Empowering patients through pharmacovigilance, transparency, and health literacy: a narrative review

Abstract

At the intersection of pharmacovigilance (PV), Participant Data Return (PDR), and health literacy lies a social contract in healthcare. This implicit agreement reflects the shared responsibilities of pharmaceutical companies, healthcare providers, and patients to protect individual rights while promoting collective well-being. PV, PDR, and health literacy form a triad that ensures patients are not only protected but actively informed and engaged in their healthcare journey, fostering transparency, trust, and empowerment. PV, as a cornerstone of drug safety, upholds this social contract by continuously monitoring, identifying, and mitigating adverse reactions through collaboration with patients and healthcare providers. By encouraging patient participation in adverse event reporting, PV systems strengthen safety surveillance and reinforce the reciprocal nature of trust and accountability in healthcare. PDR strengthens this relationship by promoting ethical transparency in clinical trials. It gives participants access to their own data, supporting informed decisions and increasing public confidence in research. Health literacy empowers individuals by helping them understand and act upon health information. By leveraging tools and strategies that simplify complex medical data, pharmaceutical companies fulfill their responsibility to equip patients with the knowledge to make informed healthcare decisions. In doing so, all three honor the social contract by fostering equitable access to information and promoting patient-centered care. This manuscript highlights how PV, PDR, and health literacy work together to uphold ethical healthcare practices. Each contributes to a system built on trust, transparency, and shared responsibility; core values that reinforce positive patient outcomes and the foundation of a fair, effective healthcare ecosystem.

Keywords: Benefit risk; health literacy; participant data return; pharmaceutical industry; pharmacovigilance.