ExCPT · Medication Safety and Quality Assurance · 8 min read
NIOSH Hazardous Drugs, Cleaning and Inventory Checks
- Identify handling, personal protective equipment, and storage standards for NIOSH hazardous drugs.
- Explain the multi-step cleaning and decontamination process required to prevent cross-contamination under USP <800>.
- Describe inventory control procedures, stock rotation methods, crash cart audits, and recall management within the technician's scope of practice.
NIOSH Hazardous Drug Identification and Engineering Controls
The National Institute for Occupational Safety and Health (NIOSH) publishes an official list of antineoplastic and other hazardous drugs used across healthcare environments. To determine if a medication is hazardous, NIOSH evaluates specific toxicity criteria. These criteria include carcinogenicity, developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, and toxicity profiles that closely resemble existing hazardous drugs. In its guidance, NIOSH identifies antineoplastic and non-antineoplastic hazardous drugs and notes reproductive risks. Rather than relying on an outdated, fixed three-category scheme, pharmacy technicians should consult the current NIOSH list to verify handling requirements.
Hazardous drugs require specialized storage conditions to prevent accidental breakage and environmental contamination. Antineoplastic hazardous drugs requiring manipulation other than counting or repackaging must be stored separately from nonhazardous inventory in an externally ventilated, negative-pressure room with at least 12 air changes per hour. Storing these items in negative pressure ensures that any airborne chemical contaminants do not migrate into general pharmacy work areas. All hazardous products must be organized securely to minimize physical drops, falls, and container breaches.
Engineering controls and dedicated tools are also essential when manipulating or preparing hazardous items. A closed-system drug-transfer device mechanically prevents environmental contaminants from entering the system while stopping hazardous drug residues or vapors from escaping. When handling hazardous oral solid dosage forms, technicians must use designated, dedicated counting trays and spatulas rather than standard counting equipment. Furthermore, automated counting or packaging machines must never be used for hazardous drugs unless that equipment is specifically dedicated to hazardous drugs and operated in full accordance with applicable facility procedures.
Common mistakes
- Assuming an intact tamper-evident seal on a crash cart means the cart does not need to be checked for expired items; scheduled audits are still required.
- Relying solely on 70% isopropyl alcohol to clean counting trays after dispensing common allergens like penicillin or sulfonamides, even though alcohol alone may not remove chemical drug residues.
- Believing an N95 respirator protects against hazardous drug vapors, when in reality an N95 does not protect against vapors and a fit-tested respirator appropriate to the exposure must be used.
- Assuming waste container color alone determines disposal requirements, when container colors vary by facility and jurisdiction and disposal must follow actual regulatory waste classifications.
Key points
- NIOSH identifies hazardous drugs using toxicity criteria including carcinogenicity, reproductive toxicity, and genotoxicity; under USP <800>, antineoplastics requiring manipulation other than counting or repackaging must be stored separately from nonhazardous inventory in an externally ventilated, negative-pressure room.
- Hazardous-drug compounding requires two pairs of chemotherapy-tested gloves, generally changed every 30 minutes unless the manufacturer recommends otherwise, and a back-closing gown resistant to hazardous-drug permeation, changed per the manufacturer or every two to three hours if no interval is specified; dedicated counting equipment is used when counting hazardous drugs.
- USP <800> outlines four cleaning steps: deactivation (such as with sodium hypochlorite), decontamination, cleaning, and disinfection (using sterile 70% isopropyl alcohol with full wet contact time for sterile areas).
- Inventory must be rotated earliest-expiration first, and expired medications must be immediately removed from dispensing stock and segregated pending return or disposal through an authorized process.
- Transfers of Schedule II controlled substances to a reverse distributor require DEA Form 222 or CSOS documentation under pharmacist oversight.
- Crash kit outer expiration dates reflect the earliest-expiring item inside, and while technicians assist in restocking carts and logging Class I and Class II recalls, clinical decisions and final verifications remain with the pharmacist.
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