Nurses and pharmacists to be given off-label prescribing rights
By Nigel Praities
Exclusive: The Medicines and Healthcare products Regulatory Agency is planning a controversial change in the law to allow nurses and pharmacists to prescribe off-label treatments, in a move that has split prescribing experts.
The UK drug regulator says it expects regulations to change by the end of the year, but critics say the move could expose patients to potentially dangerous treatments.
It is the latest in a series of developments to loosen the rules surrounding non-medical prescribing, coming just weeks after Pulse revealed proposals to extend prescribing rights to physiotherapists, dieticians and chiropodists.
The MHRA now says it wants to ‘regularise' restrictions on prescribers and allow prescribing nurses and pharmacists the same freedoms as doctors.
Such a change will require the Home Office and the Advisory Council for the Misuse of Drugs to alter Misuse of Drugs Regulations - but the Government has already accepted the recommendations, made by the MHRA's Commission on Human Medicines.
In a statement, the MHRA said: ‘We intend to regularise the position of those engaged in the prescribing and mixing of medicines in other areas of clinical practice, and are extending our advice to cover these situations.'
The plans have left the GPC divided. Dr Bill Beeby, chair of the GPC's clinical and prescribing subcommittee and a GP in Middlesbrough, said they could be useful in some scenarios, particularly in palliative care. ‘The new rights extended to non-medical prescribers will not lessen the duty of care when prescribing but will allow greater flexibility in some situations,' he said.
But Dr Peter Fellows, also a member of the sub-committee and a GP in Lydney, Gloucestershire, condemned the proposals and said pharmacists and nurses should only be able to prescribe from specific formularies ‘consistent with their skills'.
‘Medical knowledge and proper medical indemnity to protect the patient is essential for relatively safe use of unlicensed products. Some unlicenced medicines can be dangerous - Chinese herbal remedies can cause liver damage,' he said.
Professor Hugh McGavock, visiting professor of prescribing science at the University of Ulster and former member of the Committee on Safety of Medicines, said off-label prescribing was one of the riskiest elements of a doctor's work, and required a level of training not provided to nurses and pharmacists.
‘It is an absolute no no. Even doctors would require that off-label prescribing was something generally agreed by specialists or other doctors. Certainly I would not like a nurse or a pharmacist to prescribe off-label for me.
‘Prescribing off-label should be the preserve of doctors who have made a proper diagnosis.'Practice nurses and pharmacists are to be given the right to prescribe off-label treatments Practice nurses and pharmacists are to be given the right to prescribe off-label treatments Risky medicine?
• Paediatric medicines are often prescribed off-label or at doses that are not licensed, with systemic antibacterial drugs, emollients and antiasthmatic drugs some of the most common
• Tricyclics are licensed for clinical depression, but are also commonly used for neuropathic pain
• SSRIs, such as sertraline, are an effective but unlicensed treatment for premature ejaculation
• Opiods are often used in higher doses than licensed in palliative care
• Treatments for rare metabolic disorders are often prescribed off-label, such as dichloracetic acid for Leigh's encephalopathy or L-arginine Powder for urea cycle disorder