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Sample records for adrs adverse drug

  1. iADRs: towards online adverse drug reaction analysis.

    Science.gov (United States)

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

    2012-12-01

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

  2. iADRs: towards online adverse drug reaction analysis

    OpenAIRE

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

    2012-01-01

    Adverse Drug Reaction (ADR) is one of the most important issues in the assessment of drug safety. In fact, many adverse drug reactions are not discovered during limited pre-marketing clinical trials; instead, they are only observed after long term post-marketing surveillance of drug usage. In light of this, the detection of adverse drug reactions, as early as possible, is an important topic of research for the pharmaceutical industry. Recently, large numbers of adverse events and the developm...

  3. Founding an adverse drug reaction (ADR) network: a method for improving doctors spontaneous ADR reporting in a general hospital.

    Science.gov (United States)

    Goldstein, Lee Hilary; Berlin, Maya; Saliba, Walid; Elias, Mazen; Berkovitch, Matitiyahu

    2013-11-01

    Adverse drug reactions (ADR) are underreported by doctors despite numerous efforts. We aimed to determine if establishing an "ADR reporting doctor's network" within a hospital would increase the quantity of ADRs reported by hospital doctors. One hundred hospital doctors joined the network. Email reminders were sent to network members during the 1 year study period, conveying information about ADRs reported, amusingly and pleasantly reminding them to report ADRs in minimal detail, by phone, email, text message or mail to the Clinical Pharmacology Unit, who would further complete the report. A total of 114 ADRs were reported during the study period in comparison to 48, 26, and 17 in the previous 3 years (2008, 2009, 2010, respectively). In the 3 years prior, doctors reported 41.7% of the reported ADRs whereas in the study period, doctors reported 74.3% of ADRs (P reports. Ninety seven percent of doctors' reports were of ADR network members. Thirty-four (34%) network members reported an ADR during the study period and 31 of the 34 reporters had never reported ADRs before becoming network members. Establishing an ADR network of doctors substantially increases ADR reporting amongst its members.

  4. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form

    Directory of Open Access Journals (Sweden)

    Anshi Singh

    2012-01-01

    Full Text Available Despite comprehensive and stringent phases of clinical trials and surveillance efforts, unexpected and serious adverse drug reactions (ADRs repeatedly occur after the drug is marketed. ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms. This review compares similarities and dissimilarities of 13 ADR forms of countries representing their geographical location. This study extracted 73 data elements mentioned in 13 different ADR forms. Only 13 elements were common. An ADR form of Malaysia and Canada covers the highest number of data 43, while Brazil falls to the opposite end with a number of 17 data elements in lieu with the Generic ADR Form. The result of this review highlights 58 data elements of the proposed generic ADR form which ensures that requisite reporting information essential for correct causality assessment of ADRs are included. The proposed "Generic ADR form" could be adopted worldwide mandatorily for reporting any/all ADRs associated with marketed drugs.

  5. Adverse drug reaction (ADR reporting in India: a long way to go

    Directory of Open Access Journals (Sweden)

    Anant D. Patil

    2013-12-01

    Full Text Available New drugs are regularly introduced for treatment, diagnosis or prevention of diseases. Adverse drug reactions (ADR can be seen in clinical practice with both new as well as marketed medicines. Spontaneous reporting of ADR is commonly practiced method for monitoring of ADR. Healthcare practitioners have an important role in pharmacovigilance and ADR reporting. Many studies have been conducted to understand the knowledge, attitude and practice of ADR reporting among healthcare practitioners in India. The population surveyed in these studied ranged between 90-1200. One large study4 included population of 1200 physicians across India out of which 1000 were contacted for study participation. [Int J Basic Clin Pharmacol 2013; 2(6.000: 846-848

  6. International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group.

    Science.gov (United States)

    Faich, G A; Castle, W; Bankowski, Z

    1990-04-01

    A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.

  7. Documentation and evaluation of adverse drug reactions (ADR)--contribution from a poison information center.

    Science.gov (United States)

    Mey, C; Hentschel, H; Hippius, M; Balogh, A

    2002-03-01

    The Department of Clinical Pharmacology in Jena is a pharmacovigilance center in a study on intensified spontaneous adverse drug reaction reporting. Physicians specialized in clinical pharmacology screen admissions to the Department of Internal Medicine for possible adverse drug reactions. Because of the collaboration between the Pharmacology Department and the nearby Poison Information Center (PIC) in Erfurt the question occurred whether the latter might contribute to adverse drug reaction monitoring. We compared the ADR registered by the intensified spontaneous reporting system in 1999 with those of the PIC during the same period. Each symptom observed was regarded as 1 case. Every suspected drug was also treated separately. The symptoms were classified using adverse reaction terminology. The drugs were classified according to the WHO Anatomical Therapeutic Chemical (ATC) classification index. The causality assessment was based upon bibliographic data and the method of Bégaud et al. [1985]. Only possible, probable or very probable ADR were compared. The PIC registered mainly psychiatric and nervous system disorders sedation and extrapyramidal disorders were the most frequent reactions - unlike the pharmacovigilance study which registered primarily gastrointestinal and heart rate disorders. The PIC registered mainly drugs used in the therapy of disorders of the central nervous system, i.e. mostly psycholeptics and drugs acting on the alimentary tract, mostly anticholinergics. Drugs for the therapy of sensory organs disorders were frequent owing to the systemic and local adverse drug effects of anticholinergic mydriatics. The PIC and pharmacovigilance centers can benefit from co-operation. The PIC provides easy access to qualified drug information and is thus a useful tool in ADR evaluation. Although the number of adverse reactions assessed was small, their evaluation revealed problems in drug usage which would not otherwise be reported. The evaluation has

  8. [International reporting of adverse drug reactions. Final report of CIOMS ADR Working Group].

    Science.gov (United States)

    Royer, R J; Benichou, C

    1991-01-01

    Under the auspices of the Council for International Organizations of Medical Sciences, a working group composed of representatives of seven multinational pharmaceutical manufacturers and six regulatory authorities developed and implemented a standardized method for reporting post-approval adverse drug reactions (ADR). The method is based on a set of uniform definitions and procedures and a single reporting form, and has been demonstrated to be feasible and effective. Regulators and manufacturers, in establishing requirements and systems for reporting of adverse drug reactions, should consider adopting this method.

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  11. 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

  12. 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."

  13. Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia

    Directory of Open Access Journals (Sweden)

    Lense Temesgen Gurmesa

    2016-01-01

    Full Text Available Background. Adverse drug reactions are global problems of major concern. Adverse drug reaction reporting helps the drug monitoring system to detect the unwanted effects of those drugs which are already in the market. Aims. To assess the knowledge, attitude, and practice of health care professionals working in Nekemte town towards adverse drug reaction reporting. Methods and Materials. A cross-sectional study design was conducted on a total of 133 health care professionals by interview to assess their knowledge, attitude, and practice using structured questionnaire. Results. Of the total respondents, only 64 (48.2%, 56 (42.1%, and 13 (9.8% health care professionals have correctly answered the knowledge, attitude, and practice assessment questions, respectively. Lack of awareness and knowledge on what, when, and to whom to report adverse drug reactions and lack of commitments of health care professionals were identified as the major discouraging factors against adverse drug reaction reporting. Conclusion. This study has revealed that the knowledge, attitude, and practice of the health care professionals working in Nekemte town towards spontaneous adverse drug reaction reporting were low that we would like to recommend the concerned bodies to strive on the improvement of the knowledge, attitude, and practice status of health care professionals.

  14. 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.

  15. Parametric time-to-onset (TTO) modelling of common ADRs in patients using antidiabetic drugs

    NARCIS (Netherlands)

    Scholl, Joep H.G.; Van De Ven, Peter M.; Van Puijenbroek, Eugène P.

    2015-01-01

    Background: Although the time-to-onset (TTO) is an important aspect in causality assessment of adverse drug reactions (ADRs), limited information about it is available in publicly available literature. Objectives: The aim of this study was to investigate whether the TTO of common ADRs of antidiabeti

  16. 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...... reported from other sources, in terms of their type, seriousness and the suspected medicines involved. METHODS: The number of ADRs reported to the Danish ADR database from 2004 to 2006 was analysed in terms of category of reporter, seriousness, category of ADRs by system organ class (SOC) and the suspected...... 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...

  17. Epidemiology of adverse drug reactions in Europe

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  18. [Adverse drug reaction - Definitions, risk factors and pharmacovigilance].

    Science.gov (United States)

    Krähenbühl, Stephan

    2015-12-01

    Adverse drug reactions (ADR} are the downside of active pharmacotherapies and can only partially be avoided. Risk factors have been identified for certain ADR which should be taken into account for the choice and dosing of critical drugs. Medical staff have a legal obligation to report severe ADR and ADR caused by newly licensed drugs. Such reports are important for monitoring the safety of drugs that are on the market.

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

    LENUS (Irish Health Repository)

    O'Connor, Marie N

    2012-11-01

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

  20. Large-scale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs

    OpenAIRE

    Liu, Mei; Wu, Yonghui; Chen, Yukun; Sun, Jingchun; Zhao, Zhongming; Chen, Xue-wen; Matheny, Michael Edwin; Xu, Hua

    2012-01-01

    Objective Adverse drug reaction (ADR) is one of the major causes of failure in drug development. Severe ADRs that go undetected until the post-marketing phase of a drug often lead to patient morbidity. Accurate prediction of potential ADRs is required in the entire life cycle of a drug, including early stages of drug design, different phases of clinical trials, and post-marketing surveillance. Methods Many studies have utilized either chemical structures or molecular pathways of the drugs to ...

  1. 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 new...... of ADR (System Organ Class [SOC]), seriousness, suspected medicines (level 2 of the Anatomical Therapeutic Chemical [ATC] Classification System) and type of reporter. RESULTS: 2437 ADR reports corresponding to 4500 ADRs were analysed. On average, 234 ADR reports were submitted annually, corresponding...... information about ADRs. OBJECTIVE: To characterize ADRs in children reported in Denmark over a period of one decade. METHODS: We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category...

  2. Do pharmacists' reports of adverse drug reactions reflect patients' concerns?

    NARCIS (Netherlands)

    van Grootheest, A.C.; van Puijenbroek, E.P.; de Jong-van den Berg, Lolkje Theodora Wilhelmina

    2004-01-01

    Aim: The aim of the present study was to investigate whether the concerns patients express to a Drug Information Line about possible adverse drug reactions (ADRs) they have experienced, are sufficiently reflected by the ADR reports submitted by pharmacists to the Netherlands Pharmacovigilance Centre

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

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba H

    2010-01-01

    of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise...... professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women....... 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...

  5. Adverse drug reactions in internal medicine units and associated risk factors

    OpenAIRE

    Sánchez Muñoz-Torrero, Juan Francisco; Barquilla, Paloma; Velasco, Raul; Fernández Capitan, Maria Del Carmen; Pacheco, Nazaret; Vicente, Lucia; Chicón, Jose Luis; Trejo, Sara; Zamorano, Jose; Lorenzo Hernandez, Alicia

    2010-01-01

    Abstract Objectives This study was designed to assess the prevalence of adverse drug reactions (ADRs) in the internal medicine wards of two teaching Hospitals, identify the most common ADRs, the principal medications involved, and determine the risk factors implicated in the occurrence of such ADRs. Methods All admissions over 10 weeks were followed prospectively using an intensive drug surveillance method...

  6. Spontaneous adverse drug reaction monitoring in oncology: Our experience

    Directory of Open Access Journals (Sweden)

    K Kaur

    2015-01-01

    Full Text Available Background: Adverse drug reaction (ADR monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. Materials And Methods: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any, diagnosis, chemotherapy (regimen, cycles, medication history, and alteration in the treatment or co morbidities, ADRs (severity and management. Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. Results: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52% followed by pyrimidine antagonists (19.88%. The most common malignancy reported in our hospital was Carcinoma breast (20% followed by leukemia (12% and Ca ovary (12%. Alopecia (27.76% was the most common ADR followed by anemia (7.48%, thrombocytopenia (6.96% and constipation (6.16%. Conclusion: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.

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

    NARCIS (Netherlands)

    RIKKEN, F; VOS, R

    1995-01-01

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

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

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

  9. 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.

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

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    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.

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

    NARCIS (Netherlands)

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

    2006-01-01

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

  12. Adverse drug reactions in the elderly.

    Science.gov (United States)

    Brahma, Dhriti K; Wahlang, Julie B; Marak, Maxilline D; Ch Sangma, Marlina

    2013-04-01

    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.

  13. Adverse drug reactions in the elderly

    Directory of Open Access Journals (Sweden)

    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.

  14. [Development and Validation of Estimate Equations for Adverse Drug Reactions Using Risk Factors and Subjective Symptoms].

    Science.gov (United States)

    Suzuki, Ryohei; Ohtsu, Fumiko; Goto, Nobuyuki

    2015-01-01

      The purpose of this study was to develop and validate estimate equations for preventing adverse drug reactions (ADRs). We conducted five case-control studies to identify individual risk factors and subjective symptoms associated with the following five ADRs: drug-induced ischemic heart disease; renal damage; muscle disorder; interstitial pneumonia; and leucopenia. We performed logistic regression analysis and obtained eight regression equations for each ADR. We converted these to ADR estimate equations for predicting the likelihood of ADRs. We randomly selected 50 cases with non-individual ADRs from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database of over 65000 case reports of ADRs, and assigned these cases to a validation case group. We then calculated the predictive probability for 50 cases using the eight estimate equations for each ADR. The highest probability for each ADR was set as the probability of each ADR. If the probability was over 50%, the case was interpreted as ADR-positive. We calculated and evaluated the sensitivity, specificity, and positive likelihood ratio of this system. Sensitivity of the estimate equations for muscle disorder and interstitial pneumonia were ≥90%. Specificity and positive likelihood ratios of estimate equations for renal damage, interstitial pneumonia and leucopenia were ≥80% and ≥5, respectively. Our estimate equations thus showed high validity, and are therefore helpful for the prevention or early detection of ADRs.

  15. 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.

  16. 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...... statistically insignificant or inconclusive. CONCLUSIONS: Ethnicity was largely overlooked. Most studies neglected to report ADRs by ethnicity. Lack of consistency in defining ethnicities complicated further pooled analyses. Despite the higher prevalence of asthma among specific ethnic minority groups, few...

  17. 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.

  18. Adverse drug reactions in utero: perspectives on teratogens and strategies for the future.

    Science.gov (United States)

    Mitchell, A A

    2011-06-01

    Many think of an adverse drug reaction (ADR) as an adverse event caused by a medication intended for a given subject. However, as we learned from the thalidomide debacle 50 years ago, some of the most devastating ADRs affect not the subject who takes the medication but rather, in the case of pregnancy exposures, an innocent bystander--the fetus--and the ADRs include birth defects.

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

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

  20. Development and validation of a risk model for predicting adverse drug reactions in older people during hospital stay: Brighton Adverse Drug Reactions Risk (BADRI) model

    OpenAIRE

    2014-01-01

    BACKGROUND:\\ud \\ud Older patients are at an increased risk of developing adverse drug reactions (ADR). Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR during hospital stay would enable healthcare staff to put measures in place to reduce the risk of such an event developing. The current study aimed to (1) develop and (2) validate an ADR risk prediction m...

  1. ADVERSE DRUG REACTION: COMMUNITY PHARMACISTS KNOWLEDGE, ATTITUDE AND BEHAVIOR

    Directory of Open Access Journals (Sweden)

    Ravi Katti Venkappa

    2012-01-01

    Full Text Available Many hospitalizations in India are due to Adverse Drug Reactions (ADR and resulting in morbidity and mortality in majority cases in addition to the huge economic burden. A survey was conducted to assess the knowledge, attitude and behavior of community pharmacists towards ADR related aspects. One hundred and twenty eight pharmacists from various Community pharmacies in two Districts of South India were consented in this survey. A questionnaire was prepared to investigate the knowledge, attitude and behavior of pharmacists regarding ADR reporting and distributed to the identified pharmacies. The data was collected and analyzed by ANOVA and t- test. Out of 342 community pharmacies approached, 128 (37.4% community pharmacists consented to be part of the survey and the questionnaire given was filled and returned by them. Out of these respondents, only 39 (30.5% pharmacists had knowledge about ADR, 15 (11.7% and 14 (10.9% were aware of National Pharmacovigilance Program (NPP and regional reporting centers respectively. Only 54 (43% agreed that ADR reporting is a professional obligation of pharmacist and none of the respondents reported ADRs. The main reason for not reporting any ADR was ‘they did not know how to report’ and ‘did not feel its beneficial’. This survey revealed that the community pharmacists were having least scores towards knowledge, attitude and behavior on ADRs in Indian Scenario.

  2. Development and validation of a risk model for predicting adverse drug reactions in older people during hospital stay: Brighton adverse drug reactions risk (BADRI) model

    NARCIS (Netherlands)

    Tangiisuran, B.; Scutt, G.; Stevenson, J.; Wright, J.; Onder, G.; Petrovic, M.; van der Cammen, T.J.M.; Rajkumar, C.; Davies, G.

    2014-01-01

    Background: Older patients are at an increased risk of developing adverse drug reactions (ADR). Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR during hospita

  3. Development and validation of a risk model for predicting adverse drug reactions in older people during hospital stay: Brighton adverse drug reactions risk (BADRI) model

    NARCIS (Netherlands)

    B. Tangiisuran (Balamurugan); G. Scutt (Greg); J.M. Stevenson; J. Wright (Juliet); G. Onder (Graziano); M. Petrovic (Mirko); T.J.M. van der Cammen (Tischa); C. Rajkumar (Chakravarthi); G. Davies (Graham)

    2014-01-01

    textabstractBackground: Older patients are at an increased risk of developing adverse drug reactions (ADR). Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR du

  4. Improving reporting of adverse drug reactions: Systematic review

    Directory of Open Access Journals (Sweden)

    Mariam Molokhia

    2009-05-01

    Full Text Available Mariam Molokhia1, Shivani Tanna2, Derek Bell31Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK; 2Department of Primary Care and Social Medicine, Imperial College, London, UK; 3Division of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UKBackground: Adverse drug reactions (ADRs are a significant cause of morbidity and mortality, with many being identified post-marketing. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health.Objectives: To evaluate methods to improve ADR reporting via a systematic literature review.Methods: Data sources were Medline, Embase, Cochrane Library and National Library for health searches on ADR reporting (January 1997 to August 2007 including cross-referenced articles. Twenty-four out of 260 eligible studies were identified and critically assessed. Studies were grouped as follows: i spontaneous reporting (11; ii medical chart/note review (2; iii patient interviews/questionnaires (3; and iv combination methods including computer-assisted methods (8.Results: Using computerized monitoring systems (CMS to generate signals associated with changes in laboratory results with other methods can improve ADR reporting. Educational interventions combined with reminders and/or prescription card reports can improve hospitalbased ADR reporting, and showed short to medium term improvement.Conclusions: The use of electronic health data combined with other methods for ADR reporting can improve efficiency and accuracy for detecting ADRs and can be extended to other health care settings. Although methods with educational intervention appear to be effective, few studies have reviewed long-term effects to assess if the improvements can be sustained. Keywords: adverse drug reaction, reporting, ADR

  5. Feature Engineering for Recognizing Adverse Drug Reactions from Twitter Posts

    Directory of Open Access Journals (Sweden)

    Hong-Jie Dai

    2016-05-01

    Full Text Available Social media platforms are emerging digital communication channels that provide an easy way for common people to share their health and medication experiences online. With more people discussing their health information online publicly, social media platforms present a rich source of information for exploring adverse drug reactions (ADRs. ADRs are major public health problems that result in deaths and hospitalizations of millions of people. Unfortunately, not all ADRs are identified before a drug is made available in the market. In this study, an ADR event monitoring system is developed which can recognize ADR mentions from a tweet and classify its assertion. We explored several entity recognition features, feature conjunctions, and feature selection and analyzed their characteristics and impacts on the recognition of ADRs, which have never been studied previously. The results demonstrate that the entity recognition performance for ADR can achieve an F-score of 0.562 on the PSB Social Media Mining shared task dataset, which outperforms the partial-matching-based method by 0.122. After feature selection, the F-score can be further improved by 0.026. This novel technique of text mining utilizing shared online social media data will open an array of opportunities for researchers to explore various health related issues.

  6. 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.

  7. 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.

  8. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands

    NARCIS (Netherlands)

    van Hunsel, Florence; van der Welle, Christine; Passier, Anneke; van Puijenbroek, Eugene; van Grootheest, Kees

    2010-01-01

    The aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre. A web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were

  9. [Drug resistance reversal of HL-60/ADR cells by simultaneous suppression of XIAP and MRP].

    Science.gov (United States)

    Wang, Xiao-Fang; Wang, Chun; Qin, You-Wen; Yan, Shi-Ke; Gao, Yan-Rong

    2006-12-01

    This study was purposed to explore the mechanisms of drug resistance of HL-60/ADR cells and to compare the reversal drug-resistance effects of antisense oligonucleotides (AS ODN) of XIAP (X-linked inhibitor of apoptosis protein) and AS ODNs of MRP (multidrug resistance-associated protein) by use alone or in combination. Reverse transcription-PCR and Western blot were applied to detect the expression of XIAP, BCL-2, MRP and MDR1 in mRNA and protein levels of HL-60 cells and HL-60/ADR cells, respectively. Fully phosphorothioated AS ODN of XIAP and MRP was delivered into HL-60/ADR cells with Lipofectamine 2000 in the form of liposome-ODN complexes alone or in combination. CCK-8 cell viability assay was used to determine the effect of AS ODN of XIAP and MRP used alone or in combination on the chemotherapy sensitivity of HL-60/ADR cells to daunorubicin (DNR). Reverse transcription-PCR and Western blot were applied to examine the changes of XIAP, MRP in mRNA and protein levels respectively. The results showed that MRP and XIAP were both significantly higher in HL-60/ADR cells than those in HL-60 cells. AS ODN of XIAP and MRP down-regulated the expression of XIAP and MRP in HL-60/ADR cells and increased the sensitivity of HL-60/ADR cells to DNR, respectively. AS ODN of XIAP + MRP did not enhance the inhibition expression of XIAP in HL-60/ADR cells but increased the sensitivity of HL-60/ADR cells to DNR significantly as compared with AS ODN of XIAP (P MRP did not increase the concentration of DNR nor enhanced the inhibition expression of MRP in HL-60/ADR cells but increased the sensitivity of HL-60/ADR cells to DNR significantly (P MRP. It is concluded that both XIAP and MRP may be involved in the drug resistance mechanisms of HL-60/ADR cells. Drug-resistance of HL-60/ADR cells can be reversed significantly when antisense oligonucleotides of XIAP and MRP were used in combination.

  10. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

    Directory of Open Access Journals (Sweden)

    Aliasghar Farazi

    2014-01-01

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

  11. 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.

  12. 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.

  13. ADR case reports of cardiovascular drugs%我院心血管系统药物不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    孔薇

    2012-01-01

    Objective To analyze the adverse drug reactions ( ADR ) of cardiovas-cular drugs occurring in First people's Hospital so as to provide reference for the rational use of medication in clinics. Methods 315 cases of ADR report had been collected, which were reported in national adverse drug reactions monitor network from April 2004 to April 2011 in Hefei First People s Hospital. Results 315 ADR cases involved 47 cardiovascular drugs. Among the cardiovascular drugs, antihypertensive drugs accounted for the highest proportion. Skin and its accessories damage accounted for the highest percentage of ADR of cardiovascular drugs. Conclusion We should attach greater importance to ADR monitoring, strengthen the clinical management of the rational use of antibiotics and reduce the incidence of adverse drug reactions.%目的 分析该院心血管系统药物不良反应(ADR)的相关因素,为临床合理用药提供参考.方法 对该院2004年4月~2011年4月收集并上报于全国药物不良反应监测网络的315例心血管系统药物不良反应报告进行统计分析.结果 315例ADR报表中涉及的药物品种共有47个,其中发生率最高的是降压药;ADR累及皮肤及及其附件损害最多.结论 应提高对药品不良反应监测工作重要性的认识,加强临床心血管系统药物合理使用的管理,避免或减少其ADR的发生.

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

    Directory of Open Access Journals (Sweden)

    Maria Cristina Soares Rodrigues

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

  15. [Apply association rules to analysis adverse drug reactions of shuxuening injection based on spontaneous reporting system data].

    Science.gov (United States)

    Yang, Wei; Xie, Yan-Ming; Xiang, Yong-Yang

    2014-09-01

    This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. The ADR and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-07-15

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

  17. 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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  2. [Recomendations for the prevention of adverse drug reactions in older adults with dementia].

    Science.gov (United States)

    Gómez-Pavón, Javier; González García, Paloma; Francés Román, Inés; Vidán Astiz, Maite; Gutiérrez Rodríguez, José; Jiménez Díaz, Gregorio; Montero Fernández, Nuria Pilar; Alvarez Fernández, Baldomero; Jiménez Páez, José María

    2010-01-01

    The elderly are one of the groups at greatest risk for adverse drugs reactions (ADR). The mean prevalence of these reactions in this population is 30%. Dementia is not an independent risk factor of ADR, but is the main condition that increases all risk factors (polypharmacy, comorbidity, inappropriate prescribing, drug-drug interactions, advanced age, and treatment adherence). The present article discusses revised and consensual recommendations for the prevention of ADR in the elderly, as well as recommendations specifically for dementia patients in relation to the management of comorbidity and cognitive, behavioral and psychological symptoms.

  3. A time-indexed reference standard of adverse drug reactions.

    Science.gov (United States)

    Harpaz, Rave; Odgers, David; Gaskin, Greg; DuMouchel, William; Winnenburg, Rainer; Bodenreider, Olivier; Ripple, Anna; Szarfman, Ana; Sorbello, Alfred; Horvitz, Eric; White, Ryen W; Shah, Nigam H

    2014-11-11

    Undetected adverse drug reactions (ADRs) pose a major burden on the health system. Data mining methodologies designed to identify signals of novel ADRs are of deep importance for drug safety surveillance. The development and evaluation of these methodologies requires proper reference benchmarks. While progress has recently been made in developing such benchmarks, our understanding of the performance characteristics of the data mining methodologies is limited because existing benchmarks do not support prospective performance evaluations. We address this shortcoming by providing a reference standard to support prospective performance evaluations. The reference standard was systematically curated from drug labeling revisions, such as new warnings, which were issued and communicated by the US Food and Drug Administration in 2013. The reference standard includes 62 positive test cases and 75 negative controls, and covers 44 drugs and 38 events. We provide usage guidance and empirical support for the reference standard by applying it to analyze two data sources commonly mined for drug safety surveillance.

  4. Predicting adverse drug reactions using publicly available PubChem BioAssay data.

    Science.gov (United States)

    Pouliot, Y; Chiang, A P; Butte, A J

    2011-07-01

    Adverse drug reactions (ADRs) can have severe consequences, and therefore the ability to predict ADRs prior to market introduction of a drug is desirable. Computational approaches applied to preclinical data could be one way to inform drug labeling and marketing with respect to potential ADRs. Based on the premise that some of the molecular actors of ADRs involve interactions that are detectable in large, and increasingly public, compound screening campaigns, we generated logistic regression models that correlate postmarketing ADRs with screening data from the PubChem BioAssay database. These models analyze ADRs at the level of organ systems, using the system organ classes (SOCs). Of the 19 SOCs under consideration, nine were found to be significantly correlated with preclinical screening data. With regard to six of the eight established drugs for which we could retropredict SOC-specific ADRs, prior knowledge was found that supports these predictions. We conclude this paper by predicting that SOC-specific ADRs will be associated with three unapproved or recently introduced drugs.

  5. Adverse drug reactions to ibuprofen: a case report

    Directory of Open Access Journals (Sweden)

    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

  6. Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients (RETRACTED by plagiarism

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    Rajesh R

    2011-03-01

    Full Text Available THIS ARTICLE WAS RETRACTED AFTER A PLAGIARISM INVESTIGATIONObjective: To assess the incidence, severity pattern, causality, predictability and preventability of adverse drug reactions (ADRs and to identify risk factors for adverse drug reactions in highly active antiretroviral therapy.Methods: Enrolled patients were intensively monitored for ADRs to highly active antiretroviral therapy. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Multivariate logistic regressions were used to identify the risk factors for ADRs.Results: Monitoring of 130 retropositive patients by active pharmacovigilance identified 74 ADRs from 57 patients. Anemia and hepatotoxicity were the most commonly observed ADRs. The organ system commonly affected by ADR was red blood cell (21.4%.The ADRs were moderate in 77% of cases. Type A reactions (77% were more common. A total of 10.8% ADRs were definitely preventable. The incidence rate of ADRs (65.9% was highest with Zidovudine + Lamivudine + Nevirapine combination. A total of 84% interruptions to highly active antiretroviral therapy were due to toxicity. CD4 less than 200 cells/µl, female gender and tuberculosis were observed as risk factors for ADRs.Conclusion: Incidence of ADRs in intensively monitored patients was found to be 43.8%. Anemia in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretroviral in India, clinicians must focus on early detection and prevention of ADRs to highly active antiretroviral therapy.

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

    Science.gov (United States)

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

    2007-11-01

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

  8. Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

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    Francesca Scicchitano

    2012-01-01

    Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  9. 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...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...... 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...

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

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    Kazeem Adeola Oshikoya

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

  11. Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands

    NARCIS (Netherlands)

    de Vries, T.W.; de Langen-Wouterse, J J; van Puijenbroek, E; Duiverman, E J; de Jong-Van den Berg, L T W

    2006-01-01

    Objective: Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands. Methods: In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigi

  12. 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.

  13. Mining unexpected temporal associations: applications in detecting adverse drug reactions.

    Science.gov (United States)

    Jin, Huidong Warren; Chen, Jie; He, Hongxing; Williams, Graham J; Kelman, Chris; O'Keefe, Christine M

    2008-07-01

    In various real-world applications, it is very useful mining unanticipated episodes where certain event patterns unexpectedly lead to outcomes, e.g., taking two medicines together sometimes causing an adverse reaction. These unanticipated episodes are usually unexpected and infrequent, which makes existing data mining techniques, mainly designed to find frequent patterns, ineffective. In this paper, we propose unexpected temporal association rules (UTARs) to describe them. To handle the unexpectedness, we introduce a new interestingness measure, residual-leverage, and develop a novel case-based exclusion technique for its calculation. Combining it with an event-oriented data preparation technique to handle the infrequency, we develop a new algorithm MUTARC to find pairwise UTARs. The MUTARC is applied to generate adverse drug reaction (ADR) signals from real-world healthcare administrative databases. It reliably shortlists not only six known ADRs, but also another ADR, flucloxacillin possibly causing hepatitis, which our algorithm designers and experiment runners have not known before the experiments. The MUTARC performs much more effectively than existing techniques. This paper clearly illustrates the great potential along the new direction of ADR signal generation from healthcare administrative databases.

  14. Adverse Reactions to Hallucinogenic Drugs.

    Science.gov (United States)

    Meyer, Roger E. , Ed.

    This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

  15. 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

  16. Canada's Adverse Drug Reaction Reporting System: A Failing Grade.

    Science.gov (United States)

    Rawson, Nigel S B

    2015-01-01

    An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada's SRS is deficient. There are immediate and medium-term actions that could be instituted that would improve pharmacovigilance in Canada. However, education about appropriate prescribing, the recognition of ADRs, and the duty to report them is a key long-term strategy to improving the pharmacovigilance system and should be included at every opportunity in the training of healthcare professionals so that life-long habits are developed. In addition to changes at Health Canada, greater emphasis needs to be placed on training in therapeutics, understanding drug safety, and the responsibility of healthcare providers in reporting risks in the curricula of medical and nursing schools.

