Healthcare workers are incredible. They show up to work every day and expose themselves to sick patients, all to help them get better. But it’s not just sick patients they’re exposed to. Many come in contact with hazardous drugs (HDs), such as those used in chemotherapy, and protecting clinicians (or healthcare workers) from these has been a topic of concern for decades. There is growing evidence that occupational exposure to over 200 drugs commonly used in healthcare settings can lead to acute and chronic health effects.3 In an effort to address this, the United States Pharmacopeia (USP) published chapter USP <800> of the USP Compounding Compendium in December of 2019, to help increase awareness, provide uniform guidance to reduce the risk of managing HDs and help reduce the risk posed to patients and healthcare workers.6
USP <800> is much broader than previous standards. It covers handling of HDs from the loading dock all the way through to patient administration and disposal.1 The guidance includes environmental and engineering controls and drug handling guidelines, as well as guidelines for personal protective equipment (PPE).
To help protect yourself and your team and ensure compliance with these latest guidelines, here are the five things you need to know:
1) There is no safe level of exposure to cytotoxic chemotherapy drugs for healthcare workers
Exposure to chemotherapy drugs increases your risk of chromosomal damage, cancers and adverse reproductive outcomes.3 That’s why regulations issued by OSHA and USP on handling hazardous chemotherapy drugs are enforceable and apply to all healthcare workers.6 Additionally, any drug used in cancer treatment listed in National Institute for Occupational Safety and Health’s (NIOSH) group 1 requires full compliance with the USP standards.2
2) Tight control of each step in the HD life cycle, and educating all staff members, is necessary
USP <800> delineates requirements that cover the responsibilities of personnel handling HDs.6 These include facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation. Properly educating pharmacy workers and healthcare providers—as well as risk management, legal, and drug delivery personnel—is crucial to protecting patients and their healthcare team.1
3) USP <800> provides guidelines for the use of PPE6
To protect yourself and your team, it’s important to follow the latest guidelines for PPE to reduce your risk of exposure. PPE for use in administering chemotherapy includes:
- Gloves – Regulations require two pairs of chemotherapy gloves for compounding sterile and nonsterile HDs, and for administering antineoplastic HDs.
- Gowns – Regulations require gowns shown to resist permeability by HDs
- Eye protection
- Respiratory protection
- Shoe covers
4) Each type of PPE has specific requirements to ensure safe handling6
USP <800> doesn’t prescribe a one-size-fits-all approach to PPE. The standards specify the type of PPE required, and also how that PPE needs to be prepared.
Gloves must be appropriately tested for use with chemotherapy drugs. The American Society for Testing and Materials has established ASTM D6978, which is the Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The USP requirement for double gloving is meant to reduce cross-contamination rather than increasing permeation time. When double gloving, the outer gloves must extend over the cuff of the gown to ensure full protection from hazardous substances. In addition, gloves should be replaced every 30 minutes and discarded immediately in a chemotherapy waste container.
The comparable test for isolation gowns is ASTM F739. Gowns for chemotherapy use must also be poly-coated, disposable, and must not have seams or closures that could allow HDs to pass through. Therefore, they must have long sleeves with knitted or elastic cuffs. They also must close in the back, and should be replaced every two to three hours, or immediately after a spill or splash.
Additionally, healthcare personnel should also wear a full-face shield to protect their eyes from splashes and goggles should be added to protect the eyes if there is a potential for splash exposure. A fit-tested NIOSH-certified N95 respirator should also be worn to protect against airborne particles and provide a barrier to splashes, droplets, and sprays around the nose and mouth. Facilities must follow OSHA regulations for training and fit-testing respiratory protection (OSHA standard 29 CFR 1910.134).
Wearing full-coverage head and hair covers (and beard and mustache covers if applicable) is recommended. Donning a second pair of shoe-covers before entering a spill area and removing the outer pair on leaving, is also recommended. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spreading HD contamination and exposing other healthcare workers.
5) You need to put on, take off and dispose of PPE appropriately2 p.41-42
There are specific directions for donning, doffing and disposing of PPE used in the administration of chemotherapy. Before entering the treatment area and putting on PPE, inspect all PPE for defects or tears. Hair covers, shoe covers, an N95 respirator mask, goggles and a face shield should be put on before entering patient treatment areas. Wash hands and then don a chemo-rated procedure gown, followed by two pairs of gloves, placing the inner glove underneath the cuff of the chemo gown, and the outer glove over and completely covering the cuff of the chemo gown.
When taking off your PPE, remove outer gloves first, followed by the gown and other PPE before removing the inner pair of gloves. A best practice is to consider all PPE worn when handling hazardous drugs to be contaminated and disposing of it immediately in an appropriate, designated waste container. Upon removing the second pair of gloves, wash hands with soap immediately.
To ensure the utmost safety, the competency of all personnel who handle HDs must be reassessed at least every 12 months. There should also be training prior to the introduction of a new HD, or new equipment and before a new or significant change in process or standard operating procedure.6
Safety First Means People First
According to a recent study conducted by NIOSH, many female nurses acknowledged not wearing PPE when administering chemotherapy. The study, one of the first to delve into the use of PPE by pregnant and non-pregnant female nurses, gathered the results of nearly 40,000 respondents over an eight-year period. Surprisingly, many respondents reported not even wearing gloves and gowns – the minimum PPE requirements.3
Earlier studies have revealed a few reasons why healthcare personnel may not take the recommended safety precautions when it comes to PPE.4 These reasons include:
- Prioritizing care for patients over their own personal health
- A lack of concern about or awareness of the toxicity of these drugs
- Protective gloves and gowns were not available
- Nurses were not given the opportunity to put on PPE
The results of these studies clearly indicate the need for more education for both healthcare personnel and employers about the hazards of exposure to chemotherapy drugs. Proper training on the use of PPE when administering chemotherapy helps to ensure appropriate use. It’s important that everyone on the clinical team knows:5
- When it is necessary
- What kind is necessary
- How to properly put it on, adjust, wear and take it off
- The limitations of the equipment
- The proper care, maintenance, useful life, and disposal of the equipment.5
Empowering healthcare personnel and others to advocate for their own safety requires up-to-date information and easily enacted protocol reforms. After all, the best way to serve patients is to protect healthcare professionals from unnecessary hazards.
- The Chapter <800> Answer Book, ASHP Publications, Kienle, Patricia C, , 2017, p vii.
- USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, (p. 6-8). United States Pharmacoepial Convention, USP 40 -NF 35, Second Supplement (2019). www.usp.org