USP <800>: Strategies for Implementing a Successful Assessment of Risk

Sarah Newman, PharmD BCPS
Pediatric Clinical Hospital Pharmacist
Holtz Children’s Hospital—Jackson Health System
Miami, FL

The United States Pharmacopeia (USP) issued General Chapter <800> in February 2016, and institutions that prepare and administer hazardous drugs are expected to be compliant with the guidelines by July 2018.¹ As this issue of HOPA News was being prepared, USP released a notice of intent to change the official date of USP <800> to December 1, 2019.² This date will align with the next revision of USP <797>. However, USP is still encouraging “early adoption and implementation of Chapter <800> to help ensure a safe environment and protection of healthcare practitioners.”² Although each state board of pharmacy may require slight variations on USP <800>, the general requirements of the chapter will remain the same, with regard to safe handling of hazardous medications, for all institutions.

USP <800> provides specific guidance for those medications categorized as hazardous by the National Institute for Occupational Safety and Health (NIOSH). NIOSH defines a hazardous drug as a medication that has one of these six characteristics:³
carcinogenicity
teratogenicity
reproductive toxicity in humans
organ toxicity in low levels in animals or humans
genotoxicity
mimicking of a hazardous drug in structure or toxicity.

NIOSH further categorizes hazardous medications (see Tables 1, 2, and 3 in NIOSH’s 2016 publication).³ Table 1 includes those antineoplastic agents that pharmacists have traditionally viewed as hazardous, with long-standing handling precautions already in place. Agents listed in Tables 2 and 3, on the other hand, may include many drugs for which pharmacists have not implemented strict handling requirements, but all of which now require documented containment strategies under USP <800>.

Under the new USP <800>, many institutions are being challenged to rethink the safety of drugs and dispensing procedures that historically have not required the same stringent containment strategies as the antineoplastic drugs in Table 1. Institutions have two options. The first is to handle each NIOSH drug using all the containment and risk practices listed in USP <800>, a proposition that is likely to affect pharmacy workflow too adversely to be a practical or feasible solution. The second is to perform an assessment of risk to determine alternative containment strategies and work practices. This allows some dosage forms of hazardous drugs to be handled without all of the containment precautions outlined in USP <800>.¹ Most institutions are electing to follow this second option.

When the assessment of risk is completed for all hazardous drugs on an institution’s formulary, engineering controls, personal protective equipment, and workplace practices must be reviewed to ensure appropriate hazardous drug control per USP <800>.¹ Such a succinct summary may make the process sound easy, but depending on the number of hazardous NIOSH medications on an institution’s formulary, the reality is that the assessment of risk is a large undertaking, leaving staff at some institutions wondering where to start. 

Faced with this conundrum, the Department of Pharmacy at Cincinnati Children’s Hospital Medical Center recently spearheaded a Children’s Hospital Association collaborative effort between member institutions to complete an assessment of risk for each of the hazardous drugs listed in NIOSH Tables 2 and 3. When asked for some general tips on completing the assessment of risk, Chad Watkins, PharmD, director of pharmacy for Cincinnati Children’s Hospital Medical Center–Liberty Campus, recommended first prioritizing those medications that pose the highest risk to healthcare workers and work down the list toward medications that pose minimal risk.⁴ 

Watkins further advocates “establishing several levels of risk to group NIOSH Table 2 and 3 medications [into], such as: Low Risk, Moderate Risk, and High Risk.”⁴ In deciding what constitutes low, moderate, or high risk, Watkins recommends establishing criteria that would necessitate an increase in risk category, such as manufacturer’s safe handling guidelines, carcinogenicity as defined by the International Agency for Research on Cancer, American Hospital Formulary Service classification, pregnancy category, and chemical characteristics.³

Risk factors for exposure to certain hazardous drugs may vary between institutions and will affect whether a drug is categorized as low, medium, or high risk. For example, opening a unit-dose package of a hazardous drug prior to administration poses a lower risk of exposure than crushing a tablet to create a suspension.⁵ An institution that purchases and dispenses tacrolimus only in unit-dose capsules may categorize risk exposure for tacrolimus as lower risk than a facility that purchases tacrolimus capsules in bulk bottles, which necessitates repackaging prior to dispensing. The risk category for tacrolimus would be even higher in a facility where staff members open those capsules to make an oral suspension. Consider the dosage forms and the life cycle of a drug in your institution when completing the assessment of risk.⁵ These assigned risk levels will help determine the management of handling and containment precautions under USP <800>.

