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Part II .

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Prescription Monitoring Regulations

made under

Section 27 of the

Prescription Monitoring Act

S.N.S. 2004, c. 32

O.I.C. 2005-275 (June 30, 2005, effective July 4, 2005), N.S. Reg. 132/2005

as amended by O.I.C. 2013-237 (July 9, 2013, effective August 6, 2013), N.S. Reg. 254/2013

Interpretation

Citation

1 These regulations may be cited as the Prescription Monitoring Regulations .

Definitions

(1) In these regulations,

(a) “Act” means the Prescription Monitoring Act ;

(b) “compounding” means compounding as defined in the Pharmacy Act ;

Clause 2(1)(

b) replaced: O.I.C. 2013-237, N.S. Reg. 254/2013.

(c) “pharmacy” means a pharmacy as defined in the Pharmacy Act and includes a

hospital pharmacy as defined in the Pharmacy Act ;

(d) “prescription” means an authorization from a prescriber to dispense a

monitored drug;

(e) “prescription form” means a form issued by the Administrator under

Section

15 that is used to write a prescription;

(f) “Program identification number” means a unique number of identification

assigned to a prescriber under

Section 9;

(g) “Program prescription number” means a unique number of identification

assigned to a prescription form;

(h) “registrant” means a prescriber, pharmacist or pharmacy who is registered with

the Program.

(2) In the Act and these regulations,

(a) “pharmacist” is further defined to include certified dispensers as defined under

the Pharmacy Act ;

(b) “prescriber” is further defined as not including a veterinarian as defined under

the Veterinary Medical Act;

(c) “resident” is further defined as including a person who is a visitor to Nova

Scotia and has a prescription, which may be written by a physician, dentist or

optometrist from outside the Province, for a monitored drug.

Monitored Drugs

Designation of monitored drugs

3 Any drug that is a controlled drug under the Controlled Drugs and Substances Act

(Canada) and is listed in the Schedules to the Controlled Drugs and Substances Act

(Canada) or any successor legislation is designated as being subject to the Program, except

the following:

(

a) testosterone, when dispensed as a compound for topical application for local

effect;

(

b) drugs listed in Parts 1 and 2 of

Schedule 1 to the Benzodiazepines and Other

Targeted Substances Regulations made under the Controlled Drugs and

Substances Act (Canada).

Release of information on monitored drugs

4 Information on a monitored drug may be released by the Administrator to a registrant in

the manner determined by the Board.

Registration

Who must register with Program

(1) A prescriber who prescribes monitored drugs to residents must register with the

Program.

(2) A pharmacist or a pharmacy who dispenses monitored drugs to residents must

register with the Program.

Registration application form

(1) An application for registration may be made in either electronic or paper form, as

determined by the Board.

(2) An application for registration must be provided by the Administrator to a prescriber,

pharmacist or pharmacy on request.

Copy of Act and regulations provided to applicant

7 The Administrator must provide an applicant for registration with a copy of the Act and

the regulations made under the Act.

Information to be provided with application for registration

(1) A prescriber must provide the Administrator with any information about the

prescriber requested on a prescriber registration form when applying for registration

with the Program, including the following:

(

a) complete given name and surname;

(

b) date of birth;

(

c) country of birth;

(

d) gender;

(

e) year of graduation from medical school or dental school with first medical or

dental degree;

(

f) name of medical school or dental school from which first medical or dental

degree was obtained;

(

g) country where medical school or dental school from which first medical or

dental degree was obtained is located;

(

h) Nova Scotia professional license number issued by the prescriber’s licensing

authority, if applicable;

(

i) Medical Identification Number of Canada, if applicable;

(

j) medical or dental specialty, if applicable;

(

k) office mailing address;

(

l) office street address;

(

m) office e-mail address;

(

n) office telephone number;

(

o) office facsimile number;

(

p) confirmation that the prescriber is in good standing with their licensing

authority;

(

q) sample of signature.

