The Joint Council for Cosmetic Practitioners (JCCP) was established and launched formally at the House of Peers in February 2018, following an extensive stakeholder consultation process undertaken by Health Education England (HEE), in accordance with the recommendations outlined in the Keogh Review (Department of Health, 2013) on non-surgical treatments in England. The HEE standards were transferred to the JCCP by HEE in June, 2018. One of the key recommendations included in the 2015 HEE report called for the establishment of longer-term statutory regulation for the sector and for the immediate creation of a voluntary register (HEE, 2015). The JCCP's fulfils such a function.
The JCCP is a ‘not for profit’ UK charitable body charged with the responsibility of voluntary ‘self-regulation’ of the non-surgical aesthetic sector in the four UK countries. The mission statement for the JCCP and its values are set out below:
‘The JCCP is a Professional Standards Authority (PSA) Accredited Register of the non-surgical aesthetic industry in England and provides an informed and legitimate point of access for the public seeking information about this area of practice and where appropriate for raising concerns about practitioners. The JCCP places public protection and patient safety as the focus of its activities' (JCCP, 2018).
The JCCP and its ‘sister’ organisation the Cosmetic Practice Standards Authority (CPSA) regard safe and responsible prescribing practice to be an essential component of public protection and published advice on this matter in July, 2019 (JCCP, 2019a). The JCCP has worked closely with the professional statutory professional regulators that oversee healthcare professionals who work in the aesthetic sector. The General Medical Council and the General Dental Council have confirmed that the JCCP guidelines on responsible prescribing are consistent with their own guidance, whilst the Royal Pharmaceutical Society (RPS) has also stated that ‘in our view as the professional body for pharmacy, the JCCP statement is consistent with the approach of the professional regulators and will be useful for the RPS to signpost to’ (JCCP, 2019b). The Nursing and Midwifery Council (NMC) have not provided any specific comment on this statement but have advised that their own prescribing guidance reflects that provided by the RPS (2016).
The RPS has worked with the professional healthcare regulators and published guidance that supports prescribers in effective prescribing through the application of a single prescribing competence framework that was published by the National Prescribing Centre/National Institute for Health and Clinical Excellence (NICE) in 2012. The framework was developed in response to an identified need to produce ‘common set of competencies that should underpin prescribing regardless of professional background’ (RPS, 2016). NICE and Health Education England supported the framework and approached the RPS to manage an update of the framework on behalf of all the prescribing professions in the UK. A revised competence framework was subsequently published by the RPS (2016), which has now been adopted by all of the professional regulators that operate within the aesthetic sector.
The context and the associated challenge
The use of prescription only medicines (POMs) within the aesthetic sector has come under scrutiny by professional statutory regulators, by professional associations and by the media following the discovery of a range of unacceptable prescribing practices that have compromised public protection and patient safety. The use of POMs is widespread across the sector as a source of direct treatment (such as through the use of injectable toxins), as an adjunct to treatment procedures (such as the use of topical anaesthetic) or for remedial or ‘rescue’ interventions (such as adrenaline or hydrolase).
Prescribing practice itself is also becoming more complex as more NMPs elect to utilise invasive non-surgical procedures as part of their daily practice. Access to POMs for these practitioners (many of whom are beauty therapists or NMP healthcare professionals) requires legitimate and ‘regulated’ prescribers to assume longer-term responsibility, to provide oversight of the patient for whom they have prescribed the medication, and to ensure that they are satisfied that the risks have been reduced to a minimum, in the interests of patient safety. The complexity of clinical decision-making and underlying clinical risk in the aesthetic sector has been further compounded by the increasing number of younger people (and of course persons of other ages too) who elect to receive aesthetic procedures, and for whom limited pre-treatment screening has been undertaken without regard to the suitability of the treatment itself or without the consumer receiving a fully informed risk assessment. This increase in demand and complexity of the treatment process itself requires that all prescribers continue to develop and maintain prescribing competency for all aspects of their practice. These including the need for advanced decision-making skills in the exercise of clinical judgement, risk assessment, psychological and emotional screening and the ability to make an informed decision with regard to differential diagnosis and the construction of an effective treatment plan for the patient/consumer.
