Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Name of policy document:
- MLX 356 - Proposal for amendments to medicines legislation to allow mixing of medicines in palliative care
- Deadline for response:
- 27 February 2009
Background: MLX 356 seeks views on proposals to regularise the legal position of practitioners mixing and administering medicines in palliative care. The MHRA would like to remind consultees that while a permanent legal basis is secured for this long-standing practice, the Agency has issued a statement which makes clear that it would not consider enforcement action for breaches of medicines legislation by doctors, Nurse Independent Prescribers and Pharmacist Independent Prescribers 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.
MHRA also understand that the Royal Pharmaceutical Society of Great Britain (RPSGB) intend to issue a Law and Ethics Bulletin which takes the same view on this issue.
The proposals are intended to ensure that nurse and pharmacist independent prescribers and others administering mixtures of medicines in palliative care are acting within the law. In this consultation letter “palliative care” means the care of patients (children, adolescents and adults) with advanced progressive life-limiting disease which is not responsive to curative treatment.
Application to Wales, Scotland and Northern Ireland:
This consultation has been produced jointly with the Home Office and is being made available in Wales, Scotland and Northern Ireland. Northern Ireland has its own misuse of drugs regulations and the Department of Health, Social Services and Public Safety will be considering similar changes to those regulations. For non-controlled drugs, medicines control is not an excepted or reserved matter as far as NI is concerned and NI’s Health Minister will be a co-signatory to amendments to the Medicines Act 1968.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
MLX 356 – PROPOSAL FOR AMENDMENTS TO MEDICINES LEGISLATION TO ALLOW MIXING OF MEDICINES IN PALLIATIVE CARE
The Royal College of Physicians of Edinburgh is pleased to respond to The MHRA on MLX 356.
The College welcomes the opportunity to comment on these proposals and has taken advice from specialists in clinical pharmacology and palliative medicine. It has been accepted practice for many years within palliative medicine to prescribe a mixture of licensed medicines to be administered, usually by subcutaneous infusion using a battery operated syringe driver. The practice has indeed gathered extensive experience that using these mixtures is safe, effective and convenient for the patient.
Option D therefore seems the preferred way forward – to change the current medicines legislation to enable nurse and pharmacist independent prescribers to specially prepare products for their individual patients and to direct nurses and pharmacists who are not prescribers to mix drugs prior to administration.
This College has previously expressed reservations to the MHRA on the scope of independent prescribing by nurses and pharmacists for controlled drugs (May 2005) and advised that initial prescribing should always be undertaken by a doctor but that repeat prescribing by independent prescribers was acceptable within clearly defined protocols in specialist units including hospices. Also we believe that the pool of prescribers for controlled drugs should be necessarily small to avoid mistakes and abuse. The College believes these principles should be retained within any regulatory change to extend the authority for non medical prescribers for mixing and administering controlled drugs.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[27 February 2009]
|
