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Physician Reporting of Adverse Drug Reactions: Title and subTitle BreakResults of the Rhode Island Adverse Drug Reaction Reporting Project FREE

H. Denman Scott, MD; Ann Thacher-Renshaw, MS; Sara E. Rosenbaum, PhD; William J. Waters, Jr, PhD; Marilyn Green; Lisa G. Andrews, MBA; Gerald A. Faich, MD
[+] Author Affiliations

Reprint requests to Rhode Island Adverse Drug Reaction Reporting Project, Rhode Island Department of Health, 75 Davis St, Providence, RI 02908-5097 (Ms Thacher-Renshaw).


JAMA. 1990;263(13):1785-1788. doi:10.1001/jama.1990.03440130073028
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The Food and Drug Administration, Rockville, Md, contracted with the Rhode Island Department of Health, Providence, to conduct a project to increase reporting of suspected adverse drug reactions through physician education. Voluntary reporting, an important part of postmarketing surveillance that signals potential problems with marketed drugs, historically has been underused by physicians. After 2 years, there was a more than 17-fold increase in reports submitted directly from Rhode Island compared with the yearly average before initiation of the project. Increases in the total numbers of reports were paralleled by significant increases in the numbers of reports of severe reactions. Similar increases were not experienced nationally. Physicians in Rhode Island were surveyed before and 2 years after interventions began to determine changes in knowledge and attitudes about reporting of adverse drug reactions. Significant gains in knowledge and positive attitudes toward the reporting system occurred. We conclude that physicians can be stimulated to increase their reporting of suspected reactions, thereby improving the viability of the federal reporting system.

(JAMA. 1990;263:1785-1788)

REFERENCES

Faich GA.  Adverse-drug-reaction monitoring . N Engl J Med. 1986;;314:1589-1592.
Rogers AS.  Adverse drug events: identification and attribution . Drug Intell Clin Pharm. 1987;;21: 915-920.
Rossi AC, Knapp DE.  Discovery of new adverse drug reactions: a review of the Food and Drug Administration's spontaneous reporting system . JAMA. 1984;;252:1030-1033.
Venning GR.  Identification of adverse reactions to new drugs, II: how were 18 important adverse reactions discovered and with what delays? Br Med J. 1983;;286:365-368.
Rossi AC, Knapp DE, Anello C, et al.  Discovery of new adverse drug reactions: a comparison of selected phase IV studies with spontaneous reporting methods . JAMA. 1983;;249:2226-2228.
Rossi AC, Bosco L, Faich GA, Tanner A, Temple R.  The importance of adverse reaction reporting by physicians: suprofen and the flank pain syndrome . JAMA. 1988;;259:1203-1204.
Griffin JP, Weber JCP.  Voluntary systems of adverse reaction reporting: part II . Adverse Drug React Acute Poisoning Rev. 1986;;1:23-55.
Gross FH, Inman WHW, eds. Drug Monitoring . Orlando, Fla: Academic Press Inc; 1977;.
Scott HD.  Monitoring drug safety: a unique opportunity for Rhode Island physicians . RI Med J. 1986;;69:303-304.
Scott HD, Rosenbaum SE, Waters WJ, et al.  Rhode Island physicians' recognition and reporting of adverse drug reactions . RI Med J. 1987;; 70:311-316.
Scott HD, Thacher A, Rosenbaum SE, et al.  Adverse drug reaction reporting systems: the United Kingdom and the United States . RI Med J. 1988;;71:179-184.
Statistical Abstract of the United States: 1987 . 107th ed. Washington, DC: US Bureau of the Census; 1986;.
Rogers AS, Israel E, Smith CR, et al.  Physician knowledge, attitudes, and behavior related to reporting adverse drug events . Arch Intern Med. 1988;;148:1596-1600.
Fincham J.  A statewide program to stimulate reporting of adverse drug reactions . J Pharm Pract. 1989;;11:239-244.

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Faich GA.  Adverse-drug-reaction monitoring . N Engl J Med. 1986;;314:1589-1592.
Rogers AS.  Adverse drug events: identification and attribution . Drug Intell Clin Pharm. 1987;;21: 915-920.
Rossi AC, Knapp DE.  Discovery of new adverse drug reactions: a review of the Food and Drug Administration's spontaneous reporting system . JAMA. 1984;;252:1030-1033.
Venning GR.  Identification of adverse reactions to new drugs, II: how were 18 important adverse reactions discovered and with what delays? Br Med J. 1983;;286:365-368.
Rossi AC, Knapp DE, Anello C, et al.  Discovery of new adverse drug reactions: a comparison of selected phase IV studies with spontaneous reporting methods . JAMA. 1983;;249:2226-2228.
Rossi AC, Bosco L, Faich GA, Tanner A, Temple R.  The importance of adverse reaction reporting by physicians: suprofen and the flank pain syndrome . JAMA. 1988;;259:1203-1204.
Griffin JP, Weber JCP.  Voluntary systems of adverse reaction reporting: part II . Adverse Drug React Acute Poisoning Rev. 1986;;1:23-55.
Gross FH, Inman WHW, eds. Drug Monitoring . Orlando, Fla: Academic Press Inc; 1977;.
Scott HD.  Monitoring drug safety: a unique opportunity for Rhode Island physicians . RI Med J. 1986;;69:303-304.
Scott HD, Rosenbaum SE, Waters WJ, et al.  Rhode Island physicians' recognition and reporting of adverse drug reactions . RI Med J. 1987;; 70:311-316.
Scott HD, Thacher A, Rosenbaum SE, et al.  Adverse drug reaction reporting systems: the United Kingdom and the United States . RI Med J. 1988;;71:179-184.
Statistical Abstract of the United States: 1987 . 107th ed. Washington, DC: US Bureau of the Census; 1986;.
Rogers AS, Israel E, Smith CR, et al.  Physician knowledge, attitudes, and behavior related to reporting adverse drug events . Arch Intern Med. 1988;;148:1596-1600.
Fincham J.  A statewide program to stimulate reporting of adverse drug reactions . J Pharm Pract. 1989;;11:239-244.
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