Remote Prescribing of Botox by Doctors Banned by GMC

This week the General Medical Council (GMC) will issue new rules to its members, UK Doctors, stating that the practice of remotely prescribing prescription only botulinum toxin products, such as the brands Botox, Vistabel, Azzalure, Dysport, Xeomin and Bocouture will no longer be permitted and Doctors must see a patient face-to-face before issuing a prescription for the drug; (although they may still delegate the administration of it to someone under their supervision, such as a nurse).

This means that the ongoing loop-hole of writing prescriptions for Botox following a telephone call, fax, email or voice over internet connection (i.e., Skype etc.) will from this week mean that a Doctor is practicing outside of the GMC rules and could face disciplinary charges in the form of a fitness to practice hearing.

"There are good reasons why these are prescription-only medicines and we believe doctors should assess any patient in person before issuing a prescription of this kind," said Niall Dickson, chief executive of the GMC.

The story broke on the BBC London Evening News on 9th July which highlighted an investigation into the practice of remote prescribing services following concerns that were raised to the broadcaster. The BBC sent a researcher undercover to investigate operations by infiltrating training sessions with one of the UK’s largest purchasers of botulinum toxin products, Dr. Mark Harrison, who runs Harley Aesthetics a company which provides training courses and remote prescription services for registered nurses up and down the UK.

For £30 per call, nurses subscribed to his services are able to telephone Dr. Harrison on his mobile phone, whereupon he would speak to them and their patient and issue a prescription for the cosmetic injectable treatment without ever seeing the patient face-to-face.

Dr. Harrison was secretly filmed by the BBC candidly remarking to a room full of trainees on a variety of practices which leave many within the industry sharply inhaling, such as obtaining Botox via prescriptions made in the names of friends and family so that a stock of the drug could be obtained ready for injecting patients immediately – something which even Nurse Independent Prescribers (who can legally prescribe themselves as well as Doctors) are not able to do (i.e. stock must not be held, the practitioner must wait for the drug to be delivered in the name of the patient and treat on another day).

Dr. Harrison also pointed out that although ‘a little bit naughty’ if nurses were unable to reach him for a remote consultation, perhaps due to poor mobile phone signal, and wanted to treat a patient there and then, they could do so and he’d ring the patient after the treatment to conduct a retrospective consultation! This puts the nurse in a position whereby they would be injecting a patient with a prescription only medicine (POM) without any form of written prescription prior to treatment; a serious issue for patient safety.

The practice of remote prescribing has already been condemned by the Nursing and Midwifery Council (NMC) who state that nurses engaging in treating patients with botulinum toxins following a remote consultation will be going against the NMC standards and thus risk their registration (which could be withdrawn following a disciplinary hearing) if they operate via that business model.

Commenting to the BBC, Dr. Harrison said he had performed more than 50,000 remote consultations since 2005, with no adverse affects on patient health. He told them that the use of prescriptions in one person's name for the treatment of others was "common, almost universal practice throughout the aesthetics industry" and concluded; "I can confirm that I take my professional and moral obligations to both the patients who have treatments and the nurses who use the service extremely seriously."

Dr. Harrison is by no means alone in providing remote consultation services, this practice is widespread amongst individuals and smaller service-providing companies,  also extending to dentists who have prescribing powers. As the Director of the biggest organisation offering remote prescribing services within our industry, it must be no surprise to Dr. Harrison that he was targeted by an investigation such as this to highlight the issues and dangers surrounding remote prescribing of botulinum toxin products.

Consulting Room Director Ron Myers Says;

“This unequivocal statement from the GMC would seem to be the final nail in the coffin for remote prescribing business models of Botox for cosmetic purposes. The NMC have been clear on this for a while, but the GMC now comes into line and should halt the march of non-prescribers of any speciality seeking to offer this treatment via a remote consultation business model.

This decision has become increasingly important as we have even seen these prescription medicines getting into the hands of people without any medical qualifications. The insurers and underwriters now need to look had at the people that they are covering with indemnity insurance and take appropriate action.

I'm hoping that we also see moves to restrict the use of (more dangerous) dermal fillers by beauty therapists as medical devices come under more scrutiny in the near future.”

Mai Bentley Rgn Nip, Director of Training at Intraderm Limited told us;

“The GMC, NMC and MHRA have been totally aware of this situation for over two years but no significant action has been taken until now. We have tried hard to raise awareness amongst nurses about the many problems associated with some remote prescribing services but this was not welcomed by some doctors, nurses and companies within the aesthetic industry. We have always been concerned that many nurses have been misled as to the legalities of some remote prescribing services but with little support from the appropriate governing bodies and the aesthetic industry, this has been impossible to address in the correct manner.
 
