Evidence map›Paper›PMID 29972735›Full record

ArticleCroatian medical journal2018

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study.

Una Glamočlija, Biljana Tubić, Martin Kondža, Aleksandar Zolak, Nataša Grubiša

Abstract readComparative Study
In one paragraph

Article in Croatian medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Regulatory aspects of biological medicines in Bosnia and Herzegovina.Bosnian journal of basic medical sciences · 2022
    Review
  5. Article
  6. Article
  7. Article
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

5 authors.

Una GlamočlijaUna Glamočlija, School of Medicine, University of Mostar, Bijeli brijeg bb, 88 000 Mostar, Bosnia and Herzegovina, una.glamoclija@gmail.com.
Biljana Tubić
Martin Kondža
Aleksandar Zolak
Nataša Grubiša

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare individual case safety reports (ICSR) rates and characteristics between Croatia, Serbia, Montenegro, and Bosnia and Herzegovina (B&H).

methodsThis retrospective pharmacoepidemiological study used the data from ICSR received by the Agency for Medicines and Medical Devices in B&H in 2011-2016. The number, characteristics, and sources of reports, suspected drugs, and patient characteristics were analyzed. The results were compared with the publicly available data from Croatia, Serbia, and Montenegro.

resultsThe number of reported adverse drug reactions per one million of inhabitants was lowest in B&H and highest in Croatia. There were significant differences in reporter characteristics, sources of reports, and the percentage of missing data in ICSR, while the Anatomical Therapeutic Chemical product classes, patient's sex, and adverse drug reaction System Organ Classes were similar.

conclusionDespite the historical and geographical vicinity of B&H and its neighboring countries, there were significant differences in indicators of pharmacovigilance development.

Indexed as

PharmacovigilanceAdverse Drug Reaction Reporting SystemsBosnia and HerzegovinaCroatiaFemaleHumansMaleMontenegroPharmacoepidemiologyRetrospective StudiesSerbia

Identifiers

PMID29972735
PMCPMC6045893

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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.