USP 800 and Hazardous Drugs: Safety Standards and Protocols

Developed to promote patient safety, worker safety, and environmental protection and defines practice and quality standards for handling hazardous drugs

USP <800>

Drugs that can cause adverse effects for health care workers handling them whether it be receipt, storage, compounding, dispensing, administration, disposal

Hazardous Drugs (HDs)

a HD(s) is identified by at least one of the following

1. Carcinogenicity, teratogenicity, or developmental toxicity

2. reproductive toxicity

3. organ toxicity at low doses in humans

4. genotoxicity or new drugs that mimic existing HDs in structure or toxicity

_________________________ maintains a list of HDs in healthcare

National Institute for Occupational Safety and Health (NIOSH)

USP 800 requires individual ____________ to maintain a list of HDs

institutions

The list of HDs from the individual institutions must be reviewed at least every ___________

12 months

When new _________________ used, it should be reviewed

agent or dosage form

HDs drugs

1. antineoplastic drugs (Docetaxel

Cyclophosphamide)

2. non-antineoplastic drugs (Estrogens Spironolactone)

3. reproductive risks (Misoprostol

Tretinoin)

Some dosage forms of drugs defined as hazardous may not pose a significant risk of direct ____________________ exposure because of their dosage form

occupational

If assessment of ______________ is not performed, all HDs must follow USP 800

risk

what activity can come from contacting HD residue on drug containers

receipt

what activity can come from mixing components and withdrawing or diluting injectable HDs

compounding

what activity can come from generating aerosols during administration priming IV administration set

administration

what activity can come from handling body fluids or body-fluid-contaminated clothing, linens, etc.

patient-care activities

what activity can come from collection and disposal of hazardous waste and trace contaminated waste

waste

Each entity must have a designated person who is qualified and trained to be responsible for

1. Developing and implementing procedures

2. Overseeing compliance with USP 800 and other regulations

3. Ensuring competency of personnel

4. Ensuring environmental control of the storage and compounding areas

All personnel who handle HDs are responsible for understanding ___________________________

fundamental practices and precautions

Entities are required to establish __________________ to ensure worker safety during all aspects of HD handling

policies and procedures

entities must develop standard operating procedures (SOPs), including

1. Safety Data Sheets (SDS) for each hazardous chemical, and that

SDS are readily accessible

2. Personnel who may be exposed to HD must be provided information and training before working

3. Personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs

Personnel competency must be conducted prior to start of job and reassessed at least every ________________

12 months

All training and competency assessment must be _______________

documented

personnel training and competency must include

1. Overview of entity's list of HDs and their risk

2. Review of SOPs

3. Proper use of PPE and equipment

4. Spill management

5. Proper disposal of HDs and trace-contaminated materials

Facilities and Engineering Controls must have _________________ sign

prominent

Facilities and Engineering Controls access must be restricted to _______________________

authorized personnel