When the drugs and risk levels have been determined, a standardized worksheet can be used to document the assessment of risk. This worksheet should include, at a minimum, the drug name, the hazardous-drug category, dosage forms, the risk of exposure, packaging, any required manipulation, and documentation of any alternative containment strategies or work practices. Review of this assessment of risk must be documented annually.¹ A worksheet that can be tailored to meet your institution’s needs is available in a hazardous drug toolkit published by Joint Commission Resources.⁵

Following completion of the assessment of risk, institutions will need to review their personal protective equipment  (PPE) to ensure that it meets the minimum standards outlined in the assessment of risk. NIOSH Table 5 and Section 7 of the USP <800> outline recommend PPE for healthcare workers.^1,2 NIOSH has also published a detailed paper regarding appropriate PPE for the handling of hazardous drugs.⁶ Additionally, institutional policies will likely need to be reviewed, a process that Watkins says “poses a huge challenge in maintaining consistency between all hospital services.”⁴ Finally, all frontline staff must be educated on USP <800> process changes. According to Watkins, this is likely to be the biggest challenge in implementing USP <800>: “Developing a hazardous communication program that effectively reflects the process is essential in achieving compliance. The program must have the capability to direct handling precautions to all staff.”⁴ Because staff in several service areas will need to comply with USP <800>, training must be specific to each role and completed before staff members handle any hazardous drugs.¹ Some strategies that may be implemented include required orientation on USP <800> practices for new hires, completion of annual competencies by frontline staff, and department-specific training courses. Per USP <800>, reassessment must be completed and documented at least once per year.²

Given that implementation of USP <800> will affect several institutional service lines, multidisciplinary involvement in completing the assessment of risk is essential. Watkins recommends that, at a minimum, the task force should include a compounding pharmacist, pharmacy manager/director, nursing manager/director, and staff from pharmacy education, nursing education, occupational safety, and employee health.⁴ This multidisciplinary approach to the assessment of risk allows each discipline to provide input based on where in the medication administration process their handling of hazardous drugs occurs. Gathering this information early in the assessment of risk process will allow for identification of potential issues in hazardous-drug handling prior to the transition to implementing USP <800> practices. 

Implementing USP <800> will be a work in progress. As institutions complete this massive undertaking, lessons learned will likely necessitate reassessment and changes. Beginning with a focused plan for the assessment of risk, building strong training programs, and including key stakeholders early in the process will help to ensure a smooth rollout.  

References

1. United States Pharmacopeial Convention. General chapter <800> Hazardous drugs—handling in healthcare settings. USP 40−NF 35; 2017.
2. Notice of intent to revise: General chapter <800> Hazardous drugs—handling in healthcare settings. www.uspnf.com/notices/gc-800-hazardous-drugs-handling-in-healthcare-settings. Updated September 29, 2017. Accessed October 3, 2017.
3. Connor TH, MacKenzie BA, DeBord DG, et al. NIOSH list of antineoplastic and other hazardous drugs in health care settings, 2016. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2016.
4. Chad Watkins, PharmD, e-mail communication, September 19, 2017.
5. Connor TH, Douglass K, Eisenberg S, et al. Improving safe handling practices for hazardous drugs: toolkit. Oakbrook Terrace, IL: Joint Commission Resources; 2016.
6. Centers for Disease Control and Prevention. Personal protective equipment for health care workers who work with hazardous drugs. NIOSH workplace solutions. Publication no. 2009-106; 2008.