Podiatrists and facial aesthetics
Non-surgical facial enhancements by either the administration of dermal fillers containing Hyaluronic Acid to volumise the mid-dermis under lines and wrinkles and so reduce them, or by the injection of muscle relaxants such as purified botulinum toxin type-A to mitigate the strength of muscles used in frowning are a well –researched and popular aesthetic treatment in the UK and worldwide.
In order to clarify the situation of Podiatrists also involved in this market sector, the following key guidance points are given. Further detailed information is appended below them.
- Prescribing podiatrists must ensure that they only prescribe or administer medicines where legally permitted to do so and work strictly within all legislation applying to medicines.
- Prescribing or administration rights may only be used within the scope of podiatry, for example prescribing purified botulinum toxin type-A for a dynamic equinus foot deformity is within scope, prescribing it for facial aesthetics is not.
- Podiatrists working as aestheticians must ensure that clear boundaries exist between their activities as a podiatrist and those as an aesthetician.
- Botulinum toxins are prescription-only medicines throughout most of the western world, including the UK, and as such can only be obtained against a prescription issued by an appropriate practitioner. To be ‘appropriate’ that practitioner must be working within their scope of practice.
Legislation does not specifically address the issue of medicines administration except where the product is for injection . Botulinum toxin type-A products are defined as a medicine and for injection, so their administration is defined by law. Medicines for injection may only be: self-administered, administered by a doctor or subject to certain limitations, an independent nurse prescriber or supplementary prescriber or by anyone acting in accordance with the patient-specific directions of a doctor or, subject to certain limitations, an independent nurse prescriber or supplementary prescriber.
In considering the prescribing of, for example Botox®, by a podiatrist prescriber, use of the term ‘appropriate practitioner’ used in the applicable legislation should be noted. Therefore, in the event that a podiatrist prescriber wished to prescribe and administer prepared botulinum toxin type-A for dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older where this was clinically assessed to be a suitable treatment, they would be judged ‘an appropriate practitioner’ and plainly acting within the defined scope of practice of podiatry. The foregoing procedure would naturally be subject to them having appropriate training in the product and its administration.
In the event that a podiatrist prescriber wished to prescribe Botox® for facial aesthetic treatments, this would be clearly outside their scope of practice and they would not be ‘an appropriate practitioner’. Therefore any prescription issued by them for this purpose would be in contravention of the medicines act 1968 and subsequent amendments and therefore illegal.
The foregoing paragraph should be noted in the context of the fact that as podiatrists are statutorily regulated by the Health and Care Professions Council (HCPC), under the provisions of the Health Professions Order 2001, they are adjudged to be responsible for actions that are performed both within and outwith their professional activities. For example, a podiatrist who, entirely unconnected to their work, committed a criminal offence could be adjudged to be impairing their professional standing and therefore subject to sanctions by the HCPC affecting their registration status, in addition to any actions taken against them as individuals within the parameters of criminal law.
Dermal fillers, although designed for injection are classified as medical devices and as such do not require a prescription and can be purchased by any individual. UK law does not classify by whom or in what manner medical devices may be used. Dermal fillers can be utilised in podiatry when injected into areas of high pressure in the tissue under the foot, to mitigate the effects of such pressure by volumising the protective fibro-fatty padding on the bottom of the foot which can become ineffective due to a variety of factors, including glycosylation of tissue in Diabetes Mellitus.
The active ingredient of dermal fillers, Hyaluronic acid, is also frequently used in podiatry by way of injection of suitably prepared products containing it (e.g. Ostenil®) into synovial joints of the lower kinetic chain damaged by mild to moderate osteoarthritis. Such products are also medical devices, not medicines.
Although prepared from one of the most potent neurotoxins in existence, produced by the bacillus Clostridium Botulinum, the resultant purified medication; prepared botulinum toxin type-A, has an excellent safety profile when used within its licensed dosages and purposes. For example, whilst twice the licensed dose of the cardio-tonic Digitalis and five times the licensed dose of the commonly used local anaesthetic, Lidocaine, is toxic, it is estimated that it would require some fifty times the usual licensed dose of prepared botulinum toxin type-A given in aesthetic procedures for toxicity to develop in a human
Current licensed uses of botulinum toxin type-A vary by the make of the product, but Botox® manufactured by Allergan(Inc.) can be quoted as a representative example:
Botox® is also indicated for focal spasticity, including the treatment of: Dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older and wrist and hand disability due to upper limb spasticity associated with stroke in adults. It is also indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar lines), in adults. It is recognised and it is indeed entirely lawful and within their human rights, that podiatrists, particularly those in private practice, may wish to gain alternative skills in, for example, manipulation therapy, herbal medicine, acupuncture, hypnotherapy, counselling or any number of other personal care related skills. Such skills where they impact on areas that are clearly not within the scope of podiatry must however be practised as stand-alone procedures and not as ‘extensions’ of podiatry. The same conditions must apply if podiatrists choose to undertake training in the administration of facial aesthetics products. Any procedures that are performed should be demonstrably performed not as a podiatrist, but within the scope of any training that they have received in such procedures, and strictly according to law as applicable to any products used.
The laws that apply to such administration would be those pertaining to any other individual, be they a podiatrist, a beauty therapist, pharmacist, health care assistant or someone entirely unconnected to health related employment.
In the event that someone working as an aesthetics practitioner, who was also a podiatrist (whether a prescriber or not) wished to administer botulinum toxin type-A for facial aesthetics, as in the case of any other individual they must note that to comply with the law it should only be done under the named patient-specific direction of an ‘appropriate prescriber’ who takes responsibility for such administration. Irrespective of the fact that they may be highly knowledgeable and skilled in the pharmacology and use of botulinum toxin type-A for procedures within the scope of podiatry, a podiatrist cannot be an ‘appropriate practitioner’ for the purposes of prescribing botulinum for facial aesthetic purposes.
In such cases the Institute, although recognising that this is not a podiatry matter, would advise individuals performing such procedures who were also podiatrists, to ensure in writing via consent forms or similar, that people to whom they administer such procedures clearly understand that this is not a podiatry procedure and the practitioner is not acting as a podiatrist.