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Newfoundland and Labrador
Regulation 2015


NEWFOUNDLAND AND LABRADOR REGULATION 73/15

NEWFOUNDLAND AND LABRADOR
REGULATION 73/15

Authorization to Prescribe Regulations
under the
Pharmacy Act, 2012

(Filed September 21, 2015)

Under the authority of section 59 of the Pharmacy Act, 2012, the Newfoundland and Labrador Pharmacy Board, with the approval of the Minister of Health and Community Services, makes the following regulations.

Dated at St. John’s, September 8, 2015.

David Cramm
Chairperson, Newfoundland
and Labrador Pharmacy Board

Steve Kent
Minister of Health and Community Services

REGULATIONS

Analysis


        1.   Short title

        2.   Definitions

        3.   Prescribing by pharmacists

        4.   Authorization to prescribe generally

        5.   Standards

        6.   Interim supply

        7.   Extending prescription

        8.   Adapting prescription

        9.   Therapeutic substitution

      10.   Non-prescription drugs

      11.   Minor ailments and other Schedule 1 prescribing

      12.   Duty to obtain informed consent

      13.   Other duties of pharmacists

      14.   Transitional

Schedule


Short title

        1. These regulations may be cited as the Authorization to Prescribe Regulations.

Definitions

        2. In these regulations

             (a)  "Act" means the Pharmacy Act, 2012;

             (b)  "drug" means drug as defined in the Act, and includes a device;

             (c)  "minor ailment" means a common or uncomplicated health condition listed in the schedule to these regulations that can be managed with self-care strategies or minimal treatment, or both of them;

             (d)  "Newfoundland and Labrador Drug Schedules" means the Newfoundland and Labrador Drug Schedules adopted by the board, and includes any amendment to those schedules;

             (e)  "prescriber" means a person authorized by an Act of the province to provide an instruction directing that a drug be dispensed to or for a person, which instruction may be given

                      (i)  orally,

                     (ii)  in writing, or

                    (iii)  by an electronic means approved by the board;

             (f)  "Schedule I drug" means a drug listed in Schedule I of the Newfoundland and Labrador Drug Schedules;

             (g)  "Schedule II drug" means a drug listed in Schedule II of the Newfoundland and Labrador Drug Schedules;

             (h)  "Schedule III drug" means a drug listed in Schedule III of the Newfoundland and Labrador Drug Schedules;

              (i)  "therapeutic substitution" means substituting a prescribed drug with a different drug that has an equivalent therapeutic effect; and

              (j)  "unscheduled drug" means a drug which is considered to be an unscheduled drug in accordance with the Newfoundland and Labrador Drug Schedules.

Prescribing by pharmacists

        3. A pharmacist may prescribe a drug to a person in accordance with these regulations where

             (a)  his or her registration includes an authorization granted under these regulations to do so;

             (b)  the requirements set out in the standards established by the board under section 5 are met; and

             (c)  the prescribing falls into one or more of the following categories:

                      (i)  providing an interim supply of drugs,

                     (ii)  extending a prescription,

                    (iii)  adapting a prescription,

                    (iv)  therapeutic substitution,

                     (v)  prescribing non-prescription drugs, and

                    (vi)  prescribing for minor ailments.

Authorization to prescribe generally

        4. (1) The board shall add an authorization to prescribe to the registration of a pharmacist where that pharmacist

             (a)  applies in the form and manner directed by the board;

             (b)  provides proof satisfactory to the board that he or she has completed the educational and training requirements prescribed by the board; and

             (c)  pays the application fee.

             (2)  An authorization to prescribe which has been added to the registration of a pharmacist under these regulations remains in effect as long as the pharmacist holds a valid registration.

Standards

        5. (1) The standards advisory committee appointed under the Administration of Drug Therapy by Inhalation or Injection Regulations shall make recommendations to the board respecting standards relating to prescribing by pharmacists.

             (2)  The board shall establish standards relating to prescribing by pharmacists and in doing so, shall consider the recommendations of the standards advisory committee referred to in subsection (1).

             (3)  Where a pharmacist is authorized to prescribe a drug under these regulations, the pharmacist shall do so in accordance with the standards.

Interim supply

        6. (1) A pharmacist authorized under section 4 may prescribe an interim supply of drugs.

             (2)  A pharmacist who prescribes an interim supply of drugs under subsection (1) may provide a person with a minimum amount of previously prescribed drugs required in order to allow the person time to visit a prescriber or the person's usual pharmacy in order to obtain a renewal.

Extending prescription

        7. (1) A pharmacist authorized under section 4 may extend a prescription.

             (2)  A pharmacist who extends a prescription under subsection (1)

             (a)  shall only extend the prescription if the prescription filled immediately previous to it was filled at the same pharmacy; and

             (b)  shall extend the prescription no more than the amount previously filled or 90 days' supply, whichever is less.

