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O. Reg. 385/23: GENERAL

filed December 12, 2023 under Pharmacy Act, 1991, S.O. 1991, c. 36

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ontario regulation 385/23

made under the

Pharmacy Act, 1991

Made: November 27, 2023
Approved: December 7, 2023
Filed: December 12, 2023
Published on e-Laws: December 12, 2023
Published in The Ontario Gazette: December 30, 2023

Amending O. Reg. 202/94

(GENERAL)

1. (1) Paragraphs 1 and 2 of subsection 34 (1) of Ontario Regulation 202/94 are revoked and the following substituted:

1.  Administering a substance specified in Schedule 1 by injection.

2.  Administering a substance specified in Schedule 2 by inhalation.

3.  Administering a vaccine specified in Schedule 3 by injection.

(2) Subsections 34 (2) and (2.1) of the Regulation are revoked and the following substituted:

(2) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on their certificate of registration.

(2.1) A pharmacy technician who meets all the requirements in subsection (4) is authorized to perform an act provided for in paragraph 3 of subsection (1), but only with respect to the influenza vaccine and respiratory syncytial virus vaccine and subject to the terms, conditions and limitations imposed on their certificate of registration.

(3) Subsection 34 (2.1) of the Regulation, as re-made by subsection (2), is revoked and the following substituted:

(2.1) A pharmacy technician who meets all the requirements in subsection (4) is authorized to perform an act provided for in paragraph 3 of subsection (1), but only with respect to the influenza vaccine, respiratory syncytial virus vaccine and Coronavirus (COVID-19) vaccines and subject to the terms, conditions and limitations imposed on their certificate of registration.

(4) Subsection 34 (3) of the Regulation is amended by striking out the portion before paragraph 1 and substituting the following:

(3) A member referred to in subsection (2) may only perform an act provided for in subsection (1) if the member complies with the following:

. . . . .

(5) Paragraph 1 of subsection 34 (3) of the Regulation is revoked and the following substituted:

1.  Before performing the act, the member must explain the purpose of the act to the patient or the patient’s authorized agent and receive an informed consent from the patient or the patient’s authorized agent.

(6) Subsection 34 (3) of the Regulation is amended by adding the following paragraphs:

9.  Where administering an influenza vaccine by injection, the member must administer the vaccine in accordance with Ontario’s Universal Influenza Immunization Program as described on the Ministry’s website.

10.  The member may only administer a vaccine to patients who are two years of age or older in the case of the influenza vaccine, six months of age and older in the case of the COVID-19 vaccines and five years of age or older in the case of every other vaccine.

(7) Subsections 34 (4), (4.1) and (5) of the Regulation are revoked and the following substituted:

(4) A member referred to in subsection (2.1) may only perform the act of administering the influenza vaccine and respiratory syncytial virus vaccine by injection provided for in paragraph 3 of subsection (1) if the patient is two years of age or older in the case of the influenza vaccine or five years of age or older in the case of respiratory syncytial virus vaccine and if the member,

(a)  possesses sufficient knowledge, skill and judgment to be able to administer the vaccine safely;

(b)  meets all the requirements in paragraphs 2, 3 and 6 of subsection (3);

(c)  meets the requirement in paragraph 9 of subsection (3); and

(d)  has confirmed that a member referred to in subsection (2), or another regulated health professional authorized to administer the vaccine by injection, has,

(i)  received an informed consent from the patient or the patient’s authorized agent,

(ii)  a sufficient understanding of the vaccine and condition of the patient for the vaccine to be administered safely, and

(iii)  considered whether administering the vaccine by injection to the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome and any other relevant circumstances.

(8) Subsection 34 (4) of the Regulation, as re-made by subsection (7), is revoked and the following substituted:

(4) A member referred to in subsection (2.1) may only perform the act of administering the vaccine by injection provided for in paragraph 3 of subsection (1) if the patient is two years of age or older in the case of the influenza vaccine, five years of age or older in the case of respiratory syncytial virus vaccine or six months of age or older in the case of Coronavirus (COVID-19) vaccines and if the member,

(a)  possesses sufficient knowledge, skill and judgment to be able to administer the vaccine safely;

(b)  meets all the requirements in paragraphs 2, 3 and 6 of subsection (3);

(c)  meets the requirement in paragraph 9 of subsection (3), when administering an influenza vaccine by injection; and

(d)  has confirmed that a member referred to in subsection (2), or another regulated health professional authorized to administer the vaccine by injection, has,

(i)  received an informed consent from the patient or the patient’s authorized agent,

(ii)  a sufficient understanding of the vaccine and condition of the patient for the vaccine to be administered safely, and

(iii)  considered whether administering the vaccine by injection to the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome and any other relevant circumstances.

