Ensure USP <800> Compliance Beyond the Pharmacy


September 2016 - Vol. 13 No. 9 - Page #2

Q&A with Patricia C. Kienle, RPh, MPA, FASHP

Pharmacy Purchasing & Products: Now that USP <800> is finalized, what is pharmacy’s role in ensuring compliance in all areas of the facility that handle hazardous drugs (HDs)?

Patricia C. Kienle: USP <800> builds on the patient safety issues addressed in <797> and <795>, while also encompassing personnel and environmental safety. As such, pharmacy must take the lead on ensuring compliance with <800>, but pharmacy cannot accomplish this alone. Success truly requires a health system-wide endeavor, as <800> encompasses issues far beyond pharmacy. Oncology nurses as well as physicians seeing oncology patients and writing HD orders must be involved. In addition, occupational health must be aware of the issues in <800> and understand the corresponding occupational risk. While <800> does not encompass microbial issues, I would also recommend including infection control anytime sterile compounding issues are addressed.

Educating colleagues in the health system on the tenets of the regulation will require some emphasis so that <800> is not seen as simply a chemotherapy safety issue. Given the wide array of HDs within the hospital, <800> is much broader in scope. Historically, health care has taken a cavalier attitude toward occupational risk issues; <800> aims to offset that as we now have a strong understanding of the risks inherent in handling HDs.

PP&P: What trends are developing among regulatory bodies as they look to enforce USP <800> compliance?

Kienle: Regulatory interest will be strong on two fronts: the CMS conditions of participation and the state boards of pharmacy. For both critical access hospitals and regular hospitals, CMS has expanded the conditions of participation to encompass virtually all of USP <797>. CMS has yet to specifically address USP <800>, as the chapter was released after the CMS conditions of participation were revised, but given that HDs are mentioned in <797>, we can expect CMS to take a strong interest in <800> as well. As such, inspectors from CMS, the state, and accreditation surveyors (eg, The Joint Commission, DNV, and AOA) will be heavily involved in surveying for <800> compliance.

Previously, there was significant divergence in how state boards approached HD issues, wherein some state boards aggressively pursued sterile compounding compliance while others did not. With <800>, the playing field is now leveled and health systems will be held to the same standard nationwide.

Notably, many state boards are incorporating USP <800> into their regulations now, even though <800> will not be federally enforced until July 1, 2018. In these states, pharmacies can expect to be queried about their HD practices in relation to <800> in upcoming inspections.

PP&P: What are some of the common challenges to compliant practices that pharmacy will need to address?

Kienle: The facility requirements in <800> are generating a lot of interest. The good news is that facilities with a <797>-compliant negative pressure cleanroom in place are already compliant with <800>, as the facility requirements are the same in both chapters. However, we all know that even after 12 years of experience with <797>, many facilities remain noncompliant. For those that have struggled to acquire capital funding for a compliant cleanroom, now is the time to make the case for appropriate support.

Perhaps the greatest challenge lies in the fact that <800> requires compliance wherever HDs are compounded. So other parts of the health system, such as oncology clinics and doctors’ offices, may require updates. It is not unusual for staff working in these areas to be completely unfamiliar with USP requirements, resulting in a significant learning curve. Consider the number of ambulatory centers that use a chemo hood, but locate it in an open room next to a potted plant because the risks involved in compounding HDs have never been explained to the staff in these facilities.

All too often, freestanding oncology centers have largely ignored or been unaware of the requirements for facilities and personnel safety. A good starting point for educating staff in these areas is the joint statement put out by the Oncology Nursing Society, The American Society of Clinical Oncology (ASCO), and the Hematology/Oncology Pharmacy Association (HOPA)—Ensuring Health Care Worker Safety When Handling Hazardous Drugs (www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2015-safe-handling.pdf), which addresses the need to work collaboratively to achieve a safe working environment.

Every area within the health system that handles HDs must adopt <800>. When a health system acquires an oncology center, physician practice, or clinic, risk management must assess the practices in the operation to evaluate the state of compliance. As the compounding experts, pharmacy is going to be charged with ensuring the entire facility is compliant with <800>. But again, pharmacy cannot accomplish this in a vacuum; it is critical to work in conjunction with the facilities department and risk management to drive the necessary changes.

PP&P: Which requirements in <800> are likely to be new for some pharmacists?

Kienle: Like the facilities requirements, the personnel training and monitoring requirements in <800> mirror those in <797>. Where we do see a change is in personal protective equipment (PPE), particularly regarding the required gowns and gloves.

Because PPE use is basic personnel safety, we must get it right. For gloves, it is very straightforward; when handling HDs, use gloves that have been tested for permeation by ASTM’s D6978 standard (for more information see the PP&P article: Are Gloves and Gowns Safe for Chemotherapy? at www.pppmag.com/gownsandgloves). It is important to note that just because glove packaging includes the word chemo, this does not automatically denote that the gloves are safe to use with HDs. Likewise, no specific color or material connotes HD gloves. Rather, you must confirm that the gloves have been tested according to the ASTM specifications.

