Unlicensed medicines

The clinical needs of patients can usually be met by prescribing and administering a licensed medicine. There will be cases where a medicine cannot be used because the patient is unable to take it in its licensed form. In such situations, nurses may be able to arrange for the patient to be supplied with an unlicensed medicine to specifically meet that patient's special need (Human Medicines Regulations 2012, regulation 167).

The Human Medicines Regulations 2012 generally require that medicinal products for human use are supplied and administered in accordance with a product licence or marketing authorisation. This licence is granted following satisfactory completion of rigorous laboratory and clinical trials that test the safety quality and efficacy of a medicinal product (Council Directive 2001/83/EC). The marketing authorisation reassures nurses and their patients that even though there are likely to be some common adverse drug reactions, used properly, the medicine is safe and effective. It also provides the prescriber with a defence in that inherent harm from the product will be attributed to the producer under the Consumer protection Act 1987 and the Product Liability Directive (Council Directive (EEC) 85/374 1985). In Les Laboratoires Leo SA v Scovazzo [1999], a pharmaceutical company was found liable under product liability law when a medicine that had been developed with a digestible sponge coating caused gastric bleeding. Nurses are, therefore, required to administer licensed medicines that have been subject to rigorous scrutiny for safety, quality and efficacy where they meet the clinical need of the patient (Medicines and Healthcare products Regulatory Agency (MHRA), 2014)