This article is part of our Summer Webinar Series
This past Monday, we hosted our second webinar from our Summer Series! Takeda fellow, Abimbola Cole, covered Pharmacovigilance. Read her supplementary article below!
The basis of any type of drug approval is proving that your drug is safe and efficacious. Therefore, it goes without saying that the pharmacovigilance (PV) functionality plays a crucial role in drug development and management. The modern-day practice of pharmacovigilance is relatively new and its roots can be traced to distinct instances in medical history. Like many other practices of today, health care and non-healthcare alike, the regulations governing this field are reactions based on tragic events
Therefore, to truly understand the significance and foundation of pharmacovigilance one must first understand the history of the regulations that encompass it. Examples of these regulations include the 1906 Pure Food and Drug Act which Congress passed to address and fix unsanitary conditions of manufacturing plants, and the 1938 Food, Drug, and Cosmetic Act, which was a result of the 1937 elixir sulfanilamide incident that killed over 100 people. In modern day, the 2004 Vioxx disaster is another reminder of the importance of drug safety activities. Simply put, pharmacovigilance is the practice of drug safety focusing on the prevention or reduction of adverse drug reactions and harm to patients.
With the number of medicinal products on the market and the number of patients receiving these medications, it is imperative that there is an efficient way that adverse drug reactions are processed and streamlined. Like other functional areas in the pharmaceutical industry, pharmacovigilance can be broken down into distinct units: PV Operations, Medical Safety, and Risk Management.
PV operations addresses the handling and processing of safety cases that are received by pharmaceutical companies. Medical safety is involved in the medical assessment of a product’s safety profile by critically reviewing safety information on a regular basis. Medical safety also looks for adverse reactions, which can signify a change in the safety profile. Risk management is heavily involved in the assessment of a medicinal product’s benefits and risks. It also strategically implements risk minimization measures to increase the benefit profile of a product.
Pharmacovigilance is like being a detective. You are constantly looking for signs of a potential problem in an otherwise steady environment. As PV scientists we are constantly scanning large amounts of data to prevent harm and maximize patient beneft.
Abimbola Cole, PharmD, is a Global Pharmacovigilance Post-Doctoral Fellow with MCPHS University and Takeda
Missed the webinar? Head over to the link below to watch the recording! Please note that you will be asked to provide a name and email to access the replay. We ask for a login for administrative purposes for the Recruitment Team who organizes our webinars.
Webinar Replay Link (the video does take some time to load once you hit play)