42 minute read
POLICY
Safe Disposal in the COVID-19 Era
Challenges persist in managing waste for hospitals treating COVID-19 patients and aiming to limit the spread of the virus.
Institutions must now complete more steps on-site to safely collect, prepare and dispose of regulated medical and hazardous waste and sharps, while simultaneously protecting workers and the public, according to agency, state and waste hauler guidelines. These recommendations could change further as COVID-19 cases continue in hot spots throughout the United States and personal protective equipment (PPE) nt (PPE) remains in short supply.
“‘How do I dispose of (fill in the ll in the blank) from a COVID-19 patient?’ is the nt?’ is the single question I’ve been asked most ked most on waste management during this panthis pandemic,” said Cara Simaga, the director e director
Best Practices for Waste During a Pandemic
The challenges of COVID-19-related waste management led Stericycle to reinforce best practices and add temporary changes to its Packaging Guidelines and Waste Acceptance Policies. The revisions include: • Hospitals must line shipping containers with red bags for regulated medical waste, and close and tie bags with a knot. This Department of Transportation regulation protects workers who open these containers to recycle cardboard or place tubs into the tub washer for reuse. Also, stay under the 50-pound limit per container for safe loading (exceptions are roll-up boxes or carts), and double-bag and absorb or solidify all liquid waste. • Stericyle drivers won’t accept improperly packaged waste for pickup or assist in packaging it. All containers must be properly labeled, closed and ready for removal, with no red bags visible. Nonconforming waste discovered at the facility will be returned to the hospital or redirected elsewhere for disposal. • Hospitals that don’t want to sign shipping documents can have the drivers print “Generator refused to sign COVID-19,” sign and date their section, and leave a copy for the hospital’s file. • Stericycle technicians don’t service sharps or comingled sharps and pharmaceutical containers in any hospital isolation rooms, regardless of airborne, droplet or contact precautions taken. Instead,
Stericycle provides sufficient containers for hospital staff to put clean ones in patient rooms, removing the used ones and putting them in carts for pickup. “We believe it is prudent to limit the number of people that enter such rooms to limit disease
spread and preserve scarce PPE,” said Cara Simaga, maga, the director of government affairs at Stericycle. e. • Service technicians check with nursing stations before efore servicing a department to learn if there are any treatreatment areas they shouldn’t enter because of COVID-19. D-19. • Don’t place other waste types besides solid waste ste into red bags or sharps containers. Other types s of waste could pose danger to workers. “Chemiical waste, batteries, aerosol cans and gas cylinders ders could react dangerously in our processing equippment. We cannot accept [Resource Conservation on and Recovery Act] hazardous waste and radioactive active waste at our regulated medical waste facilities,” said ” said
Ms. Simaga, noting that other Stericycle divisions can handle many of y of these wastes. • Don’t place pharmaceutical waste into red bags. s.
Continue to use blue and black pharmaceutical waste containers for that service. • Regulated medical waste and sharps should conntinue to be autoclaved. Incineration is needed only only for pathology waste, trace chemotherapy waste and e and nonhazardous pharmaceutical waste. Once medical dical waste is treated, it can still be landfilled or sent to to waste-to-energy sites. • Stericycle has established a business continuity plan plan to ensure ongoing services, and centrally commu- nicates COVID-19 updates to health care facilities via its Knowledge Center (see main article). —A.H.
The sources reported no relevant fi nancial relationships.
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of governof government affairs ment affairs at Stericycle, at Stericycle, in a webinar she in a webinar she hosted with Selin hosted with Selin Hoboy, the compaHoboy, the company’s vice president of ny’s vice president of government affairs and government affairs and compliance. compliance.
Ms. Simaga assured Ms. Simaga assured listeners that “[generlisteners that “[generally, if you put waste] ally, if you put waste] in the red bag before in the red bag before COVID-19, it still goes in the COVID-19, it still goes in the red bag today. If you put waste red bag today. If you put waste in the trash before COVID-19, it in the trash before COVID-19, it can still go in the trash today …. If can still go in the trash today …. If you put something in a pharmayou put something in a pharmaceutical waste container before ceutical waste container before COVID-19, it will still go COVID-19, it will still go there today.” Yet, she and there today.” Yet, she and Ms. Hoboy also charMs. Hoboy also characterized this panacterized this pandemic period as demic period as a dynamic one, a dynamic one,
with process changes possibly ahead as scientists uncover new disease insights.
On one hand, Ms. Hoboy explained, the “enveloped virus is easily destroyed with normal disinfection procedures and typical waste treatment methods we use today. It is spread by close contact, so [social distancing is key].” On the other hand, SARS-CoV-2’s highly contagious nature and surface-sticking ability make waste management risky. The COVID-19 virus remains viable in aerosols for three hours, on plastic and steel for 48 to 72 hours, on cardboard for less than 24 hours, and on copper less than four hours (N Engl J Med 2020;382:1564-1567).
Stericycle imposed safety changes despite the CDC’s position that “medical waste (trash) coming from health care facilities treating COVID-19 patients is no different than waste coming from facilities without COVID-19 patients,” and despite a lack of federal guidance on managing regulated medical waste (sidebar).
Instead, “there’s a patchwork of regulations we must follow on a stateby-state basis,” said Ms. Hoboy, who urged those involved in waste management to “check regularly because [the
regulations] might be changregulations] might be changing.” Those tweaks, she said, ing.” Those tweaks, she said, might provide “regulatory might provide “regulatory relief, enforcement discrerelief, enforcement discretion, or fast-tracking medition, or fast-tracking medical waste generator regiscal waste generator registrations or waiving fees.” trations or waiving fees.” Ms. Hoboy steered Ms. Hoboy steered
‘There’s a patchwork of regulations we must follow on a state-by-state basis. Check regularly because they might be changing.’ —Selin Hoboy
updated sources for the latest policies and recommendations.
