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Qualification and Professional Accountability Regulations

made under subsection 80(1) of the
Pharmacy Act
S.N.S. 2001, c. 36
O.I.C. 2003-348 (August 1, 2003, effective September 1, 2003), N.S. Reg. 144/2003
as amended up to O.I.C. 2005-561 (December 15, 2005), N.S. Reg. 227/2005


Interpretation

Citation
1 These regulations may be cited as the Qualification and Professional Accountability Regulations.

Definitions
2 In these regulations,

(a) "accredited degree program in pharmacy" means a degree program in pharmacy accredited pursuant to clause 13(5)(a) of the Act or clause 1(a) of the Practice Regulations;

(b) "Act" means the Pharmacy Act;

(c) "Agreement on Internal Trade" means the agreement signed by the federal, provincial and territorial governments of Canada, which came into force on July 1, 1995, to facilitate the free movement of persons, goods, services and investments throughout Canada;

(d) "Practice Regulations" means the regulations respecting the practice of pharmacy made by the Council pursuant to Section 77 of the Act;

(e) "graduate intern" means an intern who has never been licensed to practise pharmacy in Nova Scotia or another jurisdiction;

(f) "Mutual Recognition Agreement" means the agreement respecting labour mobility requirements for the profession of pharmacy in Canada pursuant to the Agreement on Internal Trade;

(g) "practice experience" includes both structured practice experience pursuant to the Practice Regulations and unstructured practice experience;

(h) "qualifying intern" means an intern who is not licensed as a pharmacist but either

(i) is licensed to practise pharmacy in another jurisdiction, or

(ii) was formerly licensed as a pharmacist,

and is registered in accordance with Section 9;

(i) "unstructured practice experience" means practical experience under the guidance of a preceptor in a direct patient care setting in a licensed pharmacy or hospital pharmacy, or other institution approved by the Council.

Registration and Licensing

Registration of pharmacists - graduate interns
3 To be eligible for registration as a pharmacist in Nova Scotia, a graduate intern must, in addition to having successfully completed the requirements of clauses 13(5)(a) to (e) of the Act,

(a) be registered as a graduate intern in accordance with subsection 7(8) or Section 8;

(b) complete and submit the application form prescribed by the Practice Regulations;

(c) provide the Registrar with

(i) a statement of disclosure regarding any previous criminal convictions, disciplinary convictions or civil remedies relating to the practice of pharmacy obtained against the applicant, and

(ii) proof of liability insurance coverage as required by subsection 12(1),

and any other information required by the application form;

(d) have successfully completed 16 weeks of unstructured practice experience, 8 of which must have been completed after the graduate internís graduation from an accredited degree program in pharmacy; and

(e) pay the applicable fee prescribed by the Practice Regulations.

Registration of pharmacists - Mutual Recognition Agreement transfers
4 (1) To be eligible for registration as a pharmacist, a person who is licensed to practise pharmacy in a jurisdiction that is a signatory to the Mutual Recognition Agreement must, in addition to having successfully completed the requirements of clauses 13(5)(a) to (e) of the Act,

(a) complete and submit the application form prescribed by the Practice Regulations;

(b) provide the Registrar with a letter of standing from the applicantís regulatory authority pursuant to subsection 13(7) of the Act, including confirmation that there are no outstanding complaints against the applicant;

(c) meet the requirements of clause 3(c) with respect to the application form required by this Section;

(d) have successfully completed the examination in jurisprudence prescribed by the Practice Regulations; and

(e) pay the applicable fee prescribed by the Practice Regulations.

(2) A person licensed to practise pharmacy in another jurisdiction who applies for registration as a pharmacist in Nova Scotia and meets the requirements of this Section must be licensed in the same or an equivalent or comparable membership classification as the membership classification in which the person was licensed in the other jurisdiction.

