Feasibility Study of Surveying the Adverse Drug Reaction Surveillance Systems in a Large Community of Hospitals

Abstract

Spanish

French

OBJECTIVE:

To determine the feasibility of accurately assessing the types of hospital adverse drug reaction (ADR) surveillance systems.

DESIGN:

Cross-sectional survey by mailed, self-administered questionnaire followed by selected verification interviews.

SETTING:

Harris County, Texas.

PARTICIPANTS:

All hospitals in the county with different pharmacy directors.

MAIN OUTCOME MEASURE:

Self description of surveillance system and number of ADRs reported.

RESULTS:

Forty-nine of 61 hospitals (80 percent) responded to a questionnaire. Forty-seven (96 percent) of the responding hospitals collected information on ADRs with 11 (22 percent) describing their surveillance system as active. Those individuals most often cited as responsible for ADR surveillance included pharmacists, quality assurance personnel, and nurses. Data were verified by personal interviews for 10 hospitals. The number of ADRs reported during the interviews was significantly lower than that reported in the questionnaires. Overall, the reporting of fatal and severe ADRs were more reliable than the reporting of moderate ADRs. These differences were the result of inadequate documentation and the lack of a uniform definition of ADRs.

CONCLUSIONS:

These data suggest that a large-scale ongoing survey of surveillance systems and reported adverse event rates has limitations and the reliability of data derived from a questionnaire should be verified. To improve the accuracy of surveys used to monitor hospital ADR surveillance systems, it is essential to develop reliable definitions for classifying ADRs and surveillance methods, as well as accurate measures of ADR documentation procedures.

Get full access to this article

View all access options for this article.

References

Hoffman

. Adverse drug reactions revisited—JCAHO. Hosp Pharm 1988; 23: 685–7.

Faich

. National ADR surveillance 1985. JAMA 1987; 257: 2068–70.

Manasse

Jr . Medication use in an imperfect world: Drug misadventuring as an issue of public policy, part 1. Am J Hosp Pharm 1989; 46: 929–44.

Cluff

Thorton

Seidl

. Studies on the epidemiology of adverse drug reactions. JAMA 1964; 188: 976–83.

Kilarski

Ziegler

Coarse

Buchanan

. Adverse drug reaction reporting system: Developing a well-monitored program. Hosp Form 1986; 21: 949–52.

Keys

. Drug use review and risk management. Am J Hosp Pharm 1981; 38: 1533–4.

Slone

Jick

Borda

Chalmers

Feinleib

Muench

. Drug surveillance using nurse monitors. Lancet 1986; 2: 901–3.

Miwa

Randall

. Adverse drug reaction using pharmacist and nurse monitors. Hosp Form 1986; 21: 1140–6.

Magee

Garrison

. Reporting adverse drug reactions in a small hospital. Hospitals 1976; 50: 63–7.

10.

Powell

Schwartz

Rayment

Marx

. Pharmacy-based adverse drug reaction surveillance program. Am J Hosp Pharm 1982; 39: 1963–4.

11.

Chatas

Vinson

. Program for improving adverse drug reaction reporting. Am J Hosp Pharm 1990; 47: 155–7.

12.

Zellmer

. Can pharmacists prevent drug induced illness in hospitals? (editorial). Am J Hosp Pharm 1981; 38: 637.

13.

Tschepik

Segal

Sherrim

Schneider

Hammond

. Therapeutic risk-assessment for identifying patients with adverse drug reactions. Am J Hosp Pharm 1990; 47: 330–4.

14.

Tatro

Moore

Cohen

. Computer-based system for adverse drug reaction detection and prevention. Am J Hosp Pharm 1979; 36: 198–201.

15.

Kirking

Thomas

Ascione

Boyd

. Detecting and preventing adverse drug interactions: The potential contribution of computers in pharmacies. Soc Sci Med 1986; 22: 1–8.

16.

Pankoski

Dinel

. Facilitating medication incident analysis through computerization. Hosp Pharm 1988; 23: 464–8.

17.

Dillman

. Mail and telephone surveys: the total design method. New York: Wiley, 1978.

18.

Haley

Quade

Freeman

, CDC SENIC Planning Committee. The study on the efficacy of nosocomial infection control. Am J Epidemiol 1980; 111: 472–85.

19.

American Hospital Association annual survey 1986. Rockville, MD: American Hospital Association, 1987.

20.

SAS user's guide: basics, version 5 edition. Cary, NC: SAS Institute, 1985.

21.

Kleinbaum

Kupper

Muller

. eds. Applied regression analysis and other multivariate methods. 2nd ed. Boston: PWS-Kent, 1988.

22.

Length of stay by diagnoses and operations—United States. Ann Arbor, MI: CPHA Publications, 1987: X.

23.

Rosner

. Fundamentals of biostatistics. 2nd ed. Boston: Duxbury Press, 1986: 259.

24.

Karen

Lasagna

. Adverse drug reactions: A critical review. JAMA 1975; 234: 1236–41.

25.

Smith

Seidl

Cluff

. Studies on the epidemiology of adverse drug reactions. Ann Intern Med 1966; 65: 629–40.

26.

Michel

Knodel

. Program coordinated by a drug information service to improve adverse drug reactions. Am J Hosp Pharm 1986; 43: 2202–5.

27.

Ruiz

Ortiz

. Adverse drug reactions in patients with heart diseases. Comparisons between patients without and with heart failure. Int J Clin Pharmacol Ther Toxicol 1984; 22: 595–601.

28.

Juergens

Banahan

. Adverse drug reaction reporting by Mississippi physicians. J Miss Med Assoc 1986; 27: 33–7.

29.

Mowers

. A pharmacy organized ADR reporting system (abstract P-10 D). Presented at the American Society of Hospital Pharmacists Annual Meeting, San Francisco, 1988.

30.

Bennett

Lipman

. Comparative study of prospective surveillance and voluntary reporting. Am J Hosp Pharm 1977; 34: 931–6.

31.

Miller

. Drug surveillance utilizing epidemiologic methods. Am J Hosp Pharm 1973; 30: 584–92.

32.

Vakil

Kulkarni

Charbria

Chadha

Deshpande

. Intense surveillance of adverse drug reactions. J Clin Pharmacol 1975; 15: 435–41.

33.

Dick

Winship

III Wood

. A cost effectiveness comparison of a pharmacist using three methods for identifying possible drug related problems. Drug Intell Clin Pharm 1975; 9: 257–62.

34.

Miyagawa

Rivera

. Effect of pharmacist interventions on drug therapy costs in a surgical intensive-care unit. Am J Hosp Pharm 1986; 43: 3008–13.