Q&A with Patricia C. Kienle, RPh, MPA, FASHP
Director of Accreditation and Medication Safety Cardinal Health
Pharmacy Purchasing & Products: What was the motivation behind creating The Chapter <800> Answer Book?
Patricia C. Kienle, RPh, MPA, FASHP: USP sets the standards that organizations must meet to ensure safe compounding, but it does not provide instructions or guidance for how organizations should meet these standards. Therefore, pharmacists and health care facilities have had a significant number of questions since USP <800> was finalized and the enforcement date of July 1, 2018 was established. After receiving a significant number of queries about how to implement the chapter, ASHP decided to compile a book of USP <800> questions and answers to guide compliance efforts.
The direction of the book was determined based on the questions submitted to ASHP, questions asked on the listserv, and questions posed at professional meetings, and the content is organized in the same manner that the chapter is organized. The book provides questions and answers in a simple format to inform policy and procedure (P&P) development. Questions cover selecting, ordering, storing, dispensing, administering, and monitoring hazardous drugs (HDs), and are organized in line with the medication-use process and the Joint Commission and CMS recommendations.
The Chapter <800> Answer Book is designed to be used as a guide; it is critical that pharmacists read and understand the exact wording of the actual chapter. Pharmacists should also be aware that federal and state regulations may be stricter than USP <800>, and that these regulations may change moving forward. Thus, it is critical to keep abreast of state and federal requirements, as well as USP <800>. USP occasionally publishes frequently asked questions (FAQs) and updates, so be sure to review the USP website periodically. If the USP FAQs address a specific situation, they should be used to guide procedures.
PP&P: What general principles of USP <800> must pharmacists understand?
Kienle: The goal of USP <800> is to protect health care workers from exposure to HDs. For those organizations already compliant with the HD handling requirements in USP <797>, additional changes are probably not necessary. However, experience shows that many organizations are not yet compliant with <797>.
One significant new concept in USP <800> is the assessment of risk (AoR). USP <800> requires compliance with all containment strategies and work practices in the chapter when entities handle antineoplastic drugs requiring manipulation. However, organizations have the option of evaluating the HDs they use to assess the risk of each; some of these drugs, depending on their dosage forms and manipulation requirements, may be deemed exempt. An AoR can be performed to determine which dosage forms of these agents may be handled with alternative containment strategies and/or work practices that are sufficient to protect health care workers from exposure.
To conduct an AoR, develop a list of all the HDs used at the facility, based on the NIOSH HD list. Then, review each drug’s dosage form, packaging (unit dose or bulk), and whether or not it must be manipulated prior to dispense. If the drug must be manipulated, who will do so and where?
While this will require an initial time commitment, once the AoR is complete, it should be simple to maintain. Reviews will only be needed when new drugs, dosage forms, or technologies enter the facility. Note that AoRs must be reviewed and documented at least annually. For a comprehensive description of how to perform an AoR, see Perform an Assessment of Risk to Comply with USP <800>, published in the March 2017 issue of PP&P.
Two other significant changes in USP <800> are the negative pressure range requirement and elimination of the low-volume exemption in manipulation and compounding of HDs. To protect staff, USP <800> requires that all HD compounding be performed in negative pressure. When negative pressure is required in current <797>, the measurement needs to be at least 0.01” negative to the adjacent space. USP <800> requires a specific range: 0.01” to 0.03” negative to the adjacent space. The low-volume exemption, which has been allowed in USP <797>, is eliminated in USP <800>, as it does not protect personnel appropriately. All manipulation and compounding of HDs, unless they are entity-exempt in the AoR, must occur in a BSC or CACI in a negative pressure room.
In addition, USP <800> also describes primary and secondary engineering controls (PECs and SECs) that have been included in USP <797> since 2004, but adds the term containment, since they apply to HDs herein. In USP <800>, PECs and SECs are referred to as C-PECs and C-SECs.
PP&P: What are the most challenging aspects of USP <800> compliance?
Kienle: USP <800> must be addressed in a comprehensive manner, as organizations are expected to be fully compliant with all aspects of the chapter. Consider the following:
- Is the organization using the right PPE?
- Are P&Ps up-to-date?
- Is the organization using a closed system drug-transfer device (CSTD)? USP <800> requires CSTD use for HD administration and recommends CSTD use for HD compounding
- Have pharmacy and nursing been educated on how to correctly use the CSTD?
- Is staff properly trained on other HD handling topics?
- Have all staff members signed an acknowledgement of risk?
Organizations that have not yet completed a gap analysis should undertake one immediately. CriticalPoint’s gap analysis, available at 800gaptool.com, is a good resource, as it utilizes the same language in the chapter—ie, shall (for important practice) versus must (for requirements). Undertaking a gap analysis is critical to identifying areas requiring improvement.
Thereafter, compare the chapter’s requirements against those of your state board. It is critical to stay current with the state board, as many states are in the process of changing their requirements. Some states will specify that pharmacies must be compliant with all USP chapters, while others specify chapter numbers. Because state requirements vary, it is important to be cognizant of what they specify.
Three areas in USP <800> have been the most challenging to date:
- Facilities. Renovating or building compliant facilities to ensure <800> compliance is clearly challenging for many organizations, considering that capital budget expenses are required. The negative pressure requirement and venting to the outside of the facility are not new, but these requirements are still a challenge for many facilities.
