Sterile Compounding Exemption for Palliative Care Patients Amendment
At its meeting on December 9, 2022, CPhM Council approved an extension of the exemption for the drawing-up of comfort care medications for Palliative Care patients in a setting that does not meet the NAPRA Model Standards for Hazardous and Non-Hazardous Sterile Compounding. Council will review the exemption again prior to the new expiry date of January 1, 2024.
Council has further reviewed the criteria a pharmacist must comply with when deciding to implement this exemption; more specifically, the requirement for the pharmacist to have the patient or agent sign a waiver or release form acknowledging that the preparation is from a non-compliant facility “for emergency use only.” At the recent meeting on February 27, 2023, Council decided to amend the requirement for a signed waiver/release form by replacing it with the requirement to obtain informed consent.
The informed consent process is applicable in all aspects of delivering pharmacy care, not only when utilizing this exemption, and is a critical step in fully informing the patient/caregiver/decision-maker of all risks and benefits. This process ensures there is appropriate understanding of the procedures and care affecting a specific patient. Informed consent involves a meaningful discussion with the patient/caregiver/decision-maker on all associated risks, alternatives and potential outcomes/consequences of care/treatment. Informed consent does not always need to be written and can be oral. The method for maintaining the record of obtaining and documenting informed consent is up to each pharmacy based on the pharmacy-specific policy.
In addition, Council has also decided to task the development of a practice direction/standard on informed consent. This practice direction will provide a baseline framework for applying informed consent in all areas of pharmacy practice.
Stay tuned for more information about this practice direction once developed.
The decision criteria for utilizing this exemption, along with the new amendment is below:
Any pharmacy or pharmacist that is considering the utilization of this exemption must be knowledgeable and fully compliant with the following requirements:
When deciding if the service should be provided:
- The patient must be registered with the palliative care program.
- The medications should be non-hazardous, and the manipulation be low risk (as defined by NAPRA) and prepared from a commercially available sterile source only.
- The preparation should be only a single manipulation (i.e., pre-filling a syringe).
- All possibilities of training a caregiver or family member to draw up medication should be exhausted first before contemplating this option.
- The physician determines that this is the only viable method of effective treatment of the patient, and the prescription indicates “for emergency use.”
- The benefit vs. risk favours rapid access to the medication.
Once the decision has been made to provide the service:
- A process for obtaining informed consent must be implemented and followed. This must include a meaningful discussion with the patient/caregiver/decision-maker on associated risks and alternatives of the provided pharmacy service.
- The product should be monitored for signs of potential contamination at draw-up, and further education should be provided to the patient’s agent to monitor before administration.
- Preparation should take place in a designated compounding area following the standards for preparing immediate use preparations (see NAPRA Model Standards for Sterile Compounding).
- The compounder must don minimum personal protective equipment (PPE), including but not limited to sterile gloves (or gloves that have been disinfected with sterile alcohol) and a medical-grade mask.
- The preparation must be performed by a pharmacist or pharmacy technician.
- The preparation is limited to a 2-day supply that must be labelled with a maximum beyond-use date of 48 hours from the point of preparation.
- The non-compliant pharmacy is limited to supplying a maximum of 6 days (three occurrences under this exemption).
- Supply of medications beyond the limits must occur from a NAPRA compliant facility. The pharmacy must refer the patient to a compliant facility or obtain medications prepared from a compliant facility.
- The product must be stored appropriately at the pharmacy, and education must be provided to the patient’s agent on storage at home.
Prior to consideration of using the above exemption, it is imperative that pharmacists make every effort to seek the services of, or refer a patient to, a pharmacy that can provide sterile compounding that fully meets the NAPRA Model Standards for Sterile Compounding. This is considered ideal, best practice, and in the best interest of patient safety. The exemption is intended to provide timely access to necessary medications, in order to offer the pharmacist and patient/caregiver time to source out fully compliant sources of the drug product.
Pharmacist Assessments for Uncomplicated Cystitis: Misinformation Can Lead to Unnecessary Treatment Delays
Pharmacists who have completed the CPhM Uncomplicated Cystitis Independent Study Program, as outlined on the CPhM website, and have received authorization, can prescribe a drug to treat uncomplicated, recurrent cystitis in non-pregnant women.
