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PACKAGING RESOURCE CENTER: SHOW COVERAGE

PHOTO: Courtesy of the Baltimore Area Convention and Visitors Association

Today’s dosing regimens are often much more complicated than just taking two pills and calling the doctor the next day. Pharmaceutical noncompliance is a pervasive problem in homes and healthcare facilities across the United States. According to the Healthcare Compliance Packaging Council (HCPC), it is the cause of more than 125,000 deaths per year. The HCPC works to educate, and to promote unit-dose packaging formats that improve patient compliance. The organization’s 15th annual symposium on patient compliance will take place at the Tremont Plaza Hotel and Conference Center in Baltimore, May 15 and 16.

Conference sessions will tackle the issue of compliance from the point of view of packagers and end-users. John Boja, office of compliance, U.S. Consumer Product Safety Commission, will present “Ensuring Compliance with Child-Resistant/Senior-Friendly Packaging Requirements in the United States,” with a special focus on considerations for unit-dose formats. He will provide an overview of packaging requirements included in the Poison Prevention Packaging Act of 1970, as well as steps manufacturers can take to ensure compliance with the regulations. The findings of two studies on patient compliance will be presented in two sessions. Philip Schneider’s presentation, “Improving Pharmaceutical Compliance through Use of Unit-Dose Packaging,” will outline the research conducted by Ohio State University on the impact that unit-dose formats can play in improving compliance with antihypertension drugs. Jeannie Kim Lee, a clinical pharmacist with the Walter Reed Army Medical Center, will provide an overview of research that compared patient compliance rates using drugs dispensed in traditional cap-and-vial closures and using drugs packaged in multiple-medication blister cards prepared at a pharmacy.

Even the most intuitive blister card must be accompanied by drug dosing and content information. FDA requires that labeling and literature be shipped with each container of a prescription drug product.

These labels, or package inserts, are intended to ensure that the drugs are dispensed and consumed safely. Tom Henderson, chair of the board, Pharmaceutical Printed Literature Association, will present, “An Overview of FDA’s New Labeling Requirements for Package Inserts.”

FDA also requires that bar codes be affixed to all prescription and over-the-counter drug products. Philip L. Chao, office of policy and planning, FDA, has been invited to provide an overview of FDA’s efforts to implement this regulation. In addition to dosing instructions and bar codes, labeling for some drug packaging in Europe is now required to include Braille and child-resistant features. Carol Hammond, technical development director, Chesapeake Healthcare Packaging, will focus on the recent European Union requirements and cover case studies on products being packaged for sale in multiple countries in her presentation, “Labeling Prescription Products for the Global Market.”

Because bar codes aren’t enough, Ilisa Bernstein, director of pharmacy affairs, FDA, will provide a status report of FDA’s Pharmaceutical Anticounterfeiting Task Force. She will outline the task force’s goals for the coming year, as well as current efforts to create a national track-and-trace system for legitimate drug products.

Winners of HCPC’s Compliance Package of the Year 2006 awards will be announced at the symposium. A new category called Innovative Design was added to this year’s competition to recognize compliance packages not yet commercially available. Qualifying entries for the other categories were required to be in a unit-dose format, have at least one compliance-enhancing feature, have been commercially available at some point during 2006, and not require drug products to be repackaged by patients.

For more information about the symposium and the not-for-profit trade association HCPC, visit www.unitdose.org.