What is Pharmacovigilance?
Medicinal products have transformed how we treat and prevent diseases, but they may also have unexpected side effects. As defined by the World Health Organization, Pharmacovigilance is the science and activity relating to the detection, assessment, and prevention of adverse effects or any other drug-related problem. It is a key way to assess safety and covers a wide range, including drug interactions, medication errors, lack of drug efficacy, acute and chronic poisoning, drug-related mortality, and anything related to adverse drug reactions. Pharmacovigilance is not only limited to drug products; it also covers herbs, biological products, devices, blood products, and vaccines.
The Council for International Organizations of Medical Sciences (CIOMS) has played a major role in shaping Pharmacovigilance as we know it. CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949 with the mission to advance public health through guidance on health research and policy. In 1986, CIOMS set up its first Working Group on Pharmacovigilance to explore coordinating and standardizing international adverse drug reporting across pharmaceutical manufacturers and regulatory authorities. Several ICH guidelines are based on the work of the CIOMS Working Groups, and today the CIOMS Suspect Adverse Reaction Reporting Form is the industry standard.
Why is Pharmacovigilance important?
Pharmacovigilance monitoring is required during the clinical investigation phase, as well as after approval. This allows regulatory agencies to assess the risk-benefit profile of a product when considering whether to grant approval and on an ongoing basis after approval through periodic safety updates.
Clinical studies offer a detailed, well-controlled view of the safety of a treatment, but real-world use in a wide patient population over an extended period of time can uncover rare events or events that occur in just a subset of patients that may have been excluded from clinical trials. For instance, Vioxx (Rofecoxib) was approved by the FDA in 1999 based on 5,400 subjects in 8 studies showing efficacy as a non-steroidal anti-inflammatory drug with a lower risk of gastrointestinal bleeding. However, it was withdrawn in 2004 due to serious cardiovascular events which was only identified after an estimated 20 million patients took the drug.
What are keys to a successful Pharmacovigilance program?
Pharmacovigilance monitoring relies on accurate, timely reporting of safety events from Health Care Providers, and a team that can compile the safety data and accurately report to regulatory agencies as required. Education of Health Care providers can increase awareness of safety requirements and the processes to report relevant events. When selecting a partner to manage a pharmacovigilance program, it’s important to look for a team with knowledge of worldwide regulations and experience with safety reporting and signal detection across a range of products, systems to ensure consistent, timely reporting of safety events and experience in educating staff on the importance of Pharmacovigilance and the steps to take to report an event.
DZS Clinical Services is a full-service CRO providing pharmacovigilance capabilities to maximize efficiencies in your global clinical trials. We have built a reputation in the pharmaceutical industry as a premier PV services provider. When you partner with us, you receive the complete spectrum of safety services, experience and the skillset to manage your program effectively and compliantly.