Don't Assume a Drug Is Safe Because It's Not On The NIOSH Hazardous Drug List
USP <800> is the federal standard that is designed to protect healthcare workers who handle hazardous drugs. The standard applies to whole organizations, not just pharmacists or nurses.
Implementation of the standard begins with each organization's list of hazardous drugs. Each healthcare organization is tasked with listing every hazardous drug and its dosage form as a means of identifying prospective employee exposure risks. This is a daunting task, one seemingly insurmountable to those just starting out. Healthcare workers either directly handle or can be exposed to an incredibly diverse number of drugs. Which ones are considered hazardous?
Luckily, NIOSH (the National Institute for Occupational Safety and Health) publishes a list of hazardous drugs that USP has adopted as a starting point for Chapter 800 implementation. The list, originally published in 2016 and currently undergoing revision, contains over 200 unique drugs placed into various hazard categories. Importantly, the document contains the necessary health hazard criteria for placing a drug onto the list. These criteria include carcinogenicity, teratogenicity/developmental toxicity, reproductive toxicity, organ toxicity, genotoxicity, and structural/toxicological profiles of new drugs that are similar to drugs that meet the above criteria. The NIOSH list is an indispensable resource for those aiming to be compliant with USP <800> (the 2016 NIOSH list can be found here).
So does that mean a drug not on the list is automatically non-hazardous and safe?
Not at all. The NIOSH hazardous drug list is non-exhaustive. There are a significant number of FDA approved drugs that meet the criteria mentioned above but are not included in the list. Hydrocortisone (evidence of developmental toxicity), morphine (evidence of genotoxicity), and fentanyl (evidence of reproductive toxicity) are three examples of commonly handled drugs in healthcare settings which meet the NIOSH criteria but are not on the list. Moreover, biopharmaceuticals (e.g. monoclonal antibodies, or mABs) are specifically excluded from the list, yet may also meet the criteria.
Simply adopting the NIOSH hazardous list as your organizational list is the incorrect approach to implementing USP <800>. Don't let hazardous drugs slip through the cracks and place your employees at risk. Evaluate all the drugs that are administered and determine what will and will not be a health hazard to your employees.
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