Compounding

Implementing the New Model Standards for Pharmacy Compounding

Phase 1 of the new compounding standards to be completed by November 2017

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. 

The new standards include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations. 

 

A third and final Model Standards document for non-sterile preparation is expected to be released in 2017. 

Implementing First Phase of New Standards by November 2017

Pharmacies and pharmacy professionals involved in sterile compounding will want to focus on completing the first phase of the implementation plan which includes a gap analysis and site plan, together with standards that include: aseptic compounding, packaging, and personnel conduct, as well as other areas of pharmacy practice. The College recommends implementing this phase by November 2017.

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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. 

Engagement Process

Consultation
  • 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.

Phase 1
November 2017

Phase 2
May 2019

Phase 3
May 2020

Phase 4
May 2021

  • Define compounding risk level
  • Complete gap survey and prioritize a site plan
  • standards:
    • 6.3 (compounded sterile preparation log)
    • 6.4 (patient file)
    • 6.5 (personnel)
    • 6.6 (aseptic compounding of sterile preparations) 
    • 6.7 (packaging) 
    • 6.8 (storage)
    • 6.9 (transport and delivery of compounded sterile preparations) 
    • 6.10 (recall of sterile products of final compounded sterile preparations) 
  • NAPRA standards:  
    • 5.1 (personnel) 
    • 5.2 (policies and procedures) 
    • 5.4 (maintenance log)
    • 6.2 (compounded sterile preparation protocols)
  • NAPRA standards:
    • 6.1 (beyond-use date)
    • <6.11 (incident and accident management)
    • 6.12 (waste management) 
    • 7.1 (program content)
    • 7.2 (results and action levels) 
    • 7.3 (verification of equipment and facilities)
    • 7.4 (quality assurance of personnel)
    • 7.5 (quality assurance of compounded sterile preparation)
    • 7.6 (documentation of quality control activities) 
  • NAPRA standard 5.3 (facilities and equipment

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 Models 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. 
 

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. 

Questions about the New Model Standards

Questions about the new model standards? Contact PracticeSupport@bcpharmacists.org.