Bill 8 - Prescription Monitoring Act

BILL 8

Prescription Monitoring Act

Her Majesty, by and with the advice and consent of the Legislative Assembly of New Brunswick, enacts as follows:

Definitions

1 The following definitions apply in this Act.

“advisory committee” means the Prescription Monitoring Program Advisory Committee established under section 9. (comité consultatif)

“Director” means the Director of the Prescription Monitoring Program appointed under section 5. (directeur)

“licensed pharmacist” means an individual who is registered as a pharmacist with the New Brunswick Pharmaceutical Society and who holds a licence issued under section 31 of the Pharmacy Act. (pharmacien titulaire de permis)

“licensing authority” means the following bodies with statutory responsibility for the discipline of health care providers or to regulate the quality or standards of professional services provided by health care providers: (organisme chargé de la délivrance des permis)

(a) the College of Physicians and Surgeons of New Brunswick;

(b) the Dental Society of New Brunswick;

(d) any other body designated by regulation.

“member”, in relation to a licensing authority, means a person who is registered with a licensing authority and who holds a licence issued by that licensing authority. (membre)

“Minister” means the Minister of Health. (ministre)

“monitored drug” means a drug that is in a class of drugs designated by the regulations. (médicament contrôlé)

“participant” means a prescriber or licensed pharmacist registered in the program under section 6. (participant)

“patient monitoring agreement” means a written agreement between a participant and a patient where the patient agrees to comply with the terms and conditions of the agreement with respect to any monitored drug. (entente de surveillance du patient)

“personal health information” means personal health information as defined in the Personal Health Information Privacy and Access Act. (renseignements personnels sur la santé)

“pharmacy” means a pharmacy with respect to which a valid certificate of accreditation has been issued under the Pharmacy Act, other than a pharmacy designated in the regulations. (pharmacie)

“prescriber” means an individual who is entitled under an Act of the Legislature, an Act of another province or territory of Canada or an Act of the Parliament of Canada to prescribe monitored drugs, except an individual who is entitled under the Veterinarians Act to prescribe monitored drugs or under any similar Act of another province or territory of Canada or of the Parliament of Canada. (prescripteur)

“program” means the Prescription Monitoring Program established under section 3. (programme)

“program information” includes the information submitted by a pharmacy under section 10 and the information with respect to a patient monitoring agreement that is filed with the Director under this Act. (renseignements aux fins d’application du programme)

Conflict

2 If there is a conflict between a provision of this Act and a provision of the Personal Health Information Privacy and Access Act or any provision of an Act of the Legislature with respect to the protection of personal health information, this Act prevails.

Prescription monitoring program

3 There is established a Prescription Monitoring Program.

Purposes of the program

4 The program shall provide prescribers and licensed pharmacists the ability to monitor the prescribing or dispensing of monitored drugs to individuals or the use of monitored drugs by individuals through the use of a real time information network for the following purposes:

(a) to promote optimal prescribing and utilization of monitored drugs for legitimate medical purposes;

(b) to enable early identification of individuals at risk for addiction; and

Director

5(1) The Minister shall appoint an employee of the Civil Service, as defined in the Civil Service Act, as Director of the Prescription Monitoring Program.

5(2) The Director may designate persons to act on the Director’s behalf.

5(3) The Director shall

(a) prepare a list of classes of drugs that may be designated as monitored drugs,

(b) evaluate patterns in the prescribing and dispensing of monitored drugs,

(d) inform the advisory committee with respect to information relating to the program,

(e) evaluate the effectiveness of the program,

(f) provide public education on the program’s objectives and parameters, and

(g) perform or exercise any additional power or duty assigned by the Minister or that is prescribed by regulation.

Registration in the program

6(1) On application to the Director, the Director shall register in the program a prescriber who prescribes monitored drugs or a licensed pharmacist who dispenses monitored drugs.

6(2) An application shall be made in the form and manner required by the Director.

Information respecting the program

7 A participant shall have access to program information and to other information prescribed by regulation.

Information network

8(1) The Minister shall establish and maintain a real time information network to monitor the prescribing, dispensing or use of monitored drugs.

