Second

Session, 48th General Assembly

Elizabeth II, 2017

BILL 25

PRESCRIPTION MONITORING

ACT

Received and Read the First Time . ............... ..... ............. ....................

November 14, 2017

Second Reading .......... .................... .. ..... ................................................. November 20, 2017

Committee ............... ............................................... .. Amendments

1 ,

- November 20, 2017

Third Reading ........................... ............................................................ November 23, 2017

Royal Assent .........................................................................................

HONOURABLE

JOHN HAGGIE

Minister of Health and Community Services

Ordered

to be printed by the Honourable House of Assembly

EXPLANATORY NOTES

This Bill would enact the Prescription Monitoring Act to implement

a Prescription Monitoring Program.

A BILL

AN ACT RESPECTING THE MONITORING OF PRESCRIPTIONS

IN THE PROVINCE

Analysis

Short title

Interpretation

Prescription Monitoring Program

Duties of minister re: program

Powers of minister re: pharmacy network

Delegation

Duties of prescriber

Duties of dispenser

Duties of regulatory authority

Collection and disclosure of information

Inspectors

Powers of inspectors re: compliance

Report by inspector

Advisory committees

Prohibition

False or misleading information

Protection from liability

Offence

Forms

Statutory review

Lieutenant-Governor in Council

regulations

Ministerial regulations

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 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

(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

(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

(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

(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

(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

(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

(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

(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

(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.

Queen's Printer