Pharmaceutical Commerce - July/August 2013 - (Page 24)

Manufacturing & Packaging Drug labels acquire more functionality to improve health outcomes continued from page 1 Fig. 1. 3C Packaging’s newly installed flexo press handles multiple label substrates. Credit: 3C Packaging “Pharmaceutical companies are looking for intelligent and cost-effective packaging solutions that meet diverse requirements and can be adapted to their specific needs,” observes Gene Dul, president, Schreiner MediPharm US (Blauvelt, NY). “Sophisticated labels can offer special functionalities while decreasing the environmental footprint and helping to ensure drug and patient safety.” For years, FDA has emphasized the importance of providing accurate and readable information on drug labels to help educate and involve patients in their care. FDA recently took this initiative one step further by publishing a new guidance covering safety considerations for container labels and carton labeling design for Rx drugs and CDER-regulated biological products. The guidance provides a set of principles and recommendations for ensuring critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product. “The guidance mentions design features that can distract the consumer or provider’s attention away from critical drug information, including product name, strength and dosage form,” notes Hung Le, senior director, innovation, MeadWestvaco Healthcare (MWV; Richmond, VA). “Specifically, FDA notes that adequate container label size is critical to enabling container label designs that help minimize medication errors.” Patient adherence is a critical issue as industry studies reveal more than $300 billion in avoidable medical spending each year. “While patient attitudes play a significant role in adherence, pharmaceutical companies also share in this responsibility,” says Guillaume Kerboul, business consultant director, life sciences industry, Dassault Systemes (Lowell, MA). “Clear, concise directions on packaging are critical to bridging the adherence gap and directing patients to take medication regularly and call out expiration dates.” Patient interaction Indeed, there is a movement among pharma companies to focus their packaging toward the end-user patient as part of an effort to sufficiently engage with them, industry members say. “What that means is rather than including as much information into packaging as possible, pharmaceutical companies are making critical information more accessible through a variety of techniques, including larger fonts and inserts,” Kerboul says. “Focusing on the end user helps pharmaceutical companies play a larger role in helping physicians treat patients.” While patient adherence is a major consideration for drug label design, equally important is the effect it will have on deterring drug counterfeiting. In a report released earlier this year, the Institute of Medicine of the National Academies (IOM; Washington, D.C.) cited a drug industry study which revealed 1,623 counterfeiting incidents in 2011, with more than half involving fake packaging. “There is still much more conversation that needs to take place as an industry to obtain buy-in for the logistics of implementing a track and trace program that will function properly across the entire supply chain, including a discussion of data management at each stop along the way,” MWV’s Le says. “There should be discussion to ensure that the technology can be shared and transferred along the way as the drug moves from the manufacturer to the retailer.” Some of these discussions are taking place on Capitol Hill. In early June, the US House of Representatives approved legislation to establish a track and trace system throughout the pharma supply chain. Supporters hope to reconcile the US Senate version, the Pharmaceutical Distribution Supply Chain Act, in time to submit to Pres. Obama in mid- to late summer, according to published reports. The House version of this bill, the Safeguarding America’s Pharmaceuticals Act of 2013, would establish a national standard of tracking requirements for drug makers, distributors, pharmacies and re-packagers based on changes in ownership. Products are to have serial numbers attached to the individual unit level, and to have some mechanisms in place to trace a drug lot through the distribution process. At the same time, the bill proposes to supplant multiple state laws with a uniform national standard—a desired goal for manufacturers and distributors, who would otherwise contend with a mishmash of varying state laws. However, there is widespread concern that the House bill undercuts the goals of the California e-pedigree law, set to go into force in 2015, which would enhance safety and eliminate redundant regulations, according to published reports. The Senate bill, ratified by committee on May 22, would create a plan for transitioning from a lot-level to unit-level tracing system. During a seven-year period, the major areas of the supply chain would pass and maintain transaction data and history, as applicable, for individual pharma products. At the same time, FDA would create a guidance for industry participants on uniform standards to build an interoperable electronic tracing system. Industry watchers say anti-counterfeiting solutions aimed directly at protecting the patient from fraudulent medication are commonly incorporated into the drug’s primary packaging label. The best security features meet the common sense criteria of “hard to duplicate, easy to authenticate.” Which raises the question of whether anticounterfeiting features will be necessary if the serialization mandate is approved. The answer, experts say, largely depends on the details of the mandate and how it will be enforced. In California, for example, the state drug pedigree law for prescription drugs will take effect in 2015, requiring product serialization and electronic pedigrees to accompany/validate drug distributions to prevent the entry of counterfeit medicine. “Many pharmaceutical manufacturers are not waiting for a serialization mandate,” says Kregg Albrecht, vice president, solutions engineering, Nosco (Waukegan, IL). “They have built security features into their printed packaging to protect their brand and patients alike.” In the near future, some observers predict the combination of anti-counterfeiting efforts, regulatory aspects, and Obamacare will meld into a formidable force that will demand unique serialization. “The minimum mandatory requirement of the lot and batch of the medical device will make the implementation of unique serialization a logical step for corporate entities to limit liabilities and fight counterfeiting,” says Ken Koldan, new business development manager, FLEXcon (Spencer, MA). Customized brand protection can be ensured by multi-level security systems. For Figs. 2, 3. Schreiner MediPharm’s Pharma-Tac Plus label (left) offers patient-administration advantages, and its Pharma-Comb Security labels (right) provide enhanced brand protection. Credit: Schreiner. 24 Visit our website at July | August 2013

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2013

Pharmaceutical Commerce - July/August 2013
Top News
Brand Marketing & Communications
Supply Chain/Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatoryv
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2013