8(2) Subject to this Act and the regulations, the Minister may, with respect to the information network,

(a) establish requirements for information that must be supplied to the network and the format in which the information must be supplied and may make those requirements known electronically to participants and pharmacies,

(b) establish rules, procedures and guidelines respecting the use of the information network, and

(c) establish any other requirement, rule, procedure or guideline in order to ensure the proper functioning of the information network.

8(3) The Minister may delegate, in writing, any power or duty conferred or imposed on the Minister under subsections (1) and (2) to any person.

8(4) In a delegation under this section, the Minister shall

(a) establish the manner in which the delegate is to exercise the delegated authority, and

(b) impose on the delegate any limitations, terms, conditions and requirements that the Minister considers appropriate.

8(5) The Minister may revoke, in whole or in part, a delegation under this section.

8(6) A delegate under this section shall exercise the delegated authority in the manner established in, and in accordance with any limitations, terms, conditions and requirements imposed in the delegation.

8(7) A delegate under this section shall comply with the same requirements concerning the protection, retention and secure destruction of personal health information that the Minister is required to comply with under the Personal Health Information Privacy and Access Act.

8(8) Subject to this Act and the regulations, no person other than a participant or a pharmacy shall submit information to the information network.

8(9) Subject to this Act and the regulations, the Minister shall determine the persons who may have access to the information network.

Advisory committee

9(1) There is established an advisory committee known as the Prescription Monitoring Program Advisory Committee consisting of the following members:

(a) the Director;

(b) one individual appointed by the Minister for each licensing authority nominated by each licensing authority;

(d) a licensed pharmacist appointed by the Minister;

(e) a person employed in the Department of Health appointed by the Minister;

(f) one individual appointed by the Minister who has never worked as a health care provider as that term is defined in the Personal Health Information Privacy and Access Act and has never been a member of a licensing authority;

(g) no more than 2 individuals appointed by the Minister nominated by a person delegated any power or duty under this Act; and

(h) no more than 2 other individuals appointed by the Minister.

9(2) The advisory committee shall make recommendations and advise the Minister on

(a) what classes of drugs to be considered for designation as monitored drugs,

(b) policy and other matters related to the program,

(d) issues arising from the collection and reporting of information under the program, and

(e) any other matter established by regulation.

Requirements of pharmacies

10(1) Until the commencement of subsection (2), a pharmacy may submit to the Minister personal health information with respect to an individual to whom a monitored drug is dispensed.

10(2) When dispensing a monitored drug to an individual, a pharmacy shall submit to the information network, in the form and in the manner required by the Director, the following information:

(a) the Medicare number of the individual to whom a monitored drug was prescribed or any other identifier prescribed by regulation;

(b) the first name, surname, date of birth, gender and address of the individual to whom the monitored drug was prescribed;

(d) the name, address and telephone and facsimilie number of the pharmacy dispensing the monitored drug;

(e) the first name, surname and licence number of the licensed pharmacist who dispensed the monitored drug;

(f) the name, strength and quantity of the monitored drug;

(g) the identity of the manufacturer of the monitored drug;

(h) the date on which the monitored drug is dispensed; and

(i) any other information prescribed by regulation.

Duties of licensing authorities

11 A licensing authority that revokes, suspends or otherwise alters the privileges of a member or pharmacy with respect to the prescribing or dispensing of a monitored drug shall notify the Director in writing within 2 days after the date the licence was revoked, suspended or altered, as the case may be.

Patient monitoring agreement

12 A participant may, with the consent of his or her patient, file with the Director the information prescribed by regulation with respect to a patient monitoring agreement.

Administration

13 The Minister is responsible for the administration of this Act and may designate one or more persons to act on the Minister’s behalf.

Agreements

14 The Minister may enter into agreements with any institution, agency, person or other Minister of the Crown for the administration of the program and the institution, agency or person shall comply with the agreement.

