Alerts needed for adverse drug events

While awareness of the problem of drug safety has grown, the industry is still trying to make a dent in solving the problem. Efforts run the gamut from local to national initiatives.

"There seems to be heightened interest in ADEs, as illustrated by alerts from the Food and Drug Administration (FDA), black box warnings and more oversight," says Craig Stern, PharmD, president, Pro Pharma Pharmaceutical Consultants in Northridge, Calif.

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Richard Platt, MD, chair, Department of Population Medicine, Harvard Pilgrim Institute and Harvard Medical School, anticipates that Sentinel will determine risk associated with certain products and respond quickly; evaluate medical products for risk over time; and evaluate the impact of regulatory decisions made by the FDA.

"Our overall goal is to enable the FDA to have better quality information in their hands earlier and to be familiar with the safety profile of a drug or device," he says.

Prescription Solutions, a pharmacy benefits manager (PBM) based in Irvine, Calif., launched the Drug Interaction Alert Program (DIAP) last August to help patients avoid drug-to-drug interactions (DDI). According to the PBM, such interactions cost the healthcare system $1.3 billion annually and account for one-third of ADE hospitalizations. In addition, an estimated 5% to 35% of outpatients have been reported to experience ADEs, most of which are considered preventable, according to the Journal of the American Medical Society.

"Drug interactions often occur because patients–especially senior adults–are using multiple pharmacies and physicians," says Brian Solow, MD, senior medical director of Prescription Solutions. "It is a huge problem for physicians to keep track of patients who want to do the right thing under that situation."

Among older persons taking at least five medications, one in three will experience an adverse drug event each year, and about two-thirds of those patients will require medical attention. Approximately 95% of these reactions are predictable, and about 28% are preventable, as outlined in a Dec. 15, 2007, article in American Family Physician.

DIAP uses real-time notifications to alert prescribing physicians to clinically significant drug interactions.

"We know we can't afford to bog down physicians with too many alerts so we focus on the most common DDIs, those with the greatest potential to produce unnecessary costs, hospitalizations and morbidity," Dr. Solow says.

Some of these are DDIs between warfarin and drugs such as non-steroidal, anti-inflammatory drugs (NSAIDs); potassium supplements and potassium-sparing diuretics; and statins and calcium channel blockers. For example, the program saved $13,000 per avoidable adverse event between potassium supplements and diuretics.