Rx package inserts: Redesigned with fewer errors in mind
The first PI makeover in 25 years adds “highlights” and adverse event hotlines.
Contents. Physicians will be able to locate information more quickly with the Contents section. This section, which is analogous to the table of contents of a book, references all sections and subsections in the Full Prescribing Information section.12
Patient counseling. The new format now requires a Patient Counseling Information section that places a greater emphasis on the importance of communication between physicians and patients. This section provides key points, including information on dosing instructions, laboratory tests, and drug safety. This section is designed to help physicians by providing efficient and concise talking points involving drug usage.1
New design bids laundry lists farewell
The overall structure of the PI has been revised to allow easier access to important information and to group related sections.3 Information physicians frequently consult and consider most critical (ie, Boxed Warnings, Indications and Usage, Dosage Forms and Strengths, Dosage and Administration) are located at the beginning.3,12
The Adverse Reactions section no longer contains a laundry list of adverse reactions and is divided into 2 parts: clinical trials experience (adverse events identified during clinical trials) and postmarketing experience (adverse events reported spontaneously by physicians and patients).8 Additionally, the Warnings and Precautions are now consolidated into 1 section instead of being listed separately.8
The new regulations also require that the PI text be formatted in a certain way. The FDA requires that certain elements be in bold, and that there be a minimum font size to enhance the communication of important information.2,3 (Previously, there was no minimum font size requirement.) Type in the PI can now be no smaller than 6 points and labeling on promotional materials and product samples can be no smaller than 8 points.
Manufacturers worry that details will be overlooked
Manufacturers have expressed concern over the addition of the Highlights section to the PI, noting that physicians might rely too heavily on the condensed information when making prescribing decisions.2,14 Manufacturers are also concerned that they will be forced to choose certain information for the Highlights section while excluding other valuable points, increasing their liability.2,14 The FDA, though, seems to have addressed this issue: The Highlights section includes a limitation statement emphasizing that physicians should still refer to the complete prescribing information.2,14
Another concern: The revisions to the PI come at a price, albeit a relatively small one. Updating the PI is expected to cost manufacturers approximately $6190 for each new product and $8700 for each existing product.2
Overall, though, the revisions to the PI should lead to positive change by providing physicians with access to up-to-date information in a clear, concise, and easy-to-read format. Though not a panacea for medication errors, the new PI should serve as an improved tool in the physician’s arsenal.
Correspondence
Jennifer A. Fass, PharmD, Nova Southeastern University, College of Pharmacy, 3200 South university Drive, Fort lauderdale, FL 33328; fass@nova.edu.