(2) A pharmacist must provide the Administrator with any information about the

pharmacist requested on a pharmacist registration form when applying for

registration with the Program, including the following:

(

a) complete given name and surname;

(

b) date of birth;

(

c) country of birth;

(

d) gender;

(

e) year of graduation from pharmacy school with first pharmacy degree;

(

f) name of pharmacy school from which first pharmacy degree was obtained;

(

g) country where pharmacy school from which first pharmacy degree was

obtained is located;

(

h) Nova Scotia professional license number issued by the College of Pharmacists;

(

i) office mailing address;

(

j) office street address;

(

k) office e-mail address;

(

l) office telephone number;

(

m) office facsimile number;

(

n) confirmation that they are in good standing with their licensing authority;

(

o) sample of signature.

(3) A pharmacy must provide the Administrator with at least the following information

about the pharmacy on a pharmacy registration form when applying for registration

with the Program:

(

a) operating name;

(

b) store number issued to the pharmacy by the College of Pharmacists;

(

c) mailing address;

(

d) street address;

(d) [(e)] e-mail address;

(e) [(f)] telephone number;

(f) [(g)] facsimile number;

(g) [(h)] date the pharmacy began operating;

(h) [(i)] confirmation that they are in good standing with their licensing authority.

Program identification number

9 When a prescriber is registered with the Program, the Administrator must assign a

Program identification number to the prescriber.

Notifying Administrator of changes to registrant’s information

(1) The licensing authority of a prescriber, pharmacist or pharmacy who has lost the

privilege of prescribing or dispensing monitored drugs must notify the

Administrator of the loss of privilege in writing within 1 business day of the date

that the prescriber, pharmacist or pharmacy lost the privilege.

(2) A registrant must notify the Administrator in writing of a change in their street or

mailing address no later than 10 business days before the change of address comes

into effect.

(3) A pharmacy that closes must notify the Administrator in writing no later than 10

business days before the date of closure.

(4) A pharmacy that changes ownership must notify the Administrator in writing no later

than 10 business days before the date the change of ownership takes effect and must

reapply for registration with the Program.

Registrant’s forms and records required under Program

11 The Administrator must inform a registrant about what forms and records they are

required to keep under the Program.

Pharmacist or prescriber in good standing with licensing authority

12 A prescriber, pharmacist or pharmacy that is registered with the Program must be in good

standing with their licensing authority.

Prescribing Monitored Drugs

Form and manner of prescribing monitored drugs

(1) Except as provided in subsection (2), a prescriber must only prescribe a monitored

drug in the manner approved by the Board and by using a prescription form.

(2) A prescription does not have to meet the requirements of subsection (1) if the

prescription is for one of the following:

(

a) a person in a nursing home, as defined in the Homes for Special Care Act ;

(

b) a person in a home for the aged that is subject to the Homes for Special Care

Act ;

(

c) a person who is prescribed a monitored drug while an in-patient, as defined in

the Hospital Insurance Regulations made under the Health Services and

Insurance Act ;

(

d) an inmate in a federal correctional centre or penitentiary.

Monitored drugs used in office of prescriber

14 A prescriber who obtains a monitored drug from a pharmacy for use in their office must

order the monitored drug using a prescription form and in the manner approved by the

Board.

Prescription forms issued

(1) The Administrator must issue prescription forms to a prescriber.

(2) A prescription form must be encoded with all of the following:

(

a) the Program identification number of the prescriber to whom it is issued;

(

b) a Program prescription number.

Responsibility for prescription forms

(1) A prescriber is responsible for all prescription forms provided to them by the

Administrator and must ensure that all prescription forms in their possession are kept

in a secure location.

(2) A prescriber must report all of the following to the Administrator as soon as

reasonably possible:

(

a) any missing prescription forms;

(

b) any prescription forms that may have been stolen.

(3) A prescriber may report the possible theft of any prescription forms to the

appropriate law enforcement authority, their licensing authority, pharmacies and

other prescribers.

Prescription forms non-transferable

17 Prescription forms must not be transferred between prescribers.

Unused prescription forms

18 A prescriber who is no longer prescribing monitored drugs must return any unused

prescription forms to the Administrator no later than 5 days after the date they stop

prescribing monitored drugs.

One drug per prescription

19 A prescriber must prescribe only one drug per prescription form.

Copy of prescription kept by prescriber

20 A prescriber must keep a copy of each prescription form for a monitored drug prescribed

by them as required by their licensing authority.

Dispensing Monitored Drugs

Form and manner of dispensing monitored drugs

(1) A monitored drug must only be dispensed in the manner approved by the Board.

(2) A monitored drug must only be dispensed if the pharmacist dispensing the drug is

provided with a prescription form for the drug.

