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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
2 (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
5 (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
6 (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
8 (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
10 (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
13 (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
15 (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
16 (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
21 (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
22 (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 English;
(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
24 (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
26 (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.