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COVID-19 Guidance - Temporary authorizations for controlled substances

To use the exemption in context with the Standard of Practice for Pharmacists and Pharmacy Technicians, pharmacists must review all sections of the following guidance.


Page last updated on April 9, 2020, at 4:30 p.m. MT.

Background

To support Canadians in accessing controlled substances when needed for medical treatments (e.g., treatment of substance use disorders and chronic pain), on March 19, 2020 Health Canada issued the following temporary exemptions for prescriptions of controlled substances under Section 56(1) of the Controlled Drugs and Substances Act (CDSA). This exemption will expire upon being revoked, replaced by another exemption, or on September 30, 2020, whichever occurs first. With respect to controlled substances including narcotics, controlled drugs, and targeted drugs, effective immediately, the exemptions

  • permit pharmacists to extend prescriptions,
  • permit pharmacists to transfer prescriptions to other pharmacists,
  • permit prescribers to issue verbal orders (i.e., over the phone), and
  • permit pharmacy employees to deliver prescriptions of controlled substances to patients’ homes or other locations where they may be (i.e., self isolating).

These exemptions have been temporarily issued in response to the COVID-19 pandemic to provide patients uninterrupted care while adhering to the principles of social distancing and self-isolation.

Except as noted within this document, nothing in the exemptions or these guidelines relieves a pharmacist of their obligation to meet the requirements of the ACP Guidance for Assessment and Monitoring: Individuals using Opioid Medications, the Standards of Practice for Pharmacists and Pharmacy Technicians, and other related legislation and guidance. The intention of these guidelines is to provide direction on how to implement the above exemptions into practice. All standards of practice remain in force and apply, except as indicated below.

Collaboration

Collaboration with the original prescriber is always the preferred option and pharmacists should only prescribe an extension when it is in the best interests of the patient to do so and they have completed a thorough assessment.

Competence

Opioid therapy can be challenging for pharmacists to assess and monitor due to the complex nature of the underlying conditions and the risk of harm from the medications. Monitoring patients that use opioid agonist therapy (OAT) adds additional complexity as these patients have unique needs.

As this represents a new area of practice for pharmacists, it is essential that they self-evaluate their knowledge, skills, and competencies before they prescribe an extension for a controlled substance.

Guidance for the Exemptions

Pharmacists are permitted to extend prescriptions for controlled substances

Note: All standards referenced below are from the Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT)

1. Pharmacists may adapt a prescription for a controlled substance only for the purpose of renewing an existing and current prescription to ensure continuity of care. Pharmacists must not

  • alter dosages nor make therapeutic substitutions for prescriptions for controlled substances,
  • prescribe a controlled substance for emergency purposes as described in standard 13, or
  • prescribe a controlled substance at initial access as described in standard 14.

2. Pharmacists must complete a thorough assessment of each individual before prescribing a controlled substance to a patient. This assessment must include a review of the Electronic Health Record (Netcare) every time a pharmacist prescribes a controlled substance.

3. Pharmacists may prescribe an extension for a controlled substance without seeing the patient personally if:

  • they have performed an assessment and determined they can meet the conditions of SPPPT 12.5,
  • the original prescription or written order is on record at the pharmacy, and
  • they have taken reasonable steps to confirm the identity of the patient.

4. Pharmacists who prescribe an extension for a controlled substance should limit the days supply they provide to the minimum amount necessary to meet the needs of the patient and should not exceed the last quantity authorized by the original prescriber or 30 days, whichever is less.

5. In the event a pharmacist does not have the original prescription or written order at their pharmacy, before prescribing an extension, and in addition to the requirements of SPPPT 12.1 -12.4, the pharmacist must:

  • consult Netcare to verify the location of the patient’s current prescription;
  • make reasonable attempts to contact the original pharmacy to transfer the prescription; and
  • make reasonable attempts to contact the original prescriber and collaborate if the pharmacist requires additional clinical history about the patient to support their assessment and decision to prescribe.

The pharmacist may prescribe an extension without the original prescription or written order when the pharmacy possessing the original order has been temporarily closed1. In this case the pharmacist must:

  • document the temporary closure of the original pharmacy in the patient record;
  • notify the original pharmacy, as soon as reasonably possible, both orally and in writing, that they have prescribed for the patient and the original prescription must be inactivated and recorded as transferred; and
  • notify the original prescriber that patient care has been transferred.