She shared Knowledge Center links from the CDC and the Occupational Safety and Health Administration on waste: bit.ly/3gtPUnv; bit.ly/2ZKHYZe; bit.ly/2B2nwsj; and bit.ly/2yDbAfM.
For further CDC/EPA guidance, visit bit.ly/3gxJEv2.
“Having managed Ebola in 2014, I’ve never seen anything of this magnitude. We certainly are in an unprecedented time,” Ms. Hoboy said. Actual direct waste from COVID-19 patients is “minimal,” with less blood and bodily fluids than during the Ebola outbreak, but there is “a lot more PPE and other solid waste generated” in hospitals as well as at pop-up testing sites, clinics, patient triage areas and quarantine sites in unconventional settings.
—Al Heller
The sources reported no relevant fi nancial relationships.
health care professionals, hospital safety health care professionals, hospital safety directors and administrators toward directors and administrators toward state health department websites, the state health department websites, the Healthcare Waste Institute of the Healthcare Waste Institute of the National Association for Healthcare National Association for Healthcare Waste Companies, and Stericycle’s Waste Companies, and Stericycle’s own Knowledge Center (www. own Knowledge Center (www. stericycle.com/knowledgestericycle.com/knowledgecenter) as reliable, center) as reliable,
Knowledge K l d Center Resources
Clinical Questions about COVID-19: Questions and Answers
bit.ly/2XKPlgm
OSHA guidelines on COVID-19 prevention and control
bit.ly/2zHRrpv
Strategies to Optimize the Supply of PPE and Equipment
bit.ly/2BfAX8w
OHSA’s enforcement guidelines on N95 masks
bit.ly/2yJASZK
Free CME/CE now available!
Preventing Postoperative Pulmonary Complications in Patients Receiving Neuromuscular Blockade
RELEASE DATE: MAY 1, 2020 EXPIRATION DATE: MAY 1, 2021
This activity is jointly provided by Postgraduate Institute for Medicine (www.pimed.com) and MedEdicus LLC.
This activity is supported by an independent educational grant from Merck & Co., Inc.
This activity is distributed via Anesthesiology News, Pharmacy Practice News, and CMEZone.
FACULTY Sorin J. Brull, MD (Chair)
Professor Department of Anesthesiology and
Perioperative Medicine Mayo Clinic, College of Medicine and Science Jacksonville, Florida
Brian Erstad, PharmD, MCCM, FCCP, FASHP
Professor, Pharmaceutical Sciences Professor, BIO5 Institute Department Head, Pharmacy Practice and Science College of Pharmacy University of Arizona Health Sciences Tucson, Arizona
Dru Riddle, PhD, DNP, CRNA
Director, Center for Translational Research Associate Professor of Professional Practice School of Nurse Anesthesia Texas Christian University Fort Worth, Texas
Credits: 1.0 AMA PRA Category 1 Credit™, 1.0 MOCA 2.0® credit, and 1.0 contact hour (0.1 CEU) ACPE UAN: JA4008162-9999-20-2008-H01-P Type of Activity: Knowledge
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NIOSH 2020: Big Changes Are Afoot!
Charlotte A. Smith, RPh, MS
Senior Regulatory Advisor
Kathleen Skibinski, RPh, MS
Manager, Regulatory and Compliance
Monica Livingston
Senior Implementation Manager
PharmEcology Services Waste Management Sustainability Services Brookfield, Wis.
As of June 15, 2020, the National Institute for Occupational Safety and Health (NIOSH) has received 23 separate comments on its much-awaited waited document, “NIOSH List of Hazardous ardous Drugs in Healthcare Settings, 2020.” 2020.” The comments range from short paraparagraphs to relatively lengthy entries. The s. The NIOSH document was published in the in the Federal Register May 1 (bit.ly/2UYrFoq). rFoq).
Some of the comments address one ss one or two areas of concern, whereas others others include a variety of suggestions, clarificlarifications, opposing viewpoints and simple simple grammatical revisions. More feedback is back is coming: At press time, NIOSH extended ended the comment period to 90 days, ending nding July 30, 2020.
Before delving into the comments, let’s s, let’s review the key documents involved. In ed. In addition to the NIOSH list, the Federal Federal Register announcement also included cluded the “Procedures for Developing the g the NIOSH List of Hazardous Drugs in ugs in Healthcare Settings” (bit.ly/3fVXdDv). Dv). Of more practical importance to to the health care community is an n 87-page document titled “Managging Hazardous Drug Exposures: Information for Healthcare Settings,” which can be accessed in the online version of the Federal Register under “Enhanced content” (bit.ly/2Z20iLd). Your safe handling team should become familiar with the key changes that NIOSH made in these various documents. Here are a few highlights.
Guidance on Engineering Controls
In the NIOSH 2016 list, Table 5 provided valuable guidance in terms of when specific levels of engineering controls, personal protective equipment (PPE) and so forth should be used. However, there were gaps that health care facilities had to navigate on their own to develop and implement a risk management plan. The new document on managing hazardous drug exposures goes into much greater detail regarding the process of evaluating potential exposures, and assessing and mitigating risk, through the hierarchy of controls: elimination, substitution, engineering controls, administrative controls and PPE. These steps are summarized in a more robust table (yet still not representative of all handling scenarios) titled “Control Approaches for Safe Handling of Hazardous Drugs by Activity and Formulation” (bit.ly/3dudldy).
