Developing HD Contamination Monitoring Guidelines: Global Perspectives Symposium

October 3, 2021

By BD, ISOPP 2021 Virtual Symposium Sponsor

During the ISOPP 2021 Virtual Symposium in April, BD sponsored a program titled Developing HD Contamination Monitoring Guidelines: Global Perspectives. The purpose of this symposium was to explain the importance of surface monitoring to detect hazardous drug (HD) contamination and provide recommendations from recently published U.S. consensus conference proceedings and Spanish guidelines. The speakers were Patricia Kienle, MPA, BCSCP, FASHP, Director of Accreditation and Medication Safety at Cardinal Health in the United States and Silvia Valero-García, a hospital pharmacist at Hospital Universitario y Politécnico La Fe in Spain. 

Ms Kienle spoke on the recommendations of the 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination. She pointed out that limiting HD exposure is a key safety step in facilities handling such drugs. These facilities have many ways of keeping their personnel reasonably safe from exposure, but many don’t take advantage of surface sampling to identify whether such actions are effective. Demonstrating this, less than one-third of the audience reported wipe sampling at their facilities only at least every 6 months.

Ms Kienle described research dating back to the 1980s that demonstrated the effects of HDs on workers at healthcare facilities. Associations were found between antineoplastic exposure and adverse reproductive effects including miscarriage, congenital malformation, low birth weight and infertility. Worker exposure to antineoplastics has also been linked to cancer. A 2017 meta-analysis described chromosomal aberrations as biomarkers of exposure in healthcare workers exposed to antineoplastic drugs.1

HD surface contamination can result from spills, residue on packages and breakage during transport. It can be found on patient chairs, intravenous pumps, toilets, sinks and biohazard hoods. It’s therefore important to test surfaces for HDs in storage, drug compounding and patient care areas. In 2012, the US National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention evaluated a Florida clinic and found chemotherapy drugs in most of the surface wipe samples they analyzed, which highlights the importance of monitoring for HDs.2 Monitoring contamination can help organizations understand their HD manipulation processes so that they can improve HD control. Ms Kienle suggested that, just as radiologists use badges to monitor their exposure to radiation, wipe sampling should be used to monitor HD exposure in oncology healthcare settings. 

In 2017, a survey of all US hospitals by the American Society of Health-System Pharmacists found that only 26% were using wipe analysis to detect HD residue.3 Pharmacy Purchasing & Products magazine, in a parallel analysis, found that 21% of the hospitals they surveyed were using wipe analysis in 2017, but this grew to 34% in 2020, which suggests an increasing trend.4

Several publications have described methods for detecting HDs on surfaces.5,6 Common analytical techniques for detecting HDs on surfaces involve sending wipe samples to an external facility for testing for multiple agents, which typically takes weeks. The standard of reference for analyzing wipe samples is liquid chromatography with tandem mass spectroscopy (LC-MS/MS). This technique is sensitive and accurate and is recommended when establishing a baseline level of HD presence. For routine monitoring protocols, BD provides an onsite reader called the BD® HD Check System, which uses lateral flow immunoassay to detect specific agents. This qualitative method is recommended for routine use because it provides faster results, typically within an hour, which can be especially important when exposure is suspected. Organizations may consider taking advantage of both types of analysis, if possible.
 

The Safe to Touch conference provided several consensus statements on HD monitoring7:    

  • Healthcare organizations should establish administrative control, improve work practices, monitor HDs with qualitative and quantitative tests and encourage reporting of results in a standardized format.
  • Managers should react to the results and implement research to find ways to improve monitoring practices in their organizations.
  • When contamination is detected, it’s important to evaluate its site and potential sources, clean and decontaminate the surface and retest to determine the extent of mitigation success.
  • Any detection barriers (eg, cost, fear of finding contamination, lack of protocol for contamination response) should be overcome with help from organizational risk managers.  Many resources are available to help address such barriers.

Ms Valero-García spoke on the recent HD monitoring guidelines provided by the Spanish Society of Hospital Pharmacy (SEFH).8 This organization published a consensus practice guideline document in 2021 to guide hospital pharmacists in Spain in monitoring HD surface contamination. A wide variety of pharmacy stakeholders were involved in guideline development; the SEFH reviewed more than 500 relevant studies and included the cost considerations of HD monitoring in their recommendations.

According to Ms Valero-García, budgetary considerations are always a factor when determining the level of monitoring an organization can pursue; the more HDs that can be monitored, the better. When a facility is selecting which HDs to monitor, the SEFH guidelines state that the best practice is testing for those that are used most frequently, require the most manipulations, have a known transdermal absorption capacity and are carcinogenic. The choice of HD tested for in each area will, of course, depend on the specific HD used there. For example, personnel in the emergency or obstetrics department might test for methotrexate if it’s used frequently there, whereas they’d be less likely to use and test for cyclophosphamide.

The SEFH practice guideline recommends, at the very least, testing specifically for cyclophosphamide in areas where it’s used. Cyclophosphamide has been tested in most surface contamination studies; it meets best practice criteria because it’s used often in healthcare centers, requires reconstitution and multiple manipulations, has demonstrated transdermal absorption capacity and is known to be carcinogenic.9 In addition, cyclophosphamide surface contamination can be detected with both LC-MS/MS and lateral flow techniques.

The SEFH guidelines emphasize the importance of determining locations for surface contamination monitoring. The exact location plan depends on where HDs are handled, as well as the organizational budget. Ideally, a pharmacy department’s drug intake/receiving and storage areas should be among the locations tested. At a minimum, testing should be done in the central working area of the biologic safety cabinet (BSC), the floor in front of the BSC, the work surface used for staging and preparing starting materials, the final product verification work surface and the door handles of the compounding area. The SEFH guidelines recommend routine testing at the end of each working day, before the usual cleaning and decontamination protocols.

SEFH guides healthcare organizations to analyze their risk level when deciding the frequency of monitoring they’ll require. The deciding personnel should consider the types of locations being tested and the frequency of HD manipulation there. Testing should be conducted monthly in the areas of highest risk, such as in and around a BSC in which HD manipulation is frequent, although this frequency might change depending on the test results.

Organizations must also choose their own acceptable exposure threshold, as there’s no official maximum in the United States or Europe. Some researchers have suggested using cyclophosphamide as a surrogate for all HD exposure. However, on the basis of the findings of their extensive literature analysis, the SEFH recommends an exposure limit that's based on the 90th percentile of historical controls when possible. When that isn’t possible, the SEFH guideline recommends a cyclophosphamide threshold of 1 ng/cm².8

On the basis of their surface wipe analysis findings, organizations should establish an action plan, sharing results so that workers know which drugs they’ve been exposed to. It’s been demonstrated that if workers are conscious of this problem, their practice improves, which leads to reduced HD exposure. 

Cleaning and decontamination should also be part of the action plan. The choice of appropriate cleaning solution should be based on its physicochemical properties, the frequency of use, the characteristics of the surface to be cleaned, the contact time and the decontaminating volume. Some solutions are as toxic as the HDs themselves, and it’s important to avoid introducing new hazards while addressing existing ones. Manipulation of cleaning solutions should be easy and safe.

When surveyed, 89% of the audience agreed with the new SEFH recommendations described by Ms Valero-García. The speakers encouraged the creation of similar guidelines in other regions, by using the Safe to Touch conference recommendations and SEFH guidelines as a roadmap. An archived video of the hour-long symposium can be accessed here: {https://www.bd.com/en-us/clinical-excellence/bd-vascular-access-and-medi...}. If you’re interested in the availability of the BD® HD Check System in your region, please speak with a BD representative.

References

  1. Roussel C, Witt KL, Shaw PB, Connor TH. Meta-analysis of chromosomal aberrations as a biomarker of exposure in healthcare workers occupationally exposed to antineoplastic drugs. Mutat Res. 2019;781:207-217.
  2. Couch J, West C. Chemotherapy drug exposures at an oncology clinic—Florida. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2012.
  3. Schneider PJ, Pedersen CA, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2017. Am J Health Syst Pharm. 2018;75(16):1203-1226.
  4. Halvorsen D. Strong commitment to staff safety. Pharmacy Purchasing & Products. 2020;17(7 suppl):S1-8.
  5. Turci R, Sottani C, Spagnoli G, Minoia C. Biological and Environmental Monitoring of Hospital Personnel Exposed to Antineoplastic Agents: A Review of Analytical Methods. J Chromatog B. 2003 Jun 15; 789(2):169-209
  6. Connor T, Smith J. New Approaches to Wipe Sampling Methods for Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Pharm Technol Hosp Pharm. 2016 Sep; 1(3):107-114.
  7. Gabay M, Johnson P, Fanikos J, et al. Report on 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination. Am J Health Syst Pharm. 2021;zxab134.
  8. Valero-García S, González-Haba E, Gorgas-Torner MQ, et al. Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH). Farm Hosp. 2021;45(2):96-107.
  9. International Agency for Research on Cancer. Monographs on the Evaluation of Carcinogenic Risks to Humans, 100A: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. International Agency for Research on Cancer; 2012.

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