Bill 23 - An Act Respecting the Prescription Monitoring Act

BILL 23

An Act Respecting the Prescription Monitoring Act

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

Prescription Monitoring Act

1( 1) Section 1 of the Prescription Monitoring Act, chapter P-15.05 of the Acts of New Brunswick, 2009, is amended

(a) by repealing the definition “patient monitoring agreement”;

(b) in the definition “licensing authority”

( i) in paragraph (c) of the English version by striking out “and” at the end of the paragraph;

( ii) by adding after paragraph (c) the following:

(c.1) the Nurses Association of New Brunswick;

(c.2) the Midwifery Council of New Brunswick;

(c.3) the New Brunswick Association of Optometrists;

(c.4) the New Brunswick Podiatry Association; and

(c) in the definition “monitored drug” by striking out “drugs designated by the regulations” and substituting “drugs established by the advisory committee”;

(d) in the definition “participant” by striking out “licensed pharmacist” and substituting “dispenser”;

(e) in the definition “prescriber” by striking out “monitored” wherever it appears;

(f) in the definition “program information” by striking out “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” and substituting “under sections 10, 10.1 and 10.2”;

(g) by adding the following definition in alphabetical order:

“dispenser” means an individual who is entitled under an Act of the Legislature to dispense drugs, except an individual who is entitled under the Veterinarians Act to dispense drugs, or a member of a class of individuals prescribed by regulation. (préparateur)

(h) by adding the following definition in alphabetical order:

“electronic prescription” means a prescription by electronic means, including, but not limited to, by secure electronic mail or Internet or other network communications system, but does not include by telephone. (ordonnance électronique)

1( 2) The heading “Conflict” preceding section 2 of the Act is repealed.

1( 3) Section 2 of the Act is repealed.

1( 4) Section 4 of the Act is amended in the portion preceding paragraph (a) by striking out “prescribers and licensed pharmacists” and “a real time” and substituting “participants” and “an”, respectively.

1( 5) Section 6 of the Act is amended

(a) by adding before subsection (1) the following:

6( 0.1) A participant who prescribes or dispenses drugs shall make an application to the Director to be registered in the program and, once registered, shall participate in the program and use the information network by creating an account on the network.

(b) by repealing subsection (1) and substituting the following:

6( 1) On application to the Director under subsection (0.1), the Director shall register the participant in the program.

1( 6) Section 8 of the Act is amended

(a) in subsection (1) by striking out “a real time” and substituting “an”;

(b) by repealing subsection (7) of the French version and substituting the following:

8( 7) Le délégué auquel s’applique le présent article satisfait aux mêmes exigences concernant la protection, la conservation et la destruction sécuritaire des renseignements personnels sur la santé que celles auxquelles le ministre est tenu de satisfaire en application de la Loi sur l’accès et la protection en matière de renseignements personnels sur la santé.

8( 7.1) The information network shall send an alert to participants in any of the circumstances determined by the advisory committee.

(d) by repealing subsection (8);

(e) by repealing subsection (9).

1( 7) The Act is amended by adding after section 8 the following:

Access and disclosure

8.1( 1) Only the persons authorized by this Act and the regulations shall submit information to the information network.

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

8.1( 3) A participant may authorize an individual to access the information network on their behalf by approving an account for that individual on the network allowing for limited access.

8.1( 4) An individual referred to in subsection (3) shall comply with the same requirements concerning the protection, retention and secure destruction of personal health information that the participant is required to comply with under the Personal Health Information Privacy and Access Act.

8.1( 5) In an emergency situation, an individual who is authorized under the Paramedic Act to practise paramedicine, as defined in that Act, shall have access to the information network.

8.1( 6) If the Minister believes, on reasonable grounds, that an offence has been committed under this Act, the Criminal Code (Canada) or the Controlled Drugs and Substances Act (Canada), the Minister may disclose information with respect to the alleged offence to the appropriate law enforcement authority.

