Packagers Hold the Key
With this year’s annual Industry Outlook feature, we pose the question, “Is Packaging Key to Good Health?”
The Institute of Medicine (IoM) has given its answer. In “Preventing Medication Errors,” the latest entry in IoM’s Quality Chasm Series, the authors urge FDA and industry to ensure that packaging plays a role in patient safety. “A formal action plan to address naming, labeling, and packaging problems is critical to improving the safety of medication use,” IoM writes. “Product naming, labeling, and packaging should be designed for the end-user—the provider in the clinical environment and/or the consumer.”
IoM goes on to discuss the problems posed by similarly named drugs and by cluttered labels and small fonts.
But the problem goes well beyond labeling issues. It could be characterized as a packaging issue. Or, to put it bluntly, a lack of packaging issue. Quoting statistics from other sources, IoM writes, “less than 20 percent of all prescription and OTC drugs in the U.S. are produced in blister packs.” And that doesn’t mean that the other more than 80% are in bottles. For the most part, prescription drugs are repackaged from bulk containers and dispensed by neighborhood pharmacies in amber vials.
“Every time we have a prescription filled, or one is filled for us, we put our faith in the system, that the prescription was filled properly and that it is what we need to help us recover from the illness or condition we face,” said Kathleen Stevens, professor at the University of Texas Health Science Center at San Antonio, in a statement. Stevens is one of two nurses who served on the 17-member panel of IoM medication safety experts from across the nation. She is also director of the Academic Center for Evidence-Based Practice and the National League for Nursing (NLN) Board of Governors’ secretary.
If the pharmacist is a trustworthy one, why should pharmacy repackaging be a problem? Because when drug packaging is left until the very last point in the supply chain, the drug product itself travels throughout most of the chain without individual identification and protection. The potential for misuse, mix-up, or other mistakes at any point before repackaging remains.
We have pointed this out in past issues, such as in “The Next Chapter: Unit-of-Use Packaging,” published in November 2002. (The IoM committee cited this article in its report.)
Pharmacists seem to want unit-of-use packaging. IoM cites a survey showing that two-thirds of responding pharmacists believe that “unit-of-use packaging would improve efficiency, reduce errors in dispensing, improve patient compliance, and increase opportunities for patient counseling.”
IoM urges “stakeholders [to] collaborate to develop a strategy for expansion of unit-of-use packaging,” the authors write. “Additional head-to-head studies should be undertaken to evaluate various methods of presenting unit-of-use packaging and determine optimum designs to support different consumer groups in their medication management.” Bottles, blisters, pouches, calendar packs, prefilled syringes, metered-dose inhalers with counters, and other unit-of-use packages that are ready for dispensing would go a long way toward meeting IoM’s goals.
“This report is sobering, but it is the first step toward making a major dent in the issue of preventable prescription drug errors and their costs to society,” said Stevens.
In other words, another “yes” to our question, “Is Packaging Key to Good Health?”