Important Policy Reminder Regarding Compounding in Pharmacies
A prescription is not required for commercially available over the counter products, but under Health Canada Policy 51 (the policy) a pharmacy requires a prescription to dispense any pharmacy compounded product to a patient.
Health Canada policy 51 is an important document for pharmacists which outlines when a product can be compounded by a pharmacy. The purpose of Health Canada policy 51 is to provide background information on the compounding and manufacturing of drugs in Canada and to provide a policy framework to assist in distinguishing between compounding and manufacturing activities of drug products in Canada.
Section 5.1 lists 14 factors that must be considered when assessing if compounding is appropriate. Pertinent factors include:
- A pharmacy may prepare drugs in very limited quantities, in anticipation of a prescription. For the purpose of Health Canada Policy 51, preparation involves compounding or repackaging of multiple units, not for immediate use, in a single process, by the same operator in accordance with a standardized batch preparation procedure.
- Compounding should only be done if there is a therapeutic need or lack of product availability and should not be done solely for economic reasons for the healthcare professionals.
- The compounded product must provide a customized therapeutic solution to improve patient care without duplicating an approved drug product.
- When there is a shortage or no supply of a commercially available product and the healthcare professional has determined a medical need for this product, the product may be compounded during the period of shortage or no supply only.
- Drugs should not be compounded in order to be sold to third parties who will in turn sell1/deliver to patients outside of their defined patient-healthcare professional relationship. Pharmacists that do not provide specific compounding services may contract this activity to another pharmacist who provides this type of specific compounding service.
The scope of this policy framework covers drugs for human and veterinary use. This policy applies to all scheduled drugs regulated under the Food and Drug Act and Over the Counter drugs. A valid prescription2 is required for all compounded products including OTC products.
The College requests that all pharmacists review Health Canada policy 51, especially during any time of uncertainty. If you have questions or require further guidance, please contact email@example.com.
- Includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration. (
- A valid prescription is defined in the policy as an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order (Food and Drug Regulations C.01.001)
Safety IQ Compliance Deadline Reminder: Safety Self-Assessment and CQI Meeting
The deadline for completion of the mandatory safety self-assessment (SSA) and annual continuous quality improvement (CQI) meeting is fast approaching. The College of Pharmacists of Manitoba (CPhM) thanks all pharmacy teams that have already completed their SSA and annual CQI meeting.
The deadline for your pharmacy to complete an SSA and a CQI meeting is October 1, 2022, if your pharmacy:
- implemented Safety IQ on the June 1, 2021 program launch date; or
- opened between June 1 and September 31, 2021.
If your pharmacy opened after October 1, 2021, then your team must complete an SSA and CQI meeting within one year of opening.
It can take 1-3 hours to complete an SSA. Once your SSA and CQI meeting are complete, the pharmacy manager must log into the pharmacy portal on the CPhM website to declare the dates of completion.
Your pharmacy’s manager is responsible for sourcing and completing an SSA and ensuring they have conducted at least one formal annual CQI meeting. CPhM has communicated directly with pharmacy managers about the upcoming deadlines.
Your pharmacy manager is not required to share the completed SSA or CQI meeting documentation with CPhM at this time, but the SSA and CQI meeting documentation and subsequent improvement plan(s) must be documented and available for regulatory review.
Your pharmacy’s chosen medication incident reporting platform may or may not offer an SSA as part of its service. Pharmacy managers should check with the pharmacy’s platform provider for more information.
Two medication incident reporting platform providers offer an SSA as a stand-alone product:
- ISMP Canada’s Medication Safety Self-Assessment for Community/Ambulatory Pharmacy; and
- Pharmapod’s Pharmacy Safety Self-Assessment.
If your pharmacy’s reporting platform does not offer an SSA, please visit the ISMP Canada and Pharmapod links listed above for information on their SSA tools and subscribe to the one that meets your needs.
For guidance on how to complete your annual CQI meeting, please see the College of Pharmacists of Manitoba (CPhM) resource, How Are We Doing? A Toolkit for Effective Continuous Quality Improvement Meetings.
Please visit the following links for additional resources to support SSA and CQI meeting completion in your pharmacy:
- How Are We Doing? A Toolkit for Effective Continuous Quality Improvement Meetings
The Safety IQ team will be monitoring and following up on compliance with the SSA and CQI meeting requirements in the weeks following the deadline. If you have and questions, please contact the Safety IQ team by email at firstname.lastname@example.org.
Inaccurate Profiles Lead to Frustration and Confusion: Ensure You Meet Your Obligations to Provide Accurate Information to the CPhM
Recently, two separate, but linked concerns related to inaccurate registrant and pharmacy profile information have been identified:
- Pharmacists did not maintain accurate information on their Pharmacist Portal.
- Pharmacy managers did not maintain accurate pharmacy employee rosters, including current pharmacists, listed pharmacy technicians, and interns and/or students on staff on their Pharmacy Portal.
The mismatch of information has led to
- difficulty in or the inability for CPhM staff to contact registrants directly; and
- difficulty or confusion for members of the public using the Public Registers.
Pharmacy owners, managers and pharmacists are asked to review the profiles and rosters they are responsible for, to ensure all fields are accurate and up to date. Pharmacy technicians must contact the CPhM if their place of employment or contact information has changed.
Pharmacy Owner and Manager Obligations
Section 68(c) of The Pharmaceutical Act (the “Act”), outlines that it is the owner’s obligation to notify the Registrar in writing of the name of the pharmacy manager and every member, student and intern employed by the owner, and notify the Registrar of any change in the employment of those persons within seven days after the change.
The pharmacy owner and manager may or may not be the same person. If the owner and manager are different people, the pharmacy manager must ensure, on behalf of the owner, that the employee roster on their Pharmacy Profile is accurate by logging into the Pharmacy Profile and updating that information.
