Versions

[38] Bill 108 Original (PDF)

Bill 108 2006

An Act to monitor the
prescribing of certain drugs

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

Definitions

1.  In this Act,

"administrator" means the agency or person designated by the Minister to administer the program; ("administrateur du programme")

"board" means the Ontario Prescription Monitoring Board established by this Act; ("commission")

"College of Dental Surgeons" means the Royal College of Dental Surgeons of Ontario; ("Ordre des chirurgiens dentistes")

"College of Pharmacists" means the Ontario College of Pharmacists; ("Ordre des pharmaciens")

"College of Physicians and Surgeons" means the College of Physicians and Surgeons of Ontario; ("Ordre des médecins et chirurgiens")

"director" means a director of the board; ("administrateur")

"licensing authority" means the College of Physicians and Surgeons, the College of Pharmacists, the Royal College of Dental Surgeons of Ontario or other professional licensing body designated as a licensing authority by the regulations; ("organisme chargé de la délivrance des permis")

"member" means a person who is registered with a licensing authority and holds a licence; ("membre")

"Minister" means the Minister of Health and Long-Term Care; ("ministre")

"monitored drugs" means those drugs designated by the regulations as being subject to the program; ("médicament contrôlé")

"non-nominal data" means data that does not contain any personal identifiers; ("données non-nominales")

"personal information" means personal information as defined in the Freedom of Information and Protection of Privacy Act; ("renseignements personnels ")

"pharmacist" means a person licensed to practise pharmacy pursuant to the Pharmacy Act, 1991; ("pharmacien")

"prescriber" means a person who is entitled under the laws of Ontario to prescribe monitored drugs; ("personne autorisée à prescrire des médicaments")

"program" means the prescription-monitoring program established and operated by the board; ("programme")

"registrar" means a person holding the office of the registrar, or its equivalent, for a licensing authority; ("registrateur")

"resident" means a resident as defined in the regulations made under the Health Insurance Act. ("résident")

Board established

2.  There is hereby constituted a body corporate to be known in English as the Ontario Prescription Monitoring Board and in French as Commission ontarienne de surveillance pharmaceutique.

Power of board

3.  The board has the capacity, rights, powers and privileges of a natural person.

Board to establish prescription-monitoring program

4.  (1)  The board shall establish and operate a prescription-monitoring program for Ontario.

Objects of program

(2)  The objects of the program are to promote,

(a) the appropriate use of monitored drugs; and

(b) the reduction of the abuse or misuse of monitored drugs.

Other duties of board

5.  The board shall,

(a) recommend drugs for designation by the Lieutenant Governor in Council as monitored drugs to further the objects of the program;

(b) evaluate the effectiveness of the program in furthering its objects;

(c) provide policy direction to the administrator regarding the program;

(d) make recommendations to the Lieutenant Governor in Council respecting regulations that the board considers necessary or advisable to carry out the program effectively;

(e) provide advice and recommendations to the Minister; and

(f) perform other duties and functions assigned to it by the Minister.

Composition of board

6.  (1)  The board consists of,

(a) three directors, each of whom represents one of the licensing authorities and is nominated by the governing body of that licensing authority and appointed by the Lieutenant Governor in Council;

(b) the Registrar of the College of Physicians and Surgeons or a designate of the Registrar;

(c) the Registrar of the College of Dental Surgeons or a designate of the Registrar;

(d) the Registrar of the College of Pharmacists or a designate of the Registrar;

(e) two directors appointed by the Lieutenant Governor in Council who are not members of a licensing authority and who are not in a position of real or perceived conflict of interest; and

(f) two non-voting directors from the Ministry of Health and Long-Term Care appointed by the Lieutenant Governor in Council.

Where director must be a member

(2)  If a registrar or designate who holds office pursuant to clause (1) (b), (c) or (d) is not a member of the licensing authority with respect to which the registrar or designate holds office, the director appointed for that licensing authority pursuant to clause (1) (a) must be a member of that licensing authority.

Term of office

(3)  Each director holds office for a term of three years and may be reappointed.

