34 Policy
Pharmacy Practice News • January 2021
Compounding
95% USP Adherence at Ascencion a Team Effort C
omplying with compounding guidance is an onerous task for any institution, but rolling out a standardized compounding compliance program across 146 health systems and achieving 95% adherence is Herculean— and a feat that Ascension can claim to have achieved. According to Shewan Aziz, RPh, PhD, the vice president of pharmacy at Ascension Texas, in Austin, the key to his facility’s success has been implementing standardized system-level guidance while also meeting the needs of individual hospitals. “In addition to working on a national level to develop best-practice compounding guidance, we work with each hospital to provide them with the resources and tools they need to assess their own compounding preparation management risk and to create action plans, implement best practices and track their in-house compliance,” Aziz explained at the ASHP 2020 Midyear Clinical Meeting and Exposition. The path to near-perfect USP compliance at Ascension started in 2012, when the organization created a compounding subcommittee. The committee, which consisted of compounding experts from individual Ascension hospitals, scoured existing compounding guidance documents, literature and best practices issued not only by USP but by the National Institute for Occupational Safety and Health, the Occupational Safety and Health Administration, and state boards of pharmacy, Aziz said. Using these sources, the task force developed two Ascension-specific guidelines: one for nonhazardous compounds and one for hazardous compounds, he explained. According to Aziz, the guidelines outline a variety of best practices for everything from IV room contamination management to use of compounding robotics, IV workflow systems and standardized closed system drug-transfer devices for chemotherapy. The subcommittee also created documents that include compliance tips and “pearls,” he added, and they developed standardized policies and procedures that individual hospitals could implement, as well as training and competency assessment modules they could use for their staff. When it came to procuring funds for capital projects, the national team also provided this to each hospital, helping them design and build USP-compliant IV rooms. To further enhance the safety of compounded drug management, the national compounding subcommittee even created auxiliary warning labels with
handling instructions for all IV hazardous drug preparations, and they built in hazardous drug alerts for automated dispensing cabinets and electronic medication administration systems, Aziz said. Finally, the team developed key performance indicators and compounding metrics to help individual hospitals ensure they are complying with the national-level guidance, he said. “In 2012, before we undertook this standardization initiative, we had 55% compliance with USP <797>, and that’s gone up to 95% today,” said Aziz, noting that the outlying 5% of hospitals are expected to be compliant with the Ascension compounding guidance by August 2021. With regard to USP <800> compliance and any additional changes that might be contained in the revised USP <795> and <797> chapters once they are finalized and made official, “given all the work and effort that has gone on at our hospitals to adhere to our own compounding
guidances, we will be ready to meet all compounding standards when the USP appeals are resolved,” Aziz said. “I think our experience shows that if you want to implement best practices and improve care, you can do it,” he said.
Still Some Confusion Ascension’s success doesn’t mean there isn’t work to be done regarding USP compounding compliance. With the appeals process for USP General Chapters <795> and <797> now over and the chapters remanded, and with <800> currently informational, healthsystem pharmacies may be confused about which protocols and procedures they should be implementing. “None of us know what the future will hold” with regard to changes to these chapters, Robert Campbell, PharmD, the director of clinical standards interpretation for hospital and ambulatory programs at the Joint Commission, in Oakbrook Terrace, Ill., said
The Joint Commission’s Top Reasons for USP Noncompliance
T
he reasons for noncompliance with USP compounding standards vary and change from year to year, ranging from inadequate competency assessments to incomplete environmental testing. But “one thing we continue to see that hasn’t changed since day one is that those responsible for compounding are not taking the time to fully review their testing certification reports,” said Robert Campbell, PharmD, the director of clinical standards interpretation for hospital and ambulatory programs at the Joint Commission, in Oakbrook Terrace, Ill. “Too often, facilities getting the testing done do not hand the results to leadership, or pharmacy leadership takes a look at the front page of a report and does not look at the nuts and bolts of the report’s findings,” Campbell said at the ASHP 2020 Midyear Clinical Meeting and Exposition. Apart from a lack of attention to reports, Campbell pointed to several other top reasons for noncompliance, including: • for personnel: a lack of competency assessments completed, a lack of didactic testing scoring and incomplete initial competency assessments; • for products: drug shortages leading to changes in compounding products that are not accompanied by necessary changes to environment and beyonduse dating, and a lack of proper labeling; and • for environmental standards: incomplete testing and certification reports and improper resolution of these report results. Going back to the basics of USP compliance—the need to review reports in detail—“any issues identified by a certifier need to be examined,” Campbell said. —D.W.
at the ASHP Midyear meeting. For the time being, Brian Serumaga, PhD, RPh, a scientific liaison at USP, in Rockville, Md., said his organization “has continued to emphasize through stakeholder engagement and webpage updates that due to the remand of the 2019 revisions of <795> and<797>, the currently official versions of <795> and <797> are those last revised in 2014 and 2008, respectively.” Although the appeals focused on the framework for establishing beyond-usedates (BUDs) for sterile and nonsterile compounded preparations, and for extending BUDs beyond the defaults in the chapters, “the Compounding Expert Committee may consider additional changes,” Serumaga said. “In March 2020, the USP appeals panel made a decision remanding the chapters to the compounding expert committee, with a recommendation that the committee carry out further stakeholder engagement on the issues touched on in the appeals,” added Serumaga, who spoke at the ASHP meeting. In regard to USP <800>, Serumaga said USP considers it informational only, but the organization “encourages” early adoption of the chapter, and “regulatory bodies and oversight organizations may make their own determinations regarding the applicability and enforceability of <800> for entities within their jurisdiction.” Indeed, for early USP <800> adopters, Campbell said the Joint Commission surveyors will be surveying according to criteria from that chapter, and <800> guidelines will supersede the 2008 version of <797> when the two chapters conflict, Campbell said. “For example, the 2008 version of USP <797> states that you cannot compound hazardous drugs in a segregated compounding area, whereas <800> allows for compounding these preparations in a contained segregated compounding area,” Campbell noted. “If you want to adopt <800>, you need to meet all the requirements for a contained area.” Campbell emphasized that early adopters of USP <800> who are in the midst of construction projects, and therefore can’t be tested for full compliance, should ensure they are protecting staff and patients during the transition. The Joint Commission’s surveyors will be verifying that hazardous drug vapors are not escaping and personal protective equipment is being worn by compounding staff, he said. —David Wild The sources reported no relevant financial disclosures.
