Factors influencing the spontaneous reporting of adverse drug reactions--the experience of the Slovak Republic.
The system of adverse drug reaction (ADR) monitoring in the Slovak Republic is greatly influenced by changes taking place in the current health care delivery system. Under-reporting and reporting biases due to selective ADR reporting provide very serious problems in pharmacovigilance. In the year 2001, the number of reported ADRs increased due to reports of angiotensin converting enzyme (ACE) inhibitor-induced cough; this coincided with limits being imposed on the use of angiotensin-II receptor antagonists. These factors provide an example of selective ADR reporting, deforming the quality of drug safety monitoring. They also indicate that administrative strategies can significantly affect spontaneous reporting activities.
Tisonová
J
J
Department of Pharmacology, Medical Faculty Commenius University, Bratislava, Slovak Republic.
Szalayová
A
A
Kriska
M
M
Gibala
P
P
Foltán
V
V
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D003371:Cough / Q000139:chemically induced*; D016208:Databases, Factual; D006801:Humans; D018154:Slovakia
D000806:Angiotensin-Converting Enzyme Inhibitors