Objectives:

To detect previously unsuspected acute adverse effects of drugs in hospitalized infants and children.

To quantify suspected adverse effects of drugs and evaluate associated risk factors.

Methods:

This program studied pediatric inpatients on selected wards where nurse-monitors collected defined and detailed data on patient characteristics, laboratory data, pre-admission medication use, and discharge diagnoses; they also collected detailed information on all in-hospital drug exposures and on all occurrences of specified adverse events during the period of surveillance, whether or not these events were attributed to drug therapy by the ward personnel.

In addition to monitoring Children's Hospital and the Brigham and Women's Hospital in Boston , the PeDS Program has monitored children on pediatric wards in three community hospitals in the Boston area, at the Eastern Oklahoma Perinatal Center in Tulsa , Oklahoma , and at Children's Hospital of Michigan , in Detroit . The Tulsa and Detroit efforts were funded from private sources in the respective local areas.

In the later years, PeDS Program activities focused exclusively on the risks of medications in the neonatal intensive care unit (NICU), and PeDS monitors were stationed in the NICUs at The Children's Hospital and Brigham and Women's Hospital, Boston .

Data collected by the PeDS Program were reviewed by means of a variety of computer-based screening analyses to detect associations between drugs and adverse events. The data also provide a valuable resource for hypothesis testing and for case reports of specific adverse drug reactions.

Investigators:

Allen A. Mitchell, M.D., Principal Investigator;
Samuel M. Lesko, M.D., M.P.H., Coinvestigator.

Source of funding:

Food and Drug Administration
National Institute of General Management Sciences
National Institutes of Child Health and Human Development
Health Resources and Services Administration
Maternal and Child Health, DHHS

Study Period:

1974 - 1991

Publications:

Link to Publications