Underpinning these responsibilities is the need for all prescribers to consider at all times the best interests of the patient, and to ensure that they are satisfied that the treatment option selected is based on a full appraisal of risks and benefits for the patient. It is important to note that when prescribed and used effectively, the use of POMs within the aesthetic sector (such as through the appropriate use of injectable toxins) has the proven potential to significantly improve the quality of life and improve patient/consumer outcomes. However, the challenges associated with responsible and effective prescribing should not be underestimated. There is considerable evidence now emerging within the United Kingdom to confirm that much needs to be done to improve the way that we prescribe and support both NMPs and their patients to use prescription only medicines safely and effectively without causing undue or unwarranted harm to patients.
Matters of oversight have been further complicated over the past 20 years by the increasing number of people who are legally entitled to prescribe, following the agreement that independent and supplementary prescribers from a wide range of other healthcare professions are able to do so within their scope of practice, once they have completed an approved education programme, which has been recognised by their professional regulator. The MHRA identifies that ‘the following are ‘appropriate practitioners’ (Gov.uk, 2012) in relation to any prescription only medicine:
- A doctor
- A dentist
- A supplementary prescriber
- A nurse independent prescriber
- A pharmacist independent prescriber.
These regulations advise also that ‘a person may not sell or supply a prescription only medicine expect in accordance with a prescription given by an appropriate practitioner’. Furthermore, the regulations state that ‘a person may not parenterally administer (otherwise to himself or herself) a prescription only medicine unless the person is an appropriate practitioner; or is acting in accordance with the directions of such an appropriate practitioner’ (Gov.uk, 2012). The British Pharmacological Society (2019) has also published a ‘ten point’ guide to inform prescribers of the principles that underpin ‘good’ prescribing practice. The JCCP supports these principles, which are reproduced in Box 1.
Box 1.Ten principles of good prescribing
- Be clear about the reasons for prescribing
- Establish an accurate diagnosis whenever possible (although this may often be difficult)
- Be clear in what way the patient is likely to gain from the prescribed medicines
- Take into account the patient's medication history before prescribing
- Obtain an accurate list of current and recent medications (including over the counter and alternative medicines); prior adverse drug reactions; and drug allergies from the patient, their carers, or colleagues
- Take into account other factors that might alter the benefits and risks of treatment
- Consider other individual factors that might influence the prescription (for example, physiological changes with age and pregnancy, or impaired kidney, liver or heart function)
- Take into account the patient's ideas, concerns, and expectations
- Seek to form a partnership with the patient when selecting treatments, making sure that they understand and agree with the reasons for taking the medicine
- Select effective, safe, and cost-effective medicines, individualised for the patient
- The likely beneficial effect of the medicine should outweigh the extent of any potential harm, and, whenever possible this judgement should be based on published evidence
- Prescribe medicines that are unlicensed, ‘off label’, or outside standard practice only if satisfied that an alternative medicine would not meet the patient's needs (this decision will be based on evidence and/or experience of their safety and efficacy)
- Choose the best formulation, dose, frequency, route of administration, and duration of treatment
- Adhere to national guidelines and local formularies where appropriate
- Be aware of guidance produced by respected bodies (increasingly available via decision support systems), but always consider the individual needs of the patient
- Select medicines with regard to costs and needs of other patients (healthcare resources are finite)
- Be able to identify, access, and use reliable and validated sources of information (for example, British National Formulary), and evaluate potentially less reliable information critically
- Write unambiguous legal prescriptions using the correct documentation
- Be aware of common factors that cause medication errors and know how to avoid them
- Monitor the beneficial and adverse effects of medicines
- Identify how the beneficial and adverse effects of treatment can be assessed
- Understand how to alter the prescription as a result of this information
- Know how to report adverse drug reactions (in the UK via the Yellow Card scheme)
- Communicate and document prescribing decisions and the reasons for them
- Communicate clearly with patients, their carers, and colleagues
- Give patients important information about how to take the medicine, what benefits might arise
- Adverse effects (especially those that will require urgent review), and any monitoring that is required
- Use the health record and other means to document prescribing decisions accurately
- Prescribe within the limitations of your knowledge, skills and experience
- Always seek to keep the knowledge and skills that are relevant to your practice up to date
- Be prepared to seek the advice and support of suitably qualified professional colleagues
- Make sure that, where appropriate, prescriptions are checked (for example, calculations of intravenous doses)
Source: British Pharmacological Society, 2019
The JCCP guidance on responsible prescribing
Remote Prescribing
The JCCP Guidance on Responsible Prescribing (JCCP, 2019a) complements the position adopted by the General Medical Council and the General Dental Council and accords also with guidance set down by the RPS (General Medical Council, 2013; General Dental Council, 2013). Accordingly, the JCCP and the CPSA have set down their decision not to endorse or permit the remote prescribing of any prescription medicine when used for specifically for non-surgical cosmetic treatments. The Council advises that when a prescriber/appropriate person delegates treatment to other practitioners, the patient remains under the oversight of the prescriber, requiring that the prescriber must be familiar with the patient through an initial face to face consultation and diagnostic assessment of the patient's suitability for treatment. This applies to the planned administration of medicines that are specifically used for cosmetic purposes, such as botulinum toxins, injected local anaesthetic or topical adrenaline, and the emergency use of medicines such as hyaluronidase (JCCP, 2019a).