Other prescription monitoring programs

8.2( 1) It is permitted to use the information network to transmit information to and receive information from prescription monitoring programs operating outside of the Province.

8.2( 2) For the purposes of subsection (1), the Minister shall enter into written reciprocal agreements with persons or entities outside of the Province to establish the terms and conditions for the access, use and disclosure of the prescription monitoring information.

1( 8) Section 9 of the Act is amended

(a) in subsection (1)

( i) by repealing paragraph (f) and substituting the following:

(f) one individual appointed by the Minister as a public representative 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; and

( ii) by repealing paragraph (g);

( iii) in paragraph (h) by striking out “no more than 2” and substituting “no more than four”;

(b) by adding after subsection (1) the following:

9( 1.2) The advisory committee shall establish classes of drugs for the purposes of the definition “monitored drug” in section 1 and shall publish the classes of monitored drugs on the Government of New Brunswick website.

( i) by repealing paragraph (a);

( ii) in paragraph (d) of the English version by striking out “and” at the end of the paragraph;

( iii) by adding after paragraph (d) the following:

(d.1) the circumstances in which the information network shall alert participants, and

(d) by adding after subsection (2) the following:

9( 3) The Lieutenant-Governor in Council may determine the remuneration to be paid to the chair and other members of the advisory committee and may fix the rate for reimbursement of expenses incurred by them while acting on behalf of the advisory committee.

9( 4) Despite subsection (3), remuneration shall not be paid to a member of the advisory committee who is employed in the Civil Service as defined in the Civil Service Act.

1( 9) The Act is amended by adding after section 9 the following:

Requirements of prescribers

9.1( 1) When prescribing a monitored drug to an individual, a prescriber shall include on the prescription the information prescribed by regulation.

9.1( 2) Before prescribing a monitored drug to an individual, a prescriber shall review the medication profile of the individual in the information network.

1( 10) The heading “Requirements of pharmacies” preceding section 10 of the Act is amended by striking out “pharmacies” and substituting “dispensers”.

1( 11) Section 10 of the Act is amended

(a) by repealing subsection (1);

(b) in subsection (2)

( i) by repealing the portion preceding paragraph (a) and substituting the following:

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

( ii) in paragraph (a) of the English version by striking out “monitored”;

( iii) in paragraph (b) of the English version by striking out “monitored”;

( iv) in paragraph (c) by striking out “prescriber who prescribed the monitored” and substituting “prescriber of the”;

( v) by repealing paragraph (d) and substituting the following:

(d) the name, licence number, address and telephone and fax numbers of the pharmacy dispensing the drug, if applicable;

( vi) in paragraph (e) by striking out “and licence number of the licensed pharmacist who dispensed the monitored drug” and substituting “, licence number, address and telephone and fax numbers of the dispenser of the drug”;

( vii) in paragraph (f) by striking out “and quantity of the monitored drug” and substituting “, quantity and indication for use of the drug”;

( viii) in paragraph (g) by striking out “monitored”;

( ix) in paragraph (h) by striking out “monitored drug is dispensed; and” and substituting “drug is prescribed, the date on which the drug is dispensed and the date on which the drug is collected;”;

( x) by adding after paragraph (h) the following:

(h.1) if the drug is compounded, a list of all active ingredients and the drug identification number of all monitored drugs included in the compounded drug;

(h.2) the payment type chosen by the individual to whom the drug was dispensed; and

( xi) in paragraph i) of the French version by striking out “tous autres renseignements réglementaires” and substituting “tout autre renseignement prescrit par règlement”;

10( 3) When dispensing a drug that was prescribed to an animal, a dispenser shall submit to the information network, in the form and manner required by the Director, the following information:

(a) the Medicare number, surname, date of birth, address and telephone number of the owner of the animal;

(b) the first name and species of the animal;

(d) the first name, surname, licence number, address and telephone and fax numbers of the veterinarian who prescribed the drug;

(e) the first name, surname, licence number, address and telephone and fax numbers of the dispenser of the drug;

(f) the name, strength, quantity and indication for use of the drug;

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

(h) the date on which the drug is prescribed, the date on which the drug is dispensed and the date on which the drug is collected;

(i) if the drug is compounded, a list of all active ingredients and the drug identification number of all monitored drugs included in the compounded drug;

(j) the form of payment chosen by the individual to whom the drug was dispensed; and

(k) any other information prescribed by regulation.

