FPM’s Position on Post-Market Surveillance

Pharmaceutical Medicine is a recognised medical specialty that sets standards for doctors working on the development, regulation, and monitoring of medicines for as long as they are used. These doctors work within regulatory agencies, pharmaceutical companies, and universities, and continuously assess (monitor) that medicines remain safe and effective throughout their lifecycle, i.e. have an adequate risk benefit balance for use in patients

Medicines and vaccines undergo extensive testing before approval and are subject to continuous monitoring once in use. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/ or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem (WHO).

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorised for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time.

This post-marketing surveillance is led by independent regulators worldwide and is designed to rapidly detect, assess, and respond to any safety concerns. Post-marketing surveillance includes reporting possible side effects by healthcare professionals, patients, and the public, with companies, regulators, and independent researchers all playing a role in monitoring these reports. Any new safety “signals” are thoroughly investigated, and action is taken quickly and transparently where needed.

False or misleading claims risk undermining confidence in safe and effective treatments, and may cause unnecessary fear for patients and families.

We strongly encourage clinicians and the public to rely on trusted, evidence-based sources, including:

• The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 
• The European Medicines Agency (EMA) 
• The World Health Organization (WHO) 

FPM and its members remain committed to promoting the safe, effective, and evidence-based use of medicines.

For further information, please contact: media@fpm.org.uk.