Evidence map›Paper›PMID 21990078›Full record

ArticleCroatian medical journal2011

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

Nikica Mirosevic Skvrce, Viola Macolic Sarinic, Iva Mucalo, Darko Krnic, Nada Bozina, Sinisa Tomic

Abstract read
In one paragraph

Article in Croatian medical journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Risk of bleeding with concomitant use of oral anticoagulants and aspirin: A systematic review and meta-analysis.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024
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  16. Methodological Errors in Clinical Studies Published by Medical Journals of Ex-Yugoslav Countries.Acta informatica medica : AIM : journal of the Society for Medical Informatics of Bosnia & Herzegovina : casopis Drustva za medicinsku informatiku BiH · 2020
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  18. The prevalence and severity of potential drug-drug interactions among adult polypharmacy patients at outpatient clinics in Jordan.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nikica Mirosevic SkvrcePharmacovigilance Department, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia. nikica.mirosevic@halmed.hr
Viola Macolic Sarinic
Iva Mucalo
Darko Krnic
Nada Bozina
Sinisa Tomic

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Drug InteractionsDrug-Related Side Effects and Adverse ReactionsGovernment AgenciesAdverse Drug Reaction Reporting SystemsCroatiaFemaleHumansIncidenceMalePolypharmacyRetrospective Studies

Identifiers

PMID21990078
PMCPMC3195969

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.