Pharmacists at both pharmacies must make every effort to ensure that there are not active prescriptions for the same controlled substance on file at multiple pharmacies.

6. Pharmacists may prescribe an extension for OAT methadone, buprenorphine-naloxone, and slow-release oral morphine (SROM) for the purposes of renewing existing medications for continuity of care if:

  • it is not reasonably possible to contact the original prescriber;
  • there is evidence the patient is on a stable dose (i.e. no recent changes) and has not recently missed doses which may result in reduced tolerance to their OAT; and
  • the pharmacist does not extend beyond the quantity previously authorized by the prescriber.

7. Pharmacists must not prescribe an extension for injectable opioid agonist therapy for patients.

8. Pharmacists should take steps to ensure that dispensing transaction records are properly uploaded to Netcare for all controlled substances as soon as practically possible.


1“Temporarily closed” refers to a pharmacy that is closed for an indefinite period of time due to the COVID-19 pandemic. As such, this direction does not apply if the pharmacy is operational but has been contacted outside of normal operating hours.

Pharmacists are permitted to transfer prescriptions all for controlled substances to other pharmacists.

Pharmacists are permitted to transfer narcotics, controlled drugs, and targeted substances between pharmacies as they would other non-controlled medications. All existing applicable legislation and guidance regarding transferring prescriptions now applies to the transfer of controlled substances. For reference, refer to the ACP guidance for requests to transfer patient care.

  • Prescriptions for controlled substances, except for targeted substances, may only be transferred within Alberta.
  • Targeted substances may be transferred interprovincially.
  • All controlled substances, including targeted substances, may be transferred more than one time.
  • When receiving a transferred controlled substance, pharmacists must complete an assessment in accordance with the Guidance for Assessment and Monitoring: Individuals using Opioid Medications and in accordance the SPPPT.
  • Whenever practical, pharmacists should notify prescribers and other healthcare professionals in the patient’s circle of care when such prescriptions are transferred.
  • Pharmacists should take steps to ensure that dispensing transaction records are properly uploaded to Netcare for all controlled substances as soon as practically possible.

Prescribers are permitted to issue verbal orders (i.e., over the phone) for controlled substances.

Prescriptions for all controlled substances may be accepted verbally from authorized prescribers. Pharmacists should consider the following points:

  • As with any verbal prescription, pharmacists must ensure the currency, authenticity, and completeness of all verbal prescriptions for controlled substances. However, due to the high risk of diversion of these substances, additional diligence should be applied to confirm the identity of the of the caller and the authenticity of the prescription including but not limited to confirming the license number of the prescriber.
  • Pharmacists must consider relevant information on the electronic health record (i.e., Netcare) prior to dispensing a verbal prescription for a controlled substance.
  • Pharmacists are not authorized to extend a controlled substance verbally.

Pharmacy employees are permitted to deliver prescriptions of controlled substances to patient’s homes or other locations where they may be (i.e. self isolating).

  • Pharmacy staff who deliver controlled substances must adhere to the requirements of social distancing.
  • Pharmacy staff who deliver prescriptions must ensure they:
    • can confirm the identity of the patient or a person responsible for that individual’s care,
    • can ensure the security and integrity of the controlled substances provided to the patient,
    • can ensure the privacy and confidentially of the patient is maintained at all times,
    • obtain in writing a note from the pharmacist identifying
      • the name of the individual effecting the delivery,
      • that they have been tasked with delivering prescriptions for a specific list of people and the places of delivery,
      • no details about what they are delivering, and
      • contact information for the pharmacist should law enforcement need to confirm the name and quantity of the controlled substance to be delivered, and
    • have a copy of the above note as well as a copy of the Health Canada Exemption while effecting the delivery.
  • Nothing in these exemptions allow
    • pharmacists to mail or otherwise deliver a controlled substance to a patient outside of Canada, and
    • a pharmacy technician or a non-regulated individual to witness the ingestion of Opioid Agonist Therapy (OAT).

