Paper, Rock, Electronics

Despite the advancements of the electronics age, there will always be a need for paper. That was my message to a group of insert printers and their vendors, who were assembled for the first annual meeting of the newly formed Pharmaceutical Printed Literature Association on April 15 in New York City.

But by no means was I the headliner. That honor went to Bruce Cohen, director of packaging technology for GlaxoSmithKline (GSK). Cohen updated the group on the status of PhRMA's Paperless Insert Initiative, which aims to replace paper inserts provided to pharmacists by manufacturers with an on-line labeling database that can be accessed by all pharmacists via a nationwide network. The main benefit of such a system, Cohen explained, is that electronic information can be updated and disseminated to pharmacists much more quickly than can printed inserts.

Much to the audience's chagrin, PhRMA's work is progressing, albeit not as quickly as the association once predicted. PhRMA's contractors are approaching the testing phase of their solutions for electronic systems. Cohen explained that system testing would begin this month and continue through December.

After explaining the system's advantages and progress, Cohen did come under fire, which he probably expected. Attendees posed some challenging questions, like, what if the system crashes? How can every pharmacy be linked to the network, especially those found at unexpected locations? And how can pharmacies find the time for system training and upgrades? Cohen was confident these challenges could be handled.

Attendees clearly didn't share Cohen's enthusiasm, and for good reason. If the initiative is successful, many printers may see their drug inserts business fold. However, I told the audience that hope may lie in another type of paper insert—the patient package insert. I wasn't just trying to avoid the hot seat that Cohen sat in, but rather to point out that drugs with complicated regimens need inserts to guide patients. Ironically, the example of the type of insert I held up to make my point was one that Cohen himself was responsible for.

GSK's maintenance drug for asthma, Serevent, must be taken properly to control life-threatening symptoms. Delivering a sufficient amount of the medication requires a synchronization of breathing and hand movements. The inhaler must be rinsed often and patients must discard it after using the labeled number of inhalations. Serevent's insert reinforces these instructions through large and bold typefaces, branded coloring, diagrams, and pictures of patients delivering the drug. A pharmacy's printer could never output such necessary details, and pharmacists usually don't have the time to demonstrate inhaler use.

Inserts like these can never be eliminated, even if one day every patient carries around his or her own personal data assistant for accessing electronic drug information. Cohen agrees, adding that anything that encourages drug regimen compliance is right for patients. He also says that FDA is even encouraging manufacturers to consider compliance-aiding printed media, pointing out the medication guides GSK and other manufacturers have had to produce at FDA's request.

PhRMA's intention—to keep pharmacists apprised of the most current drug information—will ultimately benefit patients, enabling pharmacists to advise them using real-time information. But printed inserts are needed, too, to help patients follow instructions once they leave the pharmacy. Paper won't ever be obsolete, even if PDAs become as ubiquitous as the common cold.

Daphne Allen, Editor

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