6 STEPS HEALTHCARE ORGANIZATIONS SHOULD TAKE NOW
To meet the upcoming regulations, healthcare organizations should perform a gap analysis that compares their current state to where they need to be for compliance. This will highlight areas that must be updated. The analysis should identify areas of noncompliance across the entire organization, not just the pharmacy.
Organizations should then develop a hazardous drug management strategy. The strategy should meet applicable state regulations in addition to those of the USP and FDA. It must be actionable, prioritize implementation needs and follow these six steps:
Step 1. Complete Facility and Engineering Updates
Adhering to the compliance mandates may require organizations to make changes to their facilities and engineering controls. This will require planning, scheduling and funding. The new regulations will cover:
Receipt and Unpacking. Antineoplastic hazardous drugs and all hazardous drug active pharmaceutical ingredients (API) must be unpacked in an area that has neutral or negative air pressure relative to the surrounding areas. This way, if something is spilled or broken, it won’t spread via positive pressure.
Storage. Antineoplastic drugs requiring manipulation, including refrigeration, and any hazardous drug APIs must be stored separately from other drugs. The hazardous drugs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH).
Non-Sterile Hazardous Drug Compounding. A contaminant primary engineering control (C-PEC) is not required if drug manipulations are limited to handling the final dosage forms that do not produce particles, aerosols or gasses.
Sterile Hazardous Drug Compounding. A laminar airflow bench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of antineoplastic hazardous drugs.
Step 2. Determine Hazardous Drugs
Once facilities have their construction needs planned, they should identify hazardous drugs in which they handle. The 34 drugs added to the National Institute for Occupational Safety and Health (NIOSH) list in 2016 brought the number of NIOSH defined hazardous drugs to 264[MB1] .
Each organization must create a list of the hazardous drugs it uses, including all dosage forms of HDs. The list should be reviewed every 12 months and compared to the NIOSH list.
Step 3. Perform a Risk Assessment
Organizations should conduct an annual risk assessment to ensure they are following proper protocols for hazardous drugs. An assessment is also recommended whenever changes are made that impact occupational exposure, such as adding a new drug or process, or using a non-formulary drug.
The risk assessment should identify any potential risks for each hazardous drug, the consequences of that risk and how to mitigate the risk. Organizations must follow the standards for Group 1 (chemotherapy) agents or they can establish alternative practices for Group 2 (Non-chemotherapy, hazardous drugs) or Group 3 (reproductive risk) drugs to protect their employees.
Step 4. Develop Standard Operating Procedures
Healthcare facilities need to establish procedures for handling hazardous drugs. The procedures must cover the entire drug cycle, from receiving to compounding to administering to disposal of the drug.
The operating procedures should also cover additional aspects of handling the drugs. This includes proper hand hygiene, transporting the drugs and the management of spills.
Step 5. Train Personnel
All employees who handle hazardous drugs must be trained on the operating procedures that relate to their job functions. Each employee must demonstrate that he or she understands the training.
Hazardous drug competencies must be reassessed at least every 12 months. All training and competency assessments must be documented.
Step 6. Provide Quality Assurance
Once everything is in place for compliance, organizations need to establish a quality assurance program. This entails checking for microbial contamination and sampling surfaces for hazardous drug residue. Facilities should start a formal wipe sampling and medical surveillance programs to monitor HD exposure.
The new regulations call for a compounding supervisor, which is a designated person responsible for ensuring the regulations are followed. This person is charged with documenting training and risk assessments, overseeing the program, and ensuring quality assurance.