Health Canada clarification on platelet rich plasma and
dentistry
Distributed 7 August 2019
In light of recent communications from Health Canada
regarding the provision of cell therapy treatments, this message is intended to
clarify the preparation of platelet rich plasma treatments in dentistry.
Key information for dental patients regarding platelet rich
plasma:
-
Patients must receive a diagnosis, and a treatment plan (including a cost estimate).
- Informed consent must be obtained from the patient before treatment, arrived at in consultation with their treating dentist and based on their individual needs and preferences.
Key information for
CDSBC registrants regarding platelet rich plasma:
- Platelet rich plasma (PRP) treatments, including platelet rich fibrin treatments, are not the same as cell therapies and are, therefore, not subject to Health Canada’s Policy Position Paper on Autologous Cell Therapy Products.
- Platelet rich plasma meets the definition of a “drug” under the Food and Drugs Act. The preparation of platelet rich plasma falls under the scope of the practice of medicine and dentistry and is regulated provincially and territorially when it is:
a)
conducted by “practitioners,” including physicians and dentists;
b)
obtained from a patient; and
c)
administered back to the same patient in a single procedure.
- The preparation of platelet rich plasma cannot be delegated or authorized (supervised)
- Dental practices cannot advertise any health claims relating to the provision of compounded platelet rich plasma and platelet rich fibrin. Under the Food and Drugs Act, Health Canada can enforce matters related to non-compliant sale, deceptive advertising and unsanitary manufacturing of PRP.
- Health Canada won’t hesitate to take action to protect the health and safety of patients and the public should they become aware of practices providing this service who do not meet the expected infection prevention and control standards.
As with any treatment, informed consent must be obtained from the patient before proceeding, and the College’s Infection Prevention and Control Guidelines be adhered to.
Background
In May, Health Canada issued a safety update to Canadians
about the potential health risks associated with unauthorized cell therapy
treatments, stating that all cell therapies are considered drugs under the Food
and Drugs Act and must, therefore, be authorized by Health Canada to ensure
that they are safe and effective before they can be offered to Canadians. The
initial communication did not specifically address the provision of
platelet-rich plasma to dental patients; however, a clarification of Health
Canada’s position on platelet rich plasma treatments was issued on July 26.
Read the clarification, which speaks directly to PRP treatments >>
Questions
Enquiries can be directed to Health Canada at 613-957-2991
or 1-866-225-0709.
