O. Reg. 202/94: GENERAL, Pharmacy Act, 1991, S.O. 1991, c. 36

Pharmacy Act, 1991
Loi de 1991 sur les pharmaciens

ONTARIO REGULATION 202/94

Amended to O. Reg. 548/99

GENERAL

Historical version for the period November 29, 1999 to August 25, 2004.

This Regulation is made in English only.

PARTS I-III (ss. 1-3, 3.1, 4-23, 23.1, 24) Revoked: O. Reg. 548/99, s. 1.

PART IV
REGISTRATION

General

25. The following are prescribed as classes of certificates of registration:

1. Pharmacist.

2. Registered pharmacy student.

3. Intern. O. Reg. 280/96, s. 4.

26. A person may apply for a certificate of registration by submitting a completed application in the form provided by the Registrar together with the applicable fee. O. Reg. 280/96, s. 4.

27. A member shall return his or her certificate of registration to the Registrar on request if the certificate is suspended or revoked or the member resigns. O. Reg. 280/96, s. 4.

Certificate of Registration — Any Class

28. (1) The following are requirements for the issuance of a certificate of registration of any class:

1. The applicant must be able to speak and write in English or French with reasonable fluency.

2. The applicant must not have been found guilty of an offence under any Act regulating the practice of pharmacists or relating to the sale of drugs, or of any criminal offence.

3. The applicant must not be the subject of a current proceeding relating to an offence under any Act regulating the practice of pharmacists or relating to the sale of drugs, or relating to any criminal offence.

4. The applicant must not have been the subject of a finding of professional misconduct, incompetence or incapacity in Ontario or any other jurisdiction in relation to pharmacy or any other health profession and must not be the subject of any current professional misconduct, incompetence, or incapacity proceeding in Ontario or any other jurisdiction in relation to pharmacy or any other health profession.

5. The applicant must be a Canadian citizen or must hold the appropriate authorization under the Immigration Act (Canada) to permit the applicant to engage in the practice of pharmacy in Canada as a pharmacist, registered pharmacy student or intern.

(2) An applicant shall be deemed not to have satisfied the requirements for a certificate of registration if the applicant makes a false or misleading statement or representation in his or her application.

(3) Every certificate of registration is subject to the condition that the member shall provide the Registrar with the details of any of the following that relate to the member and that occur or arise after the registration of the member:

1. A charge relating to an offence under any Act regulating the practice of pharmacists or relating to the sale of drugs, or relating to any criminal offence.

2. A finding of guilt in relation to an offence under any Act regulating the practice of pharmacists or relating to the sale of drugs or in relation to any criminal offence.

3. A finding of professional misconduct, incompetence or incapacity in any jurisdiction in relation to pharmacy or any other health profession.

4. A proceeding for professional misconduct, incompetence or incapacity in any jurisdiction in relation to pharmacy or any other health profession. O. Reg. 280/96, s. 4.

Certificate of Registration as Pharmacist

29. (1) The following are additional requirements for the issuance of a certificate of registration as a pharmacist:

1. The applicant must have the degree of Bachelor of Science in Pharmacy from the University of Toronto, such other degree in pharmacy as the Council considers equivalent to that degree, or a degree in pharmacy that is required for the holder of the degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada.

2. The applicant must have successfully completed an examination in pharmaceutical jurisprudence approved by the Council.

3. The applicant must hold a certificate of qualification issued by the Pharmacy Examining Board of Canada.

4. The applicant must have successfully completed,

i. 48 weeks of in-service training approved by the Council while registered as a registered pharmacy student or intern, or

ii. other training of such duration and content as the Council considers equivalent to the training referred to in subparagraph i.

5. If the application for registration as a pharmacist is submitted more than three years after the applicant obtained the degree referred to in paragraph 1, the applicant must have successfully completed such additional in-service training as the Registration Committee may specify, unless the applicant has practised as a pharmacist in a pharmacy or hospital in any jurisdiction during the three years immediately preceding the submission of the application.

(2) The training referred to in paragraph 4 of subsection (1) must be completed,

(a) within three years after obtaining the degree referred to in paragraph 1 of subsection (1), unless the applicant was previously registered or licensed as a pharmacist in a jurisdiction other than Ontario; and

(b) within three years after the training was commenced. O. Reg. 280/96, s. 4.

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. O. Reg. 98/98, s. 1.

Certificate of Registration as Registered Pharmacy Student

30. (1) The following are additional requirements for the issuance of a certificate of registration as a registered pharmacy student:

1. The applicant,

i. must have been accepted as a student in the Faculty of Pharmacy of the University of Toronto,

ii. must have been accepted as a student in pharmacy at a university whose degree is considered by the Council to be equivalent to the degree of Bachelor of Science in Pharmacy from the University of Toronto, or

iii. must have obtained, in a jurisdiction other than Ontario, a degree in pharmacy that is required for the holder of the degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada, and must have successfully completed such additional training as is required for the holder of that degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada.

