Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study

Abstract

AimTo analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence.MethodsIn this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them.ResultsHALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P < 0.001) than among the remaining reports (580 out of 1982; n = 2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter.ConclusionThe study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education.

Prevalence of clinically manifested drug interactions in hospitalized patients: A systematic review and meta-analysis

“…Original observational studies were included if they met the following criteria: (a) the identification of DDIs was performed by using a DDI electronic database; (b) clinically manifested DDI was confirmed by laboratory tests and/or signs and symptoms were documented in the medical records and analyzed by specialists [ 25 ]; (c) data for the calculation of the prevalence of clinically manifested DDIs among patients, prescriptions, or DDI adverse reaction reports were available; and (d) the study was published in English, Portuguese, or Spanish. In this systematic review, we excluded: (a) duplicate records; (b) studies with unavailable abstract or full-text, even after authors were contacted; and (c) studies focusing only on specific diseases/pharmacotherapies (for example: patients receiving oncological, HIV, or diabetes treatment) or specific drugs.…”

Hospital admissions/visits associated with drug–drug interactions: a systematic review and meta‐analysis

“…Observational studies examining actual DDIs were included if they were prospective or retrospective; the patients were of any age, admitted to hospital wards, or visited outpatients/emergency department due to DDIs; and studies were published in any language and provided sufficient data for calculating the prevalence rates. The actual DIs were defined on the basis of clinical evidence; that is, they were confirmed by laboratory tests or by symptoms . Potential DIs can be defined as documented interactions that may either enhance or antagonize the pharmacological activity of the drugs, resulting in potential adverse effects …”

Methodological Errors in Clinical Studies Published by Medical Journals of Ex-Yugoslav Countries

“…Number and percent of the evaluated studies that failed to meet each of the methodological criteria tested, the number of the evaluated criteria not satisfied per country, and the number of studies that satisfied more than 4 criteria per country is presented in Table 2 . References of the analyzed studies from Bosnia and Herzegovina could be found in our previous publication ( 12 ), while the references of the studies analyzed from Croatian ( 17 - 59 ), Slovenian ( 60 - 92 ) and Serbian medical journals ( 93 - 135 ) are given on the list at the end of this article.…”