title: It is time to review how unlicensed medicines are used.
abstract: The safe and effective use of medicines is an integral part of the medicine safety agenda. We present a phenomenological topic review of the literature relating to the use of unlicensed medicines (ULM). There is evidence to demonstrate that the use of ULM is associated with increased incidence of adverse drug reactions, and that despite advances in medicine regulation and guidance from professional organisations, the use of ULM in at risk populations has not reduced. There is also evidence to suggest that patients and their carers are not being provided with adequate information about their medicines and that ULM are being used where safer licensed alternatives are available. This is contrary to the philosophy of "patient-focussed care". We conclude that organisational governance processes and professional guidelines have not kept pace with regulatory developments or changes in legal and ethical understanding. We recommend that governance procedures for ULM be updated across healthcare settings to ensure that patients are involved in the decisions made about their medicines including the regulatory status of the medicine. This includes ensuring adequate consent is obtained from the patient (or their advocate). We also recommend that professional bodies clarify their position on when ULM can be used instead of licensed medicines to ensure that licensed medicines are used wherever possible. In the current economic environment, commissioners and clinicians must resist the temptation to use lower-quality ULM in place of licensed ones to cut costs. We go on to recommend areas of further research including the extent of ULM prescribing where licensed alternatives exist and the geographical and social factors that influence clinician prescribing of ULM.
authors.affiliation: Royal Manchester Children's Hospital, Oxford Road, Manchester, M13 9WL, UK, adam.sutherland@cmft.nhs.uk.
authors.forename: Adam
authors.initials: A
authors.lastname: Sutherland
authors.forename: Stephen
authors.initials: S
authors.lastname: Waldek
mesh_terms: D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D056687:Off-Label Use / Q000941:ethics / Q000706:statistics & numerical data*; D061214:Patient Safety