Pharmacovigilance Compliance

Pharmacovigilance Compliance

According to the definition of the World Health Organization (WHO), Pharmacovigilance (PV) is “the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problems.”
While pharmaceutical companies and regulatory agencies in both the United States (U.S.) and the European Union (EU) understand the importance of producing quality and safe products for consumers, and patients due to the global nature of the industry, it’s imperative to have a clear understanding of differing policies. Pharmaceutical manufacturers are accustomed to establishing robust procedures and systems to support compliance with the pharmacovigilance regulations set forth by regulatory bodies around the globe. On the other hand, pharmacies have traditionally followed local state pharmacy law as it relates to reporting adverse events.1 Specialty pharmacies are playing an increasing role in patient support and disease management programs. This role requires compliance with the guidelines that exist in the global pharmacovigilance landscape. Here we will explore the intersection between the global regulations governing adverse event reporting and operational considerations for the specialty pharmacy. Pharmacovigilance is the science of collecting, monitoring, researching, assessing, and evaluating information from health care providers and patients on the adverse effects of medications and biologics. Below is a review of several key PV regulation changes in the U.S. and the EU over the past years that have had a significant impact on drug safety compliance and how pharmaceutical companies, and by extension their partners, operate.ce premise.

  • Identifiable reporting source
  • Identifiable patient
  • At least 1 adverse event1
  • Suspect medicinal product
  • Establishing robust procedures
  • Collecting information
  • Monitoring information
  • Researching information
  • Assessing information
  • Evaluating information

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