REVIEWThe report also noted that additional areas of drug safety concern outside of the CSD remit existed, which were:• the control of the quality of drugs; • the control of over-the-counter (OTC) sales of medicines; • the use of approved names; • the regulation of therapeutic claims. ABSTRACTThe UK laws regarding the licensing of medicines have been developed to reduce the likelihood of harm through their use. Unlicensed medicines lie outside that harm management process; they have additional risks and require professional responsibilities that are complex. Therefore, pharmacy practice applies risk management tactics that are specific to how it manages unlicensed medicines, especially in hospitals, where the risks of their use is at its highest. Due to increasing demand and costs -but static funding -healthcare in the UK's National Health Service is under stress and undergoing a period of transformation and cost savings. That transformation affects all areas of pharmacy practice and medicines procurement. Service leaders need to keep a focus on maintaining safety systems for unlicensed medicines through a period of change, including potential changes in roles and responsibilities.

Objectives To highlight the need for a comprehensive risk assessment to be conducted prior to any decision on a possible high-volume product switch. Methods A multi-disciplinary group of experts met to develop the content of this paper. They discussed their experiences and local Trust procedures and then wrote this paper. The content of this paper represents their consensus on the need to conduct risk assessments when considering a product switch, what parameters should be considered and which stakeholders. Results This paper details the key elements of a comprehensive risk assessment and the consequences of not conducting one. It will encourage a new gold standard approach when assessing whether a high-volume product switch should be considered. Conclusions Before a high-volume product switch is considered, a comprehensive risk assessment should be conducted. Numerous parameters should be included in any risk assessment. It is important that all of the necessary stakeholders, including representation from those who will be affected, are involved in varying degrees in the risk assessment process. Following comprehensive risk assessments, NHS Trusts would proceed with very few switches.