10( 4) When a dispenser sells a monitored drug to another dispenser, the dispenser selling the monitored drug shall submit to the information network, in the form and manner required by the Director, the following information:

(a) the name, licence number or corporate certificate number, address and telephone and fax numbers of the pharmacy selling the monitored drug, if applicable;

(b) the first name, surname and licence number of the dispenser selling the monitored drug and those of the dispenser purchasing the monitored drug;

(c) the name, licence number or corporate certificate number and address of the pharmacy or other corporation purchasing the monitored drug, if applicable;

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

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

(f) the date on which the monitored drug is sold;

(g) if the drug is compounded, a list of all active ingredients and the drug identification number of all monitored drugs included in the compounded drug; and

(h) any other information prescribed by regulation.

10( 5) When a dispenser purchases a monitored drug from a manufacturer or wholesale distributor, the dispenser shall submit to the information network, in the form and manner required by the Director, the following information:

(a) the name, licence number or corporate certificate number, address and telephone and fax numbers of the pharmacy or other corporation purchasing the monitored drug, if applicable;

(b) the first name, surname and licence number of the dispenser of the monitored drug;

(d) the date on which the monitored drug is purchased;

(e) the quantity of the monitored drug purchased; and

(f) the transaction or invoice number.

10( 6) If a dispenser, other than a licensed pharmacist, does not have information to submit to the information network, the dispenser shall submit a report to that effect to the information network as required by the Director.

1( 12) The Act is amended by adding after section 10 the following:

Requirements of licensed pharmacists and pharmacies

10.1 Despite subsections 10(2) to (5), if a dispenser is a licensed pharmacist who is working at a pharmacy when the dispenser dispenses a drug, sells a monitored drug or purchases a monitored drug

(a) the dispenser shall record the information referred to in subsection 10(2), (3), (4) or (5), as the case may be, in the form and manner required by the Director, and

(b) the pharmacy shall submit the information referred to in subsection 10(2), (3), (4) or (5), as the case may be, to the information network in the form and manner required by the Director.

Requirements of manufacturers, operators and wholesale distributors

10.2 A manufacturer, an operator of an outsourcing facility or repacking facility or a wholesale distributor of monitored drugs that sells a monitored drug to a participant shall submit to the information network, in the form and manner required by the Director, the following information:

(a) the name and licence number of the manufacturer, operator or wholesale distributor;

(b) the licence number of the participant;

(d) the date on which the monitored drug is sold; and

(e) the quantity of the monitored drug sold.

1( 13) The heading “Duties of licensing authorities” preceding section 11 of the Act is amended by striking out “Duties” and substituting “Requirements”.

1( 14) Section 11 of the Act is amended

(a) by renumbering the section as subsection 11(1);

(b) in subsection (1) by striking out “2 days” and substituting “two business days”;

11( 2) A licensing authority shall notify the Director in writing within 30 business days after the date the licensing authority receives notification of the death of a member.

1( 15) The Act is amended by adding after section 11 the following:

Electronic prescriptions

11.1( 1) Prescribers shall prescribe a monitored drug to an individual by submitting an electronic prescription to the information network.

11.1( 2) Despite subsection (1), a prescriber may prescribe a monitored drug to an individual by providing a written prescription to the individual in the circumstances prescribed by regulation.

1( 16) The heading “Patient monitoring agreement” preceding section 12 of the Act is repealed.

1( 17) Section 12 of the Act is repealed.

1( 18) Section 15 of the Act is amended by striking out “a delegate under subsection 8(3)” and substituting “a delegate under subsection 8(3), an individual referred to in subsection 8.1(3)”.

