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Quality Assurance Regulations
If you have any questions or comments concerning these Regulations, please contact Sandra Winkelbauer, Manager, Continuing Competency, at (416) 847-8204.

Ontario Regulation 98/98 made under the Pharmacy Act, 1996 Amending O. Reg. 202/94 (General)

Note: Since January 1, 1997, Ontario Regulation 202/94 has been amended by Ontario Regulation 121/97. For prior amendments, see the Table of Regulations in the Statutes of Ontario, 1996.

1. Ontario Regulation 202/94 is amended by adding the following section:
29.1 It is a condition of a certificate of registration of a pharmacist listed in Part B of the register referred to in section 44 that the pharmacist not,

a. dispense, sell or compound drugs;

b. provide information related to drug use in the course of providing direct patient care; or

c. be the designated manager of an accredited pharmacy.

2. The Regulation is amended by adding the following Part:

Part VIII Quality Assurance General

41. In this Part,
"assessor" means an assessor appointed under section 81 of the Health Professions Procedural Code;
"Committee" means the Quality Assurance Committee.

42. The Committee shall administer the quality assurance program, which shall include the following components:

1. Maintenance of a portfolio of continuous learning.

2. Maintenance of a two-part register for pharmacist members.

3. Practice review and remediation.

4. Remediation of behaviour and remarks of a sexual nature.

Continuous Learning Portfolio

3

1. A pharmacist shall maintain a portfolio of continuous learning activities in accordance with guidelines on such activities published by the College and
distributed to the members.

2. A pharmacist shall submit the portfolio of continuous learning to the College on request.

Two-part Register for Pharmacist Members

44.

1. The part of the register that lists pharmacist members shall have a Part A (direct patient care) and a Part B (non-direct patient care).

2. A pharmacist shall be listed in either Part A or Part B.

45.

1. Within 30 days of the day this Regulation comes into force, a pharmacist shall ask to be listed in Part A or Part B by completing and submitting the form provided by the Registrar.

2. Upon being issued a certificate of registration as a pharmacist for the first time, a pharmacist shall ask to be listed in Part A or Part B by completing and submitting the form provided by the Registrar.

3. Every year at the time of paying the annual membership fee, a pharmacist shall ask for a renewal of his or her listing in Part A or Part B or for a transfer to the other Part.

4. A pharmacist who asks for a renewal of a listing in Part A after the later of the third anniversary of the coming into force of this Regulation or of the pharmacist being issued a certificate of registration as a pharmacist for the first time shall not be listed in that Part unless he or she has dispensed, sold or compounded drugs, provided non-prescription drugs, health care aids and devices or information related to drug use for at least 600 hours during the preceding three years in the course of providing direct patient care while practising the profession in Canada.

46.

1. A pharmacist may ask for a transfer from Part A to Part B or from Part B or Part A at any time.

2. If a pharmacist listed in Part A asks for a transfer to Part B, the pharmacist shall be transferred to Part B.

3. If a pharmacist listed in Part B asks for a transfer to Part A, the pharmacists shall be transferred to Part A if he or she,

a. undergoes a practice review in accordance with section 47; and

b. satisfies the educational and practice requirements that may be specified by the Committee.

4. If the Registrar proposes to reject a request for a transfer to Part A, the request shall be referred to a panel of the Committee.

5. The pharmacist shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision.

6. A pharmacist whose request to be listed in Part A is rejected by the panel may appeal to another panel of the Committee.

7. No member of a panel that rejects a request to be listed in Part A shall sit on a panel hearing an appeal of that decision.

8. On an appeal, the pharmacist shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision.

Practice Review and Remediation

47.

1. Each year the College shall select at random the names of pharmacists required to undergo a practice review.

2. A pharmacist listed in Part A is required to undergo a practice review if his or her name is selected at random or the member is referred to the Committee by the Complaints Committee or Executive Committee.

3. If a pharmacist listed in Part A fails to undergo a required practice review, the Committee may transfer the pharmacist to Part B after giving him or her a reasonable opportunity to make written submissions.

4. A pharmacist listed in Part B is required to undergo a practice review if he or she is referred to the Committee by the Complaints Committee or Executive Committee or if the pharmacist has asked to be listed in Part A under subsection 46 (3).