Same

(4)  Despite subsection (3),

(a) the terms of office for the directors appointed pursuant to clause (1) (a) upon the first appointment of directors to the board shall be, as determined by the Lieutenant Governor in Council,

(i) two years for two of those directors, and

(ii) three years for one of those directors;

(b) the terms of office for the directors appointed pursuant to clause (1) (e) upon the first appointment of directors to the board shall be, as determined by the Lieutenant Governor in Council,

(i) two years for one of those directors, and

(ii) three years for one of those directors;

(c) if a director appointed pursuant to clause (1) (b), (c) or (d) or 7 (b) is a registrar, the director holds office until such time as the director ceases to be a registrar or appoints a designate to hold the office; and

(d) if a director appointed pursuant to clause (1) (b), (c) or (d) or 7 (b) is a designate of a registrar, the director holds office for the term specified by the registrar that appointed the designate or until such time as the registrar ceases to be a registrar.

Same

(5)  Despite subsections (3) and (4), directors continue to hold office until their successors are appointed.

Vacancy

(6)  Where a vacancy occurs during a director's term of office, a person shall be appointed in that director's place for the unexpired portion of the term.

Same

(7)  A vacancy does not impair the right of the remaining directors to act.

Expansion of number of directors

7.  In the event that an additional professional licensing body is designated by the regulations as a licensing authority, the number of directors of the board shall be expanded by the regulations to include,

(a) one director who is nominated by the governing body of the licensing authority and appointed by the Lieutenant Governor in Council; and

(b) the registrar of the licensing authority or a designate of the registrar.

Chair and vice-chair

8.  (1)  The board shall appoint two of the directors appointed pursuant to clauses 6 (1) (a), (b), (c) or (d) or section 7 to be the chair and the vice-chair of the board.

Terms of office

(2)  The chair and the vice-chair hold office for terms not exceeding three years, as determined by the board, and may be reappointed.

Reimbursement of costs

9.  A director or a member of a committee or subcommittee of the board shall be reimbursed as prescribed by the regulations for such reasonable expenses actually incurred in carrying out duties as a director or a member of a committee or a subcommittee of the board.

Board meetings

10.  The board shall meet at least twice a year.

Administrator

11.  (1)  The Minister shall appoint an administrator.

Duties of administrator

(2)  The administrator shall,

(a) administer the program to assist the board in carrying out its duties under section 5;

(b) monitor prescribing practices and dispensing practices respecting the monitored drugs;

(c) assist the board in evaluating the effectiveness of the program;

(d) provide information, professional consultation and assistance to licensing authorities about the prescribing and dispensing of monitored drugs as requested by the licensing authorities;

(e) monitor the use of monitored drugs by residents and, if the administrator is satisfied that the release of such information furthers the objects of the program, report inappropriate use to,

(i) an appropriate law enforcement agency pursuant to subsection 22 (1),

(ii) an appropriate licensing authority pursuant to subsection 22 (2), or

(iii) a pharmacist or prescriber;

(f) provide reports to the board respecting the results of the monitoring carried out pursuant to clauses (b) and (e);

(g) provide information and professional consultation and assistance to prescribers and pharmacists respecting the prescribing and dispensing of monitored drugs;

(h) educate prescribers and pharmacists about appropriate prescribing and dispensing of monitored drugs;

(i) respond to inquiries from the public with respect to the program; and

(j) report to the board, the Minister and licensing authorities on new and emerging prescribing patterns for monitored drugs in all or part of Ontario and other jurisdictions as those patterns become known to the administrator.

Collection and dissemination of information

(3)  The administrator may collect, compile and disseminate information the administrator considers necessary in accordance with this Act for the purpose of,

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

(b) evaluating the effectiveness of the program.

Program manager

(4)  The administrator shall appoint a manager of the program and seek input from the board when appointing the manager.

Acts of manager deemed actions of administrator

(5)  Any actions of the manager of the program made in respect of this Act are deemed to be the actions of the administrator.

Business plan

12.  The administrator shall prepare a business plan for the program in the form prescribed by the Minister for approval by the board and, on a date fixed by the Minister, the board shall submit the business plan to the Minister.

