For years now, contract packagers (or repackagers) who have been waging a hearts-and-minds battle with pharma brand managers to make the investment in unit-dose packaging (UDP; comprising blister cards, wallets, foil and pouches). Lately—with a view toward the shift in healthcare from the next new blockbuster to improved outcomes—they have been reinforcing the good story they have to tell on medication adherence. The Healthcare Compliance Packaging Council’s (Bon Air, VA) upcoming national meeting has been renamed “RxAdherence 2011,” and its members are involved with a new study on the subject with M.D. Anderson Cancer Center (Houston). The UDP-adherence connection is also being promoted by new studies form the Agency for Healthcare Quality and Research (AHRQ) of HHS.
On the plus side, UDP proponents have solid data that demonstrate that this form of packaging maintains better compliance with treatment regiments; that it affords numerous branding and patient-interaction pathways; and that it meshes well with workflows in patient settings like hospitals (so much so that many hospitals repackage pharmaceuticals delivered in bottles into UDP formats). On the negative side, it has a higher cost, usually, than pills in bottles, and in most parts of the retail pharmacy environment, pharmacists prefer to count pills over delivering a blister card or strip of foil-encased pills. UDP also has a harder time navigating the safety strictures of the Consumer Products Safety Commission (CPSC), which pushes manufacturers to provide both “child-resistant” and “senior-friendly” packaging, and has testing protocols for both. UDP designers have produced a steady stream of innovations to meet these requirements.
UDP is widely used for sample packages as an important brand-communication experience and is a near-necessity for drugs with different titrations over the course of a therapy, notably birth-control pills. But the game has been to expand UDP into more of the conventional multiday-dose regimens that are dominated by pharmacists’ pill bottles.
“Clearly, there are many reasons why people do not take their medication as directed,” says Walt Berghahn, executive director, Healthcare Compliance Packaging Council (HCPC; Bon Air, VA). “But the result is always the same; they don’t receive the health benefits of the medication that their health care practitioners have prescribed for them.”
HCPC attributes an estimated $100 billion in lost drug sales and more than 300 deaths daily to patients failing to take their medications in the proper dosage, or on time. Industry studies indicate the top reasons cited for non-compliance are forgetfulness, lack of education and lack of product knowledge. “This means packaging can affect over half of the reasons (for non-compliance) by providing compliance prompting features and educational materials,” reasons Joe Lally, marketing manager, Howell Packaging (Elmira, NY).
The non-adherence to medication issue has gained traction in the past year and is on the radar of more trade groups and health related associations. A case in point is the National Consumers League (NCL; Washington), which recently announced the development of a national education campaign on the importance of taking medications as prescribed. The three-year program—with planning funds from the AHRQ—aims to raise consumer awareness on the subject.
“A significant way that UDP assists in patient non-adherence is by providing a visual cue to act as a reminder in two different fashions,” notes Bill Hartzel, product manager, Catalent Pharma Solutions (Somerset, NJ). “The first being a reminder if the patient took the medicine as prescribed and the second is the indication of the number of doses remaining to remind the patient when the prescription needs refilling.”
New packaging solutions
With a greater focus on patient outcomes, and with an aging, more-prescribed patient population, UDP proponents hope the trends are leaning their way. The high cost of poor patience adherence, and pressures on drugmakers’ and retailers’ supply chains, means the healthcare industry cannot afford to use the same old packaging. The most aggressive research and development of compliance packaging has focused primarily on consumer-based concepts. The challenge has always been related to enabling two critical functions in the packaging arena: consumer acceptance and child resistance.
“With the advancements in packaging technology focused on achieving child-resistant levels of F=1 in CPSC testing through the ‘outer’ package, rather than the primary, there have been great advancements in the packaging field,” observes Kevin Carter, director of new business development at McKesson Pharmaceutical Packaging (San Francisco). “Simple calendarization is proving to be a great success in patient compliance relative to the ‘premium’ typically associated with compliance packaging.”
Some of the latest UDP feature a variety of F=1 designs, such as IntuiDose, IntuiPac, CIAB, DuraPac, and AssuraDose from AmerisourceBergen Packaging Group. “We have always maintained that compliance-prompting packaging plays a vital role in driving compliance through calendarization, convenience, and as a platform for patient education,” explains Justin Schroeder, senior director, marketing and development services, at Anderson Packaging, a business unit of AmerisourceBergen. “What’s interesting is that you are finally seeing all the other tools being integrated into more comprehensive approaches, with pharmacist and nurse counseling, enrollment programs, and other tools being combined with compliance-prompting packaging in a very robust approach.”
