A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

Abstract

Background: With the growing reliance on drug therapy in the recent era, the safety of medications is one of the vital parameters for the success of any medicine. Considering this, pharmacovigilance (PV) was developed to provide adequate identification, reporting, evaluation, and understanding of adverse drug reactions (ADR). The objective of this study was to understand the opinion of health care providers on PV, the current reporting mechanisms, identifying the causes for underreporting, and the existing process in clinical practice.Methods: A qualitative study using pretested interview guide was conducted among 20 different cadres of healthcare personnel (doctors, pharmacists, and staff nurses) from various hospitals such as government, private, corporate, and medical college of Odisha state. The data were analysed using a thematic analysis. The meaning units have been identified from the transcript and coded with MAXQDA software (MAXQDA Analytics Pro 2020, VERBI GmbH Berlin).Results: Participants showed a lack of awareness regarding the concept of PV. A cluster of challenges such as lack of ADR monitoring, non-conducive work atmosphere and lack of cooperation between staff, lack of knowledge among the health professionals, and fear of legal liability as major pitfalls causing poor ADR reporting. To enhance the pharmacovigilance practice, participants suggested context-specific strategies such as IEC activities, innovative ideas to improve ADR monitoring, regular monitoring.Conclusions: Capacity building through training, regular monitoring and supervision to strengthen the pharmacovigilance practices is the current need in India.