By Professor Saad Shakir, Director at Drug Safety Research Unit
We are delighted to be joining forces with the Royal Pharmaceutical Society to provide this course to introduce pharmacovigilance to pharmacists. Pharmacovigilance is defined by the European Medicines Agency as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.”
Monitoring safety and pharmacovigilance are key activities during the lifecycle of a medicine, both at the pre-marketing stage and once it is licensed for use in humans. No medicine is without risk of adverse effects and the science of drug safety involves assessing and optimising the risk-benefit balance for each medicine.
This course will detail the key role that pharmacists have to play in pharmacovigilance and will explain why it is important to report adverse drug reactions and methods for doing so. Presentations will be complemented by interactive sessions.
Routine risk minimisation measures are required for each drug and include the SmPC, PIL, packet size and the legal state. For products where these are considered insufficient, additional risk minimisation measures will be required in order to optimise the risk/benefit balance and maintain patient safety in everyday use of the drug. Community pharmacists are frequently involved in additional risk minimisation measures usually at the point at which a medicine is dispensed. For example, pharmacists may be asked to keep a log to indicate whether they have provided a patient card to the patient with their medicine (in addition to the PIL) and explained its use. The patient card may list serious potential side effects and actions to be taken in the event of occurrence.
This blog aims to provide you with a glimpse of the course. We do hope that you will be able to join us!