We welcome the report from the BBC this evening which has highlighted unprofessional practices that have been allowed to continue, unchecked by the regulatory bodies, for years and has thrown the situation into the light of the general public arena. The immediate response and announcement from the GMC today will go some way towards helping to protect the patients seeking prescription only aesthetic treatments in the future. However, earlier intervention by the governing bodies would have prevented the dreadful confusion that exists within the industry on the subject of remote prescribing. The Council for Healthcare Regulatory Excellence (CHRE) must surely need to look more closely at the role of the governing bodies in this situation.
 
The way forward for those nurses who are not already independent nurse prescribers may be challenging. The V300 independent nurse prescribing course is not the answer for everyone for a variety of reasons and prescribing buddy systems require a lot of trust and organisation on both side of the equation.
 
Nurses are responsible for their own actions under the NMC Code of Conduct and listening to the incorrect advice of medical or other nursing colleagues and pleading ignorance to the true facts are no defence.  We continue to offer confidential support and advice to those who may require it.”

Dr. Samantha Gammell, President of the British College of Aesthetic Medicine (Formerly the British Association of Cosmetic Doctors) Said in a Statement;

“The aim of the British College Of Aesthetic Medicine is to advance the effective, safe and ethical practice of aesthetic medicine and we, therefore, welcome the new General Medical Council (GMC) guidelines on remote prescribing.

We understand that the new guidelines will make specific reference to injectable cosmetic medicines such as Botulinum Toxin and therefore there can be no further claims of ambiguity by any medical professional. As per our Articles of Association, ALL BCAM  members are expected to understand and have a working knowledge of the Code of Practice as set out by GMC and must adhere to it in daily practice.”

Emma Davies RGN Founder Member of the British Association of Cosmetic Nurses (BACN) Stated;

“The BACN has had no communication from the NMC, except to reiterate its stance on remote prescribing in aesthetics, i.e., that this practice does not meet the Standards. 28/3/2012

The BACN requires its members to abide by the NMC Code of Conduct, and Standards. We ensure our members are well informed and have drawn attention to any advice or guidance from the NMC, relevant to aesthetics.

We have been concerned for some time with Doctors presenting convincing, but misleading reassurances to nurses, that remote prescribing was legal and met NMC standards. We are relieved that the practice has been exposed and we can move forward with absolute clarity.”

Yvonne Senior, Co-founder of the Private Independent Aesthetic Practices Association (Piapa) told us;

"I would hope that this now closes the door to Doctors who are prescribing remotely to Beauty Therapists and other non-medics."

Sally Taber, Director of the Independent Healthcare Advisory Services (IHAS) And Responsible for the Management of the Standards and Training Principles for WWW.treatmentsyoucantrust.org.UK, Responded by Saying;

“www.TreatmentsYouCanTrust.org.uk applauds the move from the General Medical Council (GMC) to ban Doctors from prescribing Botox®, a prescription-only medicine, without conducting a prior face-to-face consultation.

The inappropriate practice of remote prescribing by Doctors has to date been one of the biggest issues within the cosmetic injectable industry. Following its launch nearly two years ago, the Department of Health-backed register of regulated cosmetic injectable providers www.TreatmentsYouCanTrust.org.uk has campaigned for the GMC to review its remote prescribing guidance and close the loophole which had put patients at risk by providing unqualified providers without a clinical background with Botox®.

Botox®, a prescription only medicine, should only be prescribed to a patient following a face-to-face consultation and clinical assessment by a regulated Doctor, Dentist or an Independent Nurse Prescriber.

Relaxed attitudes to remote prescribing in the past has resulted in profit over patient safety and Botox® sold to unregulated and inappropriately qualified providers, including beauty therapists, who lack the necessary clinical background to administer injectable treatments safely. Whilst unsafe, the practice of remote prescribing in some cases is also illegal, breaking the Medicines Act 1968 for possession of a prescription-only medicine in the name of an individual who is not the designated recipient of the drug.

The cosmetic injectable industry has for many years recognised remote prescribing as unsafe and totally inappropriate. The review of prescribing guidance by the GMC marks an important step in further stamping out bad practice in the industry and ensuring patient safety.”

Dr Andrew Vallance-Owen, Chairman of Ihas Cosmetic Surgery/Treatments Working Group Added;

“As champions of best practice in the cosmetic injectable industry, and acting in the best interests of patients, www.TreatmentsYouCanTrust.org.uk  applaud the move by the GMC to dovetail their remote prescribing guidance with the other professional regulators in the UK, leaving remote prescribing behind and marking a promising future for further stamping out bad practice in the industry."