5. The Committee shall appoint an assessor to conduct a practice review.

6. The assessor shall prepare a written report on the review and submit it to the Committee.

7. After considering the report, the Committee may decide,

a. that no further action is required;

b. hat the pharmacist is required to undertake the remediation specified by the Committee to correct any deficiency in his or her knowledge, skills or judgement identified by the review; or

c. that the pharmacist is to be listed in Part A where the review took place pursuant to a request to be listed in Part A.

8. If the Committee proposes to require a pharmacist to undertake remediation under clause (7)(b), it shall not do so unless,

a. the pharmacist has been given a report of the results of the review;

b. the pharmacist has been given written notice of the Committee's intention to require him or her to undertake remediation;

c. the pharmacist has been given at least 14 days from the receipt of the notice to make written sub- missions to the Committee; and

d. the Committee has considered any such submissions.

9. After the pharmacist undertakes the specified remediation, the Committee may require him or her to undergo another practice review by an assessor, and subsections (6), (7) and (8) apply to that review.

48.

1. If the Committee requires a pharmacist to undertake remediation under section 47 and the pharmacist either fails to do so or fails to successfully complete the remediation, the Committee may direct the Registrar to impose terms, conditions or limitations on the pharmacist's certificate of registration for a specified period not exceeding six months.

2. If the Committee proposes to make a direction under subsection (1), it shall not do so unless,

a. the pharmacist has been given written notice of its intention;

b. the pharmacist has been given at least 14 days from receipt of the notice to make written sub- missions to the Committee or to request an appearance before the Committee in order to make oral submissions; and

c. the Committee has considered any such submissions.

3. A pharmacist who requests an appearance under clause (2)(b) shall be given a reasonable opportunity to appear but the Committee may dispose of the matter if he or she has been given a reasonable opportunity to appear and does not.

4. If the period specified under subsection (1) expires and the pharmacist still has not undertaken or successfully completed the remediation, the Committee may report him or her to the Executive Committee and provide it with such information as it considers appropriate, except information that may not be disclosed under section 83 of the Health Professions Procedural Code.

5. If the Registrar imposes terms, conditions or limitations on a pharmacist's certificate of registration for a specified period pursuant to a direction given by the Committee under subsection (1), the Committee may direct the Registrar to remove the terms, conditions or limitations before the end of the specified period if the Committee is satisfied that they are no longer needed.

6. After directing the imposition of terms, conditions or limitations on a pharmacist's certificate of registration for a specified period not exceeding six months under subsection (1), the Committee may direct the imposition of terms, conditions or limitations on the pharmacist's certificate or registration for a second specified period not exceeding six months under subsection (1) but, after having done so, the Committee shall not direct the imposition of terms, conditions or limitations on the pharmacist's certificate of registration for any further specified period.

7. If the Committee directs a second imposition of terms, conditions or limitation on the pharmacist's certificate, subsections (2), (3), (4) and (5) apply with respect to the second imposition.

Remediation of Behaviour and Remarks of a Sexual Nature

49.

1. This section applies to members referred to the Committee by,

a. a panel of the Complaints Committee under subsection 26(3) of the Health Professions Procedural Code; and

b. the Executive Committee under section 79.1 of the Code.

2. The chair of the Committee shall establish a panel from among members of the Committee for the purpose of considering a matter referred to in subsection (1).

3. The chair of the Committee shall appoint a mediator to attempt to resolve the matter.

4. If the mediator is unable to resolve the matter within 90 days after being appointed, the mediator shall report the failure to the chair without delay and provide the chair with a written report on the mediation.

5. The chair shall give the member complained against a copy of the mediator's report and a notice advising him or her of the right to make written submissions to the panel.

6. The member shall be given at least 14 days after receipt of the mediator's report and recommendations to make written submissions to the panel or to request an appearance before the panel to make oral submissions, or to do both.

7. A member who requests an appearance shall be given a reasonable opportunity to make an appearance, but the panel may dispose of the matter without such appearance if the member has been given a reasonable opportunity to appear.

8. If the mediation concerns a matter referred by the Complaints Committee, the chair shall give the complainant a copy of the mediator's report.

