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Originally Published July 2000

EDITOR'S PAGE

Taking the Paper out of Package Inserts

Outdated. User-unfriendly. Type so small that only a mouse could read it.

These are some of the criticisms that many pharmacists and others who dispense drugs have about the package inserts that are supplied with many prescription drugs. An electronic labeling solution currently advocated by one industry group holds promise, but there are a few concerns that need to be addressed before it can take the magnifying glasses out of pharmacists's hands.

The Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) has come up with a framework for an alternative to package inserts and is seeking vendors to make it a reality. Following the lead of FDA's Center for Drug Evaluation and Research (CDER), which is working to achieve a paperless environment by making 8.5 x 11-in., 12-point versions of approved professional labeling available on its intranet for all CDER reviewers, PhRMA proposes that drug manufacturers be allowed to provide prescription information electronically rather than on traditional paper inserts to pharmacies. In 1999, PhRMA formed a Paperless Labeling Task Force to evaluate the technologies necessary to implement such a system. The group aims to have a prototype system for industry and FDA to review sometime in 2001.

"New information technologies have enabled the world to share vast amounts of information electronically," says task the former chairman Irwin Martin, who is the former vp–international regulatory affairs at Parke-Davis's Pharmaceutical Research Div. "In contrast, prescription drug professional information, or full prescribing information, is still required to physically accompany prescription drug containers in the United States as a package insert." This information may not be current by the time it reaches the pharmacy, especially in the case of products with frequent labeling changes.

Instead, the most up-to-date information is often found on company Web sites. "The most practical method of dissemination of full prescribing information is by electronic means," adds Bert Spilker, MD and PhD, PhRMA's senior vice president for scientific and regulatory affairs.

In May, Martin presented a proposal at a public information meeting, whose audience included drug manufacturers, pharmacists, and vendors interested in developing such a system. According to the proposal, the electronic system to which drug companies would post their drug labeling and that pharmacists would use to retrieve that labeling should be available and maintained at no cost to all dispensing locations; must be available in all U.S. and U.S. territory dispensing sites; use PDF files for viewing and printing on 8.5 x 11-in. paper; provide read-only access; be accessible within 15 seconds; and enable pharmacists to scan drug bar codes or enter in National Drug Codes in order to retrieve labeling. He also explained that patient-oriented drug labeling would not be replaced by a paperless system.

At the meeting, Martin asked vendors to submit their proposals by September 2000. The task force plans to review these proposals by November 2000 and begin developing prototype systems in 2001. The group's goal is to roll out a system nationally in 2001 in order to work with FDA to revise drug-labeling regulations.

Disseminating such information to pharmacists electronically has several benefits, Martin explained at the meeting. "Pharmacists will have access to the most recent labeling, text will be readable, there will be no chance of product misbranding because of insert mix-ups, cost savings to the pharmaceutical industry could be significant, and there may even be a quicker product launch after FDA approval."

D. Bruce Cohen, director of packaging technology at Glaxo Wellcome, who is a member of the task force, calls the paperless labeling initiative a "terrific benefit to the healthcare system as well as to drug manufacturers. Up-to-the-minute product information will be available at every dispensing location in the United States, especially labeling changes about contraindications and safety indications discovered after package insert printing."

However, not everyone believes that one system can be rolled out that will work for every pharmacy and that a system can be developed and demonstrated to industry and FDA by the task force's deadline. "I don't think it is realistic to expect a vendor to design a system that can work with every proprietary computer system found at chain and independent pharmacies," says Phil Burgess, national director of pharmacy affairs at Walgreens (Deerfield, IL). "Unless you can implement the system in 100% of the pharmacies, why do it at all?"

Plus, Burgess worries about the effect such a system could have on pharmacist productivity. "With the new system, pharmacists will have to request information electronically and then wait for lengthy labeling instructions to print. And clerks who need to print out information for themselves or for customers who want to read about certain drugs will need to interrupt the pharmacists who will work the terminals. With the number of prescriptions escalating every day, anything that adds to our workload could affect our productivity."

Cohen isn't surprised that some pharmacists are skeptical. He says that one of the hardest parts to getting a pilot program started is getting enough dispensing locations to volunteer to run one.

Another concern is that the task force hasn't decided who will pay for the system. "Dispensing locations won't be charged to use the system, and we are anticipating that there will be some charges to drug manufacturers who use the system," Cohen explains. "We hope that the vendors who submit proposals will have some ideas."

Clearly, an electronic system that enables pharmacists to disseminate the most current drug information will improve patient care. If the system can somehow be tied into patient prescription records, pharmacists will be able to keep patients informed of new contraindications and warnings that relate to their entire regimens.

But PhRMA and its contracted vendors will need to work closely with both chain and independent pharmacists in order to understand how such a system will fit into a fast-paced environment that is already overburdened by the increasing number of prescriptions and the task of packaging most of those prescriptions. Otherwise, a good attempt to use today's computer technology to improve patient care will fade as quickly as the Y2K bug.

Daphne Allen, Editor
daphne.allen@cancom.com