Packaging service providers are being called upon for support over a range of critical issues confronting the pharmaceutical industry.
Suppliers of materials, packaging machinery, and software are supporting "right-the-first time" or
quality-by-design initiatives for cost effectively ensuring quality in package production.
Higher output manufacturing and lean inventory practices have advanced with more efficient and flexible machinery and film structures designed for higher production speeds.
Vendors are offering services to assist packagers in evaluating lines for overall equipment effectiveness (OEE), as integrated control of line equipment reduces downtime and waste.
For quality control extending beyond the doors of manufacturing, contract packagers and converters have established capabilities for unique product marking and RF tagging, as track and trace standards develop and package coding requirements are implemented globally.
Innovation is similarly proliferating in cold-chain packaging and tracking, as a growing body of worldwide mandates require assurance of product integrity from the dock door to the end-user.
Proposals to reform the healthcare system that focus on patient outcomes and limiting avoidable costs stand to influence how the marketplace views packaging. Drug companies can drive patient volumes and gain favorable advantages from healthcare providers with packaging that effectively communicates with patients and ultimately improves health system costs.
Newer compliance packaging that caters to patient preferences for convenience and ease of use while supporting efficient manufacturing are driving adoption of unit-of use packaging.
Growth in Unit-Dose
Sales forces have been drastically reduced at many major pharma companies as result of mergers and through cost-improvement initiatives. To promote their product with doctors and patients, drug manufacturers have stepped up sampling programs with more comprehensive sample packaging.
Catalent Pharma Solutions (Somerset, NJ) offers the HingePak, RxBarrier Plus, NextPak, and Pill Calendar compliance packaging formats.
"As companies reduce their sales forces, we have seen a tremendous increase in interest in our formats. Customers are focusing on the effectiveness of sampling in the marketplace," says John LaHaye, vice president of business development, U.S. commercial packaging, Catalent Pharma Solutions.
"If you have less feet on the street, you have to look at creative ways to distribute the samples, along with specific promotional and compliance messages to the doctors," LaHaye says.
Brands can differentiate themselves and brand their product in the market by moving to high-end compliance packaging from simple pouch or bottle packaging. "Major brands are seeing that if they put more dollars into the packaging and kitting, they can get more readership from doctors. You can embed materials for the doctors, such as very specific ‘dear doctor" messages, combine these with promotional and compliance materials, and direct ship to the doctor’s office," he says.
LaHaye says a recent study by a sample fulfillment house showed that physician readership increased to 90% from 40% when mailed sample kits with targeted promotional messages were used.
"We don’t have data for the impact on the patient level, however the pharmaceutical firms would not be moving in this direction if they were not getting positive results," he adds.
Anderson Packaging (Rockford, IL) is developing compliance blister trade and sample packaging formats for four drug brands, two of which have started commercial production in the Intuidose package from Amerisource
Bergen Packaging Group after gaining new drug application approval.
|The starter pack for Toviaz features the Intuidose format from Anderson Packaging.
"We have always felt we were talking up the chain to try to get adoption on compliance-prompting packaging. Now we are starting to get inquiries from all of our major customers. We have seen significant momentum toward compliance formats," says Justin Schroeder, director, marketing and business development, Anderson Packaging.
Anderson is packaging a drug for treating an over-active bladder condition in a comprehensive four-panel Intuidose starter pack that includes a patient guide booklet, daily tracker and 12 week plan, and a patient insert.
Kirk Kaminsky, senior vice president, McKesson Pharmaceutical Packaging, RxPak, and Sky Pharmaceuticals (Memphis, TN) notes that "a true shift to compliance packaging in the retail market" is underway.
"Cost and acceptance have been the limiting factors historically. As the technology has improved, more and more manufacturers are seeing the real benefits from the standpoint of patient adherence and brand differentiation," Kaminsky says.
Cold chain concerns
McKesson first commercialized the Burgopak in the United States with a customer’s sample kit and plans to launch the child-resistant version of the package in the middle of next year.
"We believe the Burgopak will be the next phase of this transformation from bottles to blisters. Customers we talk to believe it is differentiating technology that can drive adherence and ultimately volumes and patient outcomes," Kaminsky says.
As regulations have developed in the United States and overseas on cold- chain management, vendors are offering advanced technology in shippers and logistics programs for container system refurbishment and reducing shipping costs.
"We have found that people are becoming more savvy about available solutions. Recent guidance such as from the International Air Transport Association is evidence of the growing importance of adequate cold chain controls," says Narendra Srivatsa, business development manager, Cortegra (Fairfield, NJ).
Cortegra offers reusable electronic temperature recorders with software for documenting shipment status and temperature profiles. "For reliably providing data on temperature excursions, any data recorder has to be able to withstand the pressure differentials in aircraft. We are promoting the wireless RF Temperature Data Card, which captures supply-chain tracking information besides cold-chain temperature data," Srivatsa says.
Labeling requirements are fueling demand for package inserts (PIs) in the enhanced PI format and for Med Guides distributed with prescription drugs.
"More PIs are moving to the new format [to meet format conversion deadlines]. [Also,] one of manufacturers’ key strategies is to get new indications for a drug, in which case the new format is required," says Thomas Henderson, vice president, sales and marketing North America, Chesapeake Pharmaceutical and Healthcare Packaging. Chesapeake has helped customers with label insertion on their packaging lines. The firm offers the Multisert outsert for delivering MedGuides and PIs for distribution at pharmacies.
"Working with our Six Sigma experts, our customers have focused on inserting our printed components without sacrificing line speeds. These teams have reduced downtimes by 90%," Henderson says.
Labeling practices are likely to undergo further reform, both in label content and in methods for literature distribution.
At a recent FDA workshop on providing consumers with effective drug information, participants discussed the value of having one standardized document for dispensing with prescription drugs. It was noted that manufacturer-supplied Med Guides are often not distributed with the medication at the pharmacy, and pharmacy-supplied consumer medical information (CMI) continues to vary widely in content and quality.
"The experts are saying that key drug facts are not included in FDA labeling, and FDA is saying the information being provided to consumers is inadequate," says Henderson.
"Part of preventive medicine is involving patients more in their care by providing critical and accessible information. I think the North American market will move toward a fuller leaflet," Henderson says.