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Compliance features help patients follow medication regimens correctly.
The Healthcare Compliance Packaging Council (HCPC) honored three companies' package designs during its annual Compliance Package of the Year competition in May 2009. The awards were presented at HCPC's annual National Symposium on Patient Compliance.
This year's Compliance Package of the Year, the Prempro Starter Kit from Wyeth (Madison, NJ), combines four pouched blister physician samples of the hormone-replacement therapy with various informational materials. The kit provides 20 days of doses to help acclimate the patient to the regimen. In addition to the pouched blister, the pack includes an informational brochure, a patient-education enrollment card, a prepaid business-reply card, and a patient insert. After reviewing this package, one of the judges commented, "This is an outstanding starter kit with some very innovative features. I like the fact that the most important cautions are clearly and repeatedly spelled out. The M-Powered enrollment form is a novel way of improving compliance."
Wyeth Prempro Starter Kit won Compliance Package of the Year honors from the Healthcare Compliance Packaging Council.
The Compliance Monitoring Package for Suboxone, a drug for treating opioid dependence, was named first runner-up in the HCPC competition because it used electronics and included ample space for product information, branding, and labeling. Designed for a Suboxone treatment study at Kuopio University Hospital of Finland, this smart wallet pack incorporates an electronic microchip to record when tablets are removed from the blister cards within the lockable paperboard carton. The microchip also stores information about the patient's symptoms each day. As a result, the frequency of clinic visits can be reduced from daily to weekly. At each visit, data are collected from the cards for recordkeeping and potential use by the nurse during interaction with the patient.
An electronic microchip in a Compliance Monitoring Package for Suboxone records when each dose is dispensed and offers the potential for remote monitoring of patient compliance.
The study among patients at different stages of treatment showed that the package helped lower treatment costs by nearly 40%. In the pilot study, the package was considered easier and safer than the traditional pouch because blisters could be left intact. In addition, data showed that the majority of patients (67%) took their medication regularly as prescribed.
The winner of HCPC Innovative Design prize inserts a senior-friendly blister card inside a child-resistant secondary package.
According to study leader Ulrich Tacke, if daily visits for supervised drug administration could be replaced by take-home medication, the potential cost savings could amount to €500 per patient per week. In the next phase of the study, Tacke plans to combine the package with real-time transmission of data from readers in patients' homes. Data transmission would enable daily monitoring and make it possible for treatment staff to make contact within hours of observing an irregularity in taking the drug (Pharma DDSi wallet pack, Stora Enso, Helsinki, Finland).
Strategically positioned printing, adhesive, die-cuts and tear strip create a child-resistant compliance pack.
The Innovative Design prize for a yet-to-be-commercialized concept was awarded to a cartonlike plastic bottle with an F=1 child-resistant rating. A simple, push-down-and-slide motion removes the cap and provides access to the blister cards inside. Because the outer package provides child resistance, the burst strength of the pill cavity on the blister card can be minimized, thus improving senior friendliness. Highly portable as well as extremely sturdy, the container is easy to carry and withstands daily handling even with long-term regimens.
Blister packaging machine with tool-less changeover and many easy-to-integrate options simplifies production of compliance packaging.
In addition, the broad surfaces provide ample space for branding and product information. Brand distinction can be increased by customizing the bottle color, size, or label design. The HCPC judges noted, "At last someone has designed a unit dose with a child-resistant feature that doesn't have to be a permanent part of the package." They also appreciated the fact that the package is the size of a typical weekly wallet card, but incorporates four weeks of therapy (Compliance in a Bottle, AmerisourceBergen Packaging Group, Columbus, OH).
We'll be seeing more ...
HCPC competition winners represent just a few of the compliance packages available. A recently introduced compliance pack features a thin, durable outer plastic shell to protect tablets along with a calendarized blister card. It is designed to hold large tablets and support twice-daily dosing regimens (Shellpak 170, MeadWestvaco, Richmond, VA).
Compliance pack benefits
A related design combines a compact size with an attractive appearance. It consists of an outer protective paperboard carton integrated with a blister pack and leaflet or insert. To simplify sourcing and packaging-line operation, informational leaflets can be inserted into the top flap of the package before it's shipped to the drug maker for filling (Dosepak Express, MeadWestvaco). According to consumer research, patients rate the package as "extremely" or "very easy" to use.
A competition of compliance packaging.
At least two wallet-pack designs were shown in March 2009 at the INTERPHEX show. Both patented designs achieve an F=1 child-resistant rating, yet are senior-friendly and compatible with manual and automated assembly. A large billboard area maximizes space for information, brand elements, and detailed dosing instructions.
One design relies on parallel stripes of adhesive to seal together front and back panels of solid bleached-sulfate paperboard. Strategically placed die-cuts and perforations and a carefully registered Tyvek tear strip provide access to the proper dose (CRx Pack child-resistant wallet pack and contract packaging services, Carton Service-Packaging Insights, Norris, TN).
Another child-resistant wallet pack seen at INTERPHEX relies on a laminate of solid bleached-sulfate paperboard–polyester–heat-seal coating and patented die-cutting, which allows access for adults, but keeps kids out. Frequently used for clinical trials, the design is compatible with virtually any blister-card configuration and structure, including cold-formed foil (3C Pak, 3C Packaging, Clayton, NC).
Yet another F=1 wallet pack design was named the Best Compliance Package in 2008 at Pharmapack in Paris. RxPak, a subsidiary of McKesson (San Francisco) will commercialize the child-resistant design in 2010. Available in single or double blister-pack configurations, the design combines compact size with a high level of structural integrity and can accommodate patient-loyalty or reward cards. A patented dual sliding mechanism ensures all the components (i.e., patient-information booklet, blisters, and outer carton) remain intact until the final dose is taken. In one variation, pulling the leaflet carrier causes the blister card to slide out the opposite side, thus providing access to the tablets. Prefolded patient-information booklets can contain 4–24 pages (Burgopak wallet pack, Burgopak, London).
Machines aid compliance
One early user of the dual slider design, Bayer (Newbury, UK), launched its Rennie Ice heartburn and indigestion product in a 12-count pack with two blister cards. The package includes ample space for eye-catching Rennie Ice branding and keeps the patient-information booklet, blisters, and outer carton connected at all times. A contract packager fills the compliance pack (Contract packaging, Brecon Pharmaceuticals, Hay-on-Wye, Wales).
At the contract packager, a 17-m machine handles single or double blister formats at speeds as high as 150 packs/min. A special feeding-wheel technology for fast pick-and-place operation, combined with a transverse product-infeed chain, minimizes format changeover time (Burgopak packaging line, Sigpack Systems, Beringen, Switzerland).
Today's flexible packaging machines are well-suited for compliance packs. For example, one new blister-packaging machine features a modular feeding area that accommodates extensions for multiphase products. In fact, all product feeding drives can be integrated into one unit for a simple exchange of feeding systems. A servo-driven web with gentle, creep-feed startup precisely positions film in the workstations. Other features of the 300-blister/min machine include tool-less changeover, a platen sealing station with integrated cooling and automated monitoring and control of sealing temperatures, extensive machine diagnostics, intuitive operating menus, and smooth machine surfaces for easy cleaning. A retractable transport conveyor rejects faulty or partially filled blisters and simplifies integration with a stacking system or cartoner (OYSTAR IWK Blisterpac BP 5 blister machine, OYSTAR USA Pharmaceutical Packaging Division, Fairfield, NJ).
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org