Core Criteria for Identifying Hazardous Drugs
The National Institute for Occupational Safety and Health (NIOSH) provides the framework for identifying hazardous drugs in healthcare settings. A drug is considered hazardous if it exhibits one or more of six characteristics:
- Carcinogenicity: Can cause cancer.
- Teratogenicity or developmental toxicity: Can cause birth defects or developmental abnormalities.
- Reproductive toxicity: Can affect fertility and reproduction.
- Genotoxicity: Can damage genetic material.
- Organ toxicity at low doses: Can cause serious organ damage even at small exposure levels.
- Structure and toxicity profile: Similar characteristics to existing hazardous drugs.
Categories of Hazardous Drugs
Hazardous drugs fall into three main categories according to NIOSH:
- Antineoplastic drugs: Primarily used for chemotherapy.
- Non-antineoplastic hazardous drugs: Meet NIOSH criteria but are not used for cancer treatment, including certain antivirals, hormonal agents, and bioengineered drugs.
- Drugs with reproductive hazards only: Pose specific reproductive risks without meeting other criteria.
Exposure Routes and Health Consequences
Exposure to hazardous drugs can occur through inhalation, skin absorption, ingestion, and accidental injection. Potential health effects range from acute symptoms like rashes and headaches to chronic issues such as cancer, reproductive problems, and organ damage.
Regulations and Safe Handling
Standards like the U.S. Pharmacopeia (USP) General Chapter <800> provide requirements for safe handling. Key aspects include specialized facilities and equipment, personal protective equipment (PPE), personnel training, spill control, and risk assessment.
Comparing NIOSH Criteria and Other Hazardous Classifications
Hazardous drug classifications can differ. NIOSH focuses on occupational exposure risk in healthcare, while EPA hazardous waste classification relates to environmental disposal and public health.
| Classification System | Focus | Key Characteristics | Typical Regulation | Target Population |
|---|---|---|---|---|
| NIOSH Hazardous Drug | Occupational exposure risk in healthcare. | Carcinogenicity, Teratogenicity, Reproductive toxicity, Genotoxicity, Organ toxicity at low doses. | USP <800> | Healthcare workers and handlers of uncontained drugs. |
| EPA Hazardous Waste | Environmental disposal and public health risk. | Ignitability, Corrosivity, Reactivity, Toxicity (by leaching). | Resource Conservation and Recovery Act (RCRA) | Waste handlers and the general public affected by disposal. |
Both sets of regulations are important for comprehensive safety.
A Comprehensive Approach to Safety
Identifying hazardous drugs is crucial for implementing safety measures, including engineering controls and training. Staying updated on NIOSH and OSHA guidelines is essential. Following protocols, using proper PPE, and training on spill response are vital to minimize exposure and protect health. The NIOSH List of Hazardous Drugs in Healthcare Settings is a valuable resource.
Conclusion
The classification of a drug as hazardous is based on its potential to cause serious adverse health effects according to toxicological criteria established by NIOSH. This classification dictates necessary handling precautions to protect healthcare professionals and others from occupational exposure, as outlined in standards like USP <800>.