Financial statements and reports

13.  (1)  The board shall, in the form and with the content required by the Minister, provide to the Minister,

(a) through the administrator, annual financial statements; and

(b) such other reports as are required by the Minister.

Privacy policies

(2)  Subject to the approval of the Minister, the board shall establish policies with respect to privacy and confidentiality regarding information held by the program.

Annual report

(3)  The board shall submit to the Minister an annual report on its activities and the Minister shall table the annual report before the Assembly if it is sitting or, if it is not, during the next ensuing sitting.

Same, explanation of addition or removal or drugs

(4)  The annual report shall set out the reasons why a drug has been added to or removed from the program.

Board not a Crown agent

14.  (1)  The board is not an agent of Her Majesty in right of Ontario.

Same, board employees

(2)  A person employed or engaged by the board is not an officer, servant or agent of Her Majesty in right of Ontario.

By-laws

15.  The board may make by-laws,

(a) providing for the management of its affairs;

(b) providing for the holding of board meetings, quorum requirements and the conduct of meetings;

(c) fixing the time and place for regular meetings of the board, determining by whom meetings may be called, regulating the conduct of meetings, providing for emergency meetings and respecting the notice required in respect of meetings;

(d) providing for the appointment of such committees or subcommittees as the board considers necessary;

(e) respecting the composition, powers and duties of committees or subcommittees and providing for the holding and conduct of meetings of such committees or subcommittees.

Duty to comply: pharmacists and prescribers

16.  Pharmacists and prescribers shall comply with this Act and the regulations in relation to the prescribing and dispensing of monitored drugs.

Provision of information

17.  Upon the request of the administrator, prescribers, pharmacists or any other body or person shall provide to the administrator any information, including medical records, the administrator reasonably requires to achieve the objects of the program.

Use of information

18.  Information received by the administrator, any person employed by the administrator pursuant to this Act or the board shall only be used in accordance with this Act and the regulations and not for any other purpose.

Freedom of Information and Protection of Privacy Act

19.  Despite the Freedom of Information and Protection of Privacy Act, the administrator may release information with respect to monitored drugs and personal information with respect to a resident who has a prescription for monitored drugs to a prescriber, a pharmacist, a licensing authority or other body or person as is reasonable to achieve the objects of the program.

Communication of information by certain employees

20.  Information communicated to the administrator or the board by persons employed in the administration of the Health Insurance Act is deemed to be information communicated in accordance with that Act.

Non-nominal data

21.  (1)  Any data provided to the Minister, the Lieutenant Governor in Council or the public with respect to the program pursuant to this Act shall be non-nominal data.

Exception for resident

(2)  Despite subsection (1), a resident may have access to the resident's own personal information with respect to the program.

Communication of information to law enforcement agency

22.  (1)  If the administrator has reasonable grounds to believe that an offence has been committed contrary to the Controlled Drugs and Substances Act (Canada) or the Criminal Code (Canada) or successor legislation, information in the possession of the administrator in respect of such offence may be communicated to the appropriate law enforcement agency by the administrator or such person as may be designated by the administrator.

Administrator's complaint to licensing authority

(2)  The administrator may, at any time, file a complaint with a licensing authority regarding the activities of a member of that licensing authority if the administrator has reason to believe that the member may be practising in a manner that is inconsistent with the objects of the program.

Basis of complaint to be given

(3)  If the administrator files a complaint, the administrator shall provide the licensing authority with all relevant information on which the complaint is based.

Immunity

23.  (1)  No action or other proceeding for damages shall be brought against a licensing authority, the administrator or the board, any of their officers, directors or employees, any member of a committee or subcommittee of the board or a prescriber or pharmacist for any act done in good faith in the execution or intended execution of the person's powers or duties or for any neglect or default in the execution in good faith of the person's powers or duties.

Same, disclosure of information

(2)  No action shall be brought against any person for the disclosure of any information or any document or anything in the document pursuant to this Act if such disclosure is made in good faith.

