In the 1984 film Ghostbusters, Dr. Egon Spengler declared to Janine Melnitz, “Print is dead.” A quick search of print is dead (electronic search, of course) reveals dozens of books and articles declaring that if traditional print communications are not actually deceased, they are decidedly on life-support.
In pharmaceutical and healthcare regulation, electronic communications are the standard. Submissions to FDA are made electronically, comments are filed electronically, drug registration and listings are submitted electronically, drug product labeling is submitted electronically and posted electronically at drugs@fda, Daily Med, and on manufacturer websites and numerous other portals. Health records are electronic; prescriptions are electronic. Prescription drugs move from manufacturers to wholesale distributors to healthcare dispensing and retail sites via electronic ordering systems.
In keeping with this spirit of fostering electronic communication, the Food and Drug Administration Safety and Innovation Act (FDASIA) mandated that the General Accounting Office (GAO) study the benefits and efficiencies of electronic patient labeling of prescription drugs as a complete or partial substitute for patient labeling in paper form. The study was also to assess the implementation costs to the different levels of the distribution system, logistical barriers to utilizing a system of electronic patient labeling, and any anticipated public health impact of movement to electronic labeling.
The GAO has now completed the study and, at odds with the well-established movement away from paper, released a very frustrating report, Electronic Drug Labeling – No Consensus on the Advantages and Disadvantages of Its Exclusive Use.
Prescription drugs are distributed by their manufacturers with the full prescribing information attached, commonly referred to as the “PI.” See, e.g., 21 C.F.R. § 201.100; 72 Fed. Reg. 15,701 (April 2, 2007). This PI is intended for healthcare practitioners (as GAO notes in Table 1 of its report) and can be very, very long in printed format. It is most commonly printed front and back on lightweight paper, in a tiny 6 point font, accordion folded, affixed to the drug package. A typical PI may stretch to 24 inches in length, or more when unfolded. This PI accompanies the drug from the manufacturer, through distribution, to the pharmacy, long-term care facility, hospital, physician office, or other dispensing site.
Pharmaceutical companies have worked for many, many years with FDA and pharmacies on programs to move away from printed PIs. In 2007, FDA held a public meeting to address the feasibility of electronic distribution of the PI. As FDA stated in the Federal Register notice announcing the meeting,
Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient. Additionally, the PI may not contain the most current information, because the PI accompanying the drug’s distribution may have been printed and distributed prior to more recent labeling changes. As the healthcare system advances into the 21st century, we are considering how dissemination of the prescribing information contained in the PI can take advantage of technological advances in the electronic transmission of information.
72 Fed. Reg. at 15,702.
Regrettably, and out of step with years of steady work and the inexorable movement toward electronic communications, GAO concludes in its July report that there is still no consensus on eliminating the paper PI. Relying upon stakeholder interviews (including those whose business is to print the PIs), the report states that some physicians and pharmacists might be uncomfortable accessing electronic PIs or unable to do so, and notes that there is no reliable data source. However, there is no information in the report documenting how often practitioners actually unfurl and attempt to read the tiny print paper PIs they receive now. Assuming that practitioners are even using the printed PI provided by the manufacturer, it seems likely that supposed access difficulties could be resolved in ways that are efficient and without inconvenience to healthcare practitioners.
The report also conflates two pieces of information that should be kept separate and distinct: (1) the PI that accompanies the drug product as it moves from manufacturer to the dispensing site; and (2) the other printed information that a patient can or must receive from his or her pharmacist at time of dispensing. As discussed, the first type of information, the PI, is intended for the healthcare practitioner. The second type of information is intended for the patient. The cartoon above, from an FDLI Update article in September/October 2005, is only slightly hyperbolic, vividly illustrating the ongoing problems with the state (and volume) of the information patients receive from pharmacies about their prescription drugs.
The GAO report does a good job of describing the current, messy state of patient-directed, in-pharmacy communications, with overlapping requirements for distribution of Medication Guides, patient package inserts (PPI), and Consumer Medication Information (CMI), now referred to as Patient Medication Information (PMI). As the timeline accompanying the report indicates, FDA has been working since 1995 to figure out how to improve the information patients receive in the pharmacy. The current iteration involves possibly consolidating Medication Guides, PPIs, CMIs, and PMIs into a single document that is being pilot tested under the auspices of the Brookings Institute.
For those who hoped to see a more environmentally friendly, efficient, modern solution to the volumes of printed prescription drug information, that goal seems as elusive now as it was 20 years ago. Print is dead, unless it’s the PI.
