Drug Management, Quality and Security
There has been keen recognition over the past decade of the potential dangers of not properly protecting our drug supply chain. Many are the stories of countries experiencing counterfeiting of prescription medications and the dire consequences. Even 60 Minutes has reported such issues that helped bring these ongoing concerns to the public and supply companies alike.
Some of the new safety initiatives came via government legislation associated with the Drug Quality and Security Act (DQSA). This act is intended to be a faster and easier process for problem drug recalls from the supply chain and do a better job of protecting the supply chain from illegitimate (counterfeit) drugs.
The complicated system of securing the prescription drugs is only part of the story. Counterfeiting can be initiated as early as the start of ingredients. That suggests the processed prescription drug was actually manufactured with counterfeit ingredients. Understanding these issues creates the recognition that we need to ensure the manufacturing process also accounts for checking the ingredients. The FDA has provisions in their charter to account for some of this, but can we “guarantee” their numerical systems protect the “incoming” ingredients??
There are several ways experts believe is best to track the validation of manufacturing components. The most popular method is to secure ingredients with a pedigree (ingredients with a documented transaction history) thus allowing for a digital signature which in turn can authenticate the product identity. The most popular validation technique in this process would use barcodes.
A second method would be to use an actual barcode as the validation tool. This is done by serializing the barcode data in a customized fashion using custom firmware by keeping random the number sequence by releasing only a specific sequence of numbers or by another customized numbering process. Success is only guaranteed if the barcodes are printed and secured (validated) by the same source. This prevents more than one list of valid barcodes as well eliminating counterfeit product.
Both of the above techniques require barcodes which can accommodate even more security features. However, conventional barcodes (1D) do not have sufficient data capacity to perform certain required tasks. They are also sensitive to print variability (problems). Additionally, limited pharmaceutical package space creates yet another hurdle for traditional linear (1D) barcodes.
Subsequently, the applications will require the law to introduce 2D symbologies (e.g. PDF417, Data Matrix etc.). These symbologies are more forgiving to damaged or poorly printed labels. Data Matrix is more space efficient and engulfs significantly more amounts of data vs. linear (1D) barcodes. More information volume ensures opportunity to enhance and add security information/features. Data Matrix is used today in various pharmaceutical tracking applications in many countries.
However, the entire security system fails to perform if the bar-coded information cannot be read and decoded by the barcode reader. The law should include a requirement that all bar-coded information (reader of label) must be identified and confirmed as an ISO-compliant component. This requirement should be specified for all processes in manufacturing, packaging and compliance.