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. 2025 Jun;31(4):e70164.
doi: 10.1111/jep.70164.

Patient Voices in Pharmacovigilance: Understanding Adverse Drug Reactions Through Consumer Narratives

Shatavisa Mukherjee  1 , Siddhartha Roy  2 , Nikhil Era  3
Affiliations

Patient Voices in Pharmacovigilance: Understanding Adverse Drug Reactions Through Consumer Narratives

Shatavisa Mukherjee et al. J Eval Clin Pract. 2025 Jun.

Abstract

Background: Adverse drug reactions (ADRs) are unintended and harmful responses to medications. Although clinicians and researchers often focus on the clinical aspects and prevention of ADRs, consumers-the patients themselves-experience and interpret these events in personal, social, and cultural contexts. Understanding consumers' perspectives on ADRs is essential to improving communication, therapeutic decision-making, and patient safety strategies.

Objective: This study aimed to explore consumers' views and experiences of ADRs, including their perceptions of risk, attribution of causes, and the impact on medication adherence and trust in healthcare providers.

Methods: A qualitative research design was employed. Purposive sampling was used to recruit adult participants who had experienced at least one ADR or were caregivers of someone with an ADR experience. Four focus group discussions (FGDs) were conducted (n = 28). A semi-structured discussion guide elicited participants' personal accounts and interpretations of ADRs. Data were transcribed verbatim and analyzed using thematic analysis.

Results: Six major themes emerged: (1) Understanding and Knowledge of ADRs, (2) Severity and Impact on Daily Life, (3) Trust and Communication with Healthcare Providers, (4) Self-Medication Practices and ADR Risk, (5) Emotional and Psychological Responses, and (6) Recommendations for Improved ADR Awareness and Reporting. Participants expressed anxiety about the unpredictability of ADRs, citing both mild and severe reactions. Many shared difficulties with navigating information sources, feeling that healthcare professionals sometimes minimized or overlooked their concerns. The emotional toll of ADRs ranged from worry and frustration to lowered trust in medical recommendations.

Conclusion: Consumers' experiences of ADRs are deeply personal, often influenced by prior knowledge, trust in healthcare providers, and the perceived severity of reactions. Patient-centered communication strategies, clearer information on risks and benefits, and robust ADR reporting mechanisms are recommended to empower consumers and enhance medication safety. Understanding the consumer perspective is pivotal for healthcare policy and practice to reduce the burden of preventable ADRs and to improve patient-centered care.

Keywords: consumer experience; focus group discussion; patient's voice; pharmacovigilance.

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