STUDY ON PERCEPTION OF PHYSICIANS TOWARDS ADVERSE DRUG REACTION REPORTING - A SURVEY IN INDIA

Author : Krushangi Shah, Basant Sharma, Snehal Patel, Anupama Ramkumar, Bhoomika Patel

Page Nos : 1 - 9

Abstract :

Ongoing assessment for a positive risk–benefit profile of any medicinal product is an important aspect of lifecycle management; it is also a regulatory requirement. Important stakeholders in this process of pharmacovigilance (PV) are the patients, healthcare practitioners, pharmaceutical companies and regulatory agencies. Despite the regulations for post-marketing drug safety monitoring being well-defined, the rate of reporting of adverse drug reaction (ADR) by the healthcare community continues to be inordinately low. To understand the awareness of and patterns of ADR reporting amongst healthcare practitioners in a major city of India. This was a questionnaire-based cross-sectional survey involving 53 physicians of various specialties from Ahmedabad. Data collected was analysed descriptively to evaluate the awareness and understanding of physicians on ADR reporting. About 68% of the participating physicians were unaware of the PV reporting requirements or regulations in the country. Only 5.67% prescribers had reported a drug-related event at least once to the nearest ADR monitoring centre in the last six months from this survey. Underreporting of ADR is a major concern for the success of the PV program in India, which directly impacts public health. Spontaneously reported ADRs (SADRs) is the most commonly used methodology to gather data on a drug’s safety profile. For the number of SADR to realistically reflect the observed ADRs in practice, a greater thrust in bringing awareness amongst the medical community on PV requirements and available infrastructure is the need of the hour.