As part of the process of segregating the list itself from the implementation of safe handling practices, the “Procedures” document was created. This document describes in detail the processes and procedures used, including an evaluation of the molecular properties of the drug, which may prevent absorption through routes other than absorption through routes other than deliberate injection. The NIOSH definideliberate injection. The NIOSH defini
NIOSH’s 5 Risk Management Elements
1. Elimination 2. Substitution 3. Engineering Controls 4. Administrative Controls 5. Personal Protective Equipment
tion also includes the restriction to only drugs that have been approved for use in humans by the FDA’s Center for Drug Evaluation and Research (CDER).
A footnote indicates that biological products, including vaccines, gene therapy and several others are not included because they are approved for use by the FDA’s Center for Biologic Evaluation and Research (CBER). A summary of the processes for identifying, screening, evaluating and reviewing drugs for placement on the list is provided in Figure 1 (page 21) of the document.
What They Had to Say
Those highlights cover just a few of the changes contained in the new documents. For a more in-depth summary, see pharmacypracticenews.com (bit.ly/ 37WycoS). So, let’s move on to the public comments.
Regarding two questions asked about the NIOSH proposed list of hazardous drugs, there appeared to be agreement that 1) the generic name of the drug was the most useful unique ingredient
identifier, and 2) botulinum toxins should continue to be evaluated. In those comments was a recommendation that NIOSH should include biological drugs that are approved for use by the CBER, in addition to those approved by the CDER.
As for more general comments, we’ve summarized and divided them into eight categories:.
1. Request for additional information
or inclusion of information. These comments covered several areas, including a request for more detailed guidance in establishing an assessment of risk in nonacute practices—for example, when retail pharmacies reconstitute an oral liquid drug such as fluconazole. Additional guidance also was requested regarding the risk to an employee from crushing tablets in a hood relative to the risk to nurses from administration of that crushed dosage form. More evidence for PPE recommendations was requested, along with inclusion of DailyMed and Drug Bank as references. 2. Clarification of information. Questions were raised regarding some of the recommendations for PPE requirements, including the use of sleeve covers, closed system drug-transfer devices for subcutaneous/intramuscular administration, and PPE recommendations when withdrawing injections from a vial during administration. There also was a suggestion that an overt statement regarding the handling of “investigational drugs as hazardous drugs until adequate information becomes available to exclude them” should be included as a formal source of guidance 3. Discussion of information. Various suggestions about language used in describing the priming of IVs and current closed system drug-transfer device usage by nurses were made. There were additional suggestions to require the use of sterile gloves during sterile compounding. One commenter suggested that the PPE requirements should not apply for manufacturer-prepared kits that are selfadministered by the patient 4. Language suggestions. Several commenters provided alternative language in some areas, including engineering controls and compounding practices. 5. Statements. Concern was expressed that by including illustrations, the equipment featured was outdated or selection of a specific item demonstrated product bias. To address this concern, it was suggested that no pictures be included, as has been the case in the past. Another suggestion was to refer to the new ASTM (American Society for Testing and Materials) gown standard, which should be available by the end of June. 6. Omissions. The ommission of mitomycin and 5-fluorouracil in ophthalmology surgery and their concomitant risks were pointed out. Another commenter noted that a large group of relatively new oral antineoplastics, although not cytotoxic, have manufacturers’ cautions but are not on the new list. And concern was raised by the NIOSH statement that a drug was not listed because there was insufficient toxicity information available. The concern is that this could lead to a drug being on the market that does pose a significant risk but has not been identified as such.
7. Consideration of placement of certain drugs on NIOSH’s list or assignment to
specific tables. Several commenters were concerned that potential systemic side
effects upon injection for certain drugs were determining the listing, rather than the risks to employees from inhalation or skin contact. Several suggestions were made regarding moving some drugs from Table 1 to Table 2, including hormonal agents such as estrogens, gonadotropins and progestins. Another area of concern was the criteria used to determine reproductive risks, including black box warnings for ingestion as opposed to occupational risk, with divalproex and warfarin being called out relative to statins and angiotensin-converting enzyme inhibi
tors, which are not listed. 8. Support for efforts. A very positive comment was made regarding radiopharmaceuticals continuing to be excluded from the list since their storage, handling and compounding are regulated by the U.S. Nuclear Regulatory Commission under very different circumstances and risks. General acknowledgment was made of the value the NIOSH documents bring to compliance efforts and the degree to which they are relied upon by health care professionals to ensure a safe working environment. ■
Best Practices for Monitoring Hazardous Drug Surface Contamination A Guidance for Health Care Institutions
KATHERINE SARNA, PHARMD, BCPS
Clinical Assistant Professor University of Illinois at Chicago College of Pharmacy Chicago, Illinois
Occupational exposure to hazardous chemicals affects an estimated 13 million workers in the United States, with upwards of 8 million US health care personnel in clinical and nonclinical roles potentially exposed to hazardous drugs (HDs). 1,2
The characteristics of HDs, along with adverse health effects from workplace exposure, are well described in the literature. 1,3 Several factors determine the likelihood and severity of harm caused by exposure to HDs, including the drug toxicity profile and formulation, workplace handling procedures, and routes of exposure. 1 Dermal contact is a critical route of exposure to hazardous chemicals, including HDs, in the workplace, because substances may remain unnoticed on work surfaces for extended periods. 2,4 Contact dermatitis constitutes the vast majority of all cases of occupational skin disorders, with estimated annual costs exceeding $1 billion. 2
