Frequently asked questions

Question 1: 

I have a Degree in Nursing obtained at UNISA and also have a Certificate as a Nurse Prescriber obtained in the UK. Will the qualifications be accepted in South Africa and will I be able to administer BOTOX & Dermal Fillers to patients as a nurse?

Answer:

No, you cannot administer injections. 
Botox and fillers requires additional training skills.

There are two types of injections:
• Those that are performed standard like IV or IM injections. These require a prescription from a doctor before a nurse can inject. Nurses do have training for these.
• Then, there are injections that require additional skills only within the curriculum of training of doctors: such as spinal blocks, nerve blocks, intra-particular injections, implants such as fillers and then injections that are placed strategically and anatomically like Botox injections. These cannot be performed by nurses because it does not fall in their training.

If a medical person has completed an international training course to enable them to do more advanced medical procedures, then this will first have to be approved by HPCSA and College of Medicine Department relative to the specific procedure.
Otherwise their training does not mean anything in our country.

For e.g. – General Practitioners that have done liposuction courses abroad, their training needs to be recognised by the College of Medicine (Plastic Surgery) or a Plastic Surgery University Department.

Then after this, the HPCSA will give recognition.
Therefore, if a nurse has done a training to do what falls in the scope of practice of General Practitioners, dermatologists or plastics, then the training will have to go through Dermatology Department, Plastic Surgery Department and Family Medicine Department before being recognised.

 

Question 2: 

May a Salon administrate injections without a medical practitioner?

Answer:
No, the essence of the regulations / acts is that you need to be a registered medical practitioner registered accordingly with the Health Professions Council of SA to administer scheduled medicines/injections of any nature.

Regulations of the HPCSA:
HEALTH PROFESSIONS ACT 56 OF 1974 states that
(1) No person shall be entitled to practice within the Republic –
(a) any health profession registrable in terms of this Act; or
(b) except in so far as it is authorised by legislation regulating healthcare providers and sections 33, 34 and 39 of this Act, any health profession the practice of which mainly consists of-
(i) the physical or mental examination of persons;
(ii) the diagnosis, treatment or prevention of physical or mental defects, illnesses or deficiencies in man humankind;
(iii) the giving of advice in regard to such defects, illnesses or deficiencies; or unless he or she is registered in terms of this Act.

Any person who is not registered in terms of this Act and practises a health profession in contravention of this section or who pretends to hold such registration is guilty of an offence and on conviction is liable to a fine or to imprisonment for a period not exceeding 12 months or to both a fine and such imprisonment.

Addendum 2 - THE MEDICINES CONTROL COUNCIL OF SOUTH AFRICA
It is important to remember that injections of substances have to be done by a doctor or appropriate professional registered with the HPCSA (Health Professions Council of South Africa). These substances used for aesthetic medical procedures are scheduled substances that need to be applied by registered, qualified and trained professionals that understand anatomy, physiology, the specific medicines and its pharmacology. The professional that uses this substance on patients also needs to understand how to manage the possible side effects, reactions and complications. Injections of substances to patients by non-registered persons are illegal and these persons can be criminally prosecuted.

Addendum 3 - The Act that regulates this is Act 101:
Act 101 Section 22A - Control of medicines and Scheduled substances
Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine or Scheduled substance, except in accordance with the prescribed conditions any medicine or scheduled substance may be possessed by a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, or under the Veterinary and Para-Veterinary Professions Act, 1982, for the purposes of administering it in accordance with his or her scope of practice;

In terms of Section 22A (5)(f) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe and apply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care

Question 3:

May a Medical Practitioner or Salon advertise Botox?

Answer:
No, the essence of the regulations/acts is that you (and your practice) may not advertise a scheduled medicine (such Botox® which is also a registered trade name) to the public. 
BOTOX® is a registered trade name and a proprietary pharmaceutical product name owned by Allergan, Inc. and is registered both with the United States Patent and Trademark Office and also on the South African Trade Marks Registry.

