The Medicines and Healthcare products Regulatory Agency (MHRA) completed a public consultation in July 2009 into the legal position of practitioners mixing and administering medicines in palliative care.
The review concluded that changes were necessary:
- To allow doctors and dentists (who can already mix medicines themselves) to direct others to mix (other than a pharmacist under existing legislative provisions, or by a person holding a manufacturer’s licence)
- To allow non-medical prescribers to mix medicines themselves and direct others to mix (other than a pharmacist under existing legislative provisions, or by a person holding a manufacturer’s licence)
- To allow nurse and Pharmacist Independent Prescribers to prescribe unlicensed medicines for their patients on the same basis as doctors and supplementary prescribers
A statutory instrument (PDF) has now come into force that creates new exemptions from the restrictions imposed by sections 7 and 8 of the Medicines Act 1968.
It should be noted that the changes made do not currently extend to controlled drugs. However, the MHRA has already stated that it would not consider taking enforcement action for breaches of medicines legislation in the long standing accepted practice of prescribing and administering (and providing directions to others to administer) a mixture of licensed medication via a single injection or a syringe driver unless it would be in the public interest to do so.
Action: Clinicians can be reassured by this amendment to the law. It is hoped that the position with respect to controlled drugs will also be clarified.