) was ( 33.41±4.63) % , ( 23.07 ± 5.48) %, ( 21.82 ± 3.87) % , ( 16.62 ± 1.27) % respectively with the difference being significant among groups(P<0.05) ,and the total expression level of P-gp in cells was(37.19±5.16) %, (35.30±4.77) % , (37.45±5.19) % , ( 34.98±3.50)% respectively with the difference being not significant among groups(P>0.05). Conclusion Artemisinin can enhance the effect of adriamycin on MCF-7/ADR cells,indicating Artemisinin can partially induce reversal of multidrug resistance probably by influencing the exchange of P-gp between cytoplasm and cytomembrane, attenuating the expression of P-gp on cytomembrane, promoting the aggregation of adriamycin in cytoplasm and enhancing the killing effect of medicine on tumor cells.%目的 探讨青蒿素在乳腺癌多药耐药中的应用.方法 采用MTT法观察青蒿素联合阿霉素(ADR)对乳腺癌耐药株MCF-7/ADR细胞生长增殖的影响;应用流式细胞技术测定青蒿素联合ADR对MCF-7/ADR细胞P-糖蛋白(P-glycoprotein,P-gp)表达的影响.结果 10、20、40 μmol/L青蒿素实验组的细胞耐药逆转倍数分别为1.53、1.90和3.62倍.青蒿素联合ADR可抑制MCF-7/ADR细胞膜P-gp蛋白的表达,0、10、20、40 μmol/L青蒿素作用后的细胞表面P-gp表达阳性率分别为(33.41±4.63)%、(23.07±5.48)%、(21.82±3.87)%

  19. A statistical methodology for drug-drug interaction surveillance.

    Science.gov (United States)

    Norén, G Niklas; Sundberg, Rolf; Bate, Andrew; Edwards, I Ralph

    2008-07-20

    Interaction between drug substances may yield excessive risk of adverse drug reactions (ADRs) when two drugs are taken in combination. Collections of individual case safety reports (ICSRs) related to suspected ADR incidents in clinical practice have proven to be very useful in post-marketing surveillance for pairwise drug--ADR associations, but have yet to reach their full potential for drug-drug interaction surveillance. In this paper, we implement and evaluate a shrinkage observed-to-expected ratio for exploratory analysis of suspected drug-drug interaction in ICSR data, based on comparison with an additive risk model. We argue that the limited success of previously proposed methods for drug-drug interaction detection based on ICSR data may be due to an underlying assumption that the absence of interaction is equivalent to having multiplicative risk factors. We provide empirical examples of established drug-drug interaction highlighted with our proposed approach that go undetected with logistic regression. A database wide screen for suspected drug-drug interaction in the entire WHO database is carried out to demonstrate the feasibility of the proposed approach. As always in the analysis of ICSRs, the clinical validity of hypotheses raised with the proposed method must be further reviewed and evaluated by subject matter experts. PMID:18344185

  20. Clinical Analysis of Adverse Drug Reaction of 289 Cases Caused by Insulin%289例胰岛素不良反应病例分析

    Institute of Scientific and Technical Information of China (English)

    赵珩; 李怡; 徐厚明; 余江毅

    2013-01-01

    Objective:To analyze the clinical characteristics of adverse drug reaction cases caused by insulin to provide reasonable advice for clinical use.Methods:The adverse drug reactions cases caused by insulin were retrieved in the database of Center for ADR Monitoring of Jiangsu to analyze the clinical nanifestations,systems involved,types of drugs,etc.Results:143 cases of 289 cases involved were male,and 146 were female.The types of the suspected drugs were mostly regular insulin,ultra short-acting insulin and insulin analogue.The systems with adverse drug reactions included the skin and its appendages,metabolism and nutrition disorder and systemic damages.283 cases were healed or improved after therapy,2 cases had sequela of partial lipodystrophy,and 4 cases were not healed.Condusion:Adverse drug reactions caused by insulin occurred in more than one system at the same time; and therefore,clinical medicine use should be closely monitored,and attention should be paid to some rare adverse drug reactions to ensure the safe drug use.%目的:分析胰岛素不良反应病例发生的特点,为临床合理用药提供参考.方法:从2004年1月~2012年11月江苏省药品不良反应数据库中检索出胰岛素的不良反应病例,采用描述性分析的方法,对药品不良反应累及的系统、怀疑药品的种类等进行统计分析.结果:共检索出符合条件的病例报告表289例,其中男143,女146例.短效、超短效胰岛素,胰岛素类似物不良反应所占比例较大.药品不良反应累及的系统/器官主要有皮肤及其附件损害、代谢和营养障碍、全身性损害.其中283例通过治疗均好转或痊愈,2例病例留有皮下脂肪萎缩后遗症,4例未好转.结论:胰岛素引起的不良反应累及的系统/器官较多,常多个不良反应同时发生,临床上要进行密切的用药监护,关注少见的不良反应,确保用药安全.

  1. EVALUATION OF THE RELATIVE INCIDENCE OF ADVERSE EFFECTS LEADING TO TREATMENT DISCONTINUATION OF RECOMMENDED ANTIHYPERTENSIVE DRUGS

    Directory of Open Access Journals (Sweden)

    Yakubu Sani Ibn

    2013-06-01

    Full Text Available This study aimed at evaluating the incidence of adverse effects leading to treatment discontinuation of antihypertensive drugs within the same therapeutic class. Individual medical records were searched to identify those hypertensive patients who had been commenced on antihypertensive therapy during a 24-month period and who had subsequently for a reason(s discontinued the therapy. The results showed variation in discontinuation rates for drugs within same class, and that might be related to the relative frequency of specific adverse effects. Cough was the reason cited for discontinuation of angiotensin converting enzyme inhibitors, with linosopril appearing to be better tolerated than captopril (39% vs 48% ; peripheral oedema with calcium channel blockers, with amlodipine appearing to be better tolerated than nifedipine (29% vs 38% and bradycardia with beta adrenergic receptor blockers, with propranolol better tolerated than atenolol (0% vs 48%. Diuretics showed the lowest discontinuation rate (3.3% mainly due to hypokalemia, with thiazide better tolerated than frusemide (11% vs 43%. Prescribers should verify their use of antihypertensive drugs to ensure that they prescribe drugs with lower adverse effect rates, in order that patients with hypertension continue using the medication in the long term, thereby reducing the risk of developing cardiovascular complications associated with uncontrolled blood pressure.

  2. Enhancing adverse drug event detection in electronic health records using molecular structure similarity: application to pancreatitis.

    Directory of Open Access Journals (Sweden)

    Santiago Vilar

    Full Text Available BACKGROUND: Adverse drug events (ADEs detection and assessment is at the center of pharmacovigilance. Data mining of systems, such as FDA's Adverse Event Reporting System (AERS and more recently, Electronic Health Records (EHRs, can aid in the automatic detection and analysis of ADEs. Although different data mining approaches have been shown to be valuable, it is still crucial to improve the quality of the generated signals. OBJECTIVE: To leverage structural similarity by developing molecular fingerprint-based models (MFBMs to strengthen ADE signals generated from EHR data. METHODS: A reference standard of drugs known to be causally associated with the adverse event pancreatitis was used to create a MFBM. Electronic Health Records (EHRs from the New York Presbyterian Hospital were mined to generate structured data. Disproportionality Analysis (DPA was applied to the data, and 278 possible signals related to the ADE pancreatitis were detected. Candidate drugs associated with these signals were then assessed using the MFBM to find the most promising candidates based on structural similarity. RESULTS: The use of MFBM as a means to strengthen or prioritize signals generated from the EHR significantly improved the detection accuracy of ADEs related to pancreatitis. MFBM also highlights the etiology of the ADE by identifying structurally similar drugs, which could follow a similar mechanism of action. CONCLUSION: The method proposed in this paper provides evidence of being a promising adjunct to existing automated ADE detection and analysis approaches.

  3. Literature Analysis of 82 Cases of Adverse Drug Reactions Induced by Geiftinib%82例吉非替尼不良反应的文献分析

    Institute of Scientific and Technical Information of China (English)

    夏惠红

    2016-01-01

    Objective To investigate the characteristics and mechanism of adverse reactions induced by geiftinib, and to ifnd its risk factors and provide technical support for safe and rational use of the drugs in clinic.Methods “Geiftinib”, “adverse reaction”and “caused by” were used as key words to retrieve articles in CNKI and VIP database. 57 literatures which met the inclusion and exclusion criteria were extracted and analyzed.ResultsThere were 82 cases of ADR in literatures, which mainly involved the gastrointestinal system, skin and appendages, respiratory system. Diarrhea, acne-like rash, cough, interstitial pneumonia were most common and some cases were serious even to death. The majority cases were senile male patients.ConclusionIt is important to pay attention to the adverse reactions caused by geiftinib, especially to strengthen post-marketing surveillance for elderly lung cancer patients, so as to prevent severe and rare adverse drug reactions.%目的:分析吉非替尼致药品不良反应(ADR)相关规律和特点,发现吉非替尼使用风险点,为临床合理用药提供参照。方法以“吉非替尼”、“不良反应”、“致”、“gefitinib”等为检索词,检索中国期刊网全文数据库、维普中文期刊全文数据库,按纳入、排除标准共纳入57篇文献,并进行整理和分析。结果共提取82例病例,累及系统-器官主要为胃肠系统损害、皮肤及其附件损害、呼吸系统损害等,不良反应以腹泻、痤疮样皮疹、咳嗽、间质性肺炎等最为常见,严重可致死亡;病例多为男性中老年患者。结论重视吉非替尼在抗癌治疗中的不良反应,加强老年肺癌患者的用药监测,防范严重和罕见的不良反应发生。

  4. 磷酸奥司他韦预防甲型H1N1流感时引起不良反应206例报道%Report of 206 cases of adverse drug reactions in using oseltamivir to prevent influenza A H1N1 influenza

    Institute of Scientific and Technical Information of China (English)

    董伟; 王艳彩

    2011-01-01

    AIM To analyse the adverse drug reactions (ADRs) occurred in people who took oseltamivir phosphate to prevent influenza A H1N1 influenza. METHODS The ADRs of 2 978 cases who took oseltamivir phosphate 75 mg once daily for 7 d to prevent influenza A H1N1 influenza were recorded every day and 2 790 cases with intact data were carried out statistical analysis. RESULTS There were 206 cases of ADRs, with the total ADRs incidence rate of 7.38%. Cases with the main clinical manifestations of enteron symptoms such as diarrhea, nausea, and bellyache etc.were 157, with the incidence rate of 5.62%. The incidenec rate of ADRs was low in rash, otalgia, tachycardia, foreign body sensation of esophagus and nosebleed and insomnia etc. CONCLUSION The ADRs of oseltamivir phosphate in the prevention of influenza A HIN1 influenza mainly were enteron symptoms which do not affect the treatment in general. But if such symptoms as rash or tachyeardia occur, the drug should be immediately stopped and symptomatic treatment must be given.%目的 分析磷酸奥司他韦预防甲型H1N1流感时人群不良反应发生情况.方法 对2978例服用磷酸奥司他韦75㎎,qd,共7 d预防甲型H1N1型流感者逐日记录其不良反应并将2790例资料完整者进行分析统计.结果 206例出现不良反应,总不良反应发生率为7.38%,以腹泻、恶心、腹痛等消化道症状为主,共157例,发生率为5.62%.皮疹、耳痛、心动过速、食管异物感、鼻出血、失眠等发生率低.结论 磷酸奥司他韦预防甲型H1N1流感时不良反应以消化道症状为主,一般不影响治疗.如出现皮疹、心动过速等应停药并给予对症处理.

  5. DRUG SAFETY MONITORING IN PATIENTS ATTENDING EPILEPSY CLINIC IN A TERTIARY CARE TEACHING HOSPITAL IN RURAL BENGAL

    Directory of Open Access Journals (Sweden)

    Sourav

    2016-02-01

    Full Text Available BACKGROUND Epilepsy is the second most common neurological disorder affecting fifty million people globally. Antiepileptic Drugs (AEDs are the mainstay of management in epilepsy. Use of AEDs over prolonged duration makes occurrence of multiple Adverse Drug Reactions (ADRs frequently, especially with polytherapy. OBJECTIVES To estimate the incidence of all the ADRs among patients taking AEDs and to assess their causalities and to quantify their severity. MATERIAL AND METHODS This prospective, observational study was carried out at an Outpatient Referral Epilepsy Clinic at Neurology Department at Bankura Sammilani Medical College, West Bengal, between 1st June and 30th September 2015. The demographic data, diagnosis, drugs prescribed and ADRs experienced by the patients were recorded. Causality and severity assessment was done using Naranjo’s Scale and Hartwig’s Severity Assessment Scale respectively. RESULTS Incidence of ADRs among the patients who attended the clinic was 3.3% (105 patients among 3146 experienced at least one ADR. Total 161 ADRs were detected, among which 55.3% were CNS adverse events followed by 15.5% gastrointestinal, 14.3% endocrine, 10.6% psychiatric abnormalities and 4.3% related to dermatological and allergic manifestations. Nearly one-third of the ADRs (32.3% were found to be possible and 109 (67.7% are of probable category, whereas none were deemed to be doubtful or definite. The most commonly implicated suspect drug was valproate (51.5% followed by Phenytoin (22.9%. Most of the ADRs were mild (93.2%, 5.6% were moderate and only 1.2% were deemed severe. CONCLUSION Incidence of ADRs is found to be common in patients on AEDs. Though rare, but they can be life-threatening. Routine safety assessments and pharmacovigilance is necessary in this set up to reduce the incidence and also improve pharmacotherapy and patient compliance

  6. Literature Analysis of 124 Cases of Fosfomycin-induced ADR%磷霉素致不良反应124例文献分析

    Institute of Scientific and Technical Information of China (English)

    刘金永; 孙增先; 张骞峰; 周金玉; 高山

    2012-01-01

    目的:探讨磷霉素致不良反应(ADR)发生的一般规律及特点,为临床合理用药提供参考.方法:以“磷霉素”为关键词,检索中国期刊全文数据库、万方数据库,收集磷霉素致ADR的有效文献99篇,共124例,并按患者性别、年龄、既往药物过敏史、原患疾病、用药情况、ADR发生时间、ADR类型及临床表现、评价与转归等进行分类、统计和回顾性分析.结果:124例磷霉素致ADR患者性别与年龄比较,无显著性差异(P>0.05);37例患者有药物及食物过敏史,占49.33%(75例患者有过敏史确切记录);121例(97.58%)患者经静脉滴注给药;过敏性休克最多(42例,33.87%),其次为皮肤及附件损害(28例,22.58%);出现ADR最快的是在静脉滴注后立即发生,最迟出现在患者用药5d后;绝大多数患者停药或治疗后好转恢复,死亡8例.结论:磷霉素致ADR的临床表现复杂多样,最严重的可能引起死亡,临床医师、药师应重视其ADR的危害性.%OBJECTIVE: To explore the general regularity and characteristics of adverse drug reactions (ADR) induced by fos-fomycin, and to provide reference for rational safe use of drugs in the clinic. METHODS: Using fosfomycin as key word. CNK1 and Wangfang database were searched. A total of 99 literatures about fosfomycin-induced ADR were collected, involving 124 cases. The data were analyzed retrospectively in respect of patients' gender, age, allergy history, primary disease, medication, ADR on-set time, types and clinical manifestation of ADR, evaluation and outcome. RESULTS: There was no significant difference in patients' gender and age of 124 fosfomycin-induced ADR cases (P>0.05). 37 cases had drug and food allergy history, accounting for 49.33% (75 patients had exact record of allergy history). 121 cases (97.58%) were given fosfomycin intravenously; the most of cases were anaphylactic shock (42 cases, 33.87%), followed by lesion of skin and its appendants (28

  7. Antiepileptic Drug-Related Adverse Reactions and Factors Influencing These Reactions

    Directory of Open Access Journals (Sweden)

    Parvaneh KARIMZADEH

    2013-08-01

    Full Text Available How to Cite This Article: Karimzadeh P, Bakrani V. Antiepileptic Drug-Related Adverse Reactions And Factors Influencing These Reactions. Iran J Child Neurol. 2013 Summer; 7(3:23-27. ObjectiveAccording to the basic role of drug side effects in selection ofan appropriate drug, patient compliance and the quality of life inepileptic patients, and forasmuch as new dugs with unknown side effect have been produced and introduced, necessity of this research and similar studies is explained. This study was conducted to evaluate the incidence and clinical characteristics of anti epileptic drug (AED related adverse reactions in children treated with AEDs.Material & MethodsIn this descriptive study, children less than 14 years old with AEDside effects referred to the Children’s Medical Center and MofidChilderen’s Hospital (Tehran, Iran were evaluated during 2010-2012.The informations were: sex, age, incriminating drug, type of drug side effect, incubation period, history of drug usage, and patient and family allergy history. Exclusive criterions were age more than 14 years old and reactions due to reasons other than AEDs (Food, bite, non-AEDs, etc..ResultsA total of 70 patients with AED reaction were enrolled in thisstudy. They included 26 (37% females and 44 (63 % males. The maximum rate of incidence was seen at age less than 5 years old. All the patients had cutaneous eruptions that the most common cutaneous drug eruption was maculopapular rash. The incidence of systemic and laboratory adverse events was less than similar studies. The most common culprit was phenobarbital (70% and the least common was lamotrigine (1.4%.ConclusionIn this study, we found higher rates of drug rash in patients treated with aromatic AEDs and lower rates with non-aromatic AEDs. Various endogenous and environmental factors may influence the propensity to develop these reactions. Refrences1. Blume WT, Lu¨ders HO, Mizrahi E, et al. Glossary of descriptive terminology for

  8. Drug reaction with eosinophilia and systemic symptoms (DRESS) : an original multisystem adverse drug reaction. Results from the prospective RegiSCAR study

    NARCIS (Netherlands)

    Kardaun, S. H.; Sekula, P.; Valeyrie-Allanore, L.; Liss, Y.; Chu, C. Y.; Creamer, D.; Sidoroff, A.; Naldi, L.; Mockenhaupt, M.; Roujeau, J. C.

    2013-01-01

    BackgroundCases of severe drug hypersensitivity, demonstrating a variable spectrum of cutaneous and systemic involvement, are reported under various names, especially drug reaction with eosinophilia and systemic symptoms (DRESS). Case definition and overlap with other severe cutaneous adverse reacti

  9. [Analysis of the cardiac side effects of antipsychotics: Japanese Adverse Drug Event Report Database (JADER)].

    Science.gov (United States)

    Ikeno, Takashi; Okumara, Yasuyuki; Kugiyama, Kiyotaka; Ito, Hiroto

    2013-08-01

    We analyzed the cases of side effects due to antipsychotics reported to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) from Jan. 2004 to Dec. 2012. We used the Japanese Adverse Drug Event Report Database (JADER) and analyzed 136 of 216,945 cases using the defined terms. We also checked the cardiac adverse effects listed in the package inserts of the antipsychotics involved. We found cases of Ikr blockade resulting in sudden death (49 cases), electrocardiogram QT prolonged (29 cases), torsade de pointes (TdP, 19 cases), ventricular fibrillation (VF, 10 cases). M2 receptor blockade was observed in tachycardia (8 cases) and sinus tachycardia (3 cases). Calmodulin blockade was involved in reported cardiomyopathy (3 cases) and myocarditis (1 case). Multiple adverse events were reported simultaneously in 14 cases. Our search of package inserts revealed warnings regarding electrocardiogram QT prolongation (24 drugs), tachycardia (23), sudden death (18), TdP (14), VF (3), myocarditis (1) and cardiomyopathy (1). We suggest that when an antipsychotic is prescribed, the patient should be monitored regularly with ECG, blood tests, and/or biochemical tests to avoid adverse cardiac effects. PMID:25069255

  10. Systematic review of nonsteroidal anti-inflammatory drug-induced adverse effects in dogs.

    Science.gov (United States)

    Monteiro-Steagall, B P; Steagall, P V M; Lascelles, B D X

    2013-01-01

    The aim of this systematic review was to identify, assess, and critically evaluate the quality of evidence of nonsteroidal anti-inflammatory drug (NSAID)-induced adverse effects in dogs. Original prospective studies published in peer-reviewed journals in English (1990-2012) that reported data on the safety of NSAIDs administration in dogs were searched. For each study, design type (I, II, III, or IV) and assessment of quality (+, Ø, -) were rated. For each drug, quantity and consistency rating (***, **, *) and strength of evidence (high, moderate, low, or extremely low) were identified and evaluated. The strength of evidence was defined in terms of how applicable and relevant the conclusions were to the target population. Sixty-four studies met the inclusion criteria. Thirty-five (55%) research studies and 29 (45%) clinical trials were identified. A high strength of evidence existed for carprofen, firocoxib, and meloxicam; moderate for deracoxib, ketoprofen, and robenacoxib; and low for etodolac. Quality and consistency rating were as follows: carprofen (***/***), deracoxib (**/***), etodolac (*/unable to rate), firocoxib (***/**), ketoprofen (**/***), meloxicam (***/***), and robenacoxib (**/**), respectively. Adverse effects were detected in 35 studies (55%) and commonly included vomiting, diarrhea, and anorexia. Three studies (5%) reported a power analysis related to adverse effects of ≥80%. In randomized, placebo-controlled, blinded studies (n = 25, 39%), the incidence of adverse effects was not statistically different between treated and control dogs. Finally, most studies were not appropriately designed to determine the safety of NSAIDs, and involved a healthy nongeriatric population of research dogs. PMID:23782347

  11. 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 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

  12. Novel Data Mining Methodologies for Adverse Drug Event Discovery and Analysis

    OpenAIRE

    Harpaz, Rave; DuMouchel, William; Shah, Nigam H; Madigan, David; Ryan, Patrick; Friedman, Carol

    2012-01-01

    Discovery of new adverse drug events (ADEs) in the post-approval period is an important goal of the health system. Data mining methods that can transform data into meaningful knowledge to inform patient safety have proven to be essential. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used in support of ADE discovery and analysis.

