GOVERNMENT and LAW

PAPER CHASE

Industry debates whether electronic labeling is an idea whose time has come

Industry-led plans to see whether the familiar paper package insert (PPI) can be replaced with an electronic version are advancing. A task force formed by the Pharmaceutical Research & Manufacturers of America in 1998, and later broadened to include pharmacy, expects pilot-testing of a prototype electronic system can get the go-ahead around mid-year.

Five vendors have received positive feedback from PhRMA on their proposals, which are being further evaluated and refined. A successful alpha test could mean a national rollout next year, said Irwin G. Martin, a former Parke-Davis v.p. who chairs the task force. He readily admits, "I'm not sure [the time frame is] realistic. I hope it is."

Few would dispute that there should be a better way to provide official prescribing information, every word of which must be approved by the Food & Drug Administration. Today, PPIs generally are tightly folded sheets of thin paper jammed with tiny print, glued to a drug package or stuffed inside. The antithesis of a user-friendly format, PPIs are difficult to read, easy to tear, challenging to refold, and often removed and not replaced.

Updates with crucial new safety warnings ordered by the FDA can take weeks to arrive in a new product shipment. Brand-name drug manufacturers spend anywhere from $3 million to $5 million a year on them. Delays in printing and attaching them after FDA clearance can hold up launch of a new product. A week's delay in shipping a $500 million-a-year Rx translates to about $10 million. Small wonder the industry said it is willing to foot the bill for scrapping paper.

For pharmacists, though, paper inserts, even if low-tech, are free, compact, and convenient enough—as near as the bottle on the pharmacy shelf. Paperless labeling at a minimum should have the same attributes to persuade practicing pharmacists to endorse a change, they have made clear. The task force leader agrees. "Our goal is that the flow of information doesn't impact on the work flow at all," he told Drug Topics.

The FDA, which has an "observer" position on the task force, also must be convinced to change current regulations and give manufacturers an electronic option. "Once we can show we can deliver the labeling electronically, I think the FDA will be with us," Irwin said. The biggest hurdle seems to be that the electronic system must be available in every dispensing site in the United States and its territories—pharmacies, hospitals, clinics, and physician offices from Maine to American Samoa—and at no cost to them, just as the paper currently is. The task force also has outlined several other user requirements for vendors to meet, among them:

• Access time typically should be less than 15 seconds.

• The system should be easily installed, operated, and navigated by a user with minimal computer skills.

• Bar-codes or other rapid-access codes of the NDC number should provide immediate access to the labeling without the need for keying.

• Direct keyboard access also should be possible.

• There should be a minimal impact on work space and work flow.

• Updates should be made daily as they occur, be transparent, and not require action on the part of the dispensing site.

• The electronic labeling should be provided in a standardized electronic format such as PDF, which the FDA prefers.

• Printing should be to 8.5-by-11-inch paper, and it should be possible to print portions of the labeling.

• Labeling and software updates and other system maintenance should be provided at no cost to the dispensing site.

• The system should produce no additional direct or peripheral costs to the dispensing site.

That sounds like a tall order—too tall for Philip P. Burgess, national director of pharmacy affairs for the Walgreen Co., who represents the National Association of Chain Drug Stores on the task force. "We are just still convinced that PhRMA does not realize what it's biting into here with all the independent systems, stand-alone systems, all the different chain systems to develop a system that's going to be compatible," he told Drug Topics. "Our position toward this is, if it ain't broke, don't fix it."

Burgess questioned whether 15-second access is doable, and even if it is, it may be too long for his liking. "What hill-of-beans difference does it make if the information is more timely and no one ever looks at it because it's difficult to access?" he asks. "Isn't it better to have slightly less timely information that is readily available?"

The task force's Irwin is not deterred. "I'm convinced we will win over everyone who needs to be won over," he said.

Michael F. Conlan

Mike Conlan. Industry debates whether electronic labeling is an idea whose time has come.

Drug Topics

2001;7:56.