  17. Could adverse reactions of antibiotic drugs in children be detected in a prescription database?

    NARCIS (Netherlands)

    de Jong, Josta; Bos, Jens H J; de Vries, Tjalling W; de Jong-van den Berg, Lolkje T W

    2011-01-01

    Purpose To explore the possibility to detect adverse drug reactions (ADRs) from a pharmacy prescription database by examining the use of proxy-drugs during the treatment. Methods From a pharmacy prescription database we selected all children of 0-6 years old who started an antibiotic drug between 19

  18. 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.

  19. Causality assessment of adverse drug reaction in Pulmonology Department of a Tertiary Care Hospital

    Science.gov (United States)

    Khan, Amer; Adil, Mir S.; Nematullah, K.; Ihtisham, S.; Aamer, K.; Aamir, Syed

    2015-01-01

    Background: Adverse drug reaction (ADR) is considered to be the sixth leading cause of death. The incidence rate estimates approximately 2% of hospital admissions are due to ADRs. Objective: To monitor ADRs in Pulmonology department of a tertiary care hospital patient with pulmonary diseases in an inpatient department of pulmonology. Materials and Methods: A prospective, single centered, observational and open labeled study was carried out in Princess Esra Hospital. The patient population was broadly divided into four categories based on diagnosis - chronic obstructive pulmonary disease, Infections, Asthma and Others. Suspected ADRs were reported, analyzed, and causality assessment was carried out using Naranjo's algorithm scale. Results: A total of 302 patients were observed, of which 98 patients experienced ADRs, which accounted for 32.23% of the incidence and totally 160 ADEs were observed. Adult Patients were found to have higher incidence (32.09%) while the incidence rate was slightly greater in geriatric patients (32.39%). The highest incidence of ADEs were found in others group (78.57%). Majority of ADRs were suspected to be due to theophylline (19.39%). Gastrointestinal system (38.75%) was the most common organ system affected due to ADRs. Drug was withdrawn in 12 patients, and specific treatment was administered to 32 patients in view of clinical status. Specific treatment for the management of suspected reaction was administered in 32.65% of ADR reports. Conclusion: A relatively high incidence of adverse drug events (32.2%) have been recorded which shows that not only Geriatric patients, but also adults are more susceptible to adverse drug effects. A number of drugs in combination were used, and ADEs often get multiplied. Careful therapeutic monitoring and dose individualization is necessary. PMID:26229344

  20. Effect of adverse drug reactions on length of stay in intensive care units.

    Science.gov (United States)

    Vargas, E; Simón, J; Martin, J C; Puerro, M; Gonzalez-Callejo, M A; Jaime, M; Gomez-Mayoral, B; Duque, F; Gomez-Delgado, A; Moreno, A

    1998-01-01

    The objective of the present study was to determine the frequency of adverse drug reactions (ADRs) in intensive care units (ICUs) and to evaluate their effect on the length of stay. We performed a prospective study to detect ADRs in 420 patients hospitalised in 10 predetermined beds in the ICU of our hospital between the months of March and December 1996. While the patients were staying in the ICU, data was gathered regarding suspected ADRs and on different variables related to the length of stay. 96 different ADRs were detected in 85 of the 420 patients seen [20.2%, 95% confidence intervals (95% CI) 16.5 to 24.4]. The ADRs were most frequently caused by the following drugs: nitrates (n = 25), opiates (n = 21) and ultrashort-acting benzodiazepines (n = 10). Eight ADRs were severe, the suspected medication had to be discontinued in 51 cases and new drugs were necessary to manage the ADRs in 73 cases. The crude estimation of the effect of the number of ADRs performed with a bivariant regression model indicated that each ADR was related to a 2.38-day increase (95% CI 1.31 to 3.45) in the length of stay. Although this estimation was reduced to 1.76 days (95% CI 0.72 to 2.79), when other confounding variables associated with the length of stay were considered, it was still important.In conclusion, the ADRs were a significant clinical problem in the ICUs and were responsible for a significant increase in the length of stay.

  1. 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.

  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. Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs

    NARCIS (Netherlands)

    Scholl, Joep H G; van de Ven, Peter M; van Puijenbroek, Eugène P

    2015-01-01

    OBJECTIVES: The aim of this study was to investigate whether the time to onset (TTO) of common adverse drug reactions (ADRs) of antidiabetic drugs could be modeled using parametric distributions and whether these TTO distributions were dependent on patient characteristics. Furthermore, information r

  5. 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;

  6. 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

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

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    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. Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists.

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    Yun Mi Yu

    Full Text Available To evaluate the clinical manifestations and causative drugs associated with adverse drug reactions (ADRs spontaneously reported by community pharmacists and to compare the ADRs by age.ADRs reported to the Regional Pharmacovigilance Center of the Korean Pharmaceutical Association by community pharmacists from January 2013 to June 2014 were included. Causality was assessed using the WHO-Uppsala Monitoring Centre system. The patient population was classified into three age groups. We analyzed 31,398 (74.9% ADRs from 9,705 patients, identified as having a causal relationship, from a total pool of 41,930 ADRs from 9,873 patients. Median patient age was 58.0 years; 66.9% were female.Gastrointestinal system (34.4%, nervous system (14.4%, and psychiatric (12.1% disorders were the most frequent symptoms. Prevalent causative drugs were those for acid-related disorders (11.4%, anti-inflammatory products (10.5%, analgesics (7.2%, and antibacterials (7.1%. Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001, whereas dizziness was prevalent in the elderly (p < 0.001. Anaphylactic reaction was the most frequent serious event (19.7%, mainly associated with cephalosporins and non-steroidal anti-inflammatory drugs. Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6% and non-steroidal anti-inflammatory drugs (16.2%, respectively.According to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups.

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

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    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

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

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    Kinjal Prajapati

    2016-01-01

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

  11. 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.

  12. Report of thirty one admissions due to adverse drug reactions inBo-Ali Sina hospital, Sari, Iran

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    Mohammad Reza Rafati

    2009-01-01

    Full Text Available , (Received 16 May, 2009 ; Accepted 8 July, 2009AbstractBackground and purpose: Adverse drug reactions (ADRs are one of the leading causes of morbidity and mortality, worldwide. Mortality rate due to ADRs are ahead of pulmonary disease, AIDS, pneumonia and automobile accidents. This study evaluated the admission rates in a University teaching hospital related to ADRs.Materials and methods: During this retrospective study between 2001 and 2007, all patients admitted due to adverse drug reaction in Sari Bo-Ali Sina Hospital were evaluated.Results: In these years, 31 patients out of 71,680 were admitted, due to ADRs. Most common ADRs were skin reaction (74% and fever (22%. Phenobarbital and penicillin were the most common drugs causing ADRs.Conclusion: Only 0.04% of hospital admissions were drug related, while reported admission due to ADRs in other countries were 2.4 to 6.2%. It appears that less drug-depended hospital admissions in Iran rational drug administration, but are due to lack of enough detection, records and reporting procedures.J Mazand Univ Med Sci 2009; 19(71: 67-70 (Persian.

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

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    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. Muscle spasms: an unexpected adverse drug reaction of pemetrexed?

    Science.gov (United States)

    de Rouw, Hendrika J. A.; Jessurun, Naomi T.; Masen-Poos, Lucie J. P.; Derijks, Hieronymus J.

    2016-01-01

    In this report we describe a 53-year-old woman with advanced non-small cell lung cancer, treated with pemetrexed and cisplatin combination therapy, followed by pemetrexed monotherapy. The patient developed severe muscle spasms at least twice, shortly after administration of pemetrexed monotherapy. A possible explanation for this observation is that in combination with cisplatin therapy, the patient was hyperhydrated before administration to promote renal excretion and reduce toxicity. Pemetrexed is also renally excreted, which supports the finding that toxicity did not occur when the patient was hyperhydrated. After discontinuation of pemetrexed the symptoms did not reoccur. All aspects of this case point to a possible relationship between pemetrexed and an adverse drug reaction (ADR). We conclude that muscle spasms are a rare, but possibly dose-related ADR of pemetrexed-based therapy. PMID:28203304

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

    OpenAIRE

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

    2014-01-01

    Background Data collected for medical, filing and administrative purposes in electronic patient records (EPRs) represent a rich source of individualised clinical data, which has great potential for improved detection of patients experiencing adverse drug reactions (ADRs), across all approved drugs and across all indication areas. Objectives The aim of this study was to take advantage of techniques for temporal data mining of EPRs in order to detect ADRs in a patient- and dose-specific manner....

  16. Recurrence of adverse drug reactions following inappropriate re-prescription: better documentation, availability of information and monitoring are needed.

    Science.gov (United States)

    van der Linden, Carolien M J; Jansen, Paul A F; van Marum, Rob J; Grouls, René J E; Korsten, Erik H M; Egberts, Antoine C G

    2010-07-01

    Adverse drug reactions (ADRs) are a common, and often preventable, cause of hospital admission, especially in the elderly, and can occur during hospitalization. In this current opinion article, we present three cases of recurrence of a serious ADR due to re-prescription of a withdrawn medication that highlight the need for a system to prevent the undesirable re-prescription of medications withdrawn because of an ADR. In addition, we describe an electronic system that could help prevent undesirable re-prescription following an ADR. Such a system should document ADRs systematically at the patient level, make this information available to relevant healthcare providers and the patient, and flag re-prescription of the offending drug. The effectiveness and cost effectiveness of such a system would need to be determined.

  17. 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.

  18. 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

  19. 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

  20. 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

  1. Adverse drug reaction reporting by patients in the Netherlands - Three years of experience

    NARCIS (Netherlands)

    de Langen, Joyce; van Hunsel, Florence; Passier, Anneke; de Jong-van den Berg, Lolkje; van Grootheest, Kees

    2008-01-01

    Background: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient

  2. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, E P; van Grootheest, K; Diemont, W L; Leufkens, H G; Egberts, A C

    2001-01-01

    AIMS: Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention. The goal of th

  3. 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

  4. 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

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

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    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.

  6. 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.

  7. A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013.

    Science.gov (United States)

    Hoban, Claire L; Byard, Roger W; Musgrave, Ian F

    2015-07-01

    Herbal medicines are perceived to be safe by the general public and medical practitioners, despite abundant evidence from clinical trials and case reports that show herbal preparations can have significant adverse effects. The overall impact of adverse events to herbal medicines in Australia is currently unknown. Post marketing surveillance of medications through spontaneous adverse drug reaction (ADR) reports to the Therapeutic Goods Administration (TGA) is one way to estimate this risk. The patterns of spontaneously reported ADRs provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADRs to St. John's Wort (Hypericum perforatum), a common herbal treatment for depression which contains selective serotonin reuptake inhibitors (SSRI), to fluoxetine, a commonly prescribed synthetic SSRI antidepressant. Spontaneous ADR reports sent to the TGA between 2000-2013 for St. John's Wort (n = 84) and fluoxetine (n = 447) were obtained and analysed. The demographic information, types of interaction, severity of the ADR, and the body systems affected (using the Anatomical Therapeutic Chemical classification system) were recorded for individual ADR cases. The majority of spontaneously reported ADRs for St. John's Wort and fluoxetine were concerning females aged 26-50 years (28.6%, 22.8%). The organ systems affected by ADRs to St John's Wort and fluoxetine have a similar profile, with the majority of cases affecting the central nervous system (45.2%, 61.7%). This result demonstrates that herbal preparations can result in ADRs similar to those of prescription medications.

  8. Adverse Drug Reactions for Medicines Newly Approved in Japan from 1999 to 2013: Hypertension and Hypotension.

    Science.gov (United States)

    Nagayama, Takashi; Nishida, Minoru; Hizue, Masanori; Ogino, Yamato; Fujiyoshi, Masato

    2016-04-01

    In this survey, the correlation between adverse drug reactions (ADRs) in human and animal toxicities was investigated for 393 medicines which were approved in Japan from September 1999 to March 2013. ADRs were collected from each Japanese package insert. Comparable animal toxicities with ADRs were collected by thorough investigation of common technical documents. The results of this survey show that hypertension and/or hypotension were mainly observed in medicines affecting the central nervous system. Hypertension was also observed in antipyretics, analgesics, anti-inflammatory agents, vasoconstrictors and agents using antibody. Concordance between human ADRs and animal toxicities was analysed. True-positive rate for hypertension and hypotension is 0.29 and 0.52, respectively. Positive likelihood ratio and inverse negative likelihood ratio are 1.98 and 1.21, respectively, in hypertension and 1.67 and 1.44, respectively, in hypotension. Concordance between human ADRs and animal toxicities is not so high in hypertension and hypotension. Identified mechanisms as on-target for hypertension and hypotension are 29.8% and 30.5%, respectively. More than half of the causative factors of hypertension and hypotension were unable to be elucidated. Our results show that the intake of medicines is often linked to blood pressure variations that are not predicted in animal toxicity studies. Improvement of drug development processes may be necessary to provide safer medicines because current animal toxicity studies are insufficient to predict all ADRs in human beings.

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

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    Johnson Segun Showande

    2013-01-01

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

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

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    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

  11. Development and validation of a risk model for predicting adverse drug reactions in older people during hospital stay: Brighton Adverse Drug Reactions Risk (BADRI model.

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    Balamurugan Tangiisuran

    Full Text Available Older patients are at an increased risk of developing adverse drug reactions (ADR. Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR during hospital stay would enable healthcare staff to put measures in place to reduce the risk of such an event developing. The current study aimed to (1 develop and (2 validate an ADR risk prediction model.We used a combination of univariate analysis and multivariate binary logistic regression to identify clinical risk factors for developing an ADR in a population of older people from a UK teaching hospital. The final ADR risk model was then validated in a European population (European dataset.Six-hundred-ninety patients (median age 85 years were enrolled in the development stage of the study. Ninety-five reports of ADR were confirmed by independent review in these patients. Five clinical variables were identified through multivariate analysis and included in our final model; each variable was attributed a score of 1. Internal validation produced an AUROC of 0.74, a sensitivity of 80%, and specificity of 55%. During the external validation stage the AUROC was 0.73, with sensitivity and specificity values of 84% and 43% respectively.We have developed and successfully validated a simple model to use ADR risk score in a population of patients with a median age of 85, i.e. the oldest old. The model is based on 5 clinical variables (≥8 drugs, hyperlipidaemia, raised white cell count, use of anti-diabetic agents, length of stay ≥12 days, some of which have not been previously reported.

  12. Development and Validation of a Risk Model for Predicting Adverse Drug Reactions in Older People during Hospital Stay: Brighton Adverse Drug Reactions Risk (BADRI) Model

    Science.gov (United States)

    Tangiisuran, Balamurugan; Scutt, Greg; Stevenson, Jennifer; Wright, Juliet; Onder, G.; Petrovic, M.; van der Cammen, T. J.; Rajkumar, Chakravarthi; Davies, Graham

    2014-01-01

    Background Older patients are at an increased risk of developing adverse drug reactions (ADR). Of particular concern are the oldest old, which constitute an increasingly growing population. Having a validated clinical tool to identify those older patients at risk of developing an ADR during hospital stay would enable healthcare staff to put measures in place to reduce the risk of such an event developing. The current study aimed to (1) develop and (2) validate an ADR risk prediction model. Methods We used a combination of univariate analysis and multivariate binary logistic regression to identify clinical risk factors for developing an ADR in a population of older people from a UK teaching hospital. The final ADR risk model was then validated in a European population (European dataset). Results Six-hundred-ninety patients (median age 85 years) were enrolled in the development stage of the study. Ninety-five reports of ADR were confirmed by independent review in these patients. Five clinical variables were identified through multivariate analysis and included in our final model; each variable was attributed a score of 1. Internal validation produced an AUROC of 0.74, a sensitivity of 80%, and specificity of 55%. During the external validation stage the AUROC was 0.73, with sensitivity and specificity values of 84% and 43% respectively. Conclusions We have developed and successfully validated a simple model to use ADR risk score in a population of patients with a median age of 85, i.e. the oldest old. The model is based on 5 clinical variables (≥8 drugs, hyperlipidaemia, raised white cell count, use of anti-diabetic agents, length of stay ≥12 days), some of which have not been previously reported. PMID:25356898

  13. 药物不良反应385例分析%Drug adverse reaction analysis of 385 cases

    Institute of Scientific and Technical Information of China (English)

    郭会娟

    2016-01-01

    目的:分析药物不良反应(ADR)385例。方法:收集ADR报告385例,进行分析。结果:ADR的发生率女性比男性高;老年人较容易发生ADR;药物类型中抗生素所占比例最大(29.35%);静脉滴注ADR比例最大(71.68%);皮肤系统发生ADR最多(48.31%),其次是消化系统(16.88%)。结论:加强药品不良反应的预防和监控,提高临床用药的安全性和合理性。%Objective:To explore the adverse drug reaction(ADR) of 385 cases.Methods:385 cases of ADR reports were collected and analyzed.Results:The incidence of female ADR was higher than that of male.The elderly were more prone to ADR.Among drug types,the proportion of antibiotics was the largest(29.35% ).The proportion of intravenous infusion of ADR was the largest(71.68% ).ADR was the most in skin system(48.31% ),followed by the digestive system(16.88% ).Conclusion:We should strengthen the prevention and monitoring of ADR,improve the safety and rationality of clinical medication.

  14. A retrospective analysis of adverse drug reactions in a tertiary care teaching hospital at Dehradun, Uttarakhand

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    Shakti B. Dutta

    2015-02-01

    Conclusions: Majority of ADRs were probable according to WHO causality assessment scale. Most common ADR was fixed drug eruption. Most frequent drugs associated with ADRs were NSAIDs. ADRs contribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society. [Int J Basic Clin Pharmacol 2015; 4(1.000: 121-124

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

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    Maša Amrain

    2014-09-01

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

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

    Science.gov (United States)

    Subiela, José D; Dapena, Elida

    2016-03-01

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

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

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    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

  18. 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

  19. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands : case-control study

    NARCIS (Netherlands)

    van Hunsel, Florence; Talsma, Attje; van Puijenbroek, Eugène; de Jong-van den Berg, Lolkje; van Grootheest, Kees

    2011-01-01

    Aim To determine the contribution of patients' adverse drug reaction (ADR) reports to signals detection, through a study of the signals sent by Lareb to the Dutch Medicines Evaluation Board. Methods The percentage of patient's ADR reports contributing to generate signals of adverse drug reactions wa

  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. A STUDY TO ASSESS KNOWLEDGE , ATTITUDE AND PRACTICE OF ADVERSE DRUG REACTION REPORTING AMONG PHYSICIANS IN A TERTIARY CARE HOSPITAL

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    Jyotirmoy

    2013-02-01

    Full Text Available ABSTRACT: BACKGROUND: Adverse drug reaction (ADR monitoring and reporting activity is in its infancy in India. Spontaneous reporting of adverse drug reactions (AD R is an important method in pharmacovigilance, but under-reporting is a major limitation. AIMS: Physicians being frontline caregivers this study was conducted to assess the knowledge, a ttitude and practice (KAP of ADR reporting among physicians in a tertiar y care hospital. SETTING AND DESIGN: This cross sectional, questionnaire based study was carried out amongst all the physicians working at Rajarajeswari Medical College & hospital, Bangalore over a period of 1 month. MATERIALS AND METHODS: A questionnaire was prepared after a initial pilot st udy and was distributed among all the physicians. For every Phys ician 30 minutes was given to fill up the questionnaire. Later on the filled questionnaires w ere collected and analyzed as per the study objectives. RESULTS: A questionnaire was distributed to 189 physicians, but only 122 returned the questionnaire (response rate of 70.9% . This study revealed inadequate knowledge and poor practice of ADR reporting. Though 56.8% physician felt that they encountered ADRs, only 22.1% had actually ever reported an ADR. The most co mmon reasons of under reporting were lack of time(34.5%, followed by lack of knowledge of reporting procedure (30.4%. But the physicians showed positive attitude towards ADR report ing. 95.0% felt that that ADR reporting is necessary and 79.5% supported for establishing ADR monitoring centre in e very hospital. Most of the physicians (95.9% suggested that continuous medical education and training on ADR reporting is necessary for overcoming the problem of underreporting of ADRs. CONCLUSION: The study results revealed the existence of underr eporting of ADRs, but also the willingness of clinicians to be trained in ADR repor ting and contributing to the pharmacovigilance programme. It is desirable to initi ate workshops and

  2. Hypoglycaemic complications with diabetes mellitus management: the predominant adverse drug reaction presenting to the Accident and Emergency Department of The University Hospital of the West Indies.

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    Gossell-Williams, M; Williams-Johnson, J; Francis, L

    2010-10-01

    Evaluation of adverse drug reactions (ADRs) is important to the assessment of risk factors in an aim to ensure maximum benefits of drug therapy. This study was done to assess the types of ADRs presenting to the Accident and Emergency department (A&E) of the University Hospital of the West Indies. Admissions to the A&E associated with drugs were followed on a weekly basis for 19 weeks from October 2007 to February 2008 using the patient logbook. Medical records of patients with suspected ADRs were collected and evaluated by an Emergency Medicine Consultant of A & E to confirm the occurrence of ADRs and the suspected drug. Of the 8170 admissions to A&E, 48 (0.6%) were related to ADRs, with most occurring in females and the mean age (+/- standard error) was 58.9 (+/- 3.4) years. Drug induced hypoglycaemia accounted for 28 (56.3%) cases of ADRs and included mainly patients on insulin, with or without a sulphonylurea therapy. Most of these diabetic patients also had co-morbidities and were on multi-drug therapy (18). Allergic reactions accounted for 10 (21%) of the ADR outcomes. Other drugs accounting for ADRs included cardiovascular drugs (10.4%), analgesic/anti-inflammatory medications (8.3%), drugs acting on the central nervous system (8.3%) and anti-infectives (8.3%). It is concluded that drug-induced hypoglycaemia is the major ADR presenting to the A&E of the University Hospital of the West Indies; it is a preventable ADR and therefore further investigation should evaluate possible factors attributed to the occurrences.

  3. Adverse reactions to drug additives.

    Science.gov (United States)

    Simon, R A

    1984-10-01

    There is a long list of additives used by the pharmaceutical industry. Most of the agents used have not been implicated in hypersensitivity reactions. Among those that have, only reactions to parabens and sulfites have been well established. Parabens have been shown to be responsible for rare immunoglobulin E-mediated reactions that occur after the use of local anesthetics. Sulfites, which are present in many drugs, including agents commonly used to treat asthma, have been shown to provoke severe asthmatic attacks in sensitive individuals. Recent studies indicate that additives do not play a significant role in "hyperactivity." The role of additives in urticaria is not well established and therefore the incidence of adverse reactions in this patient population is simply not known. In double-blind, placebo-controlled studies, reactions to tartrazine or additives other than sulfites, if they occur at all, are indeed quite rare for the asthmatic population, even for the aspirin-sensitive subpopulation.

  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. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital

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    Chetna K Desai

    2011-01-01

    Full Text Available Objectives: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs. Materials and Methods: A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4 was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20 and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007 and Chi-Square test were used for statistical analysis. Results: A total of 260 (61% prescribers completed the questionnaire (mean score of completion 18.04. The response rate of resident doctors (70.7% was better than consultants (34.5% (P < 0.001. ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8% and identifying new ADRs (24.6%. A majority of the respondents opined that they would like to report serious ADRs (56%. However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70% and how (68% to report and the lack of access to reporting forms (49.2%. Preferred methods for reporting were e-mail (56% and personal communication (42%. Conclusion: The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.

  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.

  8. 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.

  9. 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.

  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. Knowledge, attitude and performance of pharmacists and nurses in Mazandaran province, Iran regarding adverse drug reaction and its reporting, 2005.

    Directory of Open Access Journals (Sweden)

    Kh. Gholami

    2007-01-01

    Full Text Available AbstractBackground and purpose: Pharmacovigilance is a science that focuses on the detection, assessment, and prevention of adverse drug reactions (ADRs in the post-marketing phase. Its back bone is spontaneous reporting by health care workers via completing the yellow cards. Due to the low reporting of ADRs in the Mazandaran province, this study was designed to evaluate the knowledge, attitude and performance of pharmacists and nurses regarding ADRs reporting.Materials and Methods: This descriptive study was done on 286 health care workers including 67 pharmacists and 219 nurses, selected randomly from different cities of the province. The standard questionnaire of European pharmacovigilance research group was used as the data collection tool. In the field of knowledge, definition of pharmacovigilance, awareness of the national criteria for reporting the ADRs and awareness about the terminology occurrence rates of ADRs were questioned. To evaluate the attitude, reaction of subjects to the some simulated ADRs and reasons of underreporting were assessed. In the field of performance, numbers of reported ADRs and also the sites where reports sent from were asked. Data were analyzed using independent sample t-test for quantitative variables and Chi-square and Kendall’s tau-b for nominal and ordinal variables, respectively using SPSS software. P< 0.05 was considered as significant level.Results: There was no satisfying knowledge in each of the two groups. In spite of exposure of more than 80% of subjects to the ADRs, the mean reported ADRs values for pharmacists and nurses were very low as 0.72 ± 2.8 and 0.17 ± 0.67 respectively (P<0.01. Nurses liked to report most of ADRs to the physicians, nursing stations and pharmacist in spite of the national center. Considering these reports, they were more active than the pharmacists (P<0.001. The main causes of underreporting of the suspected ADRs were not being sure about the causative effect of the drug

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

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    K. Arunvikram

    2014-05-01

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

  13. Comparison of the knowledge, attitudes, and perception of barriers regarding adverse drug reaction reporting between pharmacy and medical students in Pakistan

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    Muhammad Umair Khan

    2015-06-01

    Full Text Available Purpose: The goal of this study was to compare the knowledge and attitudes of pharmacy and medical students regarding adverse drug reactions (ADRs, as well as their perceptions of barriers to ADR reporting, in a Higher Education Commission-recognised Pakistani university. Methods: A cross-sectional study was conducted among final-year pharmacy (n=91 and medical (n=108 students in Pakistan from June 1 to July 31, 2014. A self-administered questionnaire was used to collect the data. The responses of pharmacy students were compared to those of medical students. Results: Pharmacy students had a significantly better knowledge of ADRs than medical students (mean±SD, 5.61±1.78 vs. 3.23±1.60; P<0.001. Gender showed a significant relationship to knowledge about ADRs, and male participants were apparently more knowledgeable than their female counterparts (P<0.001. The attitudes of pharmacy students regarding their capability to handle and report ADRs were significantly more positive than those of medical students (P<0.05. In comparison to pharmacy students, a lack of knowledge of where and how to report ADRs was the main barrier that medical students perceived to ADR reporting (P=0.001. Conclusion: Final-year pharmacy students exhibited more knowledge about ADRs and showed more positive attitudes regarding their capacity to handle and report ADRs than final-year medical students.

  14. 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

  15. A review on adverse reactions caused by traditional Chinese drugs%中药不良反应概述

    Institute of Scientific and Technical Information of China (English)

    冯克玉

    2003-01-01

    @@ 1 中药不良反应发生的概况 药品不良反应(adverse drug reaction,ADR)主要是指质量检验合格的药品,在正常用法用量情况下,出现的与用药目的无关的有害反应.

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

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    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.

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

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    Siew-Eng Choon

    2012-01-01

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

  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. [The history of adverse drug reactions, relief for these health damage and safety measures in Japan].

    Science.gov (United States)

    Takahashi, Haruo

    2009-01-01

    The first remarkable adverse drug reaction (ADR) reported in Japan was anaphylactic shock caused by penicillin. Although intradermal testing for antibiotics had been exercised as prediction method of anaphylactic shock for a long time, it was discontinued in 2004 because of no evidence for prediction. The malformation of limbs, etc. caused by thalidomide was a global problem, and thalidomide was withdrawn from the market. Teratogenicity testing during new drug development has been implemented since 1963. Chinoform (clioquinol)-iron chelate was detected from green tongue and green urine in patients with subacute myelo-optic neuropathy (SMON) and identified as a causal material of SMON in 1970. Chinoform was withdrawn from the market, and a fund for relief the health damage caused by ADR was established in 1979. The co-administration of sorivudine and fluorouracil anticancer agents induced fatal agranulocytosis, and sorivudine was withdrawn from the market after being on sale for one month in 1993. The guidelines for package inserts were corrected with this opportunity, and early phase pharmacovigilance of new drugs was introduced later. Since acquired immune deficiency syndrome, and hepatitis B and C were driven by virus-infected blood products, the Ministry of Health, Labor and Welfare tightened regulations regarding biological products in 2003, and a fund for relief of health damage caused by infections driven from biological products was established in 2004. The other remarkable ADRs were quadriceps contracture induced by the repeated administration of muscular injection products and Creutzfeldt-Jakob disease caused by the transplantation of human dry cranial dura matter, etc. The significance of safety measures for drugs based on experiences related to ADRs is worthy of notice. New drugs are approved based on a benefit-risk assessment, if the expected therapeutic benefits outweigh the possible risks associated with treatment. Since unexpected, rare and serious

  20. Profile of adverse drug reactions in patients on anti-tubercular drugs in a sub Himalayan rural tertiary care teaching hospital

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    Atal Sood

    2016-10-01

    Conclusions: ADRs involving different organ systems were seen in both categories with varied frequency. Adverse drug reactions add to hospitalization expenses, insurance costs and increase in work loss days besides addition to patient suffering and loss of compliance. Prior knowledge can help in better prescriptions and prevent valuable resource loss. [Int J Res Med Sci 2016; 4(10.000: 4465-4471

  1. Drug-induced blood consumption: the impact of adverse drug reactions on demand for blood components in German departments of internal medicine.

    Science.gov (United States)

    Rottenkolber, Dominik; Schmiedl, Sven; Rottenkolber, Marietta; Thuermann, Petra A; Hasford, Joerg

    2012-10-01

    Therapy for adverse drug reactions (ADRs) often results in the application of blood components. This study aims to assess the demand for blood components and the resulting economic burden (hospital perspective) in German hospitals induced by ADRs leading to admissions to departments of internal medicine. In this prospective study, ADRs leading to hospitalization were surveyed in four regional pharmacovigilance centres in Germany during the years 2000-2007. ADRs assessed as 'possible', 'likely' or 'very likely' were included. Market prices for blood components and hospitalization data were determined by desktop research. A probabilistic sensitivity analysis was performed. A total of 6099 patients were admitted to internal medicine departments because of an outpatient ADR of whom 1165 patients (19.1%; mean age, 73.0 ± 13.0 years) required treatment with blood components owing to major bleeding events. Overall consumption was 4185 erythrocyte concentrates (EC), 426 fresh frozen plasma (FFP) and 48 thrombocyte (TC) units. On the basis of statistical hospital data, we estimated a nationwide demand of approximately 132,020 EC, 13,440 FFP and 1515 TC units, resulting in total costs of €12.66 million per year for all German hospitals. Some 19.2% of all ADR cases were assessed as preventable. Theoretically, a nationwide decreased demand for blood components and a savings potential of €2.43 million per year could be achieved by preventing ADRs in Germany. Blood components are used in one-fifth (mainly gastrointestinal bleeding) of all ADRs, leading to hospitalizations in internal medicine departments. Both blood demand and hospital procurement costs can be significantly lowered by preventing ADRs.

  2. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? : Experiences from reports to consumer association

    OpenAIRE

    2011-01-01

    Background According to the World Health Organization (WHO) the cost of adverse drug reactions   (ADRs) in the general population is high and under-reporting by health professionals   is a well-recognized problem. Another way to increase ADR reporting is to let the   consumers themselves report directly to the authorities. In Sweden it is mandatory   for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there   are no such regulations for consumers. The non-profit a...

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

    Science.gov (United States)

    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 signal detection, can provide additional information concerning a possible relationship between a drug and an ADR. We describe the role of quantitative signal detection and the way it is applied at the Netherlands Pharmacovigilance Centre Lareb. Results of the statistical analysis are implemented in the traditional case-by-case analysis. In addition, for data-mining purposes, a list of associations of ADRs and suspected drugs that are disproportionally present in the database is periodically generated. Finally, quantitative signal generation can be used to study more complex relationships, such as drug-drug interactions and syndromes. The results of quantitative signal detection should be considered as an additional source of information, complementary to the traditional analysis. Techniques for the detection of drug interactions and syndromes offer a new challenge for pharmacovigilance in the near future.

