O. Reg. 46/22: GENERAL

 

ontario regulation 46/22

made under the

Pharmacy Act, 1991

Made: January 12, 2022
Approved: January 27, 2022
Filed: January 31, 2022
Published on e-Laws: February 1, 2022
Printed in The Ontario Gazette: February 19, 2022

Amending O. Reg. 202/94

(GENERAL)

1. Subsection 31 (1) of Ontario Regulation 202/94 is amended by adding the following definition:

“point-of-care test” means a test that employs a medical device authorized by the Minister of Health for Canada for point-of-care use;

2. (1) Subsection 39 (3) of the Regulation is amended by striking out “and” at the end of clause (a), by adding “and” at the end of clause (b) and by adding the following clause:

(c)  if the act is performed to administer a point-of-care test, a Part A pharmacist interprets the results of the test and makes any professional decision arising from those results.

(2) Paragraph 1 of subsection 39 (4) of the Regulation is revoked and the following substituted:

1.  The member may only perform the act for the purpose of demonstrating the appropriate use of lancet-type devices for the patient’s self-care and education or for the patient’s self-monitoring of his or her chronic disease, unless the act is performed to administer a point-of-care test.

1.1  The member may only perform the act to administer a point-of-care test if the test is listed in subsection 28 (2) of Ontario Regulation 45/22 and if it is administered for the purpose of assisting patients with the management of their medication to treat chronic disease.

1.2  Before performing an act described in paragraphs 1 or 1.1, the member must,

i.  explain the purpose to the patient or his or her authorized agent, and

ii.  receive an informed consent from the patient or his or her authorized agent.

(3) Paragraph 6 of subsection 39 (4) of the Regulation is revoked and the following substituted:

6.  The member must maintain a patient record that includes,

i.  the name and address of the patient,

ii.  the name and work address of the member,

iii.  the date the act was performed,

iv.  the circumstances relating to the performance of the act and any adverse reaction experienced by the patient,

v.  confirmation that an informed consent was given by the patient or his or her agent, and

vi.  if the act was performed to administer a point-of-care test,

A.  the results of the test, and

B.  the professional decision arising from the results of the test and the rationale for the decision.

7.  If the act is performed to administer a point-of-care test, the member must notify the patient’s primary care provider (if any) within a reasonable time that the member performed the act and provide details respecting the act.

Commencement

3. This Regulation comes into force on the later of the day section 2 of Schedule 3 to the Protecting Patients Act, 2017 comes into force and the day this Regulation is filed.

Made by:

Council of the Ontario College of Pharmacists:

Susan James

Acting Registrar, Director Quality

Billy Cheung

Chair, OCP Board

Date made: January 12, 2022