by Erik Swain, Senior Editor
As drug manufacturers approach the 21st century, they face a number of challenges. And, surprisingly, packaging can help meet them.
A decade ago, packaging was often an afterthought for many companies, viewed as merely the final step in manufacturing. But now, drug makers are considering packaging earlier in development. They are looking to packaging and labeling as mediums to promote their products, increase patient compliance, and meet recent regulations.
Drug makers are putting more pressure than ever on packaging service and material suppliers to keep costs down, forcing them to become more efficient. Many suppliers have undergone mergers or acquisitions in recent years in order to stay competitive. "The packaging component is a relatively small cost [of a prescription drug], but it is focused on because it is a nondrug cost," says D. Bruce Cohen, director, packaging technology, Glaxo Wellcome Inc. (Research Triangle Park, NC). "Some costs are growing, particularly with new products, so that puts pressure on older products to keep flat or reduce their packaging costs."
Despite the pressure on drug packagers to keep costs down, the demand for packaging is on the rise. The pharmaceutical packaging market grew 4.9% annually from 1993 to 1997, and is expected to increase 7.9% each year between 1997 and 2003, reports FIND/SVP Inc. (New York City). The report, published in January, estimates the drug packaging market at $2.9 billion in 1997, $3.1 billion in 1998, and $4.6 billion in 2003. In addition, organizations such as the Flexible Packaging Association and the Automated Imaging Association have identified pharmaceutical packaging as one of their fastest-growing segments.
Blisters are the largest segment of the market, followed by blow-molded plastic containers, ampules and vials, caps and closures, tubes, accessories, and glass, according to the study. Other products, such as flexible bags, pouches, and prefilled syringes, were combined in the survey to total about 4% of the current market. Blisters and blow-molded plastics are expected to gain market share in the next five years, tubes to hold steady, and the rest to decline—though most only slightly.
Blisters, say those in the industry, are beginning to dominate over-the-counter (OTC) drug packaging. But the prescription drug packaging market is wide open, and nutraceuticals—at least in the United States—are generally packaged in plastic or glass bottles. "Switch products [prescription drugs that are converted to OTC products] are a major factor in the growth of blister packaging," says Patrick Dent, marketing manager, pharmaceutical packaging, for Reynolds Metals/Flexible Packaging (Richmond, VA). There has been a slowdown, however, in such conversions since early 1997, according to Kline & Company, Inc. (Fairfield, NJ).
QUEST FOR COMPLIANCE
According to the Task Force on Compliance (Baltimore), as many as 30% of all prescriptions are not taken properly from the beginning, and as many as 50% are not continued after 1 year. Such misuse can cause a range of adverse drug reactions, including death. The occurrences add up for healthcare providers, so many insurance companies are looking for ways to minimize or eliminate them. Blister manufacturers, reports the Healthcare Compliance Packaging Council, are also trying to expand market share by showing how their products can improve patient compliance. Advocates claim that blister packaging helps clarify drug regimens and reduces the likelihood of overdoses or missed doses.
Actual and projected figures on the size of the pharmaceutical packaging industry.
Projected breakdown of the drug packaging market by segment in 2003.
With such capabilities as its claim to fame, it's no wonder that demand for blister packaging is increasing. But, says David Bloom, president of PharmaQuest Corp. (Des Plaines, IL), a contract research and consulting firm, "I don't think blister packagers have gone nearly far enough because most ethical pharmaceuticals are still dispensed in vials. They have to help the healthcare industry see that unit-dose packaging can lower costs by helping patients use medications better."
Pharmaceutical companies are also eager to enhance the appearance of their products, especially those firms marketing OTC products. The Freedonia Group (Cleveland) reports that the healthcare packaging industry will consume $280 million worth of cartons in 2000. These paperboard packages, with their colorful inks, holograms, embossed faces, and unusual shapes, help to catch consumer attention. And some carton suppliers even count prescription drug manufacturers among their clients.
Blister packaging can be used to this end, as it can display brightly colored tablets in a straightforward, easy-to-understand format. But bottle and vial suppliers are not letting the competition—blisters—gain control of the entire market. Many are looking for new ways to increase clarity and shelf life. Many have made a move toward using polyethylene terephthalate, a recyclable material that combines the clarity of glass with the safety of plastic and acts as a barrier to both moisture and oxygen. The nutritional supplement market, which is made up of many small manufacturers who may not be able to afford blister packaging, is a particularly strong growth area for bottles. And some in the pharmaceutical industry prefer to use bottles because most consumers are used to them and also because they can easily satisfy the Consumer Product Safety Commission's requirements for child-resistant and senior-friendly packaging with the use of a closure.
Polyvinyl chloride (PVC) remains a staple of many pharmaceutical packages, but in Europe, particularly the Scandinavian countries, authorities would like to see alternatives used because of concerns about the environmental impact of the plasticizers and stabilizers (such as lead and tin) used in PVC. As a result, some suppliers are offering polypropylene for blister packaging and metallocene polyolefins for flexible packages such as IV pharmaceutical bags.
Labeling has been the focus of many recent FDA regulations. For instance, an FDA rule, scheduled to be finalized this past July, aims to improve legibility on OTC labels. Word usage on labels would be standardized with simpler language, larger type, and more-prominent warnings and side effects. To help labelers meet this rule, suppliers are offering more-complex kinds of labels, such as expanded-content labels that affix to the outside of bottles and unfold to reveal all of the relevant information. Also, next year a rule will be implemented that outlines what nutraceutical labels must—and must not—contain.
Manufacturers still await a final rule on control procedures for cut labeling. It would require 100% inspection either by machine or by two individuals, or else the use of a dedicated labeling and packaging line for each product and strength. While some packagers complain the regulation will be too costly, others are responding by increasing their use of machine vision to ensure label accuracy. Vision and other packaging technologies, from data-collection systems to robotics used in drug dispensing, are becoming increasingly sophisticated.
Also on the drawing board is the industry's proposal to make changes to the packaging process without prior FDA approval. A written proposal could come within a year, according to the Pharmaceutical Research and Manufacturers of America.
Given the challenges of increasing patient compliance with drug regimens and competing with numerous prescription and OTC products, drug manufacturers may be tempted to turn solely to other mediums, such as advertising or patient inserts. But drug companies should first turn to their packaging. Creatively designed bottles, cartons, and blister packs can help products speak for themselves from pharmacy shelves. Blister packaging presents a drug treatment in an easy-to-understand format that can help prevent accidental overdoses. And expanded-content labels not only help packagers meet FDA requirements but keep the pertinent product information where it is needed most—with the product. All these packaging components, and many others, can help a drug maker grow and stay competitive into the 21st century.