  4. 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

    all indication areas.The aim of this study was to take advantage of techniques for temporal data mining of EPRs in order to detect ADRs in a patient- and dose-specific manner.We used a psychiatric hospital’s EPR system to investigate undesired drug effects. Within one workflow the method identified...... patient-specific adverse events (AEs) and links these to specific drugs and dosages in a temporal manner, based on integration of text mining results and structured data. The structured data contained precise information on drug identity, dosage and strength.When applying the method to the 3,394 patients......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...

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

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    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

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

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    Galli TB

    2016-12-01

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

  7. 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

  8. An Adverse Drug Reaction to Trimethoprim-Sulfamethoxazole Revealing Primary HIV: A Case Report and Literature Review.

    Science.gov (United States)

    Meyer, Charles; Behm, Nicole; Brown, Emily; Copeland, Nathanial K; Sklar, Marvin J

    2015-01-01

    Adverse drug reactions (ADRs) to antibiotics complicate the management of any infection, particularly opportunistic infections in advanced HIV as some ADRs are potentiated by HIV. Trimethoprim-sulfamethoxazole (TMP-SMX) causes ADRs in 40-80% of HIV infected individuals, compared to 3-5% in the general population. The incidence and severity of ADRs among HIV infected individuals appear to increase as they progress from latent infection to AIDS. We present a single case report of a 55-year-old African American male found to have an otherwise asymptomatic acute HIV infection who developed an ADR to TMP-SMX, despite having previously tolerating the medication. The proposed mechanisms for the increased incidence of sulfa hypersensitivity reactions among HIV infected individuals focus on either (1) HIV-induced changes in the immune function driven by falling levels of CD4 cells or (2) other HIV-specific factors correlated with rising viral load. To our knowledge this is the first reported case of new sulfa hypersensitivity in primary HIV and may provide clinical evidence to support the correlation between viral load and ADRs to TMP-SMX without a severely diminished CD4 count, though further research is necessary. This case also demonstrates a rare and easily overlooked presentation of HIV that may aid in early diagnosis.

  9. An Adverse Drug Reaction to Trimethoprim-Sulfamethoxazole Revealing Primary HIV: A Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Charles Meyer

    2015-01-01

    Full Text Available Adverse drug reactions (ADRs to antibiotics complicate the management of any infection, particularly opportunistic infections in advanced HIV as some ADRs are potentiated by HIV. Trimethoprim-sulfamethoxazole (TMP-SMX causes ADRs in 40–80% of HIV infected individuals, compared to 3–5% in the general population. The incidence and severity of ADRs among HIV infected individuals appear to increase as they progress from latent infection to AIDS. We present a single case report of a 55-year-old African American male found to have an otherwise asymptomatic acute HIV infection who developed an ADR to TMP-SMX, despite having previously tolerating the medication. The proposed mechanisms for the increased incidence of sulfa hypersensitivity reactions among HIV infected individuals focus on either (1 HIV-induced changes in the immune function driven by falling levels of CD4 cells or (2 other HIV-specific factors correlated with rising viral load. To our knowledge this is the first reported case of new sulfa hypersensitivity in primary HIV and may provide clinical evidence to support the correlation between viral load and ADRs to TMP-SMX without a severely diminished CD4 count, though further research is necessary. This case also demonstrates a rare and easily overlooked presentation of HIV that may aid in early diagnosis.

  10. Adverse-Drug-Reaction-Related Hospitalisations in Developed and Developing Countries: A Review of Prevalence and Contributing Factors.

    Science.gov (United States)

    Angamo, Mulugeta Tarekegn; Chalmers, Leanne; Curtain, Colin M; Bereznicki, Luke R E

    2016-09-01

    Adverse drug reactions (ADRs) are one of the leading causes of hospital admissions and morbidity in developed countries and represent a substantial burden on healthcare delivery systems. However, there is little data available from low- and middle-income countries. This review compares the prevalence and characteristics of ADR-related hospitalisations in adults in developed and developing countries, including the mortality, severity and preventability associated with these events, commonly implicated drugs and contributing factors. A literature search was conducted via PubMed, Scopus, Web of Science, Embase, ProQuest and Google Scholar to find articles published in English from 2000 to 2015. Relevant observational studies were included. The median (with interquartile range [IQR]) prevalence of ADR-related hospitalisation in developed and developing countries was 6.3 % (3.3-11.0) and 5.5 % (1.1-16.9), respectively. The median proportions of preventable ADRs in developed and developing countries were 71.7 % (62.3-80.0) and 59.6 % (51.5-79.6), respectively. Similarly, the median proportions of ADRs resulting in mortality in developed and developing countries were 1.7 % (0.7-4.8) and 1.8 % (0.8-8.0), respectively. Commonly implicated drugs in both settings were antithrombotic, non-steroidal anti-inflammatory and cardiovascular drugs. Older age, female gender, number of medications, renal impairment and heart failure were reported to be associated with an increased risk for ADR-related hospitalisation in both settings while HIV/AIDS was implicated in developing countries only. The majority of ADRs were preventable in both settings, highlighting the importance of improving medication use, particularly in vulnerable patient groups such as the elderly, patients with multiple comorbidities and, in developing countries, patients with HIV/AIDS.

  11. 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

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

    Directory of Open Access Journals (Sweden)

    Irina Piatkov

    2012-10-01

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

  13. 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.

  14. 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

    2016-05-10

    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.

  15. 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

  16. 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.

  17. Prospective observational study to evaluate the pattern of adverse drug events in cancer patients receiving anti-cancer agents in a tertiary care hospital

    OpenAIRE

    Pooja B. Joshi; Neha G. Kadhe

    2016-01-01

    Background: Adverse drug reactions (ADRs) associated with the use of anticancer drugs are a worldwide problem and cannot be overlooked. They range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to evaluate the pattern of adverse drug events to anti-cancer agents in a tertiary care hospital. Methods: This observational prospective study was carried out in a tertiary care hospital from 1st January 2011 to 31st December 2011. A total of 213 ...

  18. Adverse motor effects induced by antiepileptic drugs.

    Science.gov (United States)

    Zaccara, G; Cincotta, M; Borgheresi, A; Balestrieri, F

    2004-09-01

    Cognitive effects of anti-epileptic drugs (AEDs) have been already extensively reported. In contrast, motor disturbances, frequently induced by these drugs, have not received similar attention. We review subjective and objective adverse motor effects of traditional and new AEDs. We discuss the methodological issues caused by the heterogeneous sources of information on drug adverse effects (controlled clinical studies, open studies, and case reports). We describe specific disturbances (vestibulocerebellar, dyskinesias, parkinsonism, tics, myoclonus, and tremor) as the effects of different AEDs on distinct motor circuitries. Finally, we summarize the role of sophisticated technical studies which provide a valuable insight into the specific or subtle effects of AEDs on the central nervous system.

  19. 医院药物不良反应分析%Analysis of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    孙美玲; 李志荃; 徐存军

    2015-01-01

    Objective To study the characteristics and regularity of adverse drug reactions (ADR).Methods ADR reports of 342 cases from January 1 to December 15 in 2014 were retrospectively analyzed, including gender, age, onset time of ADR, route of administration, drug categories, organs or systems involved in ADR and clinical manifestations, occupation of the reporter, etc.Results In the 342 ADR cases, 162 were male and 180 were female;the proportion of patients > 60 years was the highest [31.6% (108/342)];intravenous administration was an important way regarding inducing ADR [90.6% (310/342)].The ADR was mostly induced by anti-infective drugs [36.8% (126/342)] and penicillins, cephalosporins, quinolones accounted for 37.3% (47/126), 31.0% (39/126), 16.7% (21/126), respectively.The main clinical manifestations included lesions of skin and its appendages [39.8% (141/354)] and digestive system damage [16.4% (58/354)].Conclusion ADR is related with a variety of factors, including age, anti-infective drug and intravenous administration;ADR monitoring and reporting work should be strengthened to ensure the safe and rational use of drugs.%目的 了解医院药物不良反应(ADR)发生的特点及规律,为临床安全、合理用药提供参考.方法 采用回顾性研究方法,对山东省寿光市人民医院2014年1月1日至2014年12月15日上报至国家不良反应监测中心的342例ADR报告,从患者性别、年龄、ADR发生时间、给药途径、药品种类、ADR累计器官或系统及临床表现、报告人职业等方面进行统计分析.结果 342例ADR报告中,男162例,女180例,多发生于60岁以上人群,占31.6% (108/342).静脉给药是引发ADR的重要途径,占90.6% (310/342).抗感染类药物引起的ADR发生率最高,占36.8%(126/342),其中青霉素类、头孢菌素类、喹诺酮类分别占37.3%(47/126)、31.0% (39/126)、16.7% (21/126).ADR临床表现以皮肤及其附件损害、消

  20. Adverse drug reactions associated with asthma medications in children: systematic review of clinical trials

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    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......, age and gender, type and seriousness of ADRs, design, setting, observation period, type of assessors, and funding sources was extracted from the articles. Results Literature searches resulted in 162 potential relevant articles. However only 12 of these studies were included in this review...... 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...

  1. Mapping of the WHO-ART terminology on Snomed CT to improve grouping of related adverse drug reactions.

    Science.gov (United States)

    Alecu, Iulian; Bousquet, Cedric; Mougin, Fleur; Jaulent, Marie-Christine

    2006-01-01

    The WHO-ART and MedDRA terminologies used for coding adverse drug reactions (ADR) do not provide formal definitions of terms. In order to improve groupings, we propose to map ADR terms to equivalent Snomed CT concepts through UMLS Metathesaurus. We performed such mappings on WHO-ART terms and can automatically classify them using a description logic definition expressing their synonymies. Our gold standard was a set of 13 MedDRA special search categories restricted to ADR terms available in WHO-ART. The overlapping of the groupings within the new structure of WHO-ART on the manually built MedDRA search categories showed a 71% success rate. We plan to improve our method in order to retrieve associative relations between WHO-ART terms.

  2. A potential causal association mining algorithm for screening adverse drug reactions in postmarketing surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Dews, Peter; Mansour, Ayman; Tran, John; Miller, Richard E; Massanari, R Michael

    2011-05-01

    Early detection of unknown adverse drug reactions (ADRs) in postmarketing surveillance saves lives and prevents harmful consequences. We propose a novel data mining approach to signaling potential ADRs from electronic health databases. More specifically, we introduce potential causal association rules (PCARs) to represent the potential causal relationship between a drug and ICD-9 (CDC. (2010). International Classification of Diseases, Ninth Revision (ICD-9). [Online]. Available: http://www.cdc.gov/nchs/icd/icd9.html) coded signs or symptoms representing potential ADRs. Due to the infrequent nature of ADRs, the existing frequency-based data mining methods cannot effectively discover PCARs. We introduce a new interestingness measure, potential causal leverage, to quantify the degree of association of a PCAR. This measure is based on the computational, experience-based fuzzy recognition-primed decision (RPD) model that we developed previously (Y. Ji, R. M. Massanari, J. Ager, J. Yen, R. E. Miller, and H. Ying, "A fuzzy logic-based computational recognition-primed decision model," Inf. Sci., vol. 177, pp. 4338-4353, 2007) on the basis of the well-known, psychology-originated qualitative RPD model (G. A. Klein, "A recognition-primed decision making model of rapid decision making," in Decision Making in Action: Models and Methods, 1993, pp. 138-147). The potential causal leverage assesses the strength of the association of a drug-symptom pair given a collection of patient cases. To test our data mining approach, we retrieved electronic medical data for 16,206 patients treated by one or more than eight drugs of our interest at the Veterans Affairs Medical Center in Detroit between 2007 and 2009. We selected enalapril as the target drug for this ADR signal generation study. We used our algorithm to preliminarily evaluate the associations between enalapril and all the ICD-9 codes associated with it. The experimental results indicate that our approach has a potential to

  3. An in vitro demonstration of overcoming drug resistance in SKOV3 TR and MCF7 ADR with targeted delivery of polymer pro-drug conjugates.

    Science.gov (United States)

    Bhattarai, Prashant; Vance, Dylan; Hatefi, Arash; Khaw, Ban An

    2017-01-05

    Drug resistance is a common phenomenon that occurs in cancer chemotherapy. Delivery of chemotherapeutic agents as polymer pro-drug conjugates (PPDCs) pretargeted with bispecific antibodies could circumvent drug resistance in cancer cells. To demonstrate this approach to overcome drug resistance, Paclitaxel (Ptxl)-resistant SKOV3 TR human ovarian- and doxorubicin (Dox)-resistant MCF7 ADR human mammary-carcinoma cell lines were used. Pre-targeting over-expressed biotin or HER2/neu receptors on cancer cells was conducted by biotinylated anti-DTPA or anti-HER2/neu affibody - anti-DTPA Fab bispecific antibody complexes. The targeting PPDCs are either D-Dox-PGA or D-Ptxl-PGA. Cytotoxicity studies demonstrate that the pretargeted approach increases cytotoxicity of Ptxl or Dox in SKOV3 TR or MCF7 ADR resistant cell lines by 5.4 and 27 times, respectively. Epifluorescent microscopy - used to track internalization of D-Dox-PGA and Dox in MCF7 ADR cells - shows that the pretargeted delivery of D-Dox-PGA resulted in a 2- to 4-fold increase in intracellular Dox concentration relative to treatment with free Dox. The mechanism of internalization of PPDCs is consistent with endocytosis. Enhanced drug delivery and intracellular retention following pretargeted delivery of PPDCs resulted in greater tumor cell toxicity in the current in vitro studies.

  4. 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...

  5. 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.

  6. [Haematological adverse effects caused by psychiatric drugs].

    Science.gov (United States)

    Mazaira, Silvina

    2008-01-01

    Almost all clases of psychiatric drugs (typical and atypical antipsychotics, antidepressants, mood stabilizers, benzodiazepines) have been reported as possible causes of haematological toxicity. This is a review of the literature in which different clinical situations involving red blood cells, white blood cells, platelets and impaired coagulation are detailed and the drugs more frequently involved are listed. The haematological adverse reactions detailed here include: aplastic anemia, haemolitic anemia, leukopenia, agranulocytosis, leukocytosis, eosinophilia, thrombocytosis, thrombocytopenia, disordered platelet function and impaired coagulation. The haematologic toxicity profile of the drugs more frequently involved: lithium, clozapine, carbamazepine, valproic acid and SSRI antidepressants is mentioned.

  7. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison.

    Directory of Open Access Journals (Sweden)

    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

  8. 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

  9. 270例药品不良反应报告%270 Cases of Adverse Drug Reaction Reports

    Institute of Scientific and Technical Information of China (English)

    王艳群

    2016-01-01

    OBJECTIVE:To investigate the characteristics and laws of adverse drug reactions (ADR)in Xinwen Mining Group Laiwu Central Hospital(hereinafter referred to as “our hospital”),so as to provide reference for the rational drug usein clinic.METHDS:270 cases of ADR reports collected and reported to National Center for ADR monitoring in 2015 werestatistically analyzed,in terms of the general information,dosage and usage,systematic classification of drugs,manifestation ofADR,report pattern of ADR and relevance evaluation,etc.RESULTS: Of the 270 cases in our hospital,patients over 40 yearsold were 87.04%(235/270).285 kinds of drugs were involved,among which injection and powder-injection took the lead,accounting for 77.54%(221/285).Of the top 10 ADR-inducing drugs,cisplatin injection dominated the first place,andhaving three kinds of antibacterial drugs.The clinical manifestations of ADR were mainly the lesion of skin and itsappendages (62 cases,22.96%),followed by gastrointestinal system damage (50 cases,18.52%).Meanwhile,68 cases(25.19%) were new ADR,and 28 cases (10.37%) were new and severe ADR,traditional Chinese medicine injections werethe main causes.CONCLUSIONS: Our hospital should strengthen the monitoring of ADR and promote the rational use ,so asto ensure the safe medication in clinic.%目的:了解新汶矿业集团莱芜中心医院(以下简称“我院”)药品不良反应( adverse drug reaction ,ADR)的发生特点及规律,为临床合理用药提供参考。方法:对我院2015年收集并上报至国家ADR监测中心的270份ADR报告进行分析,分别从患者基本信息、药品用法与用量、药品系统归类、ADR表现形式、ADR报告类型以及关联性评价等方面进行汇总分。结果:我院270例ADR报告中,主要发生于40岁以上患者,占87.04%(235/270);ADR 共涉及药品285种,其中以注射剂与粉针剂为主,占77.54%(221/285);引发ADR病例数排序居前10位

  10. 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.

  11. Association study of genetic polymorphism in ABCC4 with cyclophosphamide-induced adverse drug reactions in breast cancer patients.

    Science.gov (United States)

    Low, Siew-Kee; Kiyotani, Kazuma; Mushiroda, Taisei; Daigo, Yataro; Nakamura, Yusuke; Zembutsu, Hitoshi

    2009-10-01

    Cyclophosphamide (CPA)-based combination treatment has known to be effective for breast cancer, but often causes adverse drug reactions (ADRs). Hence, the identification of patients at risk for toxicity by CPA is clinically significant. In this study, a stepwise case-control association study was conducted using 403 patients with breast cancer who received the CPA combination therapy. A total of 143 genetic polymorphisms in 13 candidate genes (CYP2B6, CYP2C9, CYP2C19, CYP3A4, CYP3A5, ALDH1A1, ALDH3A1, GSTA1, GSTM1, GSTP1, GSTT1, ABCC2 and ABCC4), possibly involved in the activation, metabolism and transport of CPA, were genotyped using 184 cases who developed either > or =grade 3 leukopenia/neutropenia or > or =grade 2 gastrointestinal toxicity and 219 controls who did not show any ADRs throughout the treatment. The association study revealed that one SNP, rs9561778 in ABCC4, showed a significant association with CPA-induced ADRs (Cochran-Armitage trend's P-value=0.00031; odds ratio (OR)=2.06). Subgroup analysis also indicated that the SNP rs9561778 was significantly associated with two major ADR subgroups; gastrointestinal toxicity and leukopenia/neutropenia (Cochran-Armitage trend's P-value=0.00019 and 0.014; OR=2.31 and 1.83). Furthermore, the SNP rs9561778 showed an association with breast cancer patients who were treated with CA(F) drug regimen-induced ADR (Cochran-Armitage trend's P-value=0.00028; OR=3.13). The SNPs in ABCC4 might be applicable in predicting the risk of ADRs in patients receiving CPA combination chemotherapy.

  12. 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

  13. 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

  14. 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

  15. 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.

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

    Science.gov (United States)

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

    2013-12-01

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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 药品不良反应简报系统软件及应用%ADVERSE DRUG REACTION BRIEFING SYSTEM SOFTWARE AND ITS APPLICATION

    Institute of Scientific and Technical Information of China (English)

    刘金英; 林洁娜

    2009-01-01

    目的 利用计算机、网络技术开展药品不良反应(ADR)监测.方法 设计药品不良反应临床简报系统软件,利用简报系统监测药品不良反应具有方便快捷、效率高等优点.结果 药品不良反应上报率明显增加.结论 医院加强ADR监测工作有助于提高医疗质量和安全合理用药.%Objective To use computer and network technologies for Adverse Drug Reaction(ADR) monitoring.Methods Design adverse drug reaction clinical briefing system software, use the advance of the briefing system in monitoring the adverse drug reactions with fast and convenient and high efficiency.Results The reported rate of adverse drug reactions increased significantly.Conclusion Hospitals strengthen ADR monitoring will help improve quality of medical care and safety of rational drug use.

  6. Adverse drug reaction profile of oseltamivir in children

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    Prashant S Dalvi

    2011-01-01

    Full Text Available Aim: To monitor and evaluate the pattern of ADRs to oseltamivir in pediatric population suffering from H1N1 influenza at a tertiary care hospital. Materials and Methods: Children offered oseltamivir for treatment and chemoprophylaxis were monitored for adverse events by direct questioning for symptoms and clinical examination on day 5 and day 10. Assessment of neurological events was done by asking the parents or guardians regarding development of specific symptoms. Adverse events obtained were analyzed for severity, causality and age-group wise. Results: Out of 191 children (median age, 3 years, 69 (36.1% developed ADRs. Most common symptoms were vomiting (16.2% followed by diarrhea (12.0%, ear disorders (8.9%, and insomnia (6.8%. The incidence of neuropsychiatric symptoms was 12.6% which were mild-to-moderate on severity scale. There was no significant difference in the incidence of adverse events between children less than 1 year and other age groups. Conclusion: Oseltamivir is well tolerated in Indian children with suspected or confirmed H1N1 influenza. Our study also indicates safety of oseltamivir in infants.

  7. Causes for the underreporting of adverse drug events by health professionals: a systematic review

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    Fabiana Rossi Varallo

    2014-08-01

    Full Text Available Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29 for physicians (22/29, and pharmacists (10/29. The main causes related to underreporting were ignorance (24/29, insecurity (24/29 and indifference (23/29. Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

  8. 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.

  9. 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%).

  10. 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

  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. 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.

  13. 261 cases analysis of adverse drug reaction in our hospital during 2011-2013%近3年我院261例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    剡建华; 岳明

    2015-01-01

    目的:分析我院药品不良反应(ADR)发生的特点及一般规律,促进临床合理用药。方法对我院2011年至2013年收集的261例ADR报告病历进行回顾性统计分析。结果60岁以上的老年患者发生 ADR 的频率最高(占27.97%),静脉滴注给药引发的 ADR最多见(占86.21%),ADR涉及的药品以抗感染药物居首位(占31.03%),ADR 累及的器官/系统以皮肤及其附件损害最常见(占58.24%)。结论临床应加强ADR监测,促进合理用药,尽量避免或减少ADR的发生。%Objective To investigate the characteristics and regularity of adverse drug reaction (ADR) in our hospital ,and to pro‐mote the rational clinical drug use .M ethods By retrospective study method ,261 ADR cases from our hospital during 2011‐2013 were analyzed statistically .Results ADR mostly occurred in patients aged above 60 years old (73 cases ,27 .97% ) .ADR cases were mostly caused by intravenous administration (225 cases ,86 .21% ) . Antimicrobial drugs took up the first place among ADR‐inducing drugs (81cases ,31 .03% ) .Lesion of skin and its appendages were the most common clinical manifestations (152 cases ,58 .24% ) .Conclusion Great importance should be attached to ADR monitoring and rational use of drug to reduce or avoid the occurrence of ADR .

  14. Effects of SULT1A1 Copy Number Variation on Estrogen Concentration and Tamoxifen-Associated Adverse Drug Reactions in Premenopausal Thai Breast Cancer Patients: A Preliminary Study.

    Science.gov (United States)

    Charoenchokthavee, Wanaporn; Ayudhya, Duangchit Panomvana Na; Sriuranpong, Virote; Areepium, Nutthada

    2016-01-01

    Tamoxifen is a pharmacological estrogen inhibitor that binds to the estrogen receptor (ER) in breast cells. However, it shows an estrogenic effect in other organs, which causes adverse drug reactions (ADRs). The sulfotransferase 1A1 (SULT1A1) enzyme encoded by the SULT1A1 gene is involved in estrogen metabolism. Previous research has suggested that the SULT1A1 copy number is linked with the plasma estradiol (E2) concentration. Here, a total of 34 premenopausal breast cancer patients, selected from the Thai Tamoxifen (TTAM) Project, were screened for their SULT1A1 copy number, plasma E2 concentration and ADRs. The mean age was 44.3±11.1 years, and they were subtyped as ER+/ progesterone receptor (PR) + (28 patients), ER+/ PR- (5 patients) and ER-/PR- (1 patient). Three patients reported ADRs, which were irregular menstruation (2 patients) and vaginal discharge (1 patient). Most (33) patients had two SULT1A1 copies, with one patient having three copies. The median plasma E2 concentration was 1,575.6 (IQR 865.4) pg/ml. Patients with ADRs had significantly higher plasma E2 concentrations than those patients without ADRs (p = 0.014). The plasma E2 concentration was numerically higher in the patient with three SULT1A1 copies, but this lacked statistical significance.

  15. 荧光素钠注射液致不良反应分析%Analysis of 84 cases of adverse drug reaction induced by sodium fluorescein injection

    Institute of Scientific and Technical Information of China (English)

    王梓; 李艳; 王锦文

    2014-01-01

    Objective To investigate the characteristics and features of adverse drug reactions(ADRs)induced by Sodium fluorescein injection,and to provide references for rational drug use in clinic.Methods ADRs reports of Sodium fluorescein injection during Jan.2012 to Dec.2013 were collected and analyzed.Results There were 84 cases ofADRs induced by Sodium fluorescein injection,the incidence rate of ADR is 2.44%,most of them were some lesion of gastrointestinal or skin and soft tissue injury,manifesting as nausea and vomiting,rash combinedwith itching.3 cases of serious ADRs lead to hospitalizationwere out of danger after rescue.Conclusions Sodium fluorescein injection is a relatively safe drug,ADRs are generally mild.However,several serious ADRs may also occur,much attention should be paid for the purpose of a precaution and timely managing of ADRs.%目的:了解荧光素钠注射液致不良反应(ADR)的特点及规律,为临床合理使用提供参考。方法收集某院2012年1月~2013年12月荧光素钠注射液致ADR的报告,并就ADR的相关情况进行总结分析。结果共收集荧光素钠注射液致ADR 84例,不良反应发生率约为2.44%;多为消化系统及皮肤软组织损害,主要表现为恶心、呕吐、皮疹、瘙痒等;3例导致住院的严重不良反应,经抢救脱离危险。结论荧光素钠注射液是一种相对安全的药物,一般ADR较轻微,但也存在发生严重ADR的风险,临床对此应引起重视,做好预防工作,发生不良反应及时处理。

  16. Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms.

    Science.gov (United States)

    Bousquet, Cédric; Sadou, Éric; Souvignet, Julien; Jaulent, Marie-Christine; Declerck, Gunnar

    2014-06-01

    Although MedDRA has obvious advantages over previous terminologies for coding adverse drug reactions and discovering potential signals using data mining techniques, its terminological organization constrains users to search terms according to predefined categories. Adding formal definitions to MedDRA would allow retrieval of terms according to a case definition that may correspond to novel categories that are not currently available in the terminology. To achieve semantic reasoning with MedDRA, we have associated formal definitions to MedDRA terms in an OWL file named OntoADR that is the result of our first step for providing an "ontologized" version of MedDRA. MedDRA five-levels original hierarchy was converted into a subsumption tree and formal definitions of MedDRA terms were designed using several methods: mappings to SNOMED-CT, semi-automatic definition algorithms or a fully manual way. This article presents the main steps of OntoADR conception process, its structure and content, and discusses problems and limits raised by this attempt to "ontologize" MedDRA.

  17. 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.

  18. 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.

  19. Do older hospital patients recognize adverse drug reactions?

    NARCIS (Netherlands)

    C.K. Mannesse; F.H.M. Derkx (Frans); M.A.J. de Ridder (Maria); A.J. Man in 't Veld (Arie); T.J.M. van der Cammen (Tischa)

    2000-01-01

    textabstractOBJECTIVE: To establish the relationship between subjective complaints of side effects of drugs and the objective presence of adverse drug reactions in older patients. DESIGN: Observational cross-sectional study. SETTING: Five medical wards at the University

  20. 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.

  1. Analysis of 216 Cases of Adverse Drug Reactions%216例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    昝军民

    2015-01-01

    Objective: To investigate characteristics and patterns of the adverse drug reactions (ADRs) in Dingxi City People's Hospital, so as to provide references for rational drug use.Methods: The 216 cases of ADR reports collected from 2011 to 2013 were classiifed, summarized and analyzed.Results:The 216 cases of ADR reports involved 97 kinds of drugs, and the incidence for males (127 cases, 58.8%) was higher than for females (89 cases, 41.2%). Population over 60 accounted for the largest proportion (80 cases, 37.03%). Intravenous infusion was the easiest way to led to ADRs (109 cases, accounting for 48.23%). ADRs induced by anti-infective drugs ranked ifrst (79 cases, accounting for 33.3%). Cases of lesions of skin and its appendages were the most common (90 cases, accounting for 40.72%) among ADRs involving organs and/or systems. There were 8 cases of severe ADRs (3.7%). All ADRs were cured or improved.Conclusion: The occurrence of ADRs is related with many factors. The medical institutions should perfect the ADRs supervision system in cooperation of medicine, pharmacy, and nursing, strengthen the monitoring of ADRs, exert the role of clinical pharmacists in drug monitoring, and promote rational drug use, so as to reduce or avoid the occurrence of ADRs.%目的:了解定西市人民医院药品不良反应(ADR)发生的特点及规律,为合理用药提供参考。方法:对2011年至2013年收集的216例ADR报告进行分类统计和分析。结果:216例ADR报告中共涉及药品97种,男性发生率(127例,占58.8%)多于女性(89例,占41.2%);60岁以上人群所占比例最大,有80例(占37.03%);静脉滴注给药途径最易引发ADR(109例,占48.23%);抗感染药引发的ADR例数最多(79例,占33.3%);ADR累及器官和(或)系统以皮肤及其附件损害最为常见(90例,占40.72%);严重的ADR有8例(占3.7%);所有ADR均治愈或好转。结论:ADR发生与多种因素有关,医

  2. 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.

  3. Adverse drug reactions in tuberculosis patients due to directly observed treatment strategy therapy: Experience at an outpatient clinic of a teaching hospital in the city of Imphal, Manipur, India

    Directory of Open Access Journals (Sweden)

    Kumarjit Sinha

    2013-01-01

    Full Text Available Background: As to the profile of adverse drug reactions (ADRs due to directly observed treatment, short course (DOTS, there is no report available in patients receiving antituberculosis (anti-TB chemotherapy in Manipur, India. One of the main reasons for non-adherence to anti-TB therapy (ATT is ADRs, even under DOTS. Aims: This study aimed to determine the incidence of ADRs due to DOTS therapy with a TB population of Manipur, India. Setting and Design: A prospective institution-based cohort study, and performed during July 2009-December 2010. Materials and Methods: The study included 102 diagnosed TB patients on anti-TB treatment under DOTS. Every patient was followed-up for the duration he/she received the treatment. Statistical Analysis: Frequency of different ADRs was assessed and p value was determined. Results: Incidence of TB was more among males than female (76.47% against 23.53%. Seventy-one patients (69.01% showed one or more ADR. Incidence of ADRs based on affected organ was: Gastrointestinal (GI disorders in 38 patients (53.52%, generalized weakness in 12 patients (16.9%, liver dysfunction in 11 patients (15.49%, allergic skin reactions in six patients (8.45%, neurological system disorders in two patients (2.82%, and fever in two patients (2.82%. However, 30.99% did not experience any ADRs. Conclusion: Incidence of ADRs due to DOTS therapy was 69.01%. Majority of cases suffered from GI symptoms. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.

  4. System and Empirical Study on Adverse Drug Reaction Warning Based on Association Rule%基于关联规则的ADR预警系统及实证研究

    Institute of Scientific and Technical Information of China (English)

    冯秀珍; 贺小红; 冯变玲

    2012-01-01

    针对目前我国药品不良反应(ADR)预警的不足,基于数据立方的多维关联规则挖掘方法引入药品不良反应预警领域,提出基于关联规则的ADR预警系统框架,并结合药品不良反应自发呈报系统(SRSs)实际数据进行实证分析.根据支持度和置信度,从药品和用药患者两个维度实现预警,为ADR预测预警问题提供一种新方法,为医生用药提供决策支持.%To deal with the current insufficiency on adverse drug reaction (ADR) warning in our country, the paper firstly introduced the multidimensional association rule mining methods based on data cube into the field of warning of ADR, then proposed the warning system framework of ADR based on association rule, and finally carried on an empirical analysis combining the data from ADR spontaneous reporting systems. Based on the support and confidence, the paper re-alized the warning function from two dimensions of patients and drugs, which provided a new method for the problem of ADR warning. This was significantly meaningful to provide supports for prescription on the illnesses treatments.

