Frequently Asked Questions from Pharmacy Practice – Winter 2020


FAQ logoNote that these answers were current at date of publication and are meant as guidance for pharmacy professionals. The College cannot tell a registrant what course of action to take, provide legal advice or opinions, or make any decisions for a registrant. 


Q: Are pharmacies still required to subscribe to a drug information service?

ANSWER

A: No. Revisions to the College’s Required Reference Guide for Ontario Pharmacies, approved at the September 2018 Council meeting, made a subscription to a Drug Information Service optional instead of mandatory. This change occurred along with the approval of the Standards of Operations for Pharmacies in Ontario.

At a minimum, every pharmacy should have at least one reference in each of the following areas:

  • A Canadian Drug Reference / Compendium
  • A Drug Interaction Publication
  • A Drug Therapy Publication
  • A Patient Counselling Guide

By removing the Council-approved list of specific references, pharmacy professionals gained the flexibility to select the resources in each area they deem most appropriate to support them in the delivery of patient care. Registrants are also encouraged to assess their practice and select additional references based on the pharmacy’s patient population and the professional services provided. References should be reviewed, evaluated and updated on a regular basis to ensure each remains relevant, current and suitable for its intended purpose: to allow registrants to meet the Standards of Practice.


Q: Now that the Cannabis Regulations allow the sale of edibles and topicals, can a patient bring their own cannabis to a pharmacist to have it compounded into a capsule or a cream?

ANSWER

No. The Cannabis Act states that activities with cannabis are prohibited unless authorized. Under the Act, it is prohibited to obtain, or offer to obtain cannabis by any method or process, including altering its chemical or physical properties. As such, any compounding activity by a pharmacy professional involving cannabis would require enabling regulations, in addition to complying with applicable provincial requirements.

Cannabis is regulated federally by Health Canada’s Cannabis Legalization and Regulation Branch (CLRB), who is responsible for enforcement of the Cannabis Act and Cannabis Regulations as well as issuance of any licenses that may be issued to conduct activities with cannabis.

For additional information, please review the College’s Cannabis Strategy for Pharmacy or contact the CLRB at cannabis@canada.ca


Q: We received a prescription with a statement that it was electronically signed by the prescriber but there is no actual signature on it. What are the regulations around this?

ANSWER

The requirements for a prescription to be “signed” are established in the federal regulations relevant for the schedule of the drug.  There is nothing in the regulations mandating the use of a “wet” signature. As explained in the related 2014 article, Navigating Electronically Generated Prescriptions, “Health Canada has broadly defined ‘signing’ as whatever is determined to be necessary to authorize and validate the order”.

The College’s Position Statement Authenticity of Prescriptions using Unique Identifiers for Prescribers (July 2013) describes three examples of distinct authorization methods:

  • a traditional pen-and-ink signature, or
  • an electronically captured image of a unique signature (generated on a signature pad), or
  • a unique prescription authorization process which ensures that the prescriber has reviewed and authorized each individual prescription

There may be many different technologies available to prescribers, especially as computerized order entry and electronic prescriptions become increasingly common, to implement a unique authorization process and generate an order without an actual image of a signature.

Dispensers should review the Position Statement in its entirety, especially the guidance provided in the section The Responsibility of the Member.  If the pharmacist decides that they need to verify the authenticity of the order, this may be done verbally or in writing (via fax).  Prescribers should seek guidance from their regulatory College.

Please note the following message from the National Association of Pharmacy Regulatory Authorities (NAPRA):

NAPRA UPDATES ITS POLICY ON NATURAL HEALTH PRODUCTS

NAPRA is updating its policy on and approach to Natural Health Products (NHPs) in NAPRA’s National Drug Schedules with the best interest of the public as its first and foremost concern.

NAPRA will remove NHPs currently listed within the National Drug Schedules (NDS) in a stepwise, risk-based approach:

1) Effective January 2, 2020: NHPs currently listed within the Unscheduled category and within Schedule III will be removed from the NDS. At Health Canada’s request, ephedrine and pseudoephedrine will continue to be subject to the conditions of sales as outlined in NDS Schedule III until January 2, 2021.

2) Effective January 2, 2022: NHPs currently listed within Schedules I and II will be removed from the NDS.

As of 2022, all products with a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM) from Health Canada will be considered outside the scope of NAPRA’s National Drug Schedules.

The NDS were developed before Health Canada began regulating the sale of NHPs in Canada. When the Natural Health Products Regulations came into force in 2004, many products that were included in the NDS became re-classified as NHPs by Health Canada. Although NHPs are beyond the scope of NAPRA’s NDS, NAPRA agreed to maintain the substances that were already listed in the NDS on an interim basis until direction could be provided by the federal government regarding a framework for determining conditions of sale for NHPs in Canada.

This interim measure was never meant to be a permanent solution to address the risks of the entire class of NHPs. The NDS were developed to assess drugs and are not conducive to the review of NHPs, which have significantly different requirements to obtain authorization for sale in Canada than non-prescription drugs. The NDS only include a few NHPs that used to be classified as drugs before Health Canada re-classified them as NHPs. There are many other NHPs which may also present risks that have no restrictions on sale, because the federal NHP Regulations do not address conditions of sale.

Given that the interim measure initiated many years ago only addresses the risk of a small subset of NHPs while others are available to consumers without directed conditions of sale, NAPRA has determined that this approach is no longer in the best interest of the public. For full public safety, all NHPs should be evaluated for conditions of sale by an appropriate framework designed for that purpose by relevant stakeholders.

Over the past 10 years, NAPRA has recommended the development of a framework that addresses the risks of the entire class of NHPs. NAPRA will continue to work with stakeholders to encourage the development of such a framework, which would provide the public with a consistent and comprehensive approach to the sale of all NHPs in Canada.

See NAPRA’s Policy on NHPs for more information.