Temporary changes to the TPP Program

The TPP program remains in force. However, the temporary exemptions from Health Canada mean prescriptions for type 1 TPP medications that are

  • sent by verbal order from physicians, or
  • written by pharmacists

will not require a secure TPP form.

For all other circumstances, pharmacists must continue to adhere to the polices outlined in the TPP Alberta Guide unless doing so puts them or their patients in a position that contravenes the public health advice for social distancing and self-isolation.

Relevant standards

Standards of Practice for Pharmacists and Pharmacy Technicians

Standard 11.3

In accordance with Standard 12, a pharmacist may prescribe a Schedule 1 drug by adapting a prescription from another prescriber by

  1. altering the dosage, formulation or regimen;
  2. substituting another drug that is expected to have a similar therapeutic effect; or
  3. renewing a prescription to ensure continuity of care.

Standard 11.7

A pharmacist must not prescribe any drugs listed in the schedules of the Controlled Drugs and Substances Act including but not limited to drugs listed in the Narcotic Control Regulations and the Benzodiazepines and Other Targeted Substances Regulations (controlled drugs).

Standard 12

Pharmacists who adapt an existing prescription under Sections 16(1)(e) and (f) of the Pharmacists and Pharmacy Technicians Profession Regulation must:

  1. have the original prescription,
  2. determine whether adapting the prescription is appropriate in the circumstances,
  3. document the adaptation, and
  4. inform the original prescriber.

Standard 12.1

Notwithstanding Standard 12(a), a pharmacist who does not have an original prescription, but is satisfied that:

  1. the patient has presented evidence of current ongoing therapy based on a prescription (such as an empty prescription vial);
  2. there is an immediate need for drug therapy; and
  3. it is not reasonably possible:
    1. for the patient to attend the pharmacy that dispensed the original prescription to obtain a refill, or
    2. to have the prescription transferred from the pharmacy that dispensed the original prescription, may renew a prescription to ensure continuity of care.

Standard 12.2

A pharmacist who renews a prescription under Standard 12.1 must:

  1. see the patient personally before renewing the prescription, and
  2. only prescribe the minimum amount of the drug necessary to give the patient sufficient time to attend the pharmacy that dispensed the original prescription or see the prescriber of the original prescription.

Standard 12.5

In determining whether it is appropriate to adapt a prescription, a pharmacist must:

  1. obtain the patient’s informed consent for the adaptation,
  2. have sufficient knowledge about the patient’s health status and the disease or condition being treated to make the decision to adapt the prescription,
  3. consider the currency and appropriateness of the prescription being adapted,
  4. consider appropriate information as described in Standard 3,
  5. be satisfied that the adaptation will maintain or enhance the effectiveness of the therapy,
  6. be satisfied that the adaptation cannot reasonably be expected to cause a drug therapy problem,
  7. be satisfied that the adaptation will not place the patient at increased risk,
  8. be satisfied that the intended use of any drug or blood product prescribed in the process of the adaptation is for an approved use as described in Standard 11.6, and
  9. comply with any directions of Council in relation to the adaptation of prescriptions.

Standard 12.6

Unless a pharmacist has been granted additional prescribing authorization:

  1. the pharmacist:
    1. may only alter a dosage in relation to a new prescription, and
    2. must not alter a dosage in relation to a renewed prescription, and
  2. before altering a dosage in relation to a new prescription the pharmacist must:
    1. determine that the patient’s age, weight, or organ function necessitates a dosage adjustment; or
    2. determine that the prescribed dosage is not commercially available.

Standard 13

Pharmacists who prescribe for emergency purposes under Sections 16(1)(g) and (h) of the Pharmacists and Pharmacy Technicians Profession Regulation must:

  1. be satisfied that there is an immediate need for drug therapy,
  2. be satisfied that it is not reasonably possible for the patient to see another health professional to obtain the prescription, and
  3. only prescribe the minimum amount of the drug or blood product necessary to give the patient sufficient time to see a prescriber.

Standard 14

Pharmacists who have been granted additional prescribing authorization who prescribe under Sections 16(3) and (4) of the Pharmacists and Pharmacy Technicians Profession Regulation must prescribe based on:

  1. their own assessment of the patient,
  2. a recommendation from a prescriber that the patient receive a Schedule 1 drug or blood product, or
  3. a consultation with another regulated health professional.