Factors affecting the patient journey and patient care when receiving an unlicensed medicine: A systematic review.

Background: Unlicensed medicines are used across the UK to treat an individual's clinical needs when there are no appropriate licensed alternatives. Patients, carers and parents have reported facing challenges with unlicensed medicines at the points of transfer of care between settings, a key time when medication errors may occur. There is little known about the patient journey as a whole, or the factors affecting patient care when receiving an unlicensed medicine.

Objective: A systematic review of UK literature to better understand factors that affect the entire patient journey from the decision to initiate treatment with an unlicensed medicine to the point at which treatment is supplied through a community pharmacy or ends.

Methods: Scopus, OVID EMCARE, EMBASE, OVID Medline ALL, CINAHL, Web of Science and Joanna Briggs Institute were searched from 1968 (introduction of the Medicines Act) until November 2020, using the PRISMA guidelines. Narrative synthesis of UK studies was employed to analyse descriptive and qualitative data on any reported findings that would impact the patient journey or care related to the use of unlicensed medicines, and any described barriers or enablers.

Results: Forty-five studies met criteria for final inclusion, with high levels of heterogeneity in terms of designs and methods. Specific challenges that were seen to impact the continuity of care across care settings, patient safety and provision of patient-centred care included diversity of clinical needs and impact of patient population age; healthcare professional awareness and acceptability of the use of unlicensed medicines; the hierarchical structure of the NHS; inconsistent doses and formulations with varying bioequivalence; patient/parent/carer/public awareness of unlicensed medicines use and perceived acceptability.

Conclusions: This review identified a clear need for consistent information to be provided to healthcare professional and patients alike to support the safe and effective use of unlicensed medicines across care settings.