The projected changes to pharmacovigilance in the next decade

A recent article published by the European Medicines Agency (EMA) in “Clinical Pharmacology and Therapeutics”, predicts the outlook for pharmacovigilance (PV) in 2030.

The primary aim of PV is to balance the risk profile of a medicine against its benefits to enable patient access to critical treatments while making them as safe as possible. The European Union’s (EU) regulatory network has instituted a robust system for monitoring and managing the risks of medicines in clinical trials and on the market.

Recently, global PV systems have undergone significant technological advancements, which has greatly increased the safety data available for evaluation by regulators and manufacturers. Furthermore, patient engagement in health-care decision making is rapidly increasing, allowing more feedback from “real-world” data.

The EMA predict three key influencers for PV in the next ten years. Firstly, new technologies such as e-Health applications, as well as the continuing collaboration between regulators and the industry to finalise post-approval safety data management guidelines, will help to optimise the collection and management of individual case safety reports (ICSR). Enhancement of ICSRs is crucial, as they are a critical data source for detection of safety issues.

Secondly, PV monitoring will move from reactive activity from spontaneous adverse event reports, to more proactive monitoring of the product, based on careful pre-market planning, such as risk management plans. The EMA believe that by 2030, this proactive monitoring for essential new medicines will involve both safety and efficacy, allowing real-time decision making by regulators to optimise patient safety.

Finally, regulators are expected to escalate engagement with patients and health-care professionals (HCP). They envisage that electronic product information will be updated “real-time” to support the safe prescribing, dispensing and use of medicines.

Overall, the article concludes that smarter management of safety reports, measurement of on-market medicine performance, and enhanced public engagement will be the key elements of PV in 2030.

To access the full article, click here.