With the advent of a licensing scheme arises the obligation to enable practice that is both safe and legal. A long-standing concern of non-medical independent prescribers, associations and organisations—including the Joint Council of Cosmetic Practitioners (JCCP)—relates to the challenges faced by nurses and other non-medical prescribers. Striving to find a balance between assuring the safety of patients and working within the confines of legislation when faced with urgent response scenarios is not easy. The JCCP is of the opinion that amendment is required for current legislation to enable non-medical independent prescribers to respond safely and effectively to emergency situations that might arise during clinical practice.
Instruments within the Human Medicines Regulations (2012) in England permit medical prescribers—doctors and dentists—to obtain prescription medicines on a ‘wholesale’ basis, where the medicines have not been dispensed to a named patient by a pharmacist. This provides the medical prescriber with an immediate supply of a medicine, from which they can prescribe and dispense or order the same to be carried out. It is a mechanism that facilitates appropriate patient access to medicines in a manner that is governed by the professional regulator. The medical prescriber is not permitted to pass on these wholesale supplies to others, but non-medical prescribers within the same practice may access these medicines to prescribe and dispense. Again, this activity is governed by the relevant professional regulator.
An apparent anomaly arises where the non-medical prescriber, working autonomously in the cosmetic sector, acts independently of their medical peers. In this scenario there is no immediate access to medicines since, for this group, allowance is not made for wholesale provision in legislation. They can supply them only through a prescription to be dispensed and they can authorise the administration through a patient specific direction. Where timely (and often immediate) access to medicines is required, the non-medical prescriber working independently is unable to access emergency medicines due to legal constraints. The non-medical prescriber, perceiving their professional obligations as both working within the law and protecting or preventing harm to those in their charge, wishes to exercise their duty to care. In the context of an emergency response scenario, it is this dichotomy that is the driving force behind all efforts made by practitioners to test the boundaries of medicines legislation.
In addressing the findings of Sir Bruce Keogh (2013) in his review of the cosmetic sector, a key decision reached by all stakeholders was the requirement for supervision and the primacy of the prescriber in that role. This recognised that consumer safety would likely be compromised in the absence of access to the medicines required to resolve adverse events, and that recourse to the NHS to meet that demand would be unacceptable. It was also noted that remediation of dermal filler-induced complications would likely necessitate urgent attention through the provision of prescription medicines. Subsequently, the Cosmetic Practice Standards Authority (CPSA) set out its supervision standards to include:
‘For fillers it is a requirement that supervisors are able to be present within 15 minutes, as prompt delivery of hyalase (Level 7 prescriber) has a direct impact on the severity of injury in adverse incidents’.
Among some groups of cosmetic practitioners there exists an incomplete understanding of medicines legislation, a matter not improved by the inadequacies of current cosmetic education and training standards. The evidence received by the JCCP is frequently anecdotal, although compelling in its volume and, more recently, supported by the findings of local authority environmental health officers. Regarding the use of medicines in any situation, the concerns frequently point to either of two failings to adhere to legislation: the removal of dispensing labels and providing the medicine to alternative customers, or prescribing for one individual with encouragement to use the medicine for alternative individuals. This latter appears, for emergency medicines, most commonly promoted. Contrary to professional guidance, prescribing for cosmetic procedures is frequently remote, using only the patient's notes and the administration of the medicine is not authorised through a patient specific direction. It is increasingly clear that remote prescribing is not only a concern relating to the lack of appropriate assessment, but that it represents the first step in a breakdown of all subsequent safeguards designed to protect patient welfare. Currently, the supply to and use of emergency medicines by non-prescribers is frequently seen as such:
- Prescribed for an individual (often the practitioner) with the tacit agreement that it can be used on any individual as required.
- Prescribed through a mechanism where the prescriber has not at any point had sight of the patient.
- Administered in the emergency situation without recourse to the prescriber, without the necessary authorisation or direction to do so and without the necessary follow-up by the prescriber.
It remains the JCCP's intention to work with the General Pharmaceutical Council and the Medicines and Healthcare products Regulatory Agency (MHRA) in circumstances where medicines are promoted or supplied inappropriately by registered pharmacies. The JCCP is aware that several pharmacies supply emergency kits through a prescription, reinforcing the JCCP's view that emergency medicines are promoted inappropriately. An emergency kit is by its nature something required in exceptional circumstances for an unidentified individual. To supply it for this implied purpose but to require its prescription for a named patient is, at best, contradictory.
» Instruments within the Human Medicines Regulations (2012) in England permit medical prescribers—doctors and dentists included—to obtain prescription medicines on a ‘wholesale’ basis, where the medicines have not been dispensed to a named patient by a pharmacist «
» … consumer safety would likely be compromised in the absence of access to the medicines required to resolve adverse events, and that recourse to the NHS to meet that demand would be unacceptable. It was also noted that remediation of dermal filler-induced complications would likely necessitate urgent attention through the provision of prescription medicines «
» The non-medical prescriber, perceiving their professional obligations as both working within the law and protecting or preventing harm to those in their charge, wishes to exercise their duty to care. In the context of an emergency response scenario, it is this dichotomy that is the driving force behind all efforts made by practitioners to test the boundaries of medicines legislation «
These efforts to assure safe and legal practise can pose a contradiction for the JCCP and its stakeholders, including the Aesthetic Complications Expert group and insurance providers, as well as non-medical prescribers. In the absence of alternative mechanisms, success in assuring legal practice can appear to pose a risk to patient safety by preventing access to emergency medicines. However, the JCCP are also mindful that there are hazards in any scenario where the supply of medicines is contrary to legal determination.
It is a matter of priority to determine a mechanism which provides non-medical prescribers with access to a defined (to be determined) range of medicines for use in urgent situations to protect patient safety. The JCCP intend to continue its work with regulators to ensure that all non-medical prescribers, and those under their immediate supervision, will have access to the appropriate medicines in the emergency situation. However, this would not provide a solution for non-prescribers working independently. The introduction of restrictions to limit independent practice for certain procedures performed by non-prescribers, something which would align with measures being considered by Health Improvement Scotland, may be an appropriate remedial measure. The JCCP finds that current practices which undermine or seek to circumvent medicines legislation and professional credibility to be insupportable.
It is widely understood that the standard of prescribing for cosmetic procedures too frequently fails to meet the demands of legislation and the expectations of professional regulators. The JCCP believes that a framework of licensing should include controls and safeguards to ensure compliance with medicines legislation. The following should feature as part of such a safeguarding system of control. For the purposes of obtaining a license, or as part of a person/premises investigation, the Local Authority Environmental Health Officer should confirm that:
- Non-prescribing practitioners have a named prescriber to act as supervisor.
- All prescriptions provided by that supervisor, or any other prescriber, are set against a signed statement that they have been subject to a face-to-face patient consultation and assessment.
- All prescriptions should include an authorisation in the form of a Patient Specific Direction (PSD) recorded in the patient's notes.
- All PSDs should include the prescriber's name as well as their personal identification number (PIN).
- No practitioner is in possession of wholesale stocks of medicines unless they are entitled to hold the same.
- Audit procedures are in place to enable the prescribed products to be traced from front end supplier to end point consumer.
The above list is indicative only and should be informed by the published guidance provided by professional regulators for wider context. The JCCP will continue to engage with the professional regulators to ensure that, as part of a scheme of licensing, they can support a mechanism of prescribing control that meets their individual and collective standards and requirements.