Introduction

Due to the growth of the aesthetic medical procedures popularity over the past several years, such procedures are increasingly being performed in non-clinical environments such as offices in shopping malls, beauty salons or day spas. The Canadian Association of Medical Spas and Aesthetic Surgeons recognizes that combining cosmetics with medical procedures may be acceptable for enhancing the business and provide additional level of handiness and expediency to patients. However, a regulatory structure is desirable to ensure proper medical practice and clientele protection. As a general standard for health care professional that perform the procedures, the proposed regulations presented here reviews the guidelines developed, recognized and employed by worldwide health care professional organizations. The Canadian Association of Medical Spas and Aesthetic Surgeons also provided assistance to normalize the regulations according to the Canadian Standards.

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arrow_blue_forward.gif Required qualification for Botox and Injectable Dermal Fillers administration in Canada

 

 

Botox injection is a well-liked procedure medication that temporarily reduces fine facial lines and wrinkles. Many people have received these injections at "Botox parties" in private homes (NOT recommended) or doctor's offices. While these events can be a fun way to reduce the signs of aging instantly, it is important to remember that Botox injections are medical treatments that are to be given by medical professionals. 

In Canada, Botox should only be given by or under the direction of "a licensed and authorized health-care professional who is trained and qualified to provide Botox treatment. Many training courses are available, specifically for health-care professionals. Many are two-day events that cover the effects of aging, determining whether Botox is the right treatment and hands-on injection training. The training is intended for dermatologists, plastic surgeons, MDs, NDs or licensed registered nurses. In others, doing so may be illegal, and staff members may jeopardize their professional licenses, unknowingly or not. They may also be charged with unlawful practice of medicine.

While some physicians "may decide to employ supervised and authorized non-physician medical personnel to administer cosmetic Botox, CAMACS encourages physicians to satisfy consumer desires by personally assessing and treating their facial aesthetic patients."

Botox, as any other prescription medication, should be given with sterile medical equipment. The person giving the injection should wash her hands, wear gloves, dispose of the needle and any leftover serum properly, and follow all other standard health-care precautions. Seek immediate medical attention if you experience difficulty speaking, swallowing or breathing, even several weeks after a Botox injection. These may be signs that the botulinum toxin has spread beyond the injection site.

Ragistered Nurse Injectors

An aesthetic nurse injector refers to a registered nurse, or registered practical nurse who has undergone specific training for the administration of dermal fillers, volume enhancers, and neurotoxins. Furthermore, an aesthetic nurse injector acts under the direction of a Medical Director and only within the Scope of Practice in the province where they are licensed and practice.

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Who is authorized to administer Botox and fillers in Canada?

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Medical Spas Classification

Based on the types of procedures performed in medical spas, they are classified as Echelon I, Echelon II or Echelon III.

 

Echelon I Spas

Echelon I spas include those facilities in which only superficial procedures are performed. The procedures affect only the uppermost layer of skin with no invasive method. It is recommended that all personnel be certified in Basic Cardiac Life Support recognized by the Canadian Heart and Stroke Foundation. The Basic Life Support for Healthcare Providers addresses core material such as adult and pediatric CPR, foreign-body airway obstruction, and automated external defibrillator (AED) use, stroke, cardiac arrest, and special resuscitation situations.

Echelon II Spas

Echelon II include those medical Spas in which procedures with a higher risk of unfavorable consequences are performed, including Botox and dermal fillers injections and use of lasers. However, the risk of hospitalization due to these procedures is unlikely. Echelon II spas must maintain basic emergency equipment and procedures. All personnel must be certified in Basic Cardiac Lifer Support and at least one health care professional who has completed a course in Advanced Cardiac Life Support must be present in the clinic at all times. The purpose of ACLS is to prepare health care providers to initiate advanced resuscitative efforts in response to cardiovascular emergencies experienced by adults. At the end of the ACLS program the successful learner will have demonstrated both the required knowledge and skills to manage cardio-respiratory emergencies using the systematic ACLS approach.

Echelon III Spas

Level III spas include those facilities in which procedures may have complications of a serious nature and may permanently alter the skin or underlying tissue, remove tissue and/or involve injection or use of devices and products that require specific and level of professional training. A licensed physician must be on the premises and available to respond at all times. All personnel must be certified in Basic Cardiac Lifer Support and at least one health care professional who has completed a course in Advanced Cardiac Life Support must be present in the clinic at all times.

 

Patients' Statement of Rights

Medical Spa staff should recognize the basic rights of patients and value patients' rights. A patients' rights document should be available upon request.

 

Patient's Statements of Rights Principal

1. High quality health care delivered in a safe and efficient manner.

2. Treatment in accordance with accepted standards of courtesy.

3. Respect of Privacy and confidentiality.

4. Information on diagnosis, treatment options, and prognosis.

5. The risks, benefits, and possible complications of each treatment or procedure.

6. Information on the qualifications of those who will be performing the procedures.

7. The right to refuse treatment and advice on the consequences of this decision.

8. Inspection and obtaining a copy of medical records and the billing.

9. Requesting information regarding alternative appropriate care.

10. Knowing the expectations of manners and the consequences of not complying with these expectations 

 

Implementing of Medical Aesthetics Regulation

A Medical cosmetic / Aesthetic procedure or product is defined as any method or substance or mixture intended to be performed or placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external teeth whitening or the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Cosmetics Regulation

CAMACS Compliance is a specialist regulatory consultancy that manages all aspects of Medical Aesthetics / Cosmetic Regulatory Affairs to support clients. CAMACS Compliance has operations in Asia, Middle East, Europe, Canada and the USA and has a diverse team of technical staff with a wide range of experience in industry, consulting and government.

Medical Aesthetics / Cosmetic product safety Inspection
CAMACS Compliance creates and manages Cosmetic Product Safety Inspection (CPSI) that meet all of the requirements of the international regulation. The specialist staffs who perform these aspects are qualified dermatologists, MDs, plastic surgeons, toxicologists or professional Medical Aestheticians, who have successfully completed the their extensive training and practice in the field. The service comprises:

A comprehensive analysis of the physical, microbiological and toxicological properties of the product and the ingredients, Medical

Aesthetics equipment, Laser / Intense Pulsed Light machines and supplies according to Europe, FDA, and Health Canada Standard

A risk evaluation based upon expected and anticipated use, disclosure and unwanted consequences and effects.

A statement of safety by a qualified specialists and approved by the CAMACS board of directors.

Creation of Product Information Files
CAMACS Compliance creates, translate, maintain and archive the product / equipment information dossier (PEID) as needed. The (PEID) is required to contain, among other things, a description of the cosmetic product/ equipment, a description of the Manufacturers and proof of claims and information on the labels and the packaging.

Regulation development and filing

CAMACS Compliance create and review regulations for client quality service, safety, excellence and products used by the Medical Aesthetics, Laser and cosmetic Surgery clinics as well as beauty salons to ensure their compliance with the CAMACS Cosmetics Regulation.

Product safety testing and claim support

CAMACS Compliance advises and reviews product safety testing and provides advice on appropriate strategies to assure compliance. Additionally, the expert staff in CAMACS Compliance advice Clients on their product claims to ensure that they meet the strict requirements of the Medical Aesthetics / Cosmetics Regulation.

Developing and implementing market surveillance plans
CAMACS Compliance works with their Clients to develop and implement practice / client service surveillance plans. Any undesirable effects that are identified are tracked and updated to the CAMACS / PEID department as appropriate.