We Also Asked Dr. Mark Harrison for a Response to Both the BBC Investigation and the Gmc Decision on Remote Prescribing and He Provided Us With This Detailed Reply.

“So our ‘direct to consumer’ campaign got off to a premature start with the BBC undercover nurse/reporter attending a ‘botox training day’ and exposing us for using Remote Consultations (which are both widespread and routine in the NHS) to carry out more than 50,000 Botulinum Toxin treatments without a single patient claim or complaint! But then this feature has nothing to do with patient safety despite the various ludicrous claims that ‘patients are at risk of shock or infected’ presumably the reporter meant infection-but as we all know there has never been a recorded anaphylactic reaction to aesthetic botox and in over 50,000 treatments I have not recorded a single case of infection.

The claim that the practices of Harley Aesthetics are ‘potentially endangering the life of the patient’ is contemptible. How very convenient that the 50,000 treatments, without claim or complaint, is mentioned briefly towards the end of the report. The report resorts to ridiculous sensational language merely for effect as these claims are neither present in the published literature or in the specific treatments of Harley Aesthetics.

Of course, there is no story to report if it is merely concerned with some grey areas of both medical law and guidelines from professional bodies, hence having to resort to sensational journalism.

The reference to a ‘telephone salesman’ was a cheap shot that may prove expensive but perhaps it would have been more worthy of the BBC to go undercover on a ‘botox’ course training beauticians, paramedics, hygienists etc and exposing the doctors, dentists and nurses who supply them with POM to inject? 

There were numerous factual inaccuracies including there being no legal requirement for a ‘face to face’ consultation, the ‘directions to administer’ being sent from an Ipad not over the phone and Harleys Aesthetics' way of working being contrary to the NMC guideline-it is all way more complicated then this poorly researched piece give reference to.

So what did the BBC expose other than my receding hairline?

1. The common and almost universal practice throughout the aesthetics Industry to use a single vial on more than one patient (no doubt a similar covert operation by BBC would establish this). During the training day I also highlighted the fact that this is contrary to the MHRA guidelines- but a little different from a vial on insulin being used on a number of patients on an NHS ward. This practice appears to have no consequence for patient safety in a setting where only one nurse/doctor is administering the same medication to each patient at a time as opposed to a busy ward where numerous medications are given to numerous patients.

2. In extremely rare circumstances (1-2/month out of 800 remote consultations) where the patient was attending for subsequent treatment and the nurse (for whatever reason) was unable to contact the doctor but still went ahead with the treatment, the Doctor would telephone at the first opportunity having been informed by the nurse. The decision to treat has been taken by the nurse and the doctor was informed retrospectively. While this would not be uncommon in the HNS I would agree that it should not take place even extremely rarely as the nurse is exposing herself to disciplinary action.  The nurse could argue that this is a repeat prescription, as the treatment has been given previously without incident and they hold a valid ‘direction to administer’ on the patient's file however the GMC do not support the use of Patient Group Directives (PGD) for aesthetic ‘Botox’ Treatment.  If the treatment was for a medical condition (low self-esteem, excessive sweating, migraine or as part of a medical treatment plan for the prevention of sun damage) then a PDG would be acceptable.  This point illustrates that these areas of medical law and the advice and guidelines of the regulatory bodies are both complex and can even be contradictory between them. No nurse would ever administer a POM on a patient who had not had that treatment previously without a prescription/direction to administer it. The complaint that I left a message and did not speak to the patient is ridiculous as there was no patient to speak to as it was a ‘setup’.

These two practices can be shown to have no effect on patient safety.

The suggestion that the patient is not properly checked is incorrect. Before each and every treatment the patient fills in a comprehensive medical history form (these are provided in a standard 4 Page form to the nurses). The patient is required to sign the medical history form to confirm the details are accurate and complete. This form is thoroughly checked by the nurse together with the patient (this is a routine practice in the NHS and should raise no concerns). At the start of the remote consultation, the Nurse relays to the Doctor any significant information from this Form. The Doctor also specifically asked the patient about any ongoing illness or medication. It is this careful consideration of the patient’s medical history by two medical professionals that help with our enviable safety record.

The BBC report was inaccurate in its reporting in that the NMC guidelines on remote consultations do not apply to all treatments but only apply to the aesthetic use of Botulinum toxin but even in this case is not banned instead special conditions are required to be met. 

I will eagerly await the new GMC guidelines which I understand are due on Friday. I am already a little puzzled as the GMC recently dropped any specific reference to Botulinum Toxin treatments stating them to be too specific. With remote consultations being common and increasingly routine in the NHS it will be interesting to see how remote consultations are considered safe and ethical in the NHS (neurology, cardiology, dermatology and general practice) but not so in Aesthetic Medicine.

