Case History: Pharmaceutical  July 2013

A well known Midwest pharmaceutical company faced a crisis when their most important customer rejected a shipment batch because of label inaccuracy. Beyond the product and credibility loss, the pharmaceutical house faced potential litigation because it appeared that at least one suspect label had caused a dosing error at a nursing home facility.  The labels in question were produced by a supplier used reliably for many years. Barcode-Test was consulted to determine the cause of label problem and recommend a solution to prevent a future occurrence.

Our label tests revealed a number of problems with the printed barcodes. First, data encoded in the barcodes was incorrectly structured according to the healthcare industry specifications for that type of symbol. Second, the software being utilized in the printing process was producing an illegible product. And Third, the press operators were not properly trained to produce an acceptable barcode for healthcare uses.

The label supplier’s product liability insurance covered the product cost but that didn’t deter the pharmaceutical customer from reaching out to other suppliers for future orders.  In addition, the supplier risked a significant increase in their insurance premiums or even cancellation.  As their customer the pharmaceutical company had done, the supplier looked to Barcode-Test LLC for a solution.

We presented a seminar at the label supplier’s facility to the quality team and press operators. Our one-day seminar included a briefing on unique health care bar code specifications and a demonstration of how these symbols must be structured to comply with the requirements of this supply chain. Then we performed a hands-on practicum on the use of barcode verification equipment, including how to interpret the verification test report in order to improve print quality. Another module focused on appropriate software options for their printing system. The seminar concluded with a lengthy Q&A about the future of healthcare barcoding and how it will be affected by future changes in FDA regulations, now being debated before Congress.

The label supplier now uses Barcode-Test as a sounding board when issues arise with new jobs they are running. Barcode-Test is also assisting the supplier’s Q/C people as they rewrite their quality control policy and procedures manual, so it includes barcode verification.  These steps have resulted in an improved relationship with their most important customer, the pharmaceutical company.  The label supplier has acknowledged that this incident resulted in an expensive but important education which has made them a better supplier and could potentially bring them an additional income stream as they become known for their work in healthcare.