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Newfoundland Regulation 1996


NEWFOUNDLAND REGULATION 108/96

NEWFOUNDLAND REGULATION 108/96

Pharmaceutical Association Regulations
under the
Pharmaceutical Association Act

(Filed December 11, 1996)

Under the authority of section 14 of the Pharmaceutical Association Act, I make the following regulations.

Dated at St. John's, December 3, 1996.

Lloyd Matthews
Minister of Health

REGULATIONS

Analysis


        1.   Short title

        2.   Definition

        3.   Composition of disciplinary committee

        4.   Sub‑committees

        5.   Panels

        6.   Panels

        7.   Retention of counsel

        8.   Member's participation in decision

        9.   Written complaint

      10.   Service of notice

      11.   Content of notice

      12.   Rules of evidence

      13.   Hearing in public

      14.   Basis of findings

      15.   Return of records

      16.   Report to council

      17.   Release of decision

      18.   Monetary penalty

      19.   Professional misconduct defined

      20.   Meaning of expenses

      21.   Rehearing

      22.   Cancelled or suspended licence

      23.   Expiry of members term

      24.   Further inquiries

      25.   Right to examine reports

      26.   Record of proceedings

      27.   Hospital pharmacy standards

      28.   Continuing education

      29.   Commencement


Short title

        1. These regulations may be cited as the Pharmaceutical Association Regulations.

Definition

        2. In these regulations "records" include drugs, prescriptions, prescription containers, documents, papers, notes, records, photographs, books and films.

Composition of disciplinary committee

        3. (1) The discipline committee shall be comprised of not less than 3 nor more than 9 persons appointed from among the members of the association, and other persons as the council may determine.

             (2)  A member of council may not be appointed to or become a member of the discipline committee.

             (3)  The council shall appoint from the members of the discipline committee, a chairperson and vice‑chairpersons.

             (4)  The vice‑chairperson shall act for and has the powers of the chairperson when the chairperson is unable to Act.

             (5)  In the event of the death, resignation or removal of a member of the discipline committee, the council may appoint a replacement for that member to serve the remainder of the term of office of the member.

             (6)  The term of office of a member of the discipline committee shall be for a period of 3 years from the date of appointment and members may be reappointed for additional terms.

Sub‑committees

        4. (1) The discipline committee may sit as a committee of the whole, or may be divided into panels of 3 members each, at the discretion of the chairperson.

             (2)  The chairperson of the discipline committee shall appoint one member of a panel as chairperson of the panel.

             (3)  Where the discipline committee is divided into panels, a panel shall be considered for all purposes as the discipline committee.

             (4)  A report of a panel is considered to be the report of the discipline committee.

             (5)  Panels may sit separately or concurrently.

Panels

        5. (1) In order to comply with subsections 38(2), 39(1) and section 41 of the Act, the chairperson may appoint a panel of 3 members of the discipline committee to receive reports and information from the secretary‑registrar, in order to decide whether or not a hearing should take place.

             (2)  The panel referred to in subsection (1) shall not take part in a discipline hearing that it determines should be held.

Panels

        6. The chairperson may appoint a panel of 3 members or more of the discipline committee, other than the members of the panel referred to in section 4, to hear a complaint.

Retention of counsel

        7. (1) The discipline committee may engage the services of the counsel, consultants and experts that it considers necessary to assist and advise the discipline committee with respect to a matter dealt with by the discipline committee.

             (2)  The association's solicitor shall only represent the association at a hearing of the discipline committee.

Member's participation in decision

        8. A member of the discipline committee shall not participate in the decision of the committee unless that member was present throughout all of the hearing and heard all of the evidence and argument of the parties presented.

Written complaint

        9. A complaint made under subsection 35(1) of the Act shall be in writing.

Service of notice

     10. (1) The notice required by subsection 42(2) of the Act shall be served either personally, or sent by registered mail directed to the last address known to the secretary‑registrar of the complainant and the investigated person, and the service or sending by mail shall take place not less than 14 calendar days prior to the date established for a hearing.

             (2)  Subsection (1) does not apply to a notice given under section 48 of the Act.

Content of notice

     11. (1) The notice shall include a statement to the effect that the discipline committee may proceed to hear the matter in the absence of either or both of the complainant or investigated person, should either fail to appear at the time and place set for the hearing.

