The implementation of a licensing scheme mandated this year through the Health and Care Act (2020) has been the source of some confusion, misunderstanding and misinformation. It is understood that the required licence will be a two-part premises and separate practitioner competence licence, and the details will be subject to public consultation, currently set for spring 2023. There is an indication in the broadest terms of the procedures likely to be included in the licence but much else is currently conjecture. The role and activity of prescribing and the management of medicines are core features of much of the cosmetic sector. Irrespective of any speculation surrounding the detail of the licensing scheme, prescribing and medicines use are controlled by legislation and professional regulation, requirements that those responsible for implementing the scheme will be obliged to enforce.
Current licensing mechanisms (for example, relating to acupuncture and body piercing) are enforced by local authority environmental health officers (EHOs), enabled by their powers under the Local Government (Miscellaneous Provisions) Act 1982, along with any other legislation relevant to an investigation, for the purposes of this article, the Human Medicines Regulations (2012). EHOs have the power to enter premises without notice, issue enforcement or prohibition notices and, where necessary, prosecute. Perhaps the most high-profile use of these powers concerns the prosecution of ‘Dr Evil’ in 2019 (Coyne, 2019).
» The Joint Council for Cosmetic Practitioners has previously advised of the need for all healthcare practitioners who work in the aesthetic sector to adopt an assiduous approach to accurate record keeping whenever they administer medical or medically-related treatments «
The Joint Council for Cosmetic Practitioners (JCCP) works alongside EHOs, and it is relevant to note the increasing use of these powers by those investigating non-surgical cosmetic establishments. This article brings together the JCCP's prescribing guidance, informed by the Council's experience of working alongside EHOs, including their findings and concerns from their investigations, with a view to an alignment of standards to fit within a future licensing framework.
The JCCP's prescribing guidance has been reviewed for accuracy by all professional regulators and, as such, should be a valuable resource, not only for nurses, but for prescribers across all regulatory professions. Its primary focus and target audience are those prescribers who prescribe and then delegate the procedure to another person, and this is also the remit of this article.
Historically, little has been said by regulators concerning the delegation of a procedure to an unregulated practitioner. Therefore, it is worth noting a previous Nursing and Midwifery Council (NMC) statement, which states that a prescriber is accountable for their prescribing practice and, when delegating the procedure to a nurse, the nurse is accountable for the administration. Implicit in this is the additional responsibility undertaken by any prescriber when delegating to unregulated persons. For instance, in a scenario where a nurse is administering a procedure outside the terms of the direction, the injecting nurse, rather than the prescriber, would be held to account. It is not clear where the accountability lies when the procedure is delegated to an unregulated person, but it is reasonable to assume that a greater extent of responsibility applies, and that the prescriber remains accountable for having assured themselves that the patient, for whom the prescription was intended, had been fully and appropriately assessed by the prescriber.
Remote prescribing
A remote prescription is one that is issued in the absence of a face-to-face consultation, including telephone and video consultations.
There are numerous reasons why remote prescribing is inappropriate in the cosmetic sector. In addition to a balance of risk and benefit that cannot justify remote prescribing where the procedure is for cosmetic purposes, evidence suggests that there are wider risks, which are considerable. Nurses have a duty to identify and mitigate risk and, in the context of remote prescribing, the point is explicit in the Royal Pharmaceutical Society's (2021) prescribing framework. The evidence received by JCCP from EHOs and others is disturbing.
The following are the features and key findings:
- Remote prescribing is frequently undertaken after a review of a medical history only, without any form of (remote) consultation undertaken by the prescriber
- Remote prescribing is more commonly associated with a benefit to the prescriber and/or practitioner than to the patient
- EHOs are unable to identify the prescriber for a given investigation and are therefore unable to effectively perform their duties
- Both practitioner and patient are often unable to identify the prescriber, having never met them, particularly where a commercial prescribing service is used
- The supply of product per prescription may be beyond what is required and there is no direction provided with the prescription
- Unsuitable, incomplete or complete absence of patient records
- More than one prescription is issued per treatment instance, enabled by the fact that a practitioner has only to submit a medical history form to several prescribers and different pharmacies to build a stock of supplies.
Nurses offering a prescribing service remotely must be aware that they could be referred to the NMC, who will ask them to justify, on a case-by-case basis, the decision(s) to prescribe in this way. Understanding that remote prescribing is reserved for scenarios where a medical patient's need outweighs the risk, and given the wider view of risk outlined above, the NMC's recent statement that remote prescribing for cosmetic procedures is unlikely to be suitable is placed in a useful context.