The JCCP has stated aso that anytime that a designated prescriber issues medicines or treatments, they must exercise their professional and clinical judgement, have adequate knowledge of the patient's physical and psychological health status, and be satisfied the medication serves the person's needs. This applies to all medicines used specifically for cosmetic purposes that are POM whether they be injectable, topical or oral. Prescribers should therefore conduct a physical examination of patients before prescribing injectable prescription only cosmetic POMs and should not prescribe such medicines by telephone, video link, online, or at the request of others for patients whom they have not examined personally.
Delegation
When delegating to a NMP, the JCCP supports the GMC position, which recommends that wherever possible non-surgical cosmetic treatments should be delegated to a PSA-regulated practitioner but also recognises that prescribers may delegate the use of POMs for use by non-PSA registered practitioners whom they consider to be competent and proficient to administer the medication prior to agreeing to prescribe any POMs.
When the prescriber delegates the treatment after a face-to-face consultation, the JCCP then also notes that the prescriber must be satisfied that it is safe to do so (in accordance with safe administration, safe premises, safe storage of medicines/products standards etc) and reminds prescribers that, when delegating to a non-registered practitioner, the legal and professional liability for the delegation of the use of the medicine remains with the prescriber. The prescribing practitioner therefore remains responsible not only for oversight of the patient but also for the medicines they prescribe and for their subsequent use in accordance with expected professional practice and appropriate legal parameters (JCCP, 2019a).
Supply of prescription medicines
The JCCP advocates that prescriptions for POMs should only be made following a face-to-face consultation with the patient, after which the prescription should dispensed by a pharmacy. In these circumstances the purpose of this prescription is usually for the supply of the medicine only and is not commonly indicative of the treatment or dose required by the patient. Therefore, the JCCP reminds prescribers that a Patient Specific Direction (PSD) is a legal method of prescribing and that, particularly when delegating, a PSD must be provided, and treatment given in accordance with it. The JCCP (2019a) would expect to see a PSD include, at minimum:
- Name of patient and/or other individual patient identifiers
- Name, form and strength of medicine (generic or brand name where appropriate)
- Route of administration
- Dose (per facial area for complex treatments such as botulinum toxin)
- Date
- Signature of prescriber.
Doctors and dentists are eligible to hold a stock (ie where the medicines have not been dispensed by a pharmacist) of prescription medicines and are also required to complete a PSD when administering injectable medicines from this stock. In these circumstances, the JCCP would remind such practitioners of their professional responsibilities when combining their roles of prescribing and dispensing. However, medical and dental practitioners are not permitted to provide advance stock of prescription medicines to other NMPs. The MHRA advise that the supply of medicines from stock is only permissible where the doctor/dentist delegates to a practitioner employed within the same employing organisation. The JCCP reminds doctors and dentists in these circumstances that they are accountable for the safe use and storage of these medicines (JCCP, 2019a).