  5. 432例药品不良反应报告分析%Analysis of 432 cases of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    张笑颖; 叶银梅

    2016-01-01

    [AbstrAct]Objective:To investigate the characteristics and patterns of the adverse drug reactions (ADRs) in our hospital, and provide references for rational drug use.Methods:A total of 432 ADR reports in our hospital from 2014 to 2015 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 were analyzed statistically.results:The ADR occurred mostly in elderly patients and children. Among the 432 cases, 136 kinds of drugs were involved, 171 cases were induced by 32 anti-infective drugs; the ADR was mostly induced by intravenously administered drugs (289 cases) and manifested mainly as lesions of skin and its appendants, damage of digestive system and nervous system.conclusion: On the basis of the concept of patient-centered services and attention of leadership, the work of ADR monitoring was advancing all the time by taking several measures, for promoting patient's medication safety and effectiveness.%目的:探讨我院药品不良反应发生的特点及规律,为临床合理用药提供参考。方法:采用回顾性分析方法,收集我院2014–2015年432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等进行分析。结果:432例ADR中,老年人、儿童患者ADR发生率较高;引起ADR共涉及药物136种,其中抗感染药物32种,共引发ADR 171例次;引发ADR的给药途径以静脉给药为主,共计289例;ADR累及系统/器官方面,皮肤及其附件、消化系统、神经系统损害等发生率高。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,ADR监测水平逐步提高,促进了患者用药的安全、有效。

  6. Adverse Drug Reactions in 2013:Analysis of 217 Cases%2013年217例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    宋锦飞; 徐琳; 孙光春

    2014-01-01

    目的:了解复旦大学附属上海市第五人民医院(以下简称“我院”)药品不良反应( ADR)的发生情况,以促进临床合理用药。方法:回顾性调查2013年我院收集的217例ADR报告,从患者的年龄、性别、药品种类、给药途径等方面进行统计、分析。结果:217例ADR中,男女患者比例为0�7∶1�0;≥60岁患者78例(占35�94%);静脉给药147例(占67�74%),口服给药59例(占27�19%);抗感染药致ADR 119例,居首位;ADR临床表现主要为皮肤及其附件损害(80例,占36�87%)。结论:应加强医院ADR监测工作,合理、规范使用抗感染药,避免或减少严重的ADR发生。%OBJECTIVE:To investigate the characteristics of adverse drug reaction ( ADR ) in Shanghai Fifth People�s Hospital Affiliated to Fudan University ( hereinafter referred to as “our hospital“) so as to promote clinical rational use of drug. METHODS:217 ADR cases collected in our hospital during 2013 were analyzed statistically in terms of patients�age and gender, drug types and route of administration etc. RESULTS:The 217 ADR cases occurred in male/female ratio of 0�7∶ 1; 78 cases ( 35�94%) aged ≥60 years; 147 cases ( 67�74%) were induced via intravenous injection;59 cases(27�19%) were induced by oral drugs;the anti⁃infective drugs ranked the first in terms of ADR incidence; 80 cases ( 36�87%) manifested as lesions of skin and its appendants. CONCLUSIONS: It is important to strengthen ADR monitoring in hospital and achieve rational and standard use of anti⁃infective drugs so as to avoid or reduce the occurrence of severe ADR.

  7. 190例药品不良反应报告分析%Analysis of 190 Cases of Adverse Drug Reactions Reports

    Institute of Scientific and Technical Information of China (English)

    祁平; 黄炜; 尹志国

    2015-01-01

    OBJECTIVE:To investigate the incidence of adverse drug reaction ( ADR) in Ankang Central Hospital ( hereinafter referred to as “our hospital”) , and to provide reference for the promotion of clinical rational use of drug . METHODS:Retrospective analysis was adopted , 190 cases of ADR that collected in our hospital during 2012-2015 were analyzed statistically in terms of patients'gender and age , drug types and route of administration etc .RESULTS:Of the 190 ADR cases, males were 116 cases and females were 74 cases, the male/female ratio was 1.6∶1.0;46 cases(24.21%)aged >60 years;127 cases(66.84%)were induced by intravenous injection;40 cases(26.32%) were induced by oral drugs;62 cases ( 31.79% of the total 195 cases ) were induced by the anti-infectious agents , which dominated the first place of ADR incidence; the clinical manifestation of ADR manifested as skin and its accessories damage (85 cases, 33.33% of the total 255 cases).CONCLUSIONS: It is important to strengthen ADR monitoring, promote the rational and standard drug use in our hospital , so as to avoid or reduce the incidence of ADR to ensure safety in drug use .%目的:了解安康市中心医院(以下简称“我院”)药品不良反应( adverse drug reaction ,ADR)的发生情况,为临床合理用药提供参考。方法:采用回顾性分析方法,对2012—2015年我院收集的190例ADR报告中患者性别、年龄及使用药品种类、给药途径等方面进行统计分析。结果:190例ADR中,男性116例,女性74例,男女之比为1.6∶1.0;>60岁患者46例(占24.21%);静脉给药引发ADR 127例(占66.84%),口服给药引发ADR 40例(占26.32%);抗感染药引发ADR 62例次(占合计195例次的31.79%),居首位;ADR的临床表现主要为皮肤及其附件损害(85例次,占合计255例次的33.33%)。结论:应加强医院ADR监测工作,合理、规范用药,避免或减少ADR发生,保证用药安全。

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

    OpenAIRE

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

    2016-01-01

    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 de...

  9. 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.

  10. The association between drugs frequently used by the elderly and vitamin D blood levels: a review of observational and experimental studies

    NARCIS (Netherlands)

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

    2014-01-01

    The risk of adverse drug reactions (ADRs) rises with increasing age. In the field of ADRs, drug–nutrient interactions (DNIs) are a relatively unexplored area. More knowledge will contribute to the simple prevention of this type of ADR. As the prevalence of vitamin D deficiency in the elderly is high

  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. 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

  13. 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...

  14. Cadec: A corpus of adverse drug event annotations.

    Science.gov (United States)

    Karimi, Sarvnaz; Metke-Jimenez, Alejandro; Kemp, Madonna; Wang, Chen

    2015-06-01

    CSIRO Adverse Drug Event Corpus (Cadec) is a new rich annotated corpus of medical forum posts on patient-reported Adverse Drug Events (ADEs). The corpus is sourced from posts on social media, and contains text that is largely written in colloquial language and often deviates from formal English grammar and punctuation rules. Annotations contain mentions of concepts such as drugs, adverse effects, symptoms, and diseases linked to their corresponding concepts in controlled vocabularies, i.e., SNOMED Clinical Terms and MedDRA. The quality of the annotations is ensured by annotation guidelines, multi-stage annotations, measuring inter-annotator agreement, and final review of the annotations by a clinical terminologist. This corpus is useful for studies in the area of information extraction, or more generally text mining, from social media to detect possible adverse drug reactions from direct patient reports. The corpus is publicly available at https://data.csiro.au.(1).

  15. 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...

  16. Global patterns of adverse drug reactions over a decade

    DEFF Research Database (Denmark)

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

    2012-01-01

    -613 reports/million inhabitants/year) and low-income countries the lowest (range 0-21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was non-significant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines...

  17. Analysis of Case Reports of Pioglitazone's Adverse Drug Reaction%吡格列酮的不良反应病例报告分析

    Institute of Scientific and Technical Information of China (English)

    曾艳; 李晓玲; 王育琴

    2011-01-01

    Objective:To review and analyze the case reports of pioglitazone' s adverse drug reactions to provide reference for rational and safe use of pioglitazone. Method: Reactions Weekly was searched for case reports with the key word ' pioglitazone' , types of ADRs of the case reports were classified and the patients' clinical characteristics, types and outcome of ADRs were analyzed. Result:41 case reports of ADRs associated with pioglitazone were found. 41 patients consisted of 21 males, 19 females and 1 unidentified, and were aged 30 -82 years with a pioglitazone' s dosage 15 -45 mg per day and its duration from 1 week to 2 years. Their ADRs were involved in many systems such as cardiovascular system, respiratory system and biliary system. Except for 1 patient with unaquired outcome, 8 patients died, the rest recovered after pioglitazone' s discontinuation with or without therapy. Conclusion: Pioglitazone could induce severe adverse reactions such as heart failure and liver failure. The medical staff should monitor ADR as they used piolitazone.%目的:对吡格列酮药品不良反应(ADR)病例报告进行回顾分析,为临床合理安全使用提供参考.方法:以"pioglitazone"为检索词检索Reactions Weekly,将检索到的ADR病例报告分类,分别提取患者的临床特征及ADR类型、转归等信息,进行统计分析.结果:检索到与吡格列酮相关ADR病例报告41份.41名患者中男21例,女19例,1名性别不明.年龄30-82岁,吡格列酮剂量15-45 mg·d-1,疗程1周-2年.发生ADR分别涉及心血管系统、呼吸系统、肝胆系统等多个系统/器官.41名患者中1名转归不明,8名死亡,其余患者停药后或停药经治疗后好转或痊愈.结论:吡格列酮引起的心衰、肝衰竭等ADR会给患者带来较大危害,甚至危及到生命.医务人员在使用吡格列酮的同时,要关注其ADR.

  18. HOSPITALIZATIONS DUE TO ADVERSE DRUG EVENTS IN THE ELDERLY – A RETROSPECTIVE REGISTER STUDY

    Directory of Open Access Journals (Sweden)

    Outi Laatikainen

    2016-10-01

    Full Text Available 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.

  19. 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

  20. Adverse drug reactions and their measurement in the rheumatic diseases.

    Science.gov (United States)

    Day, R O; Quinn, D I; Conaghan, P G; Tett, S E

    1995-05-01

    Drugs administered as therapy for rheumatological disorders are a relatively common cause of adverse events. Important data regarding the effects of drugs on patients with rheumatological conditions is being lost or rendered inaccessible because of deficiencies in classification, measurement, and collection methods for adverse drug reactions. A significant number of adverse reactions to drugs will not be known before marketing, and hence vigilance on the part of clinicians and patients in observing and documenting these reactions is paramount in building our knowledge and modifying our practice accordingly. A variety of systems and methods for detecting adverse drug reactions are described, critically evaluated, and compared for cost, potential bias, ethical concerns, and subject recruitment required for necessary statistical power. Systems need to be developed to give access to the wealth of clinical experimental data available in the individual practices of a broad spectrum of clinicians. To facilitate this, representative organizations need to make adverse drug reactions a high priority as well as contributing expertise and finance to database formulation and accessibility.

  1. 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.

  2. 我院开展药品不良反应监测工作的探讨%Discussion of ADR monitoring in our hospital

    Institute of Scientific and Technical Information of China (English)

    林洁娜

    2009-01-01

    Objective :To strengthen the monitoring of adverse drug reactions (ADR) in hospital, streamline the managerial system of adverse drug reactions(ADR). Methods: EstabLish a monitoring network on adverse drug reactions;better monitor and report system on adverse drug reactions; improve reports in quality and quantity. Results: Increasing quantity in ADR reports, huge improvement on quality of reports. Conclusion: Effective ADR monitoring system and measures enable smooth development in hospital ADR working progress.%目的:加强医院药品不良反应的监测,规范药品不良反应管理制度.方法:建立药品不良反应监测网络,完善药品不良反应监测和报告的工作制度,提高报表的质量和数量.结果:ADR报表数量上升,报表质量大幅提高.结论:有效的ADR监测制度和措施,能促进医院ADR工作的顺利开展.

  3. [Reported adverse reactions of veterinary drugs and vaccines in 2005].

    Science.gov (United States)

    Müntener, C R; Bruckner, L; Gassner, B; Demuth, D C; Althaus, F R; Zwahlen, R

    2007-02-01

    We received 105 reports of suspected adverse events (SARs) following the use of veterinary drugs for the year 2005. This corresponds to a 35% increase compared to 2004. Practicing veterinarians sent most of these declarations. 73% of these concerned drugs used on companion animals. Antiparasitic drugs approved for topical use were the most frequently represented group with 48%, followed by drugs used to treat gastrointestinal disorders (11%) and drugs used off-label (14%; other target species or other indication). For the first time 2 declarations concerning the application of permethrin containing spot-on preparations used by mistake on cats were received. An overview of 20 declarations about adverse reactions following application of different vaccines is also presented with emphasis on the problem of fibrosarcoma in cats. We are pleased by the growing interest shown by practicing veterinarians for the vigilance system and hope to further develop this collaboration in the future.

  4. 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.

  5. Analysis of Adverse Drug Reactions of Simvastatin And Its Interaction With Other Drugs%辛伐他汀的不良反应及与其他药物的相互作用分析

    Institute of Scientific and Technical Information of China (English)

    罗敏仪

    2016-01-01

    目的:分析辛伐他汀的不良反应及与其他药物的相互作用。方法筛选医院2013年2月至2015年4月门诊开具的辛伐他汀不良反应事件处方,分析其不良反应表现及与其他药物的相互作用。结果共搜集涉及辛伐他汀的不良反应处方168张,不良反应以肌无力、横纹肌溶解、肝损害、多尿等为主要表现,并累及多个系统,主要集中在神经肌肉系统(34.52%)、肝肾系统(20.83%)、皮肤系统(15.48%)等。不良反应患者中,辛伐他汀用药20 mg∕d比例最高(58.93%),其次为10 mg∕d(17.86%)。168张不良反应处方中,因药物相互作用引起的共41张,其中大环内酯类联用比例最高(56.01%),其次为烟酸(17.07%)。结论辛伐他汀使用不当易出现不良反应,开处方时需根据实际情况,合理调整剂量及选择配伍药物。%Objective To analyze the adverse drug reactions ( ADR ) of simvastatin and its interaction with other drugs. Methods ADR events in the hospital clinic from February 2013 to April 2015 were screened,the ADR were analyzed,and simvastatin's interactions with other drugs was statistical analysis. Results Simvastatin's ADR were collected from 168 co-prescriptions,and the ADR mainly manifested as muscle weakness,rhabdomyolysis,liver damage,and diuresis. The ADR usually involved multiple systems,mainly in the neuromuscular system(34. 52%),liver and kidney systems(20. 83%),skin(15. 48%)etc. Cases of adverse reactions,the drug simvastatin 20 mg∕d had the highest percentage(58. 93%),followed by 10 mg∕d(17. 86%). In the 168 prescriptions of ADR,ADR due to drug interactions led to a total of 41,in which erythromycin combination had the highest percentage(56. 01%),followed by nicotinic acid drugs(17. 07%). Conclusion Improper use of simvastatin prone to ADR,prescription needs to be based on the actual situation,a rea-sonable adjustment of the dose,choose a

  6. 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.

  7. 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

  8. Perception of the risk of adverse reactions to analgesics: differences between medical students and residents

    Directory of Open Access Journals (Sweden)

    Sandra Castillo-Guzman

    2016-07-01

    Full Text Available Background. Medications are not exempt from adverse drug reactions (ADR and how the physician perceives the risk of prescription drugs could influence their availability to report ADR and their prescription behavior. Methods. We assess the perception of risk and the perception of ADR associated with COX2-Inbitors, paracetamol, NSAIDs, and morphine in medical students and residents of northeast of Mexico. Results. The analgesic with the highest risk perception in both group of students was morphine, while the drug with the least risk perceived was paracetamol. Addiction and gastrointestinal bleeding were the ADR with the highest score for morphine and NSAIDs respectively. Discussion. Our findings show that medical students give higher risk scores than residents toward risk due to analgesics. Continuing training and informing physicians about ADRs is necessary since the lack of training is known to induce inadequate use of drugs.

  9. 格列吡嗪致不良反应52例文献分析%Analysis of Adverse Drug Reactions Caused by Glipizide

    Institute of Scientific and Technical Information of China (English)

    马满玲; 邱晓红; 杨丽杰; 郭美华; 马妍妍; 刘世萍

    2013-01-01

    OBJECTIVE:To explore the general regularity and characteristics of adverse drug reaction of glipizide,and to provide reference for the rational use in the clinic.METHODS:52 cases induced by glipizide were statistically analyzed in terms of patient's age,gender,ADR history,clinical manifestation,use reasean and primary desease and so on.RESULTS:The ratio of male to female was 1 ∶ 1.2,with average age of (63.4 ± 6.6) years old.48.1% of the patients use drugs unreasonably,and 32.7 % combined use of drugs.Clinical types of ADR mainly were hypoglycemic (75.0%),and 94.2% of cases cured.CONCLUSIONS:Glipizide can cause severe adverse drug reactions,and even can cause death.We must be carefully considered about the age,usage and dosage and other factors when using.Rational drug use can reduce the incidence of ADR.%目的:了解格列吡嗪致不良反应(ADR)的发生特点及规律,为临床合理用药提供参考.方法:对格列吡嗪所致的52例ADR文献进行统计,分析格列吡嗪致ADR患者的性别、年龄、ADR史、用药情况、临床表现、用药原因及合并疾病等.结果:格列吡嗪致ADR患者的男女性别比例为1∶1.2,平均年龄为(63.4±6.6)岁.有48.1%的患者存在不合理用药行为,32.7%的患者联合用药.ADR临床类型以低血糖反应为主(占75.0%),其中94.2%的患者可治愈或好转.结论:格列吡嗪可引起较为严重的ADR,甚至可致死,使用时须慎重考虑患者年龄、用法用量及合并疾病等相关因素,做到合理用药,减少ADR的发生.

  10. 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...

  11. 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.

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

    Science.gov (United States)

    2016-01-01

    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

  13. 14例唑来膦酸不良反应文献分析%Literature Analysis of 14 Cases of Adverse Drug Reactions Induced by Zoledronic Acid

    Institute of Scientific and Technical Information of China (English)

    韩一萱

    2014-01-01

    Objective:To analyze the general rules and characteristics of the adverse drug reactions(ADRs)induced by zoledronic acid so as to provide a reference for rational drug use in clinical practice.Methods:ADRs of zoledronic acid were retrieved from CNKI and VIP database since it was put into market in China and the data was analyzed statistically. Results:Totally 14 cases of ADRs(including 3 men and 11 women)caused by zoledronic acid were collected. The youngest patient was 43 years old and the oldest was 78 years old. The patients over the age of 50 showed the highest incidence(n= 11,78.6%). Their ADRs were involved in systemic damage such as musculo-skeletal system damage, metabolic and nutritional disorders, and hepatobiliary system damage,etc.Conclusion:Clinicians and pharmacists should understand the rules and characteristics of the ADRs induced by zoledronic acid and strengthen monitoring on drug use so as to reduce the incidence of ADR.%目的:分析唑来膦酸不良反应发生的规律及特点,为合理用药提供参考。方法:检索唑来膦酸在中国上市以来中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)收载的不良反应文献进行统计分析。结果:唑来膦酸不良反应的个案报道共14例,男性3例,女性11例,年龄最小为43岁,最大为78岁,年龄50岁以上发生率较高(11例,78.6%);不良反应分别涉及全身性损害、肌肉骨骼系统损害、代谢和营养障碍、肝胆系统损害等。结论:临床医师和药师应了解唑来膦酸致不良反应的规律和特点,加强用药监测,以减少不良反应的发生。

  14. 细辛脑注射液不良反应137例分析%Literature analysis of 137 adverse drug reaction reports of asarone injection

    Institute of Scientific and Technical Information of China (English)

    许恒峰

    2014-01-01

    Objective To explore the types and risk factors of adverse drug reactions (ADRs) induced by Asarone injection so as to provide references for clinical rational use of drug.Methods The ADRs of Asarone injection which reported in domestic medical journal from January 1999-June 2013 were collected and analyzed.Results 72 literatures were picked up from the whole 142 results,137 cases of Asarone injection were collected.The ADRs of Asarone injection were mainly occurred in children below 9 years old (60.59%),ADRs can be accumulated and prompted several organ systems to skin damage,such as allergic reactions and gastrointestinal damage,ect.The adverse drug reaction was abrupt and usually occured within 30 minutes (81.76%),the combined medication accounted for 67.88%.Conclusion Asarone injection can cause varies type of ADRs,which happens mainly to the young adults and those use the combination of Asarone injection and other drugs at the same time.%目的 探讨细辛脑注射液不良反应的发生类型、特点及相关风险因素,为临床合理用药提供参考.方法 对1999年1月至2013年6月医药学期刊报道有关细辛脑注射液致不良反应文献进行汇总和分析.结果 共检索文献全文142篇,纳入分析的文献72篇,共137例细辛脑注射液所致不良反应,药物不良反应可累积多个系统,以皮肤损害、过敏反应、胃肠道损害最为常见,严重者可致过敏性休克、急性肾功能衰竭;9岁以下患者占60.59%,不良反应发生在30 min以内的占81.76%,联合用药时占67.88%.结论 细辛脑注射液的不良反应以速发型为主,多发于青少年,并且联合用药时不良反应发生率较高.

  15. [Photodegradation of chlorpromazine, a drug-related adverse event].

    Science.gov (United States)

    Chabi, Yossounon; Brahim, Kheira; Da Costa, Maryline; Caffin, Anne-Gaëlle; Camus, Gisèle; Paillet, Michel; Bohand, Xavier

    2016-04-01

    The photodegradation of an active substance during treatment is a rare drug-related adverse event which can sometimes have serious consequences. Health professionals must be aware of the specific storage and administration instructions with regard to chlorpromazine and ensure that they are respected.

  16. Adverse Consequences of Drug Use in the Elderly

    NARCIS (Netherlands)

    C.S. van der Hooft (Cornelis)

    2006-01-01

    textabstractAlthough drug therapy often results in beneficial effects and improves functional status, adverse consequences of pharmacotherapy are a major patient safety concern, especially in the growing older population '.In the well-known report 'To err is human: building a safer health care syste

  17. Contribution of pharmacists to the reporting of adverse drug reactions

    NARCIS (Netherlands)

    van Grootheest, AC; van Puijenbroek, EP; de Jong-van den Berg, LTW

    2002-01-01

    Purpose The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. Methods A total of 15 293 reports, sent to the Netherlands

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

    NARCIS (Netherlands)

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

    2003-01-01

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

  19. 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.

  20. Improvement of knowledge, attitude and perception of healthcare workers about ADR, a pre- and post-clinical pharmacists' interventional study

    Science.gov (United States)

    Mohebbi, Niayesh; Hendoiee, Narjes; Keshtkar, Abbas-Ali; Dashti-Khavidaki, Simin

    2012-01-01

    Purpose Healthcare workers have a main role in detection, assessment and spontaneous reporting of adverse drug reactions (ADRs), and improvement of their related knowledge, attitude and perception is essential. The goal of this study was evaluation of clinical pharmacists' interventions in improvement of knowledge, attitude and perception of healthcare workers about ADRs in a teaching referral hospital, Tehran, Iran. Method Changes in knowledge, attitude and perception of healthcare workers of Imam teaching hospital about ADRs were evaluated before and after clinical pharmacists' interventions including workshops, meetings and presentations. Results From the 100 participated subjects, 82 of them completed the study. 51% of the health workers have been aware of the Iranian Pharmacovigilance Center at the ministry of health before intervention and after that all the participants knew this centre. About awareness and detection of ADRs in patients, 69 (84.1%) healthcare workers recognised at least one, and following interventions, it was improved to 73 (89%). Only seven (8.5%) subjects have reported ADRs in before intervention phase that were increased significantly to 18 (22%) after intervention. Conclusion Clinical pharmacists' interventions were successful in improvement of healthcare workers' knowledge, attitude and perception about ADRs and spontaneous reporting in our hospital. PMID:22246555

  1. 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.

  2. 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

  3. Adverse Reaction Analysis of 572 Cases of Anti-infection Drugs%572例抗感染药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    张芸博; 张佳丽; 曹强

    2012-01-01

    0bjective T o analyze occurrence of adverse antHnfection drug reaction , and provide reference for safe drug use. M ethods A nalyzing 572 cases of adverse antHnfectbn drug reaction in our hospital from January 1, 2008 to D ecem ber 31, 2010 by retrospective m ethod . A nalyzing and evaluating 1he sex and age of 1he patients, adverse reaction in each year, drug types, dosage form and clinical manifestations of ADR . Results Annual average happened num ber present ascendant trend. Q uinobne have m ore adverse reactions, accounted for 28 .90% . The incidence of intravenous inaction pow dertnjection adverse reaction is higher than other dosage form , accounted for 56 .31% . Conclusfon The num ber of adverse antHnfectbn drug reaction is related to many factors such us drug types and route of adm inistration . M edicalw orker should pay high attention to 1he adverse anti-infectbn drug reaction, im prove 1he A D R m onitoring level, prom ote clinical rational safe drug use.%目的 分析近年来抗感染药物不良反应(Adverse drug reaction,ADR)发生情况,为安全使用药物提供参考.方法 采用回顾性方法,分析我院2008年1月1日-2010年12月31日收集到的572例抗感染药物不良反应,从患者的性别年龄、各年度不良反应发生情况、药品种类、剂型及ADR的临床表现等方面进行分析、评价.结果 年度发生例数呈现上升趋势,其中喹诺酮类发生不良反应较多,占28.90%;静脉注射粉针剂不良反应发生率高于其它剂型,占56.31%.结论 抗感染药物发生ADR的例数与药品种类、给药途径等多种因素相关.医务工作者应高度重视抗感染药物的不良反应,提高ADR监测水平,促进临床合理、安全用药.

  4. 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.

  5. 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

  6. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring

    Directory of Open Access Journals (Sweden)

    Van Erps Jan

    2011-03-01

    Full Text Available Abstract Background In spite of enhanced control efforts, malaria remains a major public health problem causing close to a million deaths annually. With support from several donors, large amounts of artemisinin-based combination therapy (ACT are being deployed in endemic countries raising safety concerns as little is known about the use of ACT in several of the settings where they are deployed. This project was undertaken to profile the provenance of the pharmacovigilance reporting of all anti-malarials, including ACT to the WHO adverse drug reaction (ADR database (Vigibase™ over the past 40 years. Methods The WHO Programme for International Drug Monitoring, the Uppsala Monitoring Centre (UMC provided anonymized extracts of Vigibase™ covering the period 1968-2008. All countries in the programme were clustered according to their malaria control phase and income status. The number of individual case safety reports (ICSRs of anti-malarials was analyzed according to those clusters. Results From 1968 to 2008, 21,312 ICSRs suspecting anti-malarials were received from 64 countries. Low-income countries, that are also malaria-endemic (categorized as priority 1 countries submitted only 1.2% of the ICSRs. Only 60 out of 21,312 ICSRs were related to ACT, 51 of which were coming from four sub-Saharan African countries. Although very few ICSRs involved artemisinin-based compounds, many of the adverse events reported were potentially serious. Conclusions This paper illustrates the low reporting of ADRs to anti-malarials in general and ACT in particular. Most reports were submitted by non-endemic and/or high-income countries. Given the current mix of large donor funding, the insufficient information on safety of these drugs, increasing availability of ACT and artemisinin-based monotherapies in public and private sector channels, associated potential for inappropriate use and finally a pipeline of more than 10 new novel anti-malarials in various stages of

  7. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

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

    2015-01-01

    and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%) were associated with "other blood glucose lowering medications," the remaining 2 (13%) with "DDP-4 inhibitors." Conclusion: Clinical notes could potentially reveal unlabeled ADRs associated with prescribed medicines and sufficient...... 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...

  8. 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

  9. 我院2009-2013年药品不良反应报告217例分析%Analysis of adverse reactions of drugs in our hospital from 2009 to 2013:on 217 cases report

    Institute of Scientific and Technical Information of China (English)

    卿常春; 罗锡; 黄春玲

    2014-01-01

    目的:了解该院药品不良反应( ADR)发生的特点及规律,掌握ADR事件发生的特点并制定相应对策,减少ADR事件的伤害。方法2009年1月-2013年11月上报ADR 217例,按性别、年龄、药物制剂、药品种类、给药途径、ADR累积器官或系统及临床表现等方面进行回顾性分析统计。结果217例ADR报告中,静脉滴注给药引发的ADR报告比例最高,占85.25%;涉及药品品种以抗菌药物为首,占38.71%;ADR累计器官或系统主要为皮肤系统,临床表现以皮疹、瘙痒、潮红、红斑为主。结论重视医院开展ADR监测工作,加强相关培训,提高医务人员上报意识,利于为调整医院用药方式及筛选用药品种提供理论依据,确保用药安全。%Objective To investigate the characteristics and general features of adverse drug reactions ( ADR ) oc-curred in our hospital for reference of clinical rational drug administration and to develop better countermeasures ,reducing the ADR event of injury.Methods Retrospectively analyzed the 217 cases ADR reports,collected from January 2009 to November 2013 in the hospital,by gender,age,drug formulations,variety of drugs,route of administration,organs and system related to ADR,clinical manifestations and other aspects .Results Among 217 cases of ADR reports ,the highest proportion of ADR re-ports was caused by administered intravenously , accounting for 85.25%;The ADR induced by antimicrobial drugs was the higheat,accounting for 38.71%;The organ or system related to ADR was skin systems ,the mainly clinical manifestations were skin rash,itching,flushing and erythema .Conclusion It is right to emphasize the ADR monitoring and improve the conscious-ness in order to ensure the clinical rational drug administration .ADR monitoring work carried out in the hospital ,help to pro-vide a theoretical basis for the adjustment of hospital medication and screening of drug varieties , to ensure

  10. Patient knowledge on reporting adverse drug reactions in Poland

    Science.gov (United States)

    Staniszewska, Anna; Dąbrowska-Bender, Marta; Olejniczak, Dominik; Duda-Zalewska, Aneta; Bujalska-Zadrożny, Magdalena

    2017-01-01

    Aim The aim of the study was to assess patient knowledge on reporting of adverse drug reactions. Materials and methods A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills. Results The respondents who lived in the city had a greater knowledge compared to the respondents who lived in the countryside (Pearson’s χ2=47.70, P=0.0013). The respondents who lived in the city were also more statistically likely to provide a correct answer to the question about the type of adverse reactions to be reported (Pearson’s χ2=50.66, P=0.012). Statistically significant associations were found between the place of residence of the respondents and the correct answer to the question about the data that must be included in the report on adverse reactions (Pearson’s χ2=11.7, P<0.0001). PMID:28096661

  11. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... FDA Form 3500A (Adverse Reaction Report) for each adverse drug experience not reported under paragraph... resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA; however, applicants must... applicant shall report to FDA adverse drug experience information, as described in this......

  12. 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.

  13. Analysis of 73 Cases of Adverse Drug Reactions Caused by Carbapenem Antibiotics%我院73例碳青霉烯类抗菌药不良反应分析

    Institute of Scientific and Technical Information of China (English)

    彭婕; 程乐

    2015-01-01

    Objective:To investigate the adverse drug reactions ( ADR) caused by carbapenem antibiotics and discuss the influen-cing factors to provide reference for the rational use of carbapenems in clinics. Methods:The ADR caused by carbapenems from March 1, 2008 to August 1, 2014 in our hospital were statistically analyzed. Results:Totally 73 cases of ADR were caused by carbapenems. The number of ADR for men and women was similar. The ADR occurred in 80-year-old people with more frequency. The incidence of ADR on the first day of administration was relative high. The ADR were mainly manifested as skin and appendages disorders and nerve system damage. Conclusion: Great attention should be paid to the ADR of carbapenems and the state of patients. The medication should be adjusted in the patients with declined renal function and nerve system basic diseases in order to reduce the damage of ADR.%目的:探讨我院碳青霉烯类抗菌药所致不良反应的特点及相关因素,为临床合理用药提供参考. 方法: 对我院2008年3月1日~2014年8月1日上报的因使用碳青霉烯类抗菌药出现的不良反应报告进行统计分析. 结果: 由碳青霉烯类引起的不良反应共73例. 发生不良反应的男女例数相当,80岁以上人群发生不良反应例数较多. 用药第1天发生不良反应例数较多. 不良反应主要为皮肤及其附件损害、神经系统损害. 结论: 临床应重视碳青霉烯类抗菌药的不良反应,用药时注意患者的临床表现,对于肾功能减退、患神经系统基础疾病的患者及时调整用药方案,减少不良反应的危害.