BOTOX ®1 identifies the botulinum toxin type Apurified neurotoxin complex product manufactured and sold by Allergan, Inc. Use of the trademark "BOTOX®” distinguishes that product from similar botulinum toxin products manufactured and sold by others. Allergan's product has received Food and Drug Administration (“FDA") approval under the proprietary name "BOTOX®” for the United states and approval under the same name in South Africa from the Medicines Control Council.

We also need to draw your attention to the fact that BOTOX® is a prescription only, Schedule 4 medicine which results in the advertising and promotion thereof being governed under the Medicines and Related Substances Control Act, Act 101 of 19652. In accordance with this Act, direct to consumer advertising of a scheduled product is not allowed and would be seen as illegal.

To enable medical practitioners to however continue promoting their businesses and services, whilst also complying with the regulatory advertising requirements for medicines, it is recommended that reference in advertisements to individual, Scheduled 4 items be deleted and substituted with phrases such as:
• Wrinkle reducing injections;
• Anti-frown injection / treatment;
• Frown injection / treatment;
• Injection / treatment for frown lines / folds;
• Injection to reduce the depth of frown lines
• Botulinum Toxin Type A

Or other words and phrases with similar meaning, but without referring to specific products or ingredient names.
In terms of the Ethical Rules a Healthcare Professional should refrain from canvassing or touting.  As per the Ethical Rules the following is included as the definition for “touting” means conduct which draws attention, either verbally or by means of printed or electronic media, to one's offers, guarantees or material benefits that do not fall in the categories of professional services or items, but are linked to the rendering of a professional service or designed to entice the public to the professional practice. Failure by a practitioner to comply with any conduct determined in these rules or an annexure to these rules shall constitute an act or omission in respect of which the board concerned may take disciplinary steps in terms of Chapter IV of the Act. Conduct determined in these rules or an annexure to these rules shall not be deemed to constitute a complete list of conduct and the board concerned may therefore inquire into and deal with any complaint of unprofessional conduct which may be brought before such board.  At an inquiry referred to in sub rule (2) the board concerned shall be guided by these rules, annexure to these rules, ethical rulings or guidelines and policy statements which the board concerned or council makes from time to time.

Advertising and canvassing or touting
A practitioner shall be allowed to advertise his or her services or permit, sanction or acquiesce to such advertisement: Provided that the advertisement is not unprofessional, untruthful, deceptive or misleading or causes consumers unwarranted anxiety that they may be suffering from any health condition.

A practitioner shall not canvass or tout or allow canvassing or touting to be done for patients on his or her behalf.

Booklet 1

7. DUTIES TO PATIENTS OF OTHER HEALTH CARE PRACTITIONERS

Health care practitioners should:
1.  Act quickly to protect patients from risk due to any reason.
2. Report violations and seek redress in circumstances where they have a good or persuasive reason to believe that the rights of patients are being violated.

10. DUTIES TO THE HEALTH CARE PROFESSION

10.1  REPORTING MISCONDUCT Health care practitioners should:

10.1.1 Report violations and seek redress in circumstances where they have good or persuasive reason to believe that the rights of patients are being violated and / or where the conduct of the practitioner is unethical.
10.1.2 Where it is in the power. Protect people who report misconduct from victimisation or intimidation.

Addendum 1 - Regulations of the HPCSA
HEALTH PROFESSIONS ACT 56 OF 1974 states that
(1) No person shall be entitled to practice within the Republic –
(a) any health profession registrable in terms of this Act; or
(b) except in so far as it is authorised by legislation regulating healthcare providers and sections 33, 34 and 39 of this Act, any health profession the practice of which mainly consists of-
(i) the physical or mental examination of persons;
(ii) the diagnosis, treatment or prevention of physical or mental defects, illnesses or deficiencies in man humankind;
(iii) the giving of advice in regard to such defects, illnesses or deficiencies; or unless he or she is registered in terms of this Act.

Any person who is not registered in terms of this Act and practises a health profession in contravention of this section or who pretends to hold such registration is guilty of an offence and on conviction is liable to a fine or to imprisonment for a period not exceeding 12 months or to both a fine and such imprisonment.