Adverse Drug Reaction Reporting and Pharmacovigilance: Knowledge, Attitudes and Perceptions amongst Resident Doctors

Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. However, underreporting is a huge problem due to lack of reporting culture amongst healthcare professionals. This cross sectional, questionnaire based study was conducted to assess the knowledge, attitudes and practices regarding adverse drug reaction reporting amongst resident (trainee) doctors. It involved 407 post graduate resident doctors who could be contacted in 2 visits on consecutive days in the resident doctor’s hostels, all the clinical wards, operation theatres and departments (convenience sampling). It was conducted in two Government teaching hospitals B.J. Medical College, Pune and Seth G.S. Medical College, Mumbai. The knowledge of the resident doctors regarding reporting responsibilities, type of event and product to be reported and the reporting mechanisms, was found to be deficient. Majority of the respondents felt that ADR reporting is necessary and is a professional obligation but should be voluntary and remunerated. Perception of reporting process being tedious, lack of time, poor knowledge of reporting mechanism and inadequate expertise were the main reasons cited for underreporting. Majority of the respondents suggested regular training sessions and a closer working relationship with the pharmacovigilance department as a possible motivating factor to improve spontaneous ADR reporting rates. The deficiencies in knowledge, attitudes and practices of resident doctors regarding ADR reporting needs urgent attention on priority basis, not only for the success of the pharmacovigilance program, but for better clinical management of the patients in general. INTRODUCTION: Safety and efficacy are the two major concerns about a drug. While efficacy of a drug can be quantified with relative ease, the same cannot be said about safety. This is because, the adverse effect of a drug may be uncommon (but very serious) and many patients may be affected or subjected to a potential risk before the relationship with the drug is established. Adverse Drug Reactions (ADRs) are associated with a significant morbidity and mortality [1, 2]. Recent estimates suggest ADRs to be the fourth major cause of death in the Unites States of America (USA) [1]. This gave birth to the branch of pharmacovigilance. By definition, pharmacovigilance is, “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems”. [3] Spontaneous reporting has contributed significantly to successful pharmacovigilance. The contribution of health professionals, in this regard, to ADRs databases is enormously significant and has encouraged ongoing ascertainment of the benefit-risk ratio of some drugs [4, 5], as well as contributed to signal detection of unsuspected and unusual ADRs previously undetected during the initial evaluation of a drug [6, 7]. The Uppsala Monitoring centre (UMC, WHO), Sweden is maintaining the international database of adverse drug reaction reports (currently about 4.7 million case reports) received from several national centres (96 member countries). However, still, it is estimated that only 6-10% of all ADRs are reported [8]. Although, India is participating in the program, its contribution to UMC database is very little. This is essentially due to the absence of a vibrant ADR monitoring system and also lack of a reporting culture among health care workers. Many factors are associated with ADRs under-reporting among health professionals. These factors have been broadly classified as personal and professional characteristics of health carers, and their knowledge and attitudes to reporting. Inman has summarized these factors as the 'seven deadly sins'. His description of the 'sins' include: attitudes relating to professional activities (financial incentives: rewards for reporting; legal aspects: fear of litigation or Pankaj Gupta et al /J. Pharm. Sci. & Res. Vol.3(2), 2011,1064-1069