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

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          Abstract

          Introduction

          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.

          Most cited references22

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          Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.

          To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. Four electronic databases were searched from 1966 to 1996. Of 153, we selected 39 prospective studies from US hospitals. Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.
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            Determinants of under-reporting of adverse drug reactions: a systematic review.

            A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting. A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman's 'seven deadly sins') associated with reporting. Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies. While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors.
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              International drug monitoring: the role of national centres. Report of a WHO meeting.

              (1971)
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2012
                2012
                19 June 2012
                : 8
                : 307-312
                Affiliations
                [1 ]Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan
                [2 ]Department of Pharmacology, Hind Institute of Medical Sciences, Safedabad, Barabanki, Lucknow, Uttar Pradesh, India
                Author notes
                Correspondence: Prerna Upadhyaya, Department of Pharmacology, Mahatma Gandhi Medical College and Hospital, Jaipur, India, Tel +99 8 333 3621, Fax +99 141 277 0900, Email drprerna@ 123456rediffmail.com
                Article
                tcrm-8-307
                10.2147/TCRM.S31482
                3387833
                22767994
                353bc9b5-7121-446c-8296-c68c624b7312
                © 2012 Upadhyaya et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                History
                Categories
                Original Research

                Medicine
                first-year postgraduate doctors,pharmacovigilance,adr reporting
                Medicine
                first-year postgraduate doctors, pharmacovigilance, adr reporting

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