what is an Assessment of risk?

Every facility/pharmacy is required to have a list of all hazardous drugs (HDs) they handle. Some HDs are required to be handled in containment strategies defined in the chapter. Other HDs are allowed to be handled outside the chapter guidelines if an Assessment of Risk (AoR) is performed. This process can take days to weeks depending on your formulary and stock.

How do you know what needs to be on the list?

USP 800, Section 2, states:

The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. An entity must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles. The entity's list must be reviewed at least every 12 months. Whenever a new agent or dosage form is used, it should be reviewed against the entity's list.

Can a Facility/Pharmacy just print the niosh list as use it as their template?

Short answer: No.

Each drug can have multiple dosage forms with different levels of risk of exposure. The exposure risk determines how that drug will be handled throughout each step in the pharmacy. Some will require full containment, others can be handled with gloves alone. Per USP 800, the Assessment of Risk (AoR) allows for a pharmacy to provide alternative containment strategies.

WHat must follow usp 800 containment requirements?

  • Any Hazardous Drug Active Pharmaceutical Ingredient (HD API) on the NIOSH list

  • Any Anti-neoplastic requiring further manipulations

  • Any HD that the facility has not performed an AoR for but is handled by that facility

What drugs can have an assessment of risk?

  • Final dosage forms of HD compounded medications

  • Conventionally manufactured HD products that require no further manipulation (besides counting and repackaging)

  • Non- antineoplastic HD dosage forms on the NIOSH list

What should be included in my Assessment of risk?

  • List each individual drug from the above categories

    • This has to be broken down further to dosage forms

  • The minimum requirements by USP for an AoR are the following:

    • Type of HD (e.g., antineoplastic, non-antineoplastic, reproductive risk only)

    • Dosage form

    • Risk of exposure

    • Packaging

    • Manipulation

  • Keep in mind, the information gathered is the justification for removing the HD out of a negative pressure containment.

Where do I gather my information and references?

  • SDS sheets

  • Package Inserts

  • NIOSH List

Do’s and dont’s for an assessment?

  • DO give your designated person and/or team time to complete this.

  • DO define what your alternative containment strategies are for your facility.

  • DO have your Designated Person regularly review any updates to the NIOSH list and update your HD list and AoR regularly.

  • DO keep an electronic version of your AoR.

  • DO make you AoR readily retrievable for your staff.

  • DO document that your AoR is reviewed at least annually.

  • DON’T make a blanket statement for a class of medications.

  • DON’T just print the NIOSH list and use that to suffice your AoR.

  • DON’T make alternative containment strategies and not follow them.