Practice Regulations

made by the Council of the Nova Scotia College of Pharmacists

pursuant to Section 77 of the Pharmacy Act

effective September 1, 2003

Definitions

D1        In the Pharmacy Act and these regulations,

(a)            “accredited university program in pharmacy” means a university program in pharmacy accredited pursuant to clause 13 (5) (a) of the Pharmacy Act or these regulations;

(b)            “compound” means to cause drugs to be mixed, prepared, altered in form, mixed with non-medicinal ingredients and otherwise changed from the manufactured form;

(c)            “graduate intern” means an intern who has never been licensed to practise pharmacy;

(d)            “Qualification and Professional Accountability Regulations” mean the regulations made by the Council pursuant to subsection 80 (1) of the Pharmacy Act as approved by the Governor in Council;

(e)            “qualifying intern” means an intern who is licensed to practise pharmacy in another jurisdiction, or who has been licensed to practise pharmacy in Nova Scotia, but who is not licensed to practise pharmacy in Nova Scotia;

(f)            “structured practice experience” means a course of guided practical experience approved by Council 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;

(g)            “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.

Part 1 - Membership, Qualifications and Licensing

Members

1.1       (1)            Members of the College are pharmacists, certified dispensers, registered students and interns.

(2)            Pharmacists may be classified as

(a)            practising direct patient care

                        (b)            practising indirect patient care, or

Mutual Recognition Agreement - Registration of Pharmacists

1.3       (1)            The Qualification and Professional Accountability Regulations require a pharmacist transferring to Nova Scotia from a jurisdiction that is a signatory to the “Mutual Recognition Agreement for the Profession of Pharmacy in Canada” to have successfully completed the requirement of clause 13 (5) (c) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.

(2)            For the purposes of successfully completing the requirements of clause 13 (5) (c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.

(3)             A letter of standing from a regulatory authority in another jurisdiction shall:

(a)            confirm that the applicant was registered in that jurisdiction;

(b)            set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practice pharmacy in that jurisdiction;

(c)            include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and

(d)            confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.

Non-MRA Registration of Pharmacists

1.4       (1)            The Qualification and Professional Accountability Regulations require a pharmacist transferring to Nova Scotia from a jurisdiction that is not a signatory to the “Mutual Recognition Agreement for the Profession of Pharmacy in Canada” to have successfully completed the requirement of clause 13 (5) (b), (c), (d) and (e) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.

(2)            For the purposes of successfully completing the requirements of clause 13 (5) (b) of the Pharmacy Act, it is sufficient to have successfully completed English language proficiency assessment at a level consistent with language fluency requirements for licensure as a pharmacist in Canada, as approved by the Council.

(3)            For the purposes of successfully completing the requirements of clause 13 (5) (c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.

(4)            For the purposes of successfully completing the requirements of clause 13 (5) (d) of the Pharmacy Act, it is sufficient to have successfully completed a structured practice experience program approved by the Council consistent with the most recent framework for assessing Canadian pharmacists’ competencies at entry-to-practice through structured practical training programs as prescribed in these regulations.

(5)            For the purposes of successfully completing the requirements of clause 13 (5) (e) of the Pharmacy Act, it is sufficient to have successfully completed a licensing examination based on the required professional competencies for Canadian pharmacists at entry-to-practice as approved by the Council.

(6)            A letter of standing from a regulatory authority in another jurisdiction shall:

(a)            confirm that the applicant was registered in that jurisdiction;

(b)            set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practice pharmacy in that jurisdiction;

(c)            include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and

(d)            confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.

Resumption of Practice

1.5       (1)            The Qualification and Professional Accountability Regulations require some pharmacists resuming practice to have successfully completed the requirement of clause 13 (5) (c) of the Pharmacy Act, and in some cases the requirement of clause 13 (5) (d) of the Pharmacy Act.

(2)            For the purposes of successfully completing the requirements of clause 13 (5) (c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.

(3)            For the purposes of successfully completing the requirements of clause 13 (5) (d) of the Pharmacy Act, it is sufficient to have successfully completed a structured practice experience program approved by the Council consistent with the most recent framework for assessing Canadian pharmacists’ competencies at entry-to-practice through structured practical training programs as prescribed in these regulations.

Registration of Qualifying Interns

1.6       (1)            The Qualification and Professional Accountability Regulations require an applicant for registration as a qualifying intern to have successfully completed the requirements of clauses 13 (5) (b) and (c) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.

(2)            For the purposes of successfully completing the requirements of clause 13 (5) (b) of the Pharmacy Act, it is sufficient to have successfully completed English language proficiency assessment at a level consistent with language fluency requirements for licensure as a pharmacist in Canada, as approved by the Council.