  13. Cancer incidence and adverse pregnancy outcome in registered nurses potentially exposed to antineoplastic drugs

    OpenAIRE

    Le Nhu D; Teschke Kay; Chow Yat; Lorenzi Maria; Beking Kris; Spinelli John J; Ratner Pamela A; Gallagher Richard P; Dimich-Ward Helen

    2010-01-01

    Abstract Background To determine the relationships of potential occupational exposure to antineoplastic drugs with cancer incidence and adverse pregnancy outcomes in a historical prospective cohort study of female registered nurses (RNs) from British Columbia, Canada (BC). Methods Female RNs registered with a professional regulatory body for at least one year between 1974 and 2000 formed the cohort (n = 56,213). The identifier file was linked to Canadian cancer registries. An RN offspring coh...

  14. Text Mining for Adverse Drug Events: the Promise, Challenges, and State of the Art

    OpenAIRE

    Harpaz, Rave; Callahan, Alison; Tamang, Suzanne; Low, Yen; Odgers, David; Finlayson, Sam; Jung, Kenneth; LePendu, Paea; Shah, Nigam H.

    2014-01-01

    Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. Text mining is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources—such as biomedical literature, clinical narrat...

  15. Multi-omic landscape of Rheumatoid Arthritis: re-evaluation of drug adverse effects

    OpenAIRE

    Paolo eTieri; XiaoYuan eZhou; Lisha eZhu; Christine eNardini

    2014-01-01

    Objective: To provide a frame to estimate the systemic impact (side/adverse events) of (novel) therapeutic targets by taking into consideration drugs potential on the numerous districts involved in rheumatoid arthritis (RA) from the inflammatory and immune response to the gut-intestinal (GI) microbiome.Methods: We curated the collection of molecules from high-throughput screens of diverse (multi-omic) biochemical origin, experimentally associated to RA. Starting from such collection we genera...

  16. Multi-omic landscape of rheumatoid arthritis: re-evaluation of drug adverse effects

    OpenAIRE

    Tieri, Paolo; Zhou, Xiaoyuan; Zhu, Lisha; Nardini, Christine

    2014-01-01

    Objective: To provide a frame to estimate the systemic impact (side/adverse events) of (novel) therapeutic targets by taking into consideration drugs potential on the numerous districts involved in rheumatoid arthritis (RA) from the inflammatory and immune response to the gut-intestinal (GI) microbiome. Methods: We curated the collection of molecules from high-throughput screens of diverse (multi-omic) biochemical origin, experimentally associated to RA. Starting from such collection we ge...

  17. Programmable Infusion Pumps in ICUs: An Analysis of Corresponding Adverse Drug Events

    OpenAIRE

    Nuckols, Teryl K; Bower, Anthony G.; Paddock, Susan M.; Hilborne, Lee H.; Wallace, Peggy; Rothschild, Jeffrey M; Griffin, Anne; Fairbanks, Rollin J; Carlson, Beverly; Panzer, Robert J.; Brook, Robert H.

    2007-01-01

    Background Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. Objectives To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software (“smart pump”) and to suggest potential improvements in smart-pump design. Design Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 ...

  18. Adræt Virksomhedsudvikling

    DEFF Research Database (Denmark)

    Mikkelsen, Hans; Riis, Jens Ove

    fra Industriens Realkredit Fond og Center for Industriel Produktion (CIP) har muliggjort gennemførelse af et projekt om Agile Project Portfolio Management, som har omfattet en sammenfattende og struktureret fremstilling af de to begreber og deres anvendelse inden for virksomhedsudvikling. Case...... principper og virkemidler, der ligger i begreberne Lean (slank) og Agile (adræt), rummer interessante perspektiver for også at kunne finde anvendelse inden for virksomhedsudvikling. En sammenstilling af de to begreber til Agilean udgør et forsøg på at uddrage det bedste fra de to begrebssæt. Økonomisk støtte...

  19. To Discuss the Adverse reaction of Chinese Patent Drug%浅谈中成药的不良反应

    Institute of Scientific and Technical Information of China (English)

    刘伦栋

    2014-01-01

    To discuss the adverse reaction of Chinese patent drug, to study and analysis the adverse reaction of Chinese patent drug in clinic, Chinese patent drug, adverse reaction should be valued and prevent drug abusing.%探讨中成药的不良反应,分析研究中成药在临床应用中的不良反应,且对中成药的不良反应应重视并防止滥用。

  20. Epigenetics and transcriptomics to detect adverse drug effects in model systems of human development.

    Science.gov (United States)

    Balmer, Nina V; Leist, Marcel

    2014-07-01

    Prenatal exposure to environmental chemicals or drugs has been associated with functional or structural deficits and the development of diseases in later life. For example, developmental neurotoxicity (DNT) is triggered by lead, and this compound may predispose to neurodegenerative diseases in later life. The molecular memory for such late consequences of early exposure is not known, but epigenetic mechanisms (modification of the chromatin structure) could take this role. Examples and underlying mechanisms have been compiled here for the field of DNT. Moreover, we addressed the question as to what readout is suitable for addressing drug memory effects. We summarize how complex developmental processes can be modelled in vitro by using the differentiation of human stem cells. Although cellular models can never replicate the final human DNT phenotype, they can model the adverse effect that a chemical has on key biological processes essential for organ formation and function. Highly information-rich transcriptomics data may inform on these changes and form the bridge from in vitro models to human prediction. We compiled data showing that transcriptome analysis can indicate toxicity patterns of drugs. A crucial question to be answered in our systems is when and how transcriptome changes indicate adversity (as opposed to transient adaptive responses), and how drug-induced changes are perpetuated over time even after washout of the drug. We present evidence for the hypothesis that changes in the histone methylation pattern could represent the persistence detector of an early insult that is transformed to an adverse effect at later time-points in life. PMID:24476462

  1. Amitriptyline adverse reactions reported by outpatients / Reacciones adversas a amitriptilina relatadas por pacientes ambulatoriales / Reações adversas a amitriptilina relatadas por pacientes ambulatoriais

    Directory of Open Access Journals (Sweden)

    Sebastião ECO

    2005-04-01

    Full Text Available Aim: The aim of the present study was to know the profile of adverse drug reactions (ADR, at ambulatory level, suffered by patients using amitrityline. Method: After an informed consent, 130 randomly chosen patients using pharmacy services from eight different health units in Riberão Preto - São Paulo (Brazil were interviewed. To gather socioeconomic, clinical data and ADR, an structured questionnaire was used. The latter were analyzed regarding their seriousness, frequency, causality and preventability. Results: All surveyed patients reported at least one ADR to amitriptyline, being doubtful (4%, possible (44% and probable (52%. From probable/possible, 29% were reported as moderate/serious, and among them, 67% were frequent. 79% of total ADR were considered as preventable. 5 more cited symptoms (29.5% were: dry mouth or taste disturbances, drowsiness, orthostatic hypotension and weakness. Conclusions: Reported amitriptylin ADRs could have been prevented or reduced their seriousness, or, at least, advised when occurring, because they may produce other drug-related problems, non-compliance or discomfort. Patients should be taken into account as ADR information sources, improving physician-patient relationship and their quality of life by improving medical care.

  2. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.

    Science.gov (United States)

    Jakobsen, Klaus Damgaard; Bruhn, Christina Hedegaard; Pagsberg, Anne-Katrine; Fink-Jensen, Anders; Nielsen, Jimmi

    2016-10-01

    Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients. PMID:27504593

  3. Medicinal plant reported with adverse reactions in Cuba: potential interactions with conventional drugs

    Directory of Open Access Journals (Sweden)

    Ioanna Martínez

    2015-04-01

    Full Text Available Context: Herbal drugs are a mixture of active compounds and the chemical complexity of each formulation increase with the possibility of interactions between them and conventional drugs. Many mechanisms are implicated in the interactions; scientific community has dedicated the attentions to enzymes as P-gp and CYP450. Aims: To investigate in the literature the principal plants with suspicions of adverse reactions in Cuba and their potential interactions with conventional drugs. Methods: PubMed was the database used as source of information until February 2014. Key words: Herb-Drug, Drug-Plant, Herbal–Drug, Interactions with scientific names of plants was used. Information was structured and analysed with EndNote X4. Analysis and integration of the information: Allium sativum L. (garlic was the plant with the high number of studies related with CYP450 and P-gp. Plants with great demand as Morinda citrifolia L. (noni, Psidium guajava L. (guayaba, Zingiber officinale Roscoe (ginger and Eucalyptus spp. (eucalyptus have a very small number of studies. The professionals of the health should keep in mind the possibility of interactions between herbal products and conventional drugs to increase the effectiveness of phytotherapy. Conclusions: It is necessary enhance reports and investigations and to put to disposition of the system of health information on the interactions of plants and to stimulate the investigation that offers information for the rational use of our medicinal plants.

  4. Analysis of 935 ADR reports in our hospital from 2010 to 2014%2010-2014年我院935例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    徐伟佳; 高勇; 梁少龙; 吴雪

    2015-01-01

    目的:了解我院药品不良反应(ADR)的发生规律及特点,总结经验以促进患者用药安全、有效。方法:采用回顾性分析方法,收集我院2010–2014年共计935例ADR监测报告,对患者性别、年龄、药品种类、给药途径、累及系统/器官及主要临床表现、转归等进行分析。结果:我院ADR报告的数量、质量逐步提高,935例报告中新的及严重的ADR 110例(11.76%),其中严重的ADR 36例(3.85%);男性患者436例(46.63%),女性患者499例(53.37%),21~50岁患者构成比(49.63%)最高;主要累及的系统/器官为皮肤及附件(43.84%);引起ADR频次最高的药物为抗感染药物(40.64%),给药途径中以静脉给药的构成比最高(78.50%)。结论:我院ADR监测工作在以患者为中心的基础上,监管部门高度重视,多措并举,特别是鼓励全体药师积极参与之后,该工作水平逐步提高,促进了患者用药的安全、有效。%Objective: To analyze and sum up the experience of adverse drug reaction (ADR) monitoring in our hospital, and promote the patient's medication safety and effectiveness.Methods:A total of 935 ADR reports in our hospital from 2010 to 2014 were collected retrospectively. The data in respect of age and gender of patients, categories of drugs, route of administration, systems and organs involved in ADR, clinical manifestations and prognosis were analyzed statistically.Results: The quantity and quality of ADR reports in our hospital improved gradually. Among 935 ADR reports, there were 110 cases (11.76%) of new and severe ADR, and 36 cases (3.85%) were severe ADR; 436 cases (46.63%) were male and 499 cases (53.37%) were female; patients aged from 21 to 50 years accounted for the largest proportion (49.63%); skin and appendages damage was the most frequent ADR (43.84%); the most frequency in suspected drugs was anti-infective drugs (40.64%); the main administration

  5. Drug adverse events and drop-out risk: a clinical case.

    Science.gov (United States)

    Scoyni, R M; Aiello, L; Trani, I; Felli, B; Masin, A M R; Camponi, V; Dignazio, L; Cortese, M; Pacitti, M T; Carratelli, D; Morocutti, C

    2007-01-01

    We report a brief discussion on a clinical case of a female patient, 85 years old, affected by severe cognitive impairment and chronic obstructive pulmonary disease (COPD). The patient was not taking drugs at home (apart from promazine: 10 drops when necessary to control her behavioral diseases). A previous neuropsychological evaluation had shown a severe cognitive impairment MMSE=16/30; ADL=3/6; IADL=0/8) due to multiple brain ischemic areas (confirmed in 2003 by MRI neuroimaging). When the patient was admitted to our center she was able to perform some basic activities of daily living such as eating and walking and was not too confused. She was included in cognitive rehabilitation groups. Since she showed signs of Parkinsonism, a therapy based on omeprazol 20mg, acetylsalicylic acid, donepezil 10mg, pramipexol 0.18 mg, nimodipine 10 drops, levodopa+carbidopa 100/25mg was started. A few days later she became sleepy during daytime and, once, she lost her balance and fell. She was not self-sufficient any more. At first this was attributed to a lung infection that the patient had, but her state continue after the infection was completely cured with appropriate antibiotics therapy. At that point an adverse drug reaction was suspected and therapy with pramipexol 0.18 mg was interrupted. In a few days the patient regained her previous level of consciousness and self-sufficiency. We consider this a typical case of complex management in a patient with dementia and comorbidity in which adverse drug reactions can play an important role in lowering the level of cognitive functions. In this case the relationship with the family of the patient was made difficult by the attitude of the patient's daughter who decided, after the onset of the adverse drug reaction, to interrupt her mother's stay in our center even at risk of the worst consequences. PMID:17317475

  6. Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board

    Science.gov (United States)

    Dorr, David A.; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

    2009-01-01

    Purpose Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients. PMID:19458059

  7. An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

    Directory of Open Access Journals (Sweden)

    Szkultecka-Debek Monika

    2014-06-01

    Full Text Available The project was performed within the Polish Society for Pharmacoeconomics (PTFE. The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

  8. Adverse health consequences of performance-enhancing drugs: an Endocrine Society scientific statement.

    Science.gov (United States)

    Pope, Harrison G; Wood, Ruth I; Rogol, Alan; Nyberg, Fred; Bowers, Larry; Bhasin, Shalender

    2014-06-01

    Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated. This scientific statement synthesizes available information on the medical consequences of PED use, identifies gaps in knowledge, and aims to focus the attention of the medical community and policymakers on PED use as an important public health problem. PED users frequently consume highly supraphysiologic doses of PEDs, combine them with other PEDs and/or other classical drugs of abuse, and display additional associated risk factors. PED use has been linked to an increased risk of death and a wide variety of cardiovascular, psychiatric, metabolic, endocrine, neurologic, infectious, hepatic, renal, and musculoskeletal disorders. Because randomized trials cannot ethically duplicate the large doses of PEDs and the many factors associated with PED use, we need observational studies to collect valid outcome data on the health risks associated with PEDs. In addition, we need studies regarding the prevalence of PED use, the mechanisms by which PEDs exert their adverse health effects, and the interactive effects of PEDs with sports injuries and other high-risk behaviors. We also need randomized trials to assess therapeutic interventions for treating the adverse effects of PEDs, such as the anabolic-androgen steroid withdrawal syndrome. Finally, we need to raise public awareness of the serious health consequences of PEDs. PMID:24423981

  9. [Adverse drug events of older patients presenting in the emergency department].

    Science.gov (United States)

    Malinovska, Alexandra; Bingisser, Roland; Nickel, Christian H

    2015-12-01

    The effect of medication is always a balance between their beneficial effects and any adverse reactions they might elicit. The main risk for adverse drug events {ADEs) is polypharmacy, which is the simultaneous use of multiple drugs.This often applies to older patients, who suffer from multiple diseases and therefore take multiple medications. Thus, itis not surprising, that ADEs are frequention older patients and account up to 16% of emergency visits. It is still under discussion, whether age is an independent risk factor for ADEs. However, there are some age-related changes in the pharmacokinetic and pharmacodynamics properties of many drugs, which may influence the highly fragile balance between benefit and harm in older patients. Though there are multiple risk factors for and causes of ADEs, it could be shown that a lot of ADEs are preventable and even predictable: Budnitz eta/. showed that almost two thirds of emergency hospitalisations occur due to four medication classes: warfarin, oral antiplatelet agents, insulin and oral hypoglycaemic agents. Nevertheless, only 40-60% ofA DEs are recognized in the emergency department. This might be explained by the broad clinical symptoms, ranging from bleeding due to anticoagulants to the more nonspecific symptom of weakness due to hyponatraemia secondary to thiazide diuretics. Detecting and avoiding ADEs could be aided by using lists such as Beers criteria or STOPP/FART which list medications which are potentially inappropriate for older patients. PMID:26654810

  10. 糖皮质激素与他克莫司软膏治疗成人特应性皮炎的不良反应对比分析%Comparative analysis of adverse drug reactions caused by Glucocorticoid and Tacrolimus Ointment in the treatment of atopic dermatitis

    Institute of Scientific and Technical Information of China (English)

    黄小玲; 赖永珲; 林渡娣; 邱梓; 杨春燕; 邓诗清; 黄福新

    2011-01-01

    Objective: To compare the adverse drug reactions (ADR) caused by Glucocorticoid (GC) and Tacrolimus Ointment in the treatment of atopic dermatitis (AD), and evaluate the safety of the two drugs in the treatment of AD in clinic.Methods: A total of 100 patients with adult AD were randomly divided into GC group and Tacrolimus Ointment group,with 50 patients in each group.Patients in the two groups were respectively given GC and Tacrolimus Oinment for extemal use, and the efficacy as well as the occurrence of ADR in the two groups were observed and compared.Results: The total efFective rate of Tacrolimus Ointment group was significantly higher than that of the GC group (94.0% vs 78.0 %, P<0.05),the incidence of drug-related ADR was obviously lower than that of GC group (24.0% vs 40.0%, P<0.01), and the main ADR were local skin pruritus and pricking pain, all the clinical manifestations of ADR were mild and could be relieved without special treatment.GC group had more and severe clinical manifestations of ADR than those of Tacrolimus Ointment group, the main ADR were local dermatrophia, 8teroid acne, crinosity, steroid-induced flush, local skin pricking pain,buming sensation and so on, and needed symptomatic treatment.Conclusion: Tacrolimus Ointment has a better efficacy in the treatment of AD, the ADR are less and mild, the medication is safe and is worthy of application in clinic.%目的:比较糖皮质激素与他克莫司软膏治疗成人特应性皮炎(AD)发生不良反应的情况,评价二者治疗成人AD的安全性.方法:将100例成人AD患者随机分为糖皮质激素组和他克莫司软膏组,每组50例,分别给予外用糖皮质激素及他克莫司软膏治疗,观察并比较两组治疗成人AD的疗效及不良反应发生情况.结果:他克莫司软膏组总有效率高于糖皮质激素组(94.0%对78.0%,P<0.05),药物相关不良反应的发生率明显低于糖皮质激素组(24.0%对40.0%,P<0.01),主要不良反应为局部瘙

  11. Quality indicators of preventable adverse drug events in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    . One study concerned the four indicators on inadequate preventive treatment after acute myocardial infarction (AMI) (Article 4), and another study concerned the four indicators on inadequate monitoring of HbA1c resulting in admission with hyper- or iii hypoglycemia (Article 5). In the AMI study...... the necessary laboratory data. iv The screening study (Article 3) revealed that most cases of preventable adverse drug events concern admissions with hyperglycemia, reduced renal function and recurrent AMI, related to inadequate treatment or monitoring. The AMI indicator study (Article 4) revealed that 77...

  12. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    Science.gov (United States)

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  13. Severe cutaneous adverse drug reactions:a review on epidemiology,etiology,clinical manifestation and pathogenesis

    Institute of Scientific and Technical Information of China (English)

    Tomy Martin; LI Hui

    2008-01-01

    Purpose To review the current progress in epidemiology, etiology, clinical manifestation, and pathophysiology of severe cutaneous adverse drug reactions(SCADRs). Data sources Data were acquired by using Blackwell-Synergy, PubMed, original articles published in the main Chinese journals and related medical textbooks materials. Study-selection and date extraction Throughout the literature review 49 articles were selected. Results SCADRs cases are rare, however, the implication is life threatening with significant mortatity rates. Epidemiology studies have shown various incidences from different regions, gender, age, race and concurrent illness. There are typical signs and symptoms for each type of SCADRs, but this is not always so. Drugs associated with inducing SCADRs are anticonvulsants, antibiotics, NSAIDs and antirheumatic drugs. In some countries, especially in Asia, traditional drugs are offen the cause of SCADRs. Genetic polymorphisms and viral infections are predisposition factors of SCADRs. Patients with certain genetic alleles and underlying diseases are vulnerable to SCADRs. The exact pathogenesis of SCADRs is not well defined. Nonetheless, recent study showed that reactive metabolites and immunological processes have a significant role in SCADRs. Conclusions The different SCADRs reactions are attributed by different intrinsic factors, such as genetic polymorphisms, gender, age and race as well as extrinsic factors, such as underlying diseases. Different regions and culprit drugs also play a role in the various types of SCADRs.

