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Unit-dose Packaging
Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA
Indiana University Health
Indianapolis, Indiana
The unit-dose packaged medication system has been available since the 1960s; however, it has become a standard of practice for health-systems in the U.S. and is required for all JCAHO-certified facilities.1 There are several advantages of this system:
- Medications are pre-measured into specific doses to reduce or eliminate the risk of a dose being measured incorrectly.
- Patients are charged for only the medications that they actually receive and not charged for an entire bulk bottle.
- Each dose can be barcoded to allow for new technologies, such as patient bedside scanning and electronic chart documentation.
Unit-dose packaging is often not very profitable for the drug manufacturers, and hundreds of common drugs are not commercially available in unit-dose packaging. Fortunately, there are several options available for unit-dose packaging drugs from bulk bottles: automated, semi-automated, manual, and outsourcing. Pharmacy administrators need to evaluate the needs of their facilities and choose the best option to meet those needs.
Automated Unit-dose Packaging Systems
Automated unit-dose packaging systems can be advantageous for large and small facilities. These systems are connected with the hospital's computer operating system, inventory system, and/or the dispensing cabinets, such as PYXIS. When the inventory drops to a certain level from an inventory area or the dispensing cabinets, it sends a message to the automated unit-dose packaging system, and the machine packages only what the area or cabinet needs with barcodes that are readable by the hospital operating system. The advantage of the system is that it keeps the inventory at an optimum level, thus reducing waste. The disadvantages of these systems are the initial purchase cost and an ongoing expense because each container in the machine has to be calibrated to the drug and to the particular brand. The container has to be obtained from the system's manufacturer and each new container can cost over $100. The turnaround time to get the container may take several weeks.
Before deciding on a particular system, pharmacy administrators should2:
- Read the information available for each system
- Visit other facilities that have the system to actually see how the system operates and to get feedback from the owners of the system
- Carefully review service contracts
- Make sure that the packaging materials meet USP standards in order to assign the maximum beyond-use dating (BUD)
The packaging is usually a foil or plastic pouch. Several systems are commercially available in the U.S. and are listed below:
- Pacmed (McKesson)
- Talyst (Autopack)
- ATP High-Speed Tablet Packager (Swisslog)
- ATP Series Automatic Tablet Packager (TCGRx)
- Medication Packager (OmniCell)
- IP128APS (Pearson Medical, Inc.)
Semi-automated Unit-dose Packaging Systems
Semi-automated unit-dose packaging systems are considerably more affordable for pharmacy departments with very conservative budgets and are more flexible to meet the needs of the facility. Most of the semi-automated systems are stand-alone systems and not connected with the hospital's operating system; however, most of the software that operates these systems is connected to an Internet drug database, such as First Data Bank. This allows the necessary information that is needed for the label to automatically populate in the software based on the NDC numbers and minimizes labeling errors. The labels can be manually modified to harmonize descriptions with the hospitals' systems and barcode labeling formats. Partial tablets and compounded medications can also be added to the software library for future packaging. Again, the packaging is usually foil or plastic packets and takes up very little space in the dispensing cabinets or on the shelves in the pharmacy. The disadvantage to a semi-automated unit-dose packaging system is that a dedicated person has to operate it, and, depending on the quantity of repackaged medication needed by the facility, it could require a full FTE position.
Again, the information for each system should be reviewed and visits made to facilities that own and operate these systems. Demonstrations are often set up at trade shows too. The semi-automated unit-dose packaging systems are available for repackaging solid dosage forms and oral liquids. The following is a list of some of the systems offered in the U.S.:
- AutoPrint and Fluidose (Medical Packaging Inc.)
- iPack Rx and IntelliPack2 (Pearson Medical, Inc.)
- Fast Pak Table Top Unit-dose Packager (Amerisource Bergen)
- The Cadet and Wet Cadet (Euclid)
- Pentapak HP 500 - packages both solid and liquid dosage forms
Manual Unit-dose Packaging and Oral Liquid Repackaging
All facilities can easily do manual unit-dose packaging and oral liquid repackaging. The cost of materials is minimal, and the labeling software is easily affordable, but it can require a lot of manpower depending on the quantity that needs to be repackaged. Most of the manual systems for the solid dosage forms are blister packs. The software will create the labeling and barcoding for the blister packs and is printed on foil-backed paper that adheres to and seals the blister packs with adhesive or heat. When choosing the materials, make sure that they meet USP standards.
Oral liquids can be drawn up into oral syringes or added to oral vials. Sometimes a peristaltic pump can be useful in filling the syringes or vials, but usually the pump must be calibrated for each liquid due to the differences in viscosity. When repackaging oral suspensions, the suspensions must be shaken or agitated often to ensure that the medication is uniformly distributed throughout the liquid base during the repackaging process. The doses should be repackaged in the syringe size that is closest to the dose being administered for better accuracy.
Several companies manufacture oral syringes, oral liquid containers, and blister pack systems, along with software labeling and barcoding systems with pre-set templates. Some of the companies that sell these containers and labeling software include Health Care Logistics and EPS.
Beyond-use Dating
Most oral solids, capsules, and tablets can be given a BUD up to 1 year from the date of repackaging or the expiration date of the manufacturer, whichever is less. Some of the chewable or oral-disintegrating tablets, however, are hygroscopic and will disintegrate over time when repackaged. The beyond-use dating may need to be considerably shortened to 1 to 2 months or not repackaged at all. Nitroglycerin tablets are not stable when repackaged and must remain in the original manufacturer's container. If these dosage forms are in the manufacturer's foil packaging as unit dose, but not properly labeled (i.e., no barcode), the labeling software can be used to create a barcoded label and attached to the manufacturer's packaging.
Beyond-use dating for repackaged oral liquids can be a challenge. Although the USP has guidelines for assigning BUDs, it can often depend on the oral liquid base. When available, use the information from the manufacturer or from published stability studies to assign BUDs. Oral liquids containing alcohol often have to be given shorter BUDs because the liquid can evaporate from the syringes. Based on years of experience, the Indiana University Health Compounding Pharmacy uses the following guidelines for oral liquids containing alcohol:
- Greater than 10% alcohol content, assign only a 30-day BUD
- 5% to 10% alcohol content, assign a 60-day BUD
- Less than 5% alcohol content, assign a 90-day BUD
Outsourcing
Outsourcing unit-dose packaging of oral solids and liquids can be an advantage to a facility that has limited manpower resources. Pharmacy administrators should make sure that the repackaging vendor is properly licensed and registered with the FDA and records are available for everything that is repackaged. The disadvantage to outsourcing is the cost. Although the facility is saving money in not purchasing the packaging equipment and materials, the cost paid per dose can be considerably higher and the repackaging vendor may require a minimum quantity to be ordered.
Conclusion
Over the years, unit-dose packaging has been proven to reduce the risk of medication errors. With the new barcode and bedside scanning technology, the risk of medication errors is improving. It is a patient-safety issue for anyone in a health-system facility, and it is in everyone's best interest to provide medications in unit-dose packaging.
References
- Murray MD, Shojania KG. Chapter 10. Unit-dose drug distribution systems. In: Making Health Care Safer: A Critical Analysis of Patient Safety. [U.S. Department of Health & Human Services Website.] Available at: www.ahrq.gov/clinic/ptsafety/chap10.htm. Accessed July 20, 2012.
- United States Pharmacopeial Convention, Inc. United States Pharmacopeia 35-National Formulary 30. Rockville, MD: US Pharmacopeial Convention, Inc.; 2011: 284-286, 759-762.
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