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Newfoundland and Labrador
Regulation 2008


NEWFOUNDLAND AND LABRADOR REGULATION 57/08

NEWFOUNDLAND AND LABRADOR
REGULATION 57/08

Pharmaceutical Services Regulations
under the
Pharmaceutical Services Act

(Filed October 8, 2008)

Under the authority of section 52 of the Pharmaceutical Services Act, I make the following regulations.

Dated at St. Johnís, October 7, 2008.

Ross Wiseman
Minister of Health and Community Services

REGULATIONS

Analysis


††††††† 1. Short title

††††††† 2. Definitions

††††††† 3. Benefits list

††††††† 4. Prescription of drugs on tamper resistant pads

††††††† 5. Information required

††††††† 6. Refills

††††††† 7. Officers

††††††† 8. Review committee appointed

††††††† 9. Terms of reference

††††† 10. Duties

††††† 11. Rules and procedures


Short title

††††††† 1. These regulations may be cited as the Pharmaceutical Services Regulations.

Definitions

††††††† 2. In these regulations

†††††††††††† (a)"Act" means the Pharmaceutical Services Act;

†††††††††††† (b)"benefits list" means the benefits list established by the minister and contained in the Coverage Status Table;

†††††††††††† (c)"committee" means the Pharmaceutical Audit Review Committee appointed under section 34 of the Act;

†††††††††††† (d)"formulary" means the Interchangeable Drug Products Formulary established by the minister; and

†††††††††††† (e)"program" means the Newfoundland and Labrador Prescription Drug Program.

Benefits list

††††††† 3. (1) A benefits list is established for drugs and related products which may be covered under the program in accordance with a person's eligibility for those benefits.

†††††††††††† (2)The benefits list as contained in the Coverage Status Table is on file with the minister and may be obtained from the offices of the program.

†††††††††††† (3)The effective date of coverage for drugs and related products for which a person may be eligible shall be specified in the Coverage Status Table.

Prescription of drugs on tamper resistant pads

††††††† 4. (1) A list of drugs is established, the prescription of which shall require the use of tamper resistant drug pads.

†††††††††††† (2)The list referred to in subsection (1) is on file with the minister and may be obtained from the offices of the program.

Information required

††††††† 5. (1) In prescribing a drug for which the use of a tamper resistant drug pad is required, the following information shall be included:

†††††††††††† (a)the complete name and address of the person for whom the drug is prescribed;

†††††††††††† (b)the medical care insurance number of the person for whom the drug is prescribed, except where the prescription is made under the authority of the Veterinary Medical Act, 2004;

†††††††††††† (c)notwithstanding paragraph (b), where a person for whom a drug is prescribed is

††††††††††††††††††††† (i)covered under the health insurance plan of another province or territory, the person's health insurance number, or

†††††††††††††††††††† (ii)a member of the Canadian Forces or the Royal Canadian Mounted Police, the member service number of that person;

†††††††††††† (d)the name of the drug being prescribed, the quantity, strength and dosage of the drug and specific instructions for the use of that drug;

†††††††††††† (e)the prescriber's license number clearly printed; and

††††††††††††† (f)the signature of the prescriber and the date of the prescription in the format DD/MM/YY.

†††††††††††† (2)The quantity and dosage of drugs prescribed on tamper resistant drug pads shall be entered in both written and numerical forms.

†††††††††††† (3)A maximum of 2 drugs shall be entered on each prescription form.

†††††††††††† (4)Approved prescription pads shall contain a pre-printed serial number and prescriber identification information.

Refills

††††††† 6. (1) A narcotic which has been prescribed using a tamper resistant drug pad shall not be refilled.

†††††††††††† (2)Notwithstanding subsection (1), drugs prescribed using tamper resistant drug pads may be part filled where

†††††††††††† (a)the total quantity of the drug;

†††††††††††† (b)the quantity of each fill; and

†††††††††††† (c)the time interval between fills

is specifically indicated on the prescription.

†††††††††††† (3)Where a drug prescribed using a tamper resistant drug pad has been part filled under subsection (2), a pharmacist shall make a†† record of that action in the patientís file.

Officers

††††††† 7. An employee of the department is an officer for the purpose of the Act.

Review committee appointed

††††††† 8. (1) The Pharmaceutical Audit Review Committee is appointed to review and advise upon matters referred to it by the minister under Part VI of the Act.

†††††††††††† (2)The committee shall be composed of 7 members:

†††††††††††† (a)the director of the Pharmaceutical Services Division;

†††††††††††† (b)a physician of the Physician Services Division;

†††††††††††† (c)the manager of program policy and professional services at the Pharmaceutical Services Division;

†††††††††††† (d)3 pharmacists who are not employees of the department appointed by the minister; and

†††††††††††† (e)a chartered accountant, certified general accountant or certified management accountant appointed by the minister.

†††††††††††† (3)The member appointed under paragraph (2)(e) shall chairthe committee.

†††††††††††† (4)Members of the committee referred to in paragraphs (2)(d) and (e) may serve a term as prescribed in their appointment to a maximum of 3 years, but where a member's term of office has expired, that member may continue to be a member of the committee until replaced or reappointed.

†††††††††††† (5)Remuneration of members of the committee appointed under paragraphs (2)(d) and (e) shall be according to Treasury Board guidelines.

†††††††††††† (6)The committee shall meet at the call of the chair.

†††††††††††† (7)Quorum of the committee is 4 or more members, provided 2 external members and one departmental member are present.

Terms of reference

††††††† 9. (1) The terms of reference for the committee shall be, where the minister refers an audit of a provider's billings to the program to the committee for professional review, to carry out that review and provide recommendations on it to the minister.

†††††††††††† (2)The committee may, where it considers it is necessary, invite legal counsel to attend and provide advice to the committee in its review of a matter, and any person so invited shall comply with subsection 10(1).

Duties

††††† 10. (1) Matters reviewed by the committee and the deliberations of the committee shall be held in confidence and, where possible, matters shall be reviewed and considered using non-identifying information.

†††††††††††† (2)The committee shall, in its review and recommendations, abide by and comply with the Act, any regulations under the Act, the policies of the department and any terms and conditions of applicable provider agreements.

Rules and procedures

††††† 11. The committee may establish rules and procedures for its operations.