There are no established minimum or safe HD exposure limits. 1 Therefore, those who come into contact with HDs are required to follow strict precautions. Numerous federal agencies and professional organizations have published recommendations and guidelines to control occupational exposure to HDs (Table 1). 1,3,5-11 Most recently, the CDC and National Institute for Occupational Safety and Health released a draft publication summarizing risk management information pertinent to HD management in health care settings; the finalized document will be posted after the period for public comment ends. 1 (See related article, page 24.) Collectively, available guidelines and
Table 1. Publications Presenting Best Practices In Hazardous Drug Management 1,3,5-11
• CDC/NIOSH: Managing Hazardous Drug Exposures: Information for
Healthcare Settings (Draft, 2020) 1 • ASCO Safe Handling of Hazardous Drugs: ASCO Standards (2019) 5 • ONS/HOPA Ensuring Health Care Worker Safety When Handling
Hazardous Drugs (2019) 6 • USP General Chapter <800> (2019) 7 • ASHP Guidelines on Handling Hazardous Drugs (2018) 8 • ONS Safe Handling of Hazardous Drugs (2017) 9 • OSHA Technical Manual: Controlling Occupational Exposure to
Hazardous Drugs (2016) 10 • USP General Chapter <797> (2008) 11 • NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs (2004; hazardous drug list is updated every 2 y) 3
ASCO, American Society of Clinical Oncology; CDC, Centers for Disease Control and Prevention; HOPA, Hematology/Oncology Pharmacy Association; NIOSH, National Institute for Occupational Safety and Health; ONS, Oncology Nursing Society; OSHA, Occupational Safety and Health Administration; USP, United States Pharmacopeia. recommendations have been adopted by state and federal enforcement agencies and are used by health care facilities to create policies and procedures to mitigate occupational risk associated with HD handling.
Along with a positive safety culture within the organization, effective HD risk management includes hazard identification, exposure assessment, risk assessment, and risk management. 1 Periodic monitoring of the effectiveness of risk management efforts also is paramount. Unfortunately, not all aspects of HD management are explicitly described in published standards to allow for standardization. Particularly in the arena of risk management, best practices concerning surface contamination monitoring are limited.
This paper summarizes best practices related to monitoring workplace surface contamination, with a focus on surface wipe sampling for HDs. An upcoming 2020 consensus conference that plans to provide more detailed guidance for HD surface contamination monitoring also is introduced. A publication summarizing recommendations from this conference is planned for early 2021.
Surface Contamination
Numerous studies in the last 30 years have demonstrated widespread HD contamination of workplace surfaces in national and international health care facilities. 3,8,10,12-14 Using wipe samples, investigators have detected measurable concentrations of HDs—notably cyclophosphamide, cytarabine, fluorouracil, ifosfamide, methotrexate, and paclitaxel—on surfaces within and adjacent to the pharmacy, in patient care areas, and in other locations. Common surfaces that contain HD residue include drug vials, biological safety cabinets and isolators, worktops, floors, storage areas, and tables and chairs. 3,12,13 Overall, these studies indicate that the potential for accidental dermal exposure to HDs in the workplace continues to be an issue, and warrants the development of practice standards aimed at preventing occupational exposure. 14
Controlling Exposure
Table 2 summarizes administrative and engineering controls used to control HD surface contamination in the workplace. 1 Both engineering and administrative controls, along with personal protective equipment (PPE), are recommended as part of a risk management plan to protect health care workers from HD exposure. 1,3,7 Details regarding these controls are described in other publications. 1,7 Briefly, engineering controls isolate workers from HDs, usually by physical barriers, whereas administrative controls rely on workers who handle HDs to follow workplace practices intended to minimize exposure. 1 Because engineering controls generally require minimal or no effort by health care workers to be effective, they are preferred to administrative controls whenever possible. However, engineering controls have more significant up-front costs.
Other methods for controlling HD exposure, such as physical removal or replacement of the HD, are highly
effective but difficult to implement in existing processes without major changes in equipment and procedures. 1 Furthermore, because HDs usually cannot be eliminated or substituted for, reducing occupational exposure to these agents is a critical component of decreasing adverse health effects in health care workers. The application of administrative and engineering controls reduces, but does not completely eliminate, HD exposure in the workplace. 7,8,10 Therefore, implementing methods to monitor workplace surface contamination is prudent when creating and evaluating institutional policies and procedures that are intended to minimize occupational risk. 1 Because occupational exposure limits are not available to guide safe levels of HD exposure based on health effects, following an ALARA (as low as reasonably achievable) approach similar to that used for radiation exposure has been suggested. 1,8,15
Surface Wipe Sampling
Surface wipe sampling, along with wipe sample analysis, is the method of choice for identifying and determining the level of workplace surface contamination where hazardous chemicals such as lead, asbestos, pesticides, and antineoplastics are handled. 8,16 Although this method does not directly measure workers’ exposure to hazardous substances, the information provided is helpful in identifying contaminated surfaces that may contribute to accidental dermal exposure. Therefore, surface wipe sampling can be used as part of a quality assurance program aimed at evaluating work practices, engineering controls, and PPE. 1,15
As previously noted, wipe sampling has been used extensively in studies evaluating locations of HD residue in health care facilities. 3,16 Unfortunately, published data supporting regular wipe sampling for decreasing HD surface contamination are scarce. In the 2013 MEWIP (Monitoring-Effect Study of Wipe Sampling in Pharmacies) study, 130 pharmacies in Germany were randomly assigned to 1 of 2 surface wipe sampling plans. 17 The test group conducted wipe sampling at 3-month intervals for 5 cycles, while the control group only conducted sampling at the beginning and end of the investigation. The wipe samples across both groups were from similar locations throughout the pharmacy, and 774 of 1,269 samples (61%) were positive for HD residue. An important finding in this study was the consistent decrease in surface contamination observed in the group that performed regular wipe sampling; there was a 13% reduction in contaminated samples between first and fifth cycles compared with no change between sample 1 and 2 in the control group.
