Medical devices; general hospital and personal use devices; classification of remote medication management system. Final rule.

The Food and Drug Administration (FDA) is classifying the remote medication management systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System," which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients.

OBJECTIVES: Medication errors in pediatric inpatients occur at similar rates as in adults but have 3 times the potential to cause harm. Error prevention strategies in this setting remain largely untested. The objective of this study was to classify the major types of medication errors in pediatric inpatients and to determine which strategies might most effectively prevent them. METHODS: A prospective cohort study was conducted of 1020 patients who were admitted to 2 academic medical centers during a 6-week period in April and May 1999. Medication errors were characterized by subtype. Physician raters evaluated error prevention strategies and identified those that might be most effective in preventing errors. RESULTS: Of 10 778 medication orders reviewed, 616 contained errors. Of these, 120 (19.5%) were classified as potentially harmful, including 115 potential adverse drug events (18.7%) and 5 preventable adverse drug events (0.8%). Most errors occurred at the ordering stage (74%) and involved errors in dosing (28%), route (18%), or frequency (9%). Three interventions might have prevented most potentially harmful errors: 1) computerized physician order entry with clinical decision support systems (76%); 2) ward-based clinical pharmacists (81%); and 3) improved communication among physicians, nurses, and pharmacists (86%). Interrater reliability of error prevention strategy assignment was good (agreement: 0.92; kappa: 0.82). CONCLUSIONS: Of the assessed interventions, computerized physician order entry with clinical decision support systems; ward-based clinical pharmacists; and improved communication among physicians, nurses, and pharmacists had the greatest potential to reduce medication errors in pediatric inpatients. Development, implementation, and assessment of such interventions in the pediatric inpatient setting are needed.