Prior to prescribing for uncomplicated cystitis an authorized pharmacist must conduct and document a patient assessment in accordance with the Prescribing Practice Direction.
The College has received several inquiries from patients about Manitoba Health’s coverage of pharmacist assessments for uncomplicated cystitis. It is important that all pharmacy staff be familiar with the proper procedures to ensure accurate information is relayed to inquiring patients. Misinformation related to coverage of the pharmacist assessment may prevent a patient from accessing timely care, which may become a patient safety issue.
All Manitobans with an active Manitoba Health card are eligible for coverage from Manitoba Health for up to three pharmacist assessments for uncomplicated cystitis per benefit year (April 1 – March 31). More information on uncomplicated cystitis assessment coverage and the claims submission procedure can be found on Manitoba Health’s website.
Enhancing Safety Culture: Thanking Pharmacy Professionals for their Valuable Feedback
Pharmacy professionals play a vital role in the healthcare system, ensuring patients receive safe and effective medications and therapies. Recently, many pharmacy professionals took the time to complete a Community Pharmacy Survey on Patient Safety Culture. The College of Pharmacists of Manitoba (CPhM) would like to take a moment to express its gratitude for their participation.
By completing the survey, which closed on March 8, 2023, pharmacy professionals have provided valuable insights into the current state of patient safety culture in pharmacy practice. Their feedback will help identify areas where improvements can be made to enhance patient safety and improve the quality of care provided.
We understand that completing a survey can be time-consuming and that pharmacy professionals have busy schedules, but their dedication to patient safety is commendable. By providing honest feedback, they are helping to create a culture of safety and accountability in pharmacy practice. CPhM will use the feedback provided in the survey to inform policy and practice decisions, with the goal of reducing the chances of patient harm from medication incidents.
Survey results will be communicated to pharmacy professionals and will be used as a benchmark for safety culture in Manitoba’s community pharmacies. CPhM thanks pharmacy professionals for their commitment to continuous quality improvement and to patient safety.
Annual Learning Portfolio Review Reminder
The College of Pharmacists of Manitoba (CPhM) is currently conducting the 2021 – 2022 Annual Learning Portfolio Review. Approximately 20 per cent of licensed pharmacists were selected to participate in this process, and emails were sent to the selected pharmacists in January. A reminder email was sent on March 6, 2023. Please check your inbox for the email address that you have provided to CPhM as well as your junk folder to see if you have been selected to participate or need to provide more information.
The Annual Learning Portfolio Review helps ensure pharmacists engage in continuous learning through accredited and non-accredited learning activities to remain eligible for licence renewal and to help maintain competence to practice.
Should you have any questions about the review process, please contact Joy Idoko at pdreview@cphm.ca.
CPhM thanks participating pharmacists for their time and cooperation.
Save the Date – Annual General Meeting and Awards Presentation 2023
Please mark your calendar and plan to attend the 145th Annual General Meeting (AGM) of the College of Pharmacists of Manitoba (CPhM), in conjunction with CPhM professional awards presentations:
Date: Tuesday, May 2, 2023
Time: 7:00 pm
Format: Virtual webinar
In its commitment for continuous process improvements, Council examined aspects of scheduling the AGM and decided to hold the event on a weekday evening. In keeping with the flexibility a virtual format provides, it is anticipated that the new day and time may further enhance registrant access to attend, regardless of where they live or practice in the province.
More information about the 145th AGM and a link to register will be circulated in the coming weeks.
Upcoming Events & Professional Development Opportunities
Pharmacists Manitoba Annual General Meeting & Complimentary Session
April 12, 2023
Click here to register.
ACS Network Heart Attack Day 2023
April 14, 2023
Click here to register and for more information.
Pharmacists Manitoba Spring Conference
April 15 & 16, 2023
Click here to register.
Opioid Agonist Therapy 101 Introduction to Clinical Practice
October 26 and 27, 2023
Click here to register.