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Kienle’s 10 New Building Blocks Of Compounding Safety
Each year, Patricia Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, shares 10 points that she believes pharmacists need to consider to ensure compounding safety and compliance with USP, state boards of pharmacy and other regulatory bodies.
Get up to speed on USP compounding-related
chapters and state regulations. USP remanded the long-anticipated revised USP General Chapters <795> and <797> on March 12, 2020, and USP <800> on hazardous drugs is not yet compendially applicable, because it ties its federal enforceability to approval of the 2019 revisions of <795> and <797>. The appeals of the USP chapters were all about beyond-use dates (BUDs) and the ability to extend them. The USP Committee isn’t finished with discussions about the new revisions, but it’s unlikely that content related to facilities, methods of environmental monitoring and other important aspects of compounding, will change. So, the information added to the remanded Chapter <797>— particularly information in the boxes in the remanded chapter—is valuable to incorporate into policies. To keep up to date, institutions should subscribe to the USP Compounding Compendium (www.usp.org/products/usp-compounding-compendium) and follow the USP compounding page (www.usp.org/compounding).
Regarding state regulations, in some cases, they are more stringent than USP standards, and some states already have incorporated aspects of the revised but remanded USP chapters into their state regulations. For example, although USP <825>, the chapter concerning radiopharmaceuticals, has been official since Dec. 1, 2020, it has the same federal delay in enforceability as <800>, but some states have announced they will consider <825> enforceable in their states. Because of ongoing confusion about which standards to adhere to—USP or state regulations—especially around BUD and frequency of personnel requalification, pharmacies should follow the more stringent regulations, which may be on the state side.
Be aware of allowances and restrictions when unusual circumstances
occur. The COVID-19 pandemic created situations no one anticipated. USP, ASHP, Institute for Safe Medication Practices (ISMP), CDC and FDA developed documents with allowances during the public health emergency. These included adjustments for BUDs, garb and personal protective equipment, as well as other components of compounding regulations and best practices, assuming appropriate oversight. As the situation has evolved, these documents have been updated.
Given these frequent changes, compounding pharmacists should monitor key sources of information: ASHP Connect, USP compounding pages, ISMP’s website and newsletters, CDC, as well as FDA guidance pages. It’s important to remember that these allowances are usually only meant for the duration of the public health emergency and are not intended to be permanent policies.
States also have issued alerts concerning their compounding expectations during the public health emergency, and many state health-system pharmacy societies provided summaries and notices to their members. So, it’s critically important to keep current with state-level changes by monitoring your state’s board of pharmacy website.
USP General Chapter <797> now includes strengthened recommendations for performing “at least monthly” surface wipe sampling for bacterial contamination in all classified areas and pass-through chambers. Photo credit: CriticalPoint Center for Training and Research
—Patricia Kienle, RPh, MPA
Be familiar with the expectations of your health system’s accreditation organization.
The four hospital accreditation organizations deemed by the Centers for Medicare & Medicaid Services include the Joint Commission (TJC), DNV Healthcare, HFAP and the Center for Improvement in Healthcare Quality. All of these organizations are focusing on sterile compounding as they survey facilities. TJC’s most recent information discussed at the ASHP 2020 Midyear Clinical Meeting (see “USP Compliance Remains a Focus of TJC,” page 6) identifies several problem areas they have found during surveys: competency assessments (including establishing a passing score for any tests), changes in BUDs when product preparations are changed, and response to certification and environmental monitoring reports. Make sure you have these items addressed before these organizations visit your site. Whatever accreditation organization you use, be sure to stay current with its guidance.
Benchmark your practices. Much of USP’s guidance focuses on existing best practices in compounding, including their 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.
Work toward full compliance with USP <800>.
Although it is not yet federally enforceable, USP <800> is designed to protect health care workers, so work toward full compliance with the chapter. One piece of guidance in the chapter is to make sure your Assessment of Risk reflects best practice as well as how you handle hazardous drugs used in your institution. This requires a team-based, interprofessional effort to make sure your practices are appropriate throughout the health system.
Other important components of the chapter include evaluation of use of closed system drug-transfer devices in the compounding and administration of antineoplastic agents, and implementation of wipe sampling for hazardous drug contamination.
