Preparing for patients of the future

Walking through New York City’s Times Square this past June, I noticed a Walgreens ad campaign that was in step with some of the themes discussed during Pharmapack North America 2014’s conference program. By joining Balance Rewards, I could earn Walgreens rewards points for immunizations, testing and logging blood pressure and blood glucose levels, and for setting and achieving fitness goals, among other health-focused behaviors (http://www.walgreens.com/topic/balancerewards/balance-find-offers.jsp). "Make every step rewarding," read a flashing screen in Times Square. I looked down at my own Nike Fuelband and wondered for a moment whether I should join.

As a consumer/patient tracking steps taken, calories burned, and other efforts, I am not alone. According to IHS Technology, the total installed base of sports, fitness, and activity monitors will expand to 120 million units in 2019, up from 84 in 2013 (https://technology.ihs.com/500868/revenue-for-sports-fitness-and-activit...
billion-through-2019). 

Hollander served as a panelist during the Pharmapack North America session, "Forthcoming Pharmaceutical Packaging Innovation: A 5-Year Forecast." Hollander spoke very frankly about packaging’s role during the panel and its need to evolve to interact with such e-health technology. "The patients of the future—us—are technology savvy," he says. So to tackle issues like nonadherence, more than "just a blister package or a nice autoinjector will be needed," he predicts; technologies like nanosensors and others that can interact with smart phones will be necessary for patients who are actively measuring their health outcomes. He believes that the role of packaging in the future will continue, "of course, to be to protect the product and not interact with it, but less on trying to address adherence within the package’s design itself. Instead, those efforts must be combined with independent systems that can interact with our patient, and the package can easily serve as a means to connect that system with the patient or HCP using the product and point to Web sites and apps that patients will use to track their health. As more and more patients track their health through such systems, their behaviors will change and outcomes will improve." So he advises that packaging professionals "think about what their own experiences as patients are and ask what would we want available for ourselves to help us get old better?"

When it comes to patient health, the two big issues currently facing pharma are adherence and correct dosing, reports Edward Dunn, vice president, tech operations, packaging, for McNeil OTC division of Johnson & Johnson. "For prescription pharmaceuticals, the challenge is getting patients to take them regularly, and for OTC products, to fully understand the correct dose for therapeutic effect and not to overdose," he explains. Pharmaceutical companies are working to identify "how best to communicate critical messages regarding these drug products."

Dunn thinks that using "QR codes on products—both OTC and Rx—can connect users to Web sites for such education, especially with regimen-based drugs and lifestyle drugs, so patients have the greatest outcome."

Hollander sees an opportunity to leverage industry’s investment in 2-D codes for serialization for e-health, such as 2-D Data Matrix. "Our companies are investing heavily in technology to support serialization efforts around the world and these same technologies can be leveraged here. By adding an additional GS1 application identifier to the GS1 Data Matrix code we are all targeting to support serialization, we can quickly enable that connectivity between patient/HCP and system. By leveraging existing technology that is designed to print directly on packs during packaging, we can extract value from an investment otherwise seen as one of regulatory compliance."

The challenge, however, is that most of today’s prescription pharmaceutical packaging in the U.S. market does not remain intact—instead, products are very often repackaged, Hollander points out. "Changing this reality will be difficult. The solution could be a blister, but it could also be another package that aims to drive adherence," he says.

Dunn says using expanded-content labels can help expand label real estate, particularly booklet labels for OTC products. He also suggests unit-of-use packaging for prescription drugs, because it provides "an opportunity to introduce or highlight directions," he adds. "There is an interest in blister packaging, because visual clues can be provided for dose counting or days of the week. At the end of a day, patients could be holding the packages in their hands and wondering whether they took their dose." Once weekly products present a huge challenge, he added.

"Companies should go beyond the minimum required," Dunn continues. "They can distinguish their products on the shelf and drive good patient-product interaction."

Presenting labeling information in a patient-friendly way is also critical. "There are tremendous things we can do," says Hollander. "We need to help prevent human error." To this end Pfizer recently redesigned new trade dress using color and layout to ease product identification and understanding.

McNeil is reviewing its packaging, in some instances to standardize features. "We’re looking at new generations of caps that are easier for patients with dexterity issues to open," reports Dunn. "There’s also the need for a blister pack that is senior friendly and child resistant. And portability matters to adherence, but you cannot ignore appropriate storage conditions."

Human factors are being considered more and more today during package and label development, and FDA is reportedly asking more about how design suits users. "Human factors are absolutely critical," reports Dunn. Design of injector pens and metered-dose inhalers, in particular, is critical "for patients to get the correct dose," he adds.

Hollander points out the additional challenge of whether pharmaceutical and medical device manufacturers should design for the patient or the practitioner. "It is, of course, essential to know who is administering the product," he says.

While Dunn agrees that patients are becoming more tech savvy, he questions whether those 75 years and older have embraced the tech world. When it comes to packaging, "we still need visual cues, and more than one," he says. "The package is always going to be the piece that connects you to technology and the product."

John Bitner of Bitner Associates Inc. says that user needs are changing, but he doesn’t see the marketplace changing to meet those issues. "Patients who are aged 65 and older have diminished capability and issues with dexterity, flexibility, and thought processes," he says. "They are also trying to retire, and cannot, and trying to get healthcare and cannot. Labeling, directions, and adherence capabilities are sadly missing."

But Bitner doesn’t advocate increasing the amount of text on the labeling, at least not on front-facing labeling. "How do you get all the labeling on packaging so it makes sense and meets practitioner needs? You should have the information available, but I’d like to see the primary label have only the product name, indication, and dose—very few words. You cannot force or expect the user to read a dictionary."

Bitner says an app designed to integrate with a pharmaceutical package might help with medication adherence, but he questions the use of alarms and buzzers to encourage adherence. "Seniors sometimes really do forget, but alarms and buzzers won’t make patients take medications if they don’t want to," he says. "What does make them compliant is knowledge. Meaningfully educating the patient more than anything will work—not fear-based motivation. If technological innovation can increase communication between a doctor or a pharmacist and a patient, improved adherence will follow."

When it comes to overall packaging development, Hollander says that packaging professionals should consider innovation in package size, weight, and more. "Why is it that the industry is using essentially the same plastic resins for the last 30 years?" he asked. "There could be technologies that allow the use of less resin to obtain the same barrier, as well as new ways to make plastic bottles that lead to more sustainable packages and, of course, cost savings."

Dunn, too, says he’s on the lookout for the "better mousetrap, looking at better materials with good barrier properties, but easy enough to open."

Thanks to recent U.S. Pharmacopeia efforts to provide a "regulatory pathway," professionals can now change materials more easily by demonstrating equivalence between container closure systems based on product needs. "There is now a tremendous opportunity for suppliers to innovate, and those that do will be rewarded," Hollander says.