Section 27(1) of the Regulation outlines that if the profile information specified in 23(1) (pharmacist profile content) becomes inaccurate or incomplete, the member must provide accurate and complete information to the Registrar within 30 days.
Additionally, section 29(2) of the Regulation states that a member must not willfully provide false, inaccurate, or incomplete information to the CPhM.
Registrants can fulfill their obligations by the logging into their Pharmacist Portal and updating the information. It is the responsibility of every pharmacist to ensure that their practices and contact information always remains current and complete with their profiles and the CPhM. Pharmacy technicians must also ensure that their practices and contact information always remains current and complete with the CPhM.
Register for the 2022 Medical Examiner Professional Development Event
The College is pleased to announce its fourth annual Medical Examiner professional development (PD) event titled “Understanding the CPSM Standards of Practice to Provide Safer Care, and OAT Provision in the Context of Other Psychoactive Drugs”
WHEN: Tuesday, October 4, 2022, from 7:00 to 8:45 pm.
REGISTRATION LINK: https://us02web.zoom.us/webinar/register/WN_GEXv74BaRPehonV80gLdzw
- This a virtual event ONLY, and is free to attend for pharmacists, pharmacy technicians, and pharmacy staff
- Deadline to register is October 3, 2022, at 4:30 p.m.
ACCREDITATION: This CPhM program can be claimed for up to 1.5 accredited CEU in the online PD Log.
- Talia Carter MOT, BSc, O.T. Reg. (MB), Prescribing Practices Program Coordinator, The College of Physicians & Surgeons of Manitoba
- Mike Sloan, B.Sc. (Pharm), Pharmacy Manager
- Review pearls from the College of Physicians & Surgeons of Manitoba (CPSM) Standards of Practice (SOPs) for Prescribing Opioids and Benzodiazepines/Z-drugs and consider some of the most common questions.
- Describe how the medical examiner collaborative work relates to the SOPs and the CPSM Prescribing Practices Program (PPP), and the role that PPP can play in supporting registrants.
- Recognize the valuable role pharmacists play in supporting prescribers and discuss ways to overcome barriers to collaboration.
- Apply learnings by considering communication methods with patients about opioids and/or benzodiazepines.
- Analyze two medical examiner case files linked to opioid overdoses in patients receiving Opioid Agonist Therapy (OAT) and apply learnings to provide safer care.
- Discuss the current SOPs related to the dispensing of OAT and psychoactive medications.
World Patient Safety Day Emphasizes WHO Challenge: Medication Without Harm
Medication incidents and unsafe medication practices are a leading cause of preventable harm across the world. The global cost of medication incidents is estimated to be $42 billion USD per year. The World Health Organization (WHO) recognized the magnitude of patient harm caused by medication incidents with its ongoing Global Patient Safety Challenge: Medication Without Harm. Building on this theme, the WHO has designated “Medication Safety” as the theme for World Patient Safety Day on September 17, 2022.
On September 15, 2022, the College of Pharmacists of Manitoba honoured World Patient Safety Day by presenting in a complimentary webinar hosted by ISMP Canada. Practice Consultant for Safety IQ, Ronda Eros, discussed Safety IQ as part of ISMP Canada’s Med Safety Exchange webinar. For more information or to view the webinar recording after September 26th, please visit https://ismpcanada.ca/resource/med-safety-exchange/#2022
Other ways that you can join the WHO mission of ‘Medication Without Harm’ to honour World Patient Safety Day:
- Keep your skills in safe medication practices up to date. ISMP Canada and the WHO offer education and resources to promote medication safety
- Participate in the WHOs World Patient Safety Day campaign
- Engage patients through shared decision-making using tools such as the 5 Moments for Medication Safety and implement actions related to the Know. Check. Ask. Campaign. ISMP Canada also offers 5 Questions to Ask About Your Medications to support patients.
- Report medication safety incidents, and share and apply lessons learned with your team and patients when possible
- Be mindful of situations where risk from medications is high and ensure safety measures are followed
- Mentor new members of your team on safe medication systems and practices
- Share your enthusiasm for medication safety with your colleagues on social media
NAPRA Recruitment Notice – Language Proficiency Standard Setting Exercises
The National Association of Pharmacy Regulatory Authorities (NAPRA) recently initiated a project to review and update its recommendations related to assessing language proficiency in English and French for safe and effective pharmacist and pharmacy technician practice in Canada.
NAPRA is looking to find qualified panelists to participate in standard-setting exercises. More information on this opportunity can be found here.
Interested candidates should complete the following expression of interest survey. Should you have any questions, please contact LShaver@napra.ca.
Upcoming Events & Professional Development Opportunities
Opioid Agonist Therapy 101 Introduction to Clinical Practice
October 20 & 21, 2022 8:00 a.m. – 4:30 p.m.
Spots are still available. Click here for more information and to register.
CPDPP Indigenous Trauma and Equity Informed Practice Webinar and Workshop
Continuing Professional Development for Pharmacy Professionals (CPDPP) in collaboration with Saskatchewan College of Pharmacy Professionals, Alberta College of Pharmacy, and College of Pharmacists of Manitoba, presents an informative and meaningful learning experience with Len Pierre Consulting. For more information and to register, click here.
CSHP- MB 2022 Fall Half Day – Inclusive Health Care
October 15, 2022 08:00 a.m.
Pharmacists Manitoba Fall Conference
October 2, 2022
ISMP Incident Analysis and Proactive Risk Assessment for Health Care Practitioners and Patient/Family Advisors
September 29-30, October 22-23, November 24-25, and December 8-9, 2022
ISMP MedRec and BPMH Training for Health Care Professionals
September 23 and November 18, 2022