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 patients 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 prescribers or dispensers 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.
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