  14. Adverse childhood experiences and prescription drug use in a cohort study of adult HMO patients

    Directory of Open Access Journals (Sweden)

    Dube Shanta R

    2008-06-01

    Full Text Available Abstract Background Prescription drugs account for approximately 11% of national health expenditures. Prior research on adverse childhood experiences (ACEs, which include common forms of child maltreatment and related traumatic stressors, has linked them to numerous health problems. However, data about the relationship of these experiences to prescription drug use are scarce. Method We used the ACE Score (an integer count of 8 different categories of ACEs as a measure of cumulative exposure to traumatic stress during childhood. We prospectively assessed the relationship of the Score to prescription drug use in a cohort of 15,033 adult HMO patients (mean follow-up: 6.1 years and assessed mediation of this relationship by documented ACE-related health and social problems. Results Nearly 1.2 million prescriptions were recorded; prescriptions rates increased in a graded fashion as the ACE Score increased (p for trend Conclusion ACEs substantially increase the number of prescriptions and classes of drugs used for as long as 7 or 8 decades after their occurrence. The increases in prescription drug use were largely mediated by documented ACE-related health and social problems.

  15. Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

    OpenAIRE

    Lakshmi Prabha M; Geetha Rani A; Meenakshi Balasubramanian; Ezhil Ramya J

    2016-01-01

    Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with ...

  16. Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

    OpenAIRE

    Ficheur, Grégoire; Chazard, Emmanuel; Beuscart, Jean-Baptiste; Merlin, Béatrice; Luyckx, Michel; Beuscart, Régis

    2014-01-01

    Background Adverse drug reactions and adverse drug events (ADEs) are major public health issues. Many different prospective tools for the automated detection of ADEs in hospital databases have been developed and evaluated. The objective of the present study was to evaluate an automated method for the retrospective detection of ADEs with hyperkalaemia during inpatient stays. Methods We used a set of complex detection rules to take account of the patient’s clinical and biological context and th...

  17. Ontology-based knowledge management for personalized adverse drug events detection.

    Science.gov (United States)

    Cao, Feng; Sun, Xingzhi; Wang, Xiaoyuan; Li, Bo; Li, Jing; Pan, Yue

    2011-01-01

    Since Adverse Drug Event (ADE) has become a leading cause of death around the world, there arises high demand for helping clinicians or patients to identify possible hazards from drug effects. Motivated by this, we present a personalized ADE detection system, with the focus on applying ontology-based knowledge management techniques to enhance ADE detection services. The development of electronic health records makes it possible to automate the personalized ADE detection, i.e., to take patient clinical conditions into account during ADE detection. Specifically, we define the ADE ontology to uniformly manage the ADE knowledge from multiple sources. We take advantage of the rich semantics from the terminology SNOMED-CT and apply it to ADE detection via the semantic query and reasoning. PMID:21893837

  18. Sumatriptan overuse in episodic cluster headache: lack of adverse events, rebound syndromes, drug dependence and tachyphylaxis.

    Science.gov (United States)

    Centonze, V; Bassi, A; Causarano, V; Dalfino, L; Cassiano, M A; Centonze, A; Fabbri, L; Albano, O

    2000-01-01

    This observational study was designed to examine the pattern of sumatriptan use in patients with cluster headache using more than the recommended daily dose of subcutaneously injected (s.c.) sumatriptan. Thirteen patients suffering from episodic cluster headache were asked to record the characteristics of their attacks and drug intake for 1 year. All reported a high daily frequency of attacks (more than 3 per day) and the related overuse of s.c. sumatriptan. The results show that the overall incidence of adverse events among patients receiving sumatriptan injections for the treatment of cluster headache is low. The extended administration of this drug in episodic cluster headache did not result in tolerance problems or tachyphylaxis. Only 4 patients experienced minor adverse events and recovered more slowly than the others. They suffered from migraine without aura and cluster headache, and showed a family history of migraine. Even though they must be viewed with caution, due to the observational nature of the study and the low number of patients included, these results suggest that the profile of sumatriptan may differ in cluster headache compared with migraine. PMID:11062845

  19. e-Prescription: An e-Health System for Preventing Adverse Drug Events in Community Healthcare

    Directory of Open Access Journals (Sweden)

    Irma M. Puspitasari

    2012-03-01

    Full Text Available The paper describes development activities of an e-health system for community health center (Puskesmas with integrated adverse drug events e-prescription module, consist of system design and development, human resource development, e-health system realization, laboratory and implementation test of e-health system. Some e-readiness evaluations were conducted, through a number of field visits and questionnaires. The results had been used in the e-health system design and development, installation of the internet access infrastructure, and implementation of the education and hands-on training for the medical and administrative staff of the healthcare units. After completing the e-health system design and development as well as system realization and laboratory tests stages, a series of field implementation and experiments have been successfully conducted at Puskesmas Babakansari in Bandung. A number of users feed back have been obtained and used for further improvements on both of the software and hardware modules. The e-health system with integrated e-prescription module has successfully developed and shown its expected functions in: patient registration, medical record, paperless prescription, producing the required reports and preventing possible adverse drug events.

  20. Adverse and Advantageous Selection in the Medicare Supplemental Market: A Bayesian Analysis of Prescription drug Expenditure.

    Science.gov (United States)

    Li, Qian; Trivedi, Pravin K

    2016-02-01

    This paper develops an extended specification of the two-part model, which controls for unobservable self-selection and heterogeneity of health insurance, and analyzes the impact of Medicare supplemental plans on the prescription drug expenditure of the elderly, using a linked data set based on the Medicare Current Beneficiary Survey data for 2003-2004. The econometric analysis is conducted using a Bayesian econometric framework. We estimate the treatment effects for different counterfactuals and find significant evidence of endogeneity in plan choice and the presence of both adverse and advantageous selections in the supplemental insurance market. The average incentive effect is estimated to be $757 (2004 value) or 41% increase per person per year for the elderly enrolled in supplemental plans with drug coverage against the Medicare fee-for-service counterfactual and is $350 or 21% against the supplemental plans without drug coverage counterfactual. The incentive effect varies by different sources of drug coverage: highest for employer-sponsored insurance plans, followed by Medigap and managed medicare plans.

  1. High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

    Science.gov (United States)

    Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

    2010-01-01

    Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates. PMID:21347109

  2. Adverse and Advantageous Selection in the Medicare Supplemental Market: A Bayesian Analysis of Prescription drug Expenditure.

    Science.gov (United States)

    Li, Qian; Trivedi, Pravin K

    2016-02-01

    This paper develops an extended specification of the two-part model, which controls for unobservable self-selection and heterogeneity of health insurance, and analyzes the impact of Medicare supplemental plans on the prescription drug expenditure of the elderly, using a linked data set based on the Medicare Current Beneficiary Survey data for 2003-2004. The econometric analysis is conducted using a Bayesian econometric framework. We estimate the treatment effects for different counterfactuals and find significant evidence of endogeneity in plan choice and the presence of both adverse and advantageous selections in the supplemental insurance market. The average incentive effect is estimated to be $757 (2004 value) or 41% increase per person per year for the elderly enrolled in supplemental plans with drug coverage against the Medicare fee-for-service counterfactual and is $350 or 21% against the supplemental plans without drug coverage counterfactual. The incentive effect varies by different sources of drug coverage: highest for employer-sponsored insurance plans, followed by Medigap and managed medicare plans. PMID:25504934

  3. Multi-omic landscape of Rheumatoid Arthritis: re-evaluation of drug adverse effects

    Directory of Open Access Journals (Sweden)

    Paolo eTieri

    2014-11-01

    Full Text Available Objective: To provide a frame to estimate the systemic impact (side/adverse events of (novel therapeutic targets by taking into consideration drugs potential on the numerous districts involved in rheumatoid arthritis (RA from the inflammatory and immune response to the gut-intestinal (GI microbiome.Methods: We curated the collection of molecules from high-throughput screens of diverse (multi-omic biochemical origin, experimentally associated to RA. Starting from such collection we generated RA-related protein-protein interaction (PPI networks (interactomes based on experimental PPI data. Pharmacological treatment simulation, topological and functional analyses were further run to gain insight into the proteins most affected by therapy and by multi-omic modelling.Results: Simulation on the administration of MTX results in the activation of expected (apoptosis and adverse (nitrogenous metabolism alteration effects. Growth factor receptor-bound protein 2 (GRB2 and Interleukin-1 Receptor Associated Kinase-4 (IRAK4, already an RA target emerge as relevant nodes. The former controls the activation of inflammatory, proliferative and degenerative pathways in host and pathogens. The latter controls immune alterations and blocks innate response to pathogens.Conclusions: This multi-omic map properly recollects in a single analytical picture known, yet complex, information like the adverse/side effects of MTX, and provides a reliable platform for in silico hypothesis testing or recommendation on novel therapies. These results can support the development of RA translational research in the design of validation experiments and clinical trials, as such we identify GRB2 as a robust potential new target for RA for its ability to control both synovial degeneracy and dysbiosis, and, conversely, warn on the usage of IRAK4-inhibitors recently promoted, as this involves potential adverse effects in the form of impaired innate response to pathogens.

  4. ASSESSMENT AND EVALUATION OF DRUG INFORMATION SERVICE PROVIDED BY PHARMACY PRACTICE DEPARTMENT BASED ON ENQUIRER’S PERSPECTIVE

    OpenAIRE

    Jeevangi V M; Neelkantreddy Patil; Anand B Geni; Hinchageri SS; Manjunath G; Shantveer H

    2012-01-01

    Drug information service refers to activities carried out by pharmacists in providing any drug related information to healthcare professionals to provide better patient care. Providing drug information is a clinical pharmacy service and delivered as part of the multidisciplinary approach to patient care. Accurate information about safety of drugs is very essential for health care professionals in identifying, preventing and managing Adverse Drug Reactions (ADRs), thereby ensuring safe use of ...

  5. Literature Analysis of Adverse Drug Reactions Induced by Fluoroquinolone in 181 cases%181例氟喹诺酮类药物药品不良反应文献分析

    Institute of Scientific and Technical Information of China (English)

    李容

    2016-01-01

    Objective To understand the adverse reaction of fluoroquinolones, and to explore its occurrence for rational drug use in clinic service. Methods The ADR literature causes related fluoroquinolones in CNKI ( 1994-2014 ) were searched, the case reports of ADR induced by fluoroquinolones were screened and collected and were summarized and analyzed according to age, sex, primary disease, oc-currence time, organs or systems as well as the treatment measures involved. Results There were a total of 12 species of fluoro-quinolones causing ADR, which were mainly the third and the fourth generation of fluoroquinolone drugs;the top three were levofloxacin ( 27. 07% ) , ciprofloxacin ( 14. 36% ) , and moxifloxacin ( 12. 71% ) . Age mainly focused on 60 years old ( 34. 81% ); occurred in less than 0. 5 h ( 32. 04% );the involved organs system relates to each big systems of the body, with the most common ADR in the central ner-vous system ( 27. 07% ) , systemic damage ( 21. 55% ) , skin and its accessories baseddamage ( 15. 47% ) . Conclusion The adverse reactions induced by fluoroquinolones are broad, and some are even very serious, such as anaphylactic shock. Clinical attention should be on this situation, and the majority of clinicians and pharmacists should be closely monitoredand actively promote the rational use of fluoro-quinolones clinical.%目的:了解氟喹诺酮类药物的药品不良反应(ADR)发生规律,为临床合理用药服务。方法检索中国期刊全文数据库(CNKI)中有关氟喹诺酮类药物引起ADR的文献(检索时间1994年至2014年),筛选收集其致ADR的案例报告,按年龄、性别、原患疾病、发生时间、累及器官或系统、治疗措施等进行汇总、分析。结果引发ADR的氟喹诺酮类药物共有12种,以第3代、4代氟喹诺酮类药物为主;居前3位的是左氧氟沙星(27.07%)、环丙沙星(14.36%)、莫西沙星(12.71%)。其中60岁以上老人发生占34.81%;0

  6. Clinical analysis of adverse drug reaction of Insulin in treatment of patients with diabetes%胰岛素治疗糖尿病不良反应的临床分析

    Institute of Scientific and Technical Information of China (English)

    周国坚; 谌剑飞

    2011-01-01

    Objective: To analyze clinical manifestation of adverse drug reaction (ADR) of Insulin in treatment of patients with diabetes mellitus, and to discuss relationship of hypoglycemia's probability and degree enhanced with different variety of Insulin, to raise the awareness of prevention. Methods: The clinical date of ADR in 516 diabetes mellitus patients treated with Insulin were analyzed, and compared with hypoglycemia rate. Results: The most ADR were hypoglycemia (20.6%), next for weight gain (7.1%), systemic or local allergic reactions (1.9%), edema of face and lower limb (1.7%); Other ADR were the fatty tissue proliferation, Somongyi phenomenon, adipose atrophy and Insulin antibody production. The inci -dence and the degree of hypoglycemia was the highest in patients who were given ordinary Insulin strengthening therapy, the next were 30/70 Mixture recombinant human Insulin, Novolin 30R, Novomix 30R, hypoglycemia rate of Humalog 25R was less, and hypoglycemia degree of Glargine was lowest, the differences were highly significant (P<0.01). When the Insulin combined with oral administrational Sulfonylureas, the incidence of hypoglycemia had close relationship with variety of In -sulin,the differences were highly significant (P<0.01). Conclusion: The hypoglycemia is common in ADR of Insulin, weight gain and allergic reactions for the next, we should pay more attention to it; the incidence and degree of hypoglycemia has close relationship with variety of Insulin and treatment method, selecting the varieties and taking positive measure for pre -vention are the key.%目的:分析胰岛素治疗糖尿病不良反应的临床表现,探讨不同品种的胰岛素与低血糖发生率的关系,以提高对其的防范意识.方法:回顾性分析516例使用胰岛素治疗糖尿病患者不良反应的临床资料,并与低血糖发生率进行比较.结果:不良反应最多为低血糖(20.6%),其次为体重增加(7.1%)、全身或局部过敏反应(1.9%)

  7. 沉默CtBP1基因逆转人子宫内膜癌耐药细胞株B-MD-C1(ADR+/+)的多药耐药性%Silencing CtBP1 gene reverses the multidrug resistance of drug-resistant endometrial cancer B-MD-C1(ADR+/+) cells

    Institute of Scientific and Technical Information of China (English)

    杨红霞; 艾军; 李巧霞; 单保恩

    2010-01-01

    目的:探讨短发夹式RNA(short hairpin RNA,shRNA)干扰羧基末端结合蛋白1(C-terminal-binding proteins 1,CtBP1)基因表达是否可以逆转多药耐药基因1(multidrug resistant gene 1,MDR1)介导的人子宫内膜癌耐药细胞株B-MD-C1(ADR+/+)的多药耐药性.方法:采用脂质体转染法将特异性的shRNA1和shRNA2及非特异性的shRNAHK质粒转染入人子宫内膜癌耐药细胞株B-MD-C1(ADR+/+)中,RT-PCR法检测各组细胞MDR1基因表达水平,Western印迹法检测各组细胞P糖蛋白(P-glycoprotein, P-gp)的表达,MTT法测定各组细胞对多柔比星的敏感性变化.结果:RT-PCR结果显示,shRNA1组和shRNA2组细胞中MDR1基因被抑制,基因表达抑制率约50%;Western印迹结果显示,shRNA1组和shRNA2组细胞P-gp蛋白的表达水平显著降低;MTT检测发现,shRNA转染48和72 h时shRNA1组和shRNA2组细胞对多柔比星的敏感性增加(P<0.01).结论:沉默CtBP1基因可抑制人子宫内膜癌耐药细胞株B-MD-C1(ADR+/+)中MDR1基因和P-gp蛋白的表达,降低细胞的耐药性.

  8. Adverse drug events associated with vitamin K antagonists: factors of therapeutic imbalance

    Directory of Open Access Journals (Sweden)

    El-Helou N

    2013-03-01

    Full Text Available Nancy El-Helou, Amal Al-Hajje, Rola Ajrouche, Sanaa Awada, Samar Rachidi, Salam Zein, Pascale SalamehClinical and Epidemiological Research Laboratory, Faculty of Pharmacy, Lebanese University, Beirut, LebanonBackground: Adverse drug events (ADE occur frequently during treatment with vitamin K antagonists (AVK and contribute to increase hemorrhagic risks.Methods: A retrospective study was conducted over a period of 2 years. Patients treated with AVK and admitted to the emergency room of a tertiary care hospital in Beirut were included. The aim of the study was to identify ADE characterized by a high international normalized ratio (INR and to determine the predictive factors responsible for these events. Statistical analysis was performed with the SPSS statistical package.Results: We included 148 patients. Sixty-seven patients (47.3% with an INR above the therapeutic range were identified as cases. The control group consisted of 81 patients (54.7% with an INR within the therapeutic range. Hemorrhagic complications were observed in 53.7% of cases versus 6.2% of controls (P < 0.0001. No significant difference was noticed between cases and controls regarding the indication and the dose of AVK. Patients aged over 75 years were more likely to present an INR above the therapeutic range (58.2%, P = 0.049. Recent infection was present in 40.3% of cases versus 6.2% of controls (P < 0.0001 and hypoalbuminemia in 37.3% of cases versus 6.1% of controls (P < 0.0001. Treatment with antibiotics, amiodarone, and anti-inflammatory drugs were also factors of imbalance (P < 0.0001.Conclusion: Many factors may be associated with ADE related to AVK. Monitoring of INR and its stabilization in the therapeutic range are important for preventing these events.Keywords: adverse drug events, vitamin K antagonists, bleeding risks, therapeutic imbalance

  9. Construct and concurrent validity of a patient-reported adverse drug event questionnaire : a cross-sectional study

    NARCIS (Netherlands)

    de Vries, Sieta T.; Haaijer-Ruskamp, Flora M.; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    Background: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is

  10. Technical modification within the healthcare industry: improving both the efficacy of the National Drug Code carrier and the accessibility of electronic health records to reduce adverse drug events

    OpenAIRE

    Dixon, Jeffrey James; McLean, Alistair Saint

    2013-01-01

    Approved for public release; distribution is unlimited The main focus of this thesis is to present the idea that QR codes could contribute to a reduction in adverse drug events (ADEs) by increasing the efficacy of the national drug code and storing an electronic health record. This research examines a change in drug coding technology that will decrease the number of ADEs by empowering patients to be more proactive in tracking their current prescription and over-the-counter drugs, and the A...

  11. Harvesting candidate genes responsible for serious adverse drug reactions from a chemical-protein interactome.

    Directory of Open Access Journals (Sweden)

    Lun Yang

    2009-07-01

    Full Text Available Identifying genetic factors responsible for serious adverse drug reaction (SADR is of critical importance to personalized medicine. However, genome-wide association studies are hampered due to the lack of case-control samples, and the selection of candidate genes is limited by the lack of understanding of the underlying mechanisms of SADRs. We hypothesize that drugs causing the same type of SADR might share a common mechanism by targeting unexpectedly the same SADR-mediating protein. Hence we propose an approach of identifying the common SADR-targets through constructing and mining an in silico chemical-protein interactome (CPI, a matrix of binding strengths among 162 drug molecules known to cause at least one type of SADR and 845 proteins. Drugs sharing the same SADR outcome were also found to possess similarities in their CPI profiles towards this 845 protein set. This methodology identified the candidate gene of sulfonamide-induced toxic epidermal necrolysis (TEN: all nine sulfonamides that cause TEN were found to bind strongly to MHC I (Cw*4, whereas none of the 17 control drugs that do not cause TEN were found to bind to it. Through an insight into the CPI, we found the Y116S substitution of MHC I (B*5703 enhances the unexpected binding of abacavir to its antigen presentation groove, which explains why B*5701, not B*5703, is the risk allele of abacavir-induced hypersensitivity. In conclusion, SADR targets and the patient-specific off-targets could be identified through a systematic investigation of the CPI, generating important hypotheses for prospective experimental validation of the candidate genes.

