Getting ahead of negative outcomes

Post-market surveillance is sometimes slow—or possibly incapable—of detecting problems shortly after medical products receive regulatory approval. This week, we have seen several examples of other systems to identify trends that may indicate potential harm to patients.

Lithium-ion batteries have dominated the news with the grounding of 787 Dreamliner jets after reports of malfunctions that included a fire and a smoldering battery. It appears that one airline, Nippon Airways, had detected an earlier-than-expected need to replace the batteries. Now federal investigators are looking into the matter.

Aviation is held to a high safety standard. Drug and medical device regulators also strive to maintain high safety standards, but passive post-market surveillance may make it difficult to spot red flags quickly. EHRs and surveys offer another pathway for tracking the emergence of adverse events.

This week Roy H. Perlis, MD, of the psychiatry department at Massachusetts General Hospital in Boston, and colleagues reported that they had found evidence of three antidepressants and methadone contributing to QT prolongation. Based on those findings, it may be prudent for physicians to prescribe alternate medications for patients with cardiovascular risk factors.

Another study published in HeartRhythm found a higher incidence of failure in two Riata lead models than had been reported using passive surveillance data. The researchers based their findings on an analysis of responses to surveys sent to 19 Canadian centers that implant cardioverter-defibrillators and two follow-up centers, all sites that participate in the Canadian Heart Rhythm Society’s device committee.

Assessing EHR data that revealed potentially harmful trends on the economic side, Lisa Bergersen, MD, MPH, of the Children’s Hospital Boston, and colleagues queried their hospital’s database in a study designed to assess whether the Current Procedural Terminology code-based relative value unit (RVU) system adequately captures the time, skill and stress components that go into determining a physician’s work RVU during pediatric catheterizations. Based on their analysis, the system falls short and is in need of a replacement. 

The data often are there. More and more cardiovascular researchers are findings ways to access and evaluate that data to inform practice. Are you among them? Let us know.

Candace Stuart

Cardiovascular Business, editor