Although US Pharmacopeial (USP) Convention’s General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings is not expected to officially go into effect until December of 2019, it is important to take steps now to start to understand and comply with this new revised standard.[i] Most notably, USP <800> describes practice and quality standards for handling hazardous drugs to promote patient safety, healthcare worker safety and environmental protection.
This new revision to the USP <800> standard was originally intended to go into effect and be enforceable starting on July 1, 2018. However, to better coordinate with the scheduled December 1, 2019 publication of the General Chapter <797> Pharmaceutical Compounding – Sterile Preparations revision, the publication and enforcement of USP <800> has been delayed to this same December 2019 date. The reasoning is to provide a unified approach to compounding practices that promotes safety for both patients and employees. That being said, “sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard…USP strongly encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings.”[ii]
The guidance within USP <800> addresses many topics, ranging from personnel requirements, policies, facility and engineering controls to safe work practices and proper use of appropriate personal protective equipment (PPE). If you need help with selecting the appropriate respiratory PPE download Respiratory Protection Guidance for Hazardous Drug Handling in Healthcare technical bulletin for informative guidance.
Prior to USP 800
Currently, many clinicians use PPE for handling hazardous drugs (HDs). While these options do offer certain levels of protection, formal training about HD management has been hard to find. The implementation of USP <800> may help change that.
Moreover, the lack of detailed policy and procedures made enforcement and optimal use of HD equipment a significant challenge. USP <800> brings this issue into focus by providing a clear explanation of the spectrum of safeguards available to help protect employees who handle HDs.
USP <795> (nonsterile) and USP <797> (sterile) describe the responsibilities of drug compounding personnel, training, facilities, environmental monitoring as well as storage and testing of finished preparations, both sterile and nonsterile. USP <800> speaks to the requirements for HDs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation. These three standards together can help personnel create a program for handling HDs in a more safe and secure fashion.
Don’t Miss this PPE Component – Respiratory Protection
Respiratory protection is an often-overlooked component of the PPE requirements for USP <800> compliance. Some may also be surprised to learn that surgical masks do not provide sufficient respiratory protection from the complexities of certain hazardous drug exposure.
The primary airborne exposure concerns are particulates and aerosols, for which NIOSH approved particulate respirators can help reduce exposure to the HDs. The exposure concerns are potentially present when:
- Unpacking, inspecting, and initially handling HDs from suppliers
- Compounding HD formulations
- Cutting, crushing or manipulating tablets or capsules
- Administering HDs to patients
- Addressing spills or leaks
- Handling patient bodily fluids with HDs or metabolites
- Cleaning patient rooms, bathrooms and handling contaminated laundry
- Handling drug contaminated wastes
- Deactivating, decontaminating and cleaning inside and underneath the work surface of engineering controls and cabinets
Specific respiratory protection equipment recommendations are outlined in detail in our technical bulletin, entitled “Respiratory Protection Guidance for Hazardous Drug Handling in Healthcare.”
The use of neutralization chemicals, such as bleach (sodium hypochlorite) and peroxide-based (peracetic acid) cleaners, should also be assessed to determine if respiratory protection is needed to help protect against unsafe exposure levels. The nuisance odor of these chemicals might still come through when using respiratory protection. A way to try and overcome these odors is by using a combination particulate cartridge with an acid gas absorbing carbon.
What you choose for your respiratory protection should be determined based on your exposure level assessment as well as what other engineering and administrative controls you have in place. Consider comparing features and regulatory requirements of powered air purifying respirators (PAPRs), disposable respirators and reusable respirators. And, keep in mind the importance and impact of fit testing.
According to the National Center for Biotechnology Information, the use of PAPRs in healthcare settings is increasing.[iii] One reason for this increase may be due to the fit test requirement if using a disposable or reusable respirator. According to US OSHA, “A fit test tests the seal between the respirator’s facepiece and the employees face. It takes about fifteen to twenty minutes to complete and is performed at least annually. After passing a fit test with a respirator, you must use the exact same make, model, style, and size respirator on the .”[iv] This is at least an annual exercise and is the duty of the employer to complete. PAPRs use hoods and head tops, with some loose-fitting options that can accommodate many full beards and does not require a fit test.
USP <800> requires that for each part of the standard, you must designate someone to help oversee implementation of USP <800> procedures and compliance. This includes evaluating the processes for personal protective equipment (PPE) and determining the protection level needed for compliance.
The effective date of USP <800> is December 1, 2019 and is the date by which affected users need to meet the requirements. Compliance enforcement for USP <800> is the responsibility of regulators including the FDA and various state regulators, such as State Boards of Pharmacy; OSHA (federal or state); hospital/healthcare accreditation agencies (Joint Commission, DNV); or Centers for Medicare and Medicaid Services (CMS).
USP is a not-for-profit organization that has an established science-driven process for assembling panels of independent experts who oversee the development and maintenance of healthcare quality standards. This process is public health-focused. USP leverages current science and technology and draws on the expertise of scientists as well as healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress. It is the USP Compounding Expert Committee that is responsible for the development of General Chapter <800>.[v]
[i] US Pharmacopeial Convention. USP general chapter <800>: hazardous drugs–handling in healthcare settings. USP website. usp.org/sites/default/ files/usp/ document/our-work/healthcare-quality-safety/general-chapter-800.pdf