A review of the Food and Drug Administration (FDA) Adverse Drug Reaction (ADR) file system. This paper describes the current operations for maintaining the on-line computerized data entry, storage and retrieval programs, and the microfilm retrieval system. Other technology developments discussed include data diskette exchange and laser disc storage and retrieval.
FaichGA. ADR monitoring. N Engl J Med.1986;314: 1589–1592.
2.
TurnerWMMilstienIBFaichGAArmstrongGD. The processing of adverse reaction reports at FDA. Drug Inf J.1986;20: 147–150.
3.
SillsJMFaichGAMilstienJBTurnerWM. Postmarketing reporting of adverse drug reactions to FDA: An overview of the 1985 guidelines. Drug Inf J.1986;20: 151–156.
4.
FaichGAMilsteinJBAnelloCBaumC.Sources of spontaneous ADR reports received by pharmaceutical manufacturers. Drug Inf J.1987;21: 251–255.
5.
BaumC.FaichGAAnelloCForbesMB. Differences in manufacturer reporting of ADRs to the FDA in 1984. Drug Inf J.1987;21: 257–266.
6.
AnelloC.Postmarketing surveillance legislation: Structure and results. Pharm Med.1988;879(2):11–22.
7.
DreisM.Routine uses of FDA's spontaneous and manufacturer's reporting system. Paper presented at the Drug Information Association meeting, Baltimore, MD; 1989, March 25.
8.
ForbesMBPerezAEGelbergA.FDA's adverse drug reaction drug dictionary and its roles in post-marketing surveillance. Drug Inf J.1986;20: 135–145.
9.
DavisDDreisMWGelbergA.Electronic submission. Workshop presented by the Division of Epidemiology and Surveillance, FDA, Rockville, MD.; 1988, May 16.
10.
GelbergAArmstrongGD. A study of the utilization of FDA's adverse reaction data base. Drug Inf J.1990;24: 785–793.
11.
DongMHAnelloCJuergensJPTurnerWMGelbergAArmstrongGD. A microcomputer-based data entry system for reporting adverse drug reactions in the United States. Drug Inf J.1988;22: 61–70.
12.
DobbsJH. A pilot study of electronic submission of periodic reports to the FDA: Flexible diskette submission — Glaxo program development. Drug Inf J.1988;22: 59–60.
13.
DongMHTurnerMWJuergensJP. Form FDA 1639 data entry. The personal computer system (user's manual). FDA 1987, Rockville, MD.
14.
AnelloC.Electronic submission of periodic reports. Drug Inf J.1989;23: 221–224.
15.
KennedyD.FDA's state contracts — an overview. Paper presented at the 25th National Meeting, Drug Information Association, Boston, MA. June 20, 1989.
16.
Thatcher-RenshawA.Rhode Island's adverse reaction reporting program. Paper presented at the 25th National Meeting, Drug Information Association, Boston, MA; 1989, June 20.
17.
NissmanEFIezzoniDG. Report on a WHO ART-COSTART translation project. Drug Inf J.1989;23: 75–79.
18.
COSTART, 3rd ed. National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (PB90-500190; PB90-500208; PB90-114026/A5); or Drug Information Association (DIA), P.O. Box 3113, Maple Glen, PA 19002.
19.
KennedyDLGoetschRADreisMW. Use and reported adverse effects of new chemical entities. Am J Hosp Pharm.1989;46: 558–565.
20.
PerryZABrittALKnappDE. Annual adverse drug reaction report: 1988. (Available from NTIS, 5285 Port Royal Road, Springfield, VA 22161. PB89–191316/AS).
DreisM.The COSTARTed label as a monitoring tool. Paper presented at the 25th National Meeting, Drug Information Association, Boston, MA.; 1989, June 20.