The Medicines and Healthcare products Regulatory Agency (MHRA) is calling for comments on proposals to regularise the legal position of practitioners mixing and administering medicines in palliative care. While it does so, it says, it will not consider enforcement action for breaches of medicines legislation “unless it would be in the public interest to do so.”

The Agency is seeking to secure a permanent legal basis for “this long-standing practice” through amendments to the Medicines Act 1968 and the Misuse of Drugs Regulations 2001 and to ensure that practitioners are acting within the law. During this process, it says, “we would not consider enforcement action for breaches of medicines legislation by doctors, nurse independent prescribers (NIPs) and pharmacist independent prescribers (PIPs) prescribing and administering (and instructing others to administer) a mixture of licensed medication unless it would be in the public interest to do so. This also applies to those mixing in accordance with the directions of the prescriber.”

The need for clarification has been heightened by the government’s recently-published End of Life Care Strategy, which is likely to increase demand for experienced and specialist palliative care practitioners (not necessarily independent prescribers) who can respond directly to the needs of patients as and when those needs change. However, unless NIPs and PIPs can mix medicines or instruct others to do so, they will be effectively unable to care for patients in their homes or, indeed, any other settings such as hospices, says the Agency.

The option for change which the Agency is recommending is to enable NIPs and PIPs to specially prepare products for their individual patients, direct nurses and pharmacists who are not prescribers to mix drugs prior to administration and, at the same time, enable doctors to direct nurses and pharmacists to mix on a similar basis.

This proposal - which, the Agency says, is strongly supported by the Department of Health - is “based on the understanding that all concerned are experienced in palliative care, that they would take full professional and clinical responsibility for their actions and their employers develop or make available appropriate guidance to ensure patient safety.”

Controlled drugs

The Home Office also intends to extend the current authority for practitioners and pharmacists to compound controlled drugs to NIPs, but not to those nurses who will often be mixing medicines in palliative care but are not NIPs. Therefore, it proposes to further extend the authority to compound controlled drugs to nurses with the supporting authority for a nurse to possess a controlled drug for this purpose. “This would be subject to the requirement that the compounding would only be in accordance with the independent prescriber’s directions for the purpose of immediate administration of medicines to the patient,” says the MHRA, which is also inviting comments on this proposal by the Home Office.

The deadline for responses is February 27, 2009, and the MHRA also notes that the Royal Pharmaceutical Society of Great Britain (RPSGB) intends to issue a Law and Ethics Bulletin which takes the same view on this issue.