Completeness of Adverse Drug Experience Reporting to the FDA: II. A Comparison of Manufacturer and Direct Reports on New Molecular Entities

Abstract

Two channels for reporting domestic, spontaneous adverse drug experiences (ADEs) on Food and Drug Administration (FDA) Form 1639 were compared for completeness: 1639 reports submitted directly by health professionals to the FDA versus ADE concerns communicated by health professionals to manufacturers who then sent this information on 1639 forms to the FDA. These two channels were compared on ADE reporting completeness for the first three years of marketing for new molecular entities (NMEs) approved in 1988 and 1989. Completion rates were computed for those FDA-computerized fields on the 1639 form for which completion is not required for data entry (eg, age, sex, ADE onset date) but is necessary for pharmacoepidemiological studies. The two channels were also compared on completion rates for reports containing outcomes of death or hospitalization.

In general, direct reports had higher completion rates than manufacturer reports; for both channels, died/hospitalized reports had higher completion rates than reports with other outcomes. It seems that manufacturers should be able to increase their reporting completion rates since health professionals are reporting more complete information directly to the FDA.

Keywords

Adverse drug events Manufacturer reporting Health professional reporting Drug safety

Get full access to this article

View all access options for this article.

References

Federal Food, Drug, and Cosmetic Act, as amended, and Related Laws. US Government Printing Office, August 1985.

21 CFR §314.80.

21 CFR §310.305.

Johnson

Barash

. A review of postmarketing adverse drug experience reporting requirements. Food Drug Cos Law J. 1991;46: 665–672.

Food and Drug Administration. Guideline for Postmarketing Reporting of Adverse Drug Experiences. Rockville, MD: Food and Drug Administration; March 1992.

Sills

Faich

Milstien

Postmarketing reporting of adverse drug reactions to FDA: An overview of the 1985 guidelines. Drug Inf J. 1986;20: 151–156.

Anello

. Postmarketing surveillance legislation: Structure and results. Pharmaceut Med. 1987;2: 11–22.

Swann

Reinstein

. Annual Adverse Drug Experience Report. Springfield, VA: National Technical Information Service; 1993. Report #PB-93218329.

McEvoy

, ed. AHFS Drug Information 93: American Hospital Formulary Service. Bethesda, MD: American Society of Hospital Pharmacists; 1993.