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Pharmacy‐led pharmacovigilance: Ready for use or missed opportunity?

In this issue of the journal, two different perspectives from Europe, ie, from Wales in the United Kingdom and Poland, are presented on the increasing, but also challenging, role of pharmacists in pharmacovigilance. This is not a new voice, and also in other regions (eg, United States, Saudi Arabia, and China) in the world, similar experiences on the potential contribution of pharmacists to pharmacovigilance are flagged and shared. By nature, pharmacovigilance is a multidisciplinary activity, and from a clinical or regulatory perspective, it should not make any difference whether a physician, a nurse, a pharmacist, or a patient is alert on any drug‐induced harm and is willing to report on such occurrences. Any pharmacovigilance system deals with underreporting, selective reporting on certain harms and exposures, time trends in reporting, and missing data on relevant variables needed to evaluate and assess the reports submitted. Any attempt to add useful information and insight to the jigsaw puzzle of sorting out the strength and validity of a drug exposure‐outcomes association should be welcomed. There is one specific dimension to pharmacoepidemiology in this context. Proper exposure ascertainment has been always key to any pharmacoepidemiological study. Over the last decades, the field moved for good reasons from a binary exposure concept, ie, patient is on drug A, yes/no, to a multidimensional, layered, and analytical picture of how medicines are prescribed, dispensed, and used. Given their position in the therapy chain and their pharmacological background, pharmacists are inheritably close to the exposure part of the exposure‐outcome equation. From that perspective, boosting pharmacy‐led pharmacovigilancemay also contribute to advances in drug exposure ascertainment, and thereby better pharmacoepidemiology. Both two studies from the United Kingdom and Poland show how important awareness and knowledge about the various pharmacological, epidemiological, and clinical aspects of drug safety among pharmacists are in order to invest in pharmacovigilance in a systematic and sustained manner. They also show that professional and institutional barriers are critical constraints for pharmacists contributing to pharmacovigilance in a way that delivers. Despite guidance from professional and regulatory bodies over the last decades, acknowledging positive exemptions, the achievements of pharmacy‐based pharmacovigilance seem to be rather limited. And there is such much to win, as both papers state. Pharmacists, because of their expertise and responsibilities in the care and dispensing chain of pharmacotherapy, are in the position to tackle