Expert advice

Medicines management: Can I administer unlicensed medicines to patients?

As long as informed consent is obtained first, unlicensed medicines can be administered to patients using a patient-specific direction, says medicines management expert Matt Griffiths.
medicines

As long as informed consent is obtained first, unlicensed medicines can be administered to patients using a patient-specific direction, says medicines management expert Matt Griffiths

All medicines go through clinical drug trials as part of their licensing procedure. If a drug has not undergone clinical trials, it is classed as an unlicensed medicine.

Medicines are licensed to show what conditions they can be used for, the normal doses, the form the medicine takes (such as tablet or liquid), which groups of patients they can be used for, and any known side effects or drug-on-drug interactions.

In line with Nursing and Midwifery Council (NMC) Standards for Medicines Management, you must gain informed consent from patients prior to administering any unlicensed medicine. The NMC standards also say that if an unlicensed

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As long as informed consent is obtained first, unlicensed medicines can be administered to patients using a patient-specific direction, says medicines management expert Matt Griffiths 

medicine
Picture: iStock

All medicines go through clinical drug trials as part of their licensing procedure. If a drug has not undergone clinical trials, it is classed as an unlicensed medicine.

Medicines are licensed to show what conditions they can be used for, the normal doses, the form the medicine takes (such as tablet or liquid), which groups of patients they can be used for, and any known side effects or drug-on-drug interactions. 

In line with Nursing and Midwifery Council (NMC) Standards for Medicines Management, you must gain informed consent from patients prior to administering any unlicensed medicine. The NMC standards also say that if an unlicensed medicine is administered to a patient, the manufacturer may not have liability for any harm that ensues, and the person who prescribes and dispenses or supplies the medicine carries the liability. 

Off-label

Unlicensed medicines also require a patient specific direction (PSD), and cannot be administered under a patient group direction (PGD). 

Once licensed, clinicians will sometimes prescribe medicines ‘off-licence’. Also known as ‘off-label’, this means the drug is licensed but is being used in another way. For example, it could be administered differently, used for a condition it wasn’t originally intended for, or used with a different patient group, such as children or older people. 

Off-licence medicines can be administered under a PGD if justified by best practice, but I would suggest that using a medicine ‘off-licence’ carries the same liability as an unlicensed medicine, as the manufacturer hasn’t tested the medicine for off-licence use.

The British National Formulary, BNF for Children, and NMC standards offer more advice on this, and you can look up individual summaries of the product characteristics of medicines – which have the licensing information on them – at medicines.org.uk.


Matt Griffiths is visiting professor of prescribing and medicines management at Birmingham City University 

 

 

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