2. The applicant must have been accepted by a preceptor acceptable to the Registration Committee.

(2) The holder of a certificate of registration as a registered pharmacy student shall be deemed to have resigned as a registered pharmacy student when,

(a) the student is granted the degree of Bachelor of Science in Pharmacy by the University of Toronto or such other degree in pharmacy as the Council considers equivalent to that degree; and

(b) the student satisfactorily completes 32 weeks of in-service training approved by the Council.

(3) The holder of a certificate as a registered pharmacy student shall be deemed to have resigned as a registered pharmacy student if,

(a) the holder of the certificate fails within one year after registration as a registered pharmacy student to commence the courses of study leading to the degree of Bachelor of Science in Pharmacy from the University of Toronto or such other degree in pharmacy as the Council considers equivalent to that degree;

(b) the holder of the certificate fails to attend the courses of study referred to in clause (a) for two consecutive years after having commenced them; or

(c) for any reason, the holder of the certificate is refused readmission to a course of study referred to in clause (a).

(4) Subsection (3) does not apply to the holder of a certificate who,

(a) has obtained, in a jurisdiction other than Ontario, a degree in pharmacy that is required for the holder of the degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada; and

(b) has successfully completed such additional training as is required for the holder of that degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada. O. Reg. 280/96, s. 4.

Certificate of Registration as Intern

31. The following are additional requirements for the issuance of a certificate of registration as an intern:

1. The applicant,

i. must have been granted the degree of Bachelor of Science in Pharmacy by the University of Toronto,

ii. must have been granted a degree in pharmacy that the Council considers equivalent to the degree of Bachelor of Science in Pharmacy from the University of Toronto, or

iii. must have obtained, in a jurisdiction other than Ontario, a degree in pharmacy that is required for the holder of the degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada, and must have successfully completed such additional training as is required for the holder of that degree to become eligible to write the examinations of the Pharmacy Examining Board of Canada.

2. The applicant must have satisfactorily completed,

i. at least 32 weeks of in-service training approved by Council; or

ii. other training of such duration and content as the Council considers equivalent to the training referred to in subparagraph i.

3. The applicant must have been accepted by a preceptor acceptable to the Registration Committee. O. Reg. 280/96, s. 4.

Certificate of Registration as Registered Pharmacy Student or Intern

32. The holder of a certificate as a registered pharmacy student or intern shall be deemed to have resigned as a registered pharmacy student or intern if,

(a) the holder of the certificate has obtained the degree of Bachelor of Science in Pharmacy from the University of Toronto or such other degree in pharmacy as the Council considers equivalent to that degree, was not previously registered or licensed as a pharmacist in a jurisdiction other than Ontario, and fails to complete the training described in paragraph 4 of subsection 29 (1) within three years after obtaining the degree; or

(b) the holder of the certificate fails to complete the training described in paragraph 4 of subsection 29(1) within three years of having commenced the training. O. Reg. 280/96, s. 4.

PART V (ss. 33-35) Revoked: O. Reg. 548/99, s. 1.

PART VI
NOTICES OF MEETINGS AND HEARINGS

36. (1) The Registrar shall ensure that notice of every Council meeting that is required to be open to the public under the Act is given in accordance with this section.

(2) The notice must be published at least fourteen days before the date of the meeting in a daily newspaper of general circulation throughout Ontario.

(3) The notice must be in English and French.

(4) The notice must contain the following information:

1. The date, time and place of the meeting.

2. A statement of the purpose of the meeting.

(5) The Registrar shall provide the information contained in the notice to every person who requests it by telephone. O. Reg. 280/96, s. 4.

37. (1) The Registrar shall ensure that the information concerning an impending hearing by a panel of the Discipline Committee to deal with allegations of professional misconduct or incompetence made against a member is given, in accordance with this section, to a person who requests the information.

(2) The information shall be given,

(a) at least 14 days before the date of the hearing, if the request is received 14 days before the date of the hearing; or

(b) as soon as possible after the request is made, if the request is received after that time but before the date of the hearing.

(3) The information given shall be as follows:

1. The name of the member against whom the allegations have been made.

2. The member’s principal place of practice.

3. The date, time and place of the hearing.

4. A statement of the purpose of the hearing.

(4) The Registrar shall provide the information in French to a person who requests that the information be provided in French, wherever reasonably possible. O. Reg. 280/96, s. 4.

PART VII
ADVERTISING

38. (1) In this section,

“advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement;

“prescription services” means the compounding, dispensing or sale by retail of drugs pursuant to prescriptions and the provision of information or advice with respect to those drugs.

