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Statutes of Newfoundland and Labrador 2017


CHAPTER P-18.2

AN ACT RESPECTING THE MONITORING OF PRESCRIPTIONS IN THE PROVINCE

(Assented to December 7, 2017)

Analysis


        1.   Short title

        2.   Interpretation

        3.   Prescription Monitoring Program

        4.   Duties of minister re: program

        5.   Powers of minister re: pharmacy network

        6.   Delegation

        7.   Duties of prescriber

        8.   Duties of dispenser

        9.   Duties of regulatory authority

      10.   Collection and disclosure of information

      11.   Inspectors

      12.   Powers of inspectors re: compliance

      13.   Report by inspector

      14.   Advisory committees

      15.   Prohibition

      16.   False or misleading information

      17.   Protection from liability

      18.   Offence

      19.   Forms

      20.   Statutory review

      21.   Lieutenant-Governor in Council regulations

      22.   Ministerial regulations

      23.   Commencement


Be it enacted by the Lieutenant-Governor and House of Assembly in Legislative Session convened, as follows:

Short title

        1. This Act may be cited as the Prescription Monitoring Act.

Interpretation

        2. (1) In this Act

             (a)  "dispenser" means a person who is entitled under the laws of the province to dispense a monitored drug directed by a prescription;

             (b)  "electronic health record" means a province-wide record of a patient’s health care history that is available electronically;

             (c)  "law enforcement authority" means

                      (i)  the Royal Canadian Mounted Police,

                     (ii)  the Royal Newfoundland Constabulary,

                    (iii)  policing agencies, including criminal intelligence operations, from other provinces, or

                    (iv)  military police employed or contracted by the Canadian Armed Forces;

             (d)  "minister" means the minister appointed under the Executive Council Act to administer this Act;

             (e)  "monitored drug" means a drug or class of drugs prescribed in the regulations;

             (f)  "personal health information" means personal health information as defined in the Personal Health Information Act;

             (g)  "pharmacy network" means the component of the electronic health record that allows dispensers to contribute to and access patient medication profiles in real-time;

             (h)  "prescriber" means a person who is entitled under the laws of the province to prescribe a monitored drug;

              (i)  "prescription" means a direction from a prescriber directing the dispensing of a monitored drug;

              (j)  "program" means the Prescription Monitoring Program established under section 3; and

             (k)  "regulatory authority" means 

                      (i)  the Association of Registered Nurses of Newfoundland and Labrador,

                     (ii)  the College of Physicians and Surgeons of Newfoundland and Labrador,

                    (iii)  the Newfoundland and Labrador Dental Board,

                    (iv)  the Newfoundland and Labrador Pharmacy Board, or

                     (v)  a professional regulating body prescribed as a regulatory authority in the regulations.

             (2)  For the purposes of this Act, "information" includes personal health information.

Prescription Monitoring Program

        3. (1) There is established a program entitled the Prescription Monitoring Program.

             (2)  The object of the program is to monitor, analyze and report information related to the prescribing and dispensing of monitored drugs in order to educate, support and assist

             (a)  individuals in the safe and appropriate use of monitored drugs by identifying and reducing instances of abuse and misuse of monitored drugs; and

             (b)  prescribers and dispensers in appropriately prescribing and dispensing monitored drugs.

Duties of minister re: program

        4. The minister shall

             (a)  administer the program;

             (b)  monitor the prescribing and dispensing of monitored drugs;

             (c)  evaluate the effectiveness of the program;

             (d)  provide information, professional consultation and assistance to the regulatory authorities relating to the prescribing and dispensing of monitored drugs;

             (e)  monitor the use of monitored drugs;

             (f)  educate prescribers and dispensers regarding the appropriate prescribing and dispensing of monitored drugs;

             (g)  educate individuals on the appropriate use of monitored drugs;

             (h)  report to regulatory authorities on new and emerging prescribing patterns for monitored drugs; and

              (i)  perform any other duties prescribed in the regulations.

Powers of minister re: pharmacy network

        5. The minister may

             (a)  establish requirements for the information to be supplied to the pharmacy network and the format in which the information is to be supplied;

             (b)  establish requirements for the information generated from the pharmacy network and the format in which the information is to be generated;

             (c)  establish rules, procedures and guidelines respecting the use of the pharmacy network; and

             (d)  establish any other requirement, rule, procedure or guideline to ensure the proper functioning of the pharmacy network.

Delegation

        6. (1) The minister may delegate, in writing, any power or duty conferred on him or her under this Act to a custodian under the Personal Health Information Act.

             (2)  A delegate referred to in subsection (1) shall comply with all the requirements and have all of the authorities of a custodian under the Personal Health Information Act, unless otherwise stated in this Act.