  12. A systematic review of observational studies evaluating costs of adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Batel Marques F

    2016-08-01

    Full Text Available Francisco Batel Marques,1,2 Ana Penedones,1,2 Diogo Mendes,1,2 Carlos Alves,1,2 1CHAD – Centre for Health Technology Assessment and Drug Research, AIBILI – Association for Innovation and Biomedical Research on Light and Image, 2School of Pharmacy, University of Coimbra, Coimbra, Portugal Introduction: The growing evidence of the increased frequency and severity of adverse drug events (ADEs, besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs.Objective: To identify and characterize the best available evidence on ADE-associated costs.Methods: MEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated.Results: Twenty-nine (94% longitudinal observational studies and two (7% cross-sectional studies were included. Twenty-three (74% studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%. Twenty (65% studies evaluated any therapeutic group. Twenty (65% studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7% also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7

  13. Cutaneous adverse drug reaction type erythema multiforme major induced by eslicarbazepine.

    Science.gov (United States)

    Massot, Andreu; Gimenez-Arnau, Ana

    2014-10-01

    Severe skin reactions occur less frequently with eslicarbazepine (ESL) than with the other aromatic anticonvulsants. We report the first case of cutaneous adverse drug reaction (CADR) to ESL and co-sensitization between ESL and betalactams. A 41-year-old white woman developed focal epilepsy due to a meningioma that was removed. As post-operatory complication, she suffered meningitis as well as a maculo-papular erythema caused by the treatment with meropenem. Subsequently, ESL was started and gradually increased until 800 mg/day. Twenty-five days later, the patient developed an Erythema Multiforme Major (EMM). Strong positive immediate reaction was induced by prick test with carbamazepine (CBZ) and ESL at 0.01 and 0.1% within 15 and 30 minutes; however the delayed reading at 48 hours was negative. The patient was not carrier of the HLA alleles A3101 and B1502 associated with CBZ induced EMM. The hypersensitivity pathogenic mechanism of EMM is unclear and a delayed hypersensitivity process is speculated. However, the patch and intradermal tests in our patient did not show a delayed reaction but an immediate cutaneous one. A first allergic episode may elicit a massive nonspecific activation of the immune system, providing an enhanced expression of co-stimulatory molecules that decreases the level of tolerance to other drugs. When prescribing ESL, we suggest ruling out previous CADR, especially to CBZ and oxcarbazepine but also other chemically unrelated drugs such as beta-lactams. PMID:25422574

  14. 63例我院儿童药品不良反应报告分析%An Analysis on 6 3 Reports on Child's ADR in Our Hospital

    Institute of Scientific and Technical Information of China (English)

    秦梦春

    2015-01-01

    Objective:To analyze the report on child's adverse drug reaction in some hospital during the period from 2013 to 2014 and find out its characteristics and laws .Methods:According to criteria specified by national ADR monitoring center,an analysis was made on the 6 3 reports on child's adverse drug reaction col-lected during the period from January 2013 to September 2014.Results:In all the 63 reports on child's ADR, the incidence rate of ADR resulted from intravenous administration was the highest ,and was up to 82.54%;the proportion of ADR resulted from antibacterial drug was the highest of all,it was up to 68.25%,and ceph-alosporins was the commonest;the commonest clinical features was the damage in skin and other accessories. Conclusion:It is necessary to strengthen ADR monitoring and report work and promote reasonable pharmacy.%目的::分析某院2013年~2014年儿童药品不良反应(ADR)发生的特点与规律,为儿科临床合理、安全用药提供参考。方法:按照国家 ADR监测中心制定的标准,对某院2013年1月~2014年12月收集到的63例儿童药品不良反应报告进行分析。结果:63例儿童不良反应报告中,静脉给药途径致 ADR发生率最高,占82.54%;抗菌药物致 ADR发生率最高,占68.25%,以头孢菌素类多见;最常见 ADR临床表现为皮肤级其附件损害。结论:加强某院 ADR监测和上报工作,促进我院合理用药。

  15. Constructing Clinical Decision Support Systems for Adverse Drug Event Prevention: A Knowledge-based Approach.

    Science.gov (United States)

    Koutkias, Vassilis; Kilintzis, Vassilis; Stalidis, George; Lazou, Katerina; Collyda, Chrysa; Chazard, Emmanuel; McNair, Peter; Beuscart, Regis; Maglaveras, Nicos

    2010-11-13

    A knowledge-based approach is proposed that is employed for the construction of a framework suitable for the management and effective use of knowledge on Adverse Drug Event (ADE) prevention. The framework has as its core part a Knowledge Base (KB) comprised of rule-based knowledge sources, that is accompanied by the necessary inference and query mechanisms to provide healthcare professionals and patients with decision support services in clinical practice, in terms of alerts and recommendations on preventable ADEs. The relevant Knowledge Based System (KBS) is developed in the context of the EU-funded research project PSIP (Patient Safety through Intelligent Procedures in Medication). In the current paper, we present the foundations of the framework, its knowledge model and KB structure, as well as recent progress as regards the population of the KB, the implementation of the KBS, and results on the KBS verification in decision support operation.

  16. A Critical Approach to Evaluating Clinical Efficacy, Adverse Events and Drug Interactions of Herbal Remedies.

    Science.gov (United States)

    Izzo, Angelo A; Hoon-Kim, Sung; Radhakrishnan, Rajan; Williamson, Elizabeth M

    2016-05-01

    Systematic reviews and meta-analyses represent the uppermost ladders in the hierarchy of evidence. Systematic reviews/meta-analyses suggest preliminary or satisfactory clinical evidence for agnus castus (Vitex agnus castus) for premenstrual complaints, flaxseed (Linum usitatissimum) for hypertension, feverfew (Tanacetum partenium) for migraine prevention, ginger (Zingiber officinalis) for pregnancy-induced nausea, ginseng (Panax ginseng) for improving fasting glucose levels as well as phytoestrogens and St John's wort (Hypericum perforatum) for the relief of some symptoms in menopause. However, firm conclusions of efficacy cannot be generally drawn. On the other hand, inconclusive evidence of efficacy or contradictory results have been reported for Aloe vera in the treatment of psoriasis, cranberry (Vaccinium macrocarpon) in cystitis prevention, ginkgo (Ginkgo biloba) for tinnitus and intermittent claudication, echinacea (Echinacea spp.) for the prevention of common cold and pomegranate (Punica granatum) for the prevention/treatment of cardiovascular diseases. A critical evaluation of the clinical data regarding the adverse effects has shown that herbal remedies are generally better tolerated than synthetic medications. Nevertheless, potentially serious adverse events, including herb-drug interactions, have been described. This suggests the need to be vigilant when using herbal remedies, particularly in specific conditions, such as during pregnancy and in the paediatric population. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26887532

  17. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    OpenAIRE

    Keith B. Hoffman; Brian M. Overstreet; Murali Doraiswamy, P.

    2013-01-01

    Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs) across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA) approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to appr...

  18. Analysis of 1416 Cases of Moxifloxacin-inducing Adverse Drug Reaction/event in Beijing Area from 2007 to 2011%北京地区2007~2011年1416例莫西沙星不良反应/事件分析

    Institute of Scientific and Technical Information of China (English)

    曾艳; 闫素英

    2013-01-01

    Objective:To analyze the reports of moxifloxacin-inducing adverse drug reaction/event(ADR/ADE)in Beijing area to provide reference for rational use of moxifloxacin.Methods:Collect reports of ADR/ADE induced by moxifloxacin received by the national drug adverse reaction monitoring center from January 1 th in 2007 to December 31 th in 2011,classify the adverse reactions according to MedDRA and make analysis of the patients'clinical characteristics and type and outcome of the ADR/ADE.Results:Off-label use of moxifloxacin was prominent.The clinical manifestations of ADR/ ADE were mostly skin and subcutaneous tissue damages,nervous system disorders and gastrointestinal disorders.And the serious ADR/ADE were mostly immune system disorders,nervous system disorders and hepatobiliary disorders.Conclusion:Safe to use with moxifloxacin is worth paying attention by clinicians,who should detect and deal with ADR/ADE of moxifloxacin in time on baisis of rational use.%目的:统计分析北京地区近5年来莫西沙星不良反应/事件报告,为莫西沙星的安全合理应用提供依据.方法:收集整理2007年1月1日~2011年12月3日全国药品不良反应监测网络接收到的北京地区怀疑药品为莫西沙星的不良反应/事件报告,提取患者一般情况、用药情况、不良反应/事件发生情况及转归等信息,按照MedDRA系统将不良反应或不良事件进行系统分类,进行统计分析.结果:莫西沙星的不良反应/事件报告中,患者超说明书用药、超适应证用药较为突出,不良反应主要表现在皮下及皮下组织症状、神经系统症状、胃肠系统症状等.而严重不良反应以免疫系统症状、神经系统症状、肝胆系统症状为主.结论:莫西沙星的安全性是临床应关注的问题,应该在合理使用的基础上,监测并及时处理其不良反应/事件.

  19. Computerized surveillance of opioid-related adverse drug events in perioperative care: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Gattis Katherine G

    2009-08-01

    Full Text Available Abstract Background Given the complexity of surgical care, perioperative patients are at high risk of opioid-related adverse drug events. Existing methods of detection, such as trigger tools and manual chart review, are time-intensive which makes sustainability challenging. Using strategic rule design, computerized surveillance may be an efficient, pharmacist-driven model for event detection that leverages existing staff resources. Methods Computerized adverse drug event surveillance uses a logic-based rules engine to identify potential adverse drug events or evolving unsafe clinical conditions. We extended an inpatient rule (administration of naloxone to detect opioid-related oversedation and respiratory depression to perioperative care at a large academic medical center. Our primary endpoint was the adverse drug event rate. For all patients with a naloxone alert, manual chart review was performed by a perioperative clinical pharmacist to assess patient harm. In patients with confirmed oversedation, other patient safety event databases were queried to determine if they could detect duplicate, prior, or subsequent opioid-related events. Results We identified 419 cases of perioperative naloxone administration. Of these, 101 were given postoperatively and 69 were confirmed as adverse drug events after chart review yielding a rate of 1.89 adverse drug events/1000 surgical encounters across both the inpatient and ambulatory settings. Our ability to detect inpatient opioid adverse drug events increased 22.7% by expanding surveillance into perioperative care. Analysis of historical surveillance data as well as a voluntary reporting database revealed that 11 of our perioperative patients had prior or subsequent harmful oversedation. Nine of these cases received intraoperative naloxone, and 2 had received naloxone in the post-anesthesia care unit. Pharmacist effort was approximately 3 hours per week to evaluate naloxone alerts and confirm adverse drug

  20. 喹诺酮类药物的不良反应报告分析%Analysis of Quinolones Adverse Reaction Reports

    Institute of Scientific and Technical Information of China (English)

    王惠霞; 陆建平

    2012-01-01

      Objective:Explore the occurrence of adverse reactions of quinolones and clinical control measures.Method:A total of 27 cases of quinolone ADR reports collected in our hospital in 2009 were analyzed statistically in respect of patients age and sex,route of administration,drug varieties,organs or systems involved and the clinical manifestation.Result:Lesions of skin and its appendages were the most common damages of quinolone ADR.Conclusion:Importance should be attached to the reporting and monitoring of quinolone ADR reports in the clinic and reduce the incidence of adverse reactions.%  目的:探讨喹诺酮类药物不良反应(ADR)的发生情况与临床控制措施。方法:对笔者所在医院2011年1-12月上报的27例喹诺酮类药物 ADR 报告,按患者年龄、性别、药品类别、ADR 累及器官或系统及临床表现等进行统计、分析。结果:喹诺酮类抗菌药物药物的不良反应临床表现以皮肤及附件损害最多见。结论:临床应重视喹诺酮类药物的不良反应,加强 ADR 监测工作,促进临床合理用药,减少不良反应的发生。

  1. Safety aspects of protease inhibitors for chronic hepatitis C: adverse events and drug-to-drug interactions

    Directory of Open Access Journals (Sweden)

    Rosângela Teixeira

    2013-04-01

    Full Text Available The standard of care therapy of chronic hepatitis C with the combination of pegylated interferon and ribavirin for 24 or 48 weeks was a remarkable accomplishment of the past decade. However, sustained virological responses rates of about 80% (genotypes 2-3 and 50% (geno 3 type 1 were not satisfactory especially for patients infected with genotype 1. Important advances in the biology of HCV have made possible the development of the direct-acting antiviral agents boceprevir and telaprevir with substantial increase in the rates of sustained virological response with shorter duration of therapy for a large number of patients. However, the complexity of triple therapy is higher and several new side effects are expected suggesting greater expertise in the patient management. Anemia and disgeusia are frequent with boceprevir while cutaneous rash, ranging from mild to severe, is expected with telaprevir. Higher risk of drug-drug interactions demand further clinical consideration of the previous well-known adverse events of pegylated interferon and ribavirin. Identification and prompt management of these potential new problems with boceprevir and telaprevir are crucial in clinical practice for optimizing treatment and assuring safety outcomes to HCV-genotype 1 patients.

  2. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard; Winterstein, Almut G; Søndergaard, Birthe;

    2007-01-01

    -months, and the pADE incidence was 5.6 per 1000 person-months (1.1-10.1). The median ADE preventability rate was 21% (11-38%). The median incidence of ADEs requiring hospital admission was 0.45 (0.10-13.1) per 1000 person-months, and the median incidence of pADEs requiring hospital admission was 4.5 per 1000 person....../pADE incidence, (2) clinical outcomes, (3) associated drug groups, and/or (4) underlying medication errors were included. Study country, year and design, sample size, follow-up time, ADE/pADE identification method, proportion of ADEs/pADEs and ADEs/pADEs requiring hospital admission, and frequency distribution...... of adverse outcome, associated drug groups, or medication errors were extracted. DATA SYNTHESIS: Twenty-nine studies met inclusion criteria: 14 were ambulatory-based and 15 were hospital-based. Seven studies enrolled only elderly patients. The median ADE incidence was 14.9 (range 4.0-91.3) per 1000 person...

  3. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    Science.gov (United States)

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. PMID:26518315

  4. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Emanuel Raschi

    Full Text Available BACKGROUND: Antipsychotics (APs have been associated with risk of torsade de Pointes (TdP. This has important public health implications. Therefore, (a we exploited the public FDA Adverse Event Reporting System (FAERS to characterize their torsadogenic profile; (b we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. METHODS: FAERS data (2004-2010 were analyzed based on the following criteria: (1 ≥ 4 cases of TdP/QT abnormalities; (2 Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers; (3 ≥ 4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD; (4 Significant ROR for VA/SCD; (5 Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled to group E (unclear/uncertain signal: only 2/5 criteria. Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID. RESULTS: Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone. In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia to 13.99 (France, 2009. Considerable increment of Group A agents was found in several Countries (+3.47 in France: the exposure to olanzapine increased across all Countries (+1.84 in France and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009. Among Group B drugs, levomepromazine peaked 3.78 (Serbia; fluphenazine 1.61 (Slovenia. CONCLUSIONS: This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  5. Association between Selective Beta-adrenergic Drugs and Blood Pressure Elevation: Data Mining of the Japanese Adverse Drug Event Report (JADER) Database.

    Science.gov (United States)

    Ohyama, Katsuhiro; Inoue, Michiko

    2016-01-01

    Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events. PMID:27374969

  6. Analysis and Prospect of the Present Situation of Grassroots Level Adverse Drug Reaction Monitoring System Construction in Our Country%我国基层药品不良反应监测体系建设现状分析及展望

    Institute of Scientific and Technical Information of China (English)

    金锋; 曲毅; 樊若曦; 李馨龄

    2015-01-01

    Objective Through analyzing researches on the current status of the grassroots adverse drug reaction (ADR) monitoring organization in the country, to provide reference for the food and medicine monitoring organizations at different levels to develop ADR monitoring system, so as to better serve the overall safety monitoring of the medicine, medical device and cosmetic product. Methods Questionnaire survey was used to conduct research on the current status of the local adverse drug reaction monitoring system in our country. Results and Conclusion Through analyzing current status, common issues of the grassroots ADR monitoring organizations are discussed. These issues include incomplete reform progress, insufficient organization functions, most of the organizations not being independent, personnel team needing improvement, etc. The author makes proposals to the future local adverse drug reaction monitoring system development in the country and gives constructive advices to all levels of the monitoring departments to improve the monitoring system development.%目的:对当前全国基层药品不良反应监测机构现状进行分析,旨在为各级食品药品监督管理部门促进药品不良反应监测体系建设提供参考,更好地服务药品、医疗器械、化妆品上市后安全性监管工作大局。方法通过问卷调研的方式对我国目前基层药品不良反应监测体系建设现状进行了调研。结果与结论通过现状分析,讨论了基层药品不良反应监测技术机构存在的普遍问题,如改革进程尚未完成、机构职责还不健全、机构设置多未独立、人员队伍建设尚需加强等,并对未来全国基层药品不良反应监测体系建设提出了愿景,对各级监管部门完善监测体系建设工作提出了建设性的意见。

  7. Unequal Sized Pupils Due to Escitalopram; Adverse Events to Dietary Supplements Causing Emergency Department Visits; Compulsive Masturbation Due to Pramipexole; Metformin-Induced Lactic Acidosis Masquerading As an Acute Myocardial Infarction.

    Science.gov (United States)

    Mancano, Michael A

    2016-05-01

    The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) Med Watch program (800-FDA-1088). If you have reported an interesting, preventable ADR to Med Watch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's Med Watchprogram and Temple University School of Pharmacy. ISMP is an FDA Med Watch partner. PMID:27303087

  8. The Clinical Manifestations, Treatment Efficacy and Adverse Drug Reactions in 62 Iranian Child with Wilson Disease

    Directory of Open Access Journals (Sweden)

    Mehri Najafi

    2014-09-01

    Full Text Available Introduction: The Wilson disease is an autosomal recessive disease in which the liver, central nervous system, eyes, blood and other parts of the body involved. Timely diagnosis and appropriate treatment of the disease requires awareness of the clinical presentations of this disease in children.Methods: This case series study included 62 patients with Wilson disease who admitted to children's Medical Center in the years 2012-2003.Results: 56% of patients were male. The average age of diagnosis was 9.73 years old (5-17 years and this was higher in patients with early neurologic symptoms (P = 0.85.( 64.5% of the patients had the hepatic symptoms at the time of diagnosis and the most common type of hepatic involvement was cirrhosis (39.3% and hepatitis (17.5% respectively. 17.7% of the patients also had early neurological symptoms. A positive family history for the Wilson Disease were found in 27.4% of patients. 74.2% of patients had KF ring and the frequency of these symptom was higher in patients with early neurological involvement. 83.9% of patients were treated successfully with D-penicillamine and In 30% of patients, adverse drug reactions were seen.Conclusion: Children with unknown liver disease should be evaluated for Wilson disease and the first-degree relatives of patients should be screened. . D-penicillamine have important side effects, but due to the low cost and the availability is an appropriate drug to treat the Wilson disease..Key words: Wilson Disease, Hepatic Involvement, Neurologic Involvement , KF ring ,D-Penicillamine.

  9. Adverse respiratory reactions to aspirin and nonsteroidal anti-inflammatory drugs.

    Science.gov (United States)

    Simon, Ronald A

    2004-01-01

    Aspirin-exacerbated respiratory disease (AERD) is an adult-onset condition that manifests as asthma, rhinosinusitis/nasal polyps, and sensitivity to aspirin and other cyclooxygenase-1 (COX-1)-inhibitor nonsteroidal anti-inflammatory drugs (NSAIDs). There is no cross-sensitivity to highly selective COX-2 inhibitors. AERD is chronic and does not improve with avoidance of COX-1 inhibitors. The diagnosis of AERD is made through provocative challenge testing. Following a positive aspirin challenge, patients can be desensitized to aspirin and NSAIDs. The desensitized state can be maintained indefinitely with continued daily administration. After desensitization, there is an approximately 48-hour refractory period to adverse effects from aspirin. The pathogenesis of AERD remains unknown, but these patients have been shown to have multiple abnormalities in arachidonic acid metabolism and in cysteinyl leukotriene 1 receptors. AERD patients can take up to 650 mg of acetaminophen for analgesic or antipyretic relief. Patients can also use weak COX-1 inhibitors, such as sodium salicylate or choline magnesium trisalicylate. Treatment of AERD patients with antileukotriene medications has been helpful but not preferential when compared with non-AERD patients. An alternative treatment for many AERD patients is aspirin desensitization. This is particularly effective in reducing upper-airway mucosal congestion, nasal polyp formation, and systemic steroids. PMID:14680616

  10. Semantic resources in pharmacovigilance: a corpus and an ontology for drug-drug interactions

    OpenAIRE

    Herrero Zazo, María

    2015-01-01

    Mención Internacional en el título de doctor Nowadays, with the increasing use of several drugs for the treatment of one or more different diseases (polytherapy) in large populations, the risk for drugs combinations that have not been studied in pre-authorization clinical trials has increased. This provides a favourable setting for the occurrence of drug-drug interactions (DDIs), a common adverse drug reaction (ADR) representing an important risk to patients safety, and an increase in heal...

  11. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients.

    LENUS (Irish Health Repository)

    Hamilton, Hilary

    2011-06-13

    Previous studies have not demonstrated a consistent association between potentially inappropriate medicines (PIMs) in older patients as defined by Beers criteria and avoidable adverse drug events (ADEs). This study aimed to assess whether PIMs defined by new STOPP (Screening Tool of Older Persons\\' potentially inappropriate Prescriptions) criteria are significantly associated with ADEs in older people with acute illness.

