Implementing the New Model Standards for Pharmacy Compounding
Phase 3 of the new compounding standards to be completed 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).
Those who compound sterile preparations will want to follow the four-year phased approach to ensure they meet the all the requirements by May 2021, when the new bylaws come into effect.
Model Standards for Pharmacy Compounding of Non-sterile Preparations
On March 28, 2018, NAPRA released its Model Standards for Pharmacy Compounding of Non-sterile Preparations. The College is currently reviewing these standards and is the process of developing an implementation plan to adopt the standards. To develop the implementation plan, the College will be seeking input from the public and registrants. Once developed and pending approval by the College’s Board, the implementation plan will be communicated out to all pharmacy managers and registrants.
Implementing the third Phase of the New Standards by may 2020
Pharmacies and pharmacy professionals involved in sterile compounding will want to focus on completing the third phase of the implementation plan which 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; and documentation of quality control activities.
- Requirements During Transition*
- New Model Standards Needed to Better Protect Public Safety
- Development of Implementation Plan
- Four-year Implementation Plan
- How to Prepare for the New Model Standards
- Questions about the New Model Standards
New Model Standards Needed to Better Protect Public Safety
Compounding plays an important role in pharmacy practice, allowing individual ingredients to be mixed together in personalized strengths and dosages based on a patient’s needs and high-quality standards are needed to ensure preparation quality and safety when compounding 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.
Development of Implementation Plan
To inform the approach to adopting and implementing the new Model Standards across BC, the College used a multi-step engagement process to seek input.
- Environmental scan of all pharmacies (community and hospital) to determine how many are engaged in non-hazardous sterile compounding, hazardous sterile compounding and non-sterile compounding.
- Gap Analysis Survey sent to pharmacy managers, pharmacists and pharmacy technicians to determine gaps in existing practice in meeting the Model Standards.
- Workshop with pharmacy managers, pharmacists and pharmacy technicians that included a review of the Gap Analysis Survey results and a series of questions to understand where potential barriers and challenges to meeting the Model Standards may exist.
- Survey for each of the Model Standards sent to pharmacy managers, pharmacists and pharmacy technicians who are involved in compounding sterile preparations (non-hazardous and hazardous).
- The results of the Gap Analysis Surveys, engagement session and surveys informed the recommendations, timelines and mitigation strategies for successful implementation of the new Model Standards.
Four-year Implementation Plan
A four-year phased implementation is recommended to bring in the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.
Each phase in the implementation plan includes specific groupings of standards from the Model Standards. The College’s existing bylaws and policies will remain in place until May 2021 (i.e. after the four-year implementation period is complete). Once these new bylaws come into effect, all existing references to compounding standards will be repealed.
Bylaw Amendments for New Model Standards
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 update their practice during the four-year period and be in full compliance with the Model Standards once the bylaws amendments come into effect.
It should be noted that some of the existing references to compounding standards in the College’s Professional Practice Policies are outdated. These references will be repealed after the implementation deadline of May 2021, once the Board has approved new bylaws to adopt the Model Standards.
Requirements During Transition
Pharmacy professionals must have the knowledge, skills and abilities to ensure patient safety when compounding. During this transition, the expectation is that compounding only continue be done according to existing professional standards:
How to Prepare for the New Model Standards
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. Pharmacies and pharmacy professionals will be required to address gaps in their current practice and ensure that they are in compliance with the new standards by May 2021.
Gap Identification Tools
To help pharmacy professionals identify gaps in their compounding program and practices, and assist with developing plans to become compliant with the new compounding standards, the College has developed Gap Identification tools for the two new Model Standards.
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
Questions about the New Model Standards
As with all College requirements, our role involves setting standards, and pharmacy professionals must decide how best to implement them within their organizations. With the NAPRA sterile compounding standards, it is the responsibility of individual pharmacies and registrants to operationalize their application in pharmacy policies, procedures and facilities as well as in pharmacist and pharmacy technician practice.
If registrants perform sterile compounding, it is their responsibility to ensure that these standards are met. This is a professional obligation that cannot be delegated to others.
The College recognizes that the NAPRA sterile compounding standards are comprehensive and registrants may have questions about their implementation options. Pharmacy professionals engaged in sterile compounding may find value in establishing and reaching out to their professional networks to act as resources of peers and experts on this topic. Feedback on the standards should be sent directly to NAPRA at firstname.lastname@example.org.
Questions about the college's implementation plan
Questions about the College's four-year implementation plan can be directed to PracticeSupport@bcpharmacists.org.