Karmanos Cancer Institute Implements New Bar Code Validation Software for Clinical Trial Drugs

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The Barbara Ann Karmanos Cancer Institute’s Investigational Drug Services (IDS) has implemented a new bar code validation program to fill prescriptions of patients participating in clinical trials safely. The program provides an extra layer of accuracy within IDS, which provides medications for patients involved in clinical trials.

IDS staff worked closely with The McCreadie Group, the company that developed the bar code validation program, to implement the software into everyday use for investigational medications. As prescriptions need to be filled, staff will enter the prescription into the computer system, select the investigational drug from the shelf, and scan the IDS-generated bar code on the prescription bottle or box. This step helps to avoid pulling an incorrect drug or lot number for a patient’s dose. IDS has been involved in the development of this system since the summer of 2022 and will be The McCreadie Group’s first institution in the U.S. to fully implement the program for investigational drugs.

“It is extremely important to avoid errors when filling patient prescriptions, and this is a tool we’re delighted to say we had a hand in developing,” said Stephen T. Smith, MS, RPh, FASHP, chief pharmacy officer at Karmanos Cancer Hospital and KSP. “Our IDS team worked well with the developer of this technology to make sure the process works for us and also so that it can be implemented in other pharmacies across the country that fill prescriptions for patients enrolled in clinical trials.”

The bar code validation program started with an idea that came from Joseph Schiavi, R.Ph., manager of the Investigational Drug Services at Karmanos, in March of 2022. Schiavi saw an issue: current software across the board only works when drugs have manufacturer-created barcode labels, but when it comes to investigational drugs, many do not have bar codes. As he brainstormed, he came up with a plan that incorporated the idea of a bar code system for investigational drugs. The IDS team reached out to many companies, but none of them had the technology at that time to process investigational drugs. In the summer of 2022, The McCreadie Group contacted the IDS team to introduce their new bar code validation software idea. From there, IDS worked closely with The McCreadie Group to develop the software for investigational drugs.

“In January 2023, they spent time on-site with us to show us the program. They gathered our feedback and edits to increase the functionality and the software, overall and they came back in June to show us the new version,” said Schiavi. “Once we had a working product, we began the process of barcode labeling all of our current investigational drug inventory and new shipments. It’s great to see an idea come to fruition and also successfully work to avoid errors.”

The IDS team at Karmanos fills prescriptions for investigational studies and clinical trials. They work closely with the Phase 1 Clinical Trials Multidisciplinary Team at Karmanos. Completing a project such as a bar code validation program is an example of Karmanos staying committed to quality care, patient safety, enhancing processes and improving outcomes. In November 2023, IDS fully implemented the bar code validation software for dispensing oral and IV medications to patients currently in clinical trials. Karmanos plans to expand the bar code validation program to additional Karmanos Cancer Network locations across the state.