Years ago, the Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) encouraged FDA to allow drug manufacturers to provide prescribing information (PI), also known as professional or pharmacist inserts, solely in electronic formats. In 1999, we reported that PhRMA formed a Paperless Labeling Task Force to evaluate the technologies necessary to implement such a system, and research has continued quietly in pilot studies in pharmacies around the country.
In FDA’s Unified Agenda this past May, however, FDA revealed that a proposed rule is in the making. “Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products” could be issued sometime in November. The rule would outline new requirements for makers of human drug and biological prescription products to provide “electronic package inserts . . . in lieu of paper,” read the agenda. Such electronic inserts would “ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.”
When asked to clarify what types of inserts fall under FDA’s definition of “electronic package inserts . . . in lieu of paper inserts,” an FDA spokesperson explained that, “under this effort, the labeling that accompanies the package, typically referred to as the paper package insert attached to the package, would be electronically available.”
Drug manufacturers are already required to submit labeling information electronically. In 2005, the agency began requiring manufacturers to submit to FDA prescribing and product information (i.e., the package insert or label) in a structured product labeling (SPL) format using standardized medical terminology. These electronic files have since populated Daily Med, a national database Web site provided by the National Library of Medicine as a public service.
Under FDA’s proposed rule, drug manufacturers would continue to provide such labeling information to the agency for inclusion in Daily Med, but would no longer be required to include printed PIs.
According to an industry veteran who has participated in the PhRMA task force, a third-party consulting firm investigated the cost impact to manufacturers and DailyMed system users and determined that there “is no hurdle here.”
Critics have argued that relying on a strictly electronic system could limit insert information retrieval to those users with readily available Internet access. For instance, the Pharmaceutical Printed Literature Association (PPLA), an association for suppliers of paper inserts, has argued against solely electronic PIs, citing potential “problems ranging from guaranteeing constant, never-ending access to an electronic system for all dispensing sites to the potential nightmare of FDA regulation of such a system.”
However, says the veteran, the task force surveyed 40,000 dispensing U.S. sites and determined that “virtually all sites have some sort of Internet connection or a viable means of connecting, so the conclusion is that everyone will have access.”
The industry veteran reports that the task force would eventually like to see the ability for dispensing sites to scan drug bar codes on labels or to type in National Drug Codes and be brought immediately to the DailyMed page with the drug’s most current electronic insert. The task force would also like to see recent electronic updates presented to pharmacists when they log on to DailyMed.
Patient package inserts (PPIs) do not appear to be part of the upcoming proposal. FDA is actually in the process of determining how to improve written prescription drug information for patients. A public workshop entitled “Providing Effective Information to Consumers about Prescription Drug Risks and Benefits” was scheduled to “explore potential approaches that will result in written prescription drug information for consumers that is comprehensible, accurate, and easy to access,” reports the agency.
However, PPLA feels that “the PI rule would establish a slippery slope toward a totally paperless system for professionals and patients alike.”
Instead, the PPLA would like to see the agency require that an FDA-approved, manufacturer-supplied MedGuide accompany every prescription. “FDA should adopt a single standard document for communicating essential information about pharmaceuticals, which would replace the current set (PPIs, Consumer Medication Inserts, and MedGuides),” PPLA advises.