A questionnaire study evaluating the completion and content of unlicensed medicines risk assessments in NHS Trusts
Authors: Sugiura G , Patel N , Grant D 
Published: November 2024

Abstract

Introduction
Unlicensed medicine (ULM) use is necessary and prevalent within the NHS. Compared to licensed medicines, there are no centralised assessments of safety, efficacy, and quality. The risks associated with using unlicensed medicines have been well documented: increased risk of adverse events, potentially poorer quality formulation and absence of regulated manufacturing and supply standards1. Therefore, there is a requirement for NHS organisations to risk assess the need and quality of unlicensed medicines to reduce harm2. There are currently minimal published data on whether NHS trusts complete these risk assessments and whether practice is standardised3. This study focuses on understanding how NHS trusts in England conduct Unlicensed Medicine Risk Assessments (ULMRA).

Aim
To determine whether there is variability in the completion, content, and volume of unlicensed medicines risk assessments for unlicensed medicines procured within NHS trusts.

Methods
An online and anonymous questionnaire was developed and distributed to procurement pharmacy professionals. The questionnaire assessed four key areas: quantity of ULMRA conducted; completion and content of ULMRA; completion of clinical ULMRA; and risk management and mitigation strategies for ULM. To increase response rates, potential respondents were contacted via regional procurement groups as well as the NHS Chief Pharmacist network.
Approval for this study was granted by the NHS Health and Research Authority and the University of Reading Ethics Committee.

Results
Content validity was ensured by a panel of six secondary care pharmacy professionals, achieving a content validity index (CVI) of greater than 0.8 for each question. Thirty-seven responses were received, representing a 20% response rate. Most respondents (48.6%) were pharmacists, followed by pharmacy technicians (45.9%). The questionnaire revealed that 73% of respondents conducted quality and clinical risk assessments for all ULMs before use, and 94.4% had a ULM policy or procedure. Most respondents procured 1-3 ULMs per month, with some conducting over 12 ULMRA monthly. 97% specified procuring imported products licensed in the country of origin and 'Specials' from UK manufacturers, and 57% indicated they procure imported medicines not licensed in the country of origin. 68% of respondents indicated that quality checks were not completed upon receipt of ULMs.

Discussion
The study highlighted significant variation and duplication in the ULMRA processes across NHS trusts. Variations were identified in the content of ULMRA, professionals completing risk assessments and the volume of unlicensed medicines procured. While most trusts performed quality and clinical risk assessments, inconsistencies in practices and ULMRA content were evident. Standard methodologies for ULMRA and collaborative data sharing could improve reliability and efficiency, reducing patient risk and resource duplication. A limitation of this study is that the low response rate limits generalisability of data.

Conclusion
This study identified areas of variation within the NHS around the content and quantity of ULMRA completed, as well as some areas of duplication, particularly in the medicines risk assessed. Future research should explore the reasons for variation identified and evaluate the acceptability of current risks. Addressing these variations could lead to improved patient safety and optimised use of NHS resources.

References
1. Bourns IM. Unlicensed medicines in the UK - legal frameworks, risks, and their management. Med. Access Point Care. 2017; 1(1).
2. Sutherland A, Waldek S. It is time to review how unlicensed medicines are used. Eur. J. Clin. Pharmacol., 2015, 71(9), 1029-1035
3. Donovan G, Parkin L, Brierley-Jones L, Wilkes S. Unlicensed medicines use: a UK guideline analysis using AGREE II, Int. J. Pharm. Pract., 2018 26(6), 515-525.