Pharmacovigilance (PV) is defined as the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, blood products, herbals, vaccines, medical devices, traditional and complementary medicines.
The purpose of PV is to identify new information about hazards associated with products and preventing harm to patients. No degree of care and caution at the pre-clinical and clinical testing stages can guarantee absolute safety, when a drug is marketed and prescribed to large populations. Continuous monitoring of drug effects, side effects, contraindications are essential to maximize benefits and minimize risks. Since clinical trials involve several thousands of patients at most, less common side effects and ADRs are often unknown at the time a drug enters the market. Post marketing PV uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.
While pharmaceutical and biotechnology companies must monitor and proactively estimate and manage drug risk throughout a product’s lifecycle, the drug regulatory agencies have the responsibility of having a well-established PV system to monitor ADRs during the drug development phase and later during the lifetime of a marketed drug.
With the challenge of maximizing drug safety and maintaining public confidence becoming increasingly complex in this century, the PV function has become an important public health issue as every stakeholder is faced with a number of challenges. As India remains the largest producer of pharmaceuticals, it is also emerging as an important clinical trial hub in the world; hence the PV role is getting more prominence and continues to grow, evolve and improve.
To be successful in the PV role, one thus needs to be strong in their fundamentals and be updated on the latest developments in the area of drug research. Besides these one has to be good at liaising, communicating and collaborating with multiple stakeholders.