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NEWFOUNDLAND AND LABRADOR
REGULATION 78/19

Prescription Monitoring Regulations
under the
Prescription Monitoring Act

(Filed October 31, 2019)

Under the authority of section 22 of the Prescription Monitoring Act , I make the following regulations.

Dated at St. John’s, October 30, 2019.

Dr. John Haggie
Minister of Health and Community Services

REGULATIONS

Analysis



Short title

1.  These regulations may be cited as the Prescription Monitoring Regulations .

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Definitions

        2. In these regulations

             (a)  "Act" means the Prescription Monitoring Act ;

             (b)  "advisory committee" means the committee established under section 3;

             (c)  "consultants committee" means the committee established under section 6;

             (d)  "department" means the department presided over by the minister;                  

             (e)  "Newfoundland and Labrador Centre for Health Information" means the Newfoundland and Labrador Centre for Health Information continued under the Centre for Health Information Act, 2018 ;

             (f)  "nurse practitioner" means a nurse practitioner as defined in the Registered Nurses Act, 2008 ;

             (g)  "pharmacist" means a pharmacist as defined in the Pharmacy Act, 2012 ; and

             (h)  "physician" means a medical practitioner as defined in the Medical Act, 2011 .

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Advisory committee

        3. (1) The advisory committee is established.

             (2)  The advisory committee shall provide advice and recommendations regarding

             (a)  drugs or classes of drugs to be monitored by the program;

             (b)  policies developed for the operation and management of the program;

             (c)  reports generated from the pharmacy network data;

             (d)  program risk management and data quality issues; and

             (e)  those matters referred to the advisory committee by the minister or his or her delegate.

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Advisory committee members

        4. (1) The advisory committee shall consist of

             (a)  a physician appointed by the minister from a list of physicians submitted by the College of Physicians and Surgeons of Newfoundland and Labrador ;

             (b)  a physician appointed by the minister from a list of physicians submitted by the Newfoundland and Labrador Medical Association;

             (c)  a pharmacist appointed by the minister from a list of pharmacists submitted by the Newfoundland and Labrador Pharmacy Board;            

             (d)  a pharmacist appointed by the minister from a list of pharmacists submitted by the Pharmacists' Association of Newfoundland and Labrador ;

             (e)  a nurse practitioner appointed by the minister from a list of nurse practitioners submitted by the College of Registered Nurses of Newfoundland and Labrador;

             (f)  a person representing the public interest and appointed in accordance with the Public Service Commission Act ;

             (g)  a member of the Royal Newfoundland Constabulary appointed by the Royal Newfoundland Constabulary;

             (h)  a member of the Royal Canadian Mounted Police appointed by the Royal Canadian Mounted Police;

              (i)  a representative of the College of Physicians and Surgeons of Newfoundland and Labrador appointed by the College of Physicians and Surgeons of Newfoundland and Labrador;

              (j)  a representative of the Newfoundland and Labrador Dental Board appointed by the Newfoundland and Labrador Dental Board;

             (k)  a representative of the College of Registered Nurses of Newfoundland and Labrador appointed by the College of Registered Nurses of Newfoundland and Labrador;

              (l)  a representative of the Newfoundland and Labrador Pharmacy Board appointed by the Newfoundland and Labrador Pharmacy Board;

           (m)  at least one employee of the Newfoundland and Labrador Centre for Health Information appointed by the chief executive officer of the Newfoundland and Labrador Centre for Health Information;

             (n)  at least one employee of the Department of Justice and Public Safety appointed by the deputy minister of the Department of Justice and Public Safety;

             (o)  at least one employee of the department appointed by the deputy minister of the department; and

             (p)  the deputy minister of the department or his or her designate.

             (2)  Where an organization referred to in paragraph (1)(a), (b), (c), (d) or (e) fails to provide a list of names in accordance with paragraph (1)(a), (b), (c), (d) or (e) within 30 days of the minister's request to provide the list, the minister may appoint a physician, pharmacist or nurse practitioner, as the case may be, notwithstanding that a list has not been provided by the organization.

             (3)  The chairperson of the advisory committee shall be the deputy minister of the department or his or her designate.

             (4)  The members of the advisory committee appointed under paragraphs (1)(a) to (f) shall be appointed for a term of 3 years and are eligible for reappointment.

             (5)  Where the term of office of a member appointed under paragraphs (1)(a) to (f) expires, the member shall continue to be a member until replaced.

             (6)  A person appointed under paragraphs (1)(a) to (f) may resign as a member by written notice to the minister.

             (7)  A person appointed under paragraphs (1)(g) to (l) may resign as a member by written notice to the organization that appointed him or her.

             (8)  Where a member resigns in accordance with subsection (7), the organization that appointed the member shall immediately appoint a member of the organization to replace the person who resigned and notify the minister, in writing, of that person's name.

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Advisory committee meetings

        5. (1) The advisory committee shall meet at least 4 times a year.