             (3)  A pharmacist shall not extend a prescription where the prescription has already been extended once under the authority of either

             (a)  the Medication Management by Community Pharmacists Standards of Pharmacy Practice; or

             (b)  these regulations.

Adapting prescription

        8. (1) A pharmacist authorized under section 4 may adapt a prescription.

             (2)  A pharmacist who adapts a prescription under subsection (1) may do the following:

             (a)  change the dosage form of the prescription;

             (b)  change the dosage regime of the prescription;

             (c)  change the quantity of the drug prescribed;

             (d)  complete missing information on the prescription; and

             (e)  make a non-formulary generic substitution.

Therapeutic substitution

        9. A pharmacist authorized under section 4 may substitute a drug within a defined therapeutic class with another drug which would have, in the opinion of the pharmacist, an equivalent therapeutic effect in order to meet the therapeutic needs of the person for whom the drug has been prescribed.  

Non-prescription drugs

      10. A pharmacist authorized under section 4 may prescribe Schedule II and III drugs and unscheduled drugs.

Minor ailments and other Schedule 1 prescribing

      11. A pharmacist authorized under section 4 may, in addition to prescribing a drug referred to in section 10, prescribe a Schedule I drug where

             (a)  that drug is indicated for the treatment of a minor ailment that is listed in the schedule to these regulations; or

             (b)  that prescribing falls into a category referred to in subparagraph 3(c)(i), (ii), (iii) or (iv).

Duty to obtain informed consent

      12. (1) A pharmacist authorized under section 4 who intends to prescribe under these regulations shall ensure that he or she obtains informed consent before so prescribing.

             (2)  In the process of obtaining informed consent as required by subsection (1), a pharmacist shall provide the following information to the person for whom the prescription is intended or his or her agent:

             (a)  the condition to be treated;  

             (b)  the drug to be prescribed;

             (c)  the anticipated benefits and risks of the drug to be prescribed;

             (d)  expected reactions and responses to the drug to be prescribed, including timeframes; and

             (e)  the common and rare side-effects of the drug to be prescribed.

             (3)  Informed consent shall be obtained from the person for whom the prescription is intended unless it is considered appropriate and in the person's best interest to obtain consent from the person's agent on his or her behalf.

Other duties of pharmacists

      13. (1) A pharmacist who prescribes under the authority of these regulations shall

             (a)  have appropriate knowledge of the person for whom the prescription is intended, the condition being treated and the drug to be prescribed;  

             (b)  reasonably believe that the prescription is appropriate in the circumstances for the person for whom it is intended, and that the prescription is in the person's best interest;

             (c)  keep those records required by the board in the form and manner directed by the board; and

             (d)  notify the following of the prescription in the manner and in the time period directed by the board:

                      (i)  the person's primary health care provider and the original prescriber, if different, and

                     (ii)  those other health care providers as requested by the person.

             (2)  A pharmacist shall, for the purpose of paragraph (1)(a), perform and document an assessment of a person in the form and manner directed by the board, which assessment may include an evaluation of the following:

             (a)  the person's symptoms, medical history, health status and personal circumstances; and

             (b)  any safety considerations.

             (3)  Notwithstanding another provision of these regulations, a pharmacist who is authorized to prescribe under these regulations shall not exercise that authorization and shall refer a person to another health care provider where the treatment the person requires is outside of the scope of practice, knowledge, skills, competencies or experience of the pharmacist.

             (4)  Notwithstanding another provision of these regulations, a pharmacist shall not prescribe a drug listed in the Controlled Drugs and Substances Act (Canada) and the regulations under that Act.

Transitional

      14. (1) Notwithstanding the coming into force of these regulations, where, before the coming into force of these regulations, a pharmacist was authorized by the board to prescribe as referred to in subsection (2), the pharmacist may continue to prescribe under the authority of that authorization until December 31, 2015.

             (2)  An authorization to prescribe by the board referred to in subsection (1) is limited to the following:

             (a)  providing an interim supply;

             (b)  extending a prescription; and

             (c)  adapting a prescription.


Schedule

Minor Ailments

Acne, Mild

Allergic Rhinitis

Atopic Dermatitis, Mild-Moderate

Callouses and Corns

Cold Sore

Contact Dermatitis

Dandruff

Diarrhea (Non-Infectious)

Dysmenorrhea

Dyspepsia

Emergency Contraception

Fungal Infections of the Skin

Gastroesophageal Reflux Disease

Headache, Mild

Hemorrhoids

Impetigo

Joint Pain, Mild

Muscle Pain, Mild

Nausea

Oral Fungal Infection

Oral Ulceration

Pinworms

Sleep Disorders, Mild

Smoking Cessation

Upper Respiratory Conditions, Mild (cough, nasal congestion, sore throat)

Urticaria, Mild (including bites and stings)

Vaginal Candidiasis

Warts (excluding facial and genital)

Xerophthalmia