  12. Salubrinal-Mediated Upregulation of eIF2α Phosphorylation Increases Doxorubicin Sensitivity in MCF-7/ADR Cells.

    Science.gov (United States)

    Jeon, Yong-Joon; Kim, Jin Hyun; Shin, Jong-Il; Jeong, Mini; Cho, Jaewook; Lee, Kyungho

    2016-02-01

    Eukaryotic translation initiation factor 2 alpha (eIF2α), which is a component of the eukaryotic translation initiation complex, functions in cell death and survival under various stress conditions. In this study, we investigated the roles of eIF2α phosphorylation in cell death using the breast cancer cell lines MCF-7 and MCF-7/ADR. MCF-7/ADR cells are MCF-7-driven cells that have acquired resistance to doxorubicin (ADR). Treatment of doxorubicin reduced the viability and induced apoptosis in both cell lines, although susceptibility to the drug was very different. Treatment with doxorubicin induced phosphorylation of eIF2α in MCF-7 cells but not in MCF-7/ADR cells. Basal expression levels of Growth Arrest and DNA Damage 34 (GADD34), a regulator of eIF2α, were higher in MCF-7/ADR cells compared to MCF-7 cells. Indeed, treatment with salubrinal, an inhibitor of GADD34, resulted in the upregulation of eIF2α phosphorylation and enhanced doxorubicin-mediated apoptosis in MCF-7/ADR cells. However, MCF-7 cells did not show such synergic effects. These results suggest that dephosphorylation of eIF2α by GADD34 plays an important role in doxorubicin resistance in MCF-7/ADR cells. PMID:26743901

  13. Adverse cutaneous drug reactions: Clinical pattern and causative agents in a tertiary care center in South India

    Directory of Open Access Journals (Sweden)

    Pudukadan David

    2004-01-01

    Full Text Available Background: Adverse cutaneous drug reactions (ACDRs are caused by a wide variety of agents. Aims: Our objective was to ascertain the clinical spectrum of ACDRs and the causative drugs in this part of India and to find any risk factors. Methods: Ninety patients with adverse cutaneous drug reactions were recruited for this study during 2001-2003. Hematological and biochemical investigations were done in all of them. The VDRL and HIV (ELISA tests were performed where the underlying risk factors were present. Patch testing, intradermal testing and oral provocation tests were done wherever feasible. Results: The mean age of the patients with cutaneous drug eruptions was 37.06 years. Most of them (52.2% were in the age group of 20-39 years. The male to female ratio was 0.87: 1. The most common eruptions observed were fixed drug eruption (31.1% and maculopapular rash (12.2%, and the most common causes were co-trimoxazole (22.2% and dapsone (17.7%. Conclusion: The pattern of ACDRs and the drugs causing them is remarkably different in our population. Knowledge of these drug eruptions, the causative drugs and the prognostic indicators is essential for the clinician.

  14. 420例别嘌醇不良反应的文献分析%Literature Analysis of 420 Cases of Adverse Drug Reactions Induced by Allopurinol

    Institute of Scientific and Technical Information of China (English)

    郑明节; 汤韧; 王春婷

    2014-01-01

    Objective To probe into the status,characterstics and influencing factors of ADR cases induced by allopurinol, for providing a reference for clinical treatment. Methods Data were collected from domestic published literatures from"China Journal Full-text Database"before 2013, and 420 case reports of adverse drug reactions induced by allopurinol were analyzed retrospectively. Results Older male patients appear to be with a high rate. Organs involved mainly are skin and its appendages(42.33%), systemic damage(22.77%), hepatobiliary system damage(9.90%). Severe damages to the skin are erythema multiforme system eruption , exfoliative dermatitis and hypersensitivity syndrome. Conclusion Allopurinol should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication.%目的:探讨别嘌醇致不良反应的一般规律特点,为临床合理用药提供参考。方法检索中国期刊全文数据库,对2013年之前国内公开发表有关别嘌醇致不良反应420例病例文献报道进行回顾性分析。结果老年男性患者发生率高,累及系统-器官主要为皮肤及其附件损害(42.33%)、全身性损害(22.77%)、肝胆系统损害(9.90%),严重皮肤系统的损害以多形红斑型药疹、剥脱性皮炎超敏综合征为主。结论别嘌醇片安全使用丞待加强,临床应重视别嘌醇的不良反应,加强用药监测,确保安全使用。

  15. 提高护士监测药品不良反应能力的方法与效果%The practice and effect in improving nurse's behavior of monitoring adverse drug reaction

    Institute of Scientific and Technical Information of China (English)

    花蕾

    2007-01-01

    目的 为了充分发挥护士在药品不良反应(adverse drug reaction,ADR)监测中的作用.方法 采取加大宣传力度,建立和完善ADR监测流程,加强护士药品相关知识的培训及考核,与药师合作指导患者用药,建立激励机制,强化护士ADR监测意识等.结果 2005年较2004年住院患者对用药指导满意度、护士ADR监测报表数均有明显提高,差异具有统计学意义(P<0.01或P<0 05).结论 护士在ADR监测中可以发挥应有的重要作用.

  16. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    Science.gov (United States)

    Wang, S F; Zhan, S Y

    2016-07-01

    Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China.

  17. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    Science.gov (United States)

    Wang, S F; Zhan, S Y

    2016-07-01

    Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China. PMID:27453095

  18. Female gender as a susceptibility factor for drug-induced liver injury.

    Science.gov (United States)

    Amacher, David E

    2014-09-01

    Adverse drug reactions (ADRs) can involve all tissues and organs, but liver injuries are considered among the most serious. A number of prospective, multicenter studies have confirmed a higher risk of ADRs in general among female subjects compared to a male cohort. Although drug-induced liver injury (DILI) is infrequently encountered, the preponderance of evidence suggests that women appear to be more susceptible than men to fulminate hepatic/acute liver failure especially in response to some anti-infective drugs and to autoimmune-like hepatitis following exposure to certain other therapeutic drugs. A number of hypotheses have been proposed to explain this sex difference in susceptibility to DILI. Collectively, these hypotheses suggest three basic sex-dependent mechanisms that include differences in various aspects of drug pharmacokinetics (PK) or pharmacodynamics following the administration of certain drugs; specific hormonal effects or interactions with immunomodulating agents or signaling molecules; and differences in the adverse response of the immune system to some drugs, reactive drug metabolites, or drug-protein adducts. At the preclinical drug safety stage, there is a need for more research on hormonal effects on drug PK and for additional research on gender differences in aberrant immune responses that may lead to idiosyncratic DILI in some female patients. Because the detection of rare but serious hepatic ADRs requires the exposure of very large patient populations, pharmacovigilance networks will continue to play a key role in the postmarketing surveillance for their detection and reporting. PMID:24299907

  19. Risk Assessment of Drug Interaction Potential and Concomitant Dosing Pattern on Targeted Toxicities in Pediatric Cancer Patients

    OpenAIRE

    Barrett, Jeffrey S.; Patel, Dimple; Dombrowsky, Erin; Bajaj, Gaurav; Skolnik, Jeffrey M.

    2013-01-01

    This investigation evaluated the impact of potential drug interactions on the incidence of reported toxicities seen with common dosing patterns in children with cancer, with the intent of being able to screen and reduce the incidence of adverse drug reactions (ADRs) in the future. Toxicity reported in pediatric cancer patients treated at the Children’s Hospital of Philadelphia from 2004 to 2010 were abstracted from a cancer tumor registry and merged with drug order profiles from the medical r...

  20. 药品不良反应循证医学证据关联性评价方法学的教学体会%Didactical Experience and Research of Causality Assessment of Evidence-based Medicine for Adverse Drug Reaction

    Institute of Scientific and Technical Information of China (English)

    杜广清; 张祥华; 门阳; 吴华; 魏永祥

    2011-01-01

    OBJECTIVE: To provide reference for the improvement of teaching level of causality assessment of evidence-based medicine for adverse drug reaction. METHODS: The experiences of causality assessment of evidence-based medicine for adverse drug reaction were summarized. The interests of students were activated by using heuristic teaching method and multimedia, combining with heuristic questions using problems as orientation, introducing classical case. RESULTS & CONCLUSION: The experience of authors indicates that the application of a variety of teaching methods is helpful to improve the interest of students and the teaching quality, culturing diagnosis and resolution ability of students in field of ADR etiology and ADR judgement in evidence-base medicine.%目的:为提高药品不良反应循证医学证据关联性评价方法学的教学水平提供参考.方法:总结药品不良反应循证医学证据关联性评价的教学体会,采用启发式教学方法并配合多媒体授课,同时结合以问题为导向、启发式提问及经典案例介绍的教学方法,激发学生学习兴趣.结果与结论:笔者的教学实践证明,多种教学方法联合运用,有助于提高学生学习兴趣,提高教学质量,培养学生药品不良反应病因学循证诊断、处理以及循证医学实践中的药品不良反应临床判断能力.

  1. Severe adverse effects of 5-fluorouracil in S-1 were lessened by haemodialysis due to elimination of the drug.

    Science.gov (United States)

    Inoue, Kazunori; Nagasawa, Yasuyuki; Yamamoto, Ryohei; Omori, Hiroki; Kimura, Tomonori; Tomida, Kodo; Furumatsu, Yoshiyuki; Imai, Enyu; Isaka, Yoshitaka; Rakugi, Hiromi

    2009-04-01

    S-1 and cisplatin are used as one of the first-line chemotherapies for gastric cancer in Japan. The plasma concentration of 5-fluorouracil (5-FU) is increased in patients with renal dysfunction because gimeracil in S-1 inhibits the degradation of 5-FU and about 50% of gimeracil is excreted in the urine. We describe a 35-year-old man with acute kidney injury while taking S-1 and cisplatin for advanced gastric cancer and who presented severe adverse effects of 5-FU. This case report describes the evolution of the plasma concentrations of 5-FU with haemodialysis along with a decrease in the adverse drug effects.

  2. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database

    OpenAIRE

    Abe, Junko; Umetsu, Ryogo; Mataki, Kanako; Kato, Yamato; Ueda, Natsumi; NAKAYAMA, Yoko; Hane, Yuuki; Matsui, Toshinobu; Hatahira, Haruna; Sasaoka, Sayaka; Motooka, Yumi; Hara, Hideaki; Kato, Zenichiro; Kinosada, Yasutomi; Inagaki, Naoki

    2016-01-01

    Background Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions associated with fatal disorders. Although many causes of SJS/TEN have been proposed, the time-to-onset for SJS/TEN and the relationship between aging and SJS/TEN are still not clear. Therefore, the aim of this study was to determine the relationship between aging and SJS/TEN using the Japanese Adverse Drug Event Report (JADER) database and analyze the time-to-onset profile of ...

  3. Adverse events with use of antiepileptic drugs: a prescription and event symmetry analysis

    DEFF Research Database (Denmark)

    Tsiropoulos, Ioannis; Andersen, Morten; Hallas, Jesper

    2009-01-01

    .5-448), of gabapentin with glaucoma (ASR 8.0; 95%CI 1.1-355) and of valproic acid with hypothyroidism (ASR 8.0; 95%CI 1.1-355). CONCLUSIONS: Few unsuspected adverse AED effects were recognized in our study. Sequence symmetry analysis is a feasible method of monitoring for adverse AED effects. Copyright (c) 2009 John...

  4. Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

    Directory of Open Access Journals (Sweden)

    Keith B. Hoffman

    2013-07-01

    Full Text Available Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS. We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.

  5. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

    Science.gov (United States)

    Jiang, Guoqian; Wang, Liwei; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2013-01-01

    A semantically coded knowledge base of adverse drug events (ADEs) with severity information is critical for clinical decision support systems and translational research applications. However it remains challenging to measure and identify the severity information of ADEs. The objective of the study is to develop and evaluate a semantic web based approach for building a knowledge base of severe ADEs based on the FDA Adverse Event Reporting System (AERS) reporting data. We utilized a normalized AERS reporting dataset and extracted putative drug-ADE pairs and their associated outcome codes in the domain of cardiac disorders. We validated the drug-ADE associations using ADE datasets from SIDe Effect Resource (SIDER) and the UMLS. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the ADEs into the CTCAE in the Web Ontology Language (OWL). We identified and validated 2,444 unique Drug-ADE pairs in the domain of cardiac disorders, of which 760 pairs are in Grade 5, 775 pairs in Grade 4 and 2,196 pairs in Grade 3.

  6. CORRELATION OF THE SERUM LEVEL OF CARBAMAZEPINE WITH SEIZURE CONTROL AND ADVERSE DRUG REACTIONS AMONG EPILEPTICS IN IBADAN, NIGERIA

    Directory of Open Access Journals (Sweden)

    Joseph O. Fadare

    2010-12-01

    Full Text Available Background: Epilepsy is a chronic neurological disorder requiring long-term treatment. Seizure control requires adequate blood levels of anti-seizure drugs. Carbarmazepine is one of the most prescribed antiepileptic drugs in Nigeria. This study was carried out to investigate the correlation between serum levels of carbamazepine and seizure control and adverse drug reactions among epileptics in Ibadan, Nigeria. Methods: In a cross-sectional study, sixty-nine patients with confirmed diagnosis of epilepsy who had been on treatment with carbamazepine alone or in combination with phenytoin for at least one month were enrolled into the study and divided into two groups based on seizure control. Drug level in pre-dose (steady state venous blood was analyzed using high performance liquid chromatography. Result: The mean serum concentration of carbamazepine (CBZ and carbamazepine-epoxide (CBZ-EP was 13.5±9.3ìg/mL and 6.34±12.61ìg/mL respectively. Patients with good seizure control had mean serum CBZ concentration of 12.7 ± 9.2ìg/mL versus 15.02 ± 9.7ìg/mL among patients with poor seizure control (P=0.33. The serum concentration of CBZ-EP in patients with good seizure control was 8.05 ± 15.2ìg/mL while it was 3.11 ± 3.5ìg/mL in the second group (P=0.122. Drowsiness was the commonest adverse drug reaction (26.1% and it did not necessitate withdrawal of the drug. Conclusion The study showed that serum level of carbamazepine does not correlate with seizure control and adverse drug reactions.

  7. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Science.gov (United States)

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  8. Spontaneous monitoring of adverse reactions to drugs by Italian dermatologists: a pilot study. Gruppo Italiano Studi Epidemiologici in Dermatologia.

    Science.gov (United States)

    1991-01-01

    During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.

  9. ADVERSE EFFECT PROFILE OF TENOFOVIR DISOPROXIL FUMARATE IN HIV POSITIVE PATIENTS - A PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Andis C

    2016-04-01

    Full Text Available BACKGROUND Acquired Immunodeficiency Syndrome, a disease of the human immune system caused by the Human Immunodeficiency Virus (HIV is a major health problem in many parts of the world. The prognosis was dramatically altered with the introduction of antiretroviral drugs in 1987 and Highly Active Antiretroviral Therapy (HAART in 1996. Despite the absence of a cure, the natural history of the disease was radically changed since then. This study aimed at documenting and analysing the adverse effect profile of Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy (ART in HIV positive patients attending Antiretroviral Therapy Centre, Government Medical College, Thrissur. METHODOLOGY HIV positive patients on Tenofovir Disoproxil Fumarate-based antiretroviral treatment attending Antiretroviral Therapy Centre, Government Medical College, Thrissur, were enrolled in the prospective cohort study conducted over 18 months from Jan 2013- June 2014. The patients were followed up for 12 months pattern of adverse drug reactions. RESULTS A total of 178 Adverse Drug Reactions (ADRs were identified, out of which 86 (48.31% were in male and 92 (51.68% were in female patients. Out of 178 suspected ADRs, 172 (96.6% ADRs were reported from outpatient departments. Six patients (3.3% required hospital admission. The most commonly identified adverse drug reactions were nausea and vomiting in 54 (30.3% patients, headache and fatigue in 30 (16.85%, heartburn and diarrhoea in 17 (9.5% cases, lab abnormalities like dyslipidaemia in 12 (6.74%, hyperphosphatemia in 10 (5.6%, hypocalcemia in 5 (2.85% patients. Out of 178 ADRs, 4 (2.2% were of acute renal failure seen. One among the four died even after discontinuation of the drug, 2 were changed to non-Tenofovir based regimen who improved later within 2 months. CONCLUSION In this study of Tenofovir based regimen, the side effects which necessitated regimen change were very few. Majority of the side effects were GI related

  10. 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.

  11. Adverse reactions of HMG—CoA reductase inhibitors as a consequence of drug—drug interaction

    Institute of Scientific and Technical Information of China (English)

    IkedaT

    2002-01-01

    Use of HMG-CoA reductase inhibitors in treating hypercholesterolemia is a well-established therapy.Presently,atorvastatin,fluvastatin,lovastatin,simvastatin and pravastatin are used clinically.Cerivastatin was pulled from the market in 2001 due to its higher risk of inducing rhabdomyolysis than all other drugs.Hepatotoxicity and rhabdomyolysis are the known adverse reactions by these drugs.However,the hepatotoxicity has been regarded to be mild,and is now referred to as transaminitis.Rhadomyolysis occurs in rare instances but is sometimes life threatening as a result of renal failure caused by myoglobinemia.The mechanism leading to rhabdomyolysis is unknown but in many of the reported cases,increased plasma concentratinos of thes drugs have been observed,most likely as a consequence of drug interaction.Inhibition of CYP 3A4 and UGT is believed to be the reason for this interaction.

  12. Percutaneous Coronary Intervention using a Full Metal Jacket with Drug-eluting Stents: Major Adverse Cardiac Events at One Year

    OpenAIRE

    Calé, Rita; Teles, Rui Campante; Almeida, Manuel; do Rosário, Ingrid; Sousa, Pedro Jerónimo; Brito, João; Raposo, Luís; Gonçalves, Pedro Araújo; Gabriel, Henrique Mesquita; Mendes, Miguel

    2013-01-01

    Background The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety. Objectives To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring > 60 mm in length, for very long lesions. Methods We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our si...

  13. A retrospective study on the incidences of adverse drug events and analysis of the contributing trigger factors

    OpenAIRE

    Sam, Aaseer Thamby; Lian Jessica, Looi Li; Parasuraman, Subramani

    2015-01-01

    Objectives: To retrospectively determine the extent and types of adverse drug events (ADEs) from the patient cases sheets and identify the contributing factors of medication errors. To assess causality and severity using the World Health Organization (WHO) probability scale and Hartwig's scale, respectively. Methods: Hundred patient case sheets were randomly selected, modified version of the Institute for Healthcare Improvement (IHI) Global Trigger Tool was utilized to identify the ADEs; caus...

  14. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    Science.gov (United States)

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  15. 264例阿洛西林钠不良反应的文献分析%Literature Analysis of 264 Cases of Adverse Drug Reactions Induced by Azlocillin Sodium

    Institute of Scientific and Technical Information of China (English)

    刘欣欣; 冯亚楠; 李永辉; 郭瑞锋

    2015-01-01

    目的:探讨阿洛西林钠不良反应的一般规律特点,为临床合理用药提供参考。方法检索中国期刊全文数据库,对2014年之前国内公开发表有关注射用阿洛西林钠264例病例文献报道进行回顾性分析。结果儿童患者发生率高,累及系统-器官主要为皮肤及其附件损害(48.43%)、全身性损害(20.24%)、胃肠系统损害(13.01%),严重全身性系统损害以过敏性休克、过敏样反应为主。结论阿洛西林钠安全使用亟待加强,临床应重视阿洛西林钠的不良反应,加强用药监测,确保安全使用。%Objective To probe into thes tatus,characterstics and influencing factors of ADR cases induced by azlocillin sodium, so as to provide a reference for clinical treatment. Methods Datas were collected from domestic published literatures from China Journal Full-text Database before 2014, and 264 case reports of adverse drug reactions induced by azlocillin sodium were analyzed retrospectively. Results Younger patients appeared to be with a high rate of ADR, which mainly involved skin and its appendages (48.43%), systemic damage (20.24), gastrointestinal system (13.01%), and the serious ones showed anaphylactic shock and anaphylactoid reaction.Conclusion Azlocillin sodium should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication.

