Pharmacovigilance is defined as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem’ (WHO & EMA). Monitoring the safety of medicines in healthcare practice allows both healthcare professionals (HCPs) and the general public to understand the associated risks and benefits. Consider the global race to identify and develop a COVID-19 vaccine. While in this example scenario it was critical to develop a vaccine rapidly, it is paramount that this is balanced with safety and efficacy –this is where pharmacovigilance comes in.
Although used interchangeably a slight difference exists between these two terms. Drug safety reactively examines and reports on data collected during clinical trials and in the post-marketing environment to inform regulatory agencies and reimbursement authorities. Pharmacovigilance, on the other hand, proactively considers the environment and identifies signals and trends within large patient populations, providing significant insight into how drugs are performing in the real world. Pharmacovigilance data is a key consideration during regulatory, reimbursement, and commercial discussions.
Pharmacovigilance analyses conducted in clinical research trials provide data on the safety profile of the drug but, in this setting, pharmacovigilance data is limited due to study restrictions. Typically, at the time of its authorisation, a medicine has been tested in a relatively small number of selected patients for a limited length of time. However, outside of the clinical research setting, the conditions of use change. Continued pharmacovigilance in the real-world is necessary to update the potential risks of drugs.
It is essential that the safety of all medicines is monitored throughout their use in healthcare practice through consistent pharmacovigilance strategies that comply with Good Pharmacovigilance Practice (GVP). The European Medicines Agency along with the Pharmacovigilance Risk Assessment Committee (PRAC), the Food and Drug Administration and Health Canada all outline specific expectations for GVP.
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