About CERTs

Annual Report Year 2

Focus on the Centers

Arizona | Duke | HMO Network | UAB | UNC | UPenn | Vanderbilt | Publications | Ongoing Projects

Reporting Adverse Drug Events in Infants, Children, and Adolescents

A voluntary system for reporting adverse drug events in hospitalized youngsters is starting to pay off at the University of North Carolina at Chapel Hill (UNC).

The World Health Organization (WHO) has defined an adverse drug reaction (ADR) as an effect that is "noxious and unintended, and that occurs at doses used in man for prophylaxis, diagnosis, or therapy." More recently, the term "adverse drug event" (ADE) has been proposed, as it is more comprehensive. It has been defined as "real or potential injury resulting from medical intervention related to a drug."

These two types of events carry huge costs, in both human and financial terms. Inpatients who have an ADE or ADR have almost twice the risk of dying during hospitalization compared with people who don't, and these events translate into costs of more than $136 billion per year in the U.S. alone.

The risk of a potential ADE/ADR can be up to three times higher in pediatric inpatients than in adult inpatients. Systems that improve the process of using medicines (prescribing, dispensing, administering, and monitoring) can greatly reduce this risk, saving lives and resources. That's what the UNC CERTs aims to develop.

Since 1996, the UNC Hospitals have collected data on ADEs and ADRs from hospitalized infants, children, and adolescents. The UNC CERTs initiative resulted in revision of the Pediatric Adverse Drug Event and Reaction reporting system.

The UNC CERTs decided to adapt this reporting system in order to strengthen the pediatric focus. The overall goal was to develop a comprehensive, convenient reporting system that would not penalize caregivers. Ideally, the system would improve both reporting and patient care, while maintaining confidentiality and protection of the information.

The group, led by Project Leaders Dr. Rowell Daniels, Dr. Tina Hussey, and Jim McCallister, developed a new reporting form that was easy and convenient to complete. The new program also included a pediatric ADE/ADR specialist, more data-entry resources, and a multidisciplinary review committee.

After 6 months of effort, they implemented a pilot version of the new reporting program in the pediatric units in February 2000. It has remained in place ever since (figure 4).

"We have been very excited at the volume of information generated through this process," notes Daniels. "The data have proven invaluable in our efforts to improve patient safety."

"After results are reviewed by our Medication Use Safety Committee, the information is then passed on to the Pharmacy and Therapeutics Committee, Medical Executive Committee, and Board of Directors. This ensures full disclosure within the Health Care System," continues Daniels.

The group recently reviewed 14 months of data gathered from the program. The results are very promising. First, the rate of pediatric ADE reporting jumped 500% during this period, to an average 5.85 reports per day and 232.5 per month. Pharmacists submitted more than 80% of the reports.

More than 70% of the reported ADEs were only potential adverse events, such as prescribing an incorrect dose, that never reached the patient because a nurse or pharmacist intervened.

When broken down by category, ADEs related to prescribing (30%) and order processing (40%) accounted for most of the reports during the first two quarters. Since then, events related to prescribing (25%), order processing (20%), dispensing (25%), and delivery (20%) have accounted for most reports.

The most common classes of drugs involved in ADEs have been antibiotics (48%), H2-blocker antacids (10%), opium-like drugs (10%), anticonvulsants (10%), and glucocorticoids (9%).

The Pediatric Adverse Drug Event and Reaction reporting system is now part of a peer-reviewed process for continuous quality improvement at UNC Hospitals.

As Daniels says, "The results of this program have been so successful that we recently have received additional budgetary support to further expand the pediatric program into all patient-care areas at UNC. We hope that this program will serve as a model and can be replicated at other institutions as a mechanism for improving patient safety."

The group has identified trends in the results and is using them to develop further, targeted interventions. Primary projects for improvement include: missing doses from the Pyxis® dispensing system, missing doses of oral syringes, prescribing errors, processing of orders on the units, pediatric and neonatal total parenteral nutrition, and errors in pump and infusion rates.

In the second phase of the project, the group will assess the effect of these interventions on the ADE reporting rate, the rate of ADEs themselves, costs, and, most important, the outcomes of the infants, children, and adolescents.

To top