Patient Safety and Quality

Use of voluntary reporting along with other strategies best identifies adverse drug events affecting children

Clinicians typically use medical chart review, voluntary reporting, or computerized adverse drug event (ADE) surveillance to identify pediatric ADEs. However, a new study found that surveillance did not detect ADEs in children as well as in adults.

The best approach to detecting pediatric ADEs is use of voluntary reporting in tandem with targeted chart review and computerized surveillance, conclude Jeffrey Ferranti, M.D., M.S., and Duke University colleagues. They found that voluntary reporting efficiently identified administration errors, while chart and computerized surveillance excelled at detecting ADEs caused by high-risk medications and identifying evolving conditions that may provoke imminent patient harm.

The researchers evaluated all medication-related events detected by the Duke University Hospital's computerized surveillance and safety reporting systems over a 1-year period. They scored ADEs for severity and causality and assigned each a drug event category. Of the total 849 medication-related reports entered into the safety reporting system, 93 caused patient harm, resulting in an ADE rate of 1.8 events per 1,000 pediatric patient-days. The two methods of detecting ADEs did not duplicate each other, but were complementary.

The most common events identified by the voluntary safety reporting system were failures in the medication use process (27 percent), drug omissions (16 percent), and dose- or rate-related events (13 percent). The most frequent ADE surveillance categories were nephrotoxins (21 percent), narcotics and benzodiazepines (19 percent), and hypoglycemia (11.5 percent). Most voluntarily reported events originated in intensive care units (72 percent), whereas surveillance events were split evenly across intensive and general care. The study was supported by the Agency for Healthcare Research and Quality (HS14882).

See "Reevaluating the safety profile of pediatrics: A comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment," by Dr. Ferranti, Monica M. Horvath, Ph.D., Heidi Cozart, R.Ph., and others, in the May 2008 Pediatrics 121, pp. e1201-e1207.

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