Registration of pharmacists - non-Mutual Recognition Agreement transfers
5 (1) To be eligible for registration as a pharmacist, a person who is licensed to practise pharmacy in a jurisdiction that is not a signatory to the Mutual Recognition Agreement must, in addition to having successfully completed the requirements of clauses 13(5)(a) to (e) of the Act,

(a) be registered as a qualifying intern in accordance with Section 9;

(b) complete and submit the application form prescribed by the Practice Regulations;

(c) provide the Registrar with any information required by the application form;

(d) provide the Registrar with proof of liability insurance coverage as required pursuant to subsection 12(1); and

(e) pay the applicable fee prescribed by the Practice Regulations.

(2) A person licensed to practise pharmacy in another jurisdiction who applies for registration as a pharmacist in Nova Scotia and meets the requirements of this Section must be licensed in the same or an equivalent or comparable membership classification as the membership classification in which the person was licensed in the other jurisdiction.

Resumption of practice
6 (1) In this Section,

(a) "applicant" means a pharmacist who is a non-practising member of the College or a person who has retired from the College and who seeks to resume practice, and in subsections (5) and (6) includes a person whose registration is cancelled pursuant to subsection 15(9) of the Act;

(b) "eligible applicant" means an applicant who has complied with subsection (2).

(2) To be eligible for registration as a pharmacist, an applicant must

(a) complete and submit the application form prescribed by the Practice Regulations;

(b) provide the Registrar with

(i) a statement of disclosure regarding any previous criminal convictions, disciplinary convictions or civil remedies relating to the practice of pharmacy obtained against the applicant, and

(ii) proof of liability insurance coverage as required pursuant to subsection 12(1),

and any other information required by the application form.

(3) If an eligible applicant has been licensed to practise pharmacy in Nova Scotia within the 2 years preceding their application, the applicant may resume practice upon

(a) complying with the requirements for continuing competence pursuant to Section 11 and the Practice Regulations; and

(b) paying the current yearís annual licence fee and the reinstatement fee prescribed by the Practice Regulations.

(4) If an eligible applicant has not been licensed to practise pharmacy in Nova Scotia within the 2 years preceding their application but has been so licensed within the preceding 5 years, the applicant may resume practice upon

(a) being registered as a qualifying intern in accordance with Section 9;

(b) complying with the requirements for continuing competence pursuant to Section 11 and the Practice Regulations;

(c) successfully completing the examination in jurisprudence prescribed by the Practice Regulations;

(d) successfully completing 1 month of unstructured practice experience as determined by the Practice Regulations for each year or part of a year since the applicant was last licensed; and

(e) paying the current yearís annual licence fee, any required examination fees and the reinstatement fee as prescribed by the Practice Regulations.

(5) If an eligible applicant has not been licensed to practise pharmacy in Nova Scotia within the 5 years preceding their application, the applicant may resume practice upon

(a) being registered as a qualifying intern in accordance with Section 9;

(b) complying with the requirements for continuing competence pursuant to Section 11 and the Practice Regulations;

(c) successfully completing the examination in jurisprudence prescribed by the Practice Regulations;

(d) successfully completing a structured practice-experience program as determined by the Practice Regulations; and

(e) paying the current yearís annual licence fee, all required examination fees, and the reinstatement fee as prescribed by the Practice Regulations.

(6) If an applicant was at any time licensed to practise pharmacy in another jurisdiction, the applicant must provide the Registrar with a letter of standing from the regulatory authority in the other jurisdiction confirming the applicantís standing and discipline record, including confirmation that there are no outstanding complaints against the applicant.

(7) An applicant may apply to Council to waive or reduce any requirement of this Section, and the Council may waive or reduce the requirement if the Council considers that the applicantís experience during the 5-year period preceding the application is equivalent to the requirement that is sought to be waived or reduced.

Registered students
7 (1) If an applicant for registration as a registered student

(a) completes and submits the application form prescribed by the Practice Regulations;

(b) provides the Registrar with

(i) a birth certificate or certificate of Canadian citizenship,

(ii) proof of enrolment in an accredited degree program in pharmacy, and

(iii) proof of liability insurance coverage as required pursuant to subsection 12(2),

and any other information required by the application form; and

(c) pays the fee prescribed by the Practice Regulations,

the Registrar will enter the applicantís name in the register respecting students maintained pursuant to subsection 12(8) of the Act.

