Plan-Do-Study-Act System Can Help Pharmacies Comply With USP <800>


Investigators developed a new Plan-Do-Study-Act cycle to meet standards of USP <800> at a central-fill pharmacy.

A poster at this year’s American Society of Health-System Pharmacists Midyear Clinical Meeting & Exposition described how a Plan-Do-Study-Act (PDSA) system was utilized at a central-fill pharmacy to meet new standards established by the United States Pharmacopoeia (USP) addressing the handling of hazardous drugs in healthcare facilities.1

The report identified areas of improvement in the current pharmacy’s PDSA system and offered recommendations so that future systems could better adhere to the new standards, referred to as USP <800>. These included updating personal protective equipment (PPE), standardizing materials used in the identifying and dispensing process, and educating staff on the new changes.

A team of health system and pharmacy leadership, pharmacy residents, and pharmacy technicians at the central-fill pharmacy conducted a gap analysis to determine the changes needed to be made to current processes for compliance with the newly implemented USP <800> standards.

Assessments of risk performed for the drugs carried by the central-fill pharmacy revealed that the pharmacy did not have hazardous sterile compounding capabilities and that IV chemotherapy was outsourced. The assessments also identified bulk and unit-dose oral formulations, topical drugs, and injectable vials, as the hazardous drugs that were most often handled. A list of hazardous drugs was posted in work areas where drugs were handled, and the pharmacy did not have to cut or compound any drugs in-house.

Analyses further reviewed the available PPE supply, spill kits, and packaging and labeling materials used to identify hazardous drugs within the pharmacy and prior to dispensing. Hazardous drugs were placed in yellow bins and identified as such by a yellow hazardous sticker, which could be found at blister card packaging areas. Whereas different bags were available at areas where drugs of other formulations were prepared for dispensing, bags storing hazardous drugs were available and differentiated by their yellow color.

Based on their initial review, investigators identified areas of improvement and suggested recommendations that would allow the pharmacy to better adhere to USP <800> standards. They found that the pharmacy’s current supply of gloves was not rated to handle hazardous drugs, and that more spill kits could be stocked in areas where hazardous drugs were handled.

They also noted that hazardous drug identification and dispensing methods and their associated materials should be standardized. Packaging materials could be labeled more consistently, as well.

A new PDSA cycle was developed and deployed after the initial PDSA cycle was completed. Not only did it address new supply requirements, but it also addressed issues related to staff knowledge; a plan for educating staff on correct usage of new PPE and spill kits was established after survey results from staff revealed that although they could identify hazardous drugs and know that special handling was required, many employees were unfamiliar with new standards set by USP <800> and no one among them had used a spill kit before.

Investigators noted that the learnings from the new PDSA cycle will guide subsequent cycles until all necessary process changes are implemented to achieve compliance with USP <800> standards.

1. Anderson H, McCabe L. Utilizing a plan-do-study-act system to implement USP <800> at a central-fill pharmacy. Presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting & Exhibition; December 3-7, 2023; Anaheim, CA. Poster 4-001.
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