(3)            For the purposes of successfully completing the requirements of clause 13 (5) (c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.

(4)            A letter of standing from a regulatory authority in another jurisdiction shall:

(a)            confirm that the applicant was registered in that jurisdiction;

(b)            set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practice pharmacy in that jurisdiction;

(c)            include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and

(d)            confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.

Application Forms

1.7       The application forms required pursuant to the Pharmacy Act, the Qualification and Professional Accountability Regulations or these regulations shall be those from time to time prescribed by the Registrar.

Return to Direct Patient Care

1.8       A pharmacist practising indirect patient care may change membership classification to direct patient care by filing a notice to that effect with the College.

Required Practice Experience

1.9         (1)            No period of less than four continuous weeks working an average of at least thirty hours a week may be included in the calculation of the unstructured practice experience required by these regulations.

(2)            Except as hereinafter provided, no period of practice experience undertaken

(a)            in the case of a registered student and an intern who was a registered student in Nova Scotia, before that person was registered as a registered student,

(b)            in the case of a registered student and an intern who was a registered student in Nova Scotia, before the commencement of the second year of that person’s pharmacy program,

(c)            in the case of a graduate intern who was not a registered student in Nova Scotia, before that person was registered as a graduate intern, and

(d)            in the case of a qualifying intern, before that person was registered as a qualifying intern

shall be counted towards the completion of the requirements of these regulations.

(3)            Practice experience shall have been completed not more than two years prior to registration as a pharmacist.

(4)            Structured or unstructured practice experience in another jurisdiction may, with the approval of the Council, be applied towards the completion of the requirements of these regulations if the Council considers that the experience is substantially similar to that which would be obtained in Nova Scotia.

(5)            The Council may approve structured and unstructured practice experience in another jurisdiction as meeting the requirements of these regulations in advance of the practice experience being undertaken where Council considers that the experience is substantially similar to that which would be obtained in Nova Scotia.

(6)            The Council may waive some or all of the practice experience requirements for an intern who provides evidence of active direct patient care practice in another jurisdiction with similar required standards of pharmacy practice.

(7)        A preceptor shall be a pharmacist licensed for and practising direct patient care who has been registered in Canada for at least one year, who has no limitations on practice, and  whose right to be a preceptor has not been revoked or suspended.

(8)            A preceptor shall at all times exercise the degree of personal supervision of an intern or registered student that, in the professional judgment of the preceptor, is required to ensure safe and effective patient care given the knowledge, skills and experience of the intern or registered student and the preceptor’s responsibilities pursuant to the Pharmacy Act.

(9)            In the case of unstructured practice experience, the participant shall advise the College, before commencing the practice experience, of  the pharmacy, hospital or other institution approved by the Council in which the practice experience will be undertaken and provide the consent of a preceptor.

(10)            A participant shall notify the College immediately if there is any change in the location in which practice experience is being undertaken or in preceptor.

(11)            Structured practice experience in excess of the minimum requirement shall be counted as unstructured practice experience.

(12)            The preceptor shall certify to the College the time spent in the practice experience and whether the participant was satisfactory or unsatisfactory.

(13)            Practice experience for which the participant has received an unsatisfactory rating  shall not be counted towards the completion of the requirements of these regulations.

Accredited University Program

1.10      (1)            In these regulations, an accredited university program in pharmacy includes, in addition to a university program accredited by the Canadian Council for Accreditation of Pharmacy Programs as provided by the Pharmacy Act,

(a)            a university program in pharmacy accredited by a body recognized as an accrediting agency by the Canadian Council for Accreditation of Pharmacy Programs;

(b)            a university program in pharmacy determined by the Pharmacy Examining Board of Canada to be the equivalent of a Canadian Council for Accreditation of Pharmacy Programs accredited program; and

(c)            a university program in pharmacy recognized pursuant to subsection (2).

(2)            In the event a program does meet any of the requirements of subsection (1), if the Council determines that the program is the equivalent of a program accredited by the Canadian Council for Accreditation of Pharmacy Programs, the Council shall recognize the program for the purpose of these regulations.

(3)            A university program in pharmacy accredited pursuant to this Section or determined to have been the equivalent of an accredited program is deemed to have been determined by the Council to be the equivalent of an accredited program pursuant to clause 13 (5) (a) of the Pharmacy Act.

Time limits

1.11      (1)            A person who has graduated from an accredited university pharmacy program shall qualify for and obtain a licence as a pharmacist within two years after graduation.

(2)            The Council may, on application, extend the period in subsection (1).

