Category: Insight

Pandora’s Bo[to]x

After twenty years of trying to keep “Botox” in its box (i.e. ensure guidance1 from MHRA*, ASA*, GPhC*, JCCP* is followed), I wonder who else in Pharmacy worries like I do about the loss of control of a Prescription Only Medicine (POM)?

Does it matter to anyone in Pharmacy that the regulations we have been entrusted to uphold since the tragic days of Thalidomide, have been ‘worked around’ to such an extent that the public perception of the ‘experts’ on the use of this medicine are now social media ‘influencers’?

These questions come to mind as in the same week the Medication Safety Officers (MSO) observatory and GPhC Regulate both referred to the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, which has come into force. More information can be found in the All-Party Parliamentary Group on Beauty, Aesthetics and Wellbeing (APPG-BAW) Report2 into advanced aesthetic non-surgical cosmetic treatments and the insights from Kingsley Napley on regulation3.

It seems incongruous that in the middle of a pandemic, parliamentary time had to be created for the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021.

The paradox is stark that regulation was required to mitigate the risks to stop injecting something that is an aesthetic ‘want’, at a time when vaccine hesitancy was gaining momentum. All the while the phrase ‘zoom face’ was being coined and procedures being offered to ‘correct’ it.

During the call for evidence, I wrote to the APPG-BAW, particularly around the role of pharmacy as the experts and leaders in medication safety, and also on informed decision making (given ubiquitous off-label use of Botulinum Toxin).

I had experience in this area, having previously given evidence in 2012 to the House of Commons Select Committee on Science and Technology into the regulation of medical devices, and I had also provided evidence in 2013 to the Review of Regulation of Cosmetic Interventions.

I did not hear back from APPG-BAW and had assumed that the expert voice of pharmacy was being picked up elsewhere.

The APPG- BAW report states that evidence was given from stakeholders including organisations representing the aesthetic industry, operators and practitioners, health bodies, regulatory agencies and consumers themselves. Written evidence was provided by GMC, HCPC and numerous nursing and dental practitioners.

However, it is the absence of pharmacy expertise that shouts out in Annexe 1 and 2 of the APPG-BAW report. The report had support from the APPG on Social Media, although it does not reference any liaison with Pharmacy APPG.

The APPG-BAW report recommendations call for more regulation, standards and enforcement, despite the failure of the POM controls on Botox. The APPG-BAW also considers ethics and mental health and looks at the evidence on the normalisation of invasive techniques. The Nuffield Council on Bioethics4 published a detailed report into the ethical issues in 2017 and raised the issues of supply and demand, as well as corporate social responsibility (CSR) as a way of protecting individuals from public health harms or discrimination. The evidence of the Centre for Appearance Research5 at UWE Bristol looked at how forces such as celebrities and influencers and image-editing phone apps have contributed to a dissatisfaction in appearance, psychological vulnerabilities and seeking “quick fixes” to achieve the “right” look.

The APPG-BAW heard that the majority of aesthetic practitioners do not have the necessary knowledge and skills to carry out psychological assessments. The licensed indications for skin use of Botox are the temporary improvement of appearance when the severity of the facial lines has an important psychological impact in adult patients. Moreover, this is restricted to vertical lines between eyebrows, crow’s feet, and forehead lines. The APPG-BAW recommendations include national minimum standards for risk assessing psychological vulnerabilities. 

The GPhC is clear in its guidance that pharmacist prescribers have an important role in making sure prescribing is safe and effective in non-surgical cosmetic medicine. The GPhC signposts to various references for prescribing cosmetic products, although does not specify the need to join the accredited registers. The Scottish Government ran a consultation6 in 2020 with the aim of closing the legislative gap by amending the definition of “independent clinic” so that it covers pharmacy professionals and would be regulated by Health Improvement Scotland7(HIS). Whilst this requirement is only where premises are not already covered by GPhC and NHS contract, it looks as though HIS separate approach to regulating independent healthcare is providing flexible options (different mechanisms apply in England). 

I am not a pharmacist prescriber and therefore I am unlikely to have direct involvement in these areas. However, I have been involved in medication safety since the NPSA focus on medicine Patient Safety Alerts, and subsequently as a Medication Safety Officer (MSO).

I have also been involved in many investigations where things go wrong, including wider governance issues where professionals work across NHS and private practice. A harmed patient, who is also a pharmacist recently said:

“If you are not actively working towards learning – you are actively letting things go wrong”.

This aligns with the words of Lieutenant General David Morrison – “the standard you walk past is the standard you accept”. In healthcare, this could be considered to be “micro-harms” in that if left unchecked these issues have the potential to lead to patient harm and erosion of professional standards.

Non-surgical cosmetic procedures are not a marginal issue but have become a barometer for wider societal behaviours and there is a need for ethical debate in pharmacy about supply and demand. The conversation about the safe and effective use of non-surgical cosmetic medicines should be a matter for all pharmacy professionals and we need to start a conversation about pharmacy leadership in this area.

Opinion by Karen Harrowing, Pharmacist and Independent Advisor in wider healthcare governance.

References

All links below were accessed 28th October 2021.

  1. *Medicines & Healthcare products Regulatory Agency (MHRA – guidance now archived) available here.

*The Advertising Standards Authority Ltd (ASA) available here.

*General Pharmaceutical Council (GPhC) available here.

*Joint Council for Cosmetic Practitioners (JCCP) available here.

  1. APPG – BAW Report available here.
  1. Kingsley Napley review of APPG – BAW Report here.
  1. Nuffield Council on Bioethics availble here.
  1. Centre for Appearance Research available here.
  1. Scottish Government Consultation available here.
  1. Health Improvement Scotland (HIS) – Independent Clinics available here.
  1. Health Improvement Scotland (HIS) – Independent Healthcare available here.