The Future of Pharmacovigilance in the European Union How Is Patient Engagement Shaping Pharmacovigilance Evolution in the EU?

The EU is improving pharmacovigilance (PV) in clinical trials and medical product distribution via three core principles: simplification, harmonization, and communication.

In 2018 EudraVision piloted a system to streamline reporting of product safety signals. However, reporting issues persist.

Low-to-middle income countries lack harmonized PV processes. Thus, the use of drug products tested in developed nations with well-defined PV may pose safety risks.

The WHO Smart Safety Surveillance project proposes to improve PV in these countries through a program of drug monitoring and focus on vaccination safety information.

Two-way patient communication mitigates risks. Experts involve patients earlier in the process both to explain the regulatory process and learn from patient impact.

3 Key Points:

  1. Though EV has simplified safety reporting, guidance to resolve under and over-reporting, as well as report duplication, is still needed.

      2. Effective PV will require a harmonization of priorities and cooperation amongst regulatory and political organizations.

      3. Active communication with patients throughout the clinical trial and drug treatment process proves beneficial for both experts and patients.

“Patient safety largely depends not only upon safe products but also on appropriate (safe) use of these products after approved for the market. “Safe use” is generally defined by identifying and communicating the benefits and risks of that product. Post-market safety monitoring keeps patients safe.” – Chris M. Slawecki, Senior Digital Copyeditor, Drug Information Association

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