56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

ISMP survey reveals major compliance gaps

56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’

By Bruce Buckley

The USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems now employ technological tools to safeguard the sterile drug workflow process.

But have health systems reached the optimal level of compliance? That’s what the Institute for Safe Medication Practices (ISMP) wanted to know. So ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded.

The answer, detailed in survey results described at a virtual Omnicell Illuminate meeting, was that although progress in achieving compounding safety has been made, significant gaps remained. Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, BSPharm, RPh, FASHP, the ISMP medication safety specialist who presented the findings. The errors ranged from incorrect dose or concentration to faulty labeling to wrong

see SOP ADHERENCE, page 20

BUILDING BLOCKS

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Read and react to your environmental monitoring

reports. Environmental monitoring results get even more scrutiny than certification elements. Your microbial environmental monitoring program must be designed to adequately detect excursions. The minimum elements need to include staff training and competency, frequency of monitoring at least as much as defined in the USP chapters, and reaction to results. (Remember: The USP chapters are minimum standards; many best practices exceed the minimum frequency.) Many organizations have their certifiers perform the semiannual electronic air and surface sampling, but the proposed frequency of monthly surface sampling is unlikely to be able to be consistently supported by your certifier if the revision requires that. In any case, your ability to do your own surface sampling—either every month or just those months when the certifier isn’t at your facility—will enhance the ability to react to concerns.

Benchmark your practices. Much of USP’s guidance focuses on existing best practices in compounding, including the requirements for master formulation records, compounding allergenic extracts, procedures for media fill and gloved fingertip testing, procedures for air and surface sampling, cleaning procedures, evaluation of environmental monitoring excursions, and certification of facilities. Review those procedural aspects and explanations and incorporate them into your own policies and procedures. To ensure that your practices meet the USP minimum standards as well as changes that evolve as practices mature, conduct gap analyses at least annually. Gap analysis tools are available at the ASHP Compounding Resource Center (www.ashp.org/Pharmacy-Practice/ Resource-Centers/Compounding), CriticalPoint (www. criticalpoint.info) and other sources.

Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee. The comments in this article are her own.

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drug used (Table). Some were found and corrected before dispensing, Ms. Michalek said, while others came to light only after leaving the pharmacy.

Ms. Michalek noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products we decide to bring into an organization,” she said. The risks involve when and how medications are prescribed and the processes of verification and communication, she added; they also extend to the workplace environment, the lack of standardized practices, production pressures and the absence of technology. “These are all risks,” she said.

An even more complete picture of compounding safety challenges emerged from an open-ended question that drew more than 600 responses. By far the biggest barrier, she said, “was the inability of pharmacists to accurately verify compounded sterile preparations using indirect processes like the syringe pull-back method.” Closely following was the difficulty in complying with USP General Chapter <797> and <800> standards. Rounding out the list were staff training and competency issues, a lack of technology, not enough workspace and heavy workloads. Insufficient leadership support and work supervision also came under fire.

The survey also addressed technology. A total of 361 respondents (57%) reported using at least some technological tools in sterile compounding. They included barcode verification with and without images, multiple ingredient compounding devices, gravimetric verification and robotic compounding.

Delving Into Best Practices

Respondents were asked to rate the implementation level of nine ISMP-defined compounding best practices. The greatest extent of implementation (73%) related to cleanroom/ sterile compounding area practices, including having enough workbenches to support only one staff member at a time per primary engineering control—laminar airflow workbench, biological safety cabinet, compounding aseptic isolator or compounding aseptic containment isolator.

The survey also focused on standard operating procedures (SOPs). Were they defined and what was the level of compliance? More than half of respondents (56%) reported that SOPs were “defined and always followed.” About onethird (34%) said they were defined and “often followed,” while 10% said they were “never, rarely or sometimes” defined and followed.

‘Alarming’ Results

Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, found this result “pretty alarming.”

“Only 56% said always? That’s crazy,” Ms. Kienle told Pharmacy Practice News. “It shows that some people still aren’t doing what they should have been doing for decades. People need to have procedures that match what they actually do and that are compliant with USP <797> and <800> standards, state regulations and best practices.”

Ms. Kienle also said these procedures need to be in place in health-system areas “outside of the pharmacy where sterile compounds are mixed, like procedural areas, operating rooms, imaging and infusion centers—places that have been under the radar for years.

“Pharmacy supports those areas, too,” she added. “This is a team sport. It’s not limited to the silo of the pharmacy.”

Although COVID-19 appears to have played little part in the survey results, Ms. Kienle said she is worried that the COVID-19 pandemic’s practice pressures might have caused people to become “even more lax on things like certification of their areas and maintaining and really upgrading the environmental pieces” that are fundamental to USP <797> and <800> standards.

Ms. Michalek ended on an upbeat note. “Pharmacists and technicians have done some amazing work to continually improve the care and delivery of sterile injectable medication,” she said. “As stewards of medication use, they are really in the best position to move forward with more improvements and more safety around compounded sterile preparations.”

A print version of the ISMP Pulse Check survey report can be found at bit.ly/3qN37fF. For ISMP’s new guidelines on sterile compounding, see page 22.

Error Percentage of mentions

Incorrect dose or concentration 58

Incorrect base solution 51

Incorrect base solution volume 43

Issue or error with labeling of CSP (including omission)

Incorrect reconstitution of drug (volume or diluent) 41

36

Incorrect drug 35

Wrong preparation technique (e.g., improper filtering, wrong tubing) 26

Expired drug, base solution or CSP 16

Wrong timing (e.g., preparing antineoplastic on wrong date) 12

Omission of a drug 5

CSP, compounded sterile preparation.

Ms. Kienle is a member of the USP Compounding Expert Committee, but her comments are her own and neither affiliated with nor endorsed by USP. Ms. Michalek reported no relevant financial disclosures.

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