The Future of Paper Inserts
FDA's proposed format changes and the desire for paperless labeling could have a profound impact on the package insert as we know it today.
by Erik Swain, Senior Editor
The pharmaceutical package insert as we know it is about to change. What form it will end up taking is a matter of debate right now, but between FDA's desire for a reformatting of content and industry's desire for paperless labeling, the package insert that healthcare professionals see in five years should be markedly different from the one they see today.
Easier to read. FDA's proposed rule that would change the labeling format calls for a bigger type size, more-prominent display of important warnings and precautions, and an index allowing healthcare professionals to locate information more easily.
Larger type. The type size requirement will mean more paper is needed to convey the same information. If FDA's proposal for the inserts to begin with a "highlights of prescribing information" section goes through, the insert will need to accommodate even more copy. This could have consequences for the insert equipment and the entire packaging process.
Electronic. If industry's attempts to launch paperless labeling are successful, some products might do away with a paper insert altogether.
Following are some details on how the two initiatives may significantly alter the look and production of the package insert.
FDA's proposed format changes, published in December 2000, call for a minimum size of eight-point type, emphasis on boxed warnings and labeling changes made within the past year, an index to help navigate the comprehensive prescribing information, and, most controversially, a highlights section at the top of the insert that repeats the most important information from the comprehensive prescribing information. [More information about this proposal can be found in the "Regulatory Focus" column on p. 24 of the March 2001 issue of PMP News.] The Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) has objected strongly to the latter proposal, because it may cause healthcare providers to ignore the rest of the insert text and potentially lead to product liability claims. A final rule could come as soon as this year.
While FDA hopes that the pharmaceutical firms will streamline the information they provide on the insert, the industry tends to err on the side of inclusion of information, often because of liability concerns. If the same information is presented in the new format, the insert will become larger, which may have repercussions for production.
"The proposed increase in minimum type size will be a significant paper increase for both the printers and the packagers," says D. Bruce Cohen, a member of PhRMA's Paperless Labeling Task Force. "Some PIs [pharmacist inserts] will increase by as much as 75%. Costs will increase for the PIs, and there may be some equipment changes required to handle the larger sizes. This rule change will push the need for an electronic PI."
So what will give? "Some inserts are very large now, and it may be pretty tough to go any larger," says Peg Slendorn, vice president of Lucas-Insertco Pharmaceutical Printing Co. (Baltimore). "But we are always looking for the newest technology to accommodate our customers."
However, many providers of inserts and insert equipment are preparing to produce a larger product.
"We will lose some smaller formats, because they do not have space available," says Tom Flottman, president of Flottman Co. (Crestview Hills, KY), a member of the RxPerts Printing Alliance. "We have larger formats that will expand as we accommodate the proposed regulations. And there is still more we can develop."
For example, Vijuk Equipment Inc. (Elmhurst, IL) is coming out with new machines to accommodate larger inserts.
"We will soon have new equipment that can handle larger pieces and, in many cases, still fold them down to their previous size," says Ron Salzano, executive director of Lehigh Press Puerto Rico (Juncos, PR). "Another way to keep the folded size down is to use lighter-weight paper. We were using 30–40 lb paper, now it is down to 24 lb."
More companies are being forced into "right angle" outserts, says Ernest Chaplin, vice president of sales, marketing, and product licensing for Pharmagraphics LLC (Greensboro, NC). "The consequences are that their speed of manufacturing is much slower than with traditional ribbon-style strip enclosures. However, the use of PDF files for soft proofing is helping productivity. The circular is the last thing approved by FDA, and that affects the ability of a converter to get up and going quickly on a product launch. If the customer can accept PDF for proofing, we can get everything to press within hours."
"If the labeling is glued to a bottle, a larger format could cause problems on faster lines, and some companies might have to go from an outsert to a folding carton," says Bill Mitchell, executive vice president of PCI Services (Philadelphia), a division of Cardinal Health.
And, says Robert Pictor, vice president of sales for Creative Press Inc. (Evansville, IN), there will be some products whose production won't be greatly affected, even if the insert does have to be larger.
"I've worked with a number of pharmaceutical products that are not affected by an increase in insert size, because the insert goes into the carton anyway," he says.
There is also a question whether upcoming regulatory intiatives on bar coding will have an effect on the insert format proposal. FDA intends to propose a rule later this year that would require a bar code on every pharmaceutical package.
