You can develop the most effective chronic care treatment in the world, but it doesn’t help if patients don’t take it as directed. With more drugs being developed for ongoing conditions, it’s critical that patients and their prescribers understand how and when to take their therapeutics.

Compliance packaging is meant to assist patients (and their caregivers) maintain their administration schedule and optimize their treatment’s effetiveness. It can also work to protect patients from accidentally taking drugs when they shouldn’t, and covers the child resistant (CR) category. We asked several packagers and suppliers for their perspectives on the growing market for compliance packaging.

Keystone Folding Box Company sees growth in the compliance packaging market, as evidenced by the Walmart’s adoption of the company’s Ecoslide-RX. According to Ward Smith, Keystone’s director of Marketing, it was a challenge to develop an all-paperboard package that meets the strict regulatory requirements set forth by the U.S. Consumer Product Safety Commission (CPSC).

“Our package has been tested per the CPSC’s protocol and received an f=1 Child-Resistant rating, as well as a Senior-Friendly rating. In the current ‘green’ climate of many large organizations, having achieved such a high rating with a package that is classified as ‘sustainable’ is very meaningful. Competing compliance packs that have been commercialized are either not as green or are not as manufacturing-friendly. Our package has run in automated filling lines at rates as high as 250 per minute, which helps make the total delivered package cost very attractive,” said Mr. Smith.

Keystone’s Ecoslide-RX has no plastic, is made of 100% recyclable material, and reduces the film and foil requirements that other paperboard compliance packs tend to have, according to Mr. Smith.

Angela Roggenhofer, National Sales Manager of Tekni-Plex, Inc., a developer and manufacturer of packaging and tubing products, mentioned several current trends in compliance packaging:

• “Since more and more drugs are moisture- and oxygen-sensitive, customers are looking for any type of Barrier packaging.”
• “The search for more sustainable materials continues. Our offerings of PVC-free materials, such as PX and PXA, are drop-in solutions not requiring any changes in thermoforming and tooling equipment. Plus, they provide energy savings due to lower thermoforming temperatures.”
• “Generic drugs and nutraceuticals seem the most inclined for ALU-LOOK films, combining the look of foil and the advantages of thermoforming.”

Through its Tekni-Films unit, the company offers mono- and multi-layer films and foils for pharma packaging applications.

Constantia Flexibles has developed a paper-free, child-resistant blister lidding foil with upgraded peel/push functionalities for consumers and an efficient packaging process for manufacturers. The solution, called easy-PIESY, is an aluminum/PET/aluminum lamination that — due to its absence of paper — requires less heat during the sealing process than traditional paper-back foil structures. According to the company, the new product is hassle-free to adopt: no modifications to existing heat-seal lacquer are necessary, nor is new or additional tooling needed.

Despite this, Frederick Lutz, Constantia Flexibles’ regional sales manager, North America Pharma Segment, sees minimal traction for the adoption of compliance packaging in North America. “Compliance packaging seems to be the focus of a good amount of favorable discussion, but the action of actually incorporating it has seen relatively slow progress.” Part of this, according to Mr. Lutz, is due to a lack of support from FDA. He noted, “However, retailers such as Walmart are taking leadership roles in adopting compliance packaging, which is an encouraging sign.”

Justin Schroeder, senior director of Marketing and Development Services at AndersonBrecon, told Contract Pharma, “We’ve seen continued strong interest in compliance prompting packaging. As we meet with clients to better understand the particular characteristics of their drug and the associated disease state, we try to ensure that the program takes a strategic and comprehensive approach to patient compliance and adherence. This is true both for clinical trial supplies as well as commercial products. Has the team taken a holistic approach in addressing the factors by which patients are non-compliant or non-adherent? Although it is true that adherence is poor across the board in the U.S., every disease state and patient population has unique factors to consider.”

