Getting Started – People and Processes
“USP <800> requires a ‘designated person’ to take a leadership role and responsibility for adhering to the standard, including implementing procedures, monitoring and maintaining reports of testing and sampling, and a list of Hazardous Drugs used.”
USP <800> contains 18 sections and bridges multiple departments and cost centers. But where, when, and how to start? Establishing a cross-functional hazardous drug working group brings the right stakeholders to the table. The chapter becomes federally enforceable in 2018, but there’s every good reason to start now. Planning and implementation take time. Use the Ready for <800>SM Checklist to understand where you stand today.
Getting Started. People and Processes.
Establish an interdisciplinary HD working group
Establishing an interdisciplinary hazardous drug working group is essential to successfully implementing USP <800>. At a minimum, this team should include Pharmacy, Nursing and Administration, and Risk or Quality Management based upon your organizational structure. USP <800> requires a “designated person” to take a leadership role and responsibility for adhering to the standard including implementing procedures, monitoring and maintaining reports of testing and sampling, and a list of Hazardous Drugs used.
Assess the NIOSH list of hazardous drugs:
Your organization must create and maintain a list of drugs handled at your facility that appear on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. This list must be reviewed at least every 12 months and whenever you add a new drug that appears on the NIOSH list. Drugs on the NIOSH list that must follow the requirements include: antineoplastics, active pharmaceutical ingredients (APIs), and any HDs requiring manipulation.
Drugs on the NIOSH list that do not have to follow all the containment requirements if an assessment of risk is performed and implemented, include final dosage forms of compounded HD preparations, conventionally manufactured HD products, including antineoplastic dosage forms that don’t require further manipulation other than counting or repacking.
Finally, for dosage forms of other HDs on the NIOSH list, an assessment of risk may be performed to determine alternative containment strategies. It is also important to note that if your facility handles a new drug that entered the market place after publication of the most recent NIOSH list, you must evaluate the hazards of that drug, using the same risk criteria as NIOSH. In cases where there is insufficient information to make a risk determination, such as investigational drugs, the drug must be considered hazardous until more information becomes available.
Determine costs and resources
Changes require resources, which include people, time, and financial investment. USP <800> is no different. Costs can be addressed and anticipated in different ways. Capital expenses, such as the need to vent primary engineering controls to the rooftop, will likely require planning and future budgeting. Variable expenses, like closed system transfer devices (CSTDs) and personal protective equipment (PPE) will also require budgeting and may change based upon your HD assessment.
Regardless, it’s important to develop a budget based upon a sound knowledge of your risk and your required adherence to USP <800>. Work with your HD workgroup when you present a plan to senior leadership.
Think about all the interaction points of a HD throughout your organization
Processes and standard work procedures need to be developed to meet USP <800>. They must be reviewed and documented every 12 months. A useful approach to help conceptualize USP <800> is to think about the journey of a HD through your organization and the HD interaction points. The standard contains handling requirements from receipt through disposal, so communicating these requirements within your organization is critical.
People make the changes happen
Effective people and personnel management may be the most important determinants of compliance with the standard. Standard work procedures are useless unless the organization supports these activities by training staff meaningfully and measuring compliance. All staff who handle HDs are responsible for understanding fundamental practices and precautions, as well as taking part in continual evaluation of quality. To facilitate compliance and build support, consider the following four activities:
- Educate early and often while empowering health care professionals to understand “the why” in addition to “the how”.
- Make the necessary investment to protect staff – nothing says an organization cares about its employees more than providing PPE, CSTDs, and appropriate primary engineering controls.
- Develop an HD environmental sampling program and conduct wipe tests before and after changes in work practices or physical plant revisions. The sampling program may provide valuable feedback about the effectiveness of these changes.
- Consider the development of a medical surveillance program in concert with employee health officers. The development of a surveillance program demonstrates caring and compassion and may help to contribute to our understanding of the nature of risk.