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IMPLEMENTING THE NEW MODEL STANDARDS FOR PHARMACY COMPOUNDING: PHASE 3
A reminder that Phase 2 of the new compounding standards should now be completed and pharmacies and pharmacy professionals should begin to shift their focus to Phase 3.
Pharmacies and pharmacy professionals involved in sterile compounding are expected to have completed Phase 2 of the new compounding standards by the end of May 2019. Phase 2 included adopting the following standards as outlined by NAPRA: personnel; policies and procedures; maintenance logs; and compounded sterile preparation protocols.
Pharmacies and pharmacy professionals should now begin identifying gaps and implementing Phase 3 of the new compounding standards.
Phase 3 includes adopting the following standards as outlined by NAPRA:
- Beyond-use date
- Incident and accident management
- Waste management
- Program content
- Results and action levels
- Verification of equipment and facilities
- Quality assurance of personnel
- Quality assurance of compounded sterile preparation
- Documentation of quality control activities
The College recommends that pharmacies and pharmacy professionals involved in sterile compounding complete phase implementing this phase by May 2020.
The College has set out a four-year implementation plan for pharmacies and pharmacy professionals to adopt the new model standards for pharmacy compounding recently released by the National Association of Pharmacy Regulatory Authorities (NAPRA).
While current pharmacy practice for the preparation of sterile products in Canada already includes many of the patient safety and quality assurance requirements contained in these new standards, additional requirements will be introduced.
The College’s existing bylaws and policies will remain in place until the implementation deadline of May 2021 (i.e., after the four-year implementation period is complete). The College expects pharmacies and pharmacy professionals to address gaps and update their practice during the four-year period and be in full compliance with the Models Standards once the bylaws amendments come into effect.
The new standards include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
New Model Standards Needed to Better Protect Public Safety
Compounding plays an important role in pharmacy practice, allowing ingredients to be mixed together in strengths and dosages personalized to a patient’s needs, and high-quality standards are needed to ensure quality and safety of compounded drugs, for patients.
Evolving practice as well as the increased awareness of the risks of compounding sterile preparations on the health of both patients and compounding personnel led NAPRA to develop new model standards for pharmacy compounding.
These model standards will set national standards for pharmacy compounding and are in the process of being adopted by health regulators across Canada.
For more information, including a detailed outline of the 4-year implementation plan, please visit:
bcpharmacists.org/compounding
QUESTIONS ABOUT THE NEW MODEL STANDARDS?
Questions about the new model standards? Contact [email protected].