What’s New in Handling Hazardous Meds?

Full update September 2019

USP provides guidance on safely handling hazardous meds (as defined by NIOSH) in all settings including inpatient and outpatient (e.g., pharmacies, physician offices) sites. USP <800> addresses ALL aspects of handling hazardous meds such as receiving, storing, compounding, transporting, administration, and disposal. The goal is to minimize the risk of contamination to the patient, the healthcare worker, and the environment.1 The chart below reviews pertinent updates for the handling of hazardous meds including conducting an assessment of risk and use of proper personal protective equipment. The list of hazardous meds identified by NIOSH is available at https://www.cdc.gov/niosh/topics/hazdrug/default.html. Share our technician tutorials, Hazardous Drugs 101 and Medication Disposal in the Hospital, with your techs to keep them up to speed on the latest in handling and disposing of hazardous meds.

Abbreviations: NIOSH = National Institute for Occupational Safety and Health; PPE = personal protective equipment; USP = United States Pharmacopeia.

 

Question

Pertinent Information

What are the differences between USP <795>, <797>, and <800>?

 

  • USP <795>: pharmaceutical compounding of NON-sterile preparations
  • USP <797>: pharmaceutical compounding of sterile preparations
  • USP <800>: handling of hazardous drugs in the healthcare setting
  • If compounding a product that includes a hazardous drug, both applicable chapters should be followed. For example:
    • Follow USP <795> and <800> when compounding a NON-sterile product containing a hazardous drug.
    • Follow USP <797> and <800> when compounding a sterile product containing a hazardous drug.
  • See our CEs, USP Chapter <800> - Handling Hazardous Meds in the Healthcare Setting, and Compounding: Sterile Compounding and USP Chapter <797>, and Compounding: A Summary of Complex Non-Sterile Compounding, for more on hazardous meds and compounding.

 

How are hazardous meds defined?

 

 

  • Use NIOSH as a tool or aid when creating your facility-specific hazardous med list, as the NIOSH list is not comprehensive.
  • The NIOSH list of hazardous meds includes drugs approved for use through the FDA Center for Drug Evaluation and Research (CDER). Drugs evaluated through the FDA Center for Biologic Evaluation and Research (CBER) are NOT included in the hazardous med list. These include vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins (e.g., Bacillus Calmette Guerin [BCG]).22
  • NIOSH defines a med as hazardous if it has one or more of the following characteristics in humans or animals:2,20
    • carcinogenicity (cancer causing).
    • teratogenicity or other developmental toxicity (causing harm to an unborn baby).
    • reproductive toxicity (interference with normal reproduction such as effects on fertility in either sex).
    • organ toxicity at low doses (harming organs, such as heart, liver, lungs, etc).
    • genotoxicity (damaging the genetic information in a cell, which could lead to cancer).
  • The NIOSH list of hazardous meds is periodically updated, therefore newer meds may not be included on the current list. The proposed 2020 update only includes meds approved through December 2015. For newer drugs or drugs approved through CBER, consider the following as an indicator of their risk: structure and toxicity profiles that are the same as existing hazardous drugs, information in product labeling, peer-reviewed literature about the hazard potential, or safety data sheets, until further guidance is available.2,20,22 For investigational drugs, if the mechanism of action suggests there may be concern, treat these as hazardous drugs until data are available to exclude them.22

 

How are hazardous meds classified?

 

  • Previously, hazardous meds were divided into THREE groups:2
    • group one: antineoplastic drugs (per the American Hospital Formulary Service [AHFS] classification)
    • group two: NON-antineoplastic drugs
    • group three: meds with primarily reproductive risk (i.e., to men and women who are trying to conceive and women who are either pregnant or breastfeeding).
  • These three groups of hazardous meds may have led to some confusion because categorizing a med as “antineoplastic” doesn’t tell the whole story. For example, meds used to treat cancer aren’t all cytotoxic. Plus, some antineoplastics have non-cancer indications.
  • There are likely to be TWO groups or tables in the 2020 NIOSH update, based on the draft guidance:20,22
    • table one: known or probable carcinogens according to the National Toxicity Program (NTP) or International Agency for Research on Cancer (IARC) or hazardous meds with special handling instructions in their product labeling.
    • table two: meds not thought to be carcinogens according to NTP or IARC, but are defined as hazardous by NIOSH due to other adverse effects (e.g., developmental toxicity, organ toxicity, reproductive effects).
    • Antineoplastics can be included in table one or table two, but only those in table one are known or probable carcinogens.
  • You can access the full NIOSH list of hazardous meds at https://www.cdc.gov/niosh/topics/hazdrug/default.html.