2. Section 35 of the Regulation is revoked and the following substituted:

35. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a Part A pharmacist is authorized to prescribe the following drugs, subject to subsections (2) and (4) of this section and to the terms, conditions and limitations imposed on their certificate of registration:

1.  For the sole purpose of smoking cessation, the following specified drugs:

i.  Varenicline Tartrate.

ii.  Bupropion Hydrochloride.

2.  For the sole purpose of treating a minor ailment listed in Column 1 of the Table to Schedule 4, a drug opposite the minor ailment in Column 3 of that Table.

3.  For the sole purpose of treating COVID-19, Nirmatrelvir/Ritonavir.

4.  For the sole purpose of treating influenza, Oseltamivir.

(2) In the case of drug referred to in paragraph 3 of subsection (1),

(a)  the Part A pharmacist shall make a determination as to the patient’s risk for any drug interactions that cannot be properly managed or that prevent Nirmatrelvir/Ritonavir from being prescribed and shall not prescribe the drug if such an interaction exists; and

(b)  the Part A pharmacist shall notify the patient’s primary care provider, if any, within a reasonable time that the pharmacist prescribed Nirmatrelvir/Ritonavir to the patient and provide details respecting the prescription.

(3) For the purposes of paragraph 3 of subsection 4 (1) of the Act, an intern or a registered pharmacy student is authorized to prescribe the following drugs, subject to subsection (4) of this section and to the terms, conditions and limitations imposed on their certificate of registration:

1.  For the sole purpose of smoking cessation, the following specified drugs:

i.  Varenicline Tartrate.

ii.  Bupropion Hydrochloride.

2.  For the sole purpose of treating a minor ailment listed in Column 1 of the Table to Schedule 4, a drug opposite the minor ailment in Column 3 of that Table.

(4) A Part A pharmacist, an intern or a registered pharmacy student may only prescribe a drug under this section if they,

(a)  possess sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient;

(b)  have considered whether prescribing the drug for the patient is appropriate, given the known risks and benefits of prescribing the drug for the patient and other relevant factors respecting the patient;

(c)  give the prescription to the patient or the patient’s authorized agent;

(d)  advise the patient or the patient’s authorized agent, at the time of giving the prescription, that they may elect to take it to a pharmacy of their choosing for dispensing;

(e)  notify the patient’s primary care provider, if any, within a reasonable time, that the Part A pharmacist, intern or registered pharmacy student prescribed a drug for the patient and provide details respecting the prescription;

(f)  comply with the additional requirements under sections 37 and 38; and

(g)  have determined, through a therapeutic assessment, that the drug is the most appropriate treatment for the patient’s condition.

3. (1) Paragraph 2 of section 38 of the Regulation is revoked and the following substituted:

2.  A copy of the prescription that the member gave to the patient or the patient’s authorized agent.

(2) Subparagraphs 4 i and ii of section 38 of the Regulation are revoked and the following substituted:

i.  The patient’s primary care provider.

ii.  The patient’s prescriber.

4. (1) Schedule 3 to the Regulation is amended by adding the following paragraphs:

16.  Respiratory Syncytial Virus (RSV) Vaccines

17.  Influenza Vaccines

(2) Schedule 3 to the Regulation is amended by adding the following paragraph:

18.  Coronavirus (COVID-19) Vaccines

Commencement

5. (1) Except as otherwise provided in this section, this Regulation comes into force on the day it is filed.

(2) Subsections 1 (3) and (8) and 4 (2) come into force on the later of April 1, 2024 and the day this Regulation is filed.

Made by:

Council of the Ontario College of Pharmacists:

James Morrison

Board Chair

Shenda Tanchak

Registrar / CEO

Date made: November 27, 2023