Patient and Public Involvement in Pharmacovigilance

Patient involvement has become increasingly important in pharmacovigilance in recent years. There should be an active and collaborative interaction between patients and other stakeholders. Decision making should be guided by patients’ contributions as partners, recognising their unique perspective, experiences, values, and expertise. In pharmacovigilance, direct patient reporting was an important first step in including the patient perspective in drug safety monitoring. Direct patient reporting has been shown to add value to pharmacovigilance, by contributing to signal detection and helping to uncover blind spots of pharmacovigilance, such as safety of the herbal medicines. Direct patient reporting also plays an important role in vaccine pharmacovigilance, as was highlighted during the COVID-19 pandemic. Patient-reported information can give us insight into the burden of adverse drug reactions (ADRs) and the course of ADRs. This is information that is relevant to patients and is not always readily available. In addition to their role as reporters, patients should have a role in regulatory decision making. This is something that regulatory agencies have focused more on in recent years. Engagement from patients requires sustained engagement strategies, since pharmacovigilance is a relatively unknown area for them. Patient involvement should be a two-way street with pharmacovigilance benefiting from patient-reported information, but also ensuring relevant information is relayed to patients and that they are involved in decision making.