Patient's reporting of adverse drug reactions: Which added value in 2023?

Abstract

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called “patient centricity in pharmacovigilance”. Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.