New Product Intended to Help Prepare for USP 800

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Ann Richards, PharmD, BCPP
USP 800 Task Force Chair

When reading the title of this USP chapter (Hazardous Drugs – Handling in Health Care Settings) one immediately thinks of antineoplastic medications as we all know those are hazardous drugs. One rarely thinks of drugs used in psychiatry. However, the NIOSH (National Institute for Occupational Safety and Health) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (2016 edition) which is used to identify drugs that are considered hazardous, includes many drugs that are used in psychiatry. The list includes clonazepam, divalproex, paliperidone, paroxetine, risperidone, temazepam, and valproic acid to name a few. Currently being considered for inclusion into the 2018 NIOSH list are: clobazam and triazolam. The NIOSH list also includes drugs that are not specific to psychiatry but are being used in psychiatric facilities. All of this of course makes the USP 800 Chapter important to us as psychiatric and neurologic pharmacists.

USP 800 and the NIOSH List

USP 800 was developed to promote patient safety, worker safety and environmental protection. It applies to entities that store, prepare, transport, or administer hazardous drugs as identified on the NIOSH list (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians' practice facilities, or veterinarians' offices). The USP 800 chapter was originally scheduled to go into effect July 1, 2018. However, it has been delayed to December 1, 2019. State boards of pharmacy will be implementing these regulations as well.

The NIOSH list, which is updated every 2 years with next publication in September, determines drugs to be hazardous if the drug exhibits one or more of the following characteristics in humans or animals:

  • Carcinogenicity
  • Teratogenicity of other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.

The NIOSH list divides the hazardous drugs into three categories:

  • Group (Table) 1: Antineoplastic drugs (AHFS Classification 10:00)
  • Group (Table) 2: Non-antineoplastic drugs that meet one or more of NIOSH’s criteria for hazardous drug
  • Group (Table) 3: Drugs that are primarily a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding

Not only does the NIOSH identify hazardous drugs, it also identifies personal protective equipment (PPE) and engineering controls for working with hazardous drugs in the healthcare setting. For example, if your facility receives, dispenses and administers paliperidone palmitate, then the following PPE would be needed:

Activity

PPE

Receiving, unpacking, and placing in storage
  • Single chemotherapy glove, unless spills can occur
  • Gown – when spills and leaks occur
  • Respiratory protection – when spills and leaks occur

Administration
  • Double chemotherapy gloves
  • Gown
  • Eye/face protection – if liquid could splash

 

CPNP USP 800 Assessments of Risk Product

The USP 800 states that any antineoplastic (Group 1) requiring manipulation and any hazardous drug active pharmaceutical ingredient must follow the requirements as established in this chapter (which references the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings).  

Drugs on the NIOSH list that do not have to follow all the containment requirements of USP 800 if an Assessment of Risk is performed and implemented include:

  • Final dosage forms of compounded hazardous drug preparations and conventionally manufactured hazardous drugs products, including antineoplastic dosage forms that do not require any further manipulation other than counting or repackaging (unless required by the manufacturer)
  • For dosage forms of other hazardous drugs on the NIOSH list, the entity may perform an Assessment of Risk to determine alternative containment strategies and/work practices

The Assessment of Risk must, at a minimum consider the following:

  • Type of hazardous drug (Group 1, 2 or 3)
  • Dosage form
  • Risk of exposure
  • Packaging
  • Manipulation

If an Assessment of Risk approach is used, the entity must document the alternative containment strategies and/or work practices being used for specific dosage forms to minimize exposure. These Assessments of Risk must be reviewed at least every 12 months and the review has to be documented.

Approximately, two years ago, CPNP anticipated the needs of their members and formed the USP 800 Task Force consisting of:

  • Antonia Alafris
  • Shellie Cassel
  • Adam Decatur
  • Tammie Lee Demler
  • Ann Richards
  • Michele Thomas

This group has been working diligently to create an Assessment of Risk database for hazardous drugs commonly used in psychiatric facilities. A product consisting of this database and an Assessment of Risk tool for these hazardous drugs (all peer reviewed) is expected to launch this summer. The product will consist of:

  • A database of hazardous drugs commonly used in psychiatric facilities.
  • A template assessment of risk tool.
  • A completed assessment for each drug including the appropriate references to support the level of risk that was determined and the PPE needed to address the identified risk.
  • An annual update and new assessments as needed. 

Learn More About this Topic

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