A Call for Stricter Medical Oversight on Botox Safety

A latest survey revealed that botulinum toxin (botox), an anti-wrinkle cosmetic injection, should be prescribed only by a healthcare professional. However, the drug is widely available in an unregulated marketplace in the UK (1^✔ ✔Trusted Source
Findings From the Great British and Northern Ireland Botulinum Toxin Survey: Treatment Outcomes, Patient Experience and Regulations From a Cross-Sectional Survey

Go to source). Conducted by Anglia Ruskin University in collaboration with KLNIK and published in Aesthetic Surgery Journal Forum, the survey highlights a need for strict professional oversight in the regulation of botox drug and its widespread use to ensure patients' safety.

The UK Government has recently announced proposals to introduce tighter restrictions around cosmetic injections, as well as certain other procedures, and these plans are now subject to public consultation and parliamentary scrutiny. An overwhelming 89% of those surveyed for the new study said they were in favor of stricter oversight.

The Issue of Consent and Information Focusing on Safety

Of the 919 participants, 91% were female, the majority (54%) had received more than five anti-wrinkle injections, and they were most commonly delivered in beauty clinics (46%). Regarding people’s motivation for treatment, 81% said anti-ageing reasons.

Despite existing requirements for botulinum toxin to be dispensed by a qualified prescriber, worryingly only 42% said that a prescriber was present during their consultation, while 9% said they were not provided with a written consent form prior to their procedure and 18% reported not being informed of possible complications.

Only 26% of participants said they received any form of post-treatment support, while just 28% recalled receiving advice on how to manage potential side effects.

Ignorance of the Yellow Card System and Regulations

Although most people reported a high level of satisfaction, with 90% expressing positive views about their treatment, short-term complications included bruising or swelling in 26% of cases, headaches (25%) and injection site pain (10%).

Long-term complications were relatively rare, with botulinum toxin resistance (3%) the most common.

Formal complaints following treatment were filed by only 5% of individuals, but at the same time only 35% admitted they were familiar with current regulations and 74% said they were unaware of the UK's Yellow Card reporting system. Through Yellow Card, the Medicine and Healthcare products Regulatory Agency (MHRA) collects information reported by the public about suspected safety concerns.

Medically Regulated Drug in an Unregulated Marketplace

Co-lead author Lee Smith, Professor of Public Health at Anglia Ruskin University (ARU), said: “The use of botulinum toxin for cosmetic purposes in the UK is a healthcare paradox – it’s a medically regulated drug but it’s widely used in an unregulated aesthetic marketplace.

“Our survey found that the public don’t know how to report issues they experience, highlighted by the lack of awareness of the Yellow Card scheme. At the same time, non-healthcare professionals, who represent a large proportion of those carrying out injections, lack formal reporting obligations as they are not members of professional bodies, indicating there could be a significant under-reporting of complications.

“The new regulations proposed by the Government, where standards and licences will be overseen by local authorities, cannot come soon enough. In the meantime, the public will continue to be able to receive cosmetic injections in unregulated settings with variable standards, and the NHS will continue to pick up the pieces when things go wrong.”

The Need for Safety, Education, and Screening for Vulnerable Patients

Co-lead author Dr Roshan Ravindran, an aesthetic doctor at KLNIK, said: “Our survey, the largest of its kind in the UK, shows that when administered correctly, botulinum toxin is generally well-tolerated and can be effective.

However, our survey reveals serious gaps in informed consent and aftercare. Nearly one in 10 people didn’t sign a consent form and almost one in five weren’t told how to manage complications.

“As the Government moves towards statutory licensing, it’s vital the scheme includes minimum educational standards, ethical codes and robust enforcement mechanisms. Technical skill alone isn’t enough.”

“Practitioners must be trained in communication, patient-centred care and the ability to screen patients, so those with conditions such as body dysmorphic disorder are instead provided with help rather than treatment.”

Reference:

1. Findings From the Great British and Northern Ireland Botulinum Toxin Survey: Treatment Outcomes, Patient Experience and Regulations From a Cross-Sectional Survey - (https://academic.oup.com/asjopenforum/advance-article/doi/10.1093/asjof/ojaf115/8256366)

Source-Eurekalert