Pharma Labeling Standards Will Help Supply Chains, Patient Safety
Analyst insight: The pharmaceutical industry is making significant progress in standardizing labels and serialization across supply chains.
A group of U.S. pharmaceutical and healthcare providers have shared a snapshot of the industry’s progress in product label standardization — a requirement of the FDA’s 2013 Drug Supply Chain Security Act.
By examining product barcodes in wholesalers’ facilities, the companies checked for four DSCSA-required data elements that support an electronic, interoperable system for identifying and tracing pharmaceuticals. The standardized data will be used to associate the physical product markings with the serialized electronic data exchange required by November 27, 2023.
As of mid 2019, more than 74% of scanned barcodes met DSCSA requirements — a 54% year-over-year improvement. With help from information standards organization GS1 US, nearly 18,000 barcodes produced by 747 manufacturers were scanned at AmerisourceBergen and McKesson distribution facilities. Another 19,000 linear and 2-D barcodes on approximately 8,000 cases from 177 manufacturers were scanned at Cardinal Health.
Prior assessments revealed critical issues that needed to be addressed in order for the industry to approach compliance. Barcode quality was inconsistent in the 2017 and 2018 assessments. Legibility was one issue: Barcodes that were printed on shiny surfaces or certain colors did not scan well. When these issues were identified and shared, manufacturers were able to adjust and fix the problem — which was negligible in the 2019 study.
Both earlier assessments had also revealed discrepancies in how companies encoded expiration dates, sometimes using “00” as the day or failing to include the day altogether. Manufacturers addressed this issue as well; in 2019, very few packages were marked with improper expiration dates.
Expiration dates skew the data in another way, too. The FDA allows products that were placed into commerce before November 27, 2018 to be “grandfathered” or exempt from serialization enforcement. This helped prevent shortages and ensure that patients could get the medications they needed. As these products become consumed or expired in the next year, the percentage of correctly serialized products will increase even more, bringing industry supply chains closer to the ultimate goal of full standardization.