             (3)  The minister may disclose information related to the objects of the program to the delegate.

Duties of prescriber

        7. (1) A prescriber who prescribes a monitored drug shall record the information prescribed in the regulations on the prescription.

             (2)  Before issuing a prescription for a monitored drug a prescriber shall

             (a)  review the patient medication profile in the electronic health record relating to the individual for whom the prescription is being written; and

             (b)  record in the manner prescribed in the regulations that the patient medication profile in the electronic health record was reviewed before the prescription was issued.

Duties of dispenser

        8. (1) A dispenser who dispenses a monitored drug shall record the information prescribed in the regulations.

             (2)  Before dispensing a monitored drug a dispenser shall

             (a)  review the patient medication profile in the electronic health record relating to the individual for whom the monitored drug is being dispensed; and

             (b)  ensure that any identity verification requirements prescribed in the regulations are satisfied.

             (3)  A dispenser shall ensure that each time a monitored drug is dispensed it is recorded in the pharmacy network in accordance with the regulations.

Duties of regulatory authority

        9. A regulatory authority shall advise the minister in the manner and within the time period prescribed in the regulations where it

             (a)  restricts the licence or registration of a prescriber or dispenser with respect to the prescribing or dispensing of a monitored drug;

             (b)  suspends the licence or registration of a prescriber or dispenser; or

             (c)  revokes the licence or registration of a prescriber or dispenser.

Collection and disclosure of information

      10. (1) Where it is reasonably necessary to achieve the objects of the program, the minister may collect, use and store information in accordance with this Act and the regulations.

             (2)  Upon the request of the minister, a prescriber, dispenser or other person shall disclose to the minister any information the minister reasonably requires to achieve the objects of the program.

             (3)  Where the minister believes on reasonable grounds that an offence under this Act, the Criminal Code (Canada) or the Controlled Drugs and Substances Act (Canada) has been committed, he or she may disclose information regarding the offence to the appropriate law enforcement authority.

             (4)  Where the minister believes on reasonable grounds that a prescriber or dispenser is acting in a manner inconsistent with the objects of the program, he or she may disclose information to the appropriate regulatory authority regarding the manner in which the prescriber or dispenser is acting inconsistently with the objects of the program.

             (5)  Where the minister believes on reasonable grounds that an individual is abusing or misusing monitored drugs, he or she may disclose information to a prescriber or dispenser.

             (6)  A law enforcement authority may disclose information relating to the administration and enforcement of this Act to the minister.

             (7)  The minister may, in accordance with this Act and the regulations, enter into an agreement relating to the sharing of information with the following persons:

             (a)  a dispenser;

             (b)  a prescriber;

             (c)  a regulatory authority;

             (d)  a law enforcement authority; or

             (e)  another person prescribed in the regulations.

             (8)  Where there is a conflict between this section and the Personal Health Information Act or the Access to Information and Protection of Privacy Act, 2015, this section applies.

Inspectors

      11. (1) The minister may appoint a custodian or an employee of a custodian under the Personal Health Information Act to act as an inspector for the purpose of this Act and the regulations.

             (2)  A person shall not knowingly make a false or misleading statement, either orally or in writing, to an inspector while he or she is exercising powers or carrying out duties or functions under this Act or the regulations.

Powers of inspectors re: compliance

      12. (1) An inspector may, at all reasonable times, for a purpose related to the administration or enforcement of this Act or the regulations, inspect or examine the premises, processes, books and records of a person that the inspector may consider relevant for the purpose of determining compliance with this Act or the regulations, and the inspector may, without a warrant,

             (a)  enter any premises

                      (i)  which is a place of practice of a prescriber or a dispenser,

                     (ii)  where any property, books or records are or may be kept, or

                    (iii)  where anything is done or is suspected by the inspector of being done in connection with a requirement of this Act or the regulations;

             (b)  make copies, extracts, photographs or videos the inspector considers necessary;

             (c)  require the owner, operator or person in charge of a premises to give the inspector all reasonable assistance, including the production of books and records as requested by the inspector, and to answer all questions relating to the administration or enforcement of this Act or the regulations and, for that purpose, require the owner, operator or person in charge to attend at the premises with the inspector; and

             (d)  require the owner, operator or person in charge to make available the means to generate and manipulate books and records that are in machine readable or electronic form and any other means or information necessary for the inspector to assess the books and records.

             (2)  Notwithstanding subsection (1), an inspector shall not enter a dwelling-house without the consent of the occupant.

Report by inspector

      13. (1) An inspector shall prepare a report which sets out the findings and results of the inspection. 

