Handling IV Solutions Presents Challenges

Pharmacy staff is directly involved in the handling, distributing, and disposing of hazardous drugs (HDs), as defined by the National Institute for Occupational Safety and Health (NIOSH).¹ HDs can cause severe effects to the handler, including cancer, congenital disabilities, fertility problems, genetic damage, and organ toxicity._^2-4 HD handling is high risk for employees, as it may expose them during routine handling through compounding aerosolization or surface contamination._⁴ Many of these products are powders or solutions for injection or intravenous (IV) infusion. Adverse effects of delay in presentation and the possibility that employees can be continually exposed to low levels of HDs throughout their careers make this particularly dangerous._^3,5

It is estimated that 8 million health care workers in the United States primarily pharmacy and oncology nursing personnel—have been exposed to HDs.⁶ This number is underestimated, as it has been found that any worker involved with a hospital’s medication circuit, such as drug preparation, transportation, and administration, may be at risk of exposure.^7,8 Nevertheless, the number of those occupationally exposed is increasing, as it has been projected that more than 20 million individuals could be affected by cancer by 2025.^9,10

Several federal and state agencies have intervened to regulate and define the safe use of IV HDs. These agencies have included the Environmental Protection Agency (EPA), NIOSH, and the United States Pharmacopeia (USP). USP Chapter <800> was introduced to describe practice and quality standards for handling HDs, and the chapter took a cradle-to grave approach to safely handling HDs. NIOSH published a list of HDs and promoted a classification system based on the type of hazard presented.⁹ The EPA, under the regulations of the Resource Conservation and Recovery Act, expected health care organizations to enact a pharmaceutical waste management program.¹¹

USP Chapter <800>

USP <800> became official in 2020 and is being enforced during inspections.¹² It was developed to protect the environment, health care workers, and patients from exposure to hazardous agents through engineering controls, personal protective equipment (PPE), and work practices.¹² Many state boards of pharmacy have also incorporated these standards into state regulations, and accrediting agencies and state board inspectors enforce compliance to them. As a result of these regulations, sites have been required to have a staff member oversee HD lists, policy development and implementation, regulatory compliance, and training.

HD Receipt

The receiving process for IV HDs represents an area with several break points that could cause staff members to be exposed.³ Pharmacies should develop internal policies and procedures to address potential exposure. In the health care environment, staff members could encounter a container that has been contaminated or open a carton that contains a broken product.¹⁰ In either case, the container should be opened in a negative pressure area, with the worker using appropriate PPE while handling the container or package.^12,13 Because of this risk, pharmacies must train employees involved in the receiving process in handling, cleaning up, and disposing of an HD spill. Equipment must be readily available for use to complete tasks correctly.¹³

Packaging, Labeling, Storing, and Transporting

It is best to develop policies to ensure safe labeling, manipulation, usage, transportation, and USP <800> compliance. Separate the storage of IV HDs from other areas and clearly label the products for special handling precautions. The storage area should be negative pressure, maintainingthe minimum number of air changes per hour,¹² and products enclosed in the glass should remain on a lower shelf.Storage units should be designed to prevent the product from falling. The storage area must maintain the temperature within the manufacturer’s identified range Maintain appropriate PPE, spill kits, and other items needed for spills within proximity to the storage area. When transporting, reduce the risk of breakage by avoiding pneumatic tubes and by using extra precautions.^12,13

Cleaning, Containing, and Disposing Spills

Training staff members to handle spills safely and correctly is important. During cleanup, staff members must ensure reusable equipment has been deactivated, decontaminated, cleaned, and disinfected.¹² Handling procedures depend on where a spill occurs. If the spill is within the biological safety cabinet, in the pharmacy storage area, or occurred during transportation, staff members should be familiar with the appropriate use of and procedures for PPE. Before cleaning up a spill, staff members must have equipment available to maintain their safety (including spill kits), follow the designated site-specific policy, and dispose of HDs appropriately. As part of the policy, staff members should have appropriate PPE and a fit-tested N95 respirator mask.¹²

Conclusion

Because of the frequency of working with HDs, pharmacy workers can quickly become exposed to IV HDs, making safety a priority for employers and regulators. Therefore, pharmacy managers should ensure appropriate monitoring procedures are in place, site-specific controls are adequate, and employee work practices prevent contamination and exposure. In addition, there have been new compliance regulatory enforcement efforts and education at state levels. Therefore, pharmacy managers must work to ensure compliance with USP <800>, risk reduction, and workplace safety.

References

1. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. US Department of Health and Human Services, CDC, and National Institute for Occupational Safety and Health. September 2016. Accessed November 10, 2022. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161

2. Graeve CU, McGovern PM, Alexander B, Church T, Ryan A, Popovich M. Occupational exposure to antineoplastic agents. Workplace Health Saf. 2017;65(1):9-20. doi:10.1177/2165079916662660

3. Hon CY, Motiwala N. Biological monitoring via urine samples to assess healthcare workers’ exposure to hazardous drugs: a scoping review. Appl Sci. 2022;12(21):11170. doi:10.3390/app122111170

4. Connor TH, Lawson CC, Polovich M, McDiarmid MA. Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings: a review of the evidence. J Occup Environ Med.2014;56(9):901-910. doi:10.1097/JOM.0000000000000249

5. Hon CY, Teschke K, Chua P, Venners S, Nakashima L. Occupational exposure to antineoplastic drugs: identification of job categories potentially exposed throughout the hospital medication system. Saf Health Work. 2011;2(3):273-281. doi:10.5491/SHAW.2011.2.3.273

6. 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 Rev Mutat Res. 2019;781:207-217. doi:10.1016/j.mrrev.2017.08.002

7. Santos AN, Oliveira RJ, Pessatto LR, Gomes RDS, Freitas CAF. Biomonitoring of pharmacists and nurses at occupational risk from handling antineoplastic agents. Int J Pharm Pract. 2020;28(5):506-511. doi:10.1111/ijpp.12590

8. Redic KA, Fang K, Christen C, Chaffee BW. Surface contamination of hazardous drug pharmacy storage bins and pharmacy distributor shipping containers. J Oncol Pharm Pract. 2018;24(2):91-97. doi:10.1177/1078155216679027

9. Domingo-Echaburu S. Lopez de Torre-Querejazu A, Valcárcel Y, Orive G, Lertxundi U. Hazardous drugs (NIOSH’s list-group 1) in healthcare settings: also a hazard for the environment? Sci Total Environ.2022;817:152954. doi:10.1016/j.scitotenv.2022.152954

10. USP Compounding Compendium. The United States Pharmacopeial Conven-tion. Chapter <800> hazardous drugs: handling in healthcaresettings. Compounding compendium current with USP-NF. 2022;(3):80-97.

11. Duty A, Robinson J, Bahmandar D, Hanson N, Lucas AJ. Creation of a regional hazardous drug handling task force. Am J Health Syst Pharm. 2021;78(13):1233-1237. doi:10.1093/ajhp/zxab181

12. Requirements for negative pressure rooms. Occupational Safety and Health Administration. June 25, 1997. Accessed November 30, 2022. https://www.osha.gov/laws-regs/standardinterpretations/1997-06-25

13. Power LA, Coyne JW. ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm. 2018;75(24):1996-2031. doi:10.2146/ajhp180564

About the Authors

Ken Maxik, MBA, BSpharm, is vice president of pharmacy operations at HealthTrustSupply Chain in Largo, Florida.

Craig Kimble, PharmD, MBA, MS, BCACP, is an associate professor of pharmacy practice, administration, and research, director of experiential learning, and manager of clinical support services atMarshall University School of Pharmacy in Huntington,West Virginia.

Umair Shariff, MD, MHA, is a senior integration analyst at DaVita Integrated Kidney Care in Houston, Texas.

Alberto Coustasse, DRPh, MD, MBA, MPh, is a professor of health care management and administrationat Marshall University Lewis Collegeof Businessin Huntington,West Virginia.