Gemma Donovan, University of Sunderland
Unlicensed medicines are medicines which have not undergone clinical trials, testing and evaluation associated with normal licensed medicines in the UK. They are usually used to manage specific patient needs that licensed medicines cannot meet. This may be because a patient requires a liquid medicine due to swallowing difficulties or because they require smaller doses such as medicines for children. It may also be that no UK licensed formulation exists for the drug that the prescriber wants to use, so prescribers select a product that has been manufactured as a food supplement or they may choose to prescribe a drug which may be licensed in another country, but remains unlicensed within the UK. This project will focus on medicines which have been prescribed which do not hold a license, and therefore will not cover alternative and complementary medicines, counterfeit medicines, or use of licensed medicines for unlicensed reasons, also know as off-label.
Because unlicensed medicines are not manufactured by pharmaceutical companies who are ordinarily liable for any adverse reactions from the drugs they produce, the liability for the use of unlicensed medicines remains with the prescriber. However, the dispensing pharmacist will source the unlicensed medicine on the prescriber’s behalf. This means that the prescriber does not usualy control where the product the patient receives is obtained from.
There is very little published evidence about the use of unlicensed medicines, although the prescribing data does tell us that these medicines are significantly more expensive than normal medicines, and some seem to be being prescribed when there are licensed medicines also available that may be appropriate. We don’t have a very good understanding about what influences the decision to use unlicensed medicines and what checks and balances are in place to ensure they are used appropriately. In addition, we are not sure what information patients are given about unlicensed medicines, what their understanding is around unlicensed medicines and how they feel about the use of these medicines.
The research team will undertake a review of the published literature along with guidance and protocols which have been produced to direct professionals and provide information to patients around unlicensed medicines. The project data collection starts with conducting one-to-one interviews with prescribers, pharmacists and patients from primary and secondary care. These will allow exploration of the issues
associated with unlicensed medicines from their perspectives. Interviews will be anonymously transcribed and analysed for themes. These themes will then be reported back to the participants from the interviews in two focus groups, one for patients and one for healthcare professisonals. These focus groups will allow the results of the interviews to be tested with the participants and generate further data on their reactions to the results and potentially identify future areas for exploration.
The results of the research may lead to the development of training materials for healthcare professionals, information for patients, guidance on the use of unlicensed medicines or inform the design of future interventions to deliver safe and effective use of these medicines.
This project ran from October 2014 to October 2015. The final report is available here.