Continuing competence

1.12      Proof of completion of the requirements of the Qualification and Professional Accountability Regulations respecting continuing competency in the twelve months preceding November 30 in any year shall be provided to the Registrar before November 30, failing which the member is suspended as provided by the Pharmacy Act and shall not practise pharmacy until reinstated.

Annual Renewal

1.13      (1)            A license to practice pharmacy in Nova Scotia expires December 31 in each year.

(2)            To renew a licence to practice pharmacy in Nova Scotia, a  pharmacist or certified dispenser shall

(a)         complete and submit the application form provided by the Registrar;

(b)            have completed the requirements for continuing competency prescribed by the Qualification and Professional Accountability Regulations;

(c)         be insured as required by the Qualification and Professional Accountability Regulations, and

(d)         pay the fee prescribed in Schedule “A”.

(3)            Where a pharmacist or certified dispenser does not submit a completed application to renew a licence before November 30 in any year, the pharmacist or certified dispenser is subject to the late payment fee prescribed in Schedule “A”.

(4)            Where a pharmacist or certified dispenser does not submit a completed application to renew a licence before December 31 in any year, the pharmacist or certified dispenser is suspended as provided by the Pharmacy Act and shall not practise pharmacy until reinstated.

Accreditation of a New Pharmacy

1.14      (1)            Every person who proposes to open a new pharmacy  or who proposes to acquire an existing pharmacy shall apply for a certificate of accreditation and a pharmacy licence in accordance with the Pharmacy Act not less than thirty days before the proposed opening date of the pharmacy.

(2)            In exceptional circumstances the Registrar may authorize a shorter notice period.

(3)            A pharmacy, in order to be accredited, shall comply with the requirements of the Pharmacy Act and the regulations.

(4)            An application for accreditation shall include

(a)            a diagram of the pharmacy as required pursuant to Part 2 of these regulations;

(b)            the name of the owner of the pharmacy and, where the owner is a body corporate, the names of the officers and directors of the body corporate;

(c)            the name of the pharmacy manager;

(d)            certification by the owner and the pharmacy manager that the pharmacy meets the requirements of the Pharmacy Act and the regulations; and

(e)            the fee prescribed in Schedule “A”.

(5)            Upon accreditation, the College shall provide the pharmacy with a certificate of accreditation and a licence for the then-current year.

(6)            A pharmacy licence shall be issued in the name of the manager of the pharmacy.

(7)            In the event of a change in the manager of the pharmacy, the pharmacy shall obtain a replacement licence upon payment of the fee prescribed in Schedule “A”.

Renewal of a Pharmacy Licence

1.15      (1)            A pharmacy licence expires December 31 in each year.

(2)            A pharmacy licence is renewable on application to the College before the last day of November in the licence year.

(3)            An application for renewal of a pharmacy licence shall include

(a)            the name of the pharmacy manager;

(b)            certification by the owner and the pharmacy manager that the pharmacy meets the requirements of the Pharmacy Act and the regulations; and

(c)            the fee prescribed in Schedule “A”.

(4)            Where a completed application to renew a pharmacy licence is not submitted before November 30 in any year, the pharmacy is subject to the late payment fee prescribed in Schedule “A”.

(5)            Where a completed application to renew a pharmacy licence is not submitted before December 31 in any year, the pharmacy is suspended as provided by the Pharmacy Act.

Document Replacement

1.16      (1)            A pharmacist requiring replacement of a certificate of registration or licence for any of the following reasons:

(a)            loss or destruction of original,

(b)            legal change of name, or

(c)            change of name to married name

may, on request, accompanied by the current document if it is in existence and the reason the replacement document is required, obtain a replacement copy from the Registrar upon payment of the fee specified in Schedule “A”.

(2)            A pharmacy requiring replacement of its licence or certificate of accreditation for any of the following reasons:

(2)              change of manager,

(3)              change of operating name,

(4)              change of corporate name,

(5)              change of location, or

(6)              loss or destruction of the original

may, on request, obtain a replacement copy from the Registrar upon payment of the fee specified in Schedule “A”.