  16. Monitoring and Evaluation of Adverse Reactions/Events of Cefoperazone Sodium and Sulbactam Sodium for Injection%注射用头孢哌酮钠舒巴坦钠不良反应/事件监测及评价分析

    Institute of Scientific and Technical Information of China (English)

    龙勇

    2014-01-01

    Objective To discuss the regularity of adverse reactions/events( ADR/ADE) of Cefoperazone Sodium and Sulbactam Sodium for Injection,to provided reference for safe and rational drug use on clinic. Methods A total of 43 ca-ses occurred ADR/ADE during intravenous drip of Cefoperazone Sodium and Sulbactam Sodium for Injection in our hospital from May 2O12 to April 2O14 were retrospectively analyzed. Results ADR/ADE of Cefoperazone Sodium and Sulbactam Sodium for Injection was related to age,past medical history,mainly occurred in patients over 5O years old who had cardiovascular disea-ses;ADR/ADE was related to drug combination,the more drugs,the higher incidence of ADR/ADE;the most ADR/ADE was general allergic reaction( skin damage and accessories damage),followed by the digestive system,respiratory system;Af-ter treatment,9 out of the 43 cases " healed",accounted for 2O. 9%;33 cases " got better“,accounted for 76. 7%;1 case died,accounted for 2. 4%. The outcome of ADR/ADE is associated with past diseases. Conclusion ADR/ADE of Cef-operazone Sodium and Sulbactam Sodium for Injection can caused by drug outside factors,such as age,past diseases,which clinical usage should be pay more attention to.%目的:探讨注射用头孢哌酮钠舒巴坦钠不良反应/事件( ADR/ADE)的发生规律,为临床安全、合理用药提供参考。方法对2O12年5月-2O14年4月在本院静脉滴注注射用头孢哌酮钠舒巴坦钠出现ADR/ADE的43例患者的临床资料进行回顾性分析。结果注射用头孢哌酮钠舒巴坦钠ADR/ADE与年龄、既往疾病等因素有关,主要发生于>5O岁年龄组中有心血管系统疾病既往病史者;ADR/ADE与联合用药有关,联用药物越多ADR/ADE发生率越高;ADR/ADE主要为一般过敏性反应(皮肤及附件损害),其次为消化系统、呼吸系统反应等,采取治疗措施后,“痊愈”9例,占2O.9%;“好转”33例,占76.7%;死亡1例,占2.4%,ADR/ADE的转归与

  17. Evaluation of a procedure to assess the adverse effects of illicit drugs.

    NARCIS (Netherlands)

    Amsterdam, J G C van; Best, W; Opperhuizen, A; Wolff, F A de

    2004-01-01

    The assessment procedure of new synthetic illicit drugs that are not documented in the UN treaty on psychotropic drugs was evaluated using a modified Electre model. Drugs were evaluated by an expert panel via the open Delphi approach, where the written score was discussed on 16 items, covering medic

  18. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  19. Risperidone-associated adverse drug reactions and CYP2D6 polymorphisms in a South African cohort

    Directory of Open Access Journals (Sweden)

    Tyren M. Dodgen

    2015-06-01

    Conclusion: CYP2D6 variation appeared not to be a good pharmacogenetic marker for predicting risperidone-related ADRs in this naturalistic South African cohort. Evaluation of a larger cohort would be needed to confirm these observations, including an examination of the role of potential intermediaries between the hypothesised genetic and clinical phenotypes.

  20. To study the pattern of adverse drug reactions among patients hospitalized in the medical wards of a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Anup Kumar

    2016-10-01

    Conclusions: There is need to explore the reasons for this relatively low incidence rate of ADR's in the Indian population. Under and shy;reporting is one of the major factors with a lack of proper pharmacovigilance system which is still in budding state in India. [Int J Basic Clin Pharmacol 2016; 5(5.000: 1972-1977

  1. Post-marketing safety evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir: A drug-use investigation in patients with high risk factors.

    Science.gov (United States)

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2016-10-01

    Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined. In total, 412 adverse events were observed in 219 patients (28.4%). Of these, 155 events were adverse drug reactions (ADRs) observed in 98 patients (12.7%). Major ADRs (≥2%) were increased aspartate aminotransferase (5.1%), increased alanine aminotransferase (3.8%) and decreased white blood cell count (2.5%). Fourteen serious ADRs were observed in 12 patients (1.6%). All serious ADRs were resolved or improved except for two events for which outcomes were unknown. Multivariate analyses revealed that ADR incidences were significantly associated with these four backgrounds of patients: medical history, no influenza vaccination, renal impairment and other infection(s). With regard to its effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration, which was the same as in other previous surveillance studies. This surveillance study indicated the safety of peramivir in the treatment of influenza inpatients with high risk factors under routine clinical settings. PMID:27497712

  2. Making a bad thing worse: adverse effects of stress on drug addiction

    OpenAIRE

    Cleck, Jessica N.; Blendy, Julie A.

    2008-01-01

    Sustained exposure to various psychological stressors can exacerbate neuropsychiatric disorders, including drug addiction. Addiction is a chronic brain disease in which individuals cannot control their need for drugs, despite negative health and social consequences. The brains of addicted individuals are altered and respond very differently to stress than those of individuals who are not addicted. In this Review, we highlight some of the common effects of stress and drugs of abuse throughout ...

  3. CONCEPT OF DRUG INTERACTION

    Directory of Open Access Journals (Sweden)

    Singh Nidhi

    2012-07-01

    Full Text Available Drug interaction is an increasingly important cause of adverse reactions (ADR, and is the modification of the effect of one drug (object by the prior or concomitant administration of another drug (precipitant drug. Drug interaction may either enhance or diminish the intended effect of one or both drugs. For example severe haemorrhage may occur if warfarin and salicylates (asprin are combined. Precipitant drugs modify the object drug's absorption, distribution, metabolism, excretion or actual clinical effect. Nonsteroidal anti-inflammatory drugs, antibiotics and, in particular, rifampin are common precipitant drugs prescribed in primary care practice. Drugs with a narrow therapeutic range or low therapeutic index are more likely to be the objects for serious drug interactions. Object drugs in common use include warfarin, fluoroquinolones, antiepileptic drugs, oral contraceptives, cisapride and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. Many other drugs, act as precipitants or objects, and a number of drugs act as both. The aim of present review is to throw light on the concept of drug interaction.

  4. Reações adversas causadas por fármacos que atuam no sistema nervoso: análise de registros de um centro de farmacovigilância do Brasil Adverse reaction caused by drugs acting in nervous system: records analysis of a farmacovigilance center in Brazil

    Directory of Open Access Journals (Sweden)

    Marta Maria de França Fonteles

    2009-01-01

    Full Text Available CONTEXTO: A morbimortalidade por uso de medicamentos é um grande problema de saúde. As reações adversas a medicamentos podem resultar em óbito, aumento de internações hospitalares e dos custos com a saúde. OBJETIVOS: Descrever e analisar as notificações de suspeitas de reações adversas causadas por medicamentos que atuam no sistema nervoso (RAM-SN, registradas no Centro de Farmacovigilância do Ceará, de janeiro de 1997 a março de 2008. MÉTODOS: As RAM-SN foram classificadas segundo os critérios da Organização Mundial da Saúde. Uma relação de causalidade entre o fármaco administrado e a reação adversa identificada foi realizada, bem como a análise da reação quanto à gravidade. RESULTADOS: Foram registradas 176 notificações de RAM-SN. A maioria (n = 145; 82,4% ocorreu no ambiente hospitalar. O principal notificador foi o farmacêutico. As RAM-SN foram classificadas como: possíveis (n = 110, prováveis (n = 37 e definidas (n = 17. Quanto à gravidade, foram consideradas: leves (n = 21, moderadas (n = 127, graves (n = 15 e fatais (n = 1. O caso fatal foi notificado por médico e envolveu medicamentos anestésicos. Geralmente, as reações adversas observadas foram causadas predominantemente por analgésicos, anestésicos e antiepilépticos. DISCUSSÃO: Os dados demonstram o valor potencial de se ter acesso a sistemas de farmacovigilância local para registrar possíveis riscos com o uso de fármacos.BACKGROUND: The morbi-mortality by the use of medicines is a major health problem. The drug adverse reactions may result in death, increased hospitalizations and healthcare costs. OBJECTIVES: Describe and analyze reports of suspected adverse reactions caused by drugs that act on the nervous system (SN-ADR, registered in the database of the Pharmacovigilance Centre of Ceará, from January 1997 to March 2008. METHODS: All the NS-ADRs were classified according to criteria of the World Health Organization. The causality

  5. A rare adverse reaction to ethambutol: drug-induced haemolytic anaemia.

    Science.gov (United States)

    Nicolini, A; Perazzo, A; Gatto, P; Piroddi, I M G; Barlascini, C; Karamichali, S; Strada, P

    2016-05-01

    Anti-tuberculosis drugs seldom cause serious haematological side effects. However, among these drugs, isoniazid and rifampicin, especially when administered intermittently, may very rarely be linked to acute autoimmune haemolytic anaemia. Ethambutol (EMB) can cause dose-related retrobulbar neuritis. In this paper, we present the first reported case of acute fatal autoimmune haemolytic anaemia due to EMB. PMID:27084828

  6. Propranolol-induced gingival hyperplasia with Nager syndrome: A rare adverse drug reaction.

    Science.gov (United States)

    Raheel, Syed Ahamed; Kujan, Omar Bashar; Tarakji, Bassel; Umar, Dilshad; Ibrahim, Salah

    2016-01-01

    Drug reactions are a group of reactionary lesions generally show their manifestations in the oral cavity. The drug reactions may vary from local rashes to well-developed swellings in the oral cavity especially involving the gingiva. Most of the drug reactions are asymptomatic and commonly triggered from the active metabolite of a drug used for a long time. Nager syndrome is a group of acrofacial dysostosis that usually results in craniofacial and limb malformations. The craniofacial defects are very similar to the mandibulofacial dysostosis. A very early intervention is needed for the habilitation of the patient especially when it is concerned with speech and language development. This paper reports a case of a 32-year-old female with craniofacial, limb, and skeletal abnormalities along with a drug-induced gingival hyperplasia.

  7. Propranolol-induced gingival hyperplasia with Nager syndrome: A rare adverse drug reaction

    Directory of Open Access Journals (Sweden)

    Syed Ahamed Raheel

    2016-01-01

    Full Text Available Drug reactions are a group of reactionary lesions generally show their manifestations in the oral cavity. The drug reactions may vary from local rashes to well-developed swellings in the oral cavity especially involving the gingiva. Most of the drug reactions are asymptomatic and commonly triggered from the active metabolite of a drug used for a long time. Nager syndrome is a group of acrofacial dysostosis that usually results in craniofacial and limb malformations. The craniofacial defects are very similar to the mandibulofacial dysostosis. A very early intervention is needed for the habilitation of the patient especially when it is concerned with speech and language development. This paper reports a case of a 32-year-old female with craniofacial, limb, and skeletal abnormalities along with a drug-induced gingival hyperplasia.

  8. Antiarrhythmic drugs use in elderly patients. Vaughan Williams class I and II drugs

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available Use of class I antiarrhythmic drugs in the elderly is limited by their adverse drug reactions (ADRs, proarrhythmic effect (I A и I C and high risk of drug interactions. Disopyramide use should be avoided due to its strong anticholinergic properties associated with the risk of cognitive and physical disorders and falls in the “very elderly” patients. Available data suggest that elderly patients do not have significant limitations for beta-blockers use. However to determine beta-blockers with the best benefit/risk ratio in elderly patients with co-morbidity further clinical trials are needed.

  9. [Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].

    Science.gov (United States)

    Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming

    2013-09-01

    This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety. PMID:24471321

  10. Magnesium Diboride Superconducting Coils for Adiabatic Demagnetization Refrigerators (ADR's) Project

    Data.gov (United States)

    National Aeronautics and Space Administration — For Adiabatic Demagnetization Refrigerators (ADRs) in space applications, it is desirable to have very light weight, small diameter, high current density...

  11. 阿片类镇痛药物的不良反应%Adverse Drug Reactions of Opioid Analgesics

    Institute of Scientific and Technical Information of China (English)

    赵文亭

    2015-01-01

    Objective To investigate the side effects of opioid analgesics.Methods The clinical data of 38 patients with opioid analgesic drugs used in District,Linzi District,January 2015 to January 2014, were colected and analyzed.Results The adverse reactions of opioid analgesics were the most common in patients aged 70 to 70 years,and the incidence of adverse reactions was 60 to years old.The highest adverse reaction rate of opioid analgesics was fentanyl,folowed by the treatment of the pain,and the main adverse reactions were constipation.Conclusion The main adverse reactions of opioid analgesics are constipation, so that the elderly patients can be seen,the clinical application should take ful account of the patient's constitution and tolerance,reduce the incidence of adverse reactions,improve the clinical rational drug use.%目的:探讨阿片类镇痛药物的不良反应。方法收集2014年1月至2015年1月临淄区妇幼保健院使用阿片类镇痛药物出现不良反应的38例患者的临床资料,统计患者的性别、年龄、用药类型、不良反应的类型等,分析导致不良反应发生的原因。结果阿片类镇痛药物的不良反应以>70岁患者最常见,其次为60~70岁;发生率最高的为芬太尼,其次为哌替啶;主要不良反应为便秘。结论阿片类镇痛药物主要不良反应为便秘,以老年患者多见,临床应用要充分考虑患者体质和耐受性,以降低不良反应的发生率,提高临床合理用药。

  12. Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

    Directory of Open Access Journals (Sweden)

    Nomura K

    2015-06-01

    Full Text Available Kaori Nomura,1 Kunihiko Takahashi,2 Yasushi Hinomura,3 Genta Kawaguchi,4 Yasuyuki Matsushita,5 Hiroko Marui,6 Tatsuhiko Anzai,7 Masayuki Hashiguchi,8 Mayumi Mochizuki8 1Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, 2Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, 3Japan Pharmaceutical Information Center, 4Global Pharmacovigilance, Kissei Pharmaceutical Co Ltd, Tokyo, 5Medical Affairs Department, Daiichi Sankyo Co Ltd, 6Drug Safety Division, Chugai Pharmaceutical Co Ltd, 7Data Science Center, EPS Corporation, 8Faculty of Pharmacy, Keio University, Tokyo, Japan Background: The use of a statistical approach to analyze cumulative adverse event (AE reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection. Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER database and the US Food and Drug Administration Adverse Event Reporting System (FAERS, and how they affect signal detection.Methods: Two AE data sources from 2010 were examined, ie, JADER cases (JP and Japanese cases extracted from the FAERS (FAERS-JP. Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS, were used on drug-event combinations for three substances frequently recorded in both systems.Results: The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37 in the JP and 3.3±3.5 (maximum 62 in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and

  13. Comparison of serious adverse reactions between thalidomide and lenalidomide: analysis in the French Pharmacovigilance database.

    Science.gov (United States)

    Olivier-Abbal, Pascale; Teisseyre, Anne-Charlotte; Montastruc, Jean-Louis

    2013-12-01

    Thalidomide and lenalidomide are structural analogs and immunomodulatory drugs. Lenalidomide appears to have a different safety profile than thalidomide and could be less toxic, and as far as we know, we did not found any study comparing their safety profile. The objective of our study was to review and compare serious adverse drug reactions (SADRs) of thalidomide and lenalidomide spontaneously reported to the French Pharmacovigilance database. We extracted all medically confirmed spontaneous reports of SADR for lenalidomide-based regimens and thalidomide-based regimens from the French Pharmacovigilance database. A "serious" adverse drug reaction (ADR) was defined as an ADR that is fatal or life threatening, which causes hospitalization or prolongation of hospitalization, or permanent or significant disability. The study period was between marketing of 2 drugs and January 15, 2012. A total of 392 SADRs related to thalidomide-based regimens were identified in 244 patients and 377 SADRs related to lenalidomide-based regimens in 220 patients. In spite of their structural analogy, this study highlights interesting differences between lenalidomide and thalidomide's safety profile: nervous system and vascular disorders are more frequent with thalidomide-based regimens while hematologic, skin, infectious disorders and secondary primary cancers are more frequent with lenalidomide-based regimens.

  14. In vitro testing for diagnosis of idiosyncratic adverse drug reactions: Implications for pathophysiology.

    Science.gov (United States)

    Elzagallaai, Abdelbaset A; Rieder, Michael J

    2015-10-01

    Idiosyncratic drug reactions (IDRs) represent a major health problem, as they are unpredictable, often severe and can be life threatening. The low incidence of IDRs makes their detection during drug development stages very difficult causing many post-marketing drug withdrawals and black box warnings. The fact that IDRs are always not predictable based on the drug's known pharmacology and have no clear dose-effect relationship with the culprit drug renders diagnosis of IDRs very challenging, if not impossible, without the aid of a reliable diagnostic test. The drug provocation test (DPT) is considered the gold standard for diagnosis of IDRs but it is not always safe to perform on patients. In vitro tests have the advantage of bearing no potential harm to patients. However, available in vitro tests are not commonly used clinically because of lack of validation and their complex and expensive procedures. This review discusses the current role of in vitro diagnostic testing for diagnosis of IDRs and gives a brief account of their technical and mechanistic aspects. Advantages, disadvantages and major challenges that prevent these tests from becoming mainstream diagnostic tools are also discussed here. PMID:25199801

  15. Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions

    OpenAIRE

    Grosso, A.; Douglas, I.; Hingorani, A.; MacAllister, R.; Smeeth, L

    2008-01-01

    AIMSPost licensing, the evaluation of drug safety relies heavily on the collation of sporadic, spontaneous reports on adverse effects. The aim was to assess the potential utility of a more systematic approach to the detection of adverse events that utilizes routinely collected clinical data from a large primary care population.METHODSWe used the UK General Practice Research Database to assess the risk of several recently reported adverse events linked to the use of strontium ranelate for oste...

  16. Carbon Nanotube-Mediated Photothermal Disruption of Endosomes/Lysosomes Reverses Doxorubicin Resistance in MCF-7/ADR Cells.

    Science.gov (United States)

    Pai, Chin-Ling; Chen, Yu-Chun; Hsu, Chia-Yen; Su, Hong-Lin; Lai, Ping-Shan

    2016-04-01

    Cancer is the leading cause of human death worldwide. Although many scientists work to fight this disease, multiple drug resistance is a predominant obstacle for effective cancer therapy. In drug-resistant MCF-7/ADR cells, the acidic organelles with lower pH value than normal one can cause the protonation of anthracycline drugs, inducing drug accumulation in these organelles. In this study, single-walled carbon nanotubes with polyethylene glycol phospholipids surface modification (PEGylated SWNTs) were utilized as near infrared-activated drug carriers for doxorubicin (DOX) delivery against MCF-7/ADR cells. Our results showed that a concentration-dependent temperature increase was observed in a solution of PEGylated SWNTs with 808 nm laser irradiation, whereas a water solution showed no significant changes in temperature under a thermal camera using the same irradiation dose. Interestingly, PEGylated DOX-SWNTs enhanced the nuclear accumulation of DOX with 808 nm irradiation whereas free DOX or PEGylated DOX-SWNTs revealed discrete red spots in MCF-7/ADR cells by confocal microscopic observation. Cell viability of PEGylated DOX-SWNTs-treated cells was also significantly decreased after 808 nm laser irradiation. Thus, photothermally activated PEGylated SWNTs can be a potential nanocarrier to deliver DOX into cancer cells and successfully overcome drug-resistant behavior in MCF-7/ADR breast cancer cells. PMID:27301189

  17. Study on the Application of Common Signal Detection Methods for Adverse Drug Reaction Reports%药品不良反应报告常用信号检测方法应用研究

    Institute of Scientific and Technical Information of China (English)

    汤榕; 李林贵; 孙维红; 顾希; 杜慧; 王晓霞

    2012-01-01

    OBJECTIVE: To provide reference for safe and rational use of drugs in the clinic and further drug safety risk evaluation. METHODS: 8 795 cases were collected from ADR monitoring network in our region from 2007 to 2010, and determined quantitatively by using proportional reporting ratio (PPR), Reporting odds ratio(ROR)and Bayesian confidence propagation neural network (BCPNN). The suspicious signal were compared and analyzed, and the quantitative signal detection method based on autonomous reporting system database and the scientific ADR signal detection way were explored. RESULTS & CONCLUSION: 3 common methods were all adopted to detect 869 types of Drug-ADR and 66 types of Drugs-ADR quantitatively. Part of signal could be detected. The results of PRR and ROR method were similar, and BCPNN method was different from them significantly. The signal strengths of 3 methods were not identical.%目的:为指导临床安全、合理用药和进一步评价药品安全风险提供参考.方法:通过收集我区2007-2010年药品不良反应(ADR)监测网络ADR报告8 795份,运用频数法中的比例报告(PRR)法、报告比值比(ROR)法和贝叶斯判别可信区间递进神经网络模型(BCPNN)法进行定量检测,对生成的可疑信号进行比较分析,探索以自发呈报系统数据库为基础的定量信号检测方法的运用和科学的ADR信号检测途径.结果与结论:通过对869种Drug-ADR组合和66种Drugs-ADR组合进行3种常用方法信号定量检测,发现对部分已知信号能够检出,PRR法、ROR法结果相近,BCPNN法差别较大,3种方法信号强度各不相同.

  18. Drug allergy

    Directory of Open Access Journals (Sweden)

    Warrington Richard

    2011-11-01

    Full Text Available Abstract Drug allergy encompasses a spectrum of immunologically-mediated hypersensitivity reactions with varying mechanisms and clinical presentations. This type of adverse drug reaction (ADR not only affects patient quality of life, but may also lead to delayed treatment, unnecessary investigations, and even mortality. Given the myriad of symptoms associated with the condition, diagnosis is often challenging. Therefore, referral to an allergist experienced in the identification, diagnosis and management of drug allergy is recommended if a drug-induced allergic reaction is suspected. Diagnosis relies on a careful history and physical examination. In some instances, skin testing, graded challenges and induction of drug tolerance procedures may be required. The most effective strategy for the management of drug allergy is avoidance or discontinuation of the offending drug. When available, alternative medications with unrelated chemical structures should be substituted. Cross-reactivity among drugs should be taken into consideration when choosing alternative agents. Additional therapy for drug hypersensitivity reactions is largely supportive and may include topical corticosteroids, oral antihistamines and, in severe cases, systemic corticosteroids. In the event of anaphylaxis, the treatment of choice is injectable epinephrine. If a particular drug to which the patient is allergic is indicated and there is no suitable alternative, induction of drug tolerance procedures may be considered to induce temporary tolerance to the drug. This article provides a backgrounder on drug allergy and strategies for the diagnosis and management of some of the most common drug-induced allergic reactions, such allergies to penicillin, sulfonamides, cephalosporins, radiocontrast media, local anesthetics, general anesthetics, acetylsalicylic acid (ASA and non-steroidal anti-inflammatory drugs.

