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5.1	Unlicensed medicines outwith clinical trials: Policy Statement
	The liability associated with the use of unlicensed medicines or medicines used outwith their product licence will be accepted by NHS Tayside provided that NHS Tayside procedures for the use of such medicines are complied with. The Area Drug and Therapeutics Committee (ADTC) has the responsibility to manage the use of unlicensed medicines within NHS Tayside. Where a licensed medicine is available, it is NHS Tayside policy to use it in preference to any unlicensed alternative⁽¹⁾. Users of unlicensed medicines are referred to the Policy on Prescribing of Medicines for Exceptional Use
5.2	Unlicensed medicines outwith clinical trials: Background Information
	The majority of medicines used within NHS Tayside are covered by Product Licences and the manufacturer is held liable for any harm caused by a defect in the product. For good clinical reasons, a large number of medicines that either do not have a product licence (Unlicensed Medicines) or are licensed but are used for indications outwith their product licence (Unlicensed Use) are used within NHS Tayside. Were this practice to be curtailed, the treatment of patients would be impeded. Prescribers of unlicensed medicines have a personal liability for their use that cannot be transferred to the manufacturer or importer of the medicine. NHS Tayside carries a liability for the actions of its employees and will accept liability for the use of unlicensed medicines or unlicensed uses of medicines provided NHS Tayside procedures are adhered to. Where it is intended that treatment will be continued after patient discharge or transfer, clear arrangements require to be agreed between primary and secondary care regarding clinical and prescribing responsibilities (See also Section 17). Prescribers are referred to the Shared Care Agreement Template for supply of unlicensed medicines to patients.
5.3	Unlicensed medicines outwith clinical trials: Unlicensed Medicines (‘Specials’)
5.3.1	The types of unlicensed medicines used within NHS Tayside may be described as follows:
5.3.1.1	Medicines manufactured or repackaged by Tayside Pharmaceuticals.
5.3.1.2	Medicines purchased from other hospital pharmacies or commercial companies who hold a Manufacturer’s ‘Specials’ Licence issued by the Medicines & Healthcare Products Regulatory Authority (MHRA).
5.3.1.3	Medicines purchased on a named patient/named consultant basis, including medicines purchased from abroad.
5.3.2	Wherever possible, unlicensed medicines should be purchased from Tayside Pharmaceuticals. This is a pharmaceutical manufacturing facility for the NHS in Scotland and information relating to the manufacture and testing of all products is readily available. Tayside Pharmaceuticals is subject to inspection by the MHRA and the results of these inspections are shared with NHS Tayside. There is therefore a considerable degree of confidence when purchasing unlicensed medicines from this source.
5.3.3	Where unlicensed medicines are obtained from other sources, Pharmacy (as the purchaser) takes responsibility for the quality of the product. The products are produced by the manufacturer in accordance with a detailed product specification approved by Pharmacy. Quality control of the product is carried out by the manufacturer and a Certificate of Analysis will be obtained by Pharmacy. On receipt in Pharmacy, compliance with the finished product specification will be confirmed.
5.3.4	Where a prescriber wishes to initiate treatment with an unlicensed medicine; this should be discussed with the responsible clinical pharmacist. The purchase of the following categories of unlicensed medicines will be approved by a senior pharmacist.
	Category 1: Licensed medicine packaged into a pack size not commercially available.
	Category 2: Licensed medicine formulated into a ready-to-use presentation.
	Category 3: Different presentations of licensed medicines where the concentration or dose unit is within recommended limits and the route of administration remains unchanged e.g. preservative-free eye drops.
5.3.5	The purchase and use of unlicensed medicines require approval of the ADTC.
5.3.6	The minutes of the ADTC will record approval for use and will note any approvals given by the Chairman outwith ADTC meetings.
5.3.7	The Pharmacy department has detailed procedures for the requesting, specification, procurement, receipt and acceptance of unlicensed medicines. A list of unlicensed medicines used within the hospitals in NHS Tayside is held by Pharmacy.
5.4	Unlicensed medicines outwith clinical trials: Unlicensed Use of Medicines Outwith their Product Licence
5.4.1	Many medicines are licensed for one or more indications but clinicians may wish to use them for an unlicensed indication or at an unlicensed dosage. Alteration of a licensed dosage form e.g. crushing of tablets is outwith the product licence of most medicines.
5.4.2	On occasion, a clinician may be unaware that the intended use is not a licensed use. This can happen where drugs within the same class do not have the same range of licensed indications.
5.4.3	Many medicines used in paediatrics are not licensed for use in neonates or children⁽²⁾.
5.4.4	Where a prescriber wishes to initiate treatment with a licensed medicine in an unlicensed context, including modification of a dosage form e.g. crushing tablets, this should be discussed with the responsible clinical pharmacist.
5.4.5	For routinely used licensed medicines in an unlicensed context, it is acknowledged that it is very difficult to maintain a comprehensive approach in NHS Tayside to secure ADTC approval. The risk assessment process is reflected only in the commonality of approach adopted by a wide range of clinicians. In any case of liability assessment, this would be the basis of defence i.e. that peer group practice clearly supported the prescriber.
5.4.6	NHS Tayside accepts that this is the case, however it expects that all unusual, not well understood unlicensed use of medicines are brought to the attention of the ADTC and approval formally granted as for unlicensed medicines above.
5.5	Unlicensed medicines outwith clinical trials: References
(1)	MCA Guidance Note 14: The supply of unlicensed relevant medicinal products for individual patients. Medicines Control Agency, February 2000.
(2)	Medicines for Children: The first UK national drug formulary for children. Royal College of Paediatrics and Child Health.