             (2)  The discipline committee, or a panel of the committee, if it is satisfied that the complainant and the investigated person were served properly with notice of the hearing, and in the absence of an explanation acceptable in the sole discretion of the discipline committee for the absence, may proceed with the hearing in the absence of the complainant or the investigated person.

Rules of evidence

     12. (1) The rules of evidence applicable in civil proceedings in the Supreme Court are applicable at a hearing and, in addition, an affidavit or statutory declaration of a person is admissible in evidence subject to the requirements, if any, that the discipline committee shall impose with respect to the presence of the deponent or declarant for the purpose of examination and cross‑examination on the document so admitted.

             (2)  Oral evidence given at a hearing shall be recorded and, if required, a written transcript of the evidence prepared.

Hearing in public

     13. An investigated person requesting that a hearing be public shall do so in writing to the secretary‑registrar or the discipline committee at least 2 days before the day fixed for the hearing.

Basis of findings

     14. The findings of the discipline committee shall be based exclusively on the evidence adduced at the hearing.

Return of records

     15. The records placed into evidence at a hearing shall, upon the request of the person who introduced them, be returned to that person by the discipline committee within a reasonable time after the matter in issue has been finally determined, including the expiry of all permitted appeal proceedings and time limits.

Report to council

     16. (1) Following a hearing, the chairperson of the discipline committee or a panel of the committee shall, within a reasonable period and in any event not later than 30 calendar days following the final date of the hearing, submit a report in writing to the council containing the findings of the committee or panel and the reasons for the decision.

             (2)  A report of the discipline committee to council shall be strictly confidential and shall not be released to or communicated to the investigated person or to another person.

Release of decision

     17. (1) The discipline committee shall, following final consideration of the matter, and in any event, not later than 30 calendar days following the final date of the hearing, serve the complainant and the investigated person with a written decision in the matter, with reasons for the decision.

             (2)  The service of a decision may be made in person or by sending the decision by prepaid registered mail to the last know address of the complainant and the investigated person known to the secretary‑registrar.

             (3)  The secretary‑registrar shall give notice of a decision of the discipline committee or a panel of the committee and an order made under it to those persons stipulated in the decision and to those other persons that the council considers appropriate in the public interest.

Monetary penalty

     18. The maximum amount of the monetary penalty that may be imposed under paragraph 49(1)(f) of the Act shall be $10,000.

Professional misconduct defined

     19. The term unprofessional conduct or professional misconduct for the purpose of consideration of a complaint and the institution of disciplinary proceedings includes

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

             (b)  entering into an agreement with a prescriber for the withholding of the composition of coded prescriptions;

             (c)  falsifying a record in respect of a prescription or the sale of a drug;

             (d)  providing a prescriber with prescription blanks, a professional diary, an appointment book or other gift which is imprinted with the name of a pharmacy;

             (e)  sharing fees with any person who has referred a person to a pharmacist or to a pharmacy or receiving fees from any person to whom a member has referred a person;

              (f)  participating in a lease of premises for a pharmacy that permits any person other than a member or the owner of the pharmacy to participate in the revenue of the pharmacy except by way of a rent normal for the area in which the premises are located;

             (g)  entering into an agreement that restricts a person's choice of pharmacist;

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

              (i)  signing or issuing a certificate or similar document that contains a statement the signing or issuing member knows or ought to know is misleading;

              (j)  announcing or holding out by a member that the member has special qualifications that are not in fact possessed by the member;

             (k)  submitting an account or charging a fee for any service as a pharmacist that is excessive or unreasonable in relation to the service performed;

              (l)  failing to fulfil the terms of an agreement with a person as to the charge for providing any service as a pharmacist to that person;

            (m)  except as specifically permitted in these regulations, returning to stock or again selling or dispensing a drug previously sold or dispensed and delivered or any physician sample or outdated pharmaceutical products;

             (n)  using improperly the authority to sell or dispense a drug or mixture of drugs;

             (o)  acting as a pharmacist while the ability to perform any act as a pharmacist is impaired by alcohol or by a drug;

             (p)  knowingly permitting the premises in which the pharmacy is located to be used for unlawful purposes;

             (q)  permitting, consenting to or approving either expressly or by implication the commission of an offence against an Act relating to the practice of a pharmacist or the sale of drugs by a corporation of which the member is a director or controlling shareholder;

