By David Vaczek
Momentum is growing for new approaches to the complex issue of patient adherence. Compliance packaging is most promising as a component of a tailored adherence solution, based on analysis of patient-level data.
Compliance formats with accompanying literature support patient self-management by making it easier for patients to understand and take their medicines. Self-management is a goal identified by the Institute of Medicine (IOM) as an approach for reducing medical errors.
Noting a paradigm shift in the patient-provider relationship in its report “Preventing Medical Errors,” IOM wrote that “patients should understand more about their medications and take more responsibility for monitoring those medications, while providers should take steps to educate, consult with, and listen to patients.”
At the 2008 EyeforPharma Patient Adherence and Persistence Summit, solutions were described that help patients and caregivers improve the medication experience. Vendors featured products including patient survey programs for reporting patients’ behavior to their physicians, and Web-based solutions that emulate healthcare coaching sessions.
Walgreens presented on the motivational interviewing techniques its pharmacists are using in face-to-face interventions in the drug stores.
Several pharma firms described how they are analyzing patient-level data to appropriately apply compliance programs to patients and subsets of patients, reports Daryl Madeira, marketing director, Alcan Pharmaceutical Packaging, and last year’s Patient Compliance USA chairman. “We are seeing vast levels of innovation happening across the board on how to really get at the noncomplier.
“Customers are not viewing this issue as one-size-fits-all anymore,” Madeira says. “They are willing to invest in patient behavior analysis and modeling to derive solutions for addressing specific brands, and, more importantly, subset demographics within those brands. This is an encouraging evolution,” he adds.
In hand with the closer scrutiny of patient behavior, Madeira says the compliance packaging market is moving toward multiple SKUs and customization. Alcan’s ComplySolutions blister package line was developed to cover a spectrum of needs. The portfolio includes ComplySolutions FOLD, a traditional F=1 wallet card; and ComplySolutions SLIDE, a creative plastic case with a child-resistant (CR) push button. ComplySolutions METER supports complex therapies such as titration, and ComplySolutions DISC is a rotary design that emulates the success of oral contraceptive packaging.
“As pharma dives deeper into the demographics to understand who is not complying and why, the market will look for a breadth of solutions, rather than forcing people into one design,” Madeira says.
Packagers have offered an increasing variety of compliance designs. Solutions include “pocketable” formats such as configurations of the Burgopack, and Stora Enso’s Pharma DDS package. For accommodating more and larger tablets,
AmerisourceBergen Packaging Group offers a two-blister version of its Compliance in a Bottle (CIAB) package. MWV (Richmond, VA) has launched a longer version of the Shellpak.
“There is marketing value in unit-of-use packaging, and I think that is what is fueling the growth today. If you also achieve adherence, the benefit increases exponentially,” Madeira says.
Anderson Packaging (Rockford, IL) is preparing to launch three trade packages in unit-dose blisters. “We have seen many mature products as well as pending new products looking for ways to influence their sales,” says Justin Schroeder, director, marketing and business development. “Studies are starting to prove out the impact of compliance packaging on patient persistence and refills. Brand manufacturer pilot studies have demonstrated 3–6% sales upticks.”
Anderson’s IntuiDose package has gained its first commercial use for a line extension of a pain management drug. The F=1 rated format will be used for trade packaging, pending the customer’s new drug application (NDA) approval, Schroeder says.
The blister in a heat-sealable card is designed for consumer-friendly dispensing. The patient simply pushes the tablets out from the blister side. Tablets egress the package through a perforated chad, and a windowed back panel on which the perforated layer is not visible.
“A lot of child-resistant packages are rather complicated to open, which can be a barrier, such as for patients with arthritis. People then tend to view the package, and ultimately the brand, in a negative light. We have eliminated the peeling, turning, and manipulation that is often necessary with child-resistant designs,” Schroeder says.
The application employs heat seal board, with an Aclar blister structure. “We are running this on our standard equipment at very high speeds, so it is a very cost-effective option,” Schroeder adds.
For trade packaging of another drug with pending NDA approval, Anderson is launching a commercial application for the CIAB package. The blister-and-bottle combination features a child-resistant cap that doesn’t require finger dexterity to open. The package will feature the CIAB configuration for multiple cards.
The contract packager is starting up a line to launch the Howell CR III package from Howell Packaging (Elmira, NY). The format is for trade packaging of a solid-dose line extension awaiting NDA approval. The Howell CR III package supports a lower-cost solution using standard SBS board and glue sealing.
The Blister Card Wallet Machine from MGS Machine Corp. (Maple Grove, MN) assembles the package. “Our traditional carding equipment has been heat-sealed based. We (MGS and Anderson) engineered a new piece of equipment for the glue seal assembly, on a line that will run in our new packaging facility,” Schroeder says.
Several Blister Card Wallet Machines have been purchased and installed since the unit’s launch last year, says Richard Bahr, president and CEO, MGS.
“The machine is modularly designed, so you can create a glued wallet, or fold and close a heat-sealed card. We have customers doing both. Also, it’s configurable for running different formats. We already have been asked to retool to run a different package,” says Bahr.
Carton Services-Packaging Insights has reported running its CRx Pack compliance format on the machine.
MWV has launched the Shellpak 170, a longer version, at 170 mm, of its standard Shellpak 140. The format accommodates larger tablets, or twice-a-day regimens such as 60 tabs for a 30-day supply.
Shellpak was originally developed for Walmart, which currently uses the package for more than a dozen generic drugs in its $4 prescription program, says Ted Lithgow, president, MWV healthcare division.
“We have interest [also] from brand and generic companies in the Shellpak 140 and 170, for distribution to and outside of Walmart,” Lithgow says. The 170 is currently being used for a number of drugs, and will be packaged by International Labs.
MWV’s Dosepak Express retains many of the compliance features of the Dosepak, with the heat-sealed inner card eliminated from the blister pack, which creates one less process during production, along with material and cost reductions.
“We named it Dosepak Express because it can run easily with minor modifications on customers’ established packaging equipment,” Lithgow says.
MGS’s Stealth and Eclipse cartoners have been developed for packaging the MWV formats.
The Stealth continuous-motion cartoner is modified for loading blisters into both Shellpak formats. The Eclipse intermittent multipacker is used by International Labs for packing the Shellpaks into Walmart’s 12-pack pharmacy dispenser cartons.
“MWV developed its own dedicated Shellpak loader [for International Labs]. We saw that there will be interest in the marketplace for a machine with more utility,” says Bahr.
The Stealth can be converted for assembling the Shellpak, and the Dosepak and Dosepak Express, where carded blisters are loaded into the formats’ folded carton configurations. “We took an existing Dosepak line and made modifications to run sample testing of the Dosepak Express. We can now run it on any of our equipment that runs the Dosepak,” Bahr says.
Sharp is using the Stealth for running Stora Enso’s Pharma DDS carded-blister-in-a-carton format.