Published: April 30, 2020
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
In response to the extraordinary challenges impacting pharmacy services during the COVID-19 pandemic, the following information is intended to support pharmacists and pharmacy technicians who are performing sterile compounding where there is a documented shortage of PPE. It is intended to ensure a sterile, quality compounded preparation and to protect the compounder.
Strategies used to conserve PPE may result in an organization being non-compliant with the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Sterile Preparations.
Pharmacists and pharmacy technicians must carefully consider the risks of undertaking compounding activities without standard PPE including the potential for contamination of the compounded preparation, the risk to patients and compounders and the risk of the patient not receiving the preparation. This risk-based discretion must include an assessment of the practice site, the development of related policies and procedures, documentation of alternative work practices and monitoring strategies.
It is imperative that pharmacists and pharmacy technicians continue to employ and enforce existing meticulous aseptic technique practices. This may require more vigilant and frequent monitoring and observation by compounding supervisors.
Conservation of PPE
It is critical that pharmacists and pharmacy technicians take measures to conserve PPE. Strategies should be evaluated and implemented based on the requirements of the individual organization. They should be developed with the intent to minimize waste and maximize efficiencies, while maintaining the integrity of compounded sterile preparations (CSPs) and ensuring patient and staff safety.
Such measures may include:
- creating an inventory to assess current and future shortages;
- eliminating the need to compound by consulting with prescribers on alternative medications or dosage forms and considering sourcing commercially available forms;
- reducing the number of sterile compounders working in the controlled areas;
- optimizing workflow to maximize use of PPE during a single compounding shift; and
- prioritizing the use of sterile gloves and gowns above other PPE.
Reuse of PPE for Hazardous Sterile Compounding
Organizations must determine which strategies to employ to balance microbial risk and patient safety, and in the case of hazardous sterile preparations, personnel safety.
PPE for hazardous compounding is designed to minimize the risk of hazardous drug exposure of healthcare workers. PPE must be prioritized for the preparation of antineoplastic agents in Table 1 of the NIOSH list. PPE for these agents may not be reused.
Reuse of PPE for Non-hazardous Sterile Compounding
The reuse of single-use PPE is not recommended. The reuse of PPE in situations of limited supply must be carefully evaluated as it may increase the risk of microbial contamination in compounded sterile preparations (CSPs) due to increased particle shedding. Risk mitigation strategies are essential to ensure contamination control and quality CSPs. The continued use of primary and secondary engineering controls is essential to these strategies.
Cleaning and Environmental Monitoring
It is critical that risk mitigation strategies are evaluated when there is a change in organizational PPE policy. This should include consideration of increasing the frequency of cleaning and disinfecting. It also includes the possibility of increased environmental monitoring.
Beyond Use Dating (BUD)
The BUDs established by NAPRA are based on full compliance with the standards and must be reviewed if non-standard PPE is used. BUDs must be assigned conservatively and are dependent on the mitigation strategies employed and any results of environmental monitoring action levels. It is recommended that the shortest feasible BUD is used while giving consideration to medication shortages and patient access.
Organizations who implement strategies that result in non-compliance with NAPRA standards must ensure that policies are developed to demonstrate that their risk mitigation strategies support a safe and quality compounded preparation for patients and the protection of staff.
When deviating from standard PPE, documentation for all compounded preparations must include (and is not limited to) the following:
- supply chain limitations;
- changes in PPE processes;
- enhanced monitoring and observation of adherence to policies and procedures;
- reduction in BUDs;
- increased cleaning and disinfecting ; and
- increased environmental monitoring.
These records may be essential for following up on any quality issues that may occur as a result in changes to process.
Food and Drug Administration – Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency
Public Health Ontario