              (r)  failing to maintain the records that are required to be kept respecting patients;

             (s)  having a conflict of interest;

              (t)  failing to maintain the standards of practice of the profession, including written standards;

             (u)  refusing to allow a duly appointed person to enter at a reasonable time the pharmacy in which the member is engaged in the practice of a pharmacist for the purpose of an inspection;

             (v)  contravening while engaged in the practice of a pharmacist a law, regulation or rule with respect to the practice of pharmacy or the distribution, sale or dispensing of alcoholic liquors;

            (w)  conduct or an act relevant to the practice of a pharmacist that having regard to all the circumstances would reasonably be regarded by members as disgraceful, dishonourable or unprofessional;

             (x)  disclosing of information relating to selling or dispensing of drugs to a person other than the person to whom the drugs are sold or dispensed, other than as required by law or with the consent of the person to whom the drugs are sold or dispensed;

             (y)  displaying of a lack of knowledge, skill or judgment or disregard for the welfare of the public he or she serves of a nature or to an extent that demonstrates a member is unfit to carry out the responsibilities of a pharmacist; and

             (z)  selling or dispensing an excessive or unreasonable or improper amount of a drug or medicine.

Meaning of expenses

     20. (1) Where the investigated person is found to be guilty and is ordered to pay expenses related to the investigation and hearing the word expenses means the exact total reasonably spent by the association on the case in question.

             (2)  When the discipline committee or a panel of the committee orders as part of the committee's or panel's decision that the investigated person pay expenses of the investigation and hearing, the committee shall

             (a)  itemize in reasonable detail the expenses to be paid by the investigated person; and

             (b)  stipulate the time within which payment of the expenses is to be made to the association.

Rehearing

     21. The discipline committee may, if evidence becomes available that was not available at the time of hearing or for good reason, as determined at the sole discretion of the discipline committee, was not presented at the hearing, rehear a matter already heard by it and for that purpose has the same power and authority and is subject to the same duties as it had and was subject to in connection with the original hearing.

Cancelled or suspended licence

     22. Upon receipt by the secretary‑registrar of a licence or certificate that is cancelled or suspended, the secretary‑registrar shall affix to or note on the licence or certificate the fact of the cancellation or suspension and shall retain the licence or certificate, in the case of suspension, for the period of the suspension and in the case of cancellation permanently.

Expiry of members term

     23. If a discipline committee member's term of office expires while a complaint is under consideration or within an appeal period that member shall continue to hold jurisdiction as a member of the discipline committee notwithstanding that a successor member may have been appointed.

Further inquiries

     24. The discipline committee or panel of the committee, after receiving the report of the preliminary investigation, may order the investigating person to conduct further inquiries and report back in writing to the discipline committee or panel within a specified time.

Right to examine reports

     25. The secretary‑registrar shall make available to a member whose conduct is being investigated, prior to the hearing, the opportunity to examine written reports or other records in the possession of the secretary‑registrar that is intended to be produced or form part of the evidence at the hearing.

Record of proceedings

     26. The discipline committee shall compile a record of a proceeding in which a hearing has been held, which shall include:

             (a)  the complaint by which the proceeding was commenced;

             (b)  the notice of a hearing;

             (c)  all documentary evidence filed with the discipline committee;

             (d)  the transcript, if there is one, of the oral evidence given at the hearing; and

             (e)  the findings of the discipline committee and the reasons for the findings.

Hospital pharmacy standards

     27. (1) Hospital pharmacists shall adhere to the Standards of Practice for Hospital Pharmacies as proposed by the committee of hospital pharmacists and approved by the council.

             (2)  All hospital pharmacies shall be supplied with a copy of the Standards of Practice for Hospital Pharmacies as approved by the council from time to time.

Continuing education

     28. (1) Commencing January 1, 1998, and continuing each year after, continuing education units, as determined by the council, shall be required for re‑licence of all active licensed pharmacists.

             (2)  The education committee appointed by the council shall make recommendations to the council with respect to continuing education requirements for re‑licence.

             (3)  The council may approve the recommendations made by the education committee and may determine other requirements with respect to continuing education.

             (4)  Upon written notice being provided to all members by ordinary mail the continuing education requirements determined by the council shall be mandatory for re‑licence for the period stated in the notice.

Commencement

     29. These regulations come into force on January 1, 1997.