 

What training is required for staff who work with hazardous meds?

 

  • Designate one person to oversee compliance with hazardous meds.1
  • Tailor training to the applicable job functions of personnel (receiving, compounding, dispensing, administering).1
  • All staff involved with hazardous meds must be fully trained prior to working with hazardous meds independently.1
  • Training and demonstration of competency are required ANNUALLY and must include:1
    • review of facility designated list of hazardous drugs and any policies and procedures related to hazardous drugs.
    • proper use of equipment and PPE.
    • what to do in case of exposure or a spill.
    • proper disposal of hazardous meds and contaminated materials.

What containment strategies and/or work practices should be followed when handling hazardous meds?

 

USP <800> containment strategies and work practices to limit exposure to hazardous meds must ALWAYS be adhered to for:1

  • hazardous med active pharmaceutical ingredients (APIs)
  • antineoplastics (per 2016 NIOSH) or table one antineoplastics (per 2020 NIOSH) requiring manipulation.

 

For certain types of hazardous meds (see below), facilities will be allowed to customize their containment strategies/work practices based on an “assessment of risk” for individual meds to determine how best to protect their employees (see the requirements for assessment of risk in the next section).1 These risk assessments can be done for the following types of NIOSH hazardous med classifications:1

    • antineoplastics (NIOSH 2016) or table one antineoplastics (NIOSH 2020) that DO NOT require manipulation (e.g., only packaging, counting)
    • NON-antineoplastic (NIOSH 2016 and 2020)
    • table two antineoplastics (NIOSH 2020)
    • meds with reproductive risk (will be identified in blue in table two in NIOSH 2020)
    • final dosage forms of compounded hazardous meds

 

Some example containment/work practice strategies to limit exposure to hazardous meds include:

  • Use disposable or dedicated equipment (e.g., counting trays, spatulas) for counting hazardous meds that only require counting or repackaging of final dosage forms.1 Use wipes (wetted with an appropriate solution), instead of spray bottles to decontaminate reusable spatulas and counting trays after EACH use. Spray bottles could spread hazardous residue.1
  • Regardless of risk assessments, DO NOT USE automatic counting or packaging machines for any antineoplastic (NIOSH 2016) or table one antineoplastics (NIOSH 2020) tablets or capsules.1 Use of these machines can create residue that could contaminate both the machine and potentially other medications used in these devices.1
  • If your facility compounds sterile and non-sterile hazardous meds, it may be easier to maintain the sterile environment if these compounding areas are separated. Sterile and non-sterile primary engineering controls can be located in the same room AS LONG AS sterile requirements are maintained. However, this is not recommended.1
  • Crushing or splitting hazardous meds is considered compounding. Where and how this is done may depend on the assessment of risk. For example, table one antineoplastics (NIOSH 2020) must be crushed in a chemo hood. However, based on the assessment of risk, crushing of some non-antineoplastics or table two antineoplastics (NIOSH 2020) may be allowed on the floor in a containment device (e.g., RxCrush).1 See our CE, USP Chapter <800> = Handling Hazardous Meds in the Healthcare Setting, for details on these engineering controls and containment strategies during compounding.

 

What are the assessment of risk requirements?

 

For hazardous meds that meet the appropriate criteria (see above), an assessment of risk can be performed to determine the containment strategies/work practices needed to protect employees. This assessment will be based on the medication’s risk and how it will be used in the facility.

  • The following must be included in the assessment of risk:1,18
    • hazardous med classification (e.g., NIOSH 2016: antineoplastic, NON-antineoplastic, reproductive risk; NIOSH 2020: table one or two antineoplastic, table one or two NON-antineoplastic)
    • dosage form (How can the hazardous med potentially enter the body: skin, inhalation, ingestion, etc?)
    • risk of exposure (What PPE is available? What engineering controls are available?)
    • manipulation (How is med handled? How often is med handled?)
    • packaging (description of packaging in which hazardous med is received)
  • Documentation must include the alternate containment strategy/work practice that will be used to minimize exposure.1
    • For example, alternate containment strategies/work practices could include:19
      • purchasing unit-dose or unit-of-use product to eliminate need for manipulation or compounding.
      • use of a dedicated plastic tote (decontaminated after each use) to transport hazardous meds from the pharmacy to other areas of the facility.
      • labeling lidded automated dispensing cabinet bins so anyone who accesses or administers these meds is reminded of necessary PPE to use when administering or handling.
  • Assessments of risk for hazardous meds must be reviewed (and documented) at least once yearly.1 An example hazardous drug assessment of risk template can be found at https://www.pppmag.com/documents/V14N3/pdfs/ppp_1703_Assessment_of%20Risk_Template.pdf.4

 

What are the cleaning requirements with hazardous meds?

