Reporting to Sponsors

The Durham team developed a mechanism for reporting concerns to study sponsors, too. “We communicate any problems with ongoing studies, but we expect limited changes in the short term. Sponsors have been readily accepting of feedback. If there is enough recognition of issues, it can lead to systematic changes to improve safety over time,” Brown said.

The team reports any errors that do occur to multiple parties. First, a note goes in the file that describes the incident and the corrective-action plan to prevent a recurrence. Then, the institutional-review board is notified, and it assesses the risk vs. benefit of the new protocol. The sponsor also is alerted and report filed with the ISMP Medication Errors Reporting Program.

Having identified many areas for improvement in investigational-drug safety, Brown’s on a personal campaign to share with others in the medical community the safe practices his team adopted to reduce medication errors. He recently presented the team’s findings and new procedures at the American Society of Health System Pharmacists Midyear Meeting in New Orleans.

“I received a very positive response to the presentation,” he said. “Patient safety is a priority for other medical centers, as well. What we’re doing here is not ground-breaking; the ideas are not that novel. What’s different is that we’re promoting universal best practices that apply to investigational drugs as well as pharmacy.”

1. Grissinger M. Reducing the Potential for Mistakes With Investigational Drugs. PT. 2011 March;35(3):120-121,138.

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