Category: Professional Posters
Purpose: United States Pharmacopeia General Chapter permits alteration of containment requirements outlined by the chapter for final dosage forms of compounded hazardous drug (HD) preparations and conventionally manufactured HD products that do not require any further manipulation other than counting or repackaging. Risk assessments must include an evaluation of the type of HD, its dosage form, the risk of exposure, packaging, as well as manipulation. Completion of a risk assessment requires a thorough review of the package insert as well as National Institute for Occupational Safety and Health (NIOSH) List manufacturer’s safe-handling guidance (MSHG) and supplemental information.
Methods: Package inserts, MSHG, and supplemental information for each formulation of medications present on the NIOSH List were reviewed and compiled onto a spreadsheet. Data was analyzed to determine similarities between dosage forms based on NIOSH List table. Additional factors were also analyzed to determine how they should impact the handling of each HD.
Handling requirements outlined in NIOSH were analyzed to determine if it would be possible to place medications into categories with corresponding containment and Personal protective equipment (PPE) requirements. Each possible part of the medication life cycle was assessed to determine all possible points of exposure to HDs.
An pharmacy technician-programmer was consulted to determine feasibility of coding a tool with the capability to generated automated risk assessments using the medication information and corresponding handling requirements.
Results: Risk assessments were rolled out to facilities in November 2018 in a webinar format. Logic was developed to assign an overarching risk level (cyctotoxic chemotherapy high, high, moderate, or low) based on NIOSH List table, route, dosage form, coating, prepackaging, and manipulation to determine a standard handling procedure for each of the following settings: storage, receipt, repackaging/counting/labeling, splitting or crushing (contained), manipulation, dispensing, transportation, administration, splash, inhalation, and spills. PPE requirements were selected for each of the risk levels based on the NIOSH List.
A risk assessment form was developed to correspond with the containment requirements for each setting. Risk assessment forms included each possible formulation or dosage form that applied to a single drug from the NIOSH List with designations for NIOSH Table number, hazard type, NIOSH–specified risk of exposure, package insert risk of exposure, and PPE requirements.
Code was written to map historical purchases for each facility to the NIOSH List, to populate risk assessments based on medication NIOSH List table, route, dosage form, coating, prepackaging, and manipulation. The final resulting Excel document was posted to the IDN intranet page. Risk assessments were then able to be exported by facilities to fulfill the requirement of risk assessment completion.
Conclusion: Risk assessments may be produced centrally in a standardized manner that permits sharing of resources throughout an organization. Logic may be developed to minimize the variability in handling strategies by NIOSH List table and dosage form. This strategy was helpful in gaining efficiencies for the organization as a whole.