 

 

 

  • All areas and equipment where hazardous meds are handled need to be deactivated, decontaminated, and cleaned. In addition, areas where hazardous drugs are involved in sterile compounding must be disinfected.
  • Follow policies and procedures for deactivation, decontamination, cleaning, and disinfecting. The requirements will vary based on the situation.
    • Two pairs of chemotherapy gloves and disposable impermeable gowns are required for these activities.1
    • Eye protection may be needed if splashing is expected.1
    • Respiratory protection may be needed if dust particles are expected.1
    • Use wipes (wetted with an appropriate solution), instead of spray bottles. Spray bottles could spread hazardous residue.1
  • See our CE, USP Chapter <800> = Handling Hazardous Meds in the Healthcare Setting, for information on surface sampling.

 

 

What personal protective equipment (PPE) should be used?

 

  • USP <800> and NIOSH both provide detailed information on the use of PPE (e.g., gloves, gowns, head, hair, shoe, and sleeve covers; eye and face protection; respiratory protection).1,2 USP plans to clarify guidance to note that the requirements for antineoplastic hazardous meds will only refer to antineoplastics in table one (known/probable carcinogens) of the updated 2020 NIOSH list.21 The antineoplastic handing requirements in USP <800> will not apply to non-antineoplastics in table one or medications in table two of the updated 2020 NIOSH list. For example:1,2
    • Single gloves are appropriate for unpacking or receiving orders of hazardous meds, unless a spill occurs (then double gloves are needed).
    • Double gloves and two pairs of shoe covers are appropriate for sterile and non-sterile compounding.
      • The outer pair of gloves must be sterile for sterile compounding.
    • Eye /face protection is appropriate when using liquids that can splash.
    • Gowns are appropriate for sterile and non-sterile compounding. Gowns must be impermeable and disposable.
    • For more details and additional practical examples concerning PPE use, refer to table 5 in the 2016 NIOSH list of antineoplastic and other hazardous drugs in healthcare settings (https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf) or chapter 8 of the 2020 NIOSH managing hazardous drug exposures: information for healthcare settings draft guidance (https://www.cdc.gov/niosh/docket/review/docket233c/pdfs/DRAFT-Managing-Hazardous-Drug-Exposures_Information-for-Healthcare-Settings.pdf).
  • For medications that undergo an assessment of risk, follow your facilities policies and procedures for PPE requirements.
    • Single gloves may be deemed appropriate for counting some hazardous meds in capsule form, but double gloves may be required for prepping an intravenous dose of the same med.
  • See our CE, USP Chapter <800> = Handling Hazardous Meds in the Healthcare Setting, for specific requirements on spill kits and use of PPE during spills.

 

What are specific pregnancy- and conception-related considerations?

 

 

 

 

  • Always follow policies and procedures when handling hazardous meds. However, consider additional precautions during pregnancy, while breastfeeding, or if trying to conceive. Note that it is appropriate for women who are pregnant or breastfeeding, or women or men who are trying to conceive, to work with their supervisor on possible alternative work assignments (i.e., involving no or less handling of hazardous meds).3
  • Refer to product labeling to see if there are specific recommendations for pregnant or breastfeeding women, or for men or women trying to conceive. For example (note this list is NOT inclusive), product labeling states pregnant women:
    • (or women who may become pregnant) should not handle dutasteride capsules (Avodart, Jalyn). If contact is made with leaking capsules, wash the area immediately with soap and water.13-16
    • (or women who may become pregnant) should not handle crushed or broken finasteride tablets (Propecia, Proscar). Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling provided that the tablets have not been broken or crushed.9-12
    • should generally avoid direct care of patients who are receiving aerosolized ribavirin (Virazole). Refer to U.S. product labeling for specific recommendations.7,8
    • should avoid exposure to testosterone gel application sites in men, as well as used testosterone packets, patches, or pumps (Androderm, AndroGel, Testim, etc).5,6 If unwashed or unclothed skin to which gel has been applied (or unwashed clothing exposed to testosterone gel) comes in direct contact with the skin of a pregnant woman, wash the general area of contact on the woman with soap and water as soon as possible.5,6

 

What medical surveillance is recommended for healthcare workers who handle hazards drugs?