Required information for dispensing or releasing monitored drugs

(1) A monitored drug must only be dispensed by a pharmacist if the following

information is provided to the pharmacist or if the pharmacist has access to all of the

following information:

(

a) the date the prescription was issued;

(

b) the resident’s health card number or equivalent provincial, federal or out-of-country number;

(

c) the resident’s complete given name and surname;

(

d) the resident’s date of birth;

(

e) the resident’s gender;

(

f) the resident’s current street address or post office box number and their city or

town of residence;

(

g) the store number assigned to the pharmacy by the College of Pharmacists;

(

h) the Program prescription number;

(

i) the date the prescription was dispensed;

(

j) the prescription number assigned by the pharmacy;

(

k) the drug identification number assigned by the Health Canada Therapeutics

Products Directorate;

(

l) the generic or proprietary name of the monitored drug;

(

m) the quantity of the monitored drug in arabic numbers and spelled out in

(o) [(n)] the number of days the monitored drug is supplied for;

(p) [(o)] the prescriber’s signature, or an electronic equivalent;

(q) [(p)] the prescriber’s Program identification number;

(r) [(q)] the prescriber’s office mailing address;

(s) [(r)] the signature, or an electronic equivalent, of the person who is accepting the

dispensed monitored drug.

(2) Any of the information listed in subsection (1) must be provided by the pharmacist

to the Administrator on request.

(3) Before releasing a monitored drug, a pharmacist must confirm the identity of the

person accepting the drug.

Copy of prescription kept by pharmacy

23 A pharmacy must keep a copy of each prescription form for a monitored drug that is

dispensed by them as required by their licensing authority.

Void prescriptions

(1) The Board must prescribe circumstances under which a prescription is deemed to be

void under these regulations.

(2) A prescriber or pharmacist must notify the Administrator as soon as they become

aware of a prescription that is deemed to be void.

(3) A prescription that is deemed to be void must not be dispensed.

Program Information

Information requested by Administrator to achieve objects of Program

25 Information that may be requested by the Administrator under

Section 18 of the Act to

achieve the objects of the Program includes information about any of the following:

(

a) the prescribing of monitored drugs;

(

b) the compounding of monitored drugs;

(

c) the dispensing of monitored drugs;

(

d) the drug utilization of monitored drugs;

(

e) clinical records;

(

f) a resident’s record;

(

g) a resident’s chart;

(

h) a resident’s health card number or equivalent provincial, federal or out-of-country number.

How information provided to Administrator

(1) Information provided to the Administrator must be provided within the time

specified by the Administrator.

(2) A registrant must provide any information required to be provided to the

Administrator in either electronic or paper form, as required by the Board.

Information not to be provided to Administrator

27 If a complaint has been initiated with a licensing authority under their regulating statute,

the licensing authority, the registrar or any other employee of the licensing authority must

not give the Administrator any of the following:

(

a) information about the complaint or the complainant, until the disciplinary

process under their regulating statute has ended;

(

b) the complainant’s name, at any time.

How information kept under Program

28 The Administrator must keep all information gathered under the Program about registrants

and residents in the manner determined by the Board.

Information released by Administrator

29 Information that may be released by the Administrator under subclause 12(2)(e)(iii) or

Section 20 of the Act to any prescriber, pharmacist or licensing authority must be released

in the manner determined by the Board.

Information exchanged between prescribers and pharmacists

30 Prescribers and pharmacists may exchange information about a resident that is released by

the Administrator under subclause 12(2)(e)(iii) or

Section 20 of the Act.

Program information that must be provided to law enforcement authority

31 The following information must be communicated when information is communicated to

the appropriate law enforcement authority under subsection 23(1) of the Act, or the

appropriate licensing authority under subsection 23(2) of the Act:

(

a) the resident’s name;

(

b) the resident’s address;

(

c) an identification of the monitored drug or drugs in use;

(

d) the number of prescriptions dispensed and the date each one was dispensed;

(

e) the number of prescribers.

Board and Committees

Reimbursement of expenses for Board, committees and sub-committees

32 In accordance with

Section 10 of the Act, travel expenses, meals and gas mileage to attend

Board, committee or subcommittee meetings are eligible for reimbursement in accordance

with the rate paid to public servants of the Province.