All healthcare practitioners working in cosmetic practice have a professional duty to report complications caused by prescription medicines and medical devices, which include dermal fillers. The Nursing and Midwifery Council states ‘encourage a learning culture by reporting adverse incidents that lead to harm, as well as near misses.’1 The General Medical Council and General Dental Council also have similar statements in their guidelines.2,3 Reporting complications provides many benefits, including identifying issues that may not have previously been known about, providing an early warning system, identifying trends, product safety and counterfeit products, enabling closer scrutiny of a medicine or a device, further research conducted by the manufacturer and experts and ultimately patient safety.4
When working in isolation in private cosmetic practice, it is not always obvious what needs to be reported and where it should be reported to. It is also important to state that an organisation or practitioner, who reports no or very few adverse events or near misses are not necessarily ‘safer’ and similarly those who report many complications may not be ‘unsafe’, it may simply reflect a culture of more openness.6
What should be reported?
The Medicine and Healthcare products Regulatory Agency (MHRA) requests that healthcare practitioners report any serious reaction to a medication or a device, any medicine on additional marketing highlighted by a black triangle (such as new products or devices), an unlisted reaction not in the summary of product characteristics, or if in any situation you are not sure to report.7 Similarly, if you are managing a complication caused by another practitioner or a non-medical person, you are still encouraged to report this to the MHRA. It is better that potential hazards are over-reported to ensure that issues can be identified and patient safety improved. Although most reputable insurance companies will indemnify you to manage these problems from other providers where you are competent to do so, it would be sensible to speak to your insurer before providing remedial treatment.
Where to report?
The MHRA is part of the Department of Health and is the Government agency responsible for regulating medicines, medical devices and blood products. They ultimately have the power and responsibility to investigate and enforce sanctions regarding medicines and devices. Reporting to the MHRA should be the first port of call for any practitioner experiencing a serious or unexpected adverse event and can be easily done via the ‘Yellow Card’ system.4,5 It is recommended to report adverse reactions to the MHRA via the ‘Yellow Card’ website, app or by the form included in the back of the British National Formulary. When completing a reporting form, as much information as possible should be included.
Information that should be provided includes (based on the Yellow Card reporting pathway):4
- Name and profession of person reporting the complication
- Contact details for the person reporting
- Date/time of complication
- Name and designation of treating practitioner
- Patient identification (ID number or initials)
- Patient age and gender
- The treatment performed resulting in an adverse event
- Type of complication occurring
- Severity of complication
- Has the complication been resolved?
- Medication or medical device leading to a complication, including batch number and expiry date
- Volume/dosage of product used and area treated
- Including a diagram of areas treated and amounts is useful
- Relevant past medical history, medication, allergies, vaccination, previous treatments and any previous adverse events
- Details of incident, including timeline of events, signs and symptoms, how the complication has been managed
- Summary of outcome at the current time
In aesthetic practice, the Aesthetic Complications Expert (ACE) Group World and manufacturers strongly recommend reporting complications that may be medicine or product related directly to the manufacturer. If this is a pharmaceutical supplier, it will almost certainly have its own pharmacovigilance department and a specific reporting form for you to complete to provide all the information required. If they do not provide their own reporting form, you should provide all the details recommended above and any other relevant information that is pertinent to the adverse event. Due to UK GDPR legislation, patient name and contact details should be omitted unless the patient has consented to this and requested direct contact or feedback.
All manufacturers supplying medicines and devices are answerable to the MHRA and to be able to sell in the UK market, they will need to have provided evidence of safety and traceability.7 Manufacturers will usually work with the MHRA to investigate adverse events and provide evidence and feedback. Reporting a complication to a manufacturer will usually also help the practitioner on how best to manage and treat a complication and to provide support for the patient.
There are also other organisations that work specifically in non-surgical aesthetic medicine, such as the ACE Group World where members can report complications.8 This provides invaluable information to the organisation who works with manufacturers, stakeholders, patient groups, professional bodies and the Joint Council for Cosmetic Practitioners (JCCP). It also allows healthcare providers to receive evidence-based guidelines and advice on how best to manage the complication via an emergency helpline, online forum, email and messaging platform.
