Qualitative study of unlicensed medicines use
Research type
Research Study
Full title
Exploring Multidisciplinary Use of unLicenSed medicines In primary and secONdary care (EMULSION)
IRAS ID
162518
Contact name
Gemma Donovan
Contact email
Sponsor organisation
University of Sunderland
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
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 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.
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 usually control where the product the patient receives is obtained from.
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.
A review of the published literature will be undertaken along with guidance and protocols which have been produced to direct professionals and provide information to patients around unlicensed medicines. This will be followed by one-to-one interviews with prescribers, pharmacists and patients from primary and secondary care. Interviews will be anonymously transcribed and analysed for themes. These themes will then be reported back to the participants from the interviews in focus groups. 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.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0191
Date of REC Opinion
11 May 2015
REC opinion
Further Information Favourable Opinion