Same

(3)  Without limiting the generality of subsection (2), no action for damages shall be brought against a prescriber or pharmacist or other person for disclosing any information, books, records, papers and other documents in their possession or control when disclosed in good faith pursuant to this Act.

Penalties

24.  (1)  A person who contravenes this Act or the regulations is guilty of an offence and is liable on conviction to a fine of not less than $1,000 and not more than $10,000.

Fines payable to board

(2)  All fines payable under this section as a result of a prosecution by or on behalf of the board belong to the board.

Consent required to institute proceeding

(3)  The chair of the board may commence a proceeding under this Act with the consent of the Minister.

Definition

25.  (1)  In this section,

"data" includes all documents and information, both physical and electronic, relating to the work of the board, the program and the administrator.

Ownership of and access to data on cessation of board operations

(2)  In the event that the board ceases to operate,

(a) ownership of the data shall be transferred to the Minister; and

(b) the Minister shall allow the licensing authorities access to the data for the purposes of promoting the appropriate use of monitored drugs and reducing the abuse and misuse of monitored drugs.

Regulations

26.  The Lieutenant Governor in Council may make regulations,

(a) providing for the implementation of the program;

(b) respecting a computerized information system to support the program;

(c) designating drugs that are subject to the program as monitored drugs;

(d) incorporating by reference, in whole or in part, a written standard, rule, regulation, guideline, designation, code, document or list, including a list of designated drugs, as it reads on a particular day;

(e) respecting the requirements that must be met for the purposes of the program before a prescriber may prescribe or a pharmacist may dispense monitored drugs;

(f) prescribing the types of forms and records to be used pursuant to this Act and the regulations;

(g) prescribing the duties, functions and responsibilities of the administrator;

(h) respecting the types of records and accounts to be kept by the administrator;

(i) respecting the types of reports to be made by the administrator to the Minister and the board;

(j) respecting when and in what form information must be provided by a pharmacist or a prescriber or other body or person to the administrator with respect to the program;

(k) respecting the release of information to a pharmacist, a prescriber and to a licensing authority or to any other body or person with respect to the program;

(l) designating additional professional licensing bodies as licensing authorities;

(m) providing for the expansion of the number of the directors of the board pursuant to section 7;

(n) respecting the reimbursement of directors and committee and subcommittee members for expenses;

(o) respecting any matter that the Lieutenant Governor in Council considers necessary or advisable to carry out effectively the intent and purpose of this Act.

Commencement

27.  (1)  Subject to subsection (2), this Act comes into force on the day it receives Royal Assent.

Same

(2)  Sections 1 to 26 come into force on a day to be named by proclamation of the Lieutenant Governor.

Short title

28.  The short title of this Act is the Prescription Monitoring Act, 2006.

EXPLANATORY NOTE

The purpose of the Bill is to establish a program for monitoring the prescription of certain drugs, to be designated by regulation of the Lieutenant Governor in Council, in order to promote the appropriate use of the monitored drugs and the reduction of their abuse and misuse. The Bill proposes the creation of the Ontario Prescription Monitoring Board composed of directors that include representatives of the College of Physicians and Surgeons of Ontario, the Royal College of Dental Surgeons of Ontario and the Ontario College of Pharmacists, as well as persons appointed by the Lieutenant Governor in Council who are not members of these licensing authorities.

The program is to be administered by an administrator. The administrator's duties are set out in subsection 11 (2). They include assisting the board in carrying out its duties, monitoring prescribing and dispensing practices respecting the monitored drugs and the use of monitored drugs by residents. The administrator may also report inappropriate use of such drugs to an appropriate law enforcement agency or licensing authority, a pharmacist or a person who is entitled under Ontario law to prescribe monitored drugs. Section 16 requires such prescribers and pharmacists to comply with the Act and the regulations with respect to the prescribing and dispensing of monitored drugs. Section 17 allows the administrator to require that prescribers and pharmacists provide information, including medical records, that the administrator reasonably requires to achieve the objects of the program. Subsection 23 (2) prevents an action being instituted against a person who, acting in good faith, discloses information or a document pursuant to the Act.