- Conducting AoRs. The AoR is a time and resource challenge, as noted earlier.
- Understanding Certification Reports. Every 6 months, organizations must have a qualified certifier come in and inspect the compounding facility. After the inspection, the certifier provides the organization with a detailed report describing any deficiencies. It can be a difficult report to understand as it often utilizes engineering language. However, it is critical that pharmacy leadership review the report in its entirely and understand the implications of any findings.
After an inspection, sit down with your certifier and have them explain what passed, what failed, and what may require attention moving forward. It is not uncommon for pharmacists to not fully evaluate and implement changes resulting from these reports. The report must not simply be filed; it must be understood and the data utilized. A good certifier will provide a detailed report that not only identifies areas that are compliant and areas that have problems, but also includes suggestions for improvement and examples of effective practices utilized at other facilities. Ask your certifier to provide a summary page that includes the major findings.
Given that the compliance date for USP <800> is 8 months from now, organizations must address these challenges head-on.
PP&P: How should an organization budget for USP <800> compliance?
Kienle: First, identify the changes necessary to become compliant and then address budget development. Budget can be delineated into three types: the capital budget, the budget for recurring expenses, and the human resources budget.
- Capital Budget. The capital budget includes all funding required for building or renovating a facility to become USP <800> compliant. Thus, depending on an organization’s existing level of compliance, the capital budget may be a significant expense, especially if a new cleanroom is required. If organizations have not yet addressed facilities changes, compliance by the July 2018 deadline may be challenging considering the length of capital budgeting cycles.
- Recurring Supplies. It is important to budget for equipment and supplies that will be purchased on an ongoing basis to ensure continued compliance. If an organization is compliant with USP <797>, many of these items may already be in place. For example, proper PPE and CSTDs must be utilized as part of the compliance plan.
- Human Resources Budget. Conducting AoRs will require time and resources, so it is critical to include these expenses in the human resources budget. In addition, USP <800> requires that a responsible person, perhaps a compounding supervisor (although the chapter is not specific), take ownership of HD compliance within the organization. This need not be a separate FTE; HD responsibility can be worked into the purview of a current staff member. Unless the organization is small, it would likely not be the DoP. Although most facilities will use a pharmacist in this role, this is not a requirement. USP <800> applies to many types of organizations, such as doctors’ offices and clinics, areas that may not have a pharmacist.
In general, financial planning should be addressed early in USP <800> compliance efforts.
PP&P: What impact does USP <800> have on practice standardization?
Kienle: USP <800> standardizes HD practice by standardizing HD containment. The chapter is designed similar to NIOSH’s Hierarchy of Controls, a method of protecting workers by controlling exposure to HDs, illustrated by an inverted triangle with the most effective controls at the top. According to the hierarchy, the most effective strategies for controlling exposure to occupational hazards are to eliminate the hazard, followed by isolating staff from the hazard using engineering controls, implementing administrative controls, and protecting staff with PPE (see the NIOSH Hierarchy of Controls at www.cdc.gov/niosh/topics/hierarchy/default.html).
From a control perspective, the best way to reduce risk is to eliminate the risk. Obviously that is not possible in a health care setting, as patients need these medications, so other solutions must be identified. Occasionally a safer drug can be substituted for an HD, but this is not a usual option. Utilizing engineering controls, including C-SECs, C-PECs, and CSTDs, are primary methods of reducing HD risk, as are administrative controls, including best practices. Requiring best practice is key to USP <800> compliance. An organization can have the highest quality equipment and PPE, but if staff is not following best practice, they will not be safe. Utilizing proper PPE is the final method of standardization.
PP&P: What additional resources are available to assist organizations in achieving USP <800> compliance?
Kienle: Each section of The Chapter <800> Answer Book contains relevant information based on the correlating section of USP <800>. The tools in the book are based on similar tools found in ASHP’s Competence Assessment Tools for Health System Pharmacies.1 For example, the HD chapter includes a checklist and exam (with an answer key) to test staff’s understanding of USP <800> compliance. Questions not answered in this ASHP resource can be emailed to firstname.lastname@example.org; these may be answered in future editions of this book.
In addition, Joint Commission Resources and BD publish a free reference, https://hazmedsafety.com, which includes a gap analysis and a toolkit to assist with USP <800> compliance.2 B. Braun Medical, Inc, also publishes a resource, https://www.readyfor800.com, which includes a series of short training videos on USP <800> compliance for an organization’s staff, including the safety committee, oncology nurses, environmental services, and the COO and CEO.3
The Chapter <800> Answer Book is available for purchase at the ASHP Book Store: https://store.ashp.org/Store/ProductListing.aspx.
- Murdaugh LB. Competence Assessment Tools for Health-System Pharmacies. 5th ed. 2015; American Society of Health-System Pharmacists, Inc.
- Joint Commission Resources and BD. Self-Assessment of Safe Handling Practices for Hazardous Drugs. https://hazmedsafety.com/. Accessed September 8, 2017.
- Ready for 800. B. Braun Medical, Inc. https://www.readyfor800.com/. Accessed September 8, 2017.
Patricia C. Kienle, RPh, MPA, FASHP, Director of Accreditation and Medication Safety for Cardinal Health, is a member of the USP Compounding Expert Committee and chair of the Hazardous Drug Subcommittee and Expert Panel, although her comments herein are her own and not official information from USP.
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