9. A mediator's proposed resolution of a matter referred to the Committee by a Complaints Committee must be acceptable to the complainant, the member complained against and the panel.

10. A mediator's proposed resolution of a matter referred to the Committee by the Executive Committee must be acceptable to the member complained against and the panel.

11. After considering the mediator's report and any written or oral submissions, the panel may require the member to undergo an assessment for the purpose of establishing if he or she requires education with respect to sexual abuse.

12. The assessment shall be carried out by an assess appointed by the Committee.

13. The assessor shall provide a written report to the panel and shall make such recommendations as the assessor considers appropriate about the member's need for education with respect to sexual abuse.

14. A copy of the report and recommendations, and a notice informing him or her of the right to make submissions in accordance with subsection (6) and (7), shall be provided to the member.

15. After considering the assessor's report and recommendation and the member's submissions, if any, the panel may require the member to attend or participate in a sexual abuse education program.

16. If the panel proposes to take action under subsection (15), the member has the right to make submissions in accordance with subsection (6) and (7).

50.

1. If a member refuses to undergo an assessment under subsection 49 (11) or to attend or participate in a program under subsection 49 (15), the panel may direct the Registrar to impose terms, conditions or limitations on the member's certificate of registration for a specified period not exceeding six months.

2. If the panel proposed to take action under subsection (1), the member has the right to make submissions in accordance with subsections 49 (6) and (7).

3. If the panel is satisfied that the terms, conditions and limitations imposed on a member's certificate of registration are no longer needed, it shall direct the Registrar to remove them before the end of the specified period.

4. If, at the end of the specified period, the member continues to refuse to undergo the required assessment or to attend or participate in the program, the panel shall refer the matter to the Executive Committee.

Panel Requirements

51.

1. The Committee may sit as a panel to consider a report on a practice review or any matter arising out of a practice review, a matter relating to the imposition of terms, conditions or limitations on a member's registration under section 48 or a matter under section 49.

2. A panel shall have at least three members appointed by the chair of the Committee from among the Committee members; at least one member of the panel shall be a member appointed to the Committee by the Lieutenant Governor in Council.

3. Three members of a panel constitute a quorum.

Ontario Regulation 98/98 made under the Pharmacy Act, 1996 Amending O. Reg. 202/94 (General)
		Note: Since January 1, 1997, Ontario Regulation 202/94 has been amended by Ontario Regulation 121/97. For prior amendments, see the Table of Regulations in the Statutes of Ontario, 1996.
1.		Ontario Regulation 202/94 is amended by adding the following section: 29.1 It is a condition of a certificate of registration of a pharmacist listed in Part B of the register referred to in section 44 that the pharmacist not,
a.		dispense, sell or compound drugs;
b.		provide information related to drug use in the course of providing direct patient care; or
c.		be the designated manager of an accredited pharmacy.

2.		The Regulation is amended by adding the following Part:

Part VIII Quality Assurance General
41.		In this Part, "assessor" means an assessor appointed under section 81 of the Health Professions Procedural Code; "Committee" means the Quality Assurance Committee.

42.		The Committee shall administer the quality assurance program, which shall include the following components:
1.		Maintenance of a portfolio of continuous learning.
2.		Maintenance of a two-part register for pharmacist members.
3.		Practice review and remediation.
4.		Remediation of behaviour and remarks of a sexual nature.

Continuous Learning Portfolio
3
1.		A pharmacist shall maintain a portfolio of continuous learning activities in accordance with guidelines on such activities published by the College and distributed to the members.
2.		A pharmacist shall submit the portfolio of continuous learning to the College on request.

Two-part Register for Pharmacist Members
44.
1.		The part of the register that lists pharmacist members shall have a Part A (direct patient care) and a Part B (non-direct patient care).
2.		A pharmacist shall be listed in either Part A or Part B.

45.
1.		Within 30 days of the day this Regulation comes into force, a pharmacist shall ask to be listed in Part A or Part B by completing and submitting the form provided by the Registrar.
2.		Upon being issued a certificate of registration as a pharmacist for the first time, a pharmacist shall ask to be listed in Part A or Part B by completing and submitting the form provided by the Registrar.
3.		Every year at the time of paying the annual membership fee, a pharmacist shall ask for a renewal of his or her listing in Part A or Part B or for a transfer to the other Part.
4.		A pharmacist who asks for a renewal of a listing in Part A after the later of the third anniversary of the coming into force of this Regulation or of the pharmacist being issued a certificate of registration as a pharmacist for the first time shall not be listed in that Part unless he or she has dispensed, sold or compounded drugs, provided non-prescription drugs, health care aids and devices or information related to drug use for at least 600 hours during the preceding three years in the course of providing direct patient care while practising the profession in Canada.

