Experience with an Adverse Drug Reaction Reporting Program in a Neurology Specialty Clinic

Abstract

Spanish

French

OBJECTIVE:

To describe an adverse drug reaction (ADR) reporting program that was developed in a university-affiliated neurology specialty clinic.

METHODS:

Reportable ADRs were identified through 3 mechanisms: by clinicians through routine visits, by patients who were encouraged to follow up with the pharmacist in the clinic, and by the pharmacist who contacted high-risk patients. Patient demographics, the suspected drug(s), elements to define probability, and outcomes were documented, collated, and analyzed for trends and opportunities for continuous quality-improvement efforts. Information was shared with clinic administrators and clinicians. Serious ADRs were reported to the Food and Drug Administration.

RESULTS:

The experience during a 1-year period, during which 40 ADRs were reported, is described. Medications by frequency of report and types of reactions are reported. None of the ADRs required admission to the hospital. Pharmacy personnel reported the majority of ADRs (92.5%).

CONCLUSIONS:

This program is successfully incorporated within daily practice and is an integral part of quality-improvement efforts.

Keywords

adverse drug reaction ambulatory care neurology outcomes research pharmacy practice reporting system

Get full access to this article

View all access options for this article.

References

Lazarou

Pomeranz

Corey

. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998; 279: 1200–5.

Schlienger

Knowles

Shear

. Quantifying the costs of serious adverse drug reactions to antiepileptic drugs. Epilepsia 1998; 39 (suppl 7):S27–32.

Johnson

Bootman

. Drug-related morbidity and mortality. A cost-of-illness model. Arch Intern Med 1995; 155: 1949–56.

Gharaibeh

Greenberg

Waldman

. Adverse drug reactions: A review. Drug Inf J 1998; 32: 323–38.

Mallet

. Counseling in special populations: The elderly patient. Am Pharm 1992: 32: 71–80.

Finn

Carlstedt

. Reporting adverse drug reactions in an ambulatory care setting. Am J Health Syst Pharm 1995; 52: 2704–6.

Sum

Gumbhir

. A national survey of hospital adverse drug event monitoring and reporting systems. Drug Inf J 1996; 30: 973–85.

Sills

Tanner

Milstein

. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm 1986; 43: 2764–75.

ASHP guidelines on adverse drug reaction monitoring and reporting. Best practices for health-system pharmacy, positions and practice standards of ASHP 1999–2000 [cited 2001 Sept 2]. Available from: URL: http://www.ashp.org/bestpractices/medmis/guide/adverse.pdf.

10.

A North American registry for epilepsy and pregnancy: A unique public/private partnership of health surveillance. Epilepsia 1998; 39: 793–8.

11.

Wysowski

Green

. Serious adverse events in Norplant users reported to the Food and Drug Administration MedWatch Spontaneous Reporting System. Obstet Gynecol 1995; 85: 538–42.

12.

Lackner

Cloyd

Thomas

Leppik

. Antiepileptic drug use in nursing home residents: Effect of age, gender, and comedication on patterns of use. Epilepsia 1998; 39: 1083–7.

13.

Karch

Lasagna

. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247–54.

14.

Naranjo

Busto

Sellers

Sandor

Ruiz

Roberts

. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45.