A more recent study retrospectively analyzed 5,842 individual surface wipe samples from 338 pharmacies, mostly in the United States, over 6 years. 18 Approximately 40% of sites performed more than 1 wipe sample during this time. Results showed that, depending on the specific location and surface tested, between 3.94% and 25.96% of samples had high levels of HD contamination. Furthermore, overall HD contamination was lowered with repeat wipe sampling; 45.24% of samples detected HDs with the first wipe compared with 31.64% for subsequent wipes. Since contamination was not completely eliminated even with repeated sampling, the authors suggested that continued monitoring is required to minimize exposure.
Sampling Procedure
Best practices concerning surface wipe sampling for HDs are limited and lack detail to allow for standardization. 15,19,20 Therefore, there is considerable variation in how sampling is performed and how results are reported. 16 The following information provides an overview of sampling methods specifically for HDs.
Wipe sampling begins by choosing a surface area and determining whether the drugs of concern can be identified with an available test kit or analytical method. 15,16 Commonly assayed drugs include
Table 2. Administrative and Engineering Controls To Minimize HD Exposure 1
Administrative Controls Engineering Controls
• Education and training • Limiting access to areas containing HDs • Limiting the time workers handle HDs • Good housekeeping practices (cleaning, etc) • Handwashing before and after handling HDs • Continuous monitoring of compliance with workplace practices
Primary controls
• Biological safety cabinets • Compounding aseptic containment isolators
Secondary controls
• Proper ventilation and negative pressure rooms
Supplemental controls (to be used in combination with primary engineering controls)
• Closed system drug-transfer devices • Robotic drug preparation system • Needleless systems
HD, hazardous drug
Table 3. Advantages and Disadvantages Of Analytical and Immunochemical Wipe Sample Analyses 16
Test Advantages Disadvantages
Analytical • Sensitive, specific, and accurate results • Quantitative results • Time-consuming and costly to complete • Requirement for specially trained personnel to run analyses • Results take weeks to return • Equipment variations resulting in differences in lower limits of detection
Immunochemical using a LFIA • Portable and easyto-use device • Quick to run • Sensitive results that correlate well to analytical methods • Can only test for selected HDs • Qualitative results only
HD, hazardous drug; LFIA, lateral flow immunoassay
cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-based antineoplastic agents. Next, a suitable solvent is applied either directly to the surface to be sampled or to the sampling material (swabs, etc). The surface then is wiped in one direction followed by wiping perpendicular to that direction. The size of the areas sampled generally range from 100 to 500 cm 2 , and a supplementary sample can be taken from the same location using a second wipe to ensure a better recovery. Once the sample has been collected, the next steps are determined by whether an analytical or immunochemical technique is employed for detecting HDs. The advantages and disadvantages of each of these technologies are summarized in Table 3. 16
Detection Using Analytical Methods
Conventional analytical methods require that wipe samples are placed in labeled containers and shipped to a laboratory for analysis. 16 The most common analytical method for detecting HDs includes high-performance liquid chromatography and in combination with mass spectrometry (MS). Other methods used in combination with MS or tandem MS include gas chromatography and ultra-high-performance
HD BEST PRACTICES
continued from page 27
liquid chromatography; inductively coupled plasma MS has been used to detect platinum compounds. Few laboratories in the United States can perform these analyses; therefore, there is a significant lag time between sending samples and obtaining results using analytical methods for HD detection. The delay in obtaining results also means that HD residue may remain on work surfaces for extended periods of time before decontamination is initiated.
Detection Using Immunochemical Techniques
A novel strategy that allows for on-site detection of HD residue on work surfaces involves immunochemical techniques. 16 Unlike analytical analyses that require complex laboratory equipment and specially trained personnel, immunochemical techniques employ competitive lateral flow immunoassay (LFIA) technology, similar to that found in point-of-care tests, to detect the presence of HDs through antibody interactions quickly and easily. The BD HD Check system is the only rapid HD detection system on the market to use competitive LFIA technology, according to BD (bit.ly/ 2YHZ3Rx). The system contains a template to place over the testing location, a collection kit that includes a swab used to collect the sample, assay cartridges to hold the sample, and an analyzer to test the sample. A positive or negative result (ie, the HD is or is not present at a level above the detection threshold) can be obtained in less than 10 minutes, allowing for immediate corrective action against surface contamination. Cyclophosphamide, doxorubicin, and methotrexate are the only HDs that can be detected using the BD HD Check system, according to the company.