Professor Sir Bruce Keogh has stated the aim that ‘remote consultations in GP and dermatology should be routine’ in the NHS within a year.

The Harley Aesthetic nurses will be hoping that I will be able to adapt the current practises of Harley Aesthetics to accommodate the new GMC guidelines. For many of the nurses, it is their whole livelihood for the rest an invaluable additional family income.

For the time being it is business as usual and we continue to welcome any nurses who wish to use the services provided. Unlike our smaller competitors, we have an extensive legal opinion to support our way of working.

If for a moment you suppose that all the remote consultation services (including Harley Aesthetics) were to close down with the subsequent loss of many hundreds of experienced and well-trained nurses- it would be easy to suppose that the various unregulated practitioners may fill the gap. Sally Taber (RGN) be careful what you wish for!”   

 

However, a shorter report on the investigation is available here  - http://www.bbc.co.uk/news/uk-england-london-18777104

At Consulting Room we always aim to be independent, unbiased and above all accurate in our presentation of the facts about a topic, especially those which are somewhat ‘grey’ or confusing and at times controversial. We support the decision by the GMC to ban Doctors for partaking in remote prescribing services for botulinum toxin products and hope that the General Dental Council will follow soon with similar explicit rules for its members. Patient safety and best practice is at the forefront of making this industry better for all.

Please feel free to discuss and debate this issue using the comment system below.

Update 10th July 2012

British Association of Cosmetic Nurses Response to the BBC news item on 9/07/12 relating to remote prescribing in aesthetics, and in particular, botulinum toxin (Botox) - Press Release – for immediate release 10th July 2012

"The British Association of Cosmetic Nurses (BACN) has been representing nurses in aesthetic practice for the last four years. The role of the BACN is to inform, advise and educate our members, and require them to practise within the law and to the highest professional standards. The Nursing and Midwifery Council (NMC) role is to safeguard the health and wellbeing of the public and ensure the highest standards of practice, all nurses working in the United Kingdom should be registered with the NMC.

Aesthetic practice is unusual in that the majority of multi-disciplinary training in aesthetics is carried out by highly specialised, experienced autonomous nurse educators.

Working closely with the Journal of Aesthetic Nursing the aesthetic nursing community continues to drive education and practice standards through educational conferences, workshops, seminars and peer reviewed academic articles, driving collaboration with allied health care professionals.

The BACN has been concerned for some time that some doctors offer reassurance to nurses that remote prescribing is accepted practice and meets NMC standards, this is not the case, as in NMC New Advice for Botox – Nurses and Midwives, published on 1st April 2011 and the NMC Standards for Medicines Management published on 9th October 2007. We welcome the fact that the practice has been highlighted and we look forward to clarity from the General Medical Council (GMC).

Nurses who have undertaken the Nurse Independent Prescribing (NIP) Course and satisfied the examiners at the NMC, and maintain both their general nursing qualification and NIP qualifications are legally able to prescribe and administer botulinum toxins and all other prescribable items within their area of competence, and have equal prescribing rights to all UK doctors. The NIP qualification has a pass mark of eighty percent for pharmacology and one hundred percent for mathematics.

Non-prescribing qualified nurses working in partnership with doctors or nurse prescribers are also working within the correct legal framework, when their patients are consulted by the prescriber who then delegates an order to administer to the nurse. This consultation process involves a physical face to face full consultation and examination by the prescriber."

 

Update 11th July 2012

Private Independent Aesthetic Practices Association (PIAPA) Response to the BBC news item on 09/07/12 relating to Remote Prescribing in Aesthetic Medicine. Press Release – for immediate release 11th July 2012

For the last six years Private Independent Aesthetic Nurses Association, PIAPA has supported and provided on-going education for aesthetic nurses across the North of England.  Promoting a framework for information support and education to all of its members. Whilst it is not our role to police our members they are required to practice within the law and the standards set out by the regulatory body, Nursing and Midwifery Council (NMC). As a group we look forward to receiving the same clarity on injectable cosmetic medicines from the General Medical Council (GMC) as was issued in an NMC statement on the 28/03/12.

Hopefully the issue of specific guidelines for injectable cosmetic medicines will help towards preventing exploitation of loopholes arising from claims of ambiguous interpretation of medicine standards from the medical profession.

As a support and education group for nurses practicing aesthetic medicine in the North of England. We have taken a proactive approach to practicing within the law and guidelines by encouraging our members to undertake the Independent Nurse Prescribing programme. In order to maintain public safety and fulfil their obligation to meet NMC guidelines. This is a rigorous programme and examination which enables nurses to legally prescribe within their area of competence. As a group we offer mentorship and a great deal of individual support including a small bursary toward costs. 