Unfortunately, there is no standard for gowns used with HDs, but they do need to be intended for HD use (typically a laminate), impervious, and have no openings (ie, no seams, zippers, or snaps) in the front. The use of bunny suits is inappropriate given the zipper up the front.

While correct PPE usage is widespread in pharmacy, this is not always the case on oncology nursing units or in oncology clinics. It is not uncommon for nurses in those areas to utilize the yellow paper isolation gowns when administering HDs. While ubiquitous in the hospital, these isolation gowns offer absolutely no HD protection. Similarly, many nurses use gloves that are labeled chemo gloves, but do not meet the ASTM standard. It is important that pharmacy ensures all staff members are using the appropriate PPE.

PP&P: Given that broken IV bags or leaking connections remain common in oncology, what are the steps for ensuring proper spill management?

Kienle: Start by examining your readiness: When a spill occurs, do your staff members know how to respond? All too often, staff is falsely confident in their ability to respond because they can point to where the spill kit is located. It is important to regularly examine the components of the spill kit to ensure they are adequate to handle any potential spill.

My recommendation is that pharmacy partner with oncology nursing and environmental services to conduct a spill drill. Observe whether all staff members know how to respond correctly. Are the policies and procedures adequate? Is there a comprehensive checklist that quickly identifies the steps to take? Are the components of the spill kit adequate to handle the types of spills that have occurred in the facility? I have heard anecdotes from many facilities wherein the responder from environmental services arrives and opens the spill kit only to find gloves and a gown that are three sizes too small. Your staff must be confident that the right equipment and supplies will be easily accessible during a crisis.

PP&P: What education and training should pharmacy provide to nurses and other employees handling HDs?

Kienle: First, pharmacy needs to convey the occupational risk that is inherent in handling HDs. Documentation has long supported these risks (eg, the ASHP Guidelines on Handling Hazardous Drugs from 2006 and the NIOSH Alert from 2004); nevertheless, few people outside of pharmacy understand the risk or believe that is applies to them. It is pharmacy’s responsibility to overcome the nothing will happen to me mind-set.

Secondly, since 2008, <797> has required that personnel who deal with HDs acknowledge in writing that they are aware of these risks. The same requirement exists in <800>, which states, “Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs.” Rather than determining who on the staff is capable of reproduction, I recommend the acknowledgement form be given to everybody who comes into contact with HDs. Keep in mind that this is not just a concern for women, as there are reproductive risks for men, too.

CriticalPoint has created a Hazardous Drug Risk Acknowledgement Form, which is available to download free of charge at www.pppmag.com/HDRiskForm.

PP&P: How will <800> impact waste policies and procedures?

Kienle: Waste disposal is not specifically addressed in the regulation; rather, <800> states that organizations must follow their municipal and state regulatory codes. This is due to the myriad rules and regulations surrounding waste segregation and disposal, which vary depending on the region or municipality.

It is important to note that HDs addressed in <800> (as defined by NIOSH) are hazardous to employees. This is different from the EPA’s approach to defining hazardous materials, as their purview is waste that is hazardous to the environment. My recommendation is that pharmacy meets with their waste hauler. As the expert on EPA, state, and regional requirements, your waste hauler is ideally suited to explain the various regulations and design appropriate separation procedures.

PP&P: Does <800> require medical surveillance for staff working with HDs?

Kienle: <800> recommends, but does not require, medical surveillance for staff handling HDs. Fortunately, establishing a staff medical surveillance program is a fairly straightforward process. Start by developing a questionnaire that addresses potential health risks. The Oncology Nursing Society has created an excellent document that identifies the types of questions to include on the assessment questionnaire (https://www.ons.org/sites/default/files/Safe%20Handling%20Medical%20Surveillance%20Questionnaire.pdf). Next, most occupational health experts recommend employees handling HDs have a baseline CBC with diff documented.

Medical surveillance seeks to help manage two separate issues: treating and documenting any acute exposures (eg, a spill or a stick), and long-term monitoring of chronic exposure. To monitor exposure over time, you need to establish the frequency at which the questionnaire and lab tests should be repeated in order to identify any unexpected developments and gather aggregate data.

PP&P: Are there common practices in areas such as oncology clinics and doctors’ offices that need to be banned completely?

Kienle: For starters, the areas where HDs are compounded need to be designated as authorized access only. People should not be walking in and out. For example, environmental services should not enter mid-shift to take out the trash, nor should pharmacists enter ungarbed to check an IV. Access to HD compounding areas needs to be much more controlled than it currently is.

In addition, the reuse of PPE must be clarified. While PPE reuse may be acceptable under certain circumstances over the course of a compounding shift, this does not apply to HD compounding. Once a staff member leaves the negative pressure room where the chemo hood is located, garb must be removed and discarded so that no contamination is tracked through the positive pressure area.

Finally, just as food and beverages are banned from the cleanroom, chewing gum and eating candy should likewise be banned. Staff members may mistakenly believe that gum does not qualify as a food, but it is equally at risk for exposure to aerosolized particles, and as such, should not be permitted in any HD area.


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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