Frequently asked questions: Supply and administration of Botox®, Vistabel®, Dysport® and other injectable medicines outside their licensed medicinal uses such as in cosmetic procedures

There are a number of medicinal products containing botulinum toxin, for example Botox and Vistabel, licensed for specific medical conditions. Some of these products are for the temporary improvement in the appearance of moderate to severe glabellar and crow’s feet  lines, when the severity of these lines has an important psychological impact in adult patients. MHRA has not licensed these products for purely cosmetic purposes (ie, to improve the physical appearance where there is no psychological impact). The following frequently asked questions provide guidance on the law and MHRA views in relation to the legality of using these medicines and other injectable products outside their licensed indications. The guidance is not an endorsement of such use and does not cover appropriate clinical practice in these circumstances.

Raised hand 
1. Who can administer these medicines?
2.  Who is an appropriate practitioner?
3. What does “in accordance with the directions of an appropriate practitioner” mean?  Must they be written?
4. Does there have to be a face-to face consultation with the practitioner before the product can be administered?
5. Can a doctor supply advance stocks of Botox® etc to nurses and others?  That is, before patients have been seen or assessed by the practitioner?
6. What about the situation where stocks are provided to nurses/therapists who are self-employed - ie separate legal entities from the organisation or company sending the stocks?
7. Can these medicines be administered under a Patient Group Direction (PGD)?
8. What are the requirements for a valid PGD in the private sector?
9. Can a service registered with the Healthcare Commission enter into an arrangement with a third party, for example, a self-employed nurse, to administer medicines under a PGD they have drawn up?
Nurse Independent Prescribers
10.  Can Nurse Independent Prescribers independently prescribe and administer injections for use in cosmetic procedures?
11. Can Nurse Independent Prescribers independently prescribe and administer Vistabel® for use in cosmetic procedures?
12. Can Nurse Independent Prescribers order and receive wholesale supplies of Botox® etc?
Annex A


1. Who can administer these medicines?

They can be:

  1. self administered
  2. administered by an appropriate practitioner
  3. administered by anyone acting in accordance with  the  directions of an appropriate practitioner.
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2.  Who is an appropriate practitioner?

A doctor, a dentist or, subject to certain limitations, a nurse or pharmacist independent prescriber or supplementary prescriber.   In this document, references to a practitioner mean an appropriate practitioner.

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3. What does “in accordance with the directions of an appropriate practitioner” mean?  Must they be written?

There is no legal requirement that the directions must be in writing.  In practice, however, such directions are frequently written – for example in a patient’s notes or on a drug chart. The practitioner must accept responsibility for the patient.  The directions must also be for a named, individual patient.  A general direction that would apply to any patient that has an appointment on any particular day is not sufficient.

 

Nurses will also wish to note (see Annex A below) that the Nursing and Midwifery Council (NMC) do not consider it good practice to administer medicines from a remote prescription or remote directions where the practitioner has not made a thorough assessment of the patient.  From the doctors’ professional practice perspective, the General Medical Council has issued guidance in a series of Frequently Asked Questions which is applicable to remote prescribing via telephone, email, fax, video link or a website. This guidance is available on the Council’s website (external link).

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4. Does there have to be a face-to face consultation with the practitioner before the product can be administered?

There is no legal requirement under the legislation for a face to face consultation with a practitioner but it is not sufficient for a nurse or other person who is going to administer the prescription only medicine to have the option to contact the practitioner.  In other words, the practitioner must be involved in the decision to administer the medicine to each individual patient. Also, a general direction applying to any patient who is going to be seen by the nurse/therapist is not sufficient to comply with the law.

However, doctors will note that the General Medical Council has issued guidance, applicable from 23 July 2012, to the effect that doctors must undertake a physical examination of patients before prescribing non-surgical injectable medicinal products for cosmetic use.  The guidance goes on to state that doctors must not, therefore, prescribe these medicines by telephone, fax, video-link, or online.

Nurses will also wish to note that updated advice issued by the Nursing and Midwifery Council and the Royal College of Nursing (external link) makes it clear that remote prescriptions or directions to administer should only be used in exceptional circumstances, and not as a routine means to administer injectable cosmetic medicinal products. This advice relates to injectable cosmetic medicinal products such as botulinum toxin (Botox®).

In respect of the GMC and NMC positions on remote prescribing, the Agency takes the view that there is no reason why professional representative bodies cannot or should not set higher standards of practice if they consider it appropriate. We consider the GMC and NMC stance is reasonable and entirely a decision for those Councils to make in the interests of patient safety

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5. Can a doctor supply advance stocks of Botox® etc to nurses and others?  That is, before patients have been seen or assessed by the practitioner?
A practitioner can supply advance stocks of these medicines to nurses and others who are employed within the same legal entity, for example a hospital or clinic.  The medicines must not be administered until the practitioner has given the patient -specific directions for the patient.