(2) The Registrar must not register a person as a registered student pursuant to subsection (1) unless the person is currently enrolled in an accredited degree program in pharmacy.

(3) The registration of a registered student continues until the student graduates from an accredited degree program in pharmacy, unless revoked pursuant to these regulations.

(4) A registered student is subject to the same requirements of professional responsibility, professional ethics and professional accountability as a pharmacist.

(5) The registration of a registered student must be revoked if the student is expelled from or refused readmission to an accredited degree program in pharmacy.

(6) The registration of a registered student must be revoked if the student fails to complete an accredited degree program in pharmacy within 6 years after the studentís initial enrolment in an accredited degree program in pharmacy, unless the Council, on application by the student, extends the time to complete the program.

(7) If a registered studentís registration is revoked for any reason,

(a) any practice experience completed by the student up to the date of revocation is not counted towards the fulfillment of the requirements of these regulations; and

(b) the student must not be registered again without the permission of the Council.

(8) Upon graduation from an accredited degree program in pharmacy, a registered student is qualified and will be registered as a graduate intern without further application or payment of any additional fee.

Registration of graduate interns
8 If an applicant for registration as a graduate intern

(a) completes and submits the application form prescribed by the Practice Regulations;

(b) provides the Registrar with

(i) a birth certificate or certificate of Canadian citizenship,

(ii) proof of graduation from an accredited degree program in pharmacy, and

(iii) proof of liability insurance coverage as required pursuant to subsection 12(1),

and any other information required by the application form; and

(c) pays the fee prescribed in the Practice Regulations,

the Registrar will enter the applicantís name in the register respecting graduate interns maintained pursuant to subsection 12(8) of the Act.

Registration of qualifying interns
9 (1) If an applicant for registration as a qualifying intern

(a) completes and submits the application form prescribed in the Practice Regulations;

(b) in addition to meeting the requirement of subsection 13(7) of the Act for a record of complaints and discipline matters, provides the Registrar with a letter of standing from the applicantís regulatory authority confirming that there are no outstanding complaints or discipline matters against the applicant;

(c) provides the Registrar with

(i) a birth certificate or certificate of Canadian citizenship,

(ii) proof of graduation from an accredited degree program in pharmacy,

(iii) a statement of disclosure regarding any previous criminal convictions, disciplinary convictions or civil remedies relating to the practice of pharmacy obtained against the applicant, and

(ii) proof of liability insurance coverage as required pursuant to subsection 12(1),
[*Note: numbering as in original.]

and any other information required by the application form;

(d) successfully completes a qualifying assessment approved by the Council based on the required professional competencies for Canadian pharmacists at entry-to-practice;

(e) has met the language requirements prescribed by the Practice Regulations;

(f) successfully completes the examination in jurisprudence prescribed by the Practice Regulations; and

(g) pays the fees prescribed by the Practice Regulations,

the Registrar will enter the applicantís name in the Register respecting qualifying interns maintained pursuant to subsection 12(8) of the Act.

(2) The requirement of clause (1)(d) may be waived for an applicant by the Council.

(3) Clause (1)(d) does not apply to an applicant pursuant to subsection 6(4).

Requirements for graduate interns and qualifying interns
10 (1) No person except a registered student is permitted to undertake a period of practice experience before the person is registered as a graduate intern or a qualifying intern.

(2) A graduate intern or a qualifying intern is subject to the same requirements of professional responsibility, professional ethics and professional accountability as a pharmacist.

(3) The registration of a graduate intern or a qualifying intern must be revoked if the intern fails to complete the practice experience required by the Practice Regulations within the 18 months immediately following the date of the registration.

(4) If a graduate internís or qualifying internís registration is revoked for any reason,

(a) any practice experience completed by the intern up to the date of revocation is not counted towards the fulfillment of the requirements of these regulations; and

(b) the intern must not be registered again without the permission of the Council.

