It is very normal to have members of an industry become highly resistant to change, particularly when that change may seem to be imposed by lawmakers perhaps not familiar with the challenges of an industry.
This was certainly the case when the Drug Quality and Security Act (DQSA) was passed into law in November of 2013. This created a uniform, national approach to managing drug supply chains that provided protections for all stakeholders involved. This includes the pharmaceutical companies, the investors, the supply chain vendors and the end consumers.
The need for pharmaceutical serialization had already been recognized and addressed by some states, but with the DQSA in place, pharmaceutical companies, and packagers, distributors and repackagers were mandated to meet serialization requirements by January of 2015 and dispensers by July of 2015. This information has to be in fully electronic format by 2017, allowing for full tracking and tracing of all medications.
Eliminating Counterfeit Drugs
It is estimated that before pharmaceutical serialization was in place, there were an estimated $75 billion dollars in counterfeit prescription drugs entering the market. Most of these drugs were produced outside of the United States but found their way into supply chains as if they were directly from the manufacturer or packager.
With serialization in place, these counterfeit pharmaceuticals can no longer be easily brought into the supply chain. Every stop and stage in the packaging, distribution, repackaging and dispensing is now traceable, eliminating the main sources of counterfeit drugs making into the supply.
Help to Reduce Recalls Due to Tampering
For consumers, as well as for pharmaceutical companies and packagers, the use of pharmaceutical serialization will also help to eliminate the risk of tampering with medications. It will not be possible to alter medications and repackage in look-alike packaging as the unique identifiers of the serialization process are designed to avoid this type of tampering.
Serialization offers benefits for both the industry as well as for consumers. While it does require more coordination between supply chain services, it is a positive for the industry.