The United States Pharmacopeia (USP) General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings1 describes standards for the safe handling of hazardous drugs (HDs), including the use of engineering controls, personal protective equipment (PPE), and safe work practices. HDs are defined as those on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.
USP <800> requires all personnel who handle HDs be trained based upon job function before independently handling HDs and that employees demonstrate the effectiveness of their training.
- Employee competency must be re-assessed every 12 months.
- Employee completion of training before the introduction of new equipment, or new HDs, and before the implementation of new or significant changes to a process, or standard operating procedure (SOP).
All training and competency assessments must be documented.
In addition, USP <800> mandates that training include the following areas:
- Overview of entity's list of HDs and their risks
- Proper disposal of HDs and trace-contaminated materials
- Proper use of equipment and devices (e.g., engineering controls)
- Proper use of PPE
- Response to known or suspected HD exposure
- Review of the entity's SOPs regarding the handling of HDs
- Spill management
Also, USP <800> requires policies and procedures that ensure worker safety during all aspects of HD handling.
SOPs for handling HDs should include, as applicable:
- Deactivation, decontamination, cleaning, and disinfection
- Designation of HD areas
- Environmental monitoring (e.g., wipe sampling)
- Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
- Hazard communication program
- Medical surveillance
- Occupational safety program
- Spill control
- Use and maintenance of proper engineering controls
Training and Development Standard Operating Procedures
When developing personnel training and competency programs and SOPs, begin by identifying each HD handling activity performed within a facility.
HD handling activities may include:
- Disposal of HD waste
Consider environmental protection, the safety of personnel and patient safety.
For each HD handling activity, define the activity, the location where the activity will be performed, and any requirements for environmental monitoring (e.g., humidity and temperature). Include who is permitted to perform the activity, what training is needed, and how competency will be assessed. Also, include PPE and Hand Hygiene requirements and cleaning procedures for each HD handling activity and location.
USP <800> does not explicitly state all PPE requirements. Refer to Table 52 on the NIOSH list for PPE recommendations by activity.
For cleaning procedures, include deactivation, decontamination, cleaning, disinfection, frequency of activities, what agents to use, any dilution required, contact or dwell time, and documentation requirements.
SOPs and personnel training and competency programs must include how HDs will be received and unpacked. Describe the process, including the use of a tiered approach, starting with a visual examination of the shipping container. And do not forget to detail how damaged packages will be handled as well as where the spill kit will be located.
USP <800> indicates that PPE, including chemotherapy gloves, must be worn. Be sure to train personnel on precisely what to wear.
Describe the process for moving HDs from the receiving area to the storage area. It is required to store HDs in a manner that prevents spillage or breakage if the container falls.
Training and competency assessments specific to compounding must follow not only the requirements in USP <800> but also other appropriate USP standards for compounding, including those in chapter <795> for nonsterile compounding and chapter <797> for sterile compounding. Personnel must also be trained and pass competency assessments on the use, maintenance, and cleaning of each piece of equipment, as well as receive training regarding proper labeling, transport, storage, and disposal of HDs and use of safety data sheets based on the Globally Harmonized System of Classification and Labelling of Chemicals.
All personnel who may be required to clean HD spills must receive proper training in spill management and the use of PPE and NIOSH-approved respirators. Personnel who transport, compound, or administer HDs must also document their training according to Occupational Safety and Health Administration standards and other applicable laws and regulations.
Information for this blog was adapted from Jensen, Brenda. How Does a Pharmacy Train Staff to Handle HDs?, Pharmacy Times®, 6 June 2019, www.pharmacytimes.com/publications/health-system-edition/2019/may2019/how-does-a-pharmacy-train-staff-to-handle-hds.
Brenda Jensen, CPhT, CNMT, MBA, is a consultant to sterile and nonsterile compounding pharmacies and an owner of Compounding Consultants, LLC, in Sioux Falls, South Dakota.
1. USP general chapter <800> hazardous drugs—handling in healthcare settings. US Pharmacopeial Convention website. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare (accessed 2019 April 9).
2. NIOSH Safety and Health Topics: Occupational exposure to antineoplastic agents and other hazardous drugs: Effects of occupational exposure. https://www.cdc.gov/niosh/topics/hazdrug/effects.html (accessed 2018 February 28).
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