Continuing competence
11 (1) Every pharmacist and certified dispenser must in each year complete 15 units of continuing education, approved pursuant to standards established and applied by Dalhousie University, in order to qualify for a licence for the following year.

(2) A pharmacist is not required to comply with the requirements of this Section in the year of graduation from an accredited degree program in pharmacy or in the year of transfer to Nova Scotia from a jurisdiction that is a signatory to the Mutual Recognition Agreement.

(3) A pharmacist transferring from another jurisdiction in Canada may apply to the Registrar for credit for any continuing education completed in the other jurisdiction, and the Registrar will allow credit for any continuing education credits that meet the criteria established for continuing education in the other jurisdiction.

(4) A pharmacist transferring from a jurisdiction outside Canada may apply to the Registrar for credit for any continuing education completed in the other jurisdiction, and the Registrar must determine whether and to what extent the continuing education completed in that jurisdiction satisfies the requirements of this Section.

Insurance coverage
12 (1) Every pharmacist practising direct or indirect patient care, every certified dispenser, every graduate intern and every qualifying intern must obtain and maintain professional liability insurance in an amount not less than $2 000 000.00 through an insurance policy approved by the Council that covers all members of the College.

(2) Every registered student must obtain and maintain professional liability insurance in an amount not less than $2 000 000.00 through an insurance policy approved by the Council.

Preservation of Patient Information

Retention of prescriptions
13 (1) A dispensed prescription must be retained in the dispensing pharmacy for at least 2 years following the date of the last transaction with respect to the prescription.

(2) A prescription must be retained in the pharmacy where it was dispensed or in a successor pharmacy.

Storage of patient records
14 A pharmacyís patient records must be stored on the pharmacy premises in a secure manner sufficient to protect patient confidentiality.

Retention of patient records
15 (1) A pharmacyís patient records must be retained by the pharmacy for at least 2 years following the date of the last transaction with respect to the patient.

(2) Patient records must be retained in the pharmacy in which they were created or in a successor pharmacy.

(3) Despite subsection (1), in the event of an audit or investigation, relevant patient records must be retained until the completion of the audit or investigation.

Disposal of records
16 Patient records must be disposed of only in a manner that preserves patient confidentiality.

Professional Accountability

Definitions
17 (1) In this Section and Sections 20 to 23, "member" and "pharmacy" have the same meaning as set out in Section 36 of theAct.

(2) In the Act, this Section and Section 20,

(a) "disciplinary matter" includes, but is not limited to,

(i) professional misconduct,

(ii) any breach of the Act or the regulations made under the Act,

(iii) alleged lack of competence,

(iv) unprofessional conduct,

(v) violation of the Code of Ethics of the College,

(vi) the provision of unsatisfactory patient care, and

(vii) the jeopardizing of the health or safety of patients and the public,

by a member or a pharmacy;

(b) "professional misconduct" includes, but is not limited to,

(i) falsifying a record in respect of a prescription or the sale of a drug,

(ii) knowingly submitting a false or misleading account or a false or misleading charge for a drug or for the compounding or dispensing of a prescription,

(iii) signing or issuing a certificate or similar document that contains a statement that the person signing or issuing knows or ought to know is false or misleading,

(iv) acting as a pharmacist while the ability to perform any action required of a pharmacist is impaired by alcohol or a drug,

(v) conduct or an act relevant to the practice of pharmacy that, having regard to the circumstances, would reasonably be regarded by the other members of the profession as disgraceful, dishonourable or unprofessional, and

(vi) any of the following acts or omissions if it jeopardizes the health or safety of any person or the quality of patient care:

(A) a violation of any provision of the Act, the regulations made under the Act, or any other enactment of Canada or the Province,

(B) a failure to abide by the terms, conditions or limitations of a licence, or

(C) a failure to maintain the standards of practice of the profession.

(3) In Sections 18 to 21,

(a) "hearing committee" means a hearing committee appointed pursuant to the Act;

(b) "investigation committee" means an investigation committee appointed pursuant to the Act.

Conflict of interest
18 A person must not be a member of both an investigation committee and a hearing committee during the same term of appointment.