46.
1.		A pharmacist may ask for a transfer from Part A to Part B or from Part B or Part A at any time.
2.		If a pharmacist listed in Part A asks for a transfer to Part B, the pharmacist shall be transferred to Part B.
3.		If a pharmacist listed in Part B asks for a transfer to Part A, the pharmacists shall be transferred to Part A if he or she,
	a.	undergoes a practice review in accordance with section 47; and
	b.	satisfies the educational and practice requirements that may be specified by the Committee.
4.		If the Registrar proposes to reject a request for a transfer to Part A, the request shall be referred to a panel of the Committee.
5.		The pharmacist shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision.
6.		A pharmacist whose request to be listed in Part A is rejected by the panel may appeal to another panel of the Committee.
7.		No member of a panel that rejects a request to be listed in Part A shall sit on a panel hearing an appeal of that decision.
8.		On an appeal, the pharmacist shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision.

Practice Review and Remediation
47.
1.		Each year the College shall select at random the names of pharmacists required to undergo a practice review.
2.		A pharmacist listed in Part A is required to undergo a practice review if his or her name is selected at random or the member is referred to the Committee by the Complaints Committee or Executive Committee.
3.		If a pharmacist listed in Part A fails to undergo a required practice review, the Committee may transfer the pharmacist to Part B after giving him or her a reasonable opportunity to make written submissions.
4.		A pharmacist listed in Part B is required to undergo a practice review if he or she is referred to the Committee by the Complaints Committee or Executive Committee or if the pharmacist has asked to be listed in Part A under subsection 46 (3).
5.		The Committee shall appoint an assessor to conduct a practice review.
6.		The assessor shall prepare a written report on the review and submit it to the Committee.
7.		After considering the report, the Committee may decide,
	a.	that no further action is required;
	b.	hat the pharmacist is required to undertake the remediation specified by the Committee to correct any deficiency in his or her knowledge, skills or judgement identified by the review; or
	c.	that the pharmacist is to be listed in Part A where the review took place pursuant to a request to be listed in Part A.
8.		If the Committee proposes to require a pharmacist to undertake remediation under clause (7)(b), it shall not do so unless,
	a.	the pharmacist has been given a report of the results of the review;
	b.	the pharmacist has been given written notice of the Committee's intention to require him or her to undertake remediation;
	c.	the pharmacist has been given at least 14 days from the receipt of the notice to make written sub- missions to the Committee; and
	d.	the Committee has considered any such submissions.
9.		After the pharmacist undertakes the specified remediation, the Committee may require him or her to undergo another practice review by an assessor, and subsections (6), (7) and (8) apply to that review.

48.
1.		If the Committee requires a pharmacist to undertake remediation under section 47 and the pharmacist either fails to do so or fails to successfully complete the remediation, the Committee may direct the Registrar to impose terms, conditions or limitations on the pharmacist's certificate of registration for a specified period not exceeding six months.
2.		If the Committee proposes to make a direction under subsection (1), it shall not do so unless,
	a.	the pharmacist has been given written notice of its intention;
	b.	the pharmacist has been given at least 14 days from receipt of the notice to make written sub- missions to the Committee or to request an appearance before the Committee in order to make oral submissions; and
	c.	the Committee has considered any such submissions.
3.		A pharmacist who requests an appearance under clause (2)(b) shall be given a reasonable opportunity to appear but the Committee may dispose of the matter if he or she has been given a reasonable opportunity to appear and does not.
4.		If the period specified under subsection (1) expires and the pharmacist still has not undertaken or successfully completed the remediation, the Committee may report him or her to the Executive Committee and provide it with such information as it considers appropriate, except information that may not be disclosed under section 83 of the Health Professions Procedural Code.
5.		If the Registrar imposes terms, conditions or limitations on a pharmacist's certificate of registration for a specified period pursuant to a direction given by the Committee under subsection (1), the Committee may direct the Registrar to remove the terms, conditions or limitations before the end of the specified period if the Committee is satisfied that they are no longer needed.
6.		After directing the imposition of terms, conditions or limitations on a pharmacist's certificate of registration for a specified period not exceeding six months under subsection (1), the Committee may direct the imposition of terms, conditions or limitations on the pharmacist's certificate or registration for a second specified period not exceeding six months under subsection (1) but, after having done so, the Committee shall not direct the imposition of terms, conditions or limitations on the pharmacist's certificate of registration for any further specified period.
7.		If the Committee directs a second imposition of terms, conditions or limitation on the pharmacist's certificate, subsections (2), (3), (4) and (5) apply with respect to the second imposition.

