No medicine is 100% safe. Drug safety (also known as pharmacovigilance), is the science of detection, assessment, understanding and prevention of side effects which allows us to understand more about the risks and benefits of a medicine.
Drug safety scientists collect and evaluate information from patients and healthcare professionals to try and identify new information about the use of medicines and any side effects experienced by patients.
Safety monitoring of medicines is a continuous process, it is performed during clinical trials when medicines are developed, once medicines are launched (also called ‘licenced’) and throughout the entire period where a medicine is available for patients to use. Medicines are often taken by large numbers of people and side effects that are rare can sometimes only be detected once a medicine has been marketed. Individual patients and healthcare professionals are encouraged to report any side effects they experience via the MHRA's Yellow Card reporting scheme or directly to the company that manufacture the medicine.
The techniques used to monitor medicine safety range from the investigation of individual case reports, to data mining in large databases and epidemiology. This information is used to ensure the safe use of medicines and prevent harm to patients, and often results in an update of the side effects for a medicine detailed in the leaflet. There are also additional legislative requirements including:
Reporting of individual case reports to regulatory agencies
Preparation of summaries of product safety at specified intervals
Preparation of risk management plans which contain actions (which can include epidemiological studies) to further characterise risks associated with medicines and ensure actions are in place to minimise risks when these have been detected
The 2010 pharmacovigilance legislation and enhanced post-marketing surveillance
Updated European pharmacovigilance legislation was implemented in July 2012 which aimed at streamlining monitoring processes and improving surveillance by introducing new tools such as post authorisation efficacy studies, the creation of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency and the collection and analysis of an even broader body of safety data.
Implementation ongoing but full use of the provisions in this legislation will help support regulatory innovation (see Regulatory affairs section), they will also be facilitated by the development of world leading health informatics tools in the UK (see eHealth section)
Working with our member companies
We work with our member companies to represent the pharmaceutical industry in the UK on matters relating to drug safety, to enhance the good reputation of the industry by instilling good practice and by driving innovative approaches to this discipline. We also keep ABPI members informed on drug safety, policy and legislative developments.
UK and European organisations regularly send out consultation documents which include questions or policy statements which affect the drug safety functions of the pharmaceutical industry or the management of the safety of medicines. Here at the ABPI, we work with our members, including our network of experts in drug safety (the ABPI Pharmacovigilance Expert Network) to share best practice, drive innovation and contribute their specialist knowledge to these consultations, to ensure the best possible outcomes for patient safety.