An analysis of awareness and acceptability of the Medicines Side Effect Reporting Form for Consumer and the quality of data entered by consumers - An Indian perspective.

Abstract

Background: Consumers are key stakeholders in drug safety, yet, till recently, their potential has remained untapped in terms of contributing to the drug safety data. The Medicines Side Effect Reporting Form for Consumer (MSERC), launched by the Pharmacovigilance Programme of India, is an important tool for the consumer to report adverse drug reactions (ADRs).

Objective: Our objective was to evaluate the awareness and acceptability of the MSERC among the general population and the quality of data entered by the consumers.

Methods: This was a cross-sectional study carried out at a tertiary healthcare center in Madhya Pradesh (Central India).

Results: The study included 203 participants, with 115 self-reports and 88 reports of ADRs experienced by a relative. All mandatory fields were filled by 149 (73.4%) participants. More than half of the reporters (113, 55.57%) took <5 min to fill the form and found it easy to fill it (123, 60.59%). Most of the participants expressed a willingness (186, 91.63%) to fill the MSERC. The time taken to complete the form and the difficulty in filling the form were significantly greater in the elderly (age >60 years). Significantly more women were aware about the MSERC (P = 0.026), as compared to men. Participants with graduate, postgraduate, or professional degrees took significantly less time to fill the form (P < 0.001) and found it easier to fill it (P = 0.019).

Conclusion: Awareness about the form was found in only 6.4% of the responders, highlighting a need to generate more awareness among the consumers about the MSERC form to improve the ADR reporting.