The modification of a medicine to enable a patient to swallow it will nearly always be an unlicensed use of the medicine. Under the Medicines Act 1968 only a medical or dental practitioner can authorise the unlicensed use of a medicine.

Marketing authorisations, or product licences, are granted on the basis that the medicine will be administered in its manufactured and tested form. Consequently, if a tablet is crushed or a medicine altered in any way it becomes an unlicensed form, and the manufacturer is considered no longer liable for any harm that occurs as a consequence of taking the medicine.

Nurses or pharmacists who advise patients to crush tablets or open capsules are effectively sanctioning the unlicensed use of a medicine and as such would be liable for any harm caused.

Where medicines are prescribed for use outside of their product licence the prescriber, pharmacist and person administering the medicine will all share a responsibility for the off-licence use.

The patient response to medication administered outside of its license can be unpredictable. Drugs may have an increased or decreased effect than when administered in its original form. There may also be an impact on the onset and duration of the drugs activity. It is also possible that side-effects may be exacerbated; these side effects will also be the responsibility of the healthcare professionals involved in the prescribing, supply and administration of the medicines.

In addition to the legal implications pharmacists should consider their ethical responsibilities. The code of ethics advises that pharmacists should always:

• Make patients their first concern.
• Ensure that services provided are safe and of an acceptable quality.
• Provide medicines and other professional services safely and when patients need them.
• Use professional judgement in the interests of the patients and public.

To satisfy these standards pharmacists have a responsibility to ensure that:

• Patients receive medication that is safe, of an acceptable quality and that it is appropriate for their medical condition.
• Specials should only be supplied where no licensed medicine is available to meet the patient's clinical needs.
• Specials are of an appropriate quality.
• Where no licensed products are available options to consider include:
  • Use of a licensed product from Europe, USA, Canada, Australia or an MHRA recognised authority.
  • Supply of a licensed preparation for use in an unlicensed manner.
  • Special produced by an external manufacturer with a specials licence.
  • Extemporaneous dispensing such as crushing tablets or opening capsules.

When determining the most appropriate option pharmacists should consider the patient’s clinical need, the option with the lowest patient risk and also the urgency with which the medicine is required. It is also recommended that pharmacists keep records of these decisions including the reason for altering the medication, alternative options considered, discussions and obtaining patient consent.