Surface wipe sampling procedures are recommended for all facilities that manage HDs as part of a comprehensive HD risk management plan. 6-8,11,21 General considerations for creating an HD wipe sampling plan have been published, but lack detailed sampling procedures (number of wipe samples, etc) and application of available technologies. 15,19,20,22
Health care institutions should consider the HDs their workers are handling when choosing a wipe sampling kit. 7 A robust wipe sampling plan may include a combination of
Table 4. Barriers to Implementation 0f Wipe Sampling Plans for HDs 7,15,22
• Lack of regulatory requirements • Incomplete guidance concerning sampling methodology • Time and/or cost associated with available sampling methods • Limitations of HD panels in available test kits • A lack of certifying agencies for vendors of wipe sample kits • Uncertain effectiveness of a specific number or size of wipe samples in determining levels of HD contamination • Unknown acceptable limits, if any, for HD surface contamination • Lack of experience by sampling personnel
HD, hazardous drug
Table 5. Development of Hazardous Drug Surface Contamination Monitoring Guidelines: 2020 Conference Objectives
• To understand other health care disciplines’ standards and best practices for the handling of hazardous substances within their respective practices, which may have applicability to hazardous drug surface contamination monitoring • To understand the current state of hazardous drug surface contamination monitoring within the medication-use system for all dosage forms across all patient care sites • To assess the capabilities, current utilization, benefits, and challenges of commercially available surface contamination monitoring technologies and systems • To promulgate best-practice recommendations for the monitoring of hazardous drug surface contamination • To produce a conference consensus statement on the topic of hazardous drug surface contamination monitoring, suitable for publication in an appropriate peer-reviewed journal
sampling techniques, such as frequent LFIA analyses for continuous monitoring and periodic quantitative analytical measurements for more comprehensive information related to surface contamination. 23 There are no certifying agencies for vendors of HD wipe sample kits; however, suggested questions for institutions when considering a vendor have been published in a previous issue of Pharmacy Practice News. 21
USP General Chapters <797> and <800> recommend routine wipe sampling, including assessments at baseline and at least every 6 months thereafter. 7,11 USP provides recommended locations for sampling that include multiple locations in pharmacy, nursing, and patient care areas where HDs are received, prepared, stored, and administered. Sampling worker PPE also may be considered in light of data showing HD contamination on the gloves of nurses and pharmacists. 13 More frequent monitoring (eg, monthly) and rotation of wipe sample sites have been implemented by some institutions. 21
If contamination is found using wipe sampling, a designated person should identify, document, and contain the cause of contamination. 7 Corrective action may include thorough deactivation, decontamination, cleaning, and improvement of administrative and engineering controls. To validate that corrective actions have been effective, wipe sampling should be repeated. The use of LFIA for detection of remaining HD residue may be particularly beneficial for this purpose. 23
Addressing Implementation Challenges
Widespread implementation of wipe sampling protocols has been slow in US and international health care facilities. 22,24 Table 4 summarizes some of the known barriers to implementation of sampling plans. 7,15,22 To address some of the knowledge gaps in this arena, a formal consensus conference (Safe to Touch) has been planned for October 2020 in Chicago, Illinois, with the purpose of providing guidance for HD surface contamination monitoring. The conference was planned in cooperation with a multidisciplinary group of nursing and pharmacy experts in the field of oncology, medication safety, and hazardous materials environmental testing, and is supported by Visante Inc. Table 5 lists the objectives of this conference.
Conclusion
An effective HD risk management plan can reduce occupational exposure to HDs and related adverse health outcomes. 1 Administrative and engineering controls and PPE have demonstrated effectiveness in reducing HD exposure; however, these strategies do not completely eliminate risk. Therefore, the implementation of processes to assess workplace surface contamination are critical to identifying and minimizing occupational risk. Wipe sampling is the preferred method to identify the need for, and effectiveness of, available controls and what type of PPE is required while handling HDs. 8,15 Newer immunochemical techniques, while currently limited in scope, have provided an opportunity for more timely and less costly measurements of surface contamination compared with traditional analytical techniques. 16 The creation of wipe sampling protocols that incorporate these newer technologies has been encouraged by professional organizations, although uptake has been limited due to knowledge gaps and lack of detailed guidance. 21,22,24 A formal consensus conference has been planned to harmonize available recommendations and provide detailed guidance for HD surface contamination monitoring.
References
1. Hodson L, Ovesen J, Couch J, et al. Managing hazardous drug exposures: information for healthcare settings. Department of Health and
Human Services, CDC, National
Institute for Occupational Safety and Health. www.regulations.gov/ document?D=CDC-2020-0046-0004.
May 1, 2020. Accessed June 12, 2020.
2. CDC. Skin exposures & effects. www.cdc. gov/niosh/topics/skin/default.html.
July 2, 2013. Accessed June 12, 2020.
3. CDC. Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. www.cdc.gov/ niosh/docs/2004-165. September 2004.
Accessed June 12, 2020.
4. US Department of Labor, Occupational
Safety and Health Administration.
Dermal exposure. www.osha.gov/SLTC/ dermalexposure/index.html. Accessed
June 12, 2020.
5. Celano P, Fausel CA, Kennedy EB, et al.
Safe handling of hazardous drugs: ASCO standards. J Clin Oncol. 2019;37(7):598-609.
6. Oncology Nursing Society. Ensuring healthcare worker safety when handling hazardous drugs. Joint position statement from the Oncology Nursing
Society and the Hematology/Oncology
Pharmacy Association. www.ons.org/ make-difference/ons-center-advocacyand-health-policy/position-statements/ ensuring-healthcare. July 2019. Accessed
June 12, 2020.
7. USP. USP General Chapter <800>
Hazardous Drugs—Handling in Healthcare
Settings. www.usp.org/compounding/ general-chapter-hazardous-drugshandling-healthcare. December 1, 2019.
Accessed June 12, 2020.
8. Power LA, Coyne JW. ASHP guidelines on handling hazardous drugs. Am J Health
Syst Pharm. 2018;75(24):1996-2031.
