High-Volume Unit Dose Packaging
On February 25, 2004, the Food and Drug Administration (FDA) issued a landmark release that outlined the rules governing barcode requirements for human drugs and blood. The new rule requires certain human drug and biological product labels to have barcodes. This rule applies to manufacturers, repackers, relabelers, and private label distributers of prescription drug products and over-the-counter drugs. However , while the barcode requirement is mandatory for packaged shipments from the manufacturer, it is not mandatory at the unit dose level.
Given that barcode labels are not required for unit doses of drugs, what solutions are available to ensure the integrity of the medication administration process from the shipments with barcode labels to unit dose medications? Is there an ROI for the organizations that adopt a high-volume unit dose packaging system? What
successes and challenges have healthcare providers reported in adopting unit dose
packaging products? Do these systems positively impact patient care?
KLAS interviewed 138 healthcare provider professionals regarding the experiences they are having with their unit dose packaging system and vendor. Three vendors are included in the main body of this study: AmerisourceBergen Technology Group (ABTG), McKesson, and Talyst. In addition, early performance data on Omnicell and Swisslog is included with the full version (190 pages) of this report.
Implementation is frequently mentioned as an area of frustration for unit dose packager customers. It was reported that many of the installation personnel have little experience implementing this equipment. Contributing to these implementation issues is the difficulty of interfacing within an automated pharmacy environment. ABTG received the highest scores in areas regarding implementation. Both Talyst and McKesson respondents indicated that inexperienced installation personnel were sent as part of the implementation teams. An advantage for Talyst was the ease of integration with the Cardinal Pyxis MedStation solution. This integration allowed Talyst AutoPack equipment to automatically resupply the decentralized medicine cabinets, thereby relieving the pharmacist of the tedious task of closely monitoring the medication stock.
Beyond implementation, there are significant operational and maintenance issues to contend with. Respondents made a point of stating that client organizations can not just start the packager and then just leave it to operate. There are frequent maintenance issues regarding canisters and print heads that arise.
Unit dose packaging systems are complex pieces of equipment that are intended to work in an exact manner for medication integrity, yet the equipment must work in a complex environment that involves a myriad of drugs, IT interfaces, as well as wear and tear. Some organizations purchased UDP solutions expecting to save an FTE, only to find those hopes quickly disappear as someone is needed almost constantly to man the packager and perform preventive maintenance.
What challenges have you had with interfacing? - by Vendor
The vendors are rolling out a number of technologies in order to better serve the market. Talyst is seen as the leader with Smart Chip technology, which tracks canisters no matter where they are placed. McKesson clients are just now seeing this technology become available to them. ABTG customers have a type of tracking technology that alerts the operator to a misplaced canister. Talyst has also introduced a Special Tablet System (STS) Tray that allows the user to place a wide range of medications into the packager and have those medications packaged immediately to circumvent the canister process.
The market for unit dose packaging systems is a challenging one. Performance scores, which reflect client satisfaction, are lower in this market segment than in other equipment market segments that KLAS monitors; at times, the scores are remarkably lower. That said, the equipment designed to fill this niche is complex and tasked to operate in a complex environment.
Products qualifying to be included in the High-Volume Unit Dose Packaging research are, alphabetically:
Early findings were also included in the full report for Omnicell and Swisslog.
Vendor Performance Research Tools:
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A complimentary executive summary of the 2008 High-Volume Unit Dose Packaging report is available for the following:
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All healthcare providers with a current Platinum KLAS subscription (summary available via download on the PK reports tab -- Log in).
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Each healthcare provider who participated in the study's research (summary delivered via email).