  19. 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...

  20. Pharmacogenetic analysis of adverse drug effect reveals genetic variant for susceptibility to liver toxicity.

    Science.gov (United States)

    Acuña, Gonzalo; Foernzler, Dorothee; Leong, Diane; Rabbia, Michael; Smit, Ralf; Dorflinger, Ernest; Gasser, Rodolfo; Hoh, Josephine; Ott, Jürg; Borroni, Edilio; To, Zung; Thompson, Annick; Li, Jia; Hashimoto, Lara; Lindpaintner, Klaus

    2002-01-01

    A retrospective pharmacogenetic study was conducted to identify possible genetic susceptibility factors in patients in whom the administration of the anti-Parkinson drug, tolcapone (TASMAR), was associated with hepatic toxicity. We studied 135 cases of patients with elevated liver transaminase levels (ELT) of >/=1.5 times above the upper limit of normal, in comparison with matched controls that had also received the drug but had not experienced ELT. DNA samples were genotyped for 30 previously described or newly characterized bi-allelic single nucleotide polymorphisms (SNPs), representing 12 candidate genes selected based on the known metabolic pathways involved in the tolcapone elimination. SNPs located within the UDP-glucuronosyl transferase 1A gene complex, which codes for the enzymes involved in the main elimination pathway of the drug, were found to be significantly associated with the occurrence of tolcapone-associated ELTs. PMID:12439739

  1. Heparin-induced thrombocytopenia: a review of concepts regarding a dangerous adverse drug reaction.

    Science.gov (United States)

    Junqueira, Daniela Rezende Garcia; Carvalho, Maria das Graças; Perini, Edson

    2013-01-01

    Heparin is a natural agent with antithrombotic action, commercially available for therapeutic use as unfractionated heparin and low molecular weight heparin. Heparin-induced thrombocytopenia (HIT) is a serious adverse reaction to heparin that promotes antibody-mediated platelet activation. HIT is defined as a relative reduction in platelet count of 50% (even when the platelet count at its lowest level is above>150 x 10(9)/L) occurring within five to 14 days after initiation of the therapy. Thrombocytopenia is the main feature that directs the clinical suspicion of the reaction and the increased risk of thromboembolic complications is the most important and paradoxical consequence. The diagnosis is a delicate issue, and requires a combination of clinical probability and laboratory tests for the detection of platelet activation induced by HIT antibodies. The absolute risk of HIT has been estimated between 1% and 5% under treatment with unfractionated heparin, and less than 1% with low molecular weight heparin. However, high-quality evidence about the risk of HIT from randomized clinical trials is scarce. In addition, information on the frequency of HIT in developing countries is not widely available. This review aims to provide a better understanding of the key features of this reaction and updated information on its frequency to health professionals and other interested parties. Knowledge, familiarity, and access to therapeutic options for the treatment of this adverse reaction are mandatory to minimize the associated risks, improving patient safety.

  2. Adverse drug reactions to tocolytic treatment for preterm labour : prospective cohort study

    NARCIS (Netherlands)

    de Heus, R.; Mol, B.W.; Erwich, J.J.H.M.; van Geijn, H.P.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; van Holsbeke, C.D.; Duvekot, J.J.; Schobben, F.F.A.M.; Wolf, Hans; Visser, G.H.A.

    2009-01-01

    Objective 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 consecutive women

  3. Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study

    NARCIS (Netherlands)

    R. de Heus; B.W. Mol; J.J.H.M. Erwich; H.P. van Geijn; W.J. Gyselaers; M. Hanssens; L. Härmark; C.D. van Holsbeke; J.J. Duvekot; F.F.A.M. Schobben; H. Wolf; G.H.A. Visser

    2009-01-01

    Objective 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 consecutive women

  4. Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study

    NARCIS (Netherlands)

    Heus, R.; Mol, B.W.; Erwich, J.J.; Geijn, van H.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; Holsbeke, van C.D.; Duvekot, J.J.; Schobben, F.F.; Wolf, de H.; Visser, G.H.A.

    2009-01-01

    OBJECTIVE: 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 consecutive w

  5. 76 FR 22848 - Alternative Dispute Resolution (ADR) and Conflict Management

    Science.gov (United States)

    2011-04-25

    ... of the Secretary 32 CFR Part 83 RIN 0790-AI63 Alternative Dispute Resolution (ADR) and Conflict... alternative means of dispute resolution and conflict management practices as an integral part of normal... DISPUTE RESOLUTION (ADR) AND CONFLICT MANAGEMENT Sec. 83.1 Purpose. 83.2 Applicability. 83.3...

  6. MT-ADRES: Multithreading on Coarse-Grained Reconfigurable Architecture

    DEFF Research Database (Denmark)

    Wu, Kehuai; Kanstein, Andreas; Madsen, Jan;

    2007-01-01

    The coarse-grained reconfigurable architecture ADRES (Architecture for Dynamically Reconfigurable Embedded Systems) and its compiler offer high instruction-level parallelism (ILP) to applications by means of a sparsely interconnected array of functional units and register files. As high......-ILP architectures achieve only low parallelism when executing partially sequential code segments, which is also known as Amdahl’s law, this paper proposes to extend ADRES to MT-ADRES (Multi-Threaded ADRES) to also exploit thread-level parallelism. On MT-ADRES architectures, the array can be partitioned in multiple...... smaller arrays that can execute threads in parallel. Because the partition can be changed dynamically, this extension provides more flexibility than a multi-core approach. This article presents details of the enhanced architecture and results obtained from an MPEG-2 decoder implementation that exploits...

  7. Epigenetics and Transcriptomics to Detect Adverse Drug Effects in Model Systems of Human Development

    OpenAIRE

    Balmer, Nina V.; Leist, Marcel

    2014-01-01

    Prenatal exposure to environmental chemicals or drugs has been associated with functional or structural deficits and the development of diseases in later life. For example, developmental neurotoxicity (DNT) is triggered by lead, and this compound may predispose to neurodegenerative diseases in later life. The molecular memory for such late consequences of early exposure is not known, but epigenetic mechanisms (modification of the chromatin structure) could take this role. Examples and underly...

  8. Endocrine and Metabolic Adverse Effects of Psychotropic Drugs in Children and Adolescents

    Directory of Open Access Journals (Sweden)

    Evrim Aktepe

    2011-12-01

    Full Text Available ABSTRACT Much as an increase in the use of psychotropic drugs is observed in children and adolescents over the last decade, the endocrine and metabolic side effects of these drugs can limit their use. Atypical antipsychotics can cause many side effects, which are not suitable for the developmental periods of children and adolescents, such as those related with thyroid, blood sugar, level of sex hormones, growth rate and bone metabolism. Children are under a more serious risk regarding the weight increasing effects of atypical antipsychotics and weight gain that is not proportionate with age is especially important due to the association between glucose or lipid abnormalities and cardiovascular mortality. Aripiprazole and ziprasidone are the least risky antipsychotic drugs when it comes to metabolic side affects. The antipsychotic drug that is associated with weight increase and diabetes in children and adolescents most is olanzapine. Even though there are no comparative long-term data concerning children, it is suggested by the currently available information that metabolic side effects including dyslipidemia and impaired glucose tolerance are at an alarming level when it comes to long-term treatment with antipsychotics. The most risky agents in terms of hyperglycemia and glucosuria development are olanzapine and clozapine. Use of risperidone and haloperidol should be undertaken with caution since it may bring about the risk of hyperprolactinemia. Among the antidepressants associated with weight loss and suppression of appetite are selective serotonin reuptake inhibitors, bupropion and venlafaxine. Thyroid functions can be affected by lithium, carbamazepine and valproate treatments. It is reported that the side effect most frequently associated with valproate is weight increase. The relationship between valproate treatment and the development of hyperandrogenism and polycystic ovary syndrome in young women should also be kept in mind. [TAF Prev

  9. A Framework of Knowledge Integration and Discovery for Supporting Pharmacogenomics Target Predication of Adverse Drug Events: A Case Study of Drug-Induced Long QT Syndrome.

    Science.gov (United States)

    Jiang, Guoqian; Wang, Chen; Zhu, Qian; Chute, Christopher G

    2013-01-01

    Knowledge-driven text mining is becoming an important research area for identifying pharmacogenomics target genes. However, few of such studies have been focused on the pharmacogenomics targets of adverse drug events (ADEs). The objective of the present study is to build a framework of knowledge integration and discovery that aims to support pharmacogenomics target predication of ADEs. We integrate a semantically annotated literature corpus Semantic MEDLINE with a semantically coded ADE knowledgebase known as ADEpedia using a semantic web based framework. We developed a knowledge discovery approach combining a network analysis of a protein-protein interaction (PPI) network and a gene functional classification approach. We performed a case study of drug-induced long QT syndrome for demonstrating the usefulness of the framework in predicting potential pharmacogenomics targets of ADEs.

  10. Adverse reactions of ceftriaxone sodium: Analysis of 6916 cases in Jiangsu Province%6916例头孢曲松钠不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    卞蓉蓉; 孙骏

    2012-01-01

    目的 头孢曲松钠临床应用广泛,其不良反应越来越引起重视.文中分析总结江苏省4年来抗感染药物头孢曲松钠的不良反应发生情况及其特点,为临床合理用药提供参考.方法 从江苏省药品不良反应监测中心数据库中提取2007年1月至2010年12月头孢曲松钠所致药物不良反应(adverse drug reaction,ADR)报告6916例,进行回顾性统计分析.结果 10岁以下儿童(18.65%)是高发组.头孢曲松钠所致ADR临床表现以皮肤及其附件损害最多(61.68%),其余依次是全身性损害、胃肠系统损害、药物热、神经系统损害等.结论 临床应重视头孢曲松钠引起ADR的各种因素,加强对其严重不良反应的预防和监测,确保临床安全、有效、合理用药.%Objective With the wide clinical application of ceftriaxone sodium, more and more attention has been drawn to its adverse reactions. This article analyzes the characteristics of the adverse drug reactions ( ADR ) of ceftriaxone sodium in Jiangsu Province to provide some reference for rational and safe medication in clinical practice. Methods We retrospectively analyzed 69f6 cases of adverse reactions of ceftriaxone sodium reported from Jan. 2007 to Dec. 20f0 from the database of our center. Results Children under the age of fO years was a high-risk cohort, with an ADR incidence of f8.65%. The clinical manifestations of the adverse reactions of ceftriaxone sodium were mostly skin lesions ( 61. 68% ), followed by systemic problems, gastrointestinal disorders, drug fever, and central and peripheral nervous system involvement. Conclusion Attention should be paid to the multiple factors causing serious ADRs of ceftriaxone sodium, and strengthened measures are necessitated for the prevention and control of ADRs.

  11. Analysis of the use and adverse effects of non-steroidal anti-inflammatory drugs: A pilot study

    Directory of Open Access Journals (Sweden)

    Perić Aneta

    2006-01-01

    Full Text Available Background/Aim. The use and adverse effects of nonsteroidal anti-inflammatory drugs (NSAIDs in outpatients with rheumatic diseases has not yet been studied enough. The aim of this study was to evaluate the data about the efficacy and safety of NSAIDs obtained from the questionnaires submitted to the outpatients receiving these drugs. Methods. The patients who had been prescribed any of NSAIDs within the period from June to September, 2004 were included in the study. The answers obtained from the questionnaires were statistically analyzed by means of χ2-test. Results. At the time of the study, 150 patients had been prescribed ibuprofen or some other NSAID. Out of the total number of dispensed questionnaires (n = 150, only 45 (30% were shown to be correctly filled-in. Their analysis showed that 64.4% of the patients had suffered from rheumatic diseases for more than five years, and had regularly used NSAIDs. The average age of these patients was about 70 years, and the number of females was double as high as that of the males. The most frequently used NSAIDs were diclofenac and ibuprofen (46.14%, and 23.24%, respectively. According to the answers given by the patients, the most often adverse reactions were gastric complaints such as nausea (11.1%, and stomach pain (8.9%. Due to this, the majority of the patients (64.4% used some of the antiulcer drugs, most often ranitidine (31.1%. Conclusion. The results of this pilot study revealed that among the outpatients suffering from rheumatic diseases, the number of females was double as high as the number of males, that these patients were of the mean age of 70 years, and that their diseases lasted longer than five years. Gastric complains such as nausea and gastric pain of mild intensity were the most often adverse effects of NSAIDs reported by our patients. It could be the consequence of the predominant use of diclofenac and ibuprofen, NSAIDs with mild to moderate ulcerogenic potential, as well as the

  12. Prediction of drug-related cardiac adverse effects in humans--B: use of QSAR programs for early detection of drug-induced cardiac toxicities.

    Science.gov (United States)

    Frid, Anna A; Matthews, Edwin J

    2010-04-01

    This report describes the use of three quantitative structure-activity relationship (QSAR) programs to predict drug-related cardiac adverse effects (AEs), BioEpisteme, MC4PC, and Leadscope Predictive Data Miner. QSAR models were constructed for 9 cardiac AE clusters affecting Purkinje nerve fibers (arrhythmia, bradycardia, conduction disorder, electrocardiogram, palpitations, QT prolongation, rate rhythm composite, tachycardia, and Torsades de pointes) and 5 clusters affecting the heart muscle (coronary artery disorders, heart failure, myocardial disorders, myocardial infarction, and valve disorders). The models were based on a database of post-marketing AEs linked to 1632 chemical structures, and identical training data sets were configured for three QSAR programs. Model performance was optimized and shown to be affected by the ratio of the number of active to inactive drugs. Results revealed that the three programs were complementary and predictive performances using any single positive, consensus two positives, or consensus three positives were as follows, respectively: 70.7%, 91.7%, and 98.0% specificity; 74.7%, 47.2%, and 21.0% sensitivity; and 138.2, 206.3, and 144.2 chi(2). In addition, a prospective study using AE data from the U.S. Food and Drug Administration's (FDA's) MedWatch Program showed 82.4% specificity and 94.3% sensitivity. Furthermore, an external validation study of 18 drugs with serious cardiotoxicity not considered in the models had 88.9% sensitivity. PMID:19941924

  13. Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos

    2013-12-01

    Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence. PMID:24037995

  14. 磷霉素致不良反应175例文献分析%Literature Analysis of Fosfomycin-induced of 175 Cases ADR

    Institute of Scientific and Technical Information of China (English)

    安秀梅

    2012-01-01

    OBJECTIVE: To study the characteristics of the ADR associated with fosfomycin to guide rational drug use. METHODS: Retrieved from domestic medical journals recorded by CNKI during 1996 - 2010, a total of 113 literatures about fosfomy-cin-inducing ADR were collected and analyzed statistically in respect of patients' gender and age, primary disease, allergic history, route of administration, organs or systems involved and clinical manifestation, etc. RESULTS: A total of 175 ADR cases were obtained. 73 cases suffered from systemic lesion (41.71%), among which there were 54 cases anaphylactic shock (30.86%), followed by lesion of skin and its appendants (n=49, 28.00% ), lesion of nervous system (w=20, 14.43%). The earliest ADR occurred within 1 min after administration while the latest occurred 8 d after administration. There were 61 cases of new serious ADR. CONCLUSION: More attention should be paid to new serious ADR induced by fosfomycin. ADR monitoring should be strengthened to reduce the occurrence of ADR.%目的:探讨磷霉素致不良反应(ADR)发生的特点,为临床安全用药提供参考.方法:检索中国期刊全文数据库(CNKI)收载的1996-2010年国内医药学期刊有关磷霉素致ADR文献113篇,并按患者性别、年龄、原患疾病与过敏史、给药途径、累及器官或系统及临床表现等方面进行统计、分析.结果:收集磷霉素致ADR 175例,全身性损害最多,为73例(41.71%),其中过敏性休克54例(30.86%),其次为皮肤及附件损害49例(28.00%),神经系统损害20例(14.43%);ADR最短的在用药1 min内发生,最长的在用药8d后发生;61例属于新的严重的ADR.结论:临床应重视磷霉素致新的严重的ADR,加强用药监测,以减少ADR的重复发生.

  15. 药品不良反应行为主体利益博弈分析%Analysis of Benefit Game on Adverse Drug Reaction Subjects

    Institute of Scientific and Technical Information of China (English)

    刘花; 冯变玲; 杨世民

    2013-01-01

    目的:研究药品不良反应监测工作中监管部门和报告者的博弈关系.方法:采用博弈模型进行分析.结果:我国应对现行的处罚政策做适当调整,引入奖励制度.结论:我国应建立奖罚分明的药品不良反应报告制度.%Objective: To analyze the game relationship between the regulatory authorities and the reporters in the monitoring of adverse drug reaction. Method: A game model was used in the game analysis. Result: The punishment policy in the current regulation for adverse drug reaction monitoring needed some appropriate adjustments, and the reward system should be introduced. Conclusion: Strict rules for reward and punishment in adverse drug reaction reporting system should be established in our country.

  16. Prevalência de admissão hospitalar por reação adversa a medicamentos em Salvador, BA Prevalence of hospital admission due to adverse drug reaction in Salvador, Bahia

    Directory of Open Access Journals (Sweden)

    Antonio Carlos Beisl Noblat

    2011-02-01

    Full Text Available OBJETIVO: Determinar a prevalência de admissão por RAM em hospitais de Salvador-BA e seus desfechos. MÉTODOS: Todos os pacientes admitidos nos quatro hospitais sentinela da Anvisa em Salvador-BA foram avaliados e seguidos para determinar a prevalência de admissão por RAM e seus desfechos de abril a dezembro de 2007. Os casos foram validados por três algorítmos. Os medicamentos foram classificados pelo Anatomical-Therapeutic-Chemical Classification, órgãos e sistemas afetados pelos critérios da OMS e a gravidade segundo Pearson et al. O tipo seguiu critérios de Rawlins e Thompson. RESULTADOS: A prevalência de admissão por RAM foi 0,56% e corrigida (expostos de 2,1%, com 316 casos. Tempo médio de hospitalização por RAM foi de 12,3 dias. Jovens e idosos representaram 28,8% e 31,1% dos pacientes. Gênero feminino e raça negra corresponderam a 60% dos casos. Os principais grupos farmacológicos envolvidos foram antineoplásicos, antibióticos e diuréticos, afetando pele, sistema gastrointestinal e hematológico. Reações certas ou provadas corresponderam 70%, 80% dos casos foram do tipo A, com 90% recuperáveis e um óbito. CONCLUSÃO: A prevalência de admissão por RAM foi semelhante às descritas na literatura e somente um paciente foi a óbito. Por tratar-se do primeiro estudo nacional, servirá de base para futuras investigações.OBJECTIVE: To determine the prevalence of hospital admissions due to ADR in Salvador, Bahia and their outcomes. METHODS: All patients admitted in four Sentinel Hospital (ANVISA in Salvador-Ba were evaluated and followed to determine the prevalence of admissions due to ADR and their outcomes from April to December 2007. Cases were validated by 03 algorithms. The drugs were classified by Anatomical-Therapeutic-Chemical Classification, organs and systems affected by the WHO criteria and severity seconds Pearson et al. Type of ADR was analyzed by Rawlins and Thompson. RESULTS: The prevalence of ADR

  17. Data Extraction and Management in Networks of Observational Health Care Databases for Scientific Research: A Comparison of EU-ADR, OMOP, Mini-Sentinel and MATRICE Strategies

    Science.gov (United States)

    Gini, Rosa; Schuemie, Martijn; Brown, Jeffrey; Ryan, Patrick; Vacchi, Edoardo; Coppola, Massimo; Cazzola, Walter; Coloma, Preciosa; Berni, Roberto; Diallo, Gayo; Oliveira, José Luis; Avillach, Paul; Trifirò, Gianluca; Rijnbeek, Peter; Bellentani, Mariadonata; van Der Lei, Johan; Klazinga, Niek; Sturkenboom, Miriam

    2016-01-01

    Introduction: We see increased use of existing observational data in order to achieve fast and transparent production of empirical evidence in health care research. Multiple databases are often used to increase power, to assess rare exposures or outcomes, or to study diverse populations. For privacy and sociological reasons, original data on individual subjects can’t be shared, requiring a distributed network approach where data processing is performed prior to data sharing. Case Descriptions and Variation Among Sites: We created a conceptual framework distinguishing three steps in local data processing: (1) data reorganization into a data structure common across the network; (2) derivation of study variables not present in original data; and (3) application of study design to transform longitudinal data into aggregated data sets for statistical analysis. We applied this framework to four case studies to identify similarities and differences in the United States and Europe: Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR), Observational Medical Outcomes Partnership (OMOP), the Food and Drug Administration’s (FDA’s) Mini-Sentinel, and the Italian network—the Integration of Content Management Information on the Territory of Patients with Complex Diseases or with Chronic Conditions (MATRICE). Findings: National networks (OMOP, Mini-Sentinel, MATRICE) all adopted shared procedures for local data reorganization. The multinational EU-ADR network needed locally defined procedures to reorganize its heterogeneous data into a common structure. Derivation of new data elements was centrally defined in all networks but the procedure was not shared in EU-ADR. Application of study design was a common and shared procedure in all the case studies. Computer procedures were embodied in different programming languages, including SAS, R, SQL, Java, and C++. Conclusion: Using our conceptual framework

  18. Magnesium Diboride Superconducting Coils for Adiabatic Demagnetization Refrigerators (ADR's) Project

    Data.gov (United States)

    National Aeronautics and Space Administration — For Adiabatic Demagnetization Refrigerators(ADR's) for space it is desirable to have very light weight, small diameter, high current density superconducting wires...