(2) A member shall not, through any medium, publish, display, distribute or use, or permit, directly or indirectly, the publication, display, distribution or use through any medium of, an advertisement relating to prescription services that,

(a) is false, misleading or deceptive, whether as a result of the inclusion of information or the omission of information;

(b) is not readily comprehensible to the persons to whom it is directed;

(c) is not dignified and in good taste;

(d) contains anything that cannot be verified;

(e) contains testimonials, comparative statements or endorsements;

(f) contains a reference to an area of practice or to a procedure or treatment, unless the advertisement discloses whether or not the member has an area of expertise and, if the member does have such an area of expertise, the particular expertise;

(g) contains references to a particular brand of equipment used to assist in providing prescription services;

(h) contains information that is not relevant to the choice of a pharmacist;

(i) contains any representations as to the safety or effectiveness or an indication for use of any specified prescription drug; or

(j) is otherwise contrary to this Part.

(3) An advertisement by a member that includes price information relating to prescription drugs shall include the price information for at least 15 different drugs, 10 of which each belong to a different one of the following drug classifications:

1. Anti-infective agents.

2. Antineoplastic agents.

3. Autonomic agents.

4. Blood formation and coagulation drugs.

5. Cardiovascular drugs.

6. Central nervous system drugs.

7. Diagnostic agents.

8. Electrolytic, caloric and water balance drugs.

9. Cough preparations.

10. Eye, ear, nose and throat preparations.

11. Gastrointestinal drugs.

12. Gold compounds.

13. Heavy metal antagonists.

14. Hormones and substitutes.

15. Oxytocics.

16. Skin and mucous membrane preparations.

17. Spasmolytics.

18. Unclassified therapeutic agents.

19. Vitamins.

(4) If an advertisement by a member includes price information relating to prescription drugs, the advertisement shall include at a minimum the following price information with respect to each drug:

1. The dispensing fee.

2. The sum of the cost to the pharmacist plus the pharmacist’s mark-up.

3. The total cost for the prescription to the purchaser.

4. The time period during which the advertised price will be available.

(5) The price information referred to in subsection (4) shall be given for the standard reference quantity of each drug. However, if the member supplies a prescription to a consumer in the package in which it was supplied to the member, the price information shall be given for the quantity contained in the package.

(6) The standard reference quantity for a drug is the reference quantity indicated in the guidelines titled “Standard Reference Quantity Guidelines”, dated January 30, 1997 and available from the College or, if it is not indicated in the College guidelines, the standard reference quantity for a drug is,

(a) for tablets or capsules, 100;

(b) for liquids, 100 millilitres; or

(c) 30 grams for solid dosage forms.

(7) An advertisement by a member that includes price information relating to prescription drugs shall include, in addition to the price information referred to in subsection (4), the following information with respect to each drug in respect of which price information is included:

1. The generic name of the drug.

2. The strength of the drug.

3. The brand name and the name of the manufacturer of the drug.

4. The dosage form of the drug.

5. The quantity of the drug for which the price information is given.

6. Any of the following list of services that are included in the price:

i. The establishment of patient medical profiles.

ii. Professional consultation.

iii. Health care services information.

iv. After hours emergency prescription services.

v. Delivery service.

(8) In an advertisement by a member that includes price information relating to prescription drugs, equal prominence shall be given to each drug for which price information is given and, for each of those drugs, equal prominence shall be given to all the information required under subsections (4) and (7). O. Reg. 121/97, s. 1.

39. It is professional misconduct for the purposes of clause 51 (1) (c) of the Health Professions Procedural Code for a member who advertises price information with respect to a prescription drug to charge any purchaser, including the Minister, more, in respect of any fee, cost or amount that is required under subsection 38 (4) to be part of the price information, than the amount set out in the advertisement. O. Reg. 121/97, s. 1.

40. Nothing in this Part prohibits a member from publishing, displaying, distributing or using, or permitting directly or indirectly the publication, display, distribution or use of, an advertisement that relates solely to the co-payment or dispensing fee charged by the member for supplying a drug that is a listed drug product under the Ontario Drug Benefit Act to an eligible person under that Act. O. Reg. 121/97, s. 1.

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. O. Reg. 98/98, s. 2.

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. O. Reg. 98/98, s. 2.

Continuous Learning Portfolio

43. (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 to the College on request. O. Reg. 98/98, s. 2.

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. O. Reg. 98/98, s. 2.

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. O. Reg. 98/98, s. 2.

46. (1) A pharmacist may ask for a transfer from Part A to Part B or from Part B to 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 pharmacist 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. O. Reg. 98/98, s. 2.

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) that the pharmacist is required to undertake the remediation specified by the Committee to correct any deficiency in his or knowledge, skills or judgment 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 receipt of the notice to make written submissions 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. O. Reg. 98/98, s. 2.

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 submissions 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 limitation on the pharmacist’s certificate of 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 limitations on the pharmacist’s certificate, subsections (2), (3), (4) and (5) apply with respect to the second imposition. O. Reg. 98/98, s. 2.

Remediation of Behaviour and Remarks of a Sexual Nature

49. (1) This section applies to matters 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 the 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 the 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 assessor 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 subsections (6) and (7), shall be provided to the member.

(15) After considering the assessor’s report and recommendations 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 subsections (6) and (7). O. Reg. 98/98, s. 2.

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 proposes 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 or 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. O. Reg. 98/98, s. 2.

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. O. Reg. 98/98, s. 2.