The National Institute for Occupational Safety and Health (NIOSH) classifies hazardous drugs (HDs) as medications that can harm healthcare workers who handle them. Exposure, often accidental, can lead to severe health problems like cancer, reproductive issues, and organ damage. Following safety guidelines, such as those in USP General Chapter <800>, is vital to minimize these risks.
The Three Classifications of Hazardous Drugs
NIOSH's 2016 list and updates categorize hazardous drugs into three groups based on their toxicity, guiding the necessary handling precautions.
Group 1: Antineoplastic Drugs
This group includes all cancer chemotherapy drugs. They are highly cytotoxic and dangerous to healthy cells upon exposure, causing various adverse effects.
- Examples of Group 1 Drugs:
- Cyclophosphamide: An alkylating agent used in cancer and autoimmune conditions.
- Doxorubicin: An anthracycline antibiotic used in various cancers.
- Methotrexate: A folate analog used for cancer and autoimmune diseases.
Group 2: Non-Antineoplastic Hazardous Drugs
This category includes non-cancer drugs meeting NIOSH criteria for hazardousness, such as carcinogenicity, genotoxicity, or organ toxicity at low doses.
- Examples of Group 2 Drugs:
- Antivirals: Some antivirals like ganciclovir have potential genotoxic effects.
- Hormones: Drugs like estradiol pose reproductive and developmental risks.
- Immunosuppressants: Medications such as cyclosporine can be toxic at low doses.
Group 3: Non-Antineoplastic Drugs with Reproductive Effects
This group focuses on non-antineoplastic drugs primarily causing reproductive toxicity. Exposure can cause infertility or fetal harm in healthcare workers.
- Examples of Group 3 Drugs:
- Ribavirin: An antiviral with severe reproductive toxicity.
- Warfarin: An anticoagulant known to cause birth defects.
- Finasteride: Can be absorbed through the skin and is a known teratogen.
Risks of Occupational Exposure to Hazardous Drugs
Workers risk exposure during various handling stages. Exposure routes include inhalation, skin contact, ingestion, or injection. Health consequences depend on the drug and exposure level.
- Acute Effects: Short-term effects include skin rashes, nausea, and eye irritation.
- Chronic and Long-Term Effects: Repeated exposure can lead to cancer, organ damage, and infertility.
Safe Handling and Protective Measures
Strict protocols from OSHA and standards like USP <800> are crucial for minimizing risks. Key measures include:
- Engineering Controls: Equipment like biological safety cabinets and isolators contain hazardous materials during preparation.
- Personal Protective Equipment (PPE): Wearing double gloves, gowns, and respiratory and eye protection is required.
- Safe Work Practices: Training on proper handling, including using closed system transfer devices and following decontamination procedures, is essential.
Comparison of Hazardous Drug Types
| Characteristic | Group 1: Antineoplastic | Group 2: Non-Antineoplastic Hazardous | Group 3: Reproductive Effects |
|---|---|---|---|
| Primary Purpose | Cancer treatment (chemotherapy) | Wide range of uses (antivirals, hormones, immunosuppressants) | Wide range of uses (anticoagulants, dermatologicals) |
| Key Hazard | High cytotoxicity, genotoxicity, carcinogenicity | Organ toxicity, genotoxicity, reproductive risk, developmental toxicity | Primary reproductive or developmental toxicity |
| Representative Examples | Cyclophosphamide, Doxorubicin | Ganciclovir, Tacrolimus, Estradiol | Ribavirin, Warfarin, Finasteride |
| Level of Precaution | Generally the highest level of containment and PPE required | High level of precaution, based on specific drug and risk assessment | High level of precaution, especially for staff with reproductive concerns |
Conclusion
Understanding the three types of hazardous drugs—antineoplastic, non-antineoplastic hazardous, and those with specific reproductive effects—is vital for healthcare safety. The NIOSH classification helps manage risks and implement protective measures, including engineering controls and PPE. Following safety standards like USP <800> significantly reduces occupational exposure risks and protects worker health. For more information, refer to the official NIOSH guidelines: NIOSH Publications on Hazardous Drugs.
