The General Medical Council (GMC) has proposed, for the first time, that doctors may prescribe a cheaper off-label alternative to a licensed medicine, provided it is approved in authoritative clinical guidelines and is equally safe and effective.

The proposal is included in draft guidance, entitled Good practice in prescribing and managing medicines and devices, which is now out for consultation and is intended to replace the GMC's 2008 guidance, Good practice in prescribing medicines. The proposed new guidance was approved by the Council's Standards and Ethics Committee following a process which included a scoping consultation, conducted from September 2010 to January 2011 and involving around 80 organisations, to identify key themes and issues for it to cover.

Most respondents to the scoping consultation agreed that doctors should be able to prescribe off-label or unlicensed medicines even when there is an appropriately licensed alternative, where authoritative clinical guidelines support such use, says the GMC.

"Examples of what many regarded as acceptable or good practice include amitriptyline as a first-line treatment for neuropathic pain (National Institute for Health and Clinical Excellence [NICE] clinical guideline 96) and sertraline, if drug treatment is chosen, for generalised anxiety disorder and panic (NICE clinical guidelines 113). In both cases, there are licensed alternatives, but they are not considered by NICE to be as cost-effective," says the consultation document.

It also asks doctors to raise concerns about adverse events and near-misses involving the use of medicines and devices, and to respond constructively to such concerns raised by colleague and patients, pointing out that "prescribing and administration errors by doctors are common, but harm is usually avoided by professional colleagues intervening before they can affect patients."

On the issue of sharing information with colleagues, it points to "long-standing concerns about the quality and timeliness of hospital discharge summaries, the quality of information sent to hospitals on admission and the processes for critically reviewing medication changes and other information and updating patients' records after they are discharged from hospital."

"This goes beyond prescribing and will be considered as part of the review of Good Medical Practice in 2011 and 2012," it adds. The current edition of Good Medical Practice - the GMC's core guidance for doctors - dates from 2006.

The consultation document also reminds doctors that they should avoid prescribing for themselves and their families and that controlled drugs should be prescribed only in an emergency, when lives or health are at serious risk.

Some contributors to the scoping exercise called for a complete ban on doctors prescribing for themselves and those close to them, given the "evidence of substance misuse and poor health among doctors."  Others suggested that such prescribing should be permitted for minor ailments and self-limiting conditions, and felt the guidance should consider the demands placed on doctors in rural and isolated communities.  

Nevertheless, the consultation document cautions that "doctors who prescribe for themselves or those close to them can lose objectivity, act outside their competence, treat symptoms without investigating the underlying cause, and many fail to keep accurate records or communicate with the patient’s general practitioner or other treating doctor." 

Turning to potential conflicts of interest, it emphasises that no inducements, gifts or hospitality which could affect or be seen to affect the ways medicines are prescribed or supplied may be offered or accepted. On the other hand, it tells doctors that: “health service financial incentives and similar schemes to improve the cost-effective use of medicines have a legitimate role to play in helping you to make good use of the resources available to you," but adds that they should also consider the safety and needs of the individual patient for whom they are prescribing, not least because frequent switching of products can harm patients' adherence to medicines.

The guidance proposes tough new standards for doctors working in sports medicine, including calling on those who suspect that an athlete's performance is being improperly enhanced to raise concerns when this would be in the public interest. It also proposes giving patients greater protection when obtaining prescriptions on-line, requiring doctors prescribing via websites to liaise with the patient's GP, unless the patient objects.

Other topics covered in the consultation document include: keeping up-to-date and prescribing safely; consent to prescribe; prescribing at the recommendation of a professional colleague; shared care prescribing; repeat prescribing and prescribing with repeats; and reviewing medicines.

Announcing the consultation, which runs until May 27, GMC chief executive Niall Dickson noted that the number of drugs prescribed by GPs had tripled from 1995 to 2009. “It is vital that our guidance on prescribing and managing medicines is up-to-date and relevant for doctors working today," he said.

During the consultation, the GMC wants "to hear the views of doctors, patients, carers and other health professionals about the difficult decisions doctors can face when prescribing and how doctors can help their patients better understand the information about the medicines they are taking," Mr Dickson added.