An unlicensed medicine is a medication that has not been approved for use by the Medicines and Healthcare products Regulatory Agency. In England, unlicensed medicines account for just under 1% of all community prescriptions, and thus, prescribers will encounter them relatively regularly during their working life. It is important to know the evidence-based guidelines about unlicensed medicines before prescribing them.
Get full access to this article
View all access options for this article.
References
1.
AveryAAndersonCBondC, et al. (2011)
Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme': Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technology Assessment15(20): 1–234. DOI: 10.3310/hta15200.
2.
BellisJRKirkhamJJNunnAJ, et al. (2014)
Adverse drug reactions and off-label and unlicensed medicines in children: A prospective cohort study of unplanned admissions to a paediatric hospital. British Journal of Clinical Pharmacology77(3): 545–553. DOI: 10.1111/bcp.12222.
3.
BournsI (2017)
Unlicensed medicines in the UK – legal frameworks, risks, and their management. Medicine Access @ Point of Care1(1): 22–28. DOI: 10.5301/maapoc.0000006.
ChisholmA (2012)
Exploring UK attitudes towards unlicensed medicines use: A questionnaire-based study of members of the general public and physicians. International Journal of General Medicine5: 27–40. DOI: 10.2147/IJGM.S28341.
6.
DonovanGParkinLBrierley-JonesL, et al. (2018)
Unlicensed medicines use: A UK guideline analysis using AGREE II. International Journal of Pharmacy Practice26(6): 515–525. DOI: 10.1111/ijpp.12436.
LenkCKochPZappelH, et al. (2009)
Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics. European Journal of Paediatrics168(12): 1473–1478. DOI: 10.1007/s00431-009-0956-6.
PavisHWilcockA (2001)
Prescribing of drugs for use outside their licence in palliative care: Survey of specialists in the United Kingdom. British Medical Journal323: 484–485. DOI: 10.1136/bmj.323.7311.484.
SutherlandAWaldekS (2015)
It is time to review how unlicensed medicines are used. European Journal of Clinical Pharmacology71(9): 1029–1035. DOI: 10.1007/s00228-015-1886-z.
20.
TurnerSNunnAJFieldingK, et al. (1999)
Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study. Acta Paediatrica, International Journal of Paediatrics88(9): 965–968. DOI: 10.1080/08035259950168469.