Evidence map›Paper›PMID 24748428›Full record

ArticleDrug safety2014

Adverse drug reaction reporting by patients: an overview of fifty countries.

Florence Margraff, Delphine Bertram