Licensing will include a system of inspection with powers of investigation by EHOs who have the expertise to identify illicit and substandard prescribing practice and medicines use. To facilitate the EHO's objective, it is likely that mechanisms will be required to identify prescribing partners, promoting transparent and accountable practice.
Directions
By law, it is required that a person may only administer a parenteral prescription medicine in accordance with the directions of a prescriber. A prescription to supply, for instance, 100 units of a botulinum toxin, does not constitute a direction.
Directions should be recorded in the notes and are most readily facilitated in the format of a patient specific direction (PSD). Prescribers wishing to delegate a procedure should be familiar with the requirements of a PSD and it should reflect the treatment plan agreed upon between the prescriber and patient.
It is commonly assumed that cosmetic botulinum toxin treatments are safe. This lack of direction facilitates autonomous and illegal decision-making by unregulated practitioners in terms of dosages used and areas in which they are used. Higher-risk procedures, including the treatment of hyperhidrosis and neck platysma, combined with a lack of regulatory restriction limiting this practice, begin to blur this line between cosmetic and medically indicated risk, and evidence of dysphagia, a potentially fatal sequela, underlines this risk.
The lack of restrictions enabled by the absence of explicit direction, combined with oversupply through remote or other improper prescribing practice, encourages high-risk practice and the assumption that cosmetic procedures are safe fails to stand up to close scrutiny.
Competence and follow-up
A key mechanism to ensure safe practice is the responsibility of the prescriber to determine that the person they delegate a procedure to is competent. It is not enough to identify that the person is trained or qualified, and it is important to note that competence extends beyond the procedure itself and includes everything that surrounds it. For the injection of botulinum toxins and other prescription procedures, evidence of a lack of competence is freely available online, particularly through forums and other social media.
An increase in procedures such as the ‘Brazilian butt lift’ and breast augmentation with dermal fillers are causes for particular concern, both high-risk interventions, that are frequently assisted and enabled through prescribing local anaesthetic injections. Therefore, it is significant to note the recent interventions by an EHO to prevent a ‘trained’ individual, who was clearly not competent in the wider sense, from performing these procedures. This assessment of competence by regulated professionals is an important safeguard in public protection and, in this scenario, the intervention required by the EHO demonstrates failings by both the trainer and the prescriber, in what must be seen as missed opportunities to protect members of the public. They are failings that reflect poorly on both the profession and the sector.
Equally ubiquitous on social media are requests for assistance from unregulated practitioners who are having difficulties with the outcomes or management of a prescribed procedure. It is the responsibility of the prescriber to determine the outcome of a procedure they have prescribed and to intervene as necessary, negating any need for such requests. The responsible approach to this method of prescribing involves clear and transparent methods and positive relationships between the prescriber, the patient and the person to whom the procedure is delegated. This approach, which incorporates these safeguarding mechanisms, assures public safety and guards against the challenges of illicit practice, which will more likely arise under a licensing scheme.
Record keeping
The JCCP has previously advised of the need for all healthcare practitioners who work in the aesthetic sector to adopt an assiduous approach to accurate record keeping whenever they administer medical or medically-related treatments. All registered nurses will be familiar with the NMC standards in this regard.
With respect to the delegation of cosmetic procedures to unregulated practitioners, the experiences of EHO investigations are important, understanding that such individuals have no professional obligation to maintain notes. This experience finds that notes are either not made at all or, when they are, they are disposed of in a matter of months. Not only does this hinder the objectives of the EHO, but it also significantly compromises the registration of any nurse who has entrusted their records with such a practitioner. Poor record keeping is a consistent cause of NMC fitness to practise concerns. Given that under a licensing scheme the EHO would have the power to request access to client/patient notes, it is advisable that nurses adopt a robust process to ensure comprehensive and accurate records are available.
Where a procedure is prescribed and delegated, notes and records should, at a minimum, reflect the prescriber's initial assessment/consultation and findings, the medical history, the PSDs and the consent. The procedure then performed must be recorded in detail and, to comply with the law, it must accurately reflect the PSD.
Summary
There are numerous mechanisms that could be introduced as part of a licensing scheme to ensure safe and legal prescribing practice and medicines management but, at this early stage, any discussion is unrealistic. Nevertheless, the very act of inspection and potential for investigation associated with any licensing scheme will exert pressure to deliver transparent and accountable practice. Much of current prescribing practice and the inappropriate use of prescription medicines is liable to both professional and criminal sanction, and the JCCP urges all prescribing practitioners to review their systems, including through audit and risk assessment, and to make the required changes to ensure patient safety and avoid professional and criminal censure.