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Commentary

Addressing Safety Gaps in Sterile Pharmacy Compounding Systems, Practices: Part II


March 11, 2021

By Damon Birkemeier, PharmD, FDA/ISMP safe medication management fellow

Damon Birkemeier, PharmD, FDA/ISMP safe medication management fellowIn part I of this two-part blog, we introduced a survey conducted by the Institute for Safe Medication Practices (ISMP) that evaluated technologies, policies, and procedures in place as well as identified major safety concerns surrounding sterile pharmacy compounding. We will continue by discussing recommended sterile compounding best practices identified by ISMP.

Safe Compounding Best Practices

ISMP identified nine best practices associated with pharmacy sterile compounding. Respondents were asked to evaluate these best practices based on degree of implementation at their facilities. Identified best practices include:

  1. Ensuring enough workbenches in the sterile compounding area to allow only one staff member per primary engineering control device
  2. Defining standard operating procedures that are utilized by all staff during compounding
  3. Ensuring drugs, diluents, and volumes used (including the number used) to prepare each compounded sterile product (CSP) during verification are easily identifiable with certainty
  4. Following a standard workflow for labeling final products
  5. Ensuring one CSP is prepared per workbench at a time
  6. Ensuring dose volume information is available on a preparation label, master formula record, or other approved document, so there is no need for calculations when compounding a CSP
  7. Ensuring sufficient counterspace is available to gather and stage each component needed to prepare CSPs to minimize risk of intermingling products
  8. Utilizing bins when compounding for each CSP to permit segregation from other CSPs
  9. Verifying that the lighting and noise in all locations where CSPs are prepared have been measured and found to be consistent with USP standards

The above identified best practices are listed in a descending order based on overall level of implementation as reported by survey respondents. For the first six best practices, at least 80% of respondents indicated that each respective best practice was implemented over 50% of the time. Seventy percent of respondents indicated that the seventh and eighth best practices were implemented over 50% of the time, while not even half (45%) of respondents indicated that the ninth best practice was implemented over 50% of the time.

The results of this survey gave great insight to where the normal lies for sterile compounding technologies and practices in pharmacies across the nation. If your pharmacy did not participate in the survey, the survey can still be found here. Consider downloading and distributing the survey to pharmacy staff in order to pinpoint your pharmacy sterile compounding vulnerabilities and to establish a plan for improvement.

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