Update staff training and requalification. The remanded 2019 revision ofUSP <797> includes a specific list of core competencies to meet current compounding requirements. Institutions can use information from these core competencies to guide staff training and requalification efforts and policies and procedures. Be sure that all pharmacy compounding staff have documented competency, and remember that part-time or PRN pharmacists who are responsible for occasional coverage in the IV suite need to do more than just check a drug name with a label; they need to be aware of all the requirements to oversee operations occurring as they sign off on compounded sterile products.
Be sure to include nurses and others, in addition to compounding personnel, in appropriate training and in-servicing. For example, nuclear medicine technologists who handle radiopharmaceuticals now have specific requirements laid out in USP <825>, and USP <797> also may apply if they prepare nonradiopharmaceutical sterile products. Environmental Services personnel who clean the compounding areas need to be made aware of the hazardous drug risks they might encounter, and they must have documented cleaning competency.
Consider advanced training. A Designated Person is defined in the proposed USP Chapter <795>, proposed <797> and official <800> as someone with a higher level of responsibility for oversight of compounding.It’s up to the organization to choose who that individual is, but there has to be someone who is the point person on compounding issues and who coordinates and monitors related activities. Most organizations have a pharmacist in this role, and some states require that, but the Designated Person also can be a highly trained technician. They don’t have to be a supervisor, and they can be responsible for multiple sites.
Pharmacists and pharmacy technicians now can attain advanced compounding certifications. For the pharmacist, Board Certified Sterile Compounding Pharmacist (BCSCP) certificates can be obtained through the Board of Pharmacy Specialties, while the Pharmacy Technician Certification Board awards Certified Compounded Sterile Preparation Technician (CSPT) certifications. Although passing a didactic test does not guarantee competency in mixing, it is a credential that demonstrates knowledge of compounding requirements.
see BUILDING BLOCKS, page 20
continued from page 19
Evaluate certification reports and environmental
monitoring program, procedures and results. Surveyors and state board inspectors often tell me that when they ask for the most recent certification and environmental monitoring reports, they find that the person supervising compounding operations hasn’t even reviewed the report.
Now is the time to evaluate what is being done at your institutionin terms of environmental monitoring, become familiar with what’s in the reports and take action based on the results. Record temperature, humidity and pressure differentials at least daily; make sure your certification reports summarize all the key required elements; and have your certifier review the areas that pass, fail or need attention after their evaluation. Be sure you receive a written report within a few days of the surveyor’s visit, and schedule the return visit within six months to be sure you will have the certification completed before six months elapses, per USP requirements. In addition, design your microbial environmental monitoring program to detect excursions, incorporate wipe sampling for the detection of hazardous drugs that have escaped containment, and update your training and policies based on these results.
Evaluate outsourcing. The way Centers for Medicare & Medicaid Services (CMS) sees it, contracting with an external compounding facility means you feel that facility is providing the same level of service as you would be if you were doing the compounding in-house. CMS’s Hospital Conditions of Participation—as well as its accreditation standards—require pharmacies to obtain sign-off from hospital leadership to use the external compounding companies and also require that written agreements be in place with the outsourcing compounders. These agreements should establish expectations and set out a plan for monitoring to make sure these expectations are met. What I suggest institutions do is develop reasonable expectations, including at least one operational and one clinical expectation. Make sure you look through FDA assessments for any outsourcing compounder you’re thinking of contracting with (bit.ly/2PvYeKq).
Use the FDA as a resource. Be sure to monitor the FDA website (bit.ly/2PzWbow) for new and revised compounding-related documents. The FDA issues compounding-related guidance documents, such as those related to insanitary conditions (bit.ly/2PvYQQe), which were updated in November 2020. Other documents concern repackaging, hospital and health-system compounding, and compounding from bulk substances. These documents may be in draft or final form, so be vigilant and make sure you have the most recent revision.
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.
USP ADHERENCE
continued from page 16
experience shows that if you want to implement best practices and improve care, you can do it.”
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 Chapters <795> and <797> now over and the chapters remanded, and with <800> currently informational, health-system 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 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-use dates (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,” Dr. Serumaga said.
“In March 2020, the USP appeals panel remanded 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 Dr. Serumaga, who spoke at the ASHP meeting.
In regard to USP <800>, Dr. 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, Dr. 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. “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,” he said. “If you want to adopt <800>, you need to meet all the requirements for a contained area.” —David Wild
The sources reported no relevant fi nancial disclosures.