1( 19) Section 16 of the English version of the Act is amended by striking out “his or her” and substituting “their”.

1( 20) The Act is amended by adding after section 16 the following:

Inspectors

16.1( 1) The Minister may appoint or designate inspectors for the purposes of this Act and shall issue to every inspector a certificate of appointment or designation.

16.1( 2) An inspector shall produce their certificate on request in the execution of their powers or duties under this Act or the regulations.

16.1( 3) The powers and duties of an inspector shall be prescribed by regulation.

1( 21) The heading “Offences” preceding section 17 of the Act is repealed and the following is substituted:

Offences and penalties

1( 22) Section 17 of the Act is amended

(a) by adding before subsection (1) the following:

17( 0.1) A person who violates or fails to comply with subsection 6(0.1) commits an offence punishable under Part 2 of the Provincial Offences Procedures Act as a category F offence.

(b) by repealing subsection (1);

17( 1.1) A person who submits false or misleading information to the information network commits an offence punishable under Part 2 of the Provincial Offences Procedures Act as a category F offence.

(d) in subsection (2) by striking out “pharmacy that violates or fails to comply with subsection 10(2) commits an offence punishable under Part II” and substituting “dispenser that violates or fails to comply with section 10 commits an offence punishable under Part 2”;

(e) by adding after subsection (2) the following:

17( 2.1) A licensed pharmacist or a pharmacy that violates or fails to comply with section 10.1 commits an offence punishable under Part 2 of the Provincial Offences Procedures Act as a category C offence.

17( 2.2) A manufacturer, an operator of an outsourcing facility or repacking facility or a wholesale distributor that violates or fails to comply with section 10.2 commits an offence punishable under Part 2 of the Provincial Offences Procedures Act as a category C offence.

(f) in subsection (3) by striking out “Part II” and substituting “Part 2”;

(g) in subsection (4) by striking out “Part II” and substituting “Part 2”;

(h) in subsection (5) by striking out “Part II” and substituting “Part 2”;

(i) in subsection (6) by striking out “Subject to subsection (7), a person” and “Part II” and substituting “A person” and “Part 2”, respectively;

(j) by repealing subsection (7);

(k) by adding after subsection (9) the following:

17( 10) If an offence is committed by a participant, the Director shall report the offence to the licensing authority of the participant who committed the offence.

1( 23) The Act is amended by adding after section 17 the following:

Administrative penalties

17.1( 1) Subject to the regulations and in accordance with the regulations, if the Minister is satisfied that a person has violated or failed to comply with this Act or the regulations, the Minister may impose an administrative penalty on the person by issuing a notice of administrative penalty.

17.1( 2) A person who pays the administrative penalty shall be deemed to have contravened the provision of this Act or the regulations in respect of which the payment was made and shall not be charged with an offence in respect of the same incident that gave rise to the administrative penalty.

17.1( 3) If a person does not pay the administrative penalty within 30 days after the date the person receives notification, the person may be charged with an offence under this Act or the regulations in respect of the same incident that gave rise to the administrative penalty.

17.1( 4) Subject to subsection (3), a person charged with an offence under this Act or the regulations is not liable to an administrative penalty in respect of the same incident that gave rise to the charge.

17.1( 5) The Minister may sue for and recover an administrative penalty in an action in any court as if the amount were a debt.

1( 24) Section 18 of the Act is amended

(a) by adding before paragraph (a) the following:

(0.a) prescribing classes of individuals for the purposes of the definition “dispenser” in section 1;

(b) by repealing paragraph (b);

(d) in paragraph (g) by striking out “, 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” and substituting “and the information to be submitted to or recorded by the information network”;

(e) by repealing paragraph (k);

(f) by adding after paragraph (l) the following:

(l.1) prescribing information to be included on a prescription for the purposes of subsection 9.1(1);

(g) in paragraph (m) by striking out “monitored”;

(h) by repealing paragraph (n) and substituting the following:

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

(i) by adding after paragraph (n) the following:

(n.1) prescribing any other information under paragraph 10(3)(k) to be submitted to the information network;

(n.2) prescribing any other information under paragraph 10(4)(h) to be submitted to the information network;

(j) by adding after paragraph (n.2) the following:

(n.3) respecting electronic prescriptions, including prescribing the circumstances in which a prescriber may prescribe a monitored drug to an individual by providing a written prescription to the individual for the purposes of subsection 11.1(2);

(k) by repealing paragraph (o);

(l) by adding before paragraph (p) the following:

(o.1) prescribing the powers and duties of inspectors for the purposes of subsection 16.1(3);

(m) in paragraph (p) by striking out “Part II” and substituting “Part 2”;

(n) by adding after paragraph (p) the following:

(p.1) governing the imposition, payment and enforcement of administrative penalties for the purposes of section 17.1, including

( i) prescribing provisions of this Act or the regulations for which a notice of administrative penalty may be issued,

( ii) prescribing the form or content of the notice of administrative penalty,

( iii) prescribing or determining the amounts that may be imposed as administrative penalties, including minimum and maximum amounts, and

( iv) varying the amount of an administrative penalty prescribed according to the nature or frequency of the violation or failure to comply and according to whether the person in violation or in non-compliance is an individual or a person other than an individual;

1( 25) The heading “Révision de la présente loi” preceding section 19 of the French version of the Act is amended by striking out “Révision” and substituting “Examen”.

1( 26) Section 19 of the Act is repealed and the following is substituted:

Review of this Act

19 The Minister shall periodically initiate a review of this Act, with the first review to be completed no later than December 31, 2030, and subsequent reviews to be completed every five years after that.

Regulation under the Prescription Monitoring Act

2( 1) The heading “Classes of drugs” preceding section 3 of New Brunswick Regulation 2014-142 under the Prescription Monitoring Act is repealed.

2( 2) Section 3 of the Regulation is repealed.

2( 3) Paragraph 4(a) of the Regulation is amended by striking out “section 11” and substituting “subsection 11(1)”.

2( 4) The heading “Information network alerts” preceding section 5 of the Regulation is repealed.

2( 5) Section 5 of the Regulation is repealed.

2( 6) Section 6 of the Regulation is amended

(a) in subsection (1) by striking out “of three years” and substituting “of up to three years”;

(b) in subsection (3) of the English version by striking out “his or her” wherever it appears and substituting “their”;

6( 4) Despite subsection (2), a member of the advisory committee whose term has ended may remain in office until the member is reappointed or replaced.

2( 7) Section 7 of the Regulation is amended

(a) by repealing subsection (1) and substituting the following:

7( 1) If the term of a member of the advisory committee ends, the Minister shall reappoint the person or replace the person to fill the vacancy.

(b) by adding after subsection (1) the following:

7( 1.1) If a member of the advisory committee dies or resigns, the Minister may appoint a person to fill the vacancy for the balance of the term of the member.

2( 8) Section 8 of the Regulation is amended

(a) in subsection (4) by striking out “a term of” wherever it appears and substituting “a term of up to”;

(b) in subsection (5) of the English version by striking out “his or her” and substituting “the chair’s”.

2( 9) Paragraph 9(1)(a) of the English version of the Regulation is amended by striking out “his or her” and substituting “their”.

2( 10) The heading “Remuneration and reimbursement of expenses” preceding section 10 of the Regulation is repealed.

2( 11) Section 10 of the Regulation is repealed.

2( 12) The heading “Patient monitoring agreement” preceding section 11 of the Regulation is repealed.

2( 13) Section 11 of the Regulation is repealed.

Commencement

3 Paragraphs 1(1)(h) and 1(5)(a), subsections 1(9), (15) and (20), paragraph 1(22)(a), subsection 1(23) and paragraphs 1(24)(j), (l) and (n) of this Act come into force on a day or days to be fixed by proclamation.