USP 800: Performing an Assessment of Risk for Hazardous Drug Handling

In this clip, Patricia Kienle, BSPharm, MPA, FASHP, Director of Accreditation and Medication Safety at Cardinal Health Innovative Delivery Solutions, discusses key steps for performing an assessment of risk in compliance with USP 800.


There is an allowance in 800 to recognize that there may be different ways we can handle some types of hazardous drugs. It’s all based on the NIOSH List of Antineoplastic and Other Hazardous Drugs. The current document of that is from 2016. NIOSH tries to update that every 2 years, and I anticipate that we will see one probably in the fall, so that will be the 2018 version.
They have 3 different tables of drugs in there, and it’s all based on the raw ingredient of the drug with the recognition that since we handle final dosage forms for a lot of these drugs, particularly the oral and other non-parenteral ones, that you can handle them, or you may be able to handle them, differently because you can identify different containment strategies or work practices that you can use.
So the assessment of risk needs to be a look at that NIOSH list that’s current, so right now it’s the 2016 one but when the 2018 comes out, folks will need to use that. Identify the drugs that you use and then drilldown to the dosage forms that you handle. Because if it’s an oral dosage form in unit dose or unit of use, and you don’t manipulate it at all, that’s a very different situation from having to make an IV chemo or having to start with raw material, active pharmaceutical ingredient (API), to make something else. So it needs to be a balance of the drug that you use, the dosage form, and do you have to manipulate it at all. People need to take a look at that and identify which ones, if they feel comfortable enough that they have other ways of handling, they can do that. 

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