Questions and Answers
What does USP 800 address?
What is the purpose of General Chapter 800?
To provide a legally enforceable standard to limit occupational exposure to hazardous drugs.
Who does USP 800 apply to?
Which of the following settings are included in the scope of USP 800?
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What is the primary focus of USP 800?
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Facilities handling hazardous drugs should follow standards in occupational safety plans and health and safety management systems, which should include a list of __________.
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What is NIOSH?
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What groups are included in the NIOSH list of drugs?
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What should be considered during an assessment of risk for hazardous drugs?
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What must be documented when an assessment of risk approach is taken?
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Under what conditions can hazardous drugs be prepared for dispensing without further containment requirements?
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Healthcare personnel should avoid crushing tablets of hazardous drugs.
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Hazardous drugs must be handled under conditions that promote _____ safety.
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Hazard signs must be prominently displayed ______ the entrance to the HD handling areas.
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Access to HD areas must be restricted to ______________ personnel.
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HD handling areas should be located away from ___________________ for personnel, patients, or visitors.
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Designated areas must be available for?
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Study Notes
USP 800 Overview
- USP 800 addresses the transport, storage, compounding, preparation, and administration of hazardous drugs (HDs), emphasizing occupational safety.
- Builds on previous regulations to enhance protection for patients, health care personnel, and the environment from hazardous drug exposure.
Handling of Hazardous Drugs
- General Chapter 800 provides legally enforceable standards to limit occupational exposure to HDs.
- Covers processes such as receipt, transfer, storage, compounding, dispensing, administration, and disposal of HDs.
Applicability
- USP 800 applies to all personnel handling HDs, including nurses, pharmacists, pharmacy technicians, physicians, physician assistants, veterinarians, and home-health care workers.
Scope of Standards
- Relevant to various health care settings: hospitals, outpatient infusion centers, cancer centers, retail pharmacies, mail order pharmacies, and non-sterile compounding pharmacies.
- Exclusions include wholesale suppliers, patient homes, and manufacturing plants.
Risk Minimization Focus
- Aims to minimize and limit exposure to HDs through containment strategies, risk assessment, and safe work practices.
Occupational Safety Requirements
- Facilities must implement health and safety management systems covering:
- A list of hazardous drugs.
- Facility engineering controls.
- Competent and trained personnel.
- Safe work practices.
- Proper use of personal protective equipment (PPE).
- Policies for HD waste isolation and disposal.
Compliance and Assessment
- Pharmacies need to conduct thorough assessments of hazardous drugs delivered to patients, referencing the NIOSH alert listing HDs in healthcare.
NIOSH Overview
- NIOSH stands for the National Institute for Occupational Safety and Health, which provides guidelines and classifications for HDs.
NIOSH Drug Classification
- The NIOSH list categorizes drugs into three groups:
- Group 1: Antineoplastic drugs with reproductive risks.
- Group 2: Non-antineoplastic drugs with potential reproductive risks.
- Group 3: Drugs primarily posing reproductive risks for those trying to conceive, pregnant, or breastfeeding.
Risk Consideration Factors
- Key factors for risk assessment include:
- Type of HD (antineoplastic/non-antineoplastic).
- Dosage form.
- Risk of exposure.
- Packaging.
- Manipulation methods.
Documenting Risk Strategies
- If an assessment approach is adopted, documentation of containment strategies and work practices to minimize exposure is essential.
Preparation and Handling Guidelines
- Hazardous drugs requiring only counting or repackaging can be processed without further containment unless specified by the manufacturer or if contamination indicators are present.
- Use clean, dedicated equipment for counting/repackaging, decontaminate after use, and avoid automated counting machines for HD tablets/capsules.
Safe Manipulation Practices
- Personnel should refrain from crushing tablets or opening capsules of HDs.
- If manipulation is necessary, PPE must be worn, and a plastic pouch should contain dust or particles.
Safety and Environmental Protection
- Handling of HDs must prioritize patient safety, worker safety, and environmental protection.
Warning Signs and Access Control
- Hazard signs must be displayed prominently at the entrance to HD handling areas.
- Access to HD handling areas is restricted to authorized personnel only, protecting others from exposure.
Location Considerations
- HD handling areas should be situated away from breakrooms, reducing risk of exposure to personnel, patients, and visitors.
Designated Areas for Handling
- Specific areas are required for receiving, unpacking, and storing HDs, as well as for non-sterile and sterile HD compounding.
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Description
Test your knowledge on USP 800 regulations with these flashcards. Focus on key aspects such as product transport, storage, and the standards for handling hazardous drugs. Perfect for healthcare professionals and students preparing for compliance in pharmacy practice.