An example of this is the Pfizer Toviaz Physician Sample, recognized by HCPC as the 2009 Compliance Package of the Year. The package, developed for the treatment of overactive bladder, utilizes the IntuiDose child-resistant, compliance-prompting design. The design has passed CPSC Child Resistant/Senior Friendly unit dose testing and received favorable scores for senior dispensability.
Achieving the appropriate child resistance level by dexterity and overcoming cognitive barriers to accessing the actual blister card are said to be among the biggest benefits of new compliance packaging solutions. Another benefit is it leaves the blister opening feature as a simple push through aluminum structure, such as the Burgopak solutions McKesson has brought to market. “We provide a full range of innovative adherence programs such as unique pharmacist-to-patient coaching services, financial assistance programs, applied behavioral expertise and insights, and call center reminders that help pharmaceutical manufacturers effectively reach and engage patients,” Carter says. “The combination of our packaging technologies and adherence programs for physician sampling provides a natural transition from a Burgopak sample to a Burgopak trade package, providing brand loyalty and recognition with patients.”
Driving dosage compliance through a patented unit dose design is a key benefit of a topical delivery system from Catalent called the DelPouch package. “Convenient and easy to apply, the DelPouch package allows patients to release contents directly onto the treatment area,” Hartzel explains. “The affected area is not touched by anything but the foam pad, with package discarded after one use, so the patient does not come into contact with either the product or the treatment area, providing a safe, sanitary means of application.” This technology is being explored by prescription Rx, OTC, cosmetics, and beauty products.
Graphic real estate
While such innovative designs provide significant value to the patient and differentiation for the brand, further developments center on incorporating more information space and utility into the blister packaging. This allows pharma companies to provide patient-education materials and clear instructions on the dosage regiment, and, most recently, event technology-based cues to serve as reminders/prompters for truly interactive solutions. The expansion of the message is powerful, experts say, in how one gains the ability to convey information about the dosing instruction, potential side effects, and drug interaction information.
“Graphic real estate is necessary to carry the educational messages pertinent to the product and therapeutic category,” Howell’s Lally says.
Products such as MeadWestvaco’s (MWV; New York) Dosepak Express and Shellpak are calendared UDPs that provide a visual record of when the patient last took their medication. The MWV formats incorporate educational materials and dosing instructions into the packaging so it stays with patients wherever they go, and are said to provide pharma and retailers with better branding and bill-boarding space.
Bristol-Myers Squibb’s Onglyza Physician Sample – submitted by Anderson Packaging and the First Runner Up in HCPC’s 2009 Compliance Package of the Year – features a two-panel Physician Sample folder design which utilizes a coldformed “foil-foil” unit dose blister design sealed into a carded blister. Indicated for the treatment of type-2 diabetes, patient prescribing information is integrated into the package. A pocket is included in the design to facilitate compliance supporting literature, allowing for placement of a wallet reminder card that directs patients to the drug website or toll-free number for further information about treatment and potential savings when filling their script.
By incorporating features to drive patients to relevant therapeutic category support Web sites, the packaging can encourage a relationship between the pharmaceutical company and patient directly. Catalent offers new technology for the healthcare industry which connects the patient with online resources through a smartphone application, right from the package and without taking up valuable real estate. Leveraging imperceptible watermarks, Media Enhanced Packaging technology can be incorporated into packages to provide real-time content management, product-specific messaging, serve up instructional videos in multiple languages, or deliver special offers and coupons directly to the customer.
“Catalent’s Media Enhanced Packaging technology increases patient engagement and improves overall outcomes,” Hartzel declares.
The fact that unit dose formats can be designed with such compliance-prompting features is reportedly helping physician’s samples get a leg up on setting compliance behavior for the eventual therapy. The mainstay for samples is blister packaging, especially when the requirements for the sample are to provide several oral-dose pills, and when promotional and safety information are a key component of the package. “Clients are interested in differentiating their products by providing support materials along with the samples/starter kits and having the packaging assure, through compliance features, that the medication is taken properly,” Howell’s Lally said. “Titration of a pharmaceutical regimen may be indicated and specialized compliance packaging can be a key element in the product’s efficacy.”
While product development is occurring against a backdrop of sample distribution changing to more of an online-request service rather than sales reps delivering samples, the overall purpose and utility of the samples and starter kits remain the same. “Physicians are treating their starter pack or experience kit as way to interact with the patient, informing them about the product itself, ways to understand the disease state and successful management, ways to enroll in support programs, tools for the patient-doctor relationship, and generally providing an ‘experience’ rather than a pocket full of free product that may or may not conclude in the filling of their script,” Anderson’s Schroeder observes. “It’s an investment in creating a lasting relationship and driving medication adherence for healthier outcomes.”
While there has been a downward trend in the volume of sample packs being produced, this has not minimized the importance of samples. Catalent reports having conducted third-party market research with brand management and found that more targeted sample programs are taking place. “Even with the increasing pressures of generics ‘shelf visibility,’ the first patient engagement is vital in obtaining new scripts,” Hartzel says.