The MHRA has advised that nurse prescribers are not eligible to be supplied with prescription medicines as stock. In Scotland, Healthcare Improvement Scotland advise that ‘with regard to nurses and people operating registered independent clinics obtaining wholesale supplies of medicines (in Scotland), the legal position is that a nurse or a nurse independent prescriber cannot order and stock POMs or pharmacy medicines in their own right’ and advise further that any ‘persons carrying on the business of an independent clinic’ are able to order and stock prescription only and pharmacy medicines in connection with the running of the clinic. Furthermore, they advise that ‘if the service is registered with Healthcare Improvement Scotland you do not need to be a prescriber to order and hold stock. However, the practitioner must be a prescriber to prescribe from the stock allocation - this relates to all types of clinic, not just non-surgical aesthetic clinic’ (JCCP, 2019a).
Repeat prescribing
The JCCP does not consider an initial face-to-face consultation to have met the requirement for all future prescribing decisions, but advises that a follow up face-to-face consultation is required whenever:
- A new medicine is prescribed
- There is a change to the dose of a previously prescribed medication
- There is a change to the medical history of the patient
- There is an adverse incident
- More than 6 months have passed since the last consultation.
When the prescriber is considering issuing a repeat prescription in the absence of a further face-to-face assessment of the patient, they must satisfy themselves that none of the above conditions apply and that mechanisms are in place to make an accurate assessment of these conditions.
Competing interests
All prescribers should recognise and address the existence of competing interests. When making a prescribing decision, practitioners must place the needs of the patient first and be transparent about their actions. The approach to shared decision-making with the patient concerned should allow for the psychological needs and signs of vulnerability to be considered and should not be influenced by personal gain or commercial interest. In support of this, the JCCP endorses the Nolan principles to be adopted as an ethical framework for safe and ethical cosmetic prescribing practice:
- Selflessness
- Integrity
- Objectivity
- Accountability
- Openness
- Honesty
- Leadership.
Conclusion
The JCCP recognises the important role that professional prescribers make to public protection, and the contribution that they make to the development and maintenance of a robust and effective patient safety culture in the aesthetic sector. The JCCP (and the CPSA) continue to strive to promote and develop standards and best practice across the whole of the aesthetic non-surgical and hair restoration surgery sector, and promote and publicise the same to the public. The JCCP's primary purpose is to raise public awareness and improve patient safety. The publication of our guidance on ‘Responsible Prescribing for Cosmetic Practitioners’ demonstrates a shared commitment to signposting and promoting safe and effective practice within the aesthetic sector.
Key Points
- Prescribers are reminded that patients remain under the oversight of the prescriber, requiring that the prescriber must be familiar with the patient through an initial face-to-face consultation and diagnostic assessment of the patient's suitability for treatment
- Prescribers are reminded of their obligation to address the existence of competing interests and to place the needs of the patient first and be transparent about their actions
- Good prescribing practice requires prescribers to undertake rigorous pre-treatment screening with regard to the suitability and safety of the treatment, informed by fully-informed risk assessment
- Prescribers should continue to develop and maintain prescribing competency for all aspects of their prescribing practice, including the need for advanced decision-making skills in the exercise of clinical judgement, risk assessment, psychological and emotional screening, and the ability to make an informed decision with regard to differential diagnosis and the construction of an effective treatment plan for the patient/consumer
- Underpinning these responsibilities is the need for all prescribers to consider (at all times) the best interests of the patient and to ensure that they are satisfied that the treatment option selected is based on a full appraisal of risks and benefits for the patient
- All prescribers should recognise and address the existence of competing interests and, when making a prescribing decision, must place the needs of the patient first and be transparent about their actions, underpinned by the principle of shared decision-making.
CPD reflective questions
- What are the ethical and professional standards that apply for the prescription of medicines that prescribers undertake to delegate for use by non-prescribing colleagues?
- What are the regulations that relate to Patient Specific Directions and under what conditions can practitioners supply medicines from stock?
- What are the key questions and issues to consider to encourage practitioners to work within the context of an ethical framework for safe and ethical cosmetic prescribing practice at all times?
- What are the ten principles of ‘good’ prescribing advocated by the British Pharmacological Society?
- Who may be designated as an ‘appropriate practitioner’ with regard to prescribing and what are their responsibilities?