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6. What about the situation where stocks are provided to nurses/therapists who are self-employed - ie separate legal entities from the organisation or company sending the stocks?

In these circumstances the organisation or company sending the stocks would be wholesale dealing. Such nurses or therapists do not fall into a category of persons entitled to be sold POMs by way of wholesale dealing.

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7. Can these medicines be administered under a Patient Group Direction (PGD)?

There is no legal requirement which prevents PGDs from being used for cosmetic treatment (but see below for constraints on operating PGDs in the private sector).  However, anyone considering including Botox® in a PGD should be aware that cosmetic use of the product is outside its licensed indications.  (As is Vistabel® if used for purposes other than the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown, in adults under 65 years old, when the severity of these lines has an important psychological impact for the patient.)

Department of Health (DH) guidance states that products for use outside their licensed indication may be included in PGDs if their use is exceptional and justified by best clinical practice.  The MHRA view is that this does not apply to the routine use of Botox® for cosmetic treatments.

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8. What are the requirements for a valid PGD in the private sector?

In the private sector, PGDs can legally be made and used by independent hospitals, clinics and medical agencies which are registered with the Healthcare Commission. There are also legal requirements which must be met in order for a PGD to be valid.  For example, it must be signed by a pharmacist and a doctor and authorised by the registered provider as well as the registered manager of the service if applicable.   Private sector services which are not registered with the Healthcare Commission are not eligible to use PGDs.

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9. Can a service registered with the Healthcare Commission enter into an arrangement with a third party, for example, a self-employed nurse, to administer medicines under a PGD they have drawn up?

This is permitted if the arrangement is with a registered pharmacist operating a retail pharmacy business. Otherwise, the PGD can only be used within the registered service.

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Nurse Independent Prescribers

10.  Can Nurse Independent Prescribers independently prescribe and administer injections for use in cosmetic procedures?

Yes. A Nurse Independent Prescriber can legally prescribe and administer licensed parenteral medicines such as Botox® in cosmetic procedures on his/her own initiative. However, as mentioned above the use of Botox for cosmetic treatment is outside the product’s licensed indications.  Nurse Independent Prescribers may prescribe medicines independently for uses outside their licensed indications (so called ‘off-licence’ or ‘off-label’). They must however, accept professional, clinical and legal responsibility for that prescribing, and should only prescribe ‘off-label’ where it is accepted clinical practice.

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11. Can Nurse Independent Prescribers independently prescribe and administer Vistabel® for use in cosmetic procedures?

Yes. A Nurse Independent Prescriber can legally prescribe and administer licensed parenteral medicines such as Vistabel® (ie medicines which have licensed indications for cosmetic use) in cosmetic procedures on his/her own initiative.  If the medicines are used outside the licensed indications for cosmetic use, that use will be ‘off-label’.

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12. Can Nurse Independent Prescribers order and receive wholesale supplies of Botox® etc?

No. The law as it currently stands prohibits this activity and there is no intention to change this in the foreseeable future. The changes to legislation to introduce nurse independent prescribing were based on the long standing principle that a prescriber prescribes and that his/her prescription is then dispensed by a pharmacist.  Nurse Independent Prescribers can administer drugs themselves and authorise others to do so under their patient specific direction. The Department of Health and the MHRA do not consider that there are compelling grounds for reviewing the position.

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Annex A

The Nursing and Midwifery Council’s position on the supply and administration of Botox® and other injectable medicines in cosmetic procedures.
  1. Under current medicines legislation an independent nurse prescriber can administer parenteral medicines such as Botox® purified neurotoxin complex in cosmetic procedures on his/her own initiative or give directions for someone else to do so.
  2. If a nurse is requested to administer in accordance with a direction from an independent prescriber, she must only do so in accordance with her own professional code of conduct and acting within her own level of competence.  It is not considered good practice for nurses to administer any medication from a remote prescription where the independent prescriber has not made a thorough assessment of the patient.  In any account the doctor would be accountable for the supply of the medication and the nurse would remain accountable for the administration of the same said medication.
  3. With regard to the supply of parenteral medication for cosmetic procedures, again an independent nurse prescriber can legally prescribe.  Independent prescribers may supply to the nurse for administration on the basis of a patient specific direction only.
  4. In the interest of patient safety and public protection, any nurse acting illegally or outside of his/her area of competence would be investigated and appropriate action taken.
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Page last modified: 24 April 2014