Actions done in good faith

15 No action or other proceeding lies against the Province of New Brunswick, the Minister, the Director, the advisory committee, a licensing authority, a participant, a pharmacy, a delegate under subsection 8(3), a party to an agreement under section 14 or any other person acting under the authority of this Act for any act done in good faith in the execution or intended execution of any duty or power under this Act or for any alleged neglect or default in the execution in good faith of any such duty or power.

Prohibition

16 No person shall use or disclose to another person any program information or any other information recorded in the information network except as is necessary to carry out his or her powers or duties under this Act or the regulations.

Offences

17(1) A person who violates or fails to comply with subsection 8(8) commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category F offence.

17(2) A pharmacy that violates or fails to comply with subsection 10(2) commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category C offence.

17(3) A licensing authority that violates or fails to comply with section 11 commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category C offence.

17(4) An institution, agency or person who has entered into an agreement under section 14 and who violates or fails to comply with the agreement commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category F offence.

17(5) A person who violates or fails to comply with section 16 commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category F offence.

17(6) Subject to subsection (7), a person who violates or fails to comply with a provision of the regulations commits an offence punishable under Part II of the Provincial Offences Procedure Act as a category C offence.

17(7) A person who violates or fails to comply with a provision of the regulations in respect of which a category has been prescribed under paragraph 18(o) commits an offence of the category prescribed by regulation.

17(8) If an offence under this Act or the regulations continues for more than one day,

(a) the minimum fine that may be imposed is the minimum fine set by the Provincial Offences Procedure Act multiplied by the number of days during which the offence continues, and

(b) the maximum fine that may be imposed is the maximum fine set by the Provincial Offences Procedure Act multiplied by the number of days during which the offence continues.

17(9) No prosecution for an offence under this Act or the regulations shall be commenced after 2 years from the date of the discovery of the alleged offence.

Regulations

18 The Lieutenant-Governor in Council may make regulations

(a) prescribing a body for the purposes of the definition “licensing authority” in section 1;

(b) designating a class of drugs for the purposes of the definition “monitored drug” in section 1;

(d) incorporating by reference, in whole or in part, a list of classes of drugs for the purposes of designating a class of drugs as monitored drugs, as it reads on a fixed day or as it is amended from time to time;

(e) prescribing the powers or duties of the Director under paragraph 5(3)(g);

(f) prescribing other information in relation to the program to which a participant shall have access;

(g) respecting the information network, including, but not limited to, the persons who may have access to the information network, the information to be submitted to or recorded by the information network, the provision of threshold alerts, patient exception status alerts and the triggering of those alerts;

(h) respecting the appointment of the advisory committee, including the size, composition, the term of office, the procedures and the quorum of the advisory committee;

(i) respecting the designation of the chair and vice-chair of the advisory committee;

(j) respecting conflicts of interest pertaining to members of the advisory committee, including the circumstances that constitute a conflict of interest, the disclosure of a conflict of interest and the manner in which a conflict of interest is to be dealt with;

(k) fixing the remuneration of members of the advisory committee and the expenses to be paid to members of advisory committees while attending meetings and otherwise carrying out their prescribed duties;

(l) establishing any other matter for the purposes of paragraph 9(2)(e);

(m) prescribing the identifier referred to in paragraph 10(2)(a) of an individual to whom a monitored drug is prescribed;

(n) prescribing any other information under paragraph 10(2)(i) to be submitted to the information network by a pharmacy;

(o) prescribing the information with respect to a patient monitoring agreement to be filed with the Director for the purposes of section 12;

(p) prescribing, in respect of offences under the regulations, categories of offences for the purposes of Part II of the Provincial Offences Procedure Act;

(q) respecting any other matter or thing necessary or advisable to carry out the intent of this Act.

Review of this Act

19 Within 4 years after the commencement of this Act, the Minister shall undertake a comprehensive review of the operation of this Act and shall, within one year after the review is undertaken or within such further time as the Legislative Assembly may allow, submit a report on the review to the Legislative Assembly.

COMMENCEMENT

Commencement

20 This Act or any provision of it comes into force on a day or days to be fixed by proclamation.