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    ). 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...

  15. 噻唑烷二酮类药物致不良反应文献分析%Literature Analysis on Adverse Drug Reactions Induced by Thiazolidinediones

    Institute of Scientific and Technical Information of China (English)

    张士勇

    2014-01-01

    Objective:To analyze the general patterns and characteristics of adverse drug reactions ( ADR ) induced by thiazolidinedi-ones ( TZDs) and provide reference for clinical medicination.Methods:ADR of TZDs reported in Chinese medical science journals were retrieved from CNKI literature base and VIP database were collected and analyzed statistically .Results:A total of 24 ADRs were identi-fied and included in the analysis.Patients over the age of 60 years showed the highest ineidence ( n=16 ,66.7%) .ADR of TZDs always attack after 1 month(n=11,45.8%).Their ADRs were involved in many system such as red blood cell disorders , cardiovascular general disorders,metabolic and nutritional disorders ,liver and biliary system disorders.Conclusion:Clinicians should use TZDs reasonably and tighten monitoring on its using to reduce the incidences of ADR.%目的:分析噻唑烷二酮类药物不良反应的发生情况及临床特点,为合理用药提供参考。方法:对在CNKI、VIP数据库收载的噻唑烷二酮类药物不良反应文献进行统计分析。结果:噻唑烷二酮类药物不良反应的文献报道共24例;年龄60岁以上患者发生率较高(16例,66.7%);多发生在用药1个月后(11例,45.8%);分别涉及红细胞异常、心血管系统一般损害、代谢和营养障碍、肝胆系统损害等多个系统-器官。结论:临床应用噻唑烷二酮类药物时,应加强用药监测,以减少不良反应的发生。

  16. 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

  17. Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile.

    Directory of Open Access Journals (Sweden)

    Marie E Gabe

    Full Text Available OBJECTIVE: To assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR Profile for Respiratory Medicine. DESIGN: Single-site parallel-arm pragmatic trial using stratified randomisation. SETTING: Nurse-led respiratory outpatient clinic in general hospital in South Wales. PARTICIPANTS: 54 patients with chronic respiratory disease receiving bronchodilators, corticosteroids or leukotriene receptor antagonists. INTERVENTION: Following initial observation of usual nursing care, we allocated participants at random to receive at follow up: either the West Wales ADR Profile for Respiratory Medicine in addition to usual care ('intervention arm' with 26 participants; or usual care alone ('control arm' with 28 participants. MAIN OUTCOME MEASURES: Problems reported and actions taken. RESULTS: We followed up all randomised participants, and analysed data in accordance with treatment allocated. The increase in numbers of problems per participant identified at follow up was significantly higher in the intervention arm, where the median increase was 20.5 [inter-quartile range (IQR 13-26], while that in the control arm was -1 [-3 to +2] [Mann-Whitney U test: z = 6.28, p<0.001]. The increase in numbers of actions per participant taken at follow up was also significantly higher in the intervention arm, where the median increase was 2.5 [1]-[4] while that in the control arm was 0 [-1.75 to +1] [Mann-Whitney U test: z = 4.40, p<0.001]. CONCLUSION: When added to usual nursing care, the West Wales ADR Profile identified more problems and prompted more nursing actions. Our ADR Profile warrants further investigation as a strategy to optimise medication management. TRIAL REGISTRATION: Controlled-trials.com ISRCTN10386209.

  18. Adverse drug reactions and cost effectiveness of non-steroidal anti-inflammatory drugs, muscle relaxants, and neurotropic drugs in patients with low back pain

    Directory of Open Access Journals (Sweden)

    I. B. Patel

    2015-04-01

    Conclusion: Patient on combination of three drugs (NSAIDs, muscle relaxants, and neurotropic agents had maximum ADRs and their prescription cost per day was highest among the three groups. [Int J Basic Clin Pharmacol 2015; 4(2.000: 273-277

  19. 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.

  20. 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

  1. 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

    , formoterol, mometasone, montelukast, salbutamol and terbutaline and the combinations of budesonide/formoterol, fenoterol/ipratropium and fluticasone/salmeterol. Main outcome measures Reported ADRs were categorized with respect to distribution on age, sex, type and seriousness of reported ADRs, medications...... and subcutaneous disorders" (9 % of total ADRs). The largest number of ADRs was reported for budesonide (21 % of total ADRs), followed by salbutamol (20 % of total ADRs) and fluticasone (19 % of total ADRs). For salbutamol, the largest numbers of serious ADRs were "tachycardia", "accidental exposure/incorrect dose...

  2. 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

  3. Pattern and incidence of adverse drug reactions observed in cardiac clinic of tertiary hospital, Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard, New Delhi

    Directory of Open Access Journals (Sweden)

    Abhishank Singh

    2015-10-01

    Conclusion: There is a need for conducting such studies in more and more patients to see the pattern of ADRs in cardiac patients. More information will help in reducing the ADR occurrence and making drug use more rational and safe for patients. [Int J Basic Clin Pharmacol 2015; 4(5.000: 847-852

  4. The New Zealand Centre for Adverse Reactions Monitoring: a source of practice-based evidence

    Directory of Open Access Journals (Sweden)

    Savage R

    2013-06-01

    Full Text Available The database of the New Zealand Centre for Adverse Reactions Monitoring (CARM is an example of the practice-based evidence discussed in the June issue of the Journal of Primary Health Care. Databases of reported adverse drug reactions (ADRs were established to generate hypotheses to be tested about previously unrecognised adverse reactions and interactions. Occasionally they are sufficient evidence in themselves. They can also identify prescribing practices that might increase the potential for ADRs to occur and provide feedback into guidelines in terms of the consequences of their use or non-use. Well-documented ADR reports can also highlight risk factors, thus providing a valuable contribution to risk benefit assessments in individual patients. Examples are discussed that support the use of ADRs as practice-based evidence in a non-hierarchical system in which case reports and case series, observational studies and randomised clinical trials contribute in a flexible relationship depending on the issue under investigation.

  5. 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.

  6. Automatic adverse drug events detection using letters to the editor.

    Science.gov (United States)

    Yang, Chao; Srinivasan, Padmini; Polgreen, Philip M

    2012-01-01

    We present and test the intuition that letters to the editor in journals carry early signals of adverse drug events (ADEs). Surprisingly these letters have not yet been exploited for automatic ADE detection unlike for example, clinical records and PubMed. Part of the challenge is that it is not easy to access the full-text of letters (for the most part these do not appear in PubMed). Also letters are likely underrated in comparison with full articles. Besides demonstrating that this intuition holds we contribute techniques for post market drug surveillance. Specifically, we test an automatic approach for ADE detection from letters using off-the-shelf machine learning tools. We also involve natural language processing for feature definitions. Overall we achieve high accuracy in our experiments and our method also works well on a second new test set. Our results encourage us to further pursue this line of research.

  7. 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; Pepper, Michael S

    2016-10-01

    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.

  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. Potential adverse effects of discontinuing psychotropic drugs. Part 3: Antipsychotic, dopaminergic, and mood-stabilizing drugs.

    Science.gov (United States)

    Howland, Robert H

    2010-08-01

    Abrupt discontinuation of antipsychotic drugs in patients with schizophrenia is associated with earlier, and often more severe, illness episodes than are seen with gradual discontinuation. Antipsychotic drugs can cause various abnormal motor syndromes, but abruptly stopping them has been associated with the seemingly paradoxical development of similar motor syndromes, such as withdrawal dyskinesias, parkinsonian symptoms, dystonias, and neuroleptic malignant syndrome. Dopamine-releasing and dopamine-agonist drugs are used to treat some of the motor syndromes caused by antipsychotic drugs, but their abrupt discontinuation can also be associated with abnormal syndromes. When antipsychotic drugs, lithium, or certain anticonvulsant drugs are used for treatment of bipolar disorder, rapid versus gradual discontinuation is more likely to lead to greater mood instability and manic relapse. If necessary, these medications should be gradually tapered to minimize all types of adverse discontinuation effects. Patients should be educated about the possible adverse effects of abrupt medication discontinuation.

  10. 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.

  11. 我院104例儿童药物不良反应报告分析%Analysis on 104 adverse drug reactions report of children in our hospital

    Institute of Scientific and Technical Information of China (English)

    董淼

    2014-01-01

    目的:调查药物不良反应(ADR)发生情况,促进临床合理用药。方法对我院儿科2011年-2013年报告的104例儿童药物不良反应进行统计与分析。结果104例药物不良反应中,抗生素占首位63.46%,静脉给药方式为主要途径,临床表现以皮肤损害最为常见。结论应重视ADR监测工作,促进临床合理用药。%Objective To study the characteristics of adverse drug reaction(ADR) in our hospital and to Promote a rational clinical use of drugs. Methods Pediatric hospital in 2011-2013 collected 104 cases of adverse drug reaction reports for statistical analysis. Results 104 cases of adverse drug reaction reports, antibiotics accounted for the first 63.46% Intravenous administration is the main way. The clinical manifestations of the most common skin lesions. Conclusions ADR monitor must be strengthened in order to guide the clinically rational use of drugs.

  12. 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

  13. Adverse drug reactions of injection during 2011-2012 at Foshan TCM Hospital%我院2011-2012年注射剂不良反应分析

    Institute of Scientific and Technical Information of China (English)

    李影雄; 黄小梅; 陈丽; 雷凯君; 肖碧波

    2014-01-01

    目的 总结我院近年的注射药品不良反应(Adverse Drug Reaction,ADR)的规律和特点,减少注射剂不良反应对患者的危害,确保临床用药安全、有效.方法 对我院2011至2012年度因临床使用注射剂出现ADR的275例患者,对性别、年龄、给药途径、药物种类、可疑药品及临床表现等方面进行回顾性统计分析.结果 275例报告中,青壮年、中老年分别为54.18%和36.00%;主要为静滴方式占91.27%;主要为抗生素占47.64%,其次为中药制剂占21.45%,而抗生素中头孢菌类占52.67%,喹诺酮类占19.85%.结论 我院注射剂ADR的发生与患者性别差异无统计学意义,年龄分布较广;给药途径以静滴为首要;药品以抗菌药物及中药制剂为主.临床应合理使用抗菌药物和中药注射剂,减少ADR的发生.%Objective To reduce the risks of adverse drug reactions (ADRs) and to safely and effectively use drugs in clinic analyzing the characteristics of the ADRs of injection during 2011-2012 at our hospital.Methods 275 patients with ADRs caused by using injection during 2011-2012 at Foshan TCM Hospital were selected.The patients' age,sex,drug categories,main ways of medication,suspected drugs,and clinical manifestations were retrospectively analyzed.Results Among the reported 275 cases of ADRs,132 were male,and 143 female; 54.18% were young adults,and 36.00% old.Intravenous infusion was the main way for drug administration,accounting for 91.27%.47.64% occurred in infusing antibiotics,and 21.45% in infusing traditional Chinese medicine.In antibiotic related ADRs reports,cephalosporin and quinolone accounted for 52.67% and 19.85%,respectively.Conclusions There was no statistical difference of sex in the ADRs reports.The patients' age range was wide.Most ADRs of the patients were caused by intravenous infusion with antibiotics and traditional Chinese medicine.So we suggest that antibiotic medicine and traditional Chinese medicine

  14. Joint Symptoms, Aromatase Inhibitor-Related Adverse Reactions, Are Indirectly Associated with Decreased Serum Estradiol

    OpenAIRE

    Junko Honda; Miyuki Kanematsu; Misako Nakagawa; Masako Takahashi; Taeko Nagao; Akira Tangoku; Mitsunori Sasa

    2011-01-01

    Background. Joint symptoms (JSs) are problematic adverse drug reactions (ADRs) of aromatase inhibitors (AIs). Involvement of decreased serum estradiol (SE) has been suggested. Patients and Methods. 104 postmenopausal breast cancer patients administered an AI were prospectively investigated regarding various clinical parameters, JS and hot flashes as ADRs, and the SE level. Results. JS manifested in 31.7% of patients and hot flashes in 18.3%. Chi-square testing showed a significantly hig...

  15. [Chinese medicine adverse reactions' literature statistical analysis in recent five years].

    Science.gov (United States)

    Xiang, Fei; Zhang, Xiaogang

    2011-10-01

    Since the state food and drug administration (SFDA) issued the first edition of adverse drug reaction(ADR) information in November, 2001, it has 32 edition, reported the drug 66 species of adverse reactions, involving the variety of 12 traditional Chinese medicines, it was effectively reminds all social concern of adverse drug reaction. For statistical analysis in recent years reported adverse drug reaction of prepared Chinese medicine, collected 462 literatures from 2005-09 CNKI Chinese journal full-text database of medicine health directory. In all the collections, about 94 literatures are closely related to adverse drug reaction report of prepared Chinese medicine. But there are only 7 references could identify traditional Chinese medicine and western medicine correctly in 72 literatures with the value of statistical analysis. That means only 8.9% of literatures can correctly identify western medicine and Chinese traditional medicine. So it proved that TCM workers' knowledge of ADR remains to be greatly improved.

  16. Streptokinase Adverse Reactions: A Review of Iranian Literature

    Directory of Open Access Journals (Sweden)

    Ava Mansouri

    2015-10-01

    Full Text Available Thrombolytic agents are among the medications that are used widely for the treatment of thromboembolic disorders and myocardial infarction (MI. Despite the world-wide availability of newer specific agents, streptokinase (SK is still the most frequently used medication from this class in Iran. Hence we conducted this study to review the adverse reactions to this medication which were reported in the Iranian studies. We preformed this study by searching the English resources such as Pubmed, Google scholar and Scopus. Additionally, we searched Google scholar, Scientific Information Database, Magiran and IranMedex to cover Persian articles.We found 50 articles from the mentioned resources after deleting the duplicated records. Nineteen articles remained after implementing the inclusion and exclusion criteria. In most of the studies the indication for SK treatment was MI. Assessment of streptokinase ADRs was the main focus of 7 studies. The most frequent adverse drug reaction (ADR was related to the cardiovascular system. Among them arrhythmia and hypotension were the most frequent ones. The second most prevalent ADR was bleeding followed by allergic reactions. In two studies only a single system ADR was studied: neurologic adverse effects and elevation in liver enzymes. Only very limited number of studies assessed the causality of the ADRs which made the interpretation of the results difficult. Among the associated factors that were assessed as risk factors of ADRs, age was the focus of 2 studies. The Iranian studies reported frequent ADRs similar to previous reports. However, due to the heterogeneity of the studies we could not describe the frequency and severity of reported ADRs in a more clear and precise conclusion.

  17. 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...... present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country......, 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....

  18. 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.

  19. 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.

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

    OpenAIRE

    Saini, V. K.; 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 ...

  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. An Analysis of 164 Cases of Anticancer and Supplementary Drugs Adverse Reactions%我院抗肿瘤及辅助治疗药物不良反应164例分析

    Institute of Scientific and Technical Information of China (English)

    刘加涛; 金亮; 汪燕燕; 周莹; 夏泉

    2012-01-01

    目的 对我院肿瘤内科不良反应(ADR)的发生情况及特点进行分析,为临床合理用药提供参考.方法 采用回顾性分类统计,对164例报告涉及的患者年龄、性别、给药途径药物类别以及临床表现进行分析.结果 164例ADR中男性76例,女性88例;40岁以上154例;细胞毒类药物的发生率居首,占77.9%;ADR的临床表现以消化系统反应为主,其次为骨髓抑制.结论 开展ADR监测工作是医务人员,特别是临床药师的重要任务,加强ADR监测,保障患者用药安全.%Objective To provide reference for clinical rational drug use, the tumor patients's advene drug reacton(ADR) occurrence and characteristics in our hospital were analyzed Methods In this paper, 164 cases of patients with anti-tumor drug adverse reaction reports were retrospective analyzed on the age, sex, administration way, drug classes and clinical manifestations. Results The results showed that adverse drug reacton mainly happened in the 40 yean and old tumor patients. Cytotoxic drugs take the highest incidence. The clinical manifestations of adverse drug reacton in gastrointestinal reaction is given priority, followed by bone marrow inhibition. Conclusion Adverse drug reacton monitoring and reporting work which ensure patients safely use their drugs is the medical staff, especially the clinical pharmacists important task.

  3. 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

  4. Summary and Analysis of Adverse Drug Reactions Induced by Salmon Calcitonin for Injection%注射用鲑鱼降钙素不良反应汇总分析

    Institute of Scientific and Technical Information of China (English)

    苏娜; 吴斌; 徐?

    2013-01-01

    Objective To study the characteristics and the general pattern of adverse drug reactions ( ADR ) induced by salmon calcitonin. Methods The literatures of ADR induced by salmon calcitonin reported in the domestic medical journals during 1994-2012 were retrieved by means of CNKI,and a related database was established for statistical analysis. Results 15 cases of ADR induced by salmon calcitonin were retrieved,which including the integumentary system,cardiovascular system,digestive system,nervous system and allergic reaction. The advanced age group and women showed the higher incidence rate. Conclusion The adverse reactions caused by salmon calcitonin should arouse clinical attention to persist its rational use.%目的 探讨鲑鱼降钙素致不良反应的一般规律和特点.方法 检索(CNKI)1994年至2012年鲑鱼降钙素所致不良反应文献,并进行统计分析.结果 共检索到不良反应病例15例,包括皮肤系统、心血管系统、消化系统、神经系统和变态反应.在高年龄段和女性患者中发生率较高.结论 临床上应重视鲑鱼降钙素的不良反应,坚持合理用药.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. [Application analysis of adverse drug reaction terminology WHOART and MedDRA].

    Science.gov (United States)

    Liu, Jing; Xie, Yan-ming; Gai, Guo-zhong; Liao, Xing

    2015-12-01

    Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country

  10. Allele frequency net 2015 update: new features for HLA epitopes, KIR and disease and HLA adverse drug reaction associations.

    Science.gov (United States)

    González-Galarza, Faviel F; Takeshita, Louise Y C; Santos, Eduardo J M; Kempson, Felicity; Maia, Maria Helena Thomaz; da Silva, Andrea Luciana Soares; Teles e Silva, André Luiz; Ghattaoraya, Gurpreet S; Alfirevic, Ana; Jones, Andrew R; Middleton, Derek

    2015-01-01

    It has been 12 years since the Allele Frequency Net Database (AFND; http://www.allelefrequencies.net) was first launched, providing the scientific community with an online repository for the storage of immune gene frequencies in different populations across the world. There have been a significant number of improvements from the first version, making AFND a primary resource for many clinical and scientific areas including histocompatibility, immunogenetics, pharmacogenetics and anthropology studies, among many others. The most widely used part of AFND stores population frequency data (alleles, genes or haplotypes) related to human leukocyte antigens (HLA), killer-cell immunoglobulin-like receptors (KIR), major histocompatibility complex class I chain-related genes (MIC) and a number of cytokine gene polymorphisms. AFND now contains >1400 populations from more than 10 million healthy individuals. Here, we report how the main features of AFND have been updated to include a new section on 'HLA epitope' frequencies in populations, a new section capturing the results of studies identifying HLA associations with adverse drug reactions (ADRs) and one for the examination of infectious and autoimmune diseases associated with KIR polymorphisms-thus extending AFND to serve a new user base in these growing areas of research. New criteria on data quality have also been included.

  11. 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

  12. 江苏省和广东省药品不良反应报告单位调查研究Δ%Study on the Adverse Drug Reaction Reporting Entities in Jiangsu Province and Guangdong Province

    Institute of Scientific and Technical Information of China (English)

    张雪梅; 冯变玲; 杨世民; 郭佳栋; 肖勋霞

    2015-01-01

    目的:了解江苏省和广东省药品不良反应(ADR)报告单位工作开展现状,为ADR监测工作的完善提供依据。方法:通过查阅文献了解国内外关于ADR监测工作的概况,以江苏省和广东省ADR报告单位(药品生产企业、药品经营企业、医疗机构)为研究对象进行整群抽样,发放调查问卷,运用描述性统计分析等方法对调查结果进行处理和分析。结果:共回收有效问卷205份。江苏省和广东省受访ADR报告单位专门建立ADR监测部门的分别为67家和60家,专门配备人员负责ADR工作的分别占98.1%和99.0%;ADR监测工作在药品生产、经营企业绝大多数隶属于质量管理部门,在医疗机构大多隶属于药剂科;大多数配备了计算机、打印机、复印机等基本办公设备;但大多数工作职责仍不够明确;有专门用于ADR监测工作的预算的分别为27家和15家;与当地ADR监测中心有交流沟通的分别占97.2%和96.9%,但信息反馈情况不理想;对工作人员进行了相关培训的分别占85.0%和86.7%;制度建设方面,建立标准工作流程的情况相对较好,其他相关制度建设尚不够理想;发现ADR后会立即上报的分别占91.6%和90.8%,会对上报的ADR进行备份记录的分别占92.5%和97.9%,以网络报告形式为主;工作满意度评价方面,江苏省的平均分高于广东省。结论:针对调查结果,建议通过完善ADR监测工作组织建设、优化办公条件、保证ADR监测经费支持、加强工作交流、加强制度建设等措施,促进其ADR监测工作的开展。%OBJECTIVE:To investigate the present situation of adverse drug reaction(ADR)reporting entities in Jiangsu prov-ince and Guangdong province,and provide reference for the improvement of ADR monitoring. METHODS:With the overview of ADR monitoring at home and abroad by reading literatures,the ADR reporting entities(drug

  13. Hypothermia following antipsychotic drug use

    NARCIS (Netherlands)

    van Marum, Rob J.; Wegewijs, Michelle A.; Loonen, Anton J. M.; Beers, Erna

    2007-01-01

    Objective Hypothermia is an adverse drug reaction (ADR) of antipsychotic drug (APD) use. Risk factors for hypothermia in ADP users are unknown. We studied which risk factors for hypothermia can be identified based on case reports. Methods Case reports of hypothermia in APD-users found in PUBMED or E

  14. Hypothermia following antipsychotic drug use

    NARCIS (Netherlands)

    Marum, R.J. van; Wegewijs, M.A.; Loonen, A.J.M.; Beers, E.

    2007-01-01

    Objective: Hypothermia is an adverse drug reaction (ADR) of antipsychotic drug (APD) use. Risk factors for hypothermia in ADP users are unknown. We studied which risk factors for hypothermia can be identified based on case reports. Method: Case reports of hypothermia in APD-users found in PUBMED or

  15. Pharmaceutical systematics: Description and preliminary investigation of an alternative method for structuring drug information

    Directory of Open Access Journals (Sweden)

    Mary E. Kiersma, Pharm.D., M.S.

    2011-01-01

    Full Text Available Objectives: To identify the 30 most common adverse drug events or reactions (ADE/ADRs within the top 200 medications: (1 by raw incidence, (2 weighted by prescription volume, (3 and weighted by retail dollars. Methods: The Pharmacy Times Top 200 Medications (as ranked by prescription volume was utilized to identify the top 200 medications in 2008. The ADE/ADRs for each medication were obtained from Facts and Comparisons, Micromedex, and Lexi-Comp and entered into a database. These ADE/ADRs were compiled and summed, identifying the number of times each appeared. These then were ranked to identify the 30 most common ADE/ADRs. The actual prescription volume and total retail dollars for each medication were obtained and listed next to each medication’s ADE/ADR. The incidence of each ADE/ADR then was weighted by actual prescription volume and retail dollars to determine the top 30 most common ADE/ADRs.Results: Initial evaluation resulted in 9829 individual ADE/ADRs and summed into 1477 distinct ADE/ADRs, after adjusting for interchangeable terminology. Examples of the 30 most common ADE/ADRs (raw incidence included: dizziness/vertigo, headache,nausea, vomiting, and diarrhea/loose stools. The list remained the same after weighting by actual prescription volume. After weighting by retail dollars, the order of ADE/ADRs changed slightly.Conclusion: Knowledge of ADE/ADRs is important for pharmacists in all healthcare settings. Consolidating ADE/ADRs for medications may enable pharmacists to recall the most common side effects and aid in earlier identification of ADE/ADRs, which may positively impact patient safety across practice settings.

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

    Directory of Open Access Journals (Sweden)

    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.

  17. Advances in adverse drug reactions of carbapenem antibiotics and corresponding prevention countermeasures%碳青霉烯抗生素的药品不良反应及其预防措施研究进展

    Institute of Scientific and Technical Information of China (English)

    金卫; 武鑫; 王瑞兰

    2016-01-01

    碳青霉烯类抗生素对β‐内酰胺酶耐受,对G+菌、G-菌、需氧菌和厌氧菌具有抗菌活性,在临床广泛使用。近年来,随着碳青霉烯类抗生素使用日渐增多,细菌耐药率不断攀升,其药品不良反应(ADRs)受到更多关注。本文对碳青霉烯类抗生素导致ADRs的原因、类型及其防治措施做一综述,以期为临床安全合理用药提供参考。%Carbapenem antibiotics are resistant toβ‐lactamases and display potent activity against gram‐positive and gram‐negative bacteria ,as well as aerobes and anaerobes ,and are widely used in clinical application .In recent years ,with the in‐creasing application of carbapenems and rising incidence of adverse drug reactions (ADRs) ,great concerns have been given to ADRs of carbapenems .In this paper ,the causes ,types and preventive countermeasures of ADRs of carbapenems are reviewed , so as to provide firm evidence for the safe and rational use of carbapenem clinically .

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

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    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

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

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    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. Mortality due to acute adverse drug reactions in Galicia: 1997-2011.

    Science.gov (United States)

    Miguel-Arias, Domingo; Pereiro Gómez, César; Bermejo Barrera, Ana M; López de Abajo Rodríguez, Benito; Sobrido Prieto, María

    2016-03-02

    The aim of this research is to study all people who died in the Autonomous Community of Galicia from acute death after drugconsumption (ADR) in which there was judicial intervention during the period from 1997 to 2011, according to inclusion and exclusión criteria established by the National Drug Plan for the entire national territory. Sociodemographic and clinical characteristics of deceased subjects were studied, in order to identify key risk factors and/or vulnerable populations.A total of 805 deaths were recorded. The distribution by provinces and municipalities corresponds to the areas of greatest population, incidence of consumption and proximity to the coast. The average age of these patients was 34.34 years, with a gradual increase over years. Most of them were male (91.2%) and single (47.7). 43.5% of the deceased habitually used the parenteral route of administration and 36.4% had positive HIV serology. The most frequently-detected substances corresponded to opiates (heroin: 61.3%, methadone: 35.6%), followed by cocaine (53.7%), although the most common pattern was that of poly-consumption. ADR mortality figures remain relatively stable throughout the study period. The predominant pattern is that of males, opiates and a long history of consumption.

  1. 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.

  2. 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

  3. 莫西沙星的不良反应分析%Adverse drug reactions induced by moxifloxacin

    Institute of Scientific and Technical Information of China (English)

    方可华; 于锋英

    2011-01-01

    目的 探讨莫西沙星不良反应发生的一般规律,为临床合理安全用药提供参考. 方法 以莫西沙星为关键词,检索维普数据资源系统、万方数据资源(2001年1月-2010年1月)系统,收集莫西沙星不良反应的文献和病例,对患者的一般情况、用药情况、不良反应类型和发生时间、临床表现和转归等资料进行回顾性分析. 结果 94例患者中,年龄≥50岁的患者有62例,占65.96%,明显高于其他年龄段,且老年伴基础疾病患者更易发生;静脉滴注66例,占70.21%,口服28例,占29.79%;发生不良反应110例次,其中神经系统损害达38例次,占34.55%,其次主要累及皮肤及附件和四肢肌肉表现各占15.45%,过敏样反应占9.09%. 结论 临床应重视莫西沙星不良反应的危害性,注意用药患者的人群特点.%OBJECTIVE To explore the general law of adverse drug reactions (ADRs) induced by moxifloxacin, and provide reference for the clinical rational use of drugs. METHODS Moxifloxacin as the search-word and VIP,WANGFANG DATA (2001. 01-2010. 01 )were searched. The data were analyzed retrospectively, including characteristics of patients, drug use, as well as type,onset time, clinical manifestations and prognosis to advese drug reaction. RESULTS In 94 case of patients, the patients aged more than 50 were 62 cases, accounting for 65.96% ; Intravenous drip were 66 cases, accounting for 70. 12%, 28 cases of oral medication, accounting for 29.79% ;Among 110 case-times of adverse reactions, 38 cases occurred to nervous system disorders (34. 55%).Next was skin and appendages disorders(15 %), limb musculo-skeletal system disorders ( 15.45 %). The ratio of allergic reactions was 9. 09%. And it is more likely to occur in elder persons (>50 years) with underlying diseases. CONCLUSION Clinical doctors should pay more attention to the dangers of ADRs induced by moxifloxacin.

  4. Refining adverse drug reaction signals by incorporating interaction variables identified using emergent pattern mining

    OpenAIRE

    Reps, Jenna M.; Aickelin, Uwe; Hubbard, Richard B.

    2016-01-01

    Purpose: To develop a framework for identifying and incorporating candidate confounding interaction terms into a regularised cox regression analysis to refine adverse drug reaction signals obtained via longitudinal observational data. Methods: We considered six drug families that are commonly associated with myocardial infarction in observational healthcare data, but where the causal relationship ground truth is known (adverse drug reaction or not). We applied emergent pattern mining to fi...

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

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    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. Establishment of multi-drug resistance human B-cell lymphoma cell line BJAB/ADR and preliminary research of its drug-resistance mechanism%人类B细胞淋巴瘤耐药细胞株BJAB/ADR的建立及其耐药机制的初步研究

    Institute of Scientific and Technical Information of China (English)

    鲍世琦; 姜琳琳; 张晓龙; 李真真; 邵晓枫; 齐怀丰; 杨雨琪; 熊冬生

    2014-01-01

    目的 建立人类淋巴瘤B JAB多药耐药细胞株BJAB/ADR,并初步研究其耐药机制.方法 采用多柔比星浓度梯度递增法建立人类B细胞淋巴瘤耐药细胞模型BJAB/ADR,观察其生长规律并绘制细胞生长曲线;用四甲基偶氮唑蓝(MTT)法鉴定耐药细胞株对多种化疗药物的耐药性并计算耐药指数;提取耐药细胞株RNA,实时定量聚合酶链反应(PCR)法检测相关耐药基因MDR1 mRNA的表达;流式细胞术检测细胞表面P糖蛋白(Pgp)的表达;通过罗丹明外排实验,检测Pgp功能.结果 成功建立B细胞淋巴瘤耐药细胞模型BJAB/ADR,并在160 ng/ml多柔比星溶液中稳定生长,耐药细胞较敏感细胞生长缓慢,细胞形态无明显变化.MTT检测结果表明BJAB/ADR细胞对多柔比星的耐药指数为43倍,同时对柔红霉素、依托泊苷、高三尖杉酯碱(HHT)及米托蒽醌(MX)也具有一定的耐药性.实时定量PCR结果表明,耐药细胞BJAB/ADR MDRl mRNA明显高于药物敏感细胞BJAB(P< 0.01).流式细胞术检测结果显示,耐药细胞表面Pgp高表达;罗丹明外排实验表明Pgp对多柔比星具有外排功能,使B JAB/ADR细胞获得耐药特性.结论 建立了人类B细胞淋巴瘤的耐药细胞株BJAB/ADR,其对多柔比星耐药性稳定,并呈现多药耐药细胞的基本生物学特性,为进一步研究肿瘤多药耐药发生的机制及逆转耐药提供有利的模型.%Objective To establish human multi-drug resistance (MDR) B-cell lymphoma cell line BJAB/ADR and investigate its biological characteristics.Methods Human B-cell lymphoma MDR cell line BJAB/ADR was induced by exposure to increasing dose of adriamycin.The growing features of BJAB/ADR were observed and cell growth was measured,IC50 of antitumor agents was evaluated by MTT assay.The expression of MDR1 mRNA was determined with real-time PCR,FACS was applied to study the expression of MDR protein P-glycoprotein (Pgp) and Rhodamine 123R efflux assay was used to

  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.

