Pharmaceutical Packaging is Experiencing Rapid Change

By Jay Singh

The pharmaceutical industry in recent years has experienced various fundamental changes in its structure due to the increasing role of substitutes and threats from generic pharmaceuticals and new entrants including the emergence of bio-

pharmaceuticals and the genome revolution. Other factors such as increased buying power and health awareness among patients, aging population, stringent regulatory environments, worldwide compliance to various regulations and emergence of e-pharmaceuticals are reshaping the industry. Global pharmaceutical packaging demand is projected to advance 6.3% annually.

Until recently, pharmaceutical packaging requirements focused exclusively on preserving the efficacy of enclosed drug. These requirements are now being extended to cover such criteria as the prevention of product tampering and counterfeiting, the assertion of product dispensing accuracy, and the promotion of patient compliance with product dosage schedules.

Growth opportunities

Pharmaceutical packaging comes in a variety of forms and uses all major packaging materials. Pharmaceutical packaging is perhaps the most sternly regulated for any type of product globally, with product labeling topping the agenda, and the FDA is responsible for regulating pharmaceutical safety in packaging and labeling.

Prefillable inhalers and syringes are expected to generate the fastest growth opportunities among all pharmaceutical products based on performance advantages in drug delivery. Plastic bottles are projected to represent the largest demand share because of their low cost, versatility, availability, and ongoing quality and design improvements.

Pharmaceutical blister packaging is expected to generate strong growth in global demand based on its adaptability to unit-dose, clinical trial, compliance, institutional, and OTC drugs. Pharmaceutical companies are also looking at 100% recycled paperboard primarily in trays and blister packs for the OTC products. The advantages are two-fold—reduction in packaging costs and an environmentally positive image.

Label hierarchy is key

Pharmaceutical labeling encompasses many things, and requires much more than the information that appears on a bottle or a package. Labeling is a concise and comprehensive statement of the best information about a drug's quality, efficacy, and safety. In the U.S., the rules for the content and format for labeling are set out in the Code of Federal Regulations (CFR) under title 21 concerning The Food and Drug Act. In December 2000, the FDA proposed a new format for prescription drug labeling to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors, and improve treatment effectiveness.

About the same time, the FDA also issued a regulation governing labels for OTC drug products to be espoused by May of last year. On the redesigned label, Drug Facts appear at the top of the information panel and include each active ingredient, its concentration per unit dosage, and its purpose of pharmaceutical action. The Drug Facts portion of the label is followed by uses, warnings, directions, other information, inactive ingredients, and contact information. FDA also set explicit labeling format requirements governing the alignment and punctuation of headings, type size, font characteristics, the use of bullets, dividing lines and graphic images, and procedures for handling multiple panes.

Pharmaceutical packaging regulations are extremely stringent with detailed requirements for labeling. Since the labels need to provide detailed use information and warnings, the labels must be resistant to chipping or scraping so the print—often very small—is always legible. The label also must adhere permanently to smooth or textured surfaces.

Toward better legibility

Earlier this year, for the first time in 25 years, FDA updated the layout of prescription drug package inserts requiring drug makers to provide doctors with easier access to important information about drug safety. This action stemmed from the fact that approximately 300,000 preventable adverse drug events occur every year in U.S. hospitals. These events are often due to sound-alike and look-alike drug names and packages. A stronger focus on decreasing medication errors presents an urgent need to develop packaging systems that are more predictable, more dependable and easier to use. To minimize the possibility of errors, labels should be easy to read and devoid of nonessential materials.

According to research, color contrast affects legibility and when related to warnings and instructions on pharmaceutical labels, yellow and black texts on red backgrounds should be avoided. Black text on white background was the most legible contrast combination according to the study. According to another study, the secondary packaging should not offer clues as to the identity of the product and the lettering of all labels should be in the same font, color, size, and style in order to avoid misleading clues. The study recommended that in order to help reduce errors due to human associative logic, congruity in packaging should be legislated, which will increase the likelihood that the label be read.

To combat the ever-increasing threat of counterfeit drugs entering global markets, overt technologies such as holograms and color-shifting inks as well as covert technologies such as security markers, or taggants are being adapted in the pharmaceutical packaging. According to the FDA more than 10% of drugs worldwide are counterfeit. The track-and-trace RFID technology is also being deployed for authenticating drugs.

The outward minimalism of packaging often belies its intricacy, particularly in the case of pharmaceutical packaging, which has a combined focus on consumer safety and efficacy of the items being dispensed. A variety of characteristics must be united to produce a quality package that meets the full range of needs. These needs may include visibility and shelf life of the product, ease of opening by a consumer of limited dexterity, child resistance, tamper resistance and so on.

Jay Singh is the Packaging Program Coordinator at California Polytechnic State University, and has written extensively on packaging materials and testing. Jay can be reached at jasingh@calpoly.edu.