Pharmacovigilance: An Ethical Issue for Clinical Psychology, Psychiatry, and Pharmacy?

Pharmacovigilance helps determine when a treatment might cause novel or unintended effects. Patients, clinicians, regulators, and pharmaceutical companies have a stake in determining how the causality of treatment-induced effects should be established and when effects should be noted in settings from the academic literature to a medicine’s label. There have been different approaches to this task in different jurisdictions, with reporting to companies more common in the United States and reporting to regulators more common in Europe. Over time, pharmacovigilance has switched from being primarily a clinical enterprise to being a regulatory one, which has led to the elimination of the names of those suffering from an adverse event and the outsourcing of the job of recording the details of events to private companies, which appears likely to reduce the recognition of adverse events. This article calls for a restoration of clinical input on adverse events aimed at increasing reporting and recognition rates for important behavioral events.