While providing medications to patients in unit dose is on its surface a simple concept, continual change in unit dose availability requires that pharmacy exert significant effort to secure these products. With manufacturers often changing their unit dose options, dedicated staff may be required to oversee this pursuit. Moreover, shifting price points require organizations to constantly weigh the value of purchasing medications in unit of use versus utilizing a different strategy, be it engaging the services of an outsourced repackaging vendor, in-house repackaging via high-volume or tabletop repackaging machines, or a combination thereof.
To satisfy ASHP’s recommendation that medications be made available to patients in ready-to-use, unit dose, or unit-of-use containers,1 each organization must determine the most efficient strategy to ensure that this occurs.
Purchasing Pre-Packaged Unit Dose Products
It is common to employ a strategy of purchasing as many medications as possible in bar coded unit dose. The primary benefits of this option are the increased safety it affords, including compliant labeling and Tall-Man lettering as well as increased operational efficiency offered by avoiding the need to in-house repackage the majority of medications.
Purchasing medications from unit dose vendors regulated by the FDA and operating under cGMP instills confidence that patients are receiving safe and effective products. Medications purchased in unit dose form arrive containing all of the necessary labeling and packaging, including safety lettering, color-coded and light-sensitive packaging, and multiple sizes. In addition, 2D bar codes are available from many vendors.
Another significant benefit of purchasing medications in unit of use is that an organization does not need to coordinate an extensive packaging infrastructure within the pharmacy. Equipment needs are reduced, as is the volume of packaging materials that must be purchased. This frees up space in the pharmacy and may help contain costs. Finally, operational efficiency can be realized by assigning staff to duties other than medication repackaging. When purchasing products in bar coded unit of use, a technician simply scans the medication upon receipt and adds it to inventory.
While organizations may strive to purchase the majority of their medications in bar coded unit of use, some medications are not available in this format. Certain medications may have a high price point, making the purchase of these products in unit dose untenable. Thus, working with an outsourced repackaging company may be a useful option. Since repackaging is the sole focus of the outsourced vendor, these sources offer the expertise, equipment, staff training, and knowledge of specific repackaging regulatory requirements to ensure safety and quality.
When choosing a repackaging vendor, consider the importance of performing due diligence, including a site visit. The vendor must be compliant with FDA guidance, state board of pharmacy requirements, as well as USP regulations. Quality considerations should include how the vendor maintains standard operating procedures, handles complaints, ensures quality control, and trains staff. In addition, investigate how long the vendor has been in business and ensure its licensure is current and liability insurance is in place. Search the vendor’s history for FDA warning letters, any product liability claims, and its recall policies and procedures. Finally, be sure to discuss contract length, billing and payment terms, and turnaround time.
Regardless of the unit dose acquisition strategy utilized, most organizations will still find the need to repackage some medications in-house. Therefore, it is critical to ensure sufficient staff and pharmacy space is available. Tabletop repackaging machines offer organizations significant flexibility, while high-volume repackagers may help manage bulk repackaging requirements. When repackaging medications in-house, determine whether a high-volume or tabletop repackaging machine, or perhaps both, best suit your needs.
Repackaging machines should have the ability to produce labels with Tall-Man lettering, scan bulk drug bottles to auto-populate the database with the necessary information, attach screen displays from a drug-reference database, update the packager’s reference database with new drug and NDC information, scan each completed product to verify accuracy, and generate the reports necessary to ensure state board of pharmacy requirements. If the organization uses 2D bar codes or plans to use them moving forward, the ability to scan 2D bar codes is another important consideration. When selecting a repackager, critical considerations should include increased efficiency, hardware requirements, the ability to interface with the pharmacy system, the process for updating the database, the reputation of the repackaging vendor, and expenses, including maintenance, repair, ongoing support, and the cost of supplies.
Manual Unit Dose Packaging
While purchasing pre-packaged unit dose products, outsourced repackaging, and in-house repackaging with tabletop or high-volume repackaging machines are common strategies for providing medications to patients in unit of use, none of these strategies can cover all contingencies. Thus, there will always be a need for effective, simple, flexible manual repackaging options. A number of excellent options are available in the marketplace.
As the market evolves, and the number of medications available in bar coded unit dose continues to fluctuate, each organization must develop a unique strategy for obtaining unit dose medications. In a real-world pharmacy environment, employing a combination of packaging strategies is oftentimes necessary to ensure safe patient access to bar coded, unit dose medications.
Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine. She can be reached at firstname.lastname@example.org.