Statement from the Medical Council on the Prescribing and Administration of Botulinum Toxin (Botox)

The Medical Council reminds all registered doctors of their professional and legal responsibilities when prescribing and administering botulinum toxin products, commonly known as Botox. Botulinum toxin is a prescription-only medicine (POM) that is regulated to protect patient safety¹. Misuse or administration by unqualified people places patients at serious risk of harm, including infection, paralysis or life-threatening complications.
Botulinum toxin administration must also fall within the boundaries of Irish law, which currently permits administration by:

• a registered doctor,
• a registered dentist, or
• others, such as registered nurse, acting ‘in accordance with the directions” of a doctor or dentist².

While the phrase “in accordance with the directions” is not explicit, the Medical Council advises that doctors must not delegate the administration of botulinum toxin to a registered nurse unless they are satisfied that the nurse has the necessary knowledge, skills and competence. A doctor may only delegate a task or activity in which they themselves are familiar, competent and appropriately trained. The doctor retains professional responsibility and accountability for the outcome.

Doctors who prescribe or administer botulinum toxin products must comply with the law, the Guide to Professional Conduct and Ethics for Registered Medical Practitioners (9th Edition, 2024) and relevant clinical guidelines. This guidance is not exhaustive, and doctors remain responsible for ensuring that their provision of botulinum toxin treatment is consistent with and accepted standards of best practice.

The following sections of the Guide are of particular relevance:
- Section 2.1: You must practise and promote a positive culture of patient safety. This
includes:

• Providing a good standard of practice and care, maintaining your professional competence, keeping your knowledge and skills up to date, reflecting on your practice and working within your sphere of competence.

- Section 33.5: Delegation involves requesting another health care professional or team to provide care on your behalf. You should take reasonable steps to ensure that the colleague or service to whom you delegate has the knowledge and skills to provide that care
- Section 34.1: You should only prescribe medication, treatment or therapy when you have adequate knowledge of the patient’s condition and believe that such prescription is indicated. You should ensure that any treatment, medication or therapy prescribed for a patient is safe and evidence based.
- Section 34.2: The prescriptions you issue must clearly identify the patient to which they refer. They must be legible, dated, signed or authorised, and must state your Medical Council registration number.
- Section 55.3: You should give professional support to colleagues including medical students and less experienced doctors. You should not ask colleagues to carry out tasks for which they are not fully competent, except under the direct supervision of senior/ competent colleagues

In addition, doctors must be familiar with the regulatory framework for botulinum toxin medicines, including:
- The Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2021 (S.I. No. 540 of 2003, as amended), which govern the prescribing and administration of POMs in Ireland.
- The role of the Health Products Regulatory Authority (HPRA) in relation to botulinum toxin is to ensure that these products are of suitable safety, quality and efficacy (where authorised for use in Ireland), are supplied only through licensed channels to appropriately qualified practitioners or health service settings and are not advertised to the general public.

The sale, supply, or administration of botulinum toxin by unqualified or unregistered individuals is illegal, unsafe and unacceptable. Patients receiving these treatments outside regulated clinical environments face unnecessary and preventable risks.

Patient safety must always take precedence. Prescribing or administering botulinum toxin for cosmetic or therapeutic purposes is a clinical decision that must be made responsibly, in line with professional standards, national legislation and within the limits of the doctor’s competence.

¹ Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2024 (SI No 540 of 2003, as amended), Regulation 5
²   https://www.irishstatutebook.ie/eli/2009/si/442/made/en/pdf