Get Ready for USP 800
on 1/19/2021 10:00:00 AM
The implementation of USP 800 is just around the corner…will you be ready? Will it apply to your organization? The answer is yes, almost all healthcare organizations will be affected to one degree or another. Hazardous drugs include some non-antineoplastics and reproductive risk medications, therefore almost all organizations will need to evaluate their practices. This blog will give you the basic requirements that will need to be considered when the revisions to Chapter 800 are implemented.
Chapter 800 revisions actually took effect on December 1, 2019, however challenges to revisions of Chapter 795 and 797 have ensued, both of which refer to 800. During the resolution of the appeals, Chapter 800 is informational only and is not enforceable. However, upon resolution of the challenges, 800 will become enforceable and accrediting organizations will begin to survey for compliance. The United States Pharmacopeia (USP) encourages organizations to proactively adopt and implement the changes in 800 to ensure a safe environment which protects healthcare practitioners when handling hazardous drugs.
Chapter 800 deals with the handling of hazardous drugs (HDs). It applies to all entities that handle any kind of hazardous drugs; including offices, clinics, hospitals, and pharmacies. The scope is broad – all personnel who may come into contact with HDs (including receiving personnel, transporters, pharmacists, technicians, nurses, and providers) are required to be included in training. Remember that hazardous drugs are not solely antineoplastics, they include a number of other commonly used medications.
First…a few abbreviations that will be used:
- HD – Hazardous drug as listed by the NIOSH
- NIOSH – National Institute for Occupational Safety and Health
- C-PEC – a type of ventilated containment primary engineering control (“hood”, “glovebox”) to promote worker safety
- C-SEC – a room where the C-PEC is placed where airflow and air exchanges are controlled
- PPE – Personal protective equipment
WHERE DO WE START?
- Identify a person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and applicable laws, regulations, and standards, ensuring competency of personnel, and ensuring environmental control of the storage and compounding areas.
- Identify a list of all areas and personnel that could be impacted and include them in an occupational safety plan. Your occupational safety plan should include information on each of the following items:
- A list of all hazardous drugs used by your organization and the locations where they are received, unpacked, stored, and administered. This should include any items on the current NIOSH list. Review the list at least every 12 months.
- Facility and engineering controls in all areas where HDs are received, stored, and compounded
- Which employees will required training in safe work practices and PPE
- Types of and proper use of PPE, including PAPR when required
- Policies for HD waste segregation and disposal
- Medical surveillance of healthcare personnel
We will discuss each of these in more detail.
Review the NIOSH list and determine what hazardous medications are on your formulary. Note that medications available in their final dosage forms that only require counting or repackaging or are only reproductive risk are not required to be on the list if the organization does a risk assessment that includes the risk of exposure and alternate containment practices. Remember though, that any antineoplastic that requires splitting, crushing, or opening for administration cannot be managed by a risk assessment – all USP 800 risk strategies must be implemented for any manipulation. Your list of NIOSH drugs must be reviewed and updated every 12 months. In addition, if you performed a risk assessment for alternate containment strategies as described above, this must also be reviewed every 12 months.
Identify types of potential exposure. Clinical and nonclinical personnel may be affected. Those who handle any type of hazardous drugs would be at risk, including staff who receive, unpack, count, compound, transport, administer, or who handle body fluids after administration. Include each type of staff member in the occupational safety plan and develop safety practices for each phase. Make certain you document the training of all staff for safety practices and PPE use.
Physical & Environmental Quality and Control
All hazardous drugs must be unpacked (e.g. removed from external shipping containers), stored, and manipulated in environmentally controlled environments that are not close to staff breakrooms or visitor waiting areas. These rooms must have restricted entry and be clearly labeled as a hazardous area at the entrance. Rooms for unpacking require negative/neutral airflow. Antineoplastic storage (including refrigerated storage) must be in a negative pressure area meeting air exchange requirements, be ventilated outside, and be stored separately from non-HD medications. Additionally, safe storage requirements include shelving that restricts breakage/falling in cases of natural disasters. Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.
USP 800 has very specific requirements for HD non-sterile and sterile compounding, types of allowable C-PECs, and engineering controls. Organizations should review the requirements carefully to assure compliance. Here are a few highlights:
- A C-PEC is not required for handling final dosage forms (counting/repackaging)
- A C-PEC is required for non-sterile and sterile compounding or manipulating non-sterile components, including crushing, splitting, or pouring antineoplastic medications.