Mr. Schroeder noted research showing that patients can have simple reasons, such as forgetfulness or confusion, but also many cognizant reasons or choices for not taking their medication as prescribed, including cost, side effects, fear, inconvenience, and other considerations. He added, “Quite often we see adherence programs start well intentioned, but commonly fade because they lack continuity amongst these many elements and lack specific tools to measure effectiveness and ROI. Clients may be implementing several strategies that can be very effective tools when combined, but they generally are taking a shotgun approach that does not capitalize on those synergies. Programs need to be carefully planned with specific measurement intervals and effective methods for measurement. Packaging can be very effective at providing the central point to interface with the patient on these multifaceted programs and interventions.”

AndersonBrecon was cited for its involvement in the 2010 and 2011 Compliance Packages of the Year, awarded by the Healthcare Compliance Packaging Council (HCPC), a non-profit trade association founded in 1990 and devoted to improving patient adherence through intelligent packaging. The 2010 winner was Novartis’ Diovan HCT, and 2011 was Novartis’ Tasigna Starter Kit. (See the end of this article for a full list of the 2011 winners.)

The Diovan package (MWV Shellpak™) is a 30-day trade package dispensed at pharmacy. In addition to providing product in a unit dose format that clearly identifies the dosing regimen, it incorporates several elements to address the other factors of non-adherence. There are tools for learning more about hypertension and blood pressure management, enrollment devices for more information, savings for script fills, and more.

The Tasigna Starter Kit takes a similarly comprehensive approach in the Oncology space. It includes 14 days of therapy in a unit dose compliance pack (MWV Dosepak™) that is paired with several tools to get patients started on their medication regimen effectively, including a dosing wheel to identify when they can and cannot take food, a CD and USB device with more electronic and interactive education information, information for discounted script fills as well as tools and support for ensuring reimbursement, a guide for tracking various tests and results such as white blood count levels, and more.

These programs recognize the importance of getting the individual patient invested in compliance, and ensure that a broad range of issues are addressed concisely and effectively.

Walt Berghahn, HCPC’s executive director, remarked, “It’s exciting to note that a major pharmaceutical manufacturer and a major retail pharmacy have teamed up to provide patients a tool that will assist them in becoming more adherent.”

“These are two excellent examples of utilizing packaging as more than simply a delivery mechanism,” said Mr. Schroeder. “Both programs demonstrate that when taking a strategic approach, packaging can be a very cost effective tool to deliver a wealth of information and assistance to patients in working towards better health outcomes.”

In collaboration with Novartis, Xcenda recently published a study analyzing the effect of these elements and their positive impact on patient adherence (http://bit.ly/SR9KJL). The 17-month study measured the medication possession ratio (MPR), proportion of days covered, and refill timing of more than 4,500 patients who received their Diovan in the 30-day color-coded, calendarized reminder package that stated when the prescription should be refilled near the end of the regimen, along with an equal number of patients who didn’t get the reminder packaging. The patients with the reminder package had a 7% higher MPR, a 13% higher proportion of days covered, as well as a refill timing that was four days earlier than those without the reminder package.

Said Mr. Berghahn, “The fact that they have publicized this information in an open access journal signifies that compliance-prompting packaging is finally being widely recognized as an efficient method of improving adherence and, as a result, improving patient outcomes.” HCPC added the findings to its recently released whitepaper, Decades of Research Studies Support Improved Patient Adherence With Calendarized, Compliance-Prompting Packaging, available at hcpconline.org.

HCPC cites studies indicating that patients failing to take their medications (not always due to packaging) result in around $300 billion in annual healthcare costs, and that 125,000 people in the U.S. die each year due to poor medication adherence. With healthcare costs and outcomes both becoming major flashpoints in our national conversation, it makes sense for pharma companies, contract packagers and component suppliers to work together on developing the best compliance packaging programs they can.  

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2011 HCPC Winners
Compliance Pakage of the Year: Novartis’ Tasigna 150/200mg Physician Sample
First Runner Up: Forest Pharmaceuticals’ Viibryd™ vilazodone HCI tablets, 30-day Treatment Pack 
Second Runner Up: Walmart’s New and Improved Shellpak® Adherence Package (from MWV)
Innovative Design: Burgopak Rx Series Child Resistant Slider

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Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com.