             (2)  A quorum of the advisory committee shall be 8 members of which

             (a)  one member shall be an employee of the Newfoundland and Labrador Centre for Health Information appointed under paragraph 4(1)(m);

             (b)  one member shall be the deputy minister of the department or his or her designate; and

             (c)  6 members shall be members appointed under paragraphs 4(1)(a) to (l).

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Consultants Committee

        6. (1) The consultants committee is established.

             (2)  The consultants committee shall, upon the request of the minister or his or her delegate, review reports generated from the pharmacy network data for the purpose of

             (a)  monitoring the prescribing, dispensing and use of monitored drugs; and

             (b)  identifying any unusual or potentially inappropriate activity trends.

             (3)  The consultants committee shall advise the minister or his or her delegate of the results of its monitoring of monitored drugs and may recommend one or more of the following to the minister or his or her delegate:

             (a)  that information be provided to prescribers, dispensers and patients for educational purposes;

             (b)  that an inspection be conducted under the Act;

             (c)  that information be provided to the appropriate regulatory authority;

             (d)  that information be provided to the appropriate law enforcement authority; or                     

             (e)  that no action be taken.

             (4)  In conducting its review the consultants committee may review

             (a)  de-identified prescriber, dispenser and patient profiles which depict prescribing, dispensing or use history in comparison to area and provincial averages;

             (b)  de-identified patient health information relating to prescriptions for monitored drugs including patient records, charts and reports;

             (c)  reports, statistical data and other information prepared by employees of the department or the Newfoundland and Labrador Centre for Health Information;

             (d)  evidence obtained from prescribers, dispensers and patients including sworn statements; and

             (e)  other information it determines necessary to complete its review.

             (5)  The consultants committee may, with the approval of the minister or his or her delegate, obtain the services of a person with expertise in a particular area.

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Consultants committee members

        7. (1) The consultants committee shall consist of

             (a)  a physician appointed by the minister from a list of physicians submitted by the College of Physicians and Surgeons of Newfoundland and Labrador which list shall include the name of at least one family physician;

             (b)  a physician appointed by the minister from a list of physicians submitted by the Newfoundland and Labrador Medical Association which list shall include the name of at least one family physician;

             (c)  a pharmacist appointed by the minister from a list of pharmacists submitted by the Newfoundland and Labrador Pharmacy Board which list shall include the name of at least one community pharmacist;                  

             (d)  a pharmacist appointed by the minister from a list of pharmacists submitted by the Pharmacists' Association of Newfoundland and Labrador which list shall include the name of at least one community pharmacist;                   

             (e)  a dentist appointed by the minister from a list of dentists submitted by the Newfoundland and Labrador Dental Board;

             (f)  a nurse practitioner appointed by the minister from a list of nurse practitioners submitted by the College of Registered Nurses of Newfoundland and Labrador;                    

             (g)  at least one employee of the Newfoundland and Labrador Centre for Health Information appointed by the chief executive officer of the Newfoundland and Labrador Centre for Health Information; and

             (h)  at least one employee of the department appointed by the deputy minister of the department.

             (2)  One of the persons appointed under

             (a)  paragraph (1)(a) or (b) shall be a family physician; and

             (b)  paragraph (1)(c) or (d) shall be a community pharmacist.

             (3)  Where an organization referred to in paragraph (1)(a), (b), (c), (d), (e) or (f) fails to provide a list of names in accordance with paragraph (1)(a), (b), (c), (d), (e) or (f) within 30 days of the minister's request to provide the list, the minister may appoint a physician, pharmacist, dentist or nurse practitioner, as the case may be, notwithstanding that a list has not been provided by the organization.

             (4)  The chairperson of the consultants committee shall be a person appointed under paragraph (1)(h).

             (5)  The members of the consultants committee appointed under paragraphs (1)(a) to (f) shall be appointed for a term of 3 years and are eligible for reappointment.

             (6)  Where the term of office of a member appointed under paragraphs (1)(a) to (f) expires, the member shall continue to be a member until replaced.

             (7)  A person appointed under paragraphs (1)(a) to (f) may resign as a member by written notice to the minister.

             (8)  Members of the committee who do not receive a salary from funds voted by the legislature shall be remunerated for their committee service in accordance with the Newfoundland and Labrador Centre for Health Information Guidelines on Honoraria for Clinicians.

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Consultants committee meetings

        8. (1) The consultants committee shall meet at the call of the chairperson.

             (2)  A quorum of the consultants committee shall be 6 members of which

             (a)  one member shall be an employee of the Newfoundland and Labrador Centre for Health Information appointed under paragraph 7(1)(g);

             (b)  one member shall be an employee of the department appointed under paragraph 7(1)(h); and

             (c)  4 members shall be members appointed under paragraphs 7(1)(a) to (f).

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Time periods

        9. (1) A notice required under section 9 of the Act shall be provided in writing no later than 24 hours after the decision to restrict, suspend or revoke the licence of a prescriber or dispenser has been communicated to the prescriber or dispenser.

             (2)  A person who receives a request from the minister or his or her delegate under subsection 10(2) of the Act shall respond to that request no later than 7 days from the date the person receives the request.

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