Sterile Compounding: Third Party Evaluators and Assessment Reminders


THIRD PARTY EVALUATORS FOR EVALUATING THE STERILE COMPOUNDING SUPERVISOR

A third party evaluator is a pharmacist or pharmacy technician with expertise in sterile preparation compounding who is free of any real or perceived conflict of interest with the individual being evaluated. The third party evaluator must be independent (at arm’s length) from the facility/pharmacy to ensure an impartial competency assessment.

The third-party evaluator (either a pharmacist or pharmacy technician) must meet the criteria set out in section 5.1.2.4 of the NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations for third-party evaluators.

The compounding supervisor must ensure that the third-party evaluator is qualified and has training that covers the compounding of sterile preparations and certification that his or her competencies (which include the same elements as those of a competency assessment program for compounding personnel) are being maintained, developed and assessed on an annual basis. Any third-party evaluator or model used must mitigate risk and meet the intended outcome of this standard.

The third-party evaluator may perform training and competency assessment at the workplace or at an alternate location.

The College does not recommend or endorse a particular pharmacy professional for this role.

COMMUNITY PHARMACIES WHO ARE ENGAGED IN STERILE COMPOUNDING: KEY REMINDERS

As of January 1, 2019, pharmacies engaged in sterile compounding must be compliant with the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations (NAPRA) and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations (NAPRA).

Following recent assessments, College operations advisors have the following reminders for community pharmacies who are engaged in sterile compounding:

  • Full compliance with the NAPRA standards is expected. In order to support pharmacy compliance with the NAPRA standards, and recognizing that pharmacies may have needed additional time to conduct education and implement infrastructure modifications, the College worked with pharmacies in 2018 and 2019 to support action plans and mitigation strategies. In 2020, it is the expectation of the College that pharmacies are now in full compliance with the standards; therefore, assessment ratings and comments may be different than the educational and informative recommendations provided in 2018 and 2019. The College’s assessment tools and approaches are regularly refined through a continuous quality improvement process to ensure that assessments are consistent and completed in a manner that supports compliance with the NAPRA standards, with the ultimate goal of protecting the public’s health and safety.
  • College assessments focus on the NAPRA standards. The College does not assess against USP or other compounding standards – the focus of the assessment is on the NAPRA standards. Pharmacies should use the Hazardous Sterile Preparations Assessment Criteria and the Non-Hazardous Sterile Preparations Assessment Criteria to prepare for their assessments.
  • Requirements regarding Beyond Use Dates (BUD) outlined in the NAPRA standards must be met. Pharmacy professionals are encouraged to review the Guideline – Extending the Beyond-Use Dates for Sterile Preparations, the Pharmacy Connection article “Beyond Use Dating – the North York General Hospital Experience,” and Cancer Care Ontario’s Beyond-Use Date Recommendations Report to ensure that requirements are met.
  • Hazardous and non-hazardous rooms must be separate for sterile compounding. The standards require that facilities that compound both hazardous and non-hazardous sterile preparations must have two clean rooms: one for the compounding of hazardous sterile preparations and the other for the compounding of non-hazardous sterile preparations.

Additional information and resources are available on the Sterile Compounding Standards and Implementation Key Initiative on the OCP website.