  19. ADR Magnets Operating at 30-40K Project

    Data.gov (United States)

    National Aeronautics and Space Administration — This program is designed to achieve high operational efficiency for superconducting ADR magnets in space, and to meet space launch requirements. The overall...

  20. Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: A case series from a local surveillance of serious adverse events

    Directory of Open Access Journals (Sweden)

    Rankin Elizabeth

    2008-04-01

    Full Text Available Abstract Background Spontaneous reporting systems for adverse drug reactions (ADRs are handicapped by under-reporting and limited detail on individual cases. We report an investigation from a local surveillance for serious adverse drug reactions associated with disease modifying anti-rheumatic drugs that was triggered by the occurrence of liver failure in two of our patients. Methods Serious ADR reports have been solicited from local clinicians by regular postcards over the past seven years. Patients', who had hepatotoxicity on sulfasalazine and met a definition of a serious ADR, were identified. Two clinicians reviewed structured case reports and assessed causality by consensus and by using a causality assessment instrument. The likely frequency of hepatotoxicity with sulfasalazine was estimated by making a series of conservative assumptions. Results Ten cases were identified: eight occurred during surveillance. Eight patients were hospitalised, two in hepatic failure – one died after a liver transplant. All but one event occurred within 6 weeks of treatment. Seven patients had a skin rash, three eosinophilia and one interstitial nephritis. Five patients were of Black British of African or Caribbean descent. Liver enzymes showed a hepatocellular pattern in four cases and a mixed pattern in six. Drug-related hepatotoxicity was judged probable or highly probable in 8 patients. The likely frequency of serious hepatotoxicity with sulfasalazine was estimated at 0.4% of treated patients. Conclusion Serious hepatotoxicity associated with sulfasalazine appears to be under-appreciated and intensive monitoring and vigilance in the first 6 weeks of treatment is especially important.

  1. Pneumothorax as an Adverse Drug Event: An Exploratory Aggregate Analysis of the US FDA AERS Database Including a Confounding by Indication Analysis Inspired by Cornfield's Condition

    OpenAIRE

    Hauben, Manfred; Hung, Eric Y.

    2013-01-01

    Introduction: Pneumothorax is either primary or secondary. Secondary pneumothorax is usually due to trauma, including various non-pharmacologic iatrogenic triggers. Although not normally thought of as an adverse drug event (ADE) secondary pneumothorax is associated with numerous drugs, though it is often difficult to determine whether this association is causal in nature, or reflects an epiphenomenon of efficacy or inefficacy, or confounding by indication (CBI). Herein we explore this associa...

  2. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events

    Science.gov (United States)

    Sasaoka, Sayaka; Matsui, Toshinobu; Hane, Yuuki; Abe, Junko; Ueda, Natsumi; Motooka, Yumi; Hatahira, Haruna; Fukuda, Akiho; Naganuma, Misa; Hasegawa, Shiori; Kinosada, Yasutomi

    2016-01-01

    Long QT syndrome (LQTS) is a disorder of the heart’s electrical activity that infrequently causes severe ventricular arrhythmias such as a type of ventricular tachycardia called torsade de pointes (TdP) and ventricular fibrillation, which can be fatal. There have been no previous reports on the time-to-onset for LQTS based on data from spontaneous reporting systems. The aim of this study was to assess the time-to-onset of LQTS according to drug treatment. We analyzed the association between 113 drugs in 37 therapeutic categories and LQTS including TdP using data obtained from the Japanese Adverse Drug Event Report database. For signal detection, we used the reporting odds ratio (ROR). Furthermore, we analyzed the time-to-onset data and assessed the hazard type using the Weibull shape parameter. The RORs (95% confidence interval) for bepridil, amiodarone, pilsicainide, nilotinib, disopyramide, arsenic trioxide, clarithromycin, cibenzoline, donepezil, famotidine, sulpiride, and nifekalant were 174.4 (148.6–204.6), 17.3 (14.7–20.4), 52.0 (43.4–62.4), 13.9 (11.5–16.7), 69.3 (55.3–86.8), 54.2 (43.2–68.0), 4.7 (3.8–5.8), 19.9 (15.9–25.0), 8.1 (6.5–10.1), 3.2 (2.5–4.1), 7.1 (5.5–9.2), and 254.8 (168.5–385.4), respectively. The medians and quartiles of time-to-onset for aprindine (oral) and bepridil were 20.0 (11.0–35.8) and 18.0 (6.0–43.0) days, respectively. The lower 95% confidence interval of the shape parameter β of bepridil was over 1 and the hazard was considered to increase over time.Our study indicated that the pattern of LQTS onset might differ among drugs. Based on these results, careful long-term observation is recommended, especially for specific drugs such as bepridil and aprindine. This information may be useful for the prevention of sudden death following LQTS and for efficient therapeutic planning. PMID:27723808

  3. 盐酸左氧氟沙星注射剂不良反应相关因素评析及建议%Analysis of 56 Case Reports of ADR Caused by Levofloxacin Hydrochloride Injection

    Institute of Scientific and Technical Information of China (English)

    赖雁威; 周学琴; 古桂花

    2014-01-01

    Objective To analyze the factors of ADR caused by Levofloxacin Hydrochloride injection and the prevention and cure measures so as to offer basis for the clinic in the rational use of drugs. Methods 56 ADR casesedby by Levofloxacin Hy-drochloride injection of all Peking University Shenzhen Hospital inpationts reported form 2010.1 to 2013.12 were analyzed re-traspectively. Results Levofloxacin Hydrochloride injection could induce dermatology system, digestive system, neurology system reaction. Conclusion Clinicians should know the characteristics of adverse reactions induced by Levofloxacin Hydrochloride in-jection so as to apply it rationally.%目的:了解盐酸左氧氟沙星注射剂在临床应用的不良反应,探讨其一般规律及特点。方法对我院2010年1月-2013年12月ADR监测室收集的56例盐酸左氧氟沙星注射剂不良反应报告进行分析。结果盐酸左氧氟沙星注射剂药物不良反应以皮肤系统损害及消化系统,其次为神经系统且主要发生于老年患者。结论规范合理用药,确保用药安全,以减少或控制ADR的发生。

  4. Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients : A cross-sectional survey

    NARCIS (Netherlands)

    De Smedt, Ruth H. E.; Denig, Petra; van der Meer, Klaas; Haaijer-Ruskamp, Flora M.; Jaarsma, Tiny

    2011-01-01

    Background: Identifying patients with heart failure (HF) who are at risk of experiencing symptomatic adverse drug events (ADEs) is important for improving patient care and quality of life. Several demographic and clinical variables have been identified as potential risk factors for ADEs but limited

  5. Pro-arrhythmic potential of oral antihistamines (H1: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Elisabetta Poluzzi

    Full Text Available There is appreciable utilisation of antihistamines (H1 in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in '90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines.To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS with drug utilization data from 13 European Countries.We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP, QT abnormalities (QTabn, ventricular arrhythmia (VA and sudden cardiac death/cardiac arrest (SCD/CA. Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance.Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine. Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden and in most European countries their use was negligible.Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by analytical studies is required, regulators

  6. Analysis of Withdrawn Drugs Because of Cardiovascular Adverse Reactions%因心血管不良反应撤市的药物情况分析

    Institute of Scientific and Technical Information of China (English)

    毛璐; 高杰

    2013-01-01

    OBJECTIVE: To investigate the drugs withdrawn from the market because of cardiovascular adverse reactions in recent years, and to sum up the characteristics leading to cardiovascular adverse reactions and provide reference for rational use of drugs in the clinic. METHODS: Retrieved from domestic and foreign literature databases and the Internet, the data of drugs withdrawn from the market because of cardiovascular adverse reactions and related information were collected and summarized in recent years. RESULTS: In recent years because of cardiovascular events, more than ten drugs were withdrawn, involving non-steroidal anti-inflammatory drugs, diet pills, anti-histamine, etc. CONCLUSION: The cardiovascular adverse drug reactions should be noticed. The dosage and combined use of drugs should be standardized, in order to improve the safety and effectiveness of clinical medication.%目的:调查近年来因心血管不良反应撤市的药品情况,总结其引发心血管不良反应的特点,为临床合理使用药物提供借鉴.方法:检索国内外文献数据库及互联网,收集近年来因引起心血管不良反应而撤市的药物及其相关信息,并进行总结.结果:近年来在国内外因心血管事件撤市的药品涉及非甾体抗炎药、减肥药、抗组胺药等十余品种.结论:临床应警惕药物的心血管不良反应,规范用药剂量及合并药物,提高临床用药的有效性和安全性.

  7. Potential Role of Pharmacogenomics in Reducing Adverse Drug Reactions A Systematic Review%药物基因组学降低不良药物反应的潜在作用系统综述

    Institute of Scientific and Technical Information of China (English)

    Kathryn A. Phillips; David L. Veenstra; Eyal Oren; Jane K. Lee; Wolfgang Sadee

    2002-01-01

    @@ 背景:不良药物反应(adverse drug reaction,ADRs)是致死和致病的重要原因.尽管许多不良药物反应都被认为是不可避免的,但是最近的进展表明,以遗传信息为基础的个体化治疗,可以避免这些反应,这也是药物基因组学(pharmacogenomics)的一种应用. 目的:评价药物基因组学降低不良药物反应发生率的潜在作用. 数据来源:于MEDLINE检索1995年1月~2000年6月发表的有关不良药物反应的英文文献,以及1997年1月~2000年8月发表的有关药物代谢酶等位基因变异的综述. 研究选择:使用详尽的纳入标准选择有关研究.从333篇不良药物反应研究中挑选了18篇,从61篇等位基因变异综述中挑选了22篇. 数据提取:所有研究者均用标准的摘要格式对有关文章进行审查及编码. 数据综合:我们选择了27种经常被不良药物反应研究提及的药物.其中59%至少由1种有变异等位基因的酶代谢,已知这种基因变异能引起代谢障碍.相反,在随机选择的药物当中,只有7%~22%由有遗传变异性酶代谢. 结论:根据个体遗传构造选择药物治疗能明显降低临床不良药物反应.我们的研究可作为将来进一步研究药物基因组学如何减少不良反应发生率的基础,也是了解其对临床、社会、经济影响的基础.

  8. The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

    Science.gov (United States)

    Smith, Meredith Y; Benattia, Isma

    2016-09-01

    Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

  9. 168例药品不良反应事件分析%Analysis of Adverse Drug Reactions in 168 Cases

    Institute of Scientific and Technical Information of China (English)

    马勇

    2016-01-01

    Objective To analyze and evaluate the adverse drug reaction events, and promote the rational use of drugs. Methods reported adverse drug reactions to events, the use of mathematical principles respectively on source, taxonomy, the crowd, the drug distribution, frequency of varieties, results and correlations for statistical processing, according to and rational use of the relevant provisions on the administration of drugs, evaluation and analysis. Results adverse events in hospital more than out-patient;report to general based (75.60%);classifi-cation to skin reaction (30.95%); elderly (45.24%) than the other age group; antibacterial drugs account for the first (27.98%); of amoxicillin and clavulanate potassium frequency was the highest (12 times); adverse events results all of the cases were cured. Conclusion the adverse drug reaction is positively correlated with the number of drug use, rational use of drugs can effectively reduce and control the risk of drug use.%目的:分析评价药品不良反应事件,促进人们合理用药。方法将上报的药品不良反应事件,运用数学原理分别对来源、类型、分类、人群、药物分布、品种频次、处理结果以及相关性等进行统计处理,按照《药品不良反应报告和监测管理办法》及合理用药管理相关规定,进行评价分析。结果不良事件住院多于门诊;报告类型以一般为主(75.60%);分类以皮肤反应为主(30.95%);老年(45.24%)较其他年龄段多;抗菌药物占首位(27.98%);阿莫西林克拉维酸钾频次最高(12次);不良事件结果均为痊愈。结论药品不良反应与药品使用的多少成正相关,合理用药能够有效减少与控制用药风险。

  10. Linking Drugs to Obscure Illnesses

    DEFF Research Database (Denmark)

    Bennett, Charles L; Starko, Karen M; Thomsen, Henrik S;

    2012-01-01

    Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye's syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998......, in 1996, the Danish Medicine Agency approved high-dose gadodiamide administration to chronic kidney disease (CKD) patients undergoing MR scans. Overall, 88 % of Danish NSF cases were from two hospitals and 97 % of United States' NSF cases were from 60 hospitals. These hospitals frequently administered......-savings considerations, and a European regulatory requirement requiring removal of albumin as a stabilizer, led to toxicity. Overall, 81, 13, and 17 years elapsed between drug introduction into practice and identification of a causal relationship for aspirin, erythropoietin, and gadodiamide, respectively. A substantial...

  11. Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Reneé de Waal

    Full Text Available BACKGROUND: Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART. Both are assumed to be antiretroviral adverse drug reactions. METHODS: We conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals. RESULTS: Twenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs showed more limb fat loss (or less fat gain with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs; efavirenz (versus protease inhibitors (PIs; and NRTI-containing (versus NRTI-sparing. RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens. CONCLUSIONS: There is clear evidence of a causal relationship between NRTIs (especially thymidine analogues and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching.

  12. [Clinical survey of tizanidine-induced adverse effects--impact of concomitant drugs providing cytochrome P450 1A2 modification--].

    Science.gov (United States)

    Momo, Kenji; Homma, Masato; Matsumoto, Sayaka; Sasaki, Tadanori; Kohda, Yukinao

    2013-01-01

    The drug-drug interactions of tizanidine and cytochrome (CYP) P450 1A2 inhibitors, which potentially alter the hepatic metabolism of tizanidine, were investigated by retrospective survey of medical records with regard to prescription. One thousand five hundred sixty-three patients treated with tizanidine at University of Tsukuba Hospital were investigated. Of those, 713 patients (45.6%) were treated with coadministration of tizanidine and CYP1A2 inhibitors (37 drugs). The patients who received a combination of tizanidine and CYP1A2 inhibitors were characterized as elderly, having multiple diseases, and taking a large number of comedications (over 10 drugs) for a long period as compared with the patients who did not receive CYP1A2 inhibitors. Tizanidine-induced adverse effects were examined in 100 patients treated with coadministration of tizanidine and 8 CYP1A2 inhibitors. Adverse effects (e.g., drowsiness: 10 patients; low blood pressure: 9 patients; low heart rate: 9 patients) were observed in 23 patients (23%) 8±10 days after CYP1A2 inhibitors were coadministered. The patients with tizanidine-induced adverse effects were of older age (64.3±9.8 vs. 57.5±18.1 years, p<0.05) and received a higher daily dose of tizanidine (3.00±0.74 vs. 2.56±0.86 mg/day, p<0.05) than the patients without adverse effects. The present results suggest that coadministration of tizanidine and CYP1A2 inhibitors enhances tizanidine-induced adverse effects, especially in elderly patients treated with a higher dose of tizanidine.

  13. Pharmacogenetic research in the association between human leukocyte antigen and adverse drug reactions%HLA与药物不良反应相关性遗传药理学方法研究进展

    Institute of Scientific and Technical Information of China (English)

    熊艳; 张伟; 陈小平

    2014-01-01

    With the rapid development of pharmacogenetics, more and more studies have shown evidence in the association between polymorphisms at the human leukocyte antigen (HLA) loci and severe adverse drug reactions (SADRs). Several HLA-B alleles proved to be associated with SADRs for drugs such as carbamazepine, allopurinol, lamotrigine, and lfucloxacillin. hTe USA Food and Drug Administration (FDA) has even recommended routine screening for HLA-B allele before the use of abacavir and carbamazepine. With the completion of human genome project and the Hapmapproject, several new pharmacogenetics approaches such as genome-wide association study (GWAS) have emerged. hTese newly developed methods will undoubtedly accelerate the identiifcation and clinical utilization of the pharmacogenetic biomakers. In addition, the immunogenetic mechanisms by which the HLA alleles cause SADRs are explored at the cellular and molecular level. hTis review focuses on the recent progresses in HLA alleles and ADRs regarding both the clinical translation and modern pharmacogenetic methods.%随着遗传药理学的迅速发展,越来越多的研究发现人类白细胞抗原(human leukocyte antigen,HLA)基因型与严重药物不良反应之间的关系,如已证实的HLA-B等位基因与阿巴卡韦、卡马西平、别嘌呤醇、拉莫三秦、氟氯西林等药物所致严重皮肤不良反应发生的风险相关。美国食品药物管理局(Food and Drug Administration,FDA)甚至已批准在阿巴卡韦和卡马西平药品标签中增加建议在用药前对HLA-B等位基因进行分型的信息。人类基因组计划(human genome project,HGP)和人类单倍型作图计划(Hapmap计划)的完成为遗传药理学研究带来了新的思路和研究方法,如全基因组关联研究等,这些无疑加快了药物基因组分子遗传标志物的发现及临床转化应用的步伐。同时, HLA等位基因导致药物不良反应发生机制的细胞分子水平研究方面也取得了较大的进展。

  14. Associations of Adverse Clinical Course and Ingested Substances among Patients with Deliberate Drug Poisoning: A Cohort Study from an Intensive Care Unit in Japan

    Science.gov (United States)

    Ichikura, Kanako; Takeuchi, Takashi

    2016-01-01

    Objectives Some patients with deliberate drug poisoning subsequently have an adverse clinical course. The present study aimed to examine whether the type of drugs ingested and psychiatric diagnoses were related to an adverse clinical course. Methods We conducted a cohort study of patients with deliberate drug poisoning admitted to the intensive care unit of a university hospital located in Tokyo, Japan, between September 2006 and June 2013. Intensive care unit (ICU) stay of ≥4 days was used as a primary outcome measure, while the incidence of aspiration pneumonitis was used as a secondary outcome measure. Ingested substances and psychiatric diagnoses were used as explanatory variables. Results Of the 676 patients with deliberate drug poisoning, 88% had a history of psychiatric treatment and 82% had ingested psychotropic drugs. Chlorpromazine-promethazine-phenobarbital combination drug (Vegetamin®) ranked fifth among the most frequently ingested substances in cases of deliberate drug poisoning and had the highest incidence of prolonged ICU stay (20%) and aspiration pneumonitis (29%). The top three major classes consisted of benzodiazepines (79%), new-generation antidepressants (25%), and barbiturates/non-barbiturates (23%). Barbiturate overdose was independently associated with increased odds of both prolonged ICU stay (8% vs. 17%; odds ratio [OR], 2.97; 95% confidence interval [CI], 1.60–5.55) and aspiration pneumonitis (8% vs. 24%; OR, 3.83; 95% CI, 2.18–6.79) relative to those associated with overdose of only other sedative-hypnotics (i.e., benzodiazepines). Conclusion These results suggest that judicious prescribing of barbiturates by psychiatrists could reduce the risk of an adverse clinical course when a patient attempts an overdose. PMID:27560966

  15. TNL-mediated immunity in Arabidopsis requires complex regulation of the redundant ADR1 gene family.

    Science.gov (United States)

    Dong, Oliver Xiaoou; Tong, Meixuezi; Bonardi, Vera; El Kasmi, Farid; Woloshen, Virginia; Wünsch, Lisa K; Dangl, Jeffery L; Li, Xin

    2016-05-01

    Nucleotide-binding leucine-rich repeat proteins (NLRs) serve as intracellular immune receptors in animals and plants. Sensor NLRs perceive pathogen-derived effector molecules and trigger robust host defense. Recent studies revealed the role of three coiled-coil-type NLRs (CNLs) of the ADR1 family - ADR1, ADR1-L1 and ADR1-L2 - as redundant helper NLRs, whose function is required for defense mediated by multiple sensor NLRs. From a mutant snc1-enhancing (MUSE) forward genetic screen in Arabidopsis targeted to identify negative regulator