"If you simplify the label copy, that might make room for a bar code, so there might be some tie-in between the two initiatives," says Tom Henderson, vice president of marketing and corporate development for the NOSCO Printing Group (Waukegan, IL) and chairman of the Pharmaceutical Printed Literature Association (PPLA; Falls Church, VA), which represents suppliers of paper inserts.
THE PAPERLESS INITIATIVE
Farther in the future is a possible move to paperless labeling. The PhRMA task force that Cohen serves on has come up with a proposal to make all labeling for all marketed prescription products available electronically at no cost to dispensing locations. Costs would be borne by the pharmaceutical companies that use the system.
The proposal attempts to address the deficiencies of the paper insert: its information is static, while a drug's labeling information is always changing; its oddly shaped configurations often lead to problems on the packaging line; they can cause misbranding if the wrong insert goes in the wrong package; and pharmacists often throw them out.
The system would provide PDF versions of the labeling that would be updated as soon as they were changed, and each pharmacist would be alerted to all changes since he or she last logged on. The goal is to use existing systems so that no extra counter space is taken up in the pharmacy.
Alpha testing to ensure that the system works is about to begin, with five sites testing a stand-alone device and five sites testing a software system that would go onto the pharmacy computer, Cohen says. If successful, the project will then move to beta testing to evaluate whether the system works in a variety of locations and environments.
To succeed, however, the system will have to pass all those tests, plus be accepted by FDA and the pharmacies. Cohen, who is also director of packaging technology, North America, for Glaxo SmithKline (Research Triangle Park, NC), says FDA has been receptive.
"These changes will be driven by FDA—they will make the PIs more user-friendly and easier to read," which are agency goals, he says. "FDA personnel were involved in the early meetings as consultants to the task force. We are waiting for information from FDA regarding their data warehouse setup in order to use it as the source of electronic PIs for the dispensing groups."
The pharmacies may be another matter. So far, the hospital pharmacies have been more receptive to the idea than the retail pharmacies. At a recent PPLA presentation, B. Douglas Hoey, RPh, MBA, vice president of professional and practice affairs for the National Community Pharmacists Association (NCPA; Alexandria, VA), shed some light on why this is the case.
"The current system works," he said. "No one's said ‘paper's driving me crazy.' There could be interference with workflow, and we need to know what the real implementation costs will be. While it is an idea that could have merit, the sharing of savings may be the key to a win-win situation."
Henderson agrees. "The paper insert is a proven technology that works extremely well," he says. "It's not hard to use, and there's no special equipment required to use it."
Whether the system could work in isolated locations is another question.
"In many cases, these are used in unusual places such as ships or other remote locations," says Carl Treleaven, chief executive officer of Pharmagraphics. "These people are without access to electronic means when they need to use the product. And there may be others who have access to a computer, but it's not where they are when they need it."
Another potential twist is a proposed rule that would require drug manufacturers to submit changes in label content to FDA electronically. While this does not specifically address the commercial package insert, there has been some debate as to whether the two issues could become linked.
Cohen says the rule could help the pharmaceutical companies in their switch to commercial electronic labeling.
"It will help set up the workflow from manufacturers to get their PIs into a usable format for electronic distribution. This will make it easier for the industry to switch to an electronic format," he said.
But others see the issues as unrelated. "Some of my fellow industry colleagues feel that [the electronic submission rule] is a possible threat, but I do not," Salzano says. "It's a logical move for FDA to speed up its own processes. I don't see it as a starting point for paperless inserts."
It will be several years before it is known whether paperless labeling will become a reality, but if it does, chances are it will exist side-by-side with paper labeling, as manufactuers decide which to use on a case-by-case basis. "Each manufacturer would look at the revised regulation and decide what works best for their products and their supply chain," Cohen says. "Products that are used in an emergency setting will probably maintain paper."
"If adopted, paperless labeling would have a negative effect on us, but it would not seriously damage us," Salzano says. "There would still be plenty of need for paper inserts for sampling, patients, and physicians."
"We think printed literature is here to stay," Flottman says. "In fact, there may be more of a move to include patient literature with all products. With direct-to-consumer advertising, the consumer is getting more involved in the medication process, breaking down—to a degree—the ‘learned intermediary' relationship with the physician. And with the industry trying to ensure the patient takes the medication properly, the packaging and attendant literature are integral to that process."