Mr Singh was diagnosed with migraine a number of years ago. During the last 6 months he has been suffering up to four attacks a month and has been debilitated by this frequency. You discussed prophylactic treatment with him and initially prescribed pizotifen. The frequency of attacks has reduced but unfortunately he is drowsy all day. You now propose prescribing sodium valproate. This would be an off-label use for this medication. What issues does prescribing this, or any, off-label medicinal product raise? In order to elicit a valid consent to taking this drug as part of Mr Singh’s clinical management and establish concordance, what information do you consider to be essential and optional to be given to him?

Prescribing drugs outside of their product licence
Take care to explain that the drug is off-label and what this means; this is particularly important as the patient information leaflet that comes with the dispensed drug could be confusing to the patient. Ensure you understand and maintain an appropriate standard of knowledge (Bolam) regarding the medicinal product and its usage.
Only prescribe within your area of competency and experience. This may mean only prescribing following transfer of patient care (e.g. Consultant to GP) after initial prescribing from a Consultant and/or senior medical colleague. Responsibility for monitoring and reviewing the patient whilst taking the drug usually lies with the Consultant who commenced the drug treatment. However remember that liability lies with the individual who signs the prescription.

(From 'Practical Prescribing for Medical Students' - Chapter 2 - Monica Murphy and Catherine Gill)

Copyright eBook 2019, University of Leeds, Leeds Institute of Medical Education.