Industry studies show markedly improved patient outcomes and drug refill sales when patients receive their Rx drugs in daily-dose blister packs. A new study embarked on by MD Anderson Cancer Center (Houston) is meant to evaluate the impact of bottles and UDP on compliance. According to HCPC, the program will measure the results of compliance-prompting packaging for blood pressure, cholesterol lowering, and diabetes medications, plus aspirin.
An electronic chip embedded into the unit-dose packaging will record each time a patient dispenses a dose. Similarly, the bottle caps on conventional vials will have embedded electronics to record when a patient opens it. “The captured package data needs to be read in the pharmacy, therefore, the patients are being paid to bring back the package to the pharmacy,” HCPC’s Berghahn explains. “The blister packs are from multiple suppliers, which is intended to neutralize the concern that one unit dose pack or another may influence adherence more readily than others.
Healthcare providers at MD Anderson will track measurable health indicators such as blood pressure, A1c (blood glucose) and cholesterol and compare these outcomes with the measured differences in adherence by patients using the unit dose packages or bottles. In this way, the study does not simply measure adherence but also the associated impact on health outcomes linked to better compliance.
MD Anderson operates a CERT (Center for Evaluation and Research on Therapeutics) for the Agency for Healthcare Research and Quality (AHRQ). MD Anderson’s CERT is focused on patient education and adherence,” Berghahn explains.
While such new developments are promising, several hurdles stand in the way of greater adoption of compliance packaging. One of the biggest relates to cost, as production, shipping and storage expenses may be viewed as unnecessary. And there remains resistance in the pharmacy community, observers say, which is reluctant to change the way it does things.
Packaging solutions providers say they are investing heavily in technology platforms to support commercialization of new unit dose formats. They offer flexibility and an ability to respond to what is working with respect to adherence features on a specific UDP, and adjust to improve other features that proved to have less utility than expected. “Having the cutting edge equipment in-house and readily available allows our customers to avoid significant capital investments, a particularly sensitive area in this economy,” Anderson’s Schroeder says. “We also offer the experience and expertise in launching pharmaceutical products, navigating the challenges of CR testing, successful qualification, and easing the general challenges and uncertainties in bringing new products to market.”
Contract packagers say their ability to offer cost-effective compliance packaging solutions is critical to the success of the brands they package for customers. They claim to configure production lines much more rapidly than pharmaceutical clients can in their own in-house operations. “Contract packagers have the opportunity to aggregate more volume from multiple projects to develop their own ROI (return on investment) for further investment in equipment and technology, thus ultimately reducing the barrier to entry for manufacturers,” McKesson’s Carter says.
An ongoing challenge for the UDP industry is weighing the ROI for investing in their format, which is reportedly a more expensive packaging option. But when costs are factored in over a long period of time, industry members say the economic benefits are huge if it results in lower overall healthcare costs, more patients taking their meds as prescribed, and refilling on time.
McKesson reports it is setting up a second pilot study in the next 12 months with its Health Mart pharmacies to determine how the Burgopak package stacks up against Rx drug bottles relative to refill and adherence behaviors. The results from the first pilot, which are expected to include qualitative and quantitative data, will only measure the impact of compliance packaging and are expected to be released this year. This data is considered crucial for vendors in gauging whether to switch their packaging vehicle from a bottle or vial.
Data is viewed as the key driver in convincing brand management to utilize patient adherence packaging, experts say. There are several different studies, such as from Ohio State University, or the Federal Study of Adherence to Medication in the Elderly (FAME), which indicate packaging is a major contributor to increasing patient adherence. “However, most studies incorporate multiple adherence drivers, so it has been difficult to obtain isolated data on just the packaging,” Catalent’s Hartzel says.
In a recent development, Catalent, through a third-party data collection agency, reports it was able to obtain patient level data comparing the same drug in a conventional package vs. a unit dose adherence package. The information revealed a significant increase in refill rates and the brand teams were able to easily convert this into projected revenue. However, providing the initial data is just the start of the conversation.
‘We do not believe ‘one size fits all’ for patient adherence packaging solutions,” Hartzel says. “We believe to improve patient adherence the package needs to incorporate multiple adherence drivers that are tailored to the needs of specific therapeutic areas.” The different types of drivers being addressed with Catalent packages are the inclusion of co-pay cards, increased billboard space, configuration for titrations, and sleek designs for portability and discretion.
Looking ahead, industry members say they remain focused on offering designs that enable packaging that is both functional and serves as a vehicle of communication between pharma companies and patients. Says Hartzel: “We believe that packaging has a unique opportunity to convey a message to patients at the point of use to improve their engagement.” PC