9. Polovich M, Olson MM, eds. Safe Handling of Hazardous Drugs. 3rd ed. Oncology
Nursing Society; 2017.
10. US Department of Labor, Occupational
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Technical Manual. Controlling occupational exposure to hazardous drugs. www.osha. gov/SLTC/hazardousdrugs/controlling_ occex_hazardousdrugs.html. February 1, 2016. Accessed June 12, 2020.
11. USP. USP General Chapter <797>
Pharmaceutical Compounding—Sterile
Preparations. www.usp.org/compounding/ general-chapter-797. Updated 2008.
Accessed June 12, 2020.
12. Davis J, McLauchlan R, Connor TH.
Exposure to hazardous drugs in healthcare: an issue that will not go away.
J Oncol Pharm Pract. 2011;17(1):9-13.
13. Call E, Bill B, McLean C, et al. Hazardous drug contamination of drug preparation devices and staff: a contamination study simulating the use of chemotherapy drugs in a clinical setting. Hosp Pharm. 2017;52(8):551-558.
14. Marie P, Christophe C, Manon R, et al.
Environmental monitoring by surface sampling for cytotoxics: a review. Environ
Monit Assess. 2017;189(2):52.
15. Connor TH, Zock MD, Snow AH. Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: methodology and recommendations. J Occup Environ Hyg. 2016;13(9):658-667. 17. Kiffmeyer TK, Tuerk J, Hahn M, et al.
Application and assessment of a regular environmental monitoring of the antineoplastic drug contamination level in pharmacies - the MEWIP project. Ann
Occup Hyg. 2013;57(4):444-455.
18. Salch SA, Zamboni WC, Zamboni BA, et al.
Patterns and characteristics associated with surface contamination of hazardous drugs in hospital pharmacies. Am J Health
Syst Pharm. 2019;76(9):591-598.
19. US Department of Labor, Occupational
Safety and Health Administration.
Evaluation guidelines for surface sampling methods. www.osha.gov/dts/sltc/methods/ surfacesampling/surfacesampling.html. 2001. Accessed June 12, 2020. 20. US Department of Labor, Occupational
Safety and Health Administration. OSHA
Technical Manual. Section II: chapter 2.
Surface contaminants, skin exposure, biological monitoring and other analyses. www.osha.gov/dts/osta/otm/otm_ii/ otm_ii_2.html#:~:text=Biological%20 monitoring%20results%20can%20 be,chemical%20of%20concern%20has%20 occurred. Updated February 14, 2007.
Accessed June 12, 2020.
21. Shaw G. Making a plan for surface wipe sampling. Pharmacy Practice News. www.pharmacypracticenews.com/
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Sampling/58126?ses=ogst. May 5, 2020.
Accessed June 12, 2020. 22. Engel J. Implement an HD wipe sampling program. Pharmacy Purchasing &
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23. Peeples L. The hunt for hazardous drug residues: surface wipe sampling a part of USP <800>. Pharmacy Practice News. www.pharmacypracticenews.com/Policy/
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24. Mathias PI, MacKenzie BA, Toennis CA, et al. Survey of guidelines and current practices for safe handling of antineoplastic and other hazardous drugs used in 24 countries. J Oncol Pharm Pract. 2019;25(1):148-162.
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Many U.S. Hospitals Already in the Red—Then COVID-19 Hit
COVID-19 has created a financial crisis for many U.S. hospitals, with no easy way out.
The math is simple: During the pandemic, hospitals lost a huge source of revenue from elective surgeries while experiencing a dramatic uptick in costs, as facilities purchase more gear to cope with the surge of infected patients, some of whom are uninsured.
“They are increasing unanticipated costs and decreasing any revenue you have to offset it,” said Halee Fischer-Wright, MD, the president and CEO of the Medical Group Management Association, one of the marquis health care associations in the United States. “I think this is the definition of the perfect storm.”
Although the federal government has taken some early actions to flood the health care system with financial relief, experts worry about the long term.
“No hospital is going to come through this unscathed,” said Jacqueline Barton True, MSW, MPH, the vice president of rural health programs at the Washington State Hospital Association. “I have a lot of concern about our ability to weather this financial crisis, and what we look like on the other side. I think it is very possible that without significant help from the federal government, there will be closures.”
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Even before COVID-19 hit, many hospitals were struggling, particularly those in rural areas. According to a February 2020 report from the Chartis Center for Rural Health, 19 rural hospitals had to shut their doors in 2019, the largest number of closures in a year since tracking began in 2010. The analysis identified more than 450 additional facilities in rural areas that are at risk for closure.
One of the hardest-hit states is Texas, where 20 rural hospitals have been forced to shut down since 2010, and 50% of the remaining facilities are vulnerable to closure, according to the Chartis report. Thankfully, small and rural facilities in the state haven’t been hit by a surge of COVID-19 patients and some elective surgeries are starting to resume, but they lost a huge source of income from the prolonged pause on those procedures, as well as the usual influx of post-acute care from larger urban facilities, according to Nancy Dickey, MD, the executive director of the Texas A&M Rural and Community Health Institute. “Many rural facilities are, in fact, extraordinarily challenged right now,” she said.
Caring for patients in rural areas is often more challenging because they
see IN THE RED, page 34
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TOC Pharm
continued from page 1
are young and relatively healthy and may not have been to a physician in years.
Some research indicates including pharmacists in care transitions makes a difference. A 2015 study (J Manag Care Spec Pharm 2015;21[3]:256-260) showed that patients discharged from the hospital who had follow-up clinic appointments with a multidisciplinary team coordinated by a clinical pharmacist practitioner were significantly less likely to be readmitted within 30 days than discharged patients whose follow-up team consisted solely of physicians (14.3% vs. 34.3%; P=0.010).
Starting in the ED
Transitions of care at AHN can take on different forms. At the end of March, as the pandemic began to take hold, the network asked ambulatory care pharmacists led by Dr. Korczynski, who is the manager of clinical services, pharmacy–ambulatory care, to join the network’s COVID ED decompression service. As part of the program, nurses and social workers call patients after they’ve left the emergency room or hospital; if patients have questions about their medications, the providers refer them to one of two members of Dr. Korczynski’s team of pharmacists: Gina Lee, PharmD, or Kara Stiely, PharmD, both in the AHN ambulatory pharmacy residency program. Since March 23, he estimated that both pharmacists have reached out to roughly a dozen patients.
A Larger Effort
The COVID-19 TOC program at Dignity Health Northridge Hospital Medical Center in Northridge, Calif., has a much bigger scope. Pharmacists follow COVID-19 patients discharged from the hospital and those diagnosed during drive-thru testing at Northridge’s testing location. Northridge TOC nurse practitioners, physicians and pharmacists have called hundreds of COVID-19 patients since the pandemic began. The pharmacists check in at least once per week for up to 30 days to ensure patients understand their medications, and recommend over-the-counter medications for symptom management. The pharmacists also ensure patients leave with the proper tools to monitor their symptoms, such as a thermometer, pulse oximeter and blood pressure monitor.
What’s more, the transitional care pharmacists help nurse practitioners and medical residents administer COVID-19 tests at the hospital’s drive-thru testing.
Much of what TOC pharmacists provide is education, said Jasmen Esfandi, PharmD, a Northridge team member. Patients have lots of questions about how to successfully quarantine themselves and engage in social distancing, she said, as well as protect their loved ones. Many didn’t even know the safest way to get groceries. This is not something many pharmacists were trained to do, Dr. Esfandi said, but they can do it. “We saw the demand and we saw the need, and we redesigned our [approach] to accommodate our community.”
In the pandemic’s early stages, AHN also saw a need for patient education and met it, said Dr. Korczynski, adding that the team used this outreach to reduce the burden on primary care offices. “Patients in the early stages of the lockdown were captive and willing to engage with the pharmacy team,” he said. “If they’re engaging with us, then they’re not calling the doctor’s office.”
Some COVID-19 patients may receive medications they’ve never heard of, and will have questions on how to get them, take them and integrate them into their existing regimen. Pharmacists can help patients with such questions, Dr. Esfandi noted. They also can help patients manage existing chronic conditions, which “often get overlooked” while they’re battling the coronavirus, she added.
Care transition teams are used to managing complex disease states, but COVID-19 is not like other chronic diseases, noted Casey Barbiera, RN, MSN, the senior director of acute rehabilitation, transitional and palliative care, diabetes and pain management at Dignity Health. So much about the new virus remains elusive. Although COVID-19 initially presented as a respiratory disease, patients are now testing positive with just a rash or intestinal symptoms, she noted. “The biggest challenge is managing the unknown,” she stressed. “We live in a world where we like to be really concrete when we give patients instructions. With COVID-19, there’s somewhat of a gray area and we have to navigate around that.”
Still, some of the TOC struggles that arise with COVID-19 match those of other chronic diseases, such as poor patient compliance with follow-up visits. Up to one-fourth of patients who request an appointment for testing at Northridge’s testing location don’t show up, and a handful who came and tested positive provided incorrect contact information, so pharmacists and other team members struggle to reach them to let them know they are infected, Ms. Barbiera said. (For more challenges with pharmacist-assisted testing and follow-up, see article, page 32.)
Many COVID-19 patients are older and may have problems with using telecommunications or text messaging, which makes access to health information even more difficult, she said.
Like other transitional care patients, people infected with COVID-19 may have issues related to insurance coverage and paying for medications. “With almost every COVID patient, we were addressing access issues,” Dr. Korczynski said. “They are probably our No. 1 gap
Patients given follow-up clinic appointments coordinated by a clinical pharmacist had a 14.3% rate of 30-day hospital readmissions, versus 34.3% in patients without such care.
Source: J Manag Care Spec Pharm 2015;21[3]:256-260.
to close. Because if the patient can’t get their medicine, all bets are off.” Even if patients had adequate access to health care, in the early stages of the pandemic, many primary care offices were closed, leaving follow-up uncertain.
As for young, otherwise healthy patients such as the 22-year-old customer, they may not have felt the need to seek medical care before falling ill with a potentially deadly disease. So, before ending the call with the young patient, the AHN pharmacist connected him with a primary care provider who was part of the AHN network, at a practice with an embedded pharmacy resource to ensure he could continue receiving his medications. “This is always a challenge with transition of care,” Dr. Korczynski said. “Where does this patient go after they leave the hospital?”
Pharmacists are well suited to make sure that the primary care gap is closed and address any other concerns patients may have, said Dr. Fera, who mentors providers at Dignity Health Northridge as part of the A3 collaborative, an initiative that supports implementation of valuebased ambulatory pharmacy programs. “Helping patients with COVID-19 is in the pharmacists’ wheelhouse. We have hugely stepped up to the plate with trying to navigate all the issues in medications related to COVID-19.” —Alison McCook
The sources reported no relevant fi nancial relationships.
HHS rule furthers COVID-19 testing, but roadblocks remain.
See story, page 32
