Understanding the Official Hazardous Drug Classification
The terms 'Level 1' and 'Level 2' are not official regulatory classifications. These are commonly facility-specific designations for hazardous drugs (HDs) informed by guidelines from NIOSH and USP <800>.
NIOSH identifies drugs as hazardous if they exhibit characteristics such as carcinogenicity, reproductive toxicity, or genotoxicity. The NIOSH list categorizes these drugs, such as Antineoplastics and non-antineoplastics, and includes updates like Manufacturer's Special Handling Information (MSHI).
The Role of USP <800> in Defining Handling Tiers
USP General Chapter <800> sets standards for the safe handling of hazardous drugs. It requires strict controls for high-risk drugs like antineoplastics. For other hazardous drugs, USP <800> permits an 'Assessment of Risk' (AOR), allowing alternative containment methods if worker exposure is minimized. This often influences a facility's internal 'Level 1' and 'Level 2' assignments.
Deconstructing the "Level 1 vs. Level 2" Distinction
A common interpretation based on USP <800> includes:
- Level 1 (Highest Risk): Often covers antineoplastic drugs and hazardous APIs. Handling typically demands stringent containment and extensive PPE. An AOR is generally not an option.
- Level 2 (Lower Risk): Commonly includes non-antineoplastic hazardous drugs and those with primarily reproductive risk. An AOR may permit less stringent controls based on factors like dosage form and handling frequency.
Comparison of Handling Requirements by Risk Level
| Feature | Potential 'Level 1' HDs (e.g., Antineoplastics) | Potential 'Level 2' HDs (e.g., Non-Antineoplastics via AOR) |
|---|---|---|
| Associated NIOSH List | Table 1 (Antineoplastics), Hazardous APIs | Tables 2 & 3 (Non-Antineoplastics, Reproductive Risk), Non-API |
| Containment Strategy | Full containment and control required (C-PEC in C-SEC) | May use alternative controls if AOR demonstrates minimized risk |
| Engineering Controls | Sterile: Class II or III Biological Safety Cabinet (BSC). Non-Sterile: Ventilated enclosure (e.g., C-PEC). | May use alternative engineering controls documented in AOR. |
| Personal Protective Equipment (PPE) | Double chemotherapy gloves, impermeable gown, eye/face protection (when risk of splash), respiratory protection (when needed). | Single chemotherapy gloves for intact tablets; PPE based on AOR for other forms. |
| Compounding | Always requires compounding in a C-PEC located within a C-SEC. | May occur with fewer controls, based on AOR, for some preparations. |
| Waste Disposal | Treated as hazardous waste; follows specific federal, state, and local regulations. | Handled as hazardous waste based on risk and waste stream. |
Ensuring Compliance and Safety in Practice
Effective hazardous drug management requires comprehensive internal policies and procedures aligned with NIOSH and USP <800>. Key practices include maintaining a facility-specific hazardous drug list, performing regular AORs for applicable drugs, providing thorough training to all personnel, implementing appropriate engineering controls, and ensuring correct PPE usage.
Conclusion
The distinction between Level 1 and Level 2 hazardous drugs is an internal classification used by healthcare facilities to manage risk, guided by NIOSH and USP <800>. This approach differentiates between drugs requiring stringent containment (often 'Level 1') and those allowing a risk assessment for alternative handling (often 'Level 2'). Adhering to these standards is vital for protecting staff and patients from hazardous drug exposure.
For further information on handling hazardous drugs in healthcare settings, refer to the CDC's resources on the NIOSH List of Hazardous Drugs.