- The C-PEC must be placed in a C-SEC with at least 12 air changes/hour and be externally vented. Redundant HEPA filtration may be used if ONLY doing non-sterile compounding
- Separate C-PECs should be used for non-sterile and sterile compounding. There is an allowance made for “occasional” non-sterile compounding to be performed in a sterile compounding C-PEC, but only if it is decontaminated, cleaned, disinfected prior to resuming sterile compounding. “Occasional” is not defined.
- Laminar airflow workbenches may NOT be used for anti-neoplastic compounding.
- Non-hazardous and hazardous drug compounding may not be done in the same C-PEC unless the non-HD is placed into a protective outer wrapper and labeled to require PPE handling precautions.
Environmental wipe sampling for HD surface residue should be performed routinely (i.e. initially as a benchmark and at least every 6 months, or more often). Surface wipe sampling locations should include the following locations:
- Interior of the C-PEC and equipment contained in it
- Pass-through chambers
- Surfaces in staging or work areas near the C-PEC
- Areas adjacent to C-PECs (e.g. floors directly under C-PEC, staging, and dispensing area)
- Areas immediately outside the HD buffer room or the C-SCA
- Patient administration areas
If measurable contamination is found, the organization’s HD safety person must identify, document, and contain potential sources of contamination through evaluation of personnel practices, performing deactivation and cleaning, and evaluating engineering controls. All actions should be documented.
Hazard Communication Strategies (policies!)
Establish standard operating procedures to ensure staff safety. The policies, at a minimum must include:
- A written plan that describes how the standard will be implemented
- How HD packages are visually inspected prior to opening
- That all containers of hazardous chemicals will be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings
- That an SDS is readily available and accessible to staff for each hazardous chemical they use
- How information and training for competency is provided to personnel who may be exposed to hazardous chemicals prior to their initial assignment to work with a hazardous chemical, and whenever the hazard changes. Include all personnel who may handle the HD at any level.
- Personnel of reproductive capability must confirm in writing that they understand the risks handling HDs
- Safe handling at each stage of HD travel within your organization (receipt, unpacking, storage, compounding (sterile and non-sterile), re-packaging, transport, administration, deactivation, decontamination, and disinfection, and spill cleanup).
Policies must be reviewed at least every 12 months. Note that the regulation states every 12 months rather than annually!
Deactivating, Decontaminating, Cleaning and Disinfecting
Products that have known deactivation agents according to the SDS should be used when possible. Areas where HD compounding is performed must be decontaminated at least daily, between compounding different HDs, when interruption occurs, and anytime a spill occurs. The area under the work tray must be decontaminated at least monthly using respiratory protection. Decontamination is followed by cleaning to remove any additional contaminants, and finally, disinfection with an appropriate agent such as 70% isopropyl alcohol. The types of agents used for each step should be appropriate to the HD and type of C-PEC used. Sprays must not be used in HD environments to avoid splashing – use wipes! Cleaning must be documented.
Medical Surveillance of Healthcare Personnel
A big change will be the addition of a requirement for personnel who handle HDs as a part of their job to be enrolled in a medical surveillance program. Medical surveillance programs involve assessment and documentation of symptom complaints, physical findings, and laboratory values (such as a blood count) to determine whether there is a deviation from the expected norms. The organization must gather data about the staff member’s baseline health, and then monitor the health for identification of early changes that could signify deviation from the norm. The program should include (but is not limited to) a medical history (including reproductive history), laboratory studies, evaluation of types of HDs handled (number and types), hours per week handled, development of a plan for any staff with health changes, and an exit exam for separated staff. Records should be maintained according to OSHA guidelines. The regulations include specific requirements if any staff have evidence of health changes potentially related to exposure or toxicity.
While USP 800 is not currently surveyable, organizations should be proactive and begin preparations. A good starting point would be to assess what formulary medications you have that are included in the NIOSH list, form a pharmacy workgroup to review standards, and perform a gap analysis. CIHQ has provided a tracer tool available on the website to assist organizations.
United States Pharmacopeia. (2019). USP General Chapter . Hazardous Drugs – Handling in Healthcare Facilities. Available from www.usp.gov.
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