             (2)  The minister may share the findings and results of an inspection with

             (a)  regulatory authorities;

             (b)  law enforcement authorities;

             (c)  the prescriber whose premises were the subject of the inspection;

             (d)  the dispenser whose premises were the subject of the inspection; and

             (e)  other persons prescribed in the regulations.

Advisory committees

      14. (1) The minister may, in accordance with the regulations, establish one or more committees to provide advice and recommendations on matters relating to the administration and enforcement of this Act that are referred to them by the minister.

             (2)  The minister shall, by regulation, prescribe the terms of reference for the committees, the composition of the committees and the duties of the committees.

             (3)  Notwithstanding subsection (2), there shall be at least 2 prescribers and 2 dispensers on each committee.

Prohibition

      15. A person shall not discipline, suspend, demote, dismiss, discharge, harass, interfere with or otherwise disadvantage another person or threaten to do any of those things to another person, where that person, in good faith, complies with a request or requirement under this Act or the regulations.

False or misleading information

      16. A person shall not provide the minister, a prescriber or a dispenser with information that he or she knows to be false or misleading.

Protection from liability

      17. (1) An action does not lie against a person who, in good faith, complies with a request or requirement to disclose information under this Act or the regulations.

             (2)  An action does not lie against the minister or his or her delegate, a dispenser, a prescriber, a regulatory authority, a law enforcement authority, an inspector, a committee member or any other person acting under the authority of this Act or the regulations for anything done or omitted to be done in good faith

             (a)  in the performance or intended performance of a duty imposed under this Act or the regulations; or

             (b)  in the exercise or intended exercise of a power conferred under this Act or the regulations.

Offence

      18. (1) A person who contravenes this Act or the regulations is guilty of an offence and is liable on summary conviction

             (a)  in the case of an individual, to a fine of not more than $10,000 or to imprisonment for a term of not more than 12 months, or to both; and

             (b)  in the case of a corporation, to a fine of not more than $20,000.

             (2)  A prosecution for an offence under this Act shall be commenced within 2 years of the date of discovery of the offence.

Forms

      19. The minister may prescribe forms for the purpose and administration of this Act.

Statutory review

      20. The minister shall, every 5 years, conduct a review of this Act and the regulations and consider the areas which may be improved.

Lieutenant-Governor in Council regulations

     21. The Lieutenant-Governor in Council may make regulations

             (a)  prescribing drugs or classes of drugs to be monitored;

             (b)  excluding the monitoring of certain drugs within a class of drugs that are being monitored;                    

             (c)  excluding a class of prescribers, dispensers or other persons from the application of this Act, or from one or more provisions of this Act, subject to any conditions, provided for in the regulations;                  

             (d)  incorporating by reference, in whole or in part, a written standard, rule, regulation, guideline, designation, code, document or list, including a list of prescribed drugs, as it reads on a prescribed day or as it is amended from time to time;

             (e)  prescribing the duties, powers and responsibilities of the minister;

             (f)  defining a word or expression used but not defined in this Act; and

             (g)  generally, to give effect to the purpose of this Act.

Ministerial regulations

      22. The minister may make regulations

             (a)  prescribing regulatory authorities for the purpose of subparagraph 2(k)(v);

             (b)  respecting the identity requirements that a dispenser shall ensure are satisfied before dispensing a monitored drug;

             (c)  respecting the information a prescriber is required to record on a prescription;

             (d)  respecting the additional requirements that are required to be met before a prescriber may prescribe or a dispenser may dispense a monitored drug;

             (e)  respecting the information a dispenser is required to record;

             (f)  respecting the pharmacy network including

                      (i)  the persons who may access the pharmacy network,

                     (ii)  the information to be submitted to or recorded in the pharmacy network, and

                    (iii)  the provision of alerts and the triggering of those alerts;

             (g)  respecting the reports to be produced under this Act;

             (h)  respecting the persons with whom the minister may enter into agreements for the sharing of information;

              (i)  respecting the persons with whom the findings and results of an inspection may be shared;

              (j)  prescribing the manner and time period in which a regulatory authority is to advise the minister of the restriction, suspension or revocation of a prescriber’s or dispenser’s licence or registration;

             (k)  prescribing the duties, powers and responsibilities of inspectors;

              (l)  respecting time periods in which a person is required to comply with a request for information from the minister or an inspector;

           (m)  respecting the establishment of advisory committees and the appointment of members, terms of office, composition, terms of reference, duties and other matters relating to advisory committees;

             (n)  defining a word or expression used but not defined in this Act; and

             (o)  generally, to give effect to the purpose of this Act.

Commencement

     23. (1) This Act, with the exception of subsection 7(2), comes into force on January 1, 2018.

            (2)  Subsection 7(2) comes into force on June 30, 2018.