 

  • Medical surveillance is used in conjunction with exposure control programs, engineering controls, safe work practices, and PPE to minimize adverse effects to staff who could be exposed to hazardous drugs.1 Expect to be involved in a medical surveillance program if you handle hazardous drugs.1
  • See our CE, USP Chapter <800> = Handling Hazardous Meds in the Healthcare Setting, for facility and employee involvement and responsibilities in medical surveillance programs.

When and how will USP <800> be enforced?

  • USP <800> will go into effect December 1, 2019.17
  • See our CE, USP Chapter <800> - Handling Hazardous Meds in the Healthcare Setting, for what USP <800> recommends to be included in policies and procedures related to hazardous meds.
  • Enforcement of compliance with USP <800> is the responsibility of regulators (e.g., FDA, state board of pharmacy). Regulatory bodies may have a different official date for enforcement. USP has no role in enforcing USP <800>.17

 

Project Leader in preparation of this clinical resource (350905): Beth Bryant, Pharm.D., BCPS, Assistant Editor, last modified May 2020

References

  1. United States Pharmacopeia. USP general chapter <800> hazardous drugs – handling in healthcare settings. February 1, 2016. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. (Accessed August 2, 2019).
  2. National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. https://www.cdc.gov/niosh/docs/2016-161/. (Accessed August 2, 2019).
  3. Power LA, Coyne JW. ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm 2018;75:1996-2031.
  4. Pharmacy Purchasing & Products. Sample pharmacy hazardous drug assessment of risk (AoR) template. January 2017. https://www.pppmag.com/documents/V14N3/pdfs/ppp_1703_Assessment_of%20Risk_Template.pdf. (Accessed August 2, 2019).
  5. Product information for AndroGel. AbbVie. North Chicago, IL 60064. May 2019.
  6. Product monograph for AndroGel. BGP Pharma ULC. Etobicoke, ON M8Z 2S6. February 2019.
  7. Product information for Virazole. Valeant. Bridgewater, NJ 08807. August 2016.
  8. Product monograph for Virazole. Valeant Canada. Laval, QC H7L 4A8. July 2014.
  9. Product information for Propecia. Merck. Whitehouse Station, NJ 08889. September 2013.
  10. Product information for Proscar. Merck. Whitehouse Station, NJ 08889. September 2013.
  11. Product monograph for Propecia. Merck Canada. Kirkland, QC H9H 4M7. October 2018.
  12. Product monograph for Proscar. Merck Canada. Kirkland, QC H9H 4M7. October 2018.
  13. Product information for Avodart. GlaxoSmithKline Research Triangle Park, NC 27709. September 2014.
  14. Product information for Jalyn. GlaxoSmithKline. Research Triangle Park, NC 27709. November 2017.
  15. Product monograph for Avodart. GlaxoSmithKline. Mississauga, ON L5N 6L4. September 2013.
  16. Product monograph for Jalyn. GlaxoSmithKline. Mississauga, ON L5N 6L4. May 2016.
  17. United States Pharmacopeia. FAQs: <800> hazardous drugs-handling in healthcare settings. Updated May 31, 2019. https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. (Accessed August 2, 2019).
  18. National Community Pharmacists Association. ASCP webinar. USP general chapter <800> and EPA: implications for long-term care and community pharmacies. https://www.youtube.com/watch?v=yVKyVwlHBbE. (Accessed August 2, 2019).
  19. Kienle P, Douglass K. Perform an assessment of risk to comply with USP <800>. March 2017. https://www.calhospital.org/sites/main/files/file-attachments/ppp_1703_usp800_risk.pdf. (Accessed August 8, 2019).
  20. CDC. NIOSH list of hazardous drugs in healthcare settings, 2020 (Draft). https://www.cdc.gov/niosh/docket/review/docket233c/pdfs/DRAFT-NIOSH-Hazardous-Drugs-List-2020.pdf. (Accessed May 20, 2020).
  21. The United States Pharmacopeial Convention. <800> hazardous drugs – handling in healthcare settings. https://www.uspnf.com/notices/800-nitr-20200501. (Accessed May 20, 2020).
  22. Regulations.gov. Draft – NIOSH procedures for developing the NIOSH list of hazardous drugs in healthcare settings. February 24, 2020/. https://www.regulations.gov/document?D=CDC-2020-0046-0002. (Accessed May 26, 2020).

Cite this document as follows: Clinical Resource, What’s New in Handling Hazardous Meds? Pharmacist’s Letter/Prescriber’s Letter. September 2019.

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