Key Challenges of Packaging and Labeling in Pharma Products

The Dire Issues of Barcodes and labeling

Barcodes are very standard tools that have been around for decades. Barcodes were first introduced and used in the Pharmaceutical Industry in the 1970’s. Many people do not truly know the critical role that barcodes must perform throughout society. When it comes to the pharmaceutical business, however; barcodes must be assigned to EACH and EVERY individual product before distribution.

Guest post by Marvin Magusara

According to HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain, distributed by Cardinal Health, Inc. with permission from HDMA; The FDA (Food and Drugs Administration), culminated a two-year review process back in February 2004. This two-year review process enforced a rule that required barcoding of the NDC (National Drug Code) on the majority of pharmaceutical and biological packages.

What is this Nation Drug Code? What role does it play and why is it imperative?

The National Drug Code, or NDC for short, is a 10-digit code assigned to all pharmaceutical products to help identify each individual item. A serious problem may arise when this code is incorrect or not applied as should be. The risk of counterfeiting becomes higher without the use of this coding. Pharmaceutical distribution becomes a lot easier with the NDC. The efficient computer systems can now systematically track and trace the outgoing, incoming, and even lost products worldwide.

The NDC is also necessary for labeling. If the label on a package is incorrect, laborers will unknowingly handle the wrong product. Laborers must be able to readily identify cases before processing them. The labels on the cases play an important role because it helps pharmaceuticals companies determine what kind of healthcare product is stored within the case. Homogeneous cases, or cases that harbor only one single product from the same lot, have to be labeled appropriately to identify the kind of product in the case, and how many are stored inside of the case.

It is no question as to whether this method implemented by the FDA is imperative or not. Of course, this conjures up another issue.

How must the National Drug Code be printed?

This question may seem simple. However, the answer is a complicated and complex one. NDC’s must be published in a DISTINCT and methodological order. If the barcode label is written incorrectly without quality assurance; the barcode will also be printed incorrectly and less likely to be looked over again.

The NDC is formulated by a series of numbers within three different formats. Within those formats, the numbers are separated by hyphens (Ex. 0001-4756-23). Each NDC, regardless of the number order, has to always equal up to 10 digits. It’s important to know that even one missing number could be detrimental to the packaging process.

Braille regulations and what they represent

Braille, as you may know, is a particular kind of language to help guide blind people through their daily lives. As sight seeing civilians, we may not show much concern for braille and the importance it has. However, pharmaceutical companies have to consider the idea of making sure all of their patients are satisfied with their product. The society of the blind is still prone to becoming sick due to weakened immune systems.

According to the European Directive 2004/27/EC – Article 56(a), all medicine that is being sold in the European Union must have the product name in Braille on the packaging.

Making sure Braille is printed correctly

The majority of the human population may not know how to read braille, however; the needs of the blind must be met appropriately when deciphering this particular language. A set of principles has been drawn between the EBU (European Blind Union) and the RNIB (Royal National Institute of Blind People) to make sure a provided braille code can be used in multiple European countries. This provided braille code will help many blind patients confirm that they have received the right package. A Braille inspection is a top priority.

Let’s take the time to speculate. Say, for instance, the braille code happened to be printed incorrectly. Not only would this depreciate the value of the pharmaceutical product, but it may also prove to be insufficient for the consumer or patient. A small, or rather, a huge mistake like misprinting could cause a well-known pharmaceutical company to lose out on millions or even billions of dollars. This speculation may sound farfetched, but unless the healthcare company itself thinks about the potential losses, mistakes will be made without a double-check.

Two specific types of pharmaceutical packaging

The way healthcare products are packaged can determine the general outcome of the effectiveness of the pharmaceutical medicine. According to Pharmaceutical Blister Packaging, Part 1, by Ron Pilchik; Packaging by itself has grown to become a $280 billion dollar industry. It has also become one of the largest industry sectors in the world.

There are people of different sizes, ages, abilities, and disabilities that can be affected by the way their medicine is packaged. The negligence of pharmaceutical laborers can cause the seal of a container to be broken or loosely sealed. Blister packaging has proven to be one of the most efficient ways of making sure medicine is free of contamination. It is also proven to keep medication fresh for a longer period of time, increasing the shelf life of the product. Blister packagings have become a universal kind of method to prolong the general effectiveness of healthcare products. This serves a great purpose in allowing consumers to feel confident about their medication. Another type of packaging is a bottle-shaped container.

The good and bad of blister and bottle packaging

As mentioned in the above paragraph, blister packaging helps conserve healthcare medicine for longer and better use. It also protects medication from becoming soiled by the water or by the air. Blister packaging makes it easier for the usually forgetful person to monitor when they have taken their medication. It may seem difficult to point out a negative aspect of blister packaging, however; this method of packaging actually proves to be an issue for the elder community. According to an internal source in the pharmaceutical business, pharmacists are often requested to extract the medication from the blister packages, and then slipping them into bottles. It must be understood that this is a timely process.

Bottle packaging makes it easier for consumers and patients to pour out the desired amount directly into a tool in their hands. Easy access is an important concept, however; this also means easy access for undesired elements. A bottle could very well chip or crack. This error in the package could go unseen. Some bottles containers have loose caps that are not correctly screwed on. With these issues in mind, it becomes easy to notice the big difference in between blister packaging and bottle packing.

Conclusion

Barcodes, labeling, printing, and packaging play important roles in the Pharmaceutical Industry while presenting their own challenges. The labels on case packages or mixed packages should represent what is contained on the inside. Braille should be formatted and printed efficiently to ensure the health and wellbeing of their blind patients are met. When health products are being packaged, the type of package should be considered for effectiveness and safety.