Pharmacy OneSource Blog

Upcoming Webinar with Eric Kastango -  USP Chapter <800> and Assessment of Risk

Posted on 03/21/17

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Join Eric S. Kastango, RPh, MBA, FASHP and Joe Coyne, RPh to review the requirements of USP <800> as it relates to handling and storage of hazardous drugs listed in Tables 1-3 within the 2016 NIOSH List of Hazardous Drugs. 

Learn how to systematically conduct an assessment of your facility’s risk as it relates to the handling and storage of hazardous drugs. The webinar will be conducted on:

April 12, 2017
12 pm EST
Click Here to register now

USP <800> Hazardous Drugs – Handling in Healthcare Settings sets the standard for protecting patients, health care personnel, and the environment. It is designed to minimize the risk of exposure to HDs for healthcare personnel (…a different issue than the EPA requirements for hazardous materials – some of which are drugs – that are harmful to the environment).The National Institute for Occupational Health and Safety (NIOSH) maintains a list of hazardous drugs (HDs, which include those drugs that have any of the following characteristics:

  • Carcinogenicity
  • Teratogenicity or other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • New drugs that mimic existing HDs in structure or toxicity

Drugs are listed in one of three tables:

Table 1 - includes antineoplastics

Table 2 - includes non-antineoplastics

Table 3 - includes HDs that are on the list only because of reproductive toxicity

Chapter <800> defines the safe strategies for receiving, transporting, storing, compounding, administering, and disposing of hazardous drugs in healthcare settings.  Entities can either implement all of the containment strategies or work practices for all of the drugs on the NIOSH list OR for those agents that are not antineoplastic, the entity may establish alternative containment strategies and/or work practices to protect employees.

Deciding on an Approach

If you choose not to do an Assessment of Risk, then you must handle all dosage forms of all the HDs using all the containment strategies and work practices listed in Chapter <800>.  Every pharmacy and healthcare setting needs to evaluate the list of HDs, even if only those drugs on tables 2 and 3 are handled, and even if only oral forms are handled.

If you choose to do an Assessment of Risk, there are some limitations:

  • All drugs listed on the NIOSH list must be evaluated at your site.
  • Antineoplastics that you manipulate (compound, mix, split, crush, etc.) cannot be included in the Assessment of Risk.

The drugs on the list that can be considered for an Assessment of Risk are

  • Drugs on Table 1 (antineoplastics) that only need to be counted or packaged
  • Drugs on Table 2 (non-antineoplastics) and Table 3 (reproductive only hazardous)

Your list must be specific to the drugs and dosage forms that you handle.

Performing an Assessment of Risk

  • Obtain a copy of <Chapter <800> which is available from USP in the USP Compounding Compendium at usp.org.
  • Download a copy of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016.
  • Determine every drug you handle (even if you purchase only unit-dose or unit-of-use items) and the dosage form of each of the drugs you handle.
  • Identify if you will follow all the requirements in <800> or if you will establish alternative practices (which must protect personnel). Chapter <800> requirements include the following (refer to <800> for details):
  • Receiving
  • Storing
  • Compounding
  • Transporting
  • Administering
  • Disposal

Register today for a free webinar with Eric S. Kastango, RPh, MBA, FASHP  on March 29, 2017 to learn about the requirements of USP <800> as it relates to handling and storage of hazardous drugs listed in Tables 1-3 within the 2016 NIOSH List of Hazardous Drug.  After participating in this webinar attendees will understand how to systematically evaluate how to conduct an Assessment of Risk. 

(Please note: Pharmacy OneSource is not an accredited organization so we cannot provide CE credit for the webinar at this time.)

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About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.