The General Medical Council has released its new prescribing guidance, a year after it was scheduled to publish the document.
The 'Good practice in prescribing and managing medicines and devices' strengthens and broadens the current advice on prescribing medicines to include medical devices, and gives key updates on using unlicensed medicines.
The issues surrounding unlicensed and off-label prescribing delayed the publication of the GMC’s documents, given the contention of this practice.
Doctors are clinically free to prescribe medicines that have no licence for a particular disease, and are often used to treat patients with rare disease where no specific therapy exists, or for young children.
But pharma has voiced concerns that doctors may be prescribing some unlicensed medicines when a licensed alternative exists in order to cut costs. Specifically, the concerns centre around the off-label use of Roche’s cancer drug Avastin for the eye condition wet AMD.
Novartis’ Lucentis is currently the only NICE-approved drug for this condition, but Avastin is much cheaper and chemically similar to Lucentis, leading to many ophthalmologists to prescribe it in an effort to save costs, which has caused much consternation at Roche - who own rights to the drug in the USA - Novartis, and for the ABPI.
The GMC has been looking to clarify its position on this, and in its new publication the doctors' regulator said clinicians can still prescribe medicines outside their licence only "when it is necessary to do so to meet the specific needs of the patient” – meaning the focus is on the patient's interest, not the NHS' finances
Stephen Whitehead, chief executive of the ABPI said: “We warmly welcome the GMC’s updated guidance to clinicians on good practice in prescribing medicines, which is a significant improvement on the draft. In particular, we welcome the guidance on the circumstances in which unlicensed medicines are prescribed, which retains the GMC’s previous position.”
“Decisions on the prescribing of unlicensed medicines are never easy, and this is why it is so critical to get this guidance right. The GMC has listened to stakeholders and taken an open and constructive approach to engaging with us. The new guidance reaffirms that patient need should be at the heart of clinical decisions.”
The guidance also says that doctors should avoid prescribing for themselves or their families, unless it is an emergency where lives or health are at serious risk.
They must, as well, not prescribe performance-enhancing drugs or treatments to athletes - any doctor who suspects that an athlete’s performance is improperly enhanced should raise concerns in the public interest.
In addition, the guidance bans doctors from remotely prescribing drugs such as Allergan’s Botox or other similar injectable cosmetics by phone, email, video-link or fax – a move which came into force in July last year.
The guidance also reminds doctors that they must report any adverse incidents involving drugs medical devices such as X-ray and other imaging equipment, pacemakers, artificial joints and anaesthetic equipment.
Niall Dickson, chief executive of the General Medical Council, said: “Safe prescribing is at the heart of good medicine and it's a skill that doctors must develop and keep up to date throughout their careers.
“This new guidance tightens the current rules on prescribing and addresses the challenges doctors face in this complex area.
“We very much hope doctors will find this guidance useful, not least in making clear what is expected from them so patients receive the best possible treatment and care.”
comes into force on 25 February and replaces the previous edition, published in 2008.