Remediation of Behaviour and Remarks of a Sexual Nature
49.
1.		This section applies to members referred to the Committee by,
	a.	a panel of the Complaints Committee under subsection 26(3) of the Health Professions Procedural Code; and
	b.	the Executive Committee under section 79.1 of the Code.
2.		The chair of the Committee shall establish a panel from among members of the Committee for the purpose of considering a matter referred to in subsection (1).
3.		The chair of the Committee shall appoint a mediator to attempt to resolve the matter.
4.		If the mediator is unable to resolve the matter within 90 days after being appointed, the mediator shall report the failure to the chair without delay and provide the chair with a written report on the mediation.
5.		The chair shall give the member complained against a copy of the mediator's report and a notice advising him or her of the right to make written submissions to the panel.
6.		The member shall be given at least 14 days after receipt of the mediator's report and recommendations to make written submissions to the panel or to request an appearance before the panel to make oral submissions, or to do both.
7.		A member who requests an appearance shall be given a reasonable opportunity to make an appearance, but the panel may dispose of the matter without such appearance if the member has been given a reasonable opportunity to appear.
8.		If the mediation concerns a matter referred by the Complaints Committee, the chair shall give the complainant a copy of the mediator's report.
9.		A mediator's proposed resolution of a matter referred to the Committee by a Complaints Committee must be acceptable to the complainant, the member complained against and the panel.
10.		A mediator's proposed resolution of a matter referred to the Committee by the Executive Committee must be acceptable to the member complained against and the panel.
11.		After considering the mediator's report and any written or oral submissions, the panel may require the member to undergo an assessment for the purpose of establishing if he or she requires education with respect to sexual abuse.
12.		The assessment shall be carried out by an assess appointed by the Committee.
13.		The assessor shall provide a written report to the panel and shall make such recommendations as the assessor considers appropriate about the member's need for education with respect to sexual abuse.
14.		A copy of the report and recommendations, and a notice informing him or her of the right to make submissions in accordance with subsection (6) and (7), shall be provided to the member.
15.		After considering the assessor's report and recommendation and the member's submissions, if any, the panel may require the member to attend or participate in a sexual abuse education program.
16.		If the panel proposes to take action under subsection (15), the member has the right to make submissions in accordance with subsection (6) and (7).

50.
1.		If a member refuses to undergo an assessment under subsection 49 (11) or to attend or participate in a program under subsection 49 (15), the panel may direct the Registrar to impose terms, conditions or limitations on the member's certificate of registration for a specified period not exceeding six months.
2.		If the panel proposed to take action under subsection (1), the member has the right to make submissions in accordance with subsections 49 (6) and (7).
3.		If the panel is satisfied that the terms, conditions and limitations imposed on a member's certificate of registration are no longer needed, it shall direct the Registrar to remove them before the end of the specified period.
4.		If, at the end of the specified period, the member continues to refuse to undergo the required assessment or to attend or participate in the program, the panel shall refer the matter to the Executive Committee.

Panel Requirements
51.
1.		The Committee may sit as a panel to consider a report on a practice review or any matter arising out of a practice review, a matter relating to the imposition of terms, conditions or limitations on a member's registration under section 48 or a matter under section 49.
2.		A panel shall have at least three members appointed by the chair of the Committee from among the Committee members; at least one member of the panel shall be a member appointed to the Committee by the Lieutenant Governor in Council.
3.		Three members of a panel constitute a quorum.