Pharmacy Compounding: Hazardous Sterile Preparations

Introduction

Pharmacy compounding of hazardous sterile preparations is a specialized practice that requires meticulous attention to safety protocols, regulatory compliance, and quality assurance. Pharmacists and pharmacy technicians who compound hazardous medications must be aware of the unique challenges and risks associated with these preparations to ensure the safety of healthcare workers, patients, and the environment.

Definition and Classification

The National Institute for Occupational Safety and Health (NIOSH) defines hazardous drugs as those that exhibit one or more of the following characteristics in humans or animals:

• Carcinogenicity
• Teratogenicity or developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing hazardous drugs

Hazardous sterile preparations are classified into three risk levels based on the potential for healthcare worker and environmental contamination:

1. Risk Level 1: Low-risk compounding with hazardous drugs
2. Risk Level 2: Medium-risk compounding with hazardous drugs
3. Risk Level 3: High-risk compounding with hazardous drugs

Regulatory Framework

Multiple organizations provide guidance and regulations for compounding hazardous sterile preparations:

• US Pharmacopeia Chapter <800> provides standards for handling hazardous drugs in healthcare settings
• US Pharmacopeia Chapter <797> outlines requirements for sterile compounding
• Occupational Safety and Health Administration (OSHA) regulations for handling hazardous substances
• The Joint Commission standards for medical staff responsibilities and facility safety
• State Boards of Pharmacy requirements

Facility Requirements

Specialized compounding facilities must be designed to contain hazardous drugs and protect personnel. Key requirements include:

• Primary engineering controls such as compounding aseptic containment isolators (CACI) or biological safety cabinets (BSC)
• Secondary engineering controls like negative pressure rooms
• Dedicated equipment for preparing hazardous drugs
• Proper decontamination procedures and systems
• Appropriate storage areas for hazardous drugs

Personal Protective Equipment

Comprehensive personal protective equipment (PPE) is essential when compounding hazardous sterile preparations:

• Double gloves (chemotherapy-rated inner gloves with overgloves)
• Respiratory protection when appropriate
• Gowns (chemotherapy-rated) with closed front and cuffs
• Face shields or eye protection
• Shoe covers and head covers

PPE must be donned in the appropriate order to minimize contamination and removed carefully to prevent self-contamination. All PPE should be disposed of as hazardous waste according to institutional policies.

Compounding Procedures

When compounding hazardous sterile preparations, pharmacists must follow specific techniques:

• Use closed system transfer devices when possible to minimize aerosol generation
• Employ aseptic technique throughout the compounding process
• Perform compounding within appropriate engineering controls
• Apply proper containment techniques when dispensing medications
• Decontaminate all surfaces and equipment following compound preparation

Storage and Segregation

Proper storage of hazardous drugs is critical to maintain stability and prevent accidental exposure:

• Store hazardous drugs separately from non-hazardous medications
• Maintain appropriate temperature and humidity conditions
• Implement secure storage access controls
• Ensure all hazardous drugs are clearly labeled
• Use negative pressure refrigeration units for refrigerated hazardous drugs

Quality Assurance

Robust quality assurance programs are essential for hazardous sterile preparations:

• Regular testing and certification of engineering controls
• Environmental monitoring and sampling
• Media-fill procedures to verify aseptic technique
• Documentation of all compounding activities
• Review of compounding practices through competency assessments
• Incident reporting and corrective action procedures

Training and Competency

Pharmacy personnel must receive specialized training regarding hazardous drugs:

• Initial training before working with hazardous substances
• Annual competency assessments
• Ongoing education on new requirements and procedures
• Documentation of all training activities
• Specific training on spill response and emergency procedures

Risk Assessment

Each facility should conduct and maintain a risk assessment for hazardous drug handling:

• Identify all hazardous drugs used in the facility
• Evaluate potential exposure routes
• Determine appropriate control measures based on risk level
• Review and update assessment regularly or when processes change
• Document findings and corrective actions

Spill and Leak Management

Proper procedures must be in place for handling spills of hazardous drugs:

• Immediate containment of the spill
• Appropriate PPE donning before cleanup
• Use of spill kits designed for hazardous drugs
• Sequential cleaning procedures
• Proper disposal of contaminated materials
• Documentation of the incident

Waste Management

Hazardous waste generated during compounding must be managed properly:

• Segregation of hazardous waste from regular pharmaceutical waste
• Use of appropriate containers for hazardous waste collection
• Packaging, labeling, and documentation according to regulations
• Proper disposal through licensed waste management companies

Documentation Requirements

Comprehensive documentation is essential for regulatory compliance:

• Standard operating procedures for all hazardous drug handling activities
• Records of staff training and competency assessments
• Environmental monitoring results
• Engineering control certification reports
• Inventory management records for hazardous drugs
• Incident reports and corrective action documentation

Conclusion

Compounding hazardous sterile preparations requires a comprehensive approach to safety and quality. Pharmacists and technicians must remain vigilant in following established protocols, staying updated on regulatory changes, and maintaining the highest standards to protect themselves, patients, and the environment from potential harm. With proper training, appropriate facilities, and diligent adherence to safety procedures, hazardous sterile preparations can be compounded safely and effectively to meet patient needs.

References

1. National Institute for Occupational Safety and Health. (2016). NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.
2. United States Pharmacopeial Convention. (2023). USP <800> Pharmaceutical CompoundingSterile Preparations.
3. United States Pharmacopeial Convention. (2023). USP <797> Pharmaceutical CompoundingSterile Preparations.
4. Occupational Safety and Health Administration. (2021). OSHA Technical Manual: Hazardous Drug Safety in Healthcare Settings.