Are you ready for DQSA? No, it’s not the newest treat from Dairy Queen!
The Drug Quality and Security Act (DQSA) was signed into law on November 17, 2013. It includes the Drug Supply Chain Security Act (DSCSA), which outlines the steps to build an electronic, interoperable system to identify and trace prescription drugs throughout the supply chain, from manufacturer to pharmacy or provider office. Certain portions of the law are scheduled to take effect on November 17, 2017, although there is a Food and Drug Administration (FDA) exception that extends the compliance date to November 17, 2018. Other portions of the law have compliance dates that range until 2023.
Under the law, the FDA is required to develop standards and guidance documents and conduct pilot programs and public meetings to ensure that implementation of the law’s requirements occurs effectively and efficiently. Many in the industry, including manufacturers, distributors, and pharmacies, are working with the FDA to gather input and create the required standards and documentation.
According to the FDA, “the system will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.”
Some components of the law took effect in 2015, including the verification requirements that impact pharmacies. Among these requirements are:
- Providing product tracing information
- Knowing how to handle suspect and illegitimate product
- Confirming authorized trading partners
The bar code problem
The primary DQSA issue today is that of a change in the bar code on the packaging label. Manufacturers have begun to remove the traditional linear bar code, GS1 UPC-A, and replace it with a GS1 DataBar. The GS1 UPC-A uses a GTIN-12, which contains the NDC, a key to product identification throughout the supply chain. The new bar code will contain the NDC, plus a serial number, lot number, and expiration date.
Downstream stakeholders are experiencing issues as the removal of the GS1 UPC-A is negatively impacting processing efficiency and patient care for wholesalers and dispensers. The GS1 UPC-A is readily scanable using current technology, while new scanners and technology are needed to read the GS1 DataBar. Most dispensers were planning for this change to take effect no later than 2020, when they are required to comply with this component of the law. As such, the necessary technology is not in place to scan and use the data in the GS1 DataBar, requiring manual processes be developed and implemented in the interim. Dispensers use scanning technology throughout their prescription processes — from inventory receipt through dispensing — and it is critical to patient safety. The changes needed to support the new technology will require software updates, hardware changes, and staff training, all of which require time and money.
Manufacturers should consider reverting to packaging that includes the GS1 UPC-A, either singly or in conjunction with the GS1 DataBar. This is one potential solution that will allow the rest of the industry to safely continue the supply chain, while also allowing for alignment in the industry as it moves to the new bar code system.
Dispensers should work closely with the suppliers and software vendors to ensure that they are prepared to safely maintain the supply chain and comply with the law.
- The FDA website offers a number of resources, including those related to drug supply chain security.
- NCPDP recently published a white paper on the GS1 DataMatrix
Marsha K. Millonig, MBA, BPharm, is president and CEO of Catalyst Enterprises, LLC, and an Associate Fellow at the University of Minnesota College of Pharmacy’s Center for Leading Healthcare Change.