Advice on Risk Management
No medicine is without risk. Some of the risks are known when a product is launched onto the market, other risks will only become apparent when the medicine is used by large numbers of people, and even then many risks can only be discovered with systematic monitoring using methods such as PEM. For effective use of medicines the harm (‘risk’) and benefit balance of any product does not only need to be favourable when it is launched onto the market but needs to continue to be favourable when it is used by large numbers of patients in day-to-day clinical practice. Risk management of medicines is therefore essential for public health, to ensure an acceptable risk/benefit balance for all patients who use the medicines. Risk management plans are now a regulatory requirement for medicines in the
Key parts of RMP’s are studies to examine the safety in large numbers of patients who receive the medicines in day-to-day clinical practice. The NHS, where nearly everyone has a GP who has comprehensive knowledge about their health, provides great opportunities to conduct studies on the safety and risk management of medicines. The DSRU, in partnership with thousands of GPs and other doctors in the NHS, utilises these opportunities in the NHS to conduct risk management and safety studies. The effective partnership that is offered by the NHS to the DSRU to protect patients has been a source of envy around the world. In order to achieve its mission to protect public health, the Unit continues to expand the studies it conducts to fulfill the requirements for risk management. Risk management of medicines must be based on good quality evidence such as that provided by studies which the DSRU and other similar research units worldwide produce.