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

What is it about?

The ADR Monitoring Centre (AMC) in Sikkim Manipal Institute of Medical Sciences (SMIMS), Gangtok, Sikkim is facing the challenge of minimal spontaneous reporting of ADRs. This study has been carried out to evaluate the knowledge, attitude, awareness, and practice of doctors working in the teaching hospital, toward ADR monitoring and pharmacovigilance with a questionnaire based research instrument. The results derived from the study would be able to give direction to the corrective measures required to be taken to enhance voluntary ADR reporting. Sikkim is a North-Eastern State characterized by an ethnically diverse population, which makes it all the more important to recognize any difference in the pattern and nature of ADR' s from the vast majority of the populace. Observing such differences would not be possible, unless a relatively significant number of ADR' s are reported, added, and compared to the existing database. This study is a preliminary effort in this direction.

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Why is it important?

Rational drug therapy is based on the two essential parameters of safety and efficacy. Practically, no drug can be absolutely devoid of adverse effects, but their use has to be associated with an acceptable risk-benefit ratio. In order to be able to make a rational and judicious selection of a therapeutic agent, it is important for the prescriber to be aware of the quantum and frequency of possible untoward risks. It is not statistically possible to encounter all the deleterious effects of a drug during the first three phases of clinical trials, largely because the population, in which they are evaluated, is a fraction of the intended target population. Apart from the limited study population, selective recruitment of patients with resulting limited heterogeneity and consideration of few predefined adverse drug reactions (ADR' s) limit the generalizability of clinical trials to clinical practice. It is possible to create a more realistic safety profile of a drug after it has been scrutinized for untoward adverse events in a larger heterogenous population of patients over an extended period. Building a database of knowledge pertaining to the adverse effects of drugs is what forms the core principle of pharmacovigilance. The Uppsala Monitoring Centre (UMC) in Sweden maintains the international database of the ADR reports. India contributes to this database in the form of the Pharmacovigilance Programme of India (PvPI) which has been operational from July 2010. Since September 2010, only 2823 ADR' s have been reported, which is obviously very small, to provide any conclusive and meaningful evidence. India has vast ethnic populations and a wide spectrum of prevalent diseases. Comprehensive knowledge on the adverse effect of drugs specific to the Indian population is lacking, and we rely mostly on data available from Western countries. It is thus imperative to have an efficient, effective, and broad-based ADR reporting culture to enhance the rather limited information and knowledge that we currently have. This is only possible when health professionals, practicing clinicians in particular, take the time and effort to voluntarily report any ADR that they encounter.