Fees

1.17      The fees set out in Schedule “A” are the fees payable in the circumstances indicated in the Schedule.

Part 2               Professional Responsibility in Community Pharmacy

Responsibilities of the Pharmacy Manager

2.1       (1)            The manager of a pharmacy is responsible for

(a)            the day to day management of the pharmacy;

(b)            the development, maintenance and enforcement of policies and procedures to comply with the standards of practice of pharmacy as set out in an enactment or a professional standard adopted by an appropriate professional organization, or otherwise required to ensure optimal patient care;

(c)            the development, maintenance and enforcement of a quality management program;

(d)            ensuring that all staff members who present themselves as pharmacists or who are employed to practise as pharmacists are licensed to practice pharmacy in Nova Scotia;

(e)            notifying the Registrar in writing of any changes in the pharmacy staff as they occur;

(f)            responding to any questions from the Registrar respecting the practice of pharmacy in the pharmacy;

(g)            advising the Registrar in writing of professional practice problems or conduct that could affect the health or safety of patients by any pharmacist, registered student, intern or certified dispenser employed in the pharmacy;

(h)            cooperating fully with any inspector appointed by the Council pursuant to the Pharmacy Act;

(i)            establishing a staffing plan commensurate with patient care requirements and taking reasonable steps to implement it;

(j)            ensuring that information directed to the pharmacy pertaining to drugs, devices, diversion tactics and the practice of pharmacy is accessible to all staff and that any pharmacist, registered student, intern or certified dispenser is informed of its location in the pharmacy;

(k)            the adoption of policies to ensure so far as possible that the pharmacy has adequate stocks of drugs and devices to meet the needs of its patients;

(l)            the adoption of a policy for implementing and documenting a drug recall procedure;

(m)            ensuring that all drugs in the pharmacy are secure from loss, theft or diversion;

(n)            maintaining confidentiality with respect to all patient records and information;

(o)            ensuring the correct and consistent use of the operating name of the pharmacy as it appears on the certificate of accreditation of the pharmacy for all pharmacy identification on labels and packaging.

(2)            A pharmacist shall not act as the manager of more than one pharmacy at a time.

(3)            The pharmacy manager shall report to the College any change in the ownership of the pharmacy, and, where the owner is a body corporate, any change in the names of the officers and directors of the body corporate.

Quality Management

2.2       (1)            Every pharmacy shall establish and maintain a continuing, documented quality assurance program that monitors staff performance, equipment, facilities and adherence to standards of practice.

(2)            The quality assurance program shall include a process for documenting and reporting known, alleged and suspected medication errors and discrepancies, and the steps taken to resolve the problem.

(3)            The quality assurance program shall include provisions to protect the confidentiality of information relating to specific patients.

Pharmacy

2.3       (1)            Every application for the accreditation of a pharmacy shall include a diagram of the pharmacy.

(2)            The diagram shall demonstrate compliance with the Pharmacy Act and these regulations before a certificate of accreditation is issued.

(3)            The pharmacy manager shall report to the College any changes in the pharmacy, made either before or after accreditation, that would affect the diagram.

(4)            The diagram shall be drawn to scale, and include

(a)         all entrances, stairs or escalators, and elevators;

(b)            washrooms, indicating whether for staff or the general public;

(c)            an indication of whether there are additional areas of the retail premises not included in the pharmacy and the approximate size of them;

(d)         storage areas;

(e)            dispensary, showing the location of the counter;

(f)          narcotic and controlled drug storage areas and any related equipment;

(g)         areas containing scheduled drugs;

(h)         patient counselling area.

(5)            The diagram shall be accompanied by a description of the type of security features employed to render the dispensary and controlled drug areas secure and, where the pharmacy is part of a larger premises, the manner in which the pharmacy is secured from the larger premises when closed.

Dispensary

2.4       (1)            The dispensary of a pharmacy must be a well-defined area clearly identified to the public by “Dispensary”, “Prescriptions” or words of like import approved by the Registrar.

(2)            The dispensary staff shall be accessible to the public at the counter and by telephone.

(3)            The dispensary area shall be inaccessible to the public.

(4)            The dispensary shall be sufficiently large and configured to allow for safe and proper storage of medications and compounding, preparation and dispensing of medication orders, taking into account the volume of business, the nature of the patients and their particular needs, and the nature of the pharmacy’s business, and:

(a)         be clean, sanitary, well ventilated and well lit;

(b)         contain sufficient drugs to permit the provision of a full dispensing service;

(c)         have adequate shelf and storage space;

(d)         include a sink with hot and cold running water;

(e)         include a secure refrigerator for storing drugs;

(f)          include a source of heat for compounding;

(g)            include a typewriter or printer, prescription numbering system and system for filing prescriptions.

(5)            A dispensary shall be adequately equipped to provide safe and proper compounding, dispensing and preparation of medication orders, and have at least:

(a)         an accurate prescription balance with a sensitivity reciprocal of 10 mg;

(b)         glass graduates;

(c)         mortars and pestles (both glass and earthenware);

(d)         metallic and non-metallic spatulas;

(e)         glass funnels;

(f)          glass stirring rods;

(g)         ointment slab or pad;

(h)         counting tray;