A step-by-step of complication reporting
1. Arrange early/immediate face-to-face review and identify the adverse event
2. Provide advice, reassurance or remedial treatment if appropriate
3. Seek advice from a more experienced practitioner or ACE Group World if needed
4. Ensure contemporaneous records and photographs are recorded
5. Contact the manufacturer and report to the relevant department
6. Complete a Yellow Card reporting system via the website or app
7. Provide appropriate follow-up and be available if the patient has further problems/concerns
8. Consider informing your insurance company
The importance of reporting
Point 7 of the JCCP 10-point plan specifically addressed the issue of reporting complications in the aesthetic sector on a national level, highlighting huge gaps in this area concerning the types and number of treatments in this field and the number of complications and adverse events.9 Several issues of concern have been brought forward by the JCCP, including evidence of under-reporting, unregulated providers having no duty to report complications, patients who have suffered an adverse event not having an idea on how to report their concerns, and products used in the aesthetic sector that do not have medical device approval, so do not benefit from medical accountability and traceability.9
The JCCP has also acknowledged the importance of complications reporting as a fundamental element of a united quest to enhance patient safety and public protection. Professor David Sines, chair of the JCCP, noted that underreporting and the lack of a mandated requirement for all practitioners to advise the MHRA of complications and adverse events has led to a systematic failure of regulators, manufacturers and suppliers to construct a robust evidence-base from which to drive up service and product quality.9
Complications and adverse events in aesthetic practice are hugely under-reported and it is only by ethical and professional practitioners reporting these that, as an industry, we can improve patient safety, product safety and help shape our industry with regards to greater regulation. The introduction of a licensing scheme will possibly make it mandatory for practitioners to report adverse events, but this is hard to enforce and there is still the negative repercussions that a practitioner might feel if they report a complication on their own practice or from the manufacturer/supplier.
However, as practitioners we have a duty of candour and professional responsibilities. Reporting complications is a duty of care and a requirement of our professional bodies and we could be negligent by not doing so. Not only this, it helps to make our practice more professional, helps to eliminate non-authorised or counterfeit products, provides a further step to inhibit non-medical practitioners from performing non-surgical aesthetic treatments and finally, safer for patients. As a conclusion, I would recommend, if in doubt, report!
1. Nursing and Midwifery Council: Read the professional duty of candour (UK: NMC, 2022) <https:// www.nmc.org.uk/standards/guidance/the-professional-duty-of-candour/read-the-professional-dutyof-candour/>
2. General Medical Council, Guidance for doctors who offer cosmetic interventions: safety and quality (England: GMC, 2022) https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/cosmetic-interventions/safety-and-quality
3. General Dental Council, Principle 8: Raise concerns if patients are at risk (UK: GDC, 2022) <https://standards.gdc-uk.org/pages/principle8/principle8.aspx>
4. Medicine and Healthcare products Regulatory Agency, Yellow Card: Making medicines and medical devices safer (UK: MHRA, 2022) <https://yellowcard.mhra.gov.uk/information>
5. Aesthetics Journal, Understanding the Yellow Card Scheme, 2019
6. Care Quality Commission, Reporting medicine related incidents (England: CQC, 2022) <https://www.cqc.org.uk/guidance-providers/adult-social-care/reporting-medicine-related-incidents>
7. Medicine and Healthcare products Regulatory Agency, Specific areas of interest for reporting suspected adverse drug reactions. (UK: MHRA, 2022). <efaidnbmnnnibpcajpcglclefindmkaj/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/403078/Specific_areas_of_interest_for_adverse_drug_reaction_reporting.pdf>
8. Aesthetic Complications Expert Group World, Report a complication (UK: ACE Group World, 2022). <https://uk.acegroup.online/report-a-complication/>
9. The Joint Council for Cosmetic Practitioners, JCCP 10-Point Plan for Safer Regulation in the Aesthetic Sector (UK: JCCP, 2021). <https://www.jccp.org.uk/NewsEvent/jccp-10-point-plan-for-safer-regulationin-the-aesthetic-sector>