NAPRA Sterile Compounding Exemption for Palliative Care Patients
College Council approved an exemption for pharmacies in the province to draw-up comfort care medications for palliative care patients in a setting that does not meet the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Sterile Compounding. The exemption is in place until January 1, 2022. This exemption will be reviewed by the College Compounding Task Force.
Council has approved the following guiding principles for this exemption to the NAPRA Model Standards for Hazardous and Non-Hazardous Sterile Compounding.
The guiding principles are below.
When deciding if the service should be provided:
- The medications should be non-hazardous and non-high-risk (i.e. not non-sterile ingredients)
- The products should be single manipulation
- There is no viable or closely equivalent commercial preparation available
- Risk vs. benefit favours rapid access to drawn-up product versus requiring product from a compliant sterile facility
- A patient must be registered with the palliative care program
- All possibilities of training 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
Once the decision has been made to provide the service:
- The patient or agent needs to sign a waiver/release form to acknowledge the risk associated with this option
- 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 as sterile an area as possible to similar standards for preparing immediate use preparations (see NAPRA Model Standards for Sterile Compounding)
- The product must be stored appropriately at the pharmacy and education provided to the patient’s agent on storage at home
- Limits for the draws, if done outside NAPRA compliant areas, have a maximum expiry of three days
It is important that before a pharmacist pursues the above exemption, they should make every effort to seek the services of, or refer a patient to, a pharmacy that can provide sterile compounding that meets the NAPRA Model Standards fully. This is best practice and in the best interest of the patient and their safety.
For more information regarding compounding and the NAPRA Model Standards please visit the Pharmacy Compounding Standards page on the College website.
Manitoba Health COVID-19 Vaccine Campaign
As Manitoba ramps up its COVID-19 immunization efforts in the coming weeks, pharmacists are encouraged to check the Manitoba Health COVID-19 Vaccine webpage regularly for the most up to date information on the provincial immunization campaign.
If any pharmacist is interested in applying to participate in the province’s COVID-19 immunization campaign according to the Ministerial Order, please visit the following website https://manitoba.ca/covid19/vaccine/jobs.html for more information and to see all positions available.
The deadline for the implementation of phase three of the NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations has come into effect as of January 1, 2021. Pharmacy facilities are expected to be fully compliant with Phase 3 of the implementation timeline for non-sterile preparations.
Requirements for Phase 3 of the implementation timeline include:
- Compliance with section 6.6 of the NAPRA Model Standards – Verification
- Compliance with section 6.7 of the NAPRA Model Standards – Labeling and packaging
- Compliance with section 6.8 of the NAPRA Model Standards – Storage
- Compliance with section 6.9 of the NAPRA Model Standards – Transport and delivery
- Compliance with section 6.10 of the NAPRA Model Standards – Product recalls
- Compliance with section 6.11 of the NAPRA Model Standards – Incidents and accidents
- Compliance with section 7 of the NAPRA Model Standards – Quality Assurance
- Compliance with Section 8.2 of the NAPRA Model Standards- Level B requirements
The deadline for the implementation of phase four is April 1, 2021.
The implementation of the NAPRA Non-sterile Compounding Standards may result in an increased cost of the compounded product for a multitude of reasons. The potential increase in cost also coincides with a higher standard including the need for PPE, quality controls, compounding facilities and compounding competence. The NAPRA Standards help protect the safety of both the patient and pharmacy staff.
To prevent barriers to treatment, pharmacists are encouraged to collaborate with patients, prescribers, other pharmacies, and insurance providers where appropriate. It is important to discuss the potential for increased cost with patients during the initial pharmacy assessment and intake of the prescription. The increase in cost can disproportionately affect seniors and those on a fixed income. It is essential to highlight the importance of the NAPRA Non-sterile Compounding Standards to impacted patients, so they understand the rationale for its implementation.
For more information on compounding, please see the College Pharmacy Compounding Standards page.
College Awards – Second Call for Nominations 2021
The College is accepting nominations or applications for the 2021 College Awards until Friday, January 15, 2021.
If you or a pharmacist you know has made a noteworthy contribution to patient care and safety or the practice of pharmacy, please consider submitting a nomination or application for one of the awards listed in the College Awards brochure.
The College has created award submission guidelines for your consideration prior to forwarding your nomination to the Awards & Nominating Committee.
Please send submissions by email to email@example.com with the subject line “Attention: Awards & Nominating Committee – CPhM Awards.”
For further instruction and to see the list of available 2021 College Awards, please click here.