Remote prescribing to nurses is the tip of the iceberg; we have had a number of concerns for some time relating to the issue of training and remote prescribing. Remote prescribing to other groups who do not fall within the three regulatory bodies, for Nurse Doctors and Dentists. We refer to situations in the North West which we are sure are not isolated cases, where sadly a few medical Doctors and Dentists have proactively recruited and trained non-medical professionals e.g., Beauty therapists in the administration of Botulinum toxin and providing remote prescribing for these groups.

Our questions as a group are;
How does public safety fit with this particular model? Will a new GMC stance on this matter remove this practice or will it continue in a more subversive manner, and will insurers continue to give false security by insuring these people?

Or will greed and market forces prevail?

Yvonne Senior
Chair of PIAPA 

 

 

 

Update 12th July 2012

Official Press Release from General Medical Council (GMC) issued on 12th July 2012 - Permission for republication granted.

New GMC guidance - doctors must not remotely prescribe Botox

Doctors are to be banned from prescribing Botox by phone, email, video-link or fax under new guidance from the General Medical Council (GMC), it was announced today (12th July).

The change means that doctors must have face-to-face consultations with patients before prescribing Botox and other injectable cosmetics to ensure they fully understand the patient’s medical history and reasons for wanting the treatment.

Under current GMC guidance doctors must adequately assess the patient’s condition before prescribing remotely and they must be confident they can justify the prescription. Where doctors cannot satisfy these conditions, they must not prescribe remotely.

The new guidance, which comes into force on 23rd July, updates and strengthens these rules.

It introduces a complete prohibition on prescribing cosmetic injectables, such as Botox, without a physical examination of the patient. Doctors who continue to prescribe Botox or similar products remotely will be putting their registration at risk.

The GMC recognises that remote prescribing may be appropriate for some drugs and treatments for some patients but stresses that doctors must consider the limitations of any electronic communication with their patient.

The guidance, which will be issued to every doctor in the UK, states: ‘You must undertake a physical examination of patients before prescribing non-surgical cosmetic medicinal products such as Botox, Dysport or Vistabel or other injectable cosmetic medicines. You must not therefore prescribe these medicines by telephone, fax, video-link, or online.’

Niall Dickson, Chief Executive of the GMC, today said: ‘We recognise that patients can benefit from communicating with their doctor by email, phone, or video-link or fax and that is fine as long as it is done safely, but our new guidance makes clear that doctors must now not prescribe medicines such as Botox remotely.

‘These are not trivial interventions and there are good reasons why products such as Botox are prescription only. We are clear that doctors should assess any patient in person before issuing a prescription of this kind. So while remote prescribing may be the right answer in many situations, this is not one of them.'

Katherine Murphy, Chief Executive of the Patients Association, added: ‘The Patients Association welcomes all guidance that strengthens rights and helps inform choice. Face to face appointments give patients the most appropriate opportunity to question clinicians directly about their care. Doctors must encourage a partnership approach, ensuring that patients are equal partners in their care and the decisions made about it.’

The new guidance on remote prescribing is part of wider updated guidance, Good practice in prescribing and managing medicines and devices which is set to be published later in the year and followed an extensive consultation on this issue with almost 200 responses received from medical, pharmaceutical and other health care professions and patient safety organisations.’

A copy of the new remote prescribing guidance can be read on the GMC’s website www.gmc-uk.org/guidance/ethical_guidance/13594.asp

 

 

 

Guidance on remote prescribing of Botox by the General Dental Council (GDC)

"Remote prescribing of Botox and other non-surgical cosmetic procedures (for example via telephone, email, or a website). Remote prescribing shall not be used in the provision of non-surgical cosmetic procedures such as the prescription or administration of Botox or injectable cosmetic medicinal products."

 

 

 

Update 19th July 2012

The Association of Nurse Prescribing statement:

“The ANP are pleased to hear that the GMC have advised doctors they must not prescribe POMs remotely for nurses to use on people receiving aesthetic treatments. This is safer for the people undertaking aesthetic treatment and safer for nurses administering such medicines rather than without a qualified prescriber seeing the patient first. Nurses who work within aesthetics and use POMs within their treatments, must ensure that they work with qualified prescribers who have the relevant aesthetic treatment experience themselves.

The ANP are clear that any nurse prescribing must have the prescribing qualification and the competency in the disease or care area and therefore are able to prescribe knowledgably and safely.”

Dr Barbara Stuttle CBE
Chair