USP 800是管理危险药品及其在无菌和非无菌制剂的接收、储存、配制、分配、管理和处置过程中的处理的标准。USP 800的存在是为了保护人员和环境免受有害药物化合物的影响，例如化疗药物或放射性药物中的化合物。美国药典800重点关注危险药品的安全处理(HDs)，以最大限度地降低暴露于医护人员、患者和环境的风险。A drug is considered hazardous if
it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.
USP 800 details numerous requirements for HDs, including the responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation.
The USP 800 standard applies to all healthcare personnel who receive, prepare, administer, transport, or come in contact with HDs and any environments where HDs are handled. Any facility that handles HDs must incorporate a number of policies into an occupational safety plan. The bare minimum of these policies to include are: a list of HDs, facility and engineering controls, competent personnel, safe work practices, proper use of PPE, and policies for HD waste segregation and disposal.
List of HDs
The documentation for HDs in a facility must include any items on the NIOSH list and must be reviewed at least every 12 months. Any new agents and dosages must be reviewed against the facility’s existing documentation. An assessment of risk should be performed.
The assessment of risk for an HD includes:
- The type of HD
- Dosage form
- Risk of exposure
- Packaging
- Manipulation
Facility and Engineering Controls
USP 800 dictates where must be designated areas for receipt, unpacking, and storage of HDs. In addition, a facility needs designated areas for Nonsterile HD compounding and Sterile HD compounding if such actions are performed within. Depending on the HD, certain areas require negative room pressure to contain the HD.
PPE
在任何地点处理或接触卫生防护人员时，包括接收、储存、运输、配制(包括无菌和非无菌)、管理、溢出控制和废物处置，都必须穿戴个人防护装备。个人防护用品包括手套;礼服;头套、头发套、袖子套、鞋套;eye and face protection, and respiratory protection.
Personnel must be trained and demonstrate handling competencies before handling any HDs. The compounding supervisor must be trained in every aspect of the HD handling process. HD waste disposal must comply with all applicable federal, state, and local regulations, including unused HDs and trace-contaminated PPE and other materials.
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