Records
19 (1) A record must be kept of any findings of and any action taken pursuant to the Act by an investigation committee or a hearing committee.

(2) A record must contain written reasons, including, if applicable, the reasons why a complaint was dismissed.

(3) Records of an investigation committee or a hearing committee must be retained for at least 2 years following the conclusion of the investigation or hearing that is the subject of the record.

Determination of disposition by hearing committee
20 In determining a disposition to be imposed pursuant to subsections 53(2) and (3) of the Act, a hearing committee must consider any relevant previous disciplinary decision regarding the person who is the subject of the proceedings, including undertakings and consents given as part of a settlement agreement pursuant to Section 46 of the Act.

Publication
21 (1) If a hearing committee revokes or suspends a licence, the College must publish the name of the party who has been found guilty and the details of the disposition made by the hearing committee.

(2) Unless otherwise ordered by the hearing committee, if a hearing committee revokes or suspends a licence, fines a member or a pharmacy, or reprimands a member or a pharmacy, the College must communicate to the members of the College the name of the party who has been found guilty and the details of the disposition made by the hearing committee.

Custodian of patient records
22 (1) A custodian appointed pursuant to Section 31 of the Act must give notice to patients, physicians and the general public that the custodian has possession of the patient records of a member or pharmacy.

(2) The notice required by subsection (1) must be given by newspaper advertisements and notices affixed to the pharmacy premises unless the Council directs that additional notice be given.

(3) On the first anniversary date of a custodianís appointment pursuant to Section 31 of the Act, or such earlier date as the Council may require, the custodian must report to the Council concerning the notices provided and action taken during the custodianship.

(4) Upon receipt of a custodianís report required by subsection (3), the Council may discharge the custodian, or make any order it considers appropriate regarding any patient records remaining in the hands of the custodian.

(5) The custodianís compliance with an order of the Council discharges the custodian in respect of those patient records affected by the Councilís order.

Professional obligation
23 (1) Every member must advise the Registrar if that member has been charged or convicted of an offence pursuant to the Controlled Drugs and Substances Act (Canada), the Food and Drug Act (Canada) or any other statute relating to the practice of pharmacy, or any offence that could reasonably be considered to affect a personís ability to practise pharmacy.

(2) A pharmacy manager must report to the Registrar any charge or conviction referred to in subsection (1) that to the managerís knowledge affects an employee of the pharmacy.

Conditional authority
24 (1) In this Section, "conditional authority" means the authority for a pharmacist to lawfully carry out medical activities, services or functions under the conditions set out in a written agreement between the College and the College of Physicians and Surgeons of Nova Scotia.

(2) The College may enter into a written agreement with the College of Physicians and Surgeons of Nova Scotia that authorizes a pharmacist to carry out medical services, activities or functions and that has as its underlying objectives, improved access to health care by the public and achieving the best health care results for the public.

(3) An agreement entered into under this Section must

(a) prescribe the conditions under which the conditional authority may be exercised, including any education or certification that may be advisable or required by a pharmacist before a pharmacist can perform any medical activities, services or functions under the conditional authority;

(b) confirm the professional responsibility and accountability of a pharmacist who performs any medical activities, services or functions under the conditional authority; and

(c) be filed with the Minister of Health and Wellness.
[Note: the reference to the Minister has been updated in accordance with Order in Council 2011-15 under the Public Service Act, R.S.N.S. 1989, effective January 11, 2011.]

(4) An agreement entered into under subsection (2) must not authorize a pharmacist to prescribe narcotic or controlled drugs and a pharmacist is prohibited from prescribing narcotic or controlled drugs under a conditional authority.

(5) A medical activity, service or function that a pharmacist carries out under a conditional authority is deemed to be practising pharmacy in accordance with the Act and the regulations made under the Act.

(6) For the purposes of Section 44 of the Medical Act, a medical activity, service or function that a pharmacist carries out under a conditional authority is deemed to not be a violation of the Medical Act or the regulations made under the Medical Act.
Section 24 added: O.I.C. 2005-561, N.S. Reg. 227/2005.