Originally Published PMPN
March 2004
EDITORIAL
Rule, Report May Bring on a Philosophy Change
FDA has had a busy week. The agency has just released two documents inside of seven days that promise to change forever the way pharmaceuticals are packaged.
The first, a report titled “Combating Counterfeit Drugs,” calls for the use of radio-frequency identification (RFID) to be used to create electronic pedigrees that cannot be altered or faked. The report also suggests the use of packaging and labeling features that can be used to authenticate products. The report was published February 18.
The second, FDA’s final rule on bar coding, was published February 26 in the Federal Register. This law requires that all drugs supplied to hospitals carry linear bar codes on all package sizes. The bar codes must encode at a minimum the National Drug Code.
We’ve been waiting for these agency actions, and it just so happens that this issue features our annual supplement on bar coding. We also include an interview with Dan Mullen, president of AIM Global and an expert on RFID. Since the rule and report came out at press time, though, we ask that you read “final“ whenever you come across the word “pending“ in our supplement.
Surprised about the rule or the report? The bar coding rule shouldn’t surprise you, especially since FDA commissioner Mark B. McClellan says there were “no fundamental changes“ to its proposal, except for cutting the implementation period from three years to two.
The counterfeiting report also may not surprise you, given the growing interest in RFID by Wal-Mart, the U.S. Department of Defense, and now Target stores. FDA, too, shows strong support. McClellan says that RFID may even be used one day to prevent medical errors, so the agency is “pushing forward with RFID, monitoring its progress.“ FDA may even revise the bar coding rule to allow the use of RFID.
But the convergence of these two actions should surprise you. By taking on medical errors and counterfeits at the same time, FDA is forcing industry to redefine its approach to packaging and labeling. Protecting product and providing information are no longer the sole purposes of packaging and labeling; they must also be designed to facilitate drug identification.
This change in approach is what will shock industry the most. Yes, applying new tools like bar coding and RFID will take time, money, and labor. But for those companies that still package the majority of their products in bulk, leaving packaging largely to pharmacists and others, this new philosophy will be hard to swallow. Bulk packaging will no longer suffice, at least at the hospital level. It alone will not facilitate drug identification at the bedside, the only surefire way of reducing errors. And while the use of RFID on bulk packaging will help retail pharmacists identify legitimate products, it will do nothing to reassure patients who will still likely receive pharmacy-generated packaging.
FDA isn’t requiring any packaging changes, though. The agency simply requires bar codes on the lowest packaging levels, which could still be bulk packaging. And it only suggests the use of RFID on all drug packages by 2007, which, again, could just be bulk packaging.
So, despite FDA’s landmark actions, any major changes to packaging will be up to the market. And the market will drive change. Now that the agency has alerted healthcare providers to the promises of bar coding and anticounterfeiting, the call for unit-of-use or unit-dose packaging will come from hospitals and pharmacies that don’t want the burden—or the liability—of packaging. They will look for products from firms that package for protection, information, and identification.
Daphne Allen
Editor
Copyright ©2004 Pharmaceutical & Medical Packaging News
