Legal changes proposed to allow mixing of medicines
Proposals to change medicines legislation to allow pharmacist and nurse independent prescribers in palliative care to mix and administer medicines have been published by the Medicines and Healthcare products Regulatory Agency.
The move would require amendments to the Medicines Act 1968 and the Misuse of Drugs Regulations 2001. Currently, when appropriate, tablets can be crushed or a capsule opened and its contents mixed with a solution to make it easier to swallow, or substances can be mixed with water before injection.
However, pharmacists cannot mix two licensed medicines where one is not a vehicle for the administration of the other, because this falls within the definition of “manufacture” and results in a new, unlicensed product being administered.
The MHRA says it recognises that this could prevent palliative care patients from receiving adequate pain relief, and issued a statement making it clear that it would not take enforcement action against a pharmacist independent prescriber, nurse or doctor who has long been engaged in the practice of administering a mixture of licensed medicines via a single injection or a syringe driver unless it would be in the public interest to do so (PJ, 13 September 2008, p291).
The Palliative Care Pharmacists’ Network has welcomed the MHRA’s consultation, and said that there is “extensive positive clinical experience with this practice spanning many years”.
The network also recognised that further research would be beneficial and added: “To ensure that patients approaching the end of their life receive the optimal treatment, we fully agree with the MHRA recommendation that the law needs to be amended to enable palliative care to be one of the exceptions to the Act.”
The MHRA has identified alternative options for changes to medicines legislation: doing nothing; amending the definition of “manufacture” in the Medicines Act (both of which it does not recommend); and developing a formulary for mixing in palliative care, which it says is a “possibility but not necessarily desirable”.
The consultation has been produced jointly with the Home Office and the MHRA is inviting comments on the proposed changes, which would apply across the UK, to arrive by 27 February 2009.
Citation: The Pharmaceutical Journal URI: 10041872
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