By Chris M. Slawecki, Senior Digital Copy Editor, DIA
Three words: Simplification and harmonization of systems and processes, and (risk) communication as a two-way process that is most effective when it engages patients framed the current and future state of pharmacovigilance (PV) in the EU.
- Simplification: The new EudraVigilance (EV) system has simplified the reporting of individual case safety reports (ICSRs) and adverse drug reactions (ADRs), but good pharmacovigilance practice (GPvP) inspections continue to identify both under-reporting and over-reporting.
- Harmonization: Aligning the safety concerns between the product safety update report and the risk management plan remains problematic in the EU; EMA and FDA continue to have different visions, and focus on different products, for signal detection; other global initiatives are working to protect patient safety in countries with limited regulatory and PV resources.
- Risk Communication: Early patient involvement in healthcare development is also shown to improve and expedite identifying risk information and communicating that risk information to the public.
Why this is important: Patient safety largely depends not only upon safe products but also on appropriate (safe) use of these products after they’re 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.