  8. 上海市部分三级医院临床医师药品不良反应认知度调查分析%Investigation and ana1ysis of clinicians' cognition of adverse drug reaction in partial first class hospitals of Shanghai

    Institute of Scientific and Technical Information of China (English)

    阎仲珩; 黄登笑; 黄淇敏

    2011-01-01

    Objective To investigate the primary clinicians' cognition of adverse drug reactions (ADR) knowledge and reporting work of clinicians. Methods Three hundred and seventy primary clinicians of 10 affiliated hospitals of Shanghai Jiaotong University School of Medicine were selected for a random questionnaire survey. The questionnaires were composed of three parts: the basic data of investigated objectives ( part one), cognition of ADR knowledge ( part two) and cognition of ADR reporting work ( part three). Results There were 347 effective questionnaires, and the effective rate was 96.12%.A total of 22.8% of clinicians knew the cause of ADR correctly, 17.6% could correctly determine ADR from a variety of drug damaging events, 58.8% had a certain degree of confidence when judging the common ADR, and 31. 1% had a certain degree of confidence to judge the new or unreported ADR. Besides, 52.2% of clinicians were aware that ADR needed to be reported, 49.6% had cognition that reporting ADR was the obligation of medical staffs, 22.8% knew that ADR needed to be reported to the Adverse Reaction Monitoring Center, and 11.0% were aware of the deadline of reporting ADR. For the cognition scoring of reporting ADR, only 17.5% of clinicians got more than 3 points. When encountering ADR, 18. 7% of the clinicians reported all the cases. The main reasons for omission of reporting procedures were unfamiliarity of reporting procedures (46.0%), busy working and lack of time (37.6%) and thinking it unnecessary to report ( 28.0% ). Conclusion Clinicians have some basic understanding of ADR, with inconsistent understanding degree and poor familiarity with the unitary reporting work. Clinicians should learn more from publicity, education and training about ADR, enhance awareness of reporting work, improve the level of ADR judgment, and improve th% quality of ADR monitoring report.%目的 研究临床一线医师对药品不良反应(ADR)相关知识和报告

  9. 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

  10. 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

  11. 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

    2016-10-02

    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.

  12. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  13. Cutaneous adverse drug reaction profile in a tertiary care out patient setting in Eastern India

    Directory of Open Access Journals (Sweden)

    Abanti Saha

    2012-01-01

    Conclusions: Cutaneous adverse drug reaction profile in this study is similar in many ways to studies conducted earlier in India. Incidence of life-threatening reactions like SJS-TEN was higher compared with studies conducted abroad. Reaction time and lesion patterns are helpful in identifying an offending drug in the setting of multiple drug therapy.

  14. 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

  15. 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.

  16. 160例阿德福韦酯不良反应特征及骨软化的风险因素分析%Analysis of 160 Cases of Adverse Drug Reaction Characteristics and Risk Factors of Osteomalacia Induced by Adefovir

    Institute of Scientific and Technical Information of China (English)

    许莉莉; 田月洁; 谢彦军; 崔小康; 翟淑越

    2015-01-01

    目的:探讨阿德福韦酯致不良反应(ADR)发生的一般规律、特点及风险因素,为临床安全用药提供参考。方法对山东省 ADR 数据库中160例涉及阿德福韦酯的 ADR 报告进行回顾性分析,对不良反应表现的时间分布等进行了探讨,重点对骨骼系统损害和低磷血症的不良反应进行分析。结果阿德福韦酯的 ADR 主要累及胃肠系统损害、皮肤及其附件损害;严重 ADR 主要累及骨骼肌肉系统损害、泌尿系统损害,多于长时间用药后发生。胃肠系统损害、皮肤及其附件损害主要是用药半年内出现,肝肾功能异常、血磷降低可于用药半年以上出现,骨骼肌肉损害可于用药1年以上出现,骨软化症可于用药4年以上出现。结论阿德福韦酯的 ADR 的具有时间关联性,长期用药产生肾毒性而导致血磷降低和骨软化症,高龄和肝硬化患者可能更易发生严重 ADR,应加强用药期间的肝肾功能及血磷的定期监测,正确诊断,及时治疗。%Objective To probe into the general rules, characteristics and risk factors of the ADR induced by adefovir so as to provide references for clinical safe medication. Methods We retrospectively analyzed 160 ADR cases induced by adefovir which were collected by Shandong adverse drug reaction database, discussed the time distribution of the ADRs, and emphatically analyzed the ADRs of the skeletal muscle system lesions and hypophosphatemia. Results The ADRs induced by adefovir mainly involved in stomach intestinal system lesions and skin and local lesions. The serious ADRs by adefovir mainly involved in skeletal muscle system lesions and urinary system lesions, and usually appeared after a long-term administration. Stomach intestinal system lesions and skin and local lesions usually appeared within half a year, abnormal liver and renal function and hypophosphatemia usually appeared after half a year, skeletal muscle system

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

    Science.gov (United States)

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

    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 73 patients of lung cancer were screened for occurrence of adverse drug reactions during their treatment with chemotherapy. About 87.36% patients experienced adverse drug reactions, 90.09% and 83.56% of breast and lung cancer patients experienced at least one adverse drug reaction respectively. In breast cancer patients, 41.58% patients were prescribed fluorouracil+doxorubicin+cyclophosphamide while paclitaxel was prescribed to 22.77% patients. Alopecia (54.94%), nail discolouration (43.96%), dysgeusia (38.46%), anorexia (30.77%), nausea (29.67%), and neuropathy (29.67%) were found to be very common in breast cancer patients treated with single/combined regimen. In lung cancer group of patients, cisplatin with docetaxel, cisplatin with pemetrexed and cisplatin with irinotecan were prescribed to 30.14, 24.65 and 17.81% patients, respectively. Dysgeusia (40.98%), diarrhoea (39.34%), anorexia (32.77%) and constipation (31.15%) and alopecia (31.15%) were commonly observed adverse drug reactions having lung cancer patients. Causality assessments using World Health Organization causality assessment scale showed that observed adverse drug reactions were of probable (64.67%) and possible (35.33%) categories. Alopecia, dysgeusia, anorexia, constipation diarrhoea, nausea, nail discoloration were more prevalent amongst the cancer patients undergoing chemotherapy.

  18. Dalteparin-sodium induced drug fever in a neonate.

    Science.gov (United States)

    Wackernagel, Dirk; Obaya, Sami; Nydert, Per

    2016-10-13

    Drug fever caused by dalteparin-sodium (DS), a low-molecular-weight derivative of heparin, is neither listed in the official drug information and nor published as a case report until today. A preterm infant, born at 26 weeks of gestation, developed fever 2 days after starting a treatment with DS for an intracardial thrombus. The fever reverses soon after changing the treatment to unfractionated heparin and reappeared after reintroduction of DS. Once again, after discontinuing DS, the infant regained normothermia. Bacterial and viral infections, tissue damage, impaired liver or kidney function, preservative agents and comedications could be ruled out as fever origin. By using the Naranjo adverse drug reaction (ADR) probability scale and the Liverpool ADR causality assessment tool, this case can be classified as 'probable ADR' and 'definite ADR'. This is the first case report of a drug fever caused by the low-molecular-weight heparin DS in a preterm infant.

  19. 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

  20. 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

  1. 药品不良反应与合理用药%Adverse drug reaction and rational use of drugs

    Institute of Scientific and Technical Information of China (English)

    赵雪华

    2014-01-01

    近年来关于药品不良反应的报道及讨论越来越引起社会的关注。通过对常见的药品不良反应类型、引起药品不良反应的因素进行分析,,提出了降低不良反应发生率及如何合理用药的举措。%The adverse drug reaction reports and discussions attracted more and more attention in recent years.We analyszed the common types of adverse drug reactions,and the causes of adverse drug reactions,thus we could put forward to reduce the incidence of adverse reactions and how to rational use of drug action.

  2. 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

  3. Drug-Related Adverse Events of Osteoporosis Therapy.

    Science.gov (United States)

    Khan, Moin; Cheung, Angela M; Khan, Aliya A

    2017-03-01

    Postmenopausal osteoporosis is associated with microarchitectural deterioration and increased risk of fracture. Osteoporosis therapy effectively reduces the risk of vertebral, nonvertebral, and hip fracture and has been associated with increased survival. Currently approved treatments for osteoporosis include bisphosphonates, denosumab, selective estrogen receptor modulators, and teriparatide. This article reviews the adverse events of therapy associated with these medical interventions. Hormone replacement therapy is not included, because it is no longer indicated for the treatment of osteoporosis in all countries. Calcitonin and strontium ranelate are also not included, because their indication for osteoporosis has recently been limited or withdrawn.

  4. Safety considerations in children:L-asparaginase-induced adverse drug reactions%左旋门冬酰胺酶不良反应引起的儿童用药安全性问题

    Institute of Scientific and Technical Information of China (English)

    黄琳; 刘一; 任晓蕾; 李玉珍

    2011-01-01

    Objective: To investigate the characteristics of adverse drug reaction (ADR) in children caused by L-asparaginase (L-ASP) from clinical practice, and to provide reference for rational use of drugs. Methods: Two cases of pediatric asthma induced by multiple doses of L-ASP were reported. Literature about L-ASP-in-duced ADR reported in domestic pharmaceutical journals from 1979 to 2011 was collected and analyzed statistically. Safety issues of L-ASP in children were further considered based on its structure, administration routes, dosing interval, and action mechanisms. Results: ADR caused by L-ASP in children was common. The main type was allergic reaction, and followed by digestive system damage and blood abnormalities. A small number of children had acute hemorrhagic necrotizing pancreatitis and severe ADR in nervous system, which had poor prognosis. Conclusion : More attention should be paid to children to avoid and reduce the occurrence of ADR induced by L-ASP.%目的:以临床实例出发探讨左旋门冬酰胺酶不良反应在儿童的发生特点,为临床用药安全提供依据.方法:报道反复使用左旋门冬酰胺酶致儿童过敏性哮喘2例,并检索1979-2011年国内医药期刊公开报道的左旋门冬酰胺酶致不良反应的病例,从药物结构、给药方式、给药时间间隔以及药物作用机制等方面进一步论述左旋门冬酰胺酶在儿童用药的安全性问题.结果:左旋门冬酰胺酶不良反应较常见,其不良反应以过敏反应为主,其次为消化系统损害和血液系统异常,且少数急性出血坏死性胰腺炎、重度神经系统不良反应患儿预后极差.结论:临床应重视左旋门冬酰胺酶的用药安全问题,积极采取措施防范不良反应的发生.

  5. 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 magnets...

  6. 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.

  7. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials

    Directory of Open Access Journals (Sweden)

    Aronson Jeffrey K

    2001-09-01

    Full Text Available Abstract Background We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may not be straightforward, for two reasons. First, not all clinical drug trials provide data on the frequency of adverse effects. Secondly, not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data. We have determined how often automated search methods, using indexing terms and/or textwords in the title or abstract, would fail to retrieve trials with adverse effects data. Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects, and measured the proportion that (i were not assigned the appropriate adverse effects indexing terms in the electronic databases, and (ii did not contain identifiable adverse effects textwords in the title or abstract. Results Of the 81 trials with records on both MEDLINE and EMBASE, 25 were not indexed for adverse effects in either database. Twenty-six trials were indexed in one database but not the other. Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper. Simultaneous use of textword and indexing terms retrieved only 82/107 (77% papers. Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects.

  8. Decisions in drug adverse reactions, intoxications and unexpected responses to herbal medicines as public health problems

    OpenAIRE

    Álvarez-Falconí, Pedro P.; Médico Farmacólogo, Bachiller en Derecho, Doctor en Medicina. Centro Nacional de Salud Pública, Instituto Nacional de Salud. Lima, Perú. Laboratorio de Investigación en Plantas Medicinales, Instituto Nacional de Salud. Lima, Perú.

    2007-01-01

    This review evaluates the relevant information on a variety of adverse drug reactions serious, real or potential, attributed to some drugs relatively recent introduction into the world market, in addition, on some intoxications by contaminated medicines, all of which contributed to decision-making in the past and present, by regulatory authorities in drugs in several countries. It explores the broad strategies related to the pillars of the drug policies, the historical and current events ...

  9. 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

  10. [Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database].

    Science.gov (United States)

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

  11. 胜利油田中心医院2014年药品不良反应报告540例分析%Adverse drug reactions during 2014 in Shengli Oil Field Central Hospital:analysis of 540 cases

    Institute of Scientific and Technical Information of China (English)

    贺德勇

    2016-01-01

    Objective To investigate the characteristics of adverse drug reaction( ADR) in Shengli Oil Field Central Hospital and promote clinical rational use of drug.Methods 540 ADR cases collected in our hospital during 2014 were analyzed statistically in terms of patients'age and gender,drug types and route of administration,clinical manifestation etc.Results The 540 ADR cases occurred in male/female ratio of 1.01:1;209 cases(38.7%) aged≥60 years;425 cases(78.7%) were induced via intravenous injection;69 cases(12.8%) were induced by oral drugs;the anti-infective drugs ranked the first in terms of ADR incidence;285 cases ( 35.14%) manifested as lesions of skin and its appendants;148 cases involved the basic drugs.Conclusion It is important to strengthen ADR monitoring in hospital and achieve rational and standard use of anti-infective drugs so as to avoid or reduce the occurrence of severe ADR.%目的:分析胜利油田中心医院(以下简称“该院”)药品不良反应( ADR)的发生情况,以促进临床合理用药。方法回顾性调查2014年该院收集、报告的540例ADR报告,从患者的年龄、性别、药品种类、给药途径、ADR的临床表现等方面进行统计、分析与评价。结果540例ADR中,男女比例接近1.01瞷1;≥60岁患者209例(占38.7%);静脉给药425例(占78.7%),口服给药69例(占12.8%);抗感染药物引起的ADR最多;ADR临床表现主要为皮肤及其附件损害285例,占52.78%;涉及基本药物148例。结论应加强医院ADR监测工作,合理、规范使用抗感染药物,避免或减少严重的ADR发生。

  12. A pilot randomised controlled trial to assess the utility of an e‐learning package that trains users in adverse drug reaction causality

    Science.gov (United States)

    Kirkham, Jamie J.; Bellis, Jennifer R.; Peak, Matthew; Smyth, Rosalind L.; Williamson, Paula R.; Pirmohamed, Munir

    2015-01-01

    Abstract Objectives Causality assessment of adverse drug reactions (ADRs) by healthcare professionals is often informal which can lead to inconsistencies in practice. The Liverpool Causality Assessment Tool (LCAT) offers a systematic approach. An interactive, web‐based, e‐learning package, the Liverpool ADR Causality Assessment e‐learning Package (LACAeP), was designed to improve causality assessment using the LCAT. This study aimed to (1) get feedback on usability and usefulness on the LACAeP, identify areas for improvement and development, and generate data on effect size to inform a larger scale study; and (2) test the usability and usefulness of the LCAT. Methods A pilot, single‐blind, parallel‐group, randomised controlled trial hosted by the University of Liverpool was undertaken. Participants were paediatric medical trainees at specialty training level 1+ within the Mersey and North‐West England Deaneries. Participants were randomised (1 : 1) access to the LACAeP or no training. The primary efficacy outcome was score by correct classification, predefined by a multidisciplinary panel of experts. Following participation, feedback on both the LCAT and the LACAeP was obtained, via a built in survey, from participants. Key findings Of 57 randomised, 35 completed the study. Feedback was mainly positive although areas for improvement were identified. Seventy‐four per cent of participants found the LCAT easy to use and 78% found the LACAeP training useful. Sixty‐one per cent would be unlikely to recommend the training. Scores ranged from 4 to 13 out of 20. The LACAeP increased scores by 1.3, but this was not significant. Conclusions Improving the LACAeP before testing it in an appropriately powered trial, informed by the differences observed, is required. Rigorous evaluation will enable a quality resource that will be of value in healthcare professional training. PMID:26032626

  13. Clinical rules in hospital pharmacy practice to prevent adverse drug events

    NARCIS (Netherlands)

    Rommers, Mirjam Kristien

    2014-01-01

    Adverse drug events (ADEs) refer to any injury from the use of a drug. ADEs occur frequently in hospitalized patients and a substantial proportion are considered preventable. A method to prevent ADEs is computerized physician order entry (CPOE) combined with a clinical decision support system (CDSS)

  14. Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text

    DEFF Research Database (Denmark)

    Eriksson, Robert; Jensen, Peter Bjødstrup; Pletscher-Frankild, Sune;

    2013-01-01

    adverse drug events (ADEs).Materials and methods Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured...

  15. ADR Cases Reported in Our Hospital:Analysis of 617 Cases in 2010%2010年我院617例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    朱虹云; 洪滟; 朱雅艳

    2012-01-01

    Objective To investigate the characteristics and regularity of adverse drug reaction! ADR )occurred in our hospital. Methods 617 ADR cases reported in our hospital in 2010 were analyzed statistically in respect of patients sex and age,routes of administration,use of drugs, organs and systems involved in ADR and its clinical manifestations, etc. Results Of 617 ADR cases, 267 cases and 70 cases were caused by anti - infectious agent and traditional Chinese medicine. The most common manifestation of ADR cases were injury of lesion of skin( 237 cases Accounting for 38.41% , followed by digestive system and its appendants( 125 cases Accounting for 20. 0%. There were new ADR of 88cases, severe ADR of 62 cases and new severe ADR of 8 cases. Conclusion Great importance should be attached to ADR monitoring in order to reduce the incidence of ADR.%目的 探讨医院药品不良反应(ADH)发生的特点及一般规律.方法 对2010年收集到的617例药品不良反应报告,分别从患者性别、年龄、给药途径、用药情况、药品不良反应累及器官或系统及临床表现等方面进行统计、分析.结果 引发药品不良反应最常见的药物为抗感染药物(267例)与中药制剂(70例).所累及的器官或系统以皮肤及其附件损害最常见,有237例(38.41%);其次为消化系统损害125例(20.26%).新的药品不良反应88例,严重的药品不良反应62例,其中新的、严重的药品不良反应8例.结论 临床应重视药品不良反应监测工作,以减少或避免药品不良反应发生.

  16. Reações adversas a medicamentos em pediatria: uma revisão sistemática de estudos prospectivos Adverse drug reactions in pediatrics: a systematic review of prospective studies

    Directory of Open Access Journals (Sweden)

    Djanilson Barbosa dos Santos

    2004-12-01

    Full Text Available O objetivo desta revisão foi explorar e comparar as informações derivadas de estudos prospectivos sobre a incidência de reações adversas a medicamentos (RAM em pediatria, publicados de janeiro de 1966 a novembro de 2003 em revistas indexadas nas bases MEDLINE, IPA e LILACS. Foram buscados trabalhos que abordassem a ocorrência de RAM em crianças atendidas em ambulatório, durante a hospitalização ou como causa de internação hospitalar não focalizados em tratamentos ou condições clínicas específicas. A análise incluiu vinte estudos de coorte prospectivos, entre os quais a incidência de RAM variou de 0,75% a 11,1% em ambulatório, de 0,6 a 4,3% como causa de internação hospitalar e de 4,4 a 18,1% entre crianças hospitalizadas. O trabalho ressalta o potencial de contribuição dos estudos prospectivos para o uso seguro de medicamentos em pediatria e sugere que a padronização de definições e de critérios metodológicos poderia torná-los mais úteis para esse objetivo.The aim of this literature review is to explore and to compare information derived from prospective studies of adverse drug reactions (ADR incidence in pediatrics. A systematic literature research was performed looking for studies involving outpatient and inpatient children as well hospitalizations due to ADR. The studies were identified in MEDLINE, IPA and LILACS databases from January 1966 to November 2003. Investigation focused on specific treatments or morbidities was not included in the review. Twenty prospective cohort studies were included in the analysis. In outpatient investigations ADR incidence varied from 0.75% to 11.1% between the studies; 0.6% to 4.3% of hospital admissions were related to ADR with ADR frequency during hospitalization varying from 4.4% to 18.1% of the children. The lack of definition standards and of methodological criteria hindered results comparison and could partly explain the different observations.

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

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    drug events in the primary care setting (Article 1). Construction of the preventable adverse drug events assessment model required four steps. The first step consisted of the development, validation, and feasibility of preventable adverse drug event indicators for type 2 diabetes (Articles 2 and 3...... associated with HbA1c monitoring and treatment was determined using logistic regression. The fourth step in the model was a health economic evaluation of the cost-effectiveness of shifting patients from inadequate to adequate medical treatment. The database used for the AMI indicator study formed...... in patients with type 2 diabetes, and apply a new register-based model with the ability to assess the epidemiology and economic impact of preventable adverse drug events in patients with type 2 diabetes, in order to give health care decision makers a clinical and health economic rationale for prioritizing...

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

    Science.gov (United States)

    Warrer, Pernille; Hansen, Ebba Holme; Juhl-Jensen, Lars; Aagaard, Lise

    2012-05-01

    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 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, medicines associated with ADRs, text-mining algorithms used and their performance. Seven studies, all from the United States, were eligible for inclusion in the review. Studies were published from 2001, the majority between 2009 and 2010. Text-mining techniques varied over time from simple free text searching of outpatient visit notes and inpatient discharge summaries to more advanced techniques involving natural language processing (NLP) of inpatient discharge summaries. Performance appeared to increase with the use of NLP, although many ADRs were still missed. Due to differences in study design 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 can be used systematically to collect new information about ADRs.

  19. Concordance and predictive value of two adverse drug event data sets

    OpenAIRE

    Cami, Aurel; Reis, Ben Y

    2014-01-01

    Background: Accurate prediction of adverse drug events (ADEs) is an important means of controlling and reducing drug-related morbidity and mortality. Since no single “gold standard” ADE data set exists, a range of different drug safety data sets are currently used for developing ADE prediction models. There is a critical need to assess the degree of concordance between these various ADE data sets and to validate ADE prediction models against multiple reference standards. Methods: We systemati...

  20. 1001份中药注射剂不良反应报告/事件分析%Analysis on 1001 Cases of Adverse Drug Reaction/Events induced by Traditional Chinese Medicine Injections

    Institute of Scientific and Technical Information of China (English)

    张开礼; 徐玉红; 吴斌; 李东

    2013-01-01

    Objective To find out the occurrence features and the regularity of the adverse drug reactions/events (ADR/ADE) induced by traditional Chinese medicine injections for promoting their rational use.Methods By using the retrospective analysis method,all ADR/ADE reported by various medical institutions in Shenzhen city from 2010 to 2011 were downloaded from the database of the Guangdong Provincial Center for ADR Monitoring in the form of Excel electronic forms.ADR/ADE reports of traditional Chinese medicine injections were screened out and analyzed.Results 1 001 cases of ADR/ADE of traditional Chinese medicine injections were screened out and involved 48 traditional Chinese medicine products from 92 manufacturers.The intravenous administration routes were used in the absolutely most of cases.The onset time of ADR/ADE was mainly within 30 min after injection.The lesions of ADR/ADE involved primarily in skin and its accessories,followed by the systemic lesions,circulation system and nerve system,etc.All age groups were involved in ADR/ADE without significant gender difference.Children 0-9 years old had the highest occurrence rate of ADR/ADE (19.48%).The prescribed single dosage in children with low age was on the high side.Among all ADR/ADE reports,446 cases (44.56%) of new ADR/ADE were presented and had good prognosis after symptomatic treatment.The severe ADR/ADE accounted for 6.89%,mainly manifested by respiratory system,circulation system symptoms and allergy shock.Conclusion ADR/ADE induced by traditional Chinese medicine injections is universal and its monitoring should be enhanced.The traditional Chinese medicine injections should be rationally used in clinic according to the traditional Chinese medicine theory,their use in children population should be reduced or avoided.The relative administration departments should strengthen the supervision and perfect the instruction contents of traditional Chinese medicine preparations for ensuring the patient

  1. 安徽省黄山市抗微生物药物不良反应报告1055例综合分析%Analysis of 1055 cases of adverse drug reaction caused by anti-microbacterial drugs in Huangshan City of Anhui ;Province

    Institute of Scientific and Technical Information of China (English)

    胡骅; 汤大娟; 谢海棠; 李静; 陈雪; 刘珍妮; 杨晓蕾

    2016-01-01

    Objective To analyze the reports of adverse drug reactions (ADR) caused by anti-microbacterial drugs from multiple hospitals in Huangshan City of Anhui Province during 2011-2013 and to summarize the data characteristics in order to reduce the ADR occurrence and promote the clinical safe and rational use of drugs. Methods A total of 1 055 cases of ADR re-port were collected in Huangshan City during 2011-2013. By using the ADR comprehensive analysis system (ADRCAS),the report data were analyzed in the aspects of the age,gender,type of involved drug and drug delivery route. Results Most of ADR caused by antimicrobial drugs in Huangshan City during 2011-2013 occurred in the age period of 40-<50 years old[22.27%(235/1 055)], most of involved organs or systems were the gastrointestinal tract system was[36.21%(382/1 055)],followed by skin and its acces-sories[23.22%(245/1 055)];amoxillin,azithromycin and roxithromycin had the highest ADR occurrence rate,which were 26.59%(271/1 055),19.53%(206/1 055) and 16.49%(174/1 055)respectively. Conclusion In the clinical treatment process of an-timicrobial drugs,the treatment effects should be paid high attention to,also their caused ADR should be highly alert, paying at-tention to safety and rationality of clinical medication.%目的:分析2011~2013年安徽省黄山市多家医院抗微生物药品不良反应(ADR)报告并总结其数据特点,以减少药品不良反应的发生,促进临床安全、合理用药。方法收集安徽省黄山市2011~2013年抗微生物ADR报告1055例,利用药品不良反应综合分析系统(ADRCAS),将报告数据按患者年龄、性别、涉及药品种类、给药途径等方面进行分析。结果2011~2013年黄山市抗微生物药品引起ADR发生最多的年龄在40~<50岁[22.27%(235/1055)];累及器官或系统最多的为胃肠道系统[36.21%(382/1055)],其次为皮肤及其附件[23.22%(245/1055)];阿莫西林、阿奇霉素和罗红霉素

  2. 简述分析几种信号监测方法在药物不良事件中的应用%Brief analysis the application of several signal monitoring methods in adverse drug events

    Institute of Scientific and Technical Information of China (English)

    代菲; 舒丽芯; 储藏; 陈盛新; 储文功

    2012-01-01

    Objective To analyze several adverse drug reaction monitoring methods in home and aboard. Methods Literature analysis and system analysis method were used to illustrate a series of calculation methods in signal extraction of adverse drug reaction. Results China had gradually begun to use different signal monitoring algorithms to detect adverse drug reaction (ADR) signals. Conclusion Medication safety issue still needed to be paid close attention to in current and future , and drug safety monitoring was mainly through the post-marketing adverse signal monitoring to achieve. Different data mining algorithms for relevant signal monitoring at home and in abroad were summarized, which would provide reference for our adverse drug reaction signal processing, and do good to the drug safety alert.%目的 分析国内外用于药物不良反应信号监测的几种监测算法.方法 运用文献分析法和系统分析法,阐述国内外针对药物不良反应信号的提取采取的一系列算法.结果 我国逐步开始引用不同的信号监测算法来发现药物不良反应(ADR)信号.结论 安全用药是当今和今后仍需要密切关注的问题,而药品安全性监测主要是通过对药品上市后不良信号监测来实现的.我们概括分析了目前国内外使用的有关信号监测的不同数据挖掘算法,为我国药品不良反应信号的处理提供参考,从而做好药物的安全警戒.

  3. Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov

    Directory of Open Access Journals (Sweden)

    Eric Wen Su

    2017-03-01

    Full Text Available Drug repositioning (i.e., drug repurposing is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics and PolyAnalyst (Megaputer were utilized. An I2E query extracts “Serious Adverse Events” (SAE data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer.

  4. 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...

  5. Suspect novel adverse drug reactions to trimethoprim-sulphonamide combinations in horses: a case series.

    Science.gov (United States)

    Stack, A; Schott, H C

    2011-01-01

    Adverse drug reactions to trimethoprim-sulphonamide combinations are common in many species, manifesting as gastrointestinal tract disorders, dermatopathies and blood dyscrasias. In this case series, neurological abnormalities in 4 horses being treated with trimethoprim-sulphonamide combinations at normal dosages and in one foal that received an overdose are described. The horses developed hypermetric gait, agitation and erratic behaviour. All signs resolved once medication was withdrawn, and no horse had residual deficits. No other cause for observed neurological deficits could be determined. These clinical signs appear to represent a novel adverse drug reaction to some commonly used antimicrobial combinations.

  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 profile of nanoparticle versus conventional formulation of paclitaxel: An observational study

    Directory of Open Access Journals (Sweden)

    Ballari Brahmachari

    2011-01-01

    Conclusions : Despite its ADR profile being statistically comparable to conventional paclitaxel, this observational study suggests that Nanoxel tolerability could be better, considering that a significantly higher dose was employed. This hypothesis needs confirmation through an interventional study.

  8. 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.

  9. 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

  10. 10523例心血管药物不良反应报告分析%Analysis of 10523 Cases of Adverse Drug Reaction of Cardiovascular A-gents

    Institute of Scientific and Technical Information of China (English)

    张桂香

    2015-01-01

    抽取湖南省上报国家不良反应中心的10523 份心血管药物不良反应报告,按患者年龄、给药途径、药品种类、涉及器官或系统、临床表现及转归等进行统计、分析. 结果显示:静脉滴注较其它给药途径更易发生ADR (5375 例,占51.1%);降压药引发 ADR 的比例最高(4052例,占59.3%);ADR 的临床表现以头痛、头晕等神经系统损害为主. 应加强心血管药物ADR 监测,减少 ADR的发生,促进临床合理用药.%The data of a total of 10523 ADR cases from Hunan were analyzed according to age,route of ad-ministration, types of drug and organ systems in-volved.The results showed that ADR cases caused by intravenous drip was the most (5375 cases,51.1%);ADR cases were mainly caused by antihypertensive a-gents ( 4052 cases, 59.3%); The ADR manifested mainly as lesions of Nervous system.Medical staff must strengthen the monitoring of ADR in cardiovascular a-gents to promote rational use of drug and reduce the in-cidence of ADR.

  11. 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.

  12. Analysis of 92 Cases of Adverse Drug Reacation/Event of Terazosin%92例特拉唑嗪不良反应/事件报告分析

    Institute of Scientific and Technical Information of China (English)

    彭丹冰; 彭源

    2011-01-01

    目的 初步了解和分析特拉唑嗪发生不良反应/事件的情况,为临床合理用药提供参考依据.方法 对笔者对收集的2006~2009年间某院92例特拉唑嗪所致不良反应/事件报告进行回顾性分析.结果 92例不良反应/事件报告中,男性远多于女性,全部是18岁以上的成年患者,其中以中老年患者居多;不良反应的临床表现以神经系统、心脏及循环系统损害最为常见.结论 医疗机构应重视特拉唑嗪的不良反应,加强对其临床应用的监管.%Objective To investigate the situation of adverse drug reaction/event(ADR/ADE) of Terazosin, and provide bases and references for rational use of Terazosin.Methods 92 ADR reports of Terazosin were collected and analyzed in a hospital from 2006 to 2010.Results In 92 reports, males were far more than females.Adult patients that older than 50 years were accounted for the majority(66.3%).The damage to the nervous system and cardiovascular system were the commonest type.Conclusion We should pay attention to the ADR/ADE of Terazosin, and strengthen the supervision of clinical application of Terazosin.

