Compounding

Clarissa Chan, PharmD

Pharmacists should be gearing up for changes to USP Chapter 797–Sterile Preparations. USP published proposed revisions to <797> in early September 2021 and welcomed feedback until March 2022.

In general, pharmacists should review USP <795> (nonsterile compound-ing), <800> (hazardous drugs), and <797> to make sure processes are compliant with existing standards.

Proposed USP changes

The proposed <797> changes offer a third category, Category 3, allowing for extended beyond use dates (BUD) past those already introduced for Category 1 and 2 compounded sterile preparations (CSPs), said Helen McKnight, PharmD, director of pharmacy services at Princeton Baptist Medical Center in Birmingham, AL.

Category 1 and 2 CSPs replace low-, medium-, and high-risk designations: Category 1 CSPs have BUD of ≤ 12 hours at controlled room temperature or ≤ 24 hours refrigerated; Category 2 indicates CSPs with BUD of > 12 hours at controlled room temperature or
> 24 hours refrigerated; the proposed Category 3 CSPs’ BUD range from 60–90 days at controlled room temperature to 90–120 days refrigerated, she said.

According to the National Institute for Occupational Safety and Health, closed system drug-transfer devices (CSTDs) work as a physical barrier or utilize air-cleaning technology to provide worker protection from the escape of hazardous drugs in the environment. USP <800> required the use of CSTDs for administration of hazardous drugs when the dosage form allows, said McKnight.

While CSTDs can be a costly upfront investment that health systems may be resistant to purchase, these devices could help extend BUD by reducing chemotherapeutic drug waste and financial burdens for institutions.

Revised ISMP compounding guidelines

The Safe Preparations of Compounded Sterile Preparations guideline from the Institute of Safe Medication Practices (ISMP) stems from medication errors that the ISMP National Medication Errors Reporting Program has received in the last decade.

The ISMP guidelines are meant to complement the USP standards. USP <797> is focused on sterile compounding standards that prevent harm from contamination and inappropriate ingredients and the ISMP guidelines are focused on best practices to prevent errors involving I.V. medications to ensure patient safety, said Nam Tran, PharmD, from Summit Pharmacy in Centennial, CO.

New technologies available to help comply

“The latest [ISMP] guideline focuses on sterile compounding automation, including automated compounding devices, I.V. workflow management systems, and I.V. robots,” said McKnight. “Unlike USP <797>, these guidelines are not enforceable by regulatory agencies.” Compliance management software can help with several <797> requirements such as: cleaning of facilities, calibration of equipment, and temperature checking of compounding/storage areas.

“Systems like RxPestle can electronically schedule, alert, document, and track these routine tasks. Otherwise, using paper-based hardcopy systems can easily pile up and become unwieldy. Electronic management also allows for data trends to be identified and tracked,” said Tran. “This can help with troubleshooting and quality improvement.”

Utilize I.V. workflow management systems

There are many benefits to implementing I.V. workflow management systems. Systems that integrate automated compounding devices with electronic health record systems can minimize the risk of errors that might occur if pharmacists transcribe orders between 2 different platforms.

They can electronically log data like timestamps for improved tracking of compounding events to thoroughly investigate incidents.

They also allow improved verification of ingredients with barcode scanning, said Tran.

Develop a robust environmental sampling process

Environmental sampling is performed routinely as part of ongoing quality management. According to Tran, in-house viable air and surface sampling can be conducted using the appropriate contact plates and incubators. Microbial growth can be monitored and tracked. From this, Tran said, investigations for potential sources of contamination can take place. Lapses in storage and compounding practices can be identified and improved as well.

These routine sampling processes take place in addition to the environmental testing that is required for certification/recertification of primary and secondary engineering controls. This testing is often performed by qualified, contracted certification companies. Ideally, routine in-house testing will better prepare the pharmacy and staff ahead of time, Tran said.

Regularly check performance of pharmacy automation systems

“Automated compounding devices aren’t ‘magic boxes’ that automatically produce sterile products free of errors,” said Tran. “Calibration checks still need to be performed and logged regularly. Warnings and alerts still need to be carefully considered and not hastily overridden. Independent double checks should still be performed when making changes to databases.”

Other tips for pharmacists

Other tips McKnight suggests include:  Designate one employee to field questions from stakeholders; update environmental policies and procedures before <797> final publication; factor in compounding facility environmental monitoring trends into workplace practices; and prepare compounding pharmacy staff with mock interviews and didactic training well in advance of regulatory surveys.

“It is important to know why you are following each practice, both in terms of rationale and the standards from which they originated,” said Tran. “For these reasons, it can be helpful to read the full and original text of USP <797>.” ■

Resources to help stay up-to-date on USP <797> and <800>

While there are many resources that help summarize overall principles and concepts, it is important to examine the actual chapters themselves (www.usp.org). This is often necessary for firm understanding of finer details.

■   The Compounding Sterile Preparations Competency Library from the American Society of Health-System Pharmacists (ASHP) (for both pharmacists and technicians), includes several lessons on USP <797> and USP <800> in written slide decks and videos. Each lesson concludes with an online exam that evaluates each student’s understanding of the material (elearning.ashp.org/subscriptions/1001/ashp-sterile-compounding-competency-library). This can be used to fulfill the training, didactic review, and written testing requirements of USP chapters, said Tran.

■   More resources to learn about <797> and <800> include: The United States Pharmacopeial Convention, Inc. (go.usp.org/Proposed_2021_Revisions_795_797) and various publications by ASHP, such as “The Chapter <800> Answer Book” (www.ashp.org/products-and-meetings-aliases/chapter-800-book?loginreturnUrl=SSOCheckOnly).

■   A summary document of the evolution of USP 800 can be found at: www.pda.org/pda-letter-portal/home/full-article/the-evolution-of-usp-800-a-q-a-with-cathy-zhao-and-allison-radwick.

ISMP publishes monthly newsletters that highlight sterile compounding dangers and suggestions to improve drug labeling and workplace practices, said McKnight. ASHP also has extensive resources to help supervising pharmacists to stay compliant with sterile compounding practices. ■