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Overcoming Unit Dose Availability Challenges


November 2012 - Vol.9 No. 11 - Page #30

The cornerstone of safe, patient-centered drug distribution is the provision of prescribed medications in unit-of-use format. Under this method, individual doses are provided in single unit packaging with labeling that includes the generic name, lot number, beyond-use dating, and when possible a bar code. This minimizes the potential for medication calculation errors, provides improved identification of medication doses, offers a protective barrier for individual doses, and affords improved inventory accountability. In recent years, we have witnessed changes in the availability of medications in unit-of-use packaging from manufacturers, thereby threatening the integrity of drug distribution systems. As a result, hospitals have pursued alternative means of acquiring medications in unit dose packaging. These options range from in-house preparation and packaging to outsourced third party repackaging. All have advantages and disadvantages that must be carefully considered prior to making a final decision.

Hartford Hospital, an 819-bed level-one trauma center, is the largest teaching facility at the University of Connecticut Schools of Pharmacy and Medicine. It offers a full complement of inpatient and outpatient services, with centers of excellence in cardiology, oncology, and transplant medicine. The pharmacy department provides comprehensive 24/7 decentralized pharmacy services, a USP <797>-compliant cleanroom complex, and an institution-wide distribution system employing automated dispensing cabinets (ADCs) in 88 locations. Whenever possible, oral dosage forms are provided to patient care areas in a unit-of-use format, with 5.7 million oral doses dispensed in FY 2012. Unfortunately, the lack of availability of a growing number of medications in unit dose format presents a formidable challenge to the integrity of the drug distribution chain. This requires the dedication of a significant commitment of resources and manpower to in-house repackaging activities. During this same time period, over 525,000 oral doses—almost 10% of our total oral doses dispensed—required in-house unit-of-use repackaging. 



Evaluate Repackaging Needs
A number of factors contribute to the need for repackaging. Many new medications are initially provided only in bulk package format. This is particularly true for those medications that are high cost, have a narrow therapeutic range, or are provided in a bulk package size that may be directly relabeled by retail pharmacies for ambulatory use. Further contributing to this challenge is the increasing number of generic manufacturers who choose to only provide medications in bulk containers to avoid the expense of unit dose packaging.
When evaluating solutions to this problem one must carefully consider the institution’s needs in regard to the following factors: 

  • Available floor space for repackaging operations and storage of repackaging supplies
  • Anticipated volume of repackaging and the ability of each repackaging methodology to meet the facility’s needs
  • Availability of sufficient FTEs to safely and accurately conduct repackaging
  • Cost per dose for various repackaging approaches
  • Annual cost of packaging disposables 
  • Required turnaround time for repackaged medications
  • Ability of each methodology to meet the organization’s emergent needs

Outsourced vs In-house Repackaging
Outsourced, third party repackaging offers unit-of-use packaging customized to each institution’s specific labeling needs without incurring the manpower and hardware costs associated with in-house production. However, this can be an expensive option, placing large scale outsourced repackaging beyond the means of many institutions. It is important to evaluate the cost effectiveness of this method for low-volume, low-use products; incorporate the cost of waste from any outdated or unused products in this analysis. Another consideration with this option is the turnaround time for outsourced repackaging; this can range from two days to two weeks, which may pose a challenge when emergent responses are required for acute medication outages.

Subsequent to a detailed financial and operational evaluation at our facility, we chose to proceed with a tabletop repackaging unit at Hartford. Careful consideration was given to a number of high volume repackaging units, however, these were rejected due to their higher cost, space constraints, and floor weight loading. Turning our attention to tabletop units, we reviewed several existing products and consulted with current users of each. When determining the correct tabletop repackager for your facility, consider several key issues: 

  • Does the tabletop repackager have a strong reputation for operational reliability and low maintenance requirements?
  • Are disposables reasonably priced and readily available on a 24/7 basis from the manufacturer?
  • Is the labeling function flexible? Does it offer programmable fonts, font sizes, tall-man lettering, and programmable data space on the label?
  • Does it include a bar code scan check function that verifies the proper drug has been selected prior to repackaging?
  • Are multicolored packaging materials available?
  • Is bar code generation software included with and/or within the packager?
  • What is the footprint of the packager? Is minimal space required for both the unit and storage of its disposables? (It is important to be cognizant of space constraints and, in the case of large systems, the floor weight load.)
  • Does the repackager operate easily and quietly?

When considering medication repackaging systems, a commonly overlooked expense involves disposables, most notably the system’s packaging materials. Over the lifespan of the system disposables will account for a significant expense. Therefore it is important to consider several factors prior to finalizing a purchase, including the cost and availability of disposable materials, the manner in which unit dose packets are sealed, the failure rate of packet sealing, the availability of color-coded packaging materials, the ability to package small, custom volumes, and the ability for bar code integration with BCMA. 

Tabletop Repackaging Process 
Hartford Hospital’s commitment to a strict unit-of-use distribution philosophy requires nearly 44,000 doses to be repackaged monthly. All in-house medication repackaging is conducted under the direct supervision of the drug distribution coordinator, a senior pharmacy technician who is also responsible for coordinating all ADC activities. Pharmacy technicians who have had one-on-one instruction perform the medication repackaging. Initially these staff members must complete the repackaging process under the direct observation and approval of the drug distribution coordinator or his designee. 

The need for medication repackaging is triggered through the replenishment process for ADCs. Centrally generated refill reports detail those medications requiring replenishment. Medications reaching a critical low, based on experience and stock levels, are noted on a repackaging dry erase work board. Bulk containers of medications to be repackaged are procured from stock, and the original product data is entered on a repackaging log. Technicians repackage the bulk products using a tabletop unit dose repackaging machine. Finished products are then quarantined until checked and approved by a pharmacist. Once checked, pharmacy technicians place the repackaged medications into bins containing active stock, which are arranged alphabetically by generic name. Repackaging of controlled substances is conducted in much smaller volumes by dedicated controlled substance pharmacy technicians. Due to the minimal number of controlled substance doses repackaged, a manual bubble pack system is employed, with pharmacists checking products in a similar manner to non-controlled substances. They are then stored in the controlled substances vault to ensure security.

We are very pleased with our choice to implement a tabletop unit dose packaging machine. In our four year history with the tabletop repackaging machine, we have experienced zero mechanical failures. It provides a highly legible label that fosters ease of identification and efficiently handles tablets and capsules of all sizes that are processed at approximately 60 doses per minute. The preventive maintenance functions are minimal and the machine easily disassembles in order to facilitate regular cleaning. The software included with the packager is intuitive in nature, and affords users the luxury of a customized label. It also creates a label library, thereby reducing setup time for future use. The tabletop repackager has proven highly beneficial to our facility financially, and its reliability and ease of operation have positively impacted our workflow and operations. 

Conclusion 
Numerous options exist to create unit-of-use packaging, both in-house and via outsourced solutions. Selecting of the best option for your institution depends on available financial and staffing resources, physical compatibility with available space, performance expectations, and desired options. It is important to dedicate time to clearly define your pharmacy’s needs, and if at all possible, conduct a detailed investigation of the experiences of users of each repackaging method prior to making a final decision.


Ralph J. Frank Jr, RPh, MPH has served as the pharmacy manager at Hartford Hospital since 2005. He received his RPh from the University of Connecticut School of Pharmacy in 1975 and his masters in public health from UConn in 1990. Ralph maintains a professional interest in substance abuse trends as well as epidemiological trends of poisoning and overdose events. Ralph is a past president of the Connecticut Society of Health System Pharmacists and is active in both CSHP and the American Society of Health Systems Pharmacists.

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