  13. Galactorrhea due to psychotropic drugs.

    Science.gov (United States)

    Kropp, S; Ziegenbein, M; Grohmann, R; Engel, R R; Degner, D

    2004-03-01

    Within the drug safety program in psychiatry AMSP ( Arzneimittelsicherheit in der Psychiatrie), severe adverse drug reactions (ADRs) are assessed. Currently 35 psychiatric hospitals and departments are participating in detecting severe ADRs. This paper focuses on prolactin-dependent ADRs such as gynecomastia and galactorrhea due to psychotropic medications. Related to the number of patients surveyed (122,562 from 1993 to 2000), these are rare events (0.03 % or 35 cases). Imputed drugs were mostly antipsychotics, but antidepressants were also imputed in single cases. In the group of antipsychotics, relative frequencies of galactorrhea were highest for amisulpride and risperidone and corresponded to the degree of D2 binding. Galactorrhea assessed as "severe" was accompanied by distressing symptoms such as pain, tension, enlargement of breasts, or soaked clothing. The AMSP data contribute to the knowledge on endocrine ADRs by the large number of patients examined and help clinicians select the appropriate drug if their patients have been prone to for these ADRs in the past.

  14. 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 prob...

  15. 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

  16. ADR Caused by Quinolones: Analysis of 199 Cases in Our Hospital%我院199例喹诺酮类药不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    高杰; 谢诚; 缪丽燕

    2009-01-01

    OBJECTIVE: To investigate the characteristics of adverse drug reactions (ADR) caused by quinolones in our hospital and to promote their rational use in clinic. METHODS: By a retrospective review, a total of 199 quinolones - induced ADR cases collected from May 2004 to December 2007 in our hospital were analyzed statistically in respect of patients' gender and age, drug species involved, past ADR history, route of administration, clinic manifestations, etc. RESULTS: A total of 9 kinds of quinolones involved in the 199 ADR cases, of which, 118 cases were induced by levofloxacin, 16.1% had past ADR history, 93.5% of the ADR cases were induced via intravenous drip, and most common presentations of the ADR were lesions of skin and its appendants as well as digestive system. There were 7 serious ADR cases. CONCLUSION: The indications of quinolones should be controlled strictly, which should be preferably administered orally and monitoring of its administration should be emphasized in clinical practice to decrease and avoid the occurrence of ADR.%目的:了解我院喹诺酮类药不良反应发生的特点,促进临床合理用药.方法:采用回顾性调查方法,对我院2004年5月~2007年12月收集到的喹诺酮类药所致的199例不良反应报告表,分别从患者性别、年龄、涉及药品、既往不良反应史、给药途径、临床表现等方面进行统计、分析.结果:199例不良反应涉及9种喹诺酮类药,其中左氧氟沙星引起的不良反应118例;既往有不良反应史者占16.1%;93.5%的患者通过静脉滴注给药;临床表现主要以皮肤及其附件和消化系统损害最为常见,严重不良反应7例.结论:应严格掌握药物使用适应证,尽可能采用口服给药方式,重视用药监护,以减少和避免不良反应的发生.

  17. Adverse drug reactions of haloperidol used in critically ill children for the treatment of delirium

    NARCIS (Netherlands)

    Spaans, E.; Slooff, V.; Van Puijenbroek, E.; Jessurun, N.; De Hoog, M.; Tibboel, D.; De Wildt, S.

    2013-01-01

    BACKGROUND: As delirium in critically ill children is increasingly recognized, more children are treated with the antipsychotic drug haloperidol. However, little is known about its safety in this context. The objective of this study was to investigate the incidence and nature of adverse events assoc

  18. 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.

  19. Reliability of the assessment of preventable adverse drug events in daily clinical practice

    NARCIS (Netherlands)

    van Doormaal, J.E.; Mol, P.G.; van den Bemt, P.M.; Egberts, A.C.; Kosterink, J.G.; Haaijer-Ruskamp, F.M.; Zaal, Rianne J.

    2008-01-01

    Purpose To determine the reliability of the assessment of preventable adverse drug events (ADES) in daily practice and to explore the impact of the assessors' professional background and the case characteristics on reliability. Methods We used a combination of the simplified Yale algorithm and the N

  20. Risk of serious adverse effects of biological and targeted drugs in patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Tarp, Simon; Eric Furst, Daniel; Boers, Maarten

    2016-01-01

    OBJECTIVES: To determine possible differences in serious adverse effects among the 10 currently approved biological and targeted synthetic DMARDs (b/ts-DMARDs) for RA. METHODS: Systematic review in bibliographic databases, trial registries and websites of regulatory agencies identified randomized...... differences in rates of SAEs. Our data suggest caution should be taken when deciding among available drugs. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42014014842....

  1. Perceived Adverse Drug Events in Heart Failure Patients' Perception and Related Factors

    NARCIS (Netherlands)

    De Smedt, Ruth H. E.; Haaijer-Ruskamp, Flora M.; Groenier, Klaas H.; van der Meer, Klaas; Jaarsma, Tiny

    2011-01-01

    Background: Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors r

  2. Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

    Science.gov (United States)

    Federer, Callie; Yoo, Minjae; Tan, Aik Choon

    2016-12-01

    Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

  3. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    Science.gov (United States)

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.

  4. [Reversing effects of emodin on multidrug resistance in resistant HL-60/ADR cells].

    Science.gov (United States)

    Chen, Ying-Yu; Li, Jing; Hu, Jian-Da; Zheng, Jing; Zheng, Zhi-Hong; Zhu, Liang-Fang; Chen, Xin-Ji; Lin, Zhen-Xing

    2013-12-01

    This study was aimed to investigate the reversing effects of emodin on multidrug resistance (MDR) in resistant HL-60/ADR cells, and to explore the underlying mechanisms. The MTT assay was used to assess the chemoresistance of HL-60/ADR cells to emodin and 8 chemotherapeutic agents commonly used in clinic. The reversal effects of emodin on MDR of HL-60/ADR cells were also evaluated by MTT method. DNA ploidy analysis and DNA Ladder assay were used to detect apoptosis-induced effects on HL-60/ADR cells via the adriamycin (ADR) and emodin combination. The expression changes of the drug resistance-associated genes and proteins were detected by RT-PCR and Western Blot respectively. The intracellular accumulation and subcellular distribution of ADR and DNR were measured by flow cytometry and confocal laser scanning microscopy. The results showed that emodin inhibited HL-60/ADR cell proliferation with an average IC50 value of 24.09 ± 1.72 µmol/L, which was similar to that of the parental HL-60 cells (average IC50 = 23.18 ± 0.87 µmol/L). HL-60/ADR cells were resistant to a variety of chemotherapeutic agents, such as ADR, DNR, VP16, VCR,Ara-C, HHT, MTZ and THP. The reversal multiple were between 1.58 and 4.12 after the treatment with low concentration of emodin combined with the above mentioned different agents. The combination of ADR with emodin showed the best reversal effects, and the typical hypodiploid peak (apoptotic peak) and DNA ladder could be detected after the co-treatment.In addition, emodin down-regulated the mRNA and protein expression levels of MRP1, TOPOIIβ, GST π and BCL-2. Furthermore, the addition of emodin enhanced ADR and DNR intracellular accumulation and subcellular distribution in HL-60/ADR cells in dose-dependent manner. It is concluded that the emodin shows reversing effects on the multidrug resistant HL-60/ADR cells, possibly via decreasing the expression levels of drug resistance-associated genes, increasing the intracellular accumulation of

  5. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy

    Science.gov (United States)

    Petrova, Guenka; Stoimenova, Assena; Dimitrova, Maria; Kamusheva, Maria; Petrova, Daniela; Georgiev, Ognian

    2017-01-01

    Introduction: Adverse drug reactions can cause increased morbidity and mortality, and therefore information needs to be studied systematically. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system. Methods: This was a prospective, observational, 1-year, real-life study about the pharmacotherapy of a sample of 390 chronic obstructive pulmonary disease patients. Prescribed medicines were systematized and national pharmacovigilance databases were searched for reported adverse drug reactions. The expectedness was evaluated through the review of the summary of product characteristics, the seriousness was evaluated by the clinicians based on the life threatening nature of the adverse drug reactions, and the severity was evaluated through Hartwig’s Severity Assessment Scale. Descriptive statistics of the reported adverse drug reactions was performed and the relative risk of developing an adverse drug reaction with all international non-proprietary names included in the analysis was calculated. Results: Results confirm that the chronic obstructive pulmonary disease is a disease with high appearance of adverse drug reactions, and causes many additional costs to the healthcare system. Unexpected and severe adverse drug reactions are frequent. A total of 4.8% of adverse drug reactions were evaluated as life threatening. Majority of adverse drug reactions are classified in Levels 1 (32.6%), 2 (26.4%) and 3 (19%) according to Hartwig’s Severity Assessment Scale. Approximately 22% of reported adverse drug reactions affect people’s everyday life to a greater extent and require additional therapy which might further increase the risk. The relative risk of developing an adverse drug reaction was highest for

  6. 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

  7. 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.

  8. 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.

  9. 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。

  10. 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.

  11. Investigation of prevention and response of clinicians to disputes of adverse drug reactions%临床医师防范和应对药品不良反应纠纷的调查分析

    Institute of Scientific and Technical Information of China (English)

    阎仲珩; 黄登笑; 黄淇敏

    2011-01-01

    Objective To investigate the prevention and response of clinicians to disputes of adverse drug reactions ( ADR), and explore effective ways for medical institutions to deal with disputes of ADR.Methods Questionnaire survey was conducted in 370 clinicians selected from 10 affiliated hospitals of Shanghai Jiaotong University School of Medicine.The questionnaires were composed of two sections.The basic conditions of clinicians were included in one section, and the other section was about a specific survey concerned with the basic concept of ADR, and the recognition and application of prevention measures and methods dealing with ADR disputes.Results A total of 361 questionnaires ( 97.57% ) were recovered, with 347 effective questionnaires (96.12%).Most clinicians were in favor of the commonly adopted prevention measures and methods dealing with ADR disputes.More than 60% of clinicians believed that all the prevention measures to ADR disputes were effective.For the methods dealing with ADR disputes, 37.5% of clinicians were for the measure of “waiving charges”, and more than 60% of clinicians approved the other methods dealing with ADR disputes.Conclusion At present, “standard reporting cases”, “referring to drug manual”, “notification before treatment” and “guidance of clinical pharmacists” are commonly used in medical institutions for the prevention of disputes, and “establishing a uniform and standard process”, “dealing with ADR in the first time” and “making relevant records” are common responses to disputes, while “waiving charges” has a low recognition degree.%目的 调查临床医师对药品不良反应(ADR)纠纷的防范和应对情况,探索医疗机构防范和应对ADR纠纷较为有效的方法.方法 对上海交通大学及其医学院的10家附属医院中的370名临床医师进行问卷调查,问卷分为两部分:第一部分为被调查者的基本情况;第二部分为专题调查,包括ADR基本概

  12. 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

  13. PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs

    OpenAIRE

    Corrigan, Kerry A.

    1995-01-01

    In 1938 the Food and Drug Administration (FDA) adopted regulations which created a category of prescription drugs to be distributed only by order of a physician or other licensed medical personnel. This categorization, along with the extensive regulation of the approval, labelling and marketing of human drugs, has substantially reduced the risks which accompanied self-medication. However, the current regulatory regime does not place any limits on physician prescribing. This shortfall in regul...

  14. 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

  15. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

    Directory of Open Access Journals (Sweden)

    Schjøtt J

    2014-07-01

    Full Text Available Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest, Haukeland University Hospital, Bergen, Norway Background: RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR reports published in a question–answer pair (QAP database (the RELIS database and the Norwegian ADR database, respectively. Objective: To describe the potential of RELIS's dual service to improve detection and communication of drug-safety problems. Materials and methods: We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS's potential to detect new drug-safety information through a limited number of QAPs and ADR reports. Results: A total of 5,427 (26% of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4% of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7% of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin and different aspects of abuse. Conclusion: RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the

  16. Quinolones: review of psychiatric and neurological adverse reactions.

    Science.gov (United States)

    Tomé, Ana M; Filipe, Augusto

    2011-06-01

    Quinolones are a class of antibacterial agents for the treatment of several infectious diseases (e.g. urinary and respiratory tract infections). They are used worldwide due to their broad spectrum of activity, high bioavailability and good safety profile. The safety profile varies from quinolone to quinolone. The aim of this article was to review the neurological and psychiatric adverse drug reaction (ADR) profile of quinolones, using a literature search strategy designed to identify case reports and case series. A literature search using PubMed/MEDLINE (from inception to 31 October 2010) was performed to identify case reports and case series related to quinolone-associated neurological and psychiatric ADRs. The search was conducted in two phases: the first phase was the literature search and in the second phase relevant articles were identified through review of the references of the selected articles. Relevant articles were defined as articles referring to adverse events/reactions associated with the use of any quinolone. Abstracts referring to animal studies, clinical trials and observational studies were excluded. Identified case reports were analysed by age group, sex, active substances, dosage, concomitant medication, ambulatory or hospital-based event and seriousness, after Medical Dictionary for Regulatory Activities (MedDRA®) coding. From a total of 828 articles, 83 were identified as referring to nervous system and/or psychiatric disorders induced by quinolones. 145 individual case reports were extracted from the 83 articles. 40.7% of the individual case reports belonged to psychiatric disorders only, whereas 46.9% related to neurological disorders only. Eight (5.5%) individual case reports presented both neurological and psychiatric ADRs. Ciprofloxacin, ofloxacin and pefloxacin were the quinolones with more neurological and psychiatric ADRs reported in the literature. Ciprofloxacin has been extensively used worldwide, which may explain the higher number

  17. 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.

  18. 预防用药在化疗所致不良反应中的作用调查分析%Investigation and Analysis of the Effect of Preventive Medication on Adverse Drug Reactions due to Chemotherapy

    Institute of Scientific and Technical Information of China (English)

    张霞; 谢嵩

    2011-01-01

    目的 探讨预防用药在化疗所致不良反应中的作用,为临床合理应用抗肿瘤药物、提高患者生存质量提供参考.方法 选择我院恶性肿瘤患者306例,调查分析预防用药的作用,探索其规律性.结果与结论 预防用药可以减少化疗时引起的不良反应,5-羟色胺类药物对减少化疗引起的胃肠道不良反应有很大作用,基因重组人粒细胞集落刺激因子对化疗所致骨髓抑制有良好的预防和治疗作用.合理使用预防药物可以保障化疗的顺利进行,提高患者对化疗的耐受性及生存质量.%OBJECTIVE: To investigate the pathological data of the tumor patients and analyze the effect of preventive medication on adverse drug reactions (ADR) due to chemotherapy, and to provide reference for rational use of antineoplastic drug and improve quality of life of patients. METHODS: 306 patients with malignant tumors were selected to investigate and analyze the effect of preventive medication, explore regularity of it and guide drug use in the clinic. RESULTS & CONCLUSION: Preventive medication could reduce ADR caused by chemotherapy, 5-HT amine played a significant role on reducing gastrointestinal side effects, and recombinant human granulocyte colony stimulating factor could prevent and treat myelosuppression induced by chemotherapy. Rational use of preventive medications can protect the smooth progress of chemotherapy, improve patient tolerance to chemotherapy, and enhance patient health.

  19. Drug Eruptions Induced by Allopurinol Associated with HLA-BFNx015801

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    Meihua Zeng

    2015-01-01

    Full Text Available Allopurinol, a drug commonly used for treating gout and hyperuricemia, is a frequent cause of drug eruptions. Recent investigations suggest that HLA-BFNx015801 allele is a very strong marker for allopurinol-induced cutaneous adverse drug reactions (cADRs. In this article we report two cases of allopurinol-induced drug eruptions in patients carrying the HLA-BFNx015801 allele and review the literature on the association between HLA-BFNx015801 and allopurinol-induced cADRs based on a MEDLINE and PubMed search

  20. 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

    2010-11-13

    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.

  1. 吉西他滨相关性血液系统不良反应的自动监测研究%Study on gemcitabine-related hematologic adverse drug reaction by automatic surveillance

    Institute of Scientific and Technical Information of China (English)

    寇炜; 郭代红; 王伟兰; 贾王平; 王啸宇

    2016-01-01

    [AbstrAct]Objective:To study the incidence of hematologic adverse drug reaction caused by gemcitabine.Methods:The research objects were screened out by adverse drug events' active surveillance and assessment system developed by our hospital. The collected data of the hospitalized patients in General Hospital of PLA who received gemcitabine from January 1, 2016 to June 30, 2016 were analyzed retrospectively. The incidence of hematologic ADR caused by gemcitabine and the related factors were investigated. results: A total of 620 cases using gemcitabine were automatically monitored. Positive alarm rate of leukopenia, neutropenia, thrombocytopenia and anemia were 92.11%, 98.73%, 95.08% and 85.00% respectively. Incidence of leukopenia, neutropenia, thrombocytopenia and anemia induced by gemcitabine were 33.18%, 18.48%, 10.49% and 18.48% respectively. And the incidences of severe ADR were 4.27%, 4.50%, 3.44% and 0 respectively. By analyzing the data of the three modules as a whole, it was found that overall incidence of gemcitabine-related hematologic ADR was 45.29%, and the adverse reactions occurred mostly in the age of 45 to 75 years old. There was no signiifcant difference in incidence of hematologic ADR among the gender, age, BMI and frequencies of hospitalization (P > 0.05).conclusion:By using the automatic surveillance and assessment system, pharmacists can effectively and accurately screen the hematologic ADR induced by anti-cancer drugs and make guidance for rational drug use in order to reduce and avoid the occurrence of adverse reactions. The rate of gemcitabine-related hematologic ADR is high and hematological indexes should be closely monitored in the course of clinical drug use to prevent the occurrence of adverse reactions.%目的:研究住院患者使用吉西他滨致血液系统药品不良反应发生情况。方法:采用回顾性分析,通过对我院开发的“医疗机构ADE主动监测与智能评估警示系统”事件

  2. Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital

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    Anshu Kumar Jha

    2015-01-01

    Full Text Available Context: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs in HIV patients. Aims: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Settings and Design: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo′s scale. Results: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5% were males and 20 (46.5% were females. A total of 53 (16.21% AEs were reported. Antitubercular drugs caused the maximum AEs (28.3% followed by zidovudine (20.7%, nevirapine (15.0% and efavirenz (5.6%. Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo′s scale revealed that 66.04% AEs were ′probable′ and 33.96% were ′possible′. Conclusions: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.

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

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    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. Preventing drug-related adverse events following hospital discharge: the role of the pharmacist

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    Nicholls J

    2017-02-01

    Full Text Available Justine Nicholls,1 Craig MacKenzie,1 Rhiannon Braund2 1Dunedin Hospital Pharmacy, 2School of Pharmacy, University of Otago, Dunedin, New Zealand Abstract: Transition of care (ToC points, and in particular hospital admission and discharge, can be associated with an increased risk of adverse drug events (ADEs and other drug-related problems (DRPs. The growing recognition of the pharmacist as an expert in medication management, patient education and communication makes them well placed to intervene. There is evidence to indicate that the inclusion of pharmacists in the health care team at ToC points reduces ADEs and DRPs and improves patient outcomes. The objectives of this paper are to outline the following using current literature: 1 the increased risk of medication-related problems at ToC points; 2 to highlight some strategies that have been successful in reducing these problems; and 3 to illustrate how the role of the pharmacist across all facets of care can contribute to the reduction of ADEs, particularly for patients at ToC points. Keywords: pharmacist, adverse drug events, drug-related problems, transitions of care, hospital discharge

  5. Adverse reactions to immunotherapy are associated with different patterns of sensitization to grass allergens.

    Science.gov (United States)

    Sastre, J; Rodríguez, F; Campo, P; Laffond, E; Marín, A; Alonso, M D

    2015-05-01

    The aim of the study was to investigate whether adverse drug reactions (ADRs) during immunotherapy with a grass extract (AVANZ® Phleum, ALK-Abelló) are related to the different patterns of sensitization of patients to grass allergens. A total of 192 patients with rhinitis and/or asthma sensitized to grass pollen received a 4-week updosing with five injections. ADRs were evaluated following EAACI guidelines. A total of 432 ADRs in 133 (69%) patients were recorded, 64% local and 31% systemic. There was a significant association between the number of grass allergens that sensitized the patients and the total number of ADRs (P = 0.004) occurred locally (P = 0.003) and systemically (P = 0.01). Sensitization to Phl p1 + Phl p5 or Phl p1 + Phl p5 + Phl p12 was significantly associated with a higher frequency of local or systemic reactions (P = 0.001, both). Different patterns of sensitization to grass allergens may potentially be considered a risk marker to the development of ADRs to immunotherapy.

  6. Adverse effects of drug therapies on male and female sexual function.

    Science.gov (United States)

    Stadler, Th; Bader, M; Uckert, S; Staehler, M; Becker, A; Stief, C G

    2006-12-01

    Sexual dysfunctions (SD) are adverse effects of common drug therapies that have rarely been considered in investigations so far. Possibly it is barely known that many widespread and frequently prescribed medications and drug therapies can have significant impact on vascular and nerval processes as well as on endocrinologic and psychoneuroendocrinologic systems and therefore can influence sexual functions. Impotence and disorders of the erectile function can mainly be caused by antidopaminergic mechanisms, whereas ejaculatory disorders and anorgasmia often can be explained by antiserotoninergic effects. Anticholinergic and adrenoloytic agents can also cause a particular impairment of erectile functions. The following considerations will show that the detection and treatment of SD (also in women!) should be given much more attention since drug-induced SDs occur predominantly in indications where a SD itself can be a symptom of the disease.

  7. 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

  8. 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.

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

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    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.

  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. Shielded ADR Magnets For Space Applications Project

    Data.gov (United States)

    National Aeronautics and Space Administration — An important consideration of the use of superconducting magnets in ADR applications is shielding of the other instruments in the vicinity of the superconducting...

  12. Pharmacokinetic drug interaction profile of omeprazole with adverse consequences and clinical risk management

    Directory of Open Access Journals (Sweden)

    Li W

    2013-05-01

    Full Text Available Wei Li,1 Su Zeng,2 Lu-Shan Yu,2 Quan Zhou31Division of Medical Affairs, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People’s Republic of China; 2Department of Pharmaceutical Analysis and Drug Metabolism, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, People’s Republic of China; 3Department of Pharmacy, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People’s Republic of ChinaBackground: Omeprazole, a proton pump inhibitor (PPI, is widely used for the treatment of dyspepsia, peptic ulcer, gastroesophageal reflux disease, and functional dyspepsia. Polypharmacy is common in patients receiving omeprazole. Drug toxicity and treatment failure resulting from inappropriate combination therapy with omeprazole have been reported sporadically. Systematic review has not been available to address the pharmacokinetic drug-drug interaction (DDI profile of omeprazole with adverse consequences, the factors determining the degree of DDI between omeprazole and comedication, and the corresponding clinical risk management.Methods: Literature was identified by performing a PubMed search covering the period from January 1988 to March 2013. The full text of each article was critically reviewed, and data interpretation was performed.Results: Omeprazole has actual adverse influences on the pharmacokinetics of medications such as diazepam, carbamazepine, clozapine, indinavir, nelfinavir, atazanavir, rilpivirine, methotrexate, tacrolimus, mycophenolate mofetil, clopidogrel, digoxin, itraconazole, posaconazole, and oral iron supplementation. Meanwhile, low efficacy of omeprazole treatment would be anticipated, as omeprazole elimination could be significantly induced by comedicated efavirenz and herb medicines such as St John's wort, Ginkgo biloba, and yin zhi huang. The mechanism for DDI involves induction or inhibition of cytochrome P450, inhibition of P-glycoprotein or breast

  13. Analysis of 105 Docetaxel Related ADR Reports in Our Hospital%我院105例多西紫杉醇不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    江彦; 傅彦妍; 宋洪涛

    2016-01-01

    OBJECTIVE:To investigate the characteristics and influential factors of adverse drug reactions(ADRs)of docetax-el in our hospital,and to provide suggestions for clinical rational drug use and individualized administration. METHODS:Medical records of patients receiving anti-tumor chemotherapy were extracted from hospital information system(HIS)of our hospital during Apr. 2014 and Oct. 2015,and Docetaxel related ADR reports were collected and comprehensively analyzed by retrospective classi-fied statistics. RESULTS:Among 417 cases,105 cases of docetaxel related ADR were reported. There were 69 patients aged 50-69 with highest ADR frequency. The ADR incidence of female patients was higher than that of male patients (29.29% vs. 19.66%). The incidence of docetaxel related ADR and arrest of bone marrow increased as the increase of drug dosage;the incidence of breast cancer ADR was the highest (46.03%),followed by lung cancer (37.25%) and gastric cancer (25.00%). The incidence of docetaxel+platinum chemotherapy plan ADR was the highest (35.10%). Main organs/system involved in ADR was hematological system (55.65%). CONCLUSIONS:The individual difference of docetaxal related ADR are great and affected by several factors. Individual physical condition of patients should be taken into consideration as early as possible,which can reduce the incidence of ADR and promote clinical rational drug use.%目的:了解我院多西紫杉醇不良反应(ADR)发生的特点及其影响因素,为临床合理用药及个体化给药提供参考。方法:通过医院信息系统(HIS)导出我院2014年4月-2015年10月所有使用多西紫杉醇进行抗肿瘤化疗患者的病历,从中调取多西紫杉醇相关ADR报告,通过回顾性分类统计法对ADR报告进行综合分析。结果:417份病例中,有105份多西紫杉醇相关ADR报告,其中50~69岁年龄段的患者有69例次,ADR发生频次最高;女性患者的ADR发生率高于男性患者(29

  14. Pattern of chemotherapy-related adverse effects among adult cancer patients treated at Gondar University Referral Hospital, Ethiopia: a cross-sectional study

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    Belachew SA

    2016-12-01

    Full Text Available Sewunet Admasu Belachew,1 Daniel Asfaw Erku,2 Abebe Basazn Mekuria,3 Begashaw Melaku Gebresillassie1 1Department of Clinical Pharmacy, 2Department of Pharmaceutical Sciences, 3Department of Pharmacology, School of Pharmacy, University of Gondar, Gondar, Ethiopia Background: Adverse drug reactions (ADRs are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the present study was to assess the pattern of ADRs occurring in cancer patients treated with chemotherapy in a tertiary care teaching hospital in Ethiopia.Methods: A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted on cancer patients undergoing chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. The reported ADRs were assessed for causality using the World Health Organization’s causality assessment scale and Naranjo’s algorithm. The severities of the reported reactions were also assessed using National Cancer Institute Common Terminology CTCAE version 4.0. The Pearson’s chi-square test was employed to examine the association between two categorical variables.Results: A total of 815 ADRs were identified per 203 patients included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%, infections (16.7%, neutropenia (14.7%, fever and/or chills (11.3%, and anemia (9.3%. Platinum compounds (31.4% were the most common group of drugs causing ADRs. Of the reported ADRs, 65.8% were grades 3–4 (severe level, 29.9% were grades 1–2 (mild level, and 4.3% were grade 5 (toxic level. Significant association was found between age, number of chemotherapeutic agents, as well as dose of chemotherapy with the occurrence of grades 3–5 toxicity.Conclusion: The high incidence of

  15. Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007-2013

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    Aagaard L

    2016-05-01

    Full Text Available Lise Aagaard,1 Anette Bygum,2 1Section for Clinical Pharmacology, Institute of Public Health, Faculty of Health Sciences, University of Southern Denmark, 2Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark Abstract: Information about long-term safety issues from use of orphan drugs in treatment of hereditary angioedema (HAE is limited and must be studied further. As clinical trials in patients with rare diseases are limited, prescribers and patients have to rely on spontaneous adverse drug reaction (ADR reports for obtaining major information about the serious, rarely occurring, and unknown ADRs. In this study, we aimed to characterize ADRs reported for HAE medications in Europe from 2007 to 2013. ADR reports submitted for C1-inibitors and bradykinin receptor antagonists to the European ADR database, EudraVigilance (EV, were included in this study. The ADR reports were categorized with respect to age and sex of the patients, category of the reporter, type and seriousness of the reported ADRs, and medications. The unit of analysis was one adverse event (AE. Totally, 187 AEs were located in EV, and of these, 138 AEs were reported for Cinryze® (C1-inhibitor (73% of the total and 49 AEs for Firazyr® (icatibant (26% of the total AEs. Approximately 60% of all AEs were serious, including three fatal cases. Less than 5% of AEs were reported in children. In total, 62% of AEs were reported for women and 38% for men. For both Cinryze® and Firazyr®, the majority of reported AEs were of the type “general disorders and administration site conditions”. For Cinryze®, a large number of AEs of the type “HAE” and “drug ineffective” was reported, but only few of these were serious. For Firazyr®, several nonserious reports on injection site reactions were reported. In conclusion, this study showed that in EV, several ADR reports from use of HAE medications were identified, and a large number of these were

  16. [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.

  17. Amiodarone-induced ADR reports in Anhui from 2005~2009%安徽省2005~2010年胺碘酮药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张树强; 叶根深

    2012-01-01

    Objective To study the condition and analyze the related factors of amiodarone-induced adverse drug reactions( ADR ) in An-hui province. Methods Amiodarone-related ADR reports reported in Anhui province from Jan 1,2005 to Nov 31,2010 were searched, from which a total of 120 qualified amiodarone-induced ADR reports were screened out and analyzed statistically. Results Amiodarone-induced ADR occurred more in males, aged from 40 to 80, most of which were not serious. They were majorly induced by oral administration, and majorly occurred within 1 to 7 days. They might involve multi-organs or systems, and their clinical manifestations were chiefly nausea,vomiting or constipation. Most were relatively mild,and subsided after amiodarone withdrawal. Conclusion Medical staffs should pay much attention to amiodarone -induced ADR,and ADR monitoring should be more strengthened.%目的 调查安徽省胺碘酮致药品不良反应(ADR)情况并分析相关因素.方法 检索安徽省2005年1月1日~2010年11月31日呈报的与胺碘酮相关的ADR报告表,筛选合格报告表120例,进行统计分析.结果 ADR多发生在40~80岁,男性多于女性;以一般不良反应居多.主要由口服途径给药引起,多发生于给药后1~7 d内;可累及多个系统/器官,多为恶心、呕吐或便秘;多数较轻微,停药或/和对症处理后可好转、治愈.结论 医务人员应重视胺碘酮所致ADR,并进一步加强ADR监测.

  18. ADR KSHARSUTRA KIT: A BREAKTHROUGH IN THE STANDARDIZATION OF KSHARSUTRA

    Directory of Open Access Journals (Sweden)

    Dwivedi Amarprakash P.

    2013-04-01

    Full Text Available ‘Ksharsutra’ can be defined as an Ayurvedic medicated thread coated with herbal alkaline drugs. ‘Ksharasutra therapy’ has been described as a treatment of choice for the treatment of fistula-in-ano due to low recurrence rate. However, Ksharsutra procedure is not yet globally accepted basically due to lack of standardization and poor acceptability by modern surgeons due to lack of training and fear of complications. Standardization of ‘Ksharsutra’ requires standardization in preparation process and quality standards including its packaging, storage, labeling and developing scientific parameters for maintaining its uniform coating, pH, microbial check etc. To overcome all these limitations, ‘ADR- Ksharsutra Kit’ which is a disposable, non traumatic ‘Ksharsutra Carrier cum Application device’ made up of High Density Poly Ethelene was invented by me. The Ksharsutra prepared as per ICMR guidelines after UV treatment, is embedded in the instrument and is kept in airtight silver foil sachet and sealed. The method of ‘ADR-Ksharsutra’ application is simple and time conserving. The tip of the ‘ADR-Ksharsutra Carrier cum Application device’ is introduced in the external opening and allowed to follow the track up to the internal opening situated in the anal canal. Once the tip comes out through the internal opening, cap is removed and the Ksharsutra is held and then instrument is withdrawn from outside opening. By doing this, the embedded Ksharsutra is automatically placed in the fistula track whose two ends are tied together. ‘ADR-Ksharsutra’ has truly made the entire procedure very smooth. No probe is required in the procedure and Ksharsutra kept in the instrument remains sterile as well. Hence, this ‘Ksharsutra carrier cum application device’ will be helpful in Globalization of Ksharsutra technique for fistula ablation.

  19. 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.

  20. 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.

  1. Literature Analysis of 44 ADR Cases Induced by Moxifloxacin Hydrochloride%盐酸莫西沙星致不良反应44例文献分析

    Institute of Scientific and Technical Information of China (English)

    欧阳小青; 蔡德; 林燕

    2011-01-01

    目的:探讨盐酸莫西沙星致不良反应(ADR)的类型及特点,为临床合理用药提供参考.方法:对2002年1月-2010年8月以来国内公开发行的医药期刊报道的盐酸莫西沙星致ADR,共计44例进行分类统计、分析.结果:ADR临床主要表现为中枢及外周神经系统损害(17.4%)、交感副交感神经系统损害(11.8%)、呼吸系统损害(10.4%)、皮肤及其附件损害(9.0%)、胃肠系统损害(8.3%)等;有基础疾病的中老年人ADR发生率高;ADR治愈16例(36.4%),好转26例(59.1%),有后遗症2例(4.5%).结论:临床应重视盐酸莫西沙星的ADR,坚持合理用药.%OBJECTIVE: To evaluate the type and characteristics of adverse drug reactions (ADR) induced by oxifloxacin hydrochloride, and to provide reference for rational use of drugs in the clinic. METHODS: 44 moxifloxacin hydrochloride-inducing ADR cases reported in domestic publication medicine periodicals since 2002.1.-2010.8. were analyzed statistically. RESULTS: The clinical main manifestations were central and perpheral nervous system disorders (17.4%), sympathetic and parasympathetic nervous system disorders (11.8%), respiration system disorder (10.4%), lesion of skin and appendants (9.0%), gastro-intestinal system disorders (8.3%), the incidence of ADR in middle and old aged people was high, 16 cases were cured (36.4%), 26 cases were improved (59.1%), 2 cases suffered from sequelae (4.5%). CONCLUSION: Great importance should be attached to ADR induced by moxifloxacin hydrochloride and rational use of drugs.

  2. Abuse of methylphenidate in Germany: data from spontaneous reports of adverse drug reactions.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Hiemke, Christoph; Kölle, Markus A; Schönfeldt-Lecuona, Carlos

    2014-01-30

    To retrieve insights into abuse/dependence of methylphenidate (MPH) in Germany, a query of a pharmacovigilance database was performed (observation interval: 1993 until 2012). From 1190 reports of any ADR related to MPH, n=23 (2%) cases of MPH abuse were identified (mean age 29 years; male sex 78%; mean daily MPH-dosage 111 ± 126.6 mg). As oral application was predominant (70%), the majority of reported cases of MPH abuse might be due to pharmacologic neuroenhancement.

  3. 100例前列地尔不良反应分析%Analysis of 100 Cases of Adverse Drug Reactions Induced by Alprostadil

    Institute of Scientific and Technical Information of China (English)

    沈颖; 吴泊

    2015-01-01

    Objective To provide references for clinical prevention and treatment by analyzing the clinical features and related factors of adverse drug reactions due to alprostadil. Methods The incidences of ADRs caused by alprostadil reported in the hospital from 2010 to 2014 were analyzed in terms of gender, age, primary disease, specification and dosage, the method of administration, clinical manifestation, relevance evaluation, treatment and prognosis. Results Totally, 100 cases of ADR caused by alprostadil were reported. In 100 patients, 56 cases were male, average age was (65.5+1.7) years old, while 44 cases was female, average age was (52.5 + 26.5) years old. Mainly primary disease were fracture (20 cases), nephropathy (19 cases), varicose vein (13 cases). Alprostadil doses were 10 μg·d-1 (2 cases) and 20 μg·d-1 (27 cases). 96 patients were treated with intravenous infusion, 4 cases with intravenous injection. Medication time was 2 d (2.9 + 2.8) d. Clinical manifestations of adverse reactions were mainly cardiac vascular system damage, accounting for 62.4%. In all 100 cases of ADR, 2 cases were "must", 47 cases "very likely", 51 cases "possible". Treatment methods of adverse reaction were withdrawal, external application, oxygen inhalation, intravenous injection of glucocorticoid. Among the outcomes, 17 cases were cured, 83 cases improved. Conclusion Adverse reactions of alprostadil have occurred from time to time, clinical attention should be paid to the proper preservation and use of alprostadil and alprostadil adverse reactions monitoring.%目的:分析前列地尔不良反应的临床特点和相关因素,为临床预防及治疗提供参考。方法检索我院2010至2014年收到的前列地尔不良反应报告(ADR),分析患者的性别、年龄、原患疾病、前列地尔规格及用药剂量、给药方式、临床表现、关联性评价、处置方法和预后。结果共收集到前列地尔不良反应100例。100例患者中男性56

  4. Severe cutaneous adverse drug reaction to leflunomide: A report of five cases

    Directory of Open Access Journals (Sweden)

    Shastri Veeranna

    2006-01-01

    Full Text Available Medications used to treat human ailments are known to cause cutaneous reactions which may vary in their severity. Leflunomide, an immunomodulating agent recently introduced to treat rheumatoid arthritis, is reported to cause severe cutaneous reactions. We are reporting five such cases. All our patients were started on leflunomide for rheumatoid arthritis, 4-6 weeks before the onset of cutaneous reaction and were admitted to the hospital with the common complaints of fever, skin rash and generalized weakness. All of them had characteristic pattern of events such as delayed onset of reaction, widespread and long lasting skin rash and internal organ involvement. These features suggest a possibility of drug hypersensitivity syndrome to leflunomide. Careful dosing and periodic monitoring of patients treated with leflunomide for possible adverse drug reaction is recommended.

  5. Analysis and countermeasures of adverse drug reactions of traditional Chinese medicine injections in children%中药注射剂儿童不良反应分析及对策

    Institute of Scientific and Technical Information of China (English)

    张喜莲; 李梦; 戎萍; 马融

    2012-01-01

    Objective: We aimed to analyse the adverse drug reactions (ADR) in children due to traditional Chinese medicine (TCM) injections and the related factors,and explored the rational use of medicines and safty countermeasures in clinical. Method: We preformed statistical analyses on data from the CNKI and researched on literatures,from April 1987 to May 2012,relevant to the TCM injections which lead to reactions of clinical adverse,to conduct a analysis of the species,cases,clinical manifestations and related factors of these injections. Result: The incidence of ADR in children leaded by TCM injections is high and the manifestations were chiefly characterized by the luscious of skin and appendages. In addition to the correlation with the physiological and pathologic characteristic in childhood,the ADR is also closely related with preparing technology,irrational use and imperfect supervisory system. Conclusion ; Because of the high incidence,we should taking appropriate measures,such as constructing strict supervision system and strengthening rational drug use,to reduce the occurrence of ADRs to the greatest extent.%目的:对中药注射剂引起的儿童不良反应及相关因素进行分析,探讨儿童临床合理用药及安全性对策.方法:采用文献计量分析法,选用CNKI期刊库为资料来源,以1987年4月至2012年5月中药注射剂导致儿童不良反应的文献为研究对象,对发生不良反应的中药注射剂种类、例数、临床表现、相关因素等进行统计分析.结果:中药注射剂导致儿童不良反应的发生率较高,表现类型以皮肤及其附件损害最为常见;其相关因素与儿童特殊的生理病理特点、药物制备工艺、临床不合理用药、监管制度不完善等有关.结论:中药注射剂导致儿童不良反应的发生率较高,应积极采取相应措施,提高药物质量,加强临床合理用药,严格监管制度,最大程度地减少不良反应的发生.

  6. 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

  7. 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.

  8. 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。

  9. A distributed, collaborative intelligent agent system approach for proactive postmarketing drug safety surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Farber, Margo S; Yen, John; Dews, Peter; Miller, Richard E; Massanari, R Michael

    2010-05-01

    Discovering unknown adverse drug reactions (ADRs) in postmarketing surveillance as early as possible is of great importance. The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (computers located in different places, are capable of continuously and autonomously collaborating with each other and assisting the human users (e.g., the food and drug administration (FDA), drug safety professionals, and physicians). The agents should enhance current systems and accelerate early ADR identification. To evaluate the performance of the ADRMonitor with respect to the current spontaneous reporting approach, we conducted simulation experiments on identification of ADR signal pairs (i.e., potential links between drugs and apparent adverse reactions) under various conditions. The experiments involved over 275,000 simulated patients created on the basis of more than 1000 real patients treated by the drug cisapride that was on the market for seven years until its withdrawal by the FDA in 2000 due to serious ADRs. Healthcare professionals utilizing the spontaneous reporting approach and the ADRMonitor were separately simulated by decision-making models derived from a general cognitive decision model called fuzzy recognition-primed decision (RPD) model that we recently developed. The quantitative simulation results show that 1) the number of true ADR signal pairs detected by the ADRMonitor is 6.6 times higher than that by the spontaneous reporting strategy; 2) the ADR detection rate of the ADRMonitor agents with even moderate decision-making skills is five times higher than that of spontaneous reporting; and 3) as the number of patient cases increases, ADRs could be detected significantly earlier by the ADRMonitor.

  10. Impact of pharmaceutical care interventions on the occurrence and resolution of side/adverse drug effects associated with antiretroviral drug therapy

    Directory of Open Access Journals (Sweden)

    Nwaozuzu, E.E.

    2012-12-01

    Full Text Available Pharmaceutical care (PC has been shown to improve the outcome of drug therapy in many disease conditions. HIV/AIDS is one of the disease conditions that are fraught with many problems that can benefit from this new emphasis of pharmacy practice also known as ‘pharmacists care’. Adverse drug reactions or effects are unintended and undesirable effects of drugs other than their known and expected actions which can be unpleasant and sometimes fatal. This study is designed to evaluate the impact of pharmaceutical care activities on the occurrence of side/adverse drug reactions in HIV/AIDS patients receiving antiretroviral drugs. The components of the American society of health-system pharmacists (ASHP guidelines on ‘standardized method for pharmaceutical care’ was used as a data collection instrument to evaluate, document and intervene in the antiretroviral therapy of about one thousand four hundred and seventy three (1,473 patients. The study identified about sixty (60 different types of side/adverse effects occurring among these patients through observation and patient complaints. The study also showed significant reduction in the incidence of side/adverse drug effects following the Pharmacist’s intervention activities, p ≥ 0.5. The study showed that pharmacists’ interventions in antiretroviral drug therapy through Pharmaceutical care can significantly reduce the incidence of side/adverse drug effects in HIV/AIDS patients receiving antiretroviral drugs.

  11. 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

  12. Antibiotics-induced Adverse Drug Reactions in Our Hospital:Analysis of 139 Cases%139例抗菌药物致不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    鄂翔

    2015-01-01

    目的:了解抗菌药物致不良反应的特点及规律,为临床安全、有效用药提供参考。方法:对2012—2013年德阳市第二人民医院(以下简称“我院”)上报的139例抗菌药物致不良反应报告进行回顾性分析。结果:139例不良反应涉及的抗菌药物中,以氟喹诺酮类药为最多(43例次,占总计149例次的28.86%);给药途径以静脉滴注所占的比例为最高(135例,占总病例数的97.12%);累及多个器官和(或)系统,以皮肤及其附件损害最为常见(80例次,占总计167例次的47.90%)。结论:必须合理使用抗菌药物,应加强临床用药过程中的监测,以避免或减少不良反应的发生。%OBJECTIVE:To analyze the adverse drug reactions ( ADRs) induced by antibiotics in our hospital from 2012 to 2013 for clinical reference of safe ,effective and rational use of antibiotics .METHODS:139 antibiotic-induced ADR cases in our hospital from 2012 to 2013 were analyzed retrospectively .RESULTS: The 139 cases were mostly induced by fluoroquinolones ( 28.86%, 43/149 ) and mostly induced via intravenous drip infusion ( 135 cases, 97.12%);multiple organs and ( or ) systems were involved , mostly lesions of skin and its appendants ( 80/167 , 47.90%) .CONCLUSIONS:It is important to emphasize the rational use of antibiotics by tightening monitoring during medication in order to avoid or reduce the incidence of ADRs .

  13. 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。

  14. 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

  15. 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

  16. 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.

  17. Oxidative stress and leukocyte migration inhibition response in cutaneous adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Prashant Verma

    2012-01-01

    Full Text Available Background: Cutaneous adverse drug reactions (CADRs may either be immunological or non-immunological. The precise mechanisms, however, are largely obscure. Other concomitant mechanisms may amplify and/or contribute to the severity and duration of a reaction. One such mechanism could be oxidative stress, a state of imbalance between reactive oxygen species, and their subsequent detoxification by antioxidants. Aims: (a to assess the oxidative stress status in the blood of cutaneous drug reaction patients by assaying for reduced glutathione (GSH and malondialdehyde (MDA levels, (b to determine the leukocyte migration inhibition (LMI response in these patients in response to the suspected drug (s, and (c to look for the association between oxidative stress parameters and LMI. Methods: Ethical committee approval was obtained for this study. Fresh venous blood samples were obtained from the patients of CADRs (group A during the acute phase of reaction and healthy control subjects (group B. MDA levels, a measure of oxidative lipid damage, and reduced GSH levels, a measure of anti-oxidant capacity, were assayed in the blood samples of both groups using spectrophotometry. LMI response was measured by challenging the patients′ peripheral blood mononuclear cells with the suspected drug to confirm immunological perturbation. Results: Totally 66 participants, 33 cases in group A and equal number of controls in group B, were studied. The mean MDA levels were found to be raised (P < 0.001, but GSH levels were significantly reduced in group A when compared with group B (P = <0.001. LMI response against drug(s was performed in 33 cases (group A, out of which 25 cases showed a positive LMI response as follows: fixed drug eruption (10/25, SJS (5/25, urticaria (3/25, exfoliative dermatitis (2/25, morbilliform rash (2/25, erythroderma (1/25, vasculitis (1/25, and dapsone syndrome (1/25. The mean MDA levels were found to be significantly higher in the LMI positive

  18. 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.

  19. 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.

  20. Building a time-saving and adaptable tool to report adverse drug events.

    Science.gov (United States)

    Parès, Yves; Declerck, Gunnar; Hussain, Sajjad; Ng, Romain; Jaulent, Marie-Christine

    2013-01-01

    The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.

  1. Text mining for adverse drug events: the promise, challenges, and state of the art.

    Science.gov (United States)

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

    2014-10-01

    Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. It is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event (ADE) 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 narratives, product labeling, social media, and Web search logs-that are amenable to text mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

  2. 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.

  3. Nonsteroidal, antiinflammatory drug-induced gastrointestinal injuries and related adverse reactions: Epidemiology, pathogenesis and management

    Directory of Open Access Journals (Sweden)

    Al Mofleh Ibrahim

    2007-01-01

    Full Text Available A large proportion of the population all over the world consumes acetylsalicylic acid (ASA: aspirin or other nonsteroidal, antiinflammatory drugs (NSAIDs. This is associated with a considerable morbidity and mortality. Elderly patients, patients with prior history of peptic ulcer disease (PUD or its complications, those who require high doses of NSAIDs and those undergoing concomitant therapy with corticosteroids or anticoagulants, are at particularly high risk of developing gastroduodenal injuries and related adverse reactions. Gastroduodenal mucosal injuries induced by NSAIDs vary from subtle microscopic to gross macroscopic changes including ulcers. These injuries are induced by both topical and systemic actions of NSAIDs. Inhibition of gastroduodenal cyclooxygenase (COX enzyme by NSAIDs is considered to be a major pathogenetic factor. Reactive oxygen species (ROS appear also to play a significant role in the pathogenesis of mucosal injury. Withdrawal of NSAIDs is preferably the first therapeutic option; however, it is not feasible in the majority of patients. Therefore, several drugs including antisecretory drugs (ASDs-proton pump inhibitors and Histamine-2 receptor antagonists and misoprostol, a prostaglandin analog are used for the prevention and treatment of NSAID-induced gastroduodenal injuries. Among ASDs, proton pump inhibitors (PPIs are the most commonly used drugs. The antiulcerogenic effect of PPIs is similar to that of misoprostol and superior to standard doses of histamine-2 receptor antagonists (H2-RAs. The adverse effects of m,isoprostol such as diarrhea, abdominal pain, nausea, flatulence, headache, dyspepsia, vomiting, constipation, abortifacient and teratogenicity limit its general use. Aside from their antisecretory action, PPIs also possess an antioxidative effect. PPI maintenance is recommended in chronic NSAID treatment in those with an increased risk of complications and is more effective than Helicobacter pylori

  4. 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

  5. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Ebbers, Hans C; Straus, Sabine M J M;

    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......) reports, drug exposure may, however, be misclassified, that is, attributed to the incorrect product. The aim of this study was to explore the effect of exposure misclassification on the time to detection of product-specific risks in spontaneous reporting systems. METHODS: We used data simulations...... reports may result in a delayed detection of product-specific risks, particularly in the detection of weak drug-event associations. Our findings can help inform the future implementation and refinement of product-specific and batch-specific signal detection procedures....

  6. 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.

  7. 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。

  8. 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.

  9. 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

  10. 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.

  11. Analysis on domestic and foreign case report on the adverse drug reaction of metronidazole%甲硝唑不良反应的国内外文献分析

    Institute of Scientific and Technical Information of China (English)

    余佳文; 林能明; 程斌; 施亮

    2014-01-01

    目的:分析国内外甲硝唑引起的不良反应并分析其一般规律,为临床合理安全用药提供依据。方法以“甲硝唑”为关键词检索2002年1月-2012年12月CNKI与CALIS系统中有关不良反应的个案报道,对用药原因、给药剂量、不良反应发生时间、临床表现等进行回顾性分析。结果75例患者中国内以静脉滴注给药居多占55.0%,国外口服给药占80.0%;联合用药34例占45.3%,单独用药41例占54.7%;选择甲硝唑治疗的原因主要包括牙周疾病占22.7%、预防感染占22.7%、生殖系统占14.7%及胃肠道感染占12.0%等;甲硝唑的主要不良反应为全身性损害占29.3%、皮肤及附件损害占22.3%、神经系统损害占13.3%等,出现不良反应的日剂量集中在≥0.5g占84.0%,不良反应发生时间集中在给药后3d内占76.0%。结论甲硝唑常规剂量口服较安全但临床仍应重视其不良反应的危害性,尽量避免长期与大剂量使用。%OBJECTIVE To analyze the adverse drug reaction (ADR) and the general law of metronidazole from domestic and foreign case report so as to provide reference for the clinical rational use of drugs .METHODS The retrospective analysis was made on pathogeny ,dosage ,adverse reaction onset time and clinical manifestations by collecting the case reports using “metronidazole”as a key word to research from CNKI and CALIS database (Jan 2002-Jan 2012) .RESULTS In the total 75 cases ,domestic cases mostly used intravenous infusion ,which accoun-ted for 55 .0% ,and foreign cases mostly used oral administration ,which accounted for 80 .0% .There were 34 cases with combined use of drugs ,accounting for 45 .3% ,as well as 41 cases of single medication ,accounting for 54 .7% .The etiology on using metronidazole mainly included periodontal disease (22 .7% ) ,infection prevention (22 .7% ) ,reproductive system infection (14 .7% ) and

  12. Are adverse effects of antiepileptic drugs different in symptomatic partial and idiopathic generalized epilepsies? The Portuguese-Brazilian validation of the Liverpool Adverse Events Profile.

    Science.gov (United States)

    Martins, H H; Alonso, N B; Vidal-Dourado, M; Carbonel, T D; de Araújo Filho, G M; Caboclo, L O; Yacubian, E M; Guilhoto, L M

    2011-11-01

    We report the results of administration of the Portuguese-Brazilian translation of the Liverpool Adverse Events Profile (LAEP) to 100 patients (mean age=34.5, SD=12.12; 56 females), 61 with symptomatic partial epilepsy (SPE) and 39 with idiopathic generalized epilepsy (IGE) (ILAE, 1989) who were on a stable antiepileptic drug (AED) regimen and being treated in a Brazilian tertiary epilepsy center. Carbamazepine was the most commonly used AED (43.0%), followed by valproic acid (32.0%). Two or more AEDs were used by 69.0% of patients. The mean LAEP score (19 questions) was 37.6 (SD=13.35). The most common adverse effects were sleepiness (35.0%), memory problems (35.0%), and difficulty in concentrating (25.0%). Higher LAEP scores were associated with polytherapy with three or more AEDs (P=0.005), female gender (P0.001) and Hospital Anxiety and Depression Scale (Depression: r=0.637, P<0.001; Anxiety: r=0.621, P<0.001) dimensions. LAEP overall scores were similar in people with SPE and IGE and were not helpful in differentiating adverse effects in these two groups. Clinical variables that influenced global LAEP were seizure frequency (P=0.050) and generalized tonic-clonic seizures in the last month (P=0.031) in the IGE group, and polytherapy with three or more AEDs (P=0.003 and P=0.003) in both IGE and SPE groups.

  13. 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.

  14. Relationship between dose of antithyroid drugs and adverse events in pediatric patients with Graves’ disease

    Science.gov (United States)

    Yasuda, Kie; Miyoshi, Yoko; Tachibana, Makiko; Namba, Noriyuki; Miki, Kazunori; Nakata, Yukiko; Takano, Toru; Ozono, Keiichi

    2017-01-01

    Abstract. Graves’ disease (GD) accounts for a large proportion of pediatric hyperthyroidism, and the first-line treatment is antithyroid drug (ATD) therapy. Methimazole (MMI) is effective in most patients but is associated with significant adverse events (AEs). We reviewed the medical records of GD patients (n = 56) with onset age of <15 yr and investigated the relationship between MMI dose and AEs. The study population comprised 11 male and 45 female patients and the median age at diagnosis was 11 yr. All patients were initially treated with ATDs. Among the 52 patients initially treated with MMI, 20 received a low dose, and 32 received a high dose of MMI (< 0.7 vs ≥ 0.7 mg/kg/day, respectively). AEs occurred in 20% of the patients in the low-dose MMI group, and in 50% patients in the high-dose MMI group (p = 0.031). A greater variety of AEs was observed in the high-dose group. Neutropenia and rash were observed in both groups. With treatment transition to low-dose MMI according to the Japanese Society for Pediatric Endocrinology guidelines, we expect a decrease in the incidence of AEs in future. However, we should be careful as neutropenia and rash can occur independently of the MMI dose.

  15. A comprehensive study of the association between drug hepatotoxicity and daily dose, liver metabolism, and lipophilicity using 975 oral medications.

    Science.gov (United States)

    Weng, Zuquan; Wang, Kejian; Li, Haibo; Shi, Qiang

    2015-07-10

    It was recently suggested that daily dose, liver metabolism and lipophilicity were associated with an oral drug's potential to cause hepatotoxicity, but this has not been widely accepted. A likely reason is that published data lack comprehensiveness, as they were based on only about one third of all FDA approved single-active-ingredient oral prescription drugs. Here the 975 oral drugs used worldwide which have a Defined Daily Dose (DDD) designated in the World Health Organization's Anatomical Therapeutic Chemical classification system and whose hADRs potential and metabolism data are available in the Micromedex Drugdex® compendium were studied, with their lipophilicity calculated by the partition coefficient LogP. Of the 975 drugs examined, 49% (478) have the potential to induce at least one type of hepatic adverse drug reactions (hADRs) such as fatal hepatotoxicity, acute liver failure, significant ALT/AST elevation, hepatitis, and jaundice. By single factor analysis, a higher DDD (≥100 mg) was found to be associated with all types of hADRs, and extensive liver metabolism (≥50%) was associated with a subset of hADRs including fatal hADRs, hepatitis and jaundice, while LogP showed no relation to any types of hADRs. Contrary to previous reports, none of the combination, neither DDD and liver metabolism, nor DDD and LogP, was found to be more predictive of hADRs than using DDD or liver metabolism alone. These data provide convincing evidence that a higher daily dose and extensive liver metabolism, but not lipophilicity, are independent but not synergistic risk factors for oral drugs to induce hepatotoxicity.

  16. Retrospective Analysis on the Adverse Drug Reactions(ADR)Induced by Second Generation Antihistamine Drugs%第2代抗组胺药不良反应回顾性分析

    Institute of Scientific and Technical Information of China (English)

    徐珽; 吴逢波; 杨梅; 唐尧

    2007-01-01

    目的:分析第2代抗组胺药所致不良反应的临床特征、相关因素,为临床用药提供参考依据.方法:检索1986~2006年国内文献库收载的第2代抗组胺药的不良反应资料,得到符合标准的病例128例,并按世界卫生组织(WHO)国际药品监测合作中心的不良反应分类方法进行分类、研究.结果:128例ADR报告中女性明显多于男性;不良反应以心血管系统损害最多(38例,占29.69%),其次为皮肤及其附件损害(36例,占28.13%)和全身性损害(20例,占15.63%);不良反应预后较好.结论:患者的性别、体质、合并用药等因素均能影响不良反应的发生,对于引起过敏性休克和心律失常的不良反应临床应提高警惕.

  17. Discussion on the Inspiration for the Practice of Adverse Drug Reaction Monitoring in China by FDA "Sentinel Initiative"%试论FDA"哨点行动"对我国药品不良反应监测工作的启示

    Institute of Scientific and Technical Information of China (English)

    沈璐

    2011-01-01

    By introducing the executive summary of sentinel initiative, the sentinel system vision, progress building the sentinel system, progress ensuring security and privacy, to analyse the practical meaning and inspiration for Adverse Drug Reaction(ADR) monitoring in China by the sentinel system and try to establish the fundamental principle and developmental trend of ADR monitoring in the current period.%通过全面介绍美国FDA 的哨点行动概况、哨点系统的特点和作用、哨点系统的建设进程、数据安全及隐私保护等方面内容,分析了哨点系统这种主动监测模式对于我国开展药品不良反应监测工作的现实意义和启发,并尝试提出现阶段我国药品不良反应监测工作发展的基本原则和方向.

  18. 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...

  19. AOP: An R Package For Sufficient Causal Analysis in Pathway-based Screening of Drugs and Chemicals for Adversity

    Science.gov (United States)

    Summary: How can I quickly find the key events in a pathway that I need to monitor to predict that a/an beneficial/adverse event/outcome will occur? This is a key question when using signaling pathways for drug/chemical screening in pharma-cology, toxicology and risk assessment. ...

  20. 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.

  1. 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。

  2. 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......, 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 identified causes of these sADRs and reviewed factors contributing to delayed identification of these toxicities......, 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...

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

    Directory of Open Access Journals (Sweden)

    Le Nhu D

    2010-09-01

    Full Text Available 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 cohort from 1986 was created by linkages with the BC Birth and Health Status Registries. Exposure was assessed by work history in oncology or cancer agencies (method 1 and by estimating weighted duration of exposure developed from a survey of pharmacists and nursing unit administrators of all provincial hospitals and treatment centers and the work history of the nurses (method 2. Relative risks (RR were calculated using Poisson regression for cancer incidence and odds ratios (OR were calculated for congenital anomaly, stillbirth, low birth weight, and prematurity incidence, with 95% confidence intervals. Results In comparison with other female RNs, method 1 revealed that RNs who ever worked in a cancer center or in an oncology nursing unit had an increased risk of breast cancer (RR = 1.83; 95% CI = 1.03 - 3.23, 12 cases and their offspring were at risk for congenital anomalies of the eye (OR = 3.46, 95% CI = 1.08 - 11.14, 3 cases. Method 2 revealed that RNs classified as having the highest weighted durations of exposure to antineoplastic drugs had an excess risk of cancer of the rectum (RR = 1.87, 95% CI = 1.07 - 3.29, 14 cases. No statistically significant increased risks of leukemia, other cancers, stillbirth, low birth weight, prematurity, or other congenital anomalies in the RNs' offspring were noted. Conclusions Female RNs having had potential exposure to antineoplastic drugs were not found to have an excess risk of leukemia, stillbirth, or congenital

  4. 醒脑静注射液致不良反应20例文献分析%LITERATURE ANALYSIS OF 20 ADR CASES INDUCED BY XINGNAOJING INJECTION

    Institute of Scientific and Technical Information of China (English)

    甄娜

    2011-01-01

    [Objective] To study the clinical application of Xingnaojing injection and the types and number of adverse drug reactions (ADR) in order to provide reference for rational application of Xingnaojing injection in the clinic. [Methods] 20 Xingnaojing injection-inducing ADR cases reported in domestic publication medicine periodicals since 2000.1.-2011.2. Were analyzed statistically. [Results] The clinical main manifestations were respiration system disorder (33.0%), cardiology system disorder (17.0%), lesion of skin and appendants (13.2%), whole body disorder (12.3%), sympathetic and parasympathelic nervous system disorders (12.3%), central and perpheral nervous system disorders (6.6%), gastro-intestinal system disorders (3.8%), and other types (1.9%). [Conclusion] The literature study is able to find new type of ADR induced by Xingnaojing injection after the listing, great importance should be attached to ADR induced by Xingnaojing injection and rational use of drugs.%[目的]研究醒脑静注射液在临床的使用情况及发生不良反应的类型和数量,为醒脑静注射液的临床合理应用提供参考.[方法]对2000年1月~2011年2月以来,国内公开发行的医药期刊报道的醒脑静注射液致ADR,共计20例进行分类统计、分析. [结果] ADR临床主要表现为呼吸系统损害(33.0%)、心血管系统一般性损害(17.0%)、皮肤及其附件损害(13.2%)、全身性损害(12.3%)、交感副交感神经系统损害(12.3%)、中枢和外周神经系统损害(6.6%)、胃肠系统损害(3.8%)、其他类型约占(1.9%).[结论]文献研究法能发现醒脑静注射液上市后的新不良反应,临床应重视醒脑静注射液的ADR,坚持合理用药.

  5. 2009-2014年军队医院5099例儿童药品不良反应报告分析%Analysis on 5099 ADR reports occurred in children in military hospitals from 2009 to 2014

    Institute of Scientific and Technical Information of China (English)

    谢婷婷; 郭代红; 赵粟裕; 马亮; 赵靓; 徐元杰; 朱曼; 赵鹏芝; 郭俊荣

    2015-01-01

    Objective:To investigate the characteristics and general pattern of adverse drug reaction (ADR) occurred in children, and provide reference for clinical rational drug use.Methods:With the retrospective method, a total of 5099 ADR reports occurred in children were collected from 2009 to 2014 in the database of PLA ADR monitoring center. The data in respect of age and gender of patients, categories of drugs, route of administration, dosage form, systems and organs involved in ADR and clinical manifestations, relevance evaluation and prognosis were analyzed statistically.Results:Among 5099 ADR reports, new and severe ADR reports were 261 cases (5.11%), the male to female ratio was 1.56 : 1, the average age of the patients was (5.12 ± 2.55) years, the incidence of ADR was the highest in the childeren of 1 – 3 years old (28.85%). Intravenous infusion and injection type were the main administration route and dosage form, respectively. The ADRs were related to 16 kinds of drug categories. The top 3 drug categories involved in ADRs were anti-infection drugs (54.17%), Chinese patent medicine (8.16%), electrolyte and acid-base balance and nutrition drugs (7.79%), respectively. These children's ADRs involved multiple systems and organs (7046 frequencies), the most common clinical manifestation was skin and its accessories damage (3458 frequencies, 49.08%), followed by gastrointestinal system damage (1547 frequencies, 21.96%) and systemic damage (595 frequencies, 8.44%).Conclusion:We should strengthen the risk prevention work on children's drugs and the rational use of drugs in pediatrics. ADR monitoring and drug consulting work need to be paid more attention to, in order to reduce or avoid the occurrence of ADR.%目的:了解儿童药品不良反应(ADR)发生的特点及一般规律,为临床合理用药提供参考。方法:采用回顾性方法,收集2009–2014年军队药品不良反应监测管理系统中儿童药品不良反应报告5099例,对患者

  6. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

    Institute of Scientific and Technical Information of China (English)

    Klaus Bielefeldt

    2016-01-01

    AIM:To investigate the nature and severity of AE related to sacral neurostimulation(SNS).METHODS:Based on Pubmed an