Protocol Support Committee Column: Safe Handling of Hazardous Drugs

January 22 2020

Safe Handling of Hazardous Drugs
by Joan Cahill BNS, RN, OCN

In January 2019, Lawson et al published the findings of their study “Antineoplastic Drug Administration by Pregnant and Nonpregnant Nurses: An Exploration of the Use of Protective Gloves and Gowns.” The study team enrolled participants from the Nurses’ Health Study; a data base of over 40,000 nurses. The study findings were concerning; there are well established recommendations for handling antineoplastic drugs and hazardous drugs (HDs), however, many nurses reported not wearing the minimum protective equipment (gloves and gowns) when administering antineoplastic drugs.

  • 42% of nonpregnant nurses and 38% of pregnant nurses reported never using a gown
  • 14% of pregnant nurses did not always wear gloves and 48% did not wear a gown when administering antineoplastic drugs during the first 20 weeks of pregnancy
  • 12% nonpregnant nurses and 9% of pregnant nurses indicated that they never wore gloves when administering antineoplastic drugs
  • 32% of those who administered antineoplastic drugs only as crushed pills never wore gloves

The Lawson study highlights the need for continuous education and competency assessment for nurses so that safe practice requirements and guidelines are followed.

The US Pharmacopeial Convention (USP) website states that more than 8 million US healthcare workers are exposed to Hazardous drugs every year. Studies have shown contamination on work surfaces, trace amounts in the air of work areas, and in the urine of healthcare workers (Conner TH 2006).

Personal safety is as important as patient safety when handing antineoplastic drugs.

The Oncology Nursing Society (ONS) Toolkit for Safe Handing of Hazardous Drugs recommends that nurses who work in areas where Hazardous Drugs (HDs) are used need to have initial training and competency assessments before working with HDs. Furthermore, ONS emphasizes the need for annual competency reassessment programs to include, “content regarding principles of safe preparation, storage, labeling, transportation, and disposal of HD agents and appropriate use and disposal of PPE.”
ONS strongly encourages nurses to integrate safety practices with Personal Protective Equipment (PPE) recommending:
  • Do not wear contaminated gloves to use the phone, type on a computer keyboard, program IV pumps, open doors and cabinets, or touch body parts (e.g., face, adjusting a mask) 
  • Inspect PPE for defects or tears before use 
  • Do not reuse gloves, gowns, shoe covers, or any other disposable PPE 
  • Change gloves after 30 minutes of wear, if damaged, or contaminated 
  • Change gowns when leaving the handling area, after a spill or splash, or after two to three hours of continuous use 
  • Remove shoe covers when leaving compounding area or after cleaning a spill 
  • Do not use eyeglasses as your sole means of eye protection; use goggles with side shields or a face shield when splashing is a possibility 
  • Dispose of all disposable PPE in a hazardous waste container after use For non-disposable PPE (i.e., respirators, eye, and face protection), decontaminate and clean after use and take care to properly dispose of the materials used to decontaminate this equipment

Nurses who are pregnant, planning to become pregnant or breastfeeding have an increased susceptibility to harm from exposure. To reduce exposure during these specific times the ONS toolkit recommends:

  1. Employers have a responsibility to ensure workers understand the risks of exposure to HDs. 
  2. All staff involved in the handling and administration of HDs should be familiar with and adhere to local and national policies and follow safe practice with HDs using standard operating procedures. 
  3. Each healthcare setting should identify available options for alternative duty and educate staff of these options. 
  4. It is the responsibility of employees, male and female, to inform the employer if they have medical reasons to avoid exposure, such as trying to conceive, when they become pregnant, or when lactating. 
  5. Upon notification that a staff member has a medical reason to avoid exposure to HDs, employers should give those staff the option of alternative duties, if available. 
  6. For employees trying to conceive or who are pregnant, collaboration with the employee’s primary care physician and obstetrician/gynecologist should be part of the decision-making process. 
  7. Though the risk of exposure may be lower for non-nursing personnel such as ancillary staff, risk still exists. All staff involved in handling and administering chemotherapy must undergo appropriate training and education for safe handling of HD

The Safe Handling of Hazardous Drugs guidance is based on the recommendations of The National Institute for Occupational Safety and Health (NIOSH), OSHA, ONS, the American Society of Health System Pharmacists (ASHP), and USP.

NIOSH defines a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs (biosimilar).

USP General Chapter 800, published in February 2016 with an implementation date of December 1 2019 provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment.USP 800 details the requirements including responsibilities of personnel handling hazardous drugs; decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.

With implementation of USP 800, using Closed System Transfer Devices (CSTDs) is required when administering IV antineoplastic drugs. A CSTD is a device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Research has shown that CSTDs can reduce exposure to hazardous drug administration but CTSDs are just one step in protection; nurses must develop 100% vigilance using PPE. Additionally work places must employ engineering controls, medical and environmental monitoring, and hazard identification which are critical in contributing to a safer work environment.

What can you do to ensure you are practicing safely?

Become educated on your institution or workplace policies and SOPs that address the required standards of USP 800. 
Make use of the following tools about USP800 so you can be safe in your practice.
  1. Meet the experts for a 60 minute FAQ at Ready for 800 https://www.readyfor800.com/what-is-usp-800/
  2. Download and follow the Oncology Nursing Society (ONS) Toolkit for Safe Handling of Hazardous Drugs for Nurses in Oncology https://www.ons.org/sites/default/files/2018-06/ONS_Safe_Handling_Toolkit_0.pdf
  3. Download the USP HazRx free app to identify if the drug you are handling is hazardous, how to safely handle HDs and stay up to date with the list of hazardous drugs. https://www.usp.org/hazrx-app
  4. Download the USP 800 “Know your Exposure to Hazardous Drugs” infographic and post it in your workplace https://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/800-know-your-exposure-to-hazardous-drugs.pdf
  5. Use the USP Safety Data Sheets available online
  6. Join the USP Chapter to stay informed and ensure your personal safety through daily implementation of evidence based practice. It is free!
  7. Always use safety equipment in your workplace. Mentor and educate your nursing colleagues about evidence based practice in PPE and CSTDs.

Lawson C. et al 2019 Antineoplastic Drug Administration by Pregnant and Nonpregnant Nurses An Exploration of the Use of Protective Gloves and Gowns AJN, American Journal of Nursing. 119(1):28–35, JANUARY 2019

DOI: 10.1097/01.NAJ.0000552583.69729.51

Connor T.H., (2006) Hazardous Anticancer Drugs in Health Care

Environmental Exposure Assessment

https://doi.org/10.1196/annals.1371.021

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