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Context Licensed medicines have been evaluated by the Medicines Health Regulatory Authority (MHRA) to ensure their pharmaceutical quality, safety, and efficacy. In contrast, unlicensed medicines fall outside the MHRA licensing framework, meaning pharmacy teams and prescribers have a responsibility to take appropriate steps to satisfy themselves of the quality, safety, and efficacy of any unlicensed medicine they prescribe, purchase, manufacture, or supply. 1 Ongoing medication supply challenges and evolving paediatric care needs have led to increased reliance on unlicensed medicines, including imports, UK-manufactured specials, and food supplements.Strategy for Change Our pharmacy team recognised the need to review and enhance practice for identifying, sourcing, and assessing the quality of unlicensed medicines. We developed in-house guidance based on national resources 1 and a risk assessment process tailored to paediatric use to ensure our products undergo a thorough evaluation to help assure us of quality and safety and mitigate risks. Unlicensed medicines/food supplements are now subject to a structured quality assessment prior to purchase and quarantined until a comprehensive risk assessment is completed.Measures of Improvement This process prompts consideration of multiple aspects including clinical use, packaging, administration, excipients, and the impact on all stakeholders, including prescribers, pharmacy, nurses, and parents/carers. The system also supports ongoing monitoring of subsequent supplies to detect changes.Results Since implementation the pharmacy team have reviewed 55 new unlicensed products using the new method, 35 of these were associated with challenges and 7 of these were not approved for use for reasons such as unacceptable excipients, lack of quality assurance, unacceptable final product and identified updated safety concerns. Key challenges encountered included legal packaging requirements across countries, excipient variations, translation errors, good manufacturing practice (GMP) verification, and supply chain transparency.For example:Trying to establish the supply chain of products marketed as ‘international packs’. These products are technically not licensed anywhere; therefore, it is important to verify the supply chain and quality.Identifying changes to raw materials within the product, without prior warning from the manufacturer. Some excipients may not be suitable for use in children; therefore, it is important to obtain an excipient list and quantity of concerning excipients prior to agreement of purchase.Suppliers providing products marketed as food supplements, where a licensed medicinal product or a special manufactured under a specials license was expected. Food supplements are dietary supplements, not medicines and are covered under EU Food law, therefore cannot be considered to be of comparable quality to medicines, and the quality and content is not guaranteed.Conclusion Pharmacy staff should ensure systems are in place and regularly reviewed to support the safe procurement and supply of specials of an appropriate quality. 2 We successfully implemented a systematic approach to the quality and risk assessment of unlicensed medicines within our Trust. This has improved patient safety and compliance with governance standards. The process revealed that assessing unlicensed medicines can often be complex and requires persistent communication with importers/manufacturers, and use of knowledge/specialist resources to obtain sufficient information for informed decision-making.References Specialist Pharmacy Service. Understanding unlicensed medicines [Internet]. NHS Specialist Pharmacy Service; 2025 May 13 [cited 2025 Jul 6]. Available from: https://www.sps.nhs.uk/articles/understanding-unlicensed-medicines/ Royal Pharmaceutical Society. Professional Guidance for the Procurement and Supply of Specials [Internet]. London: Royal Pharmaceutical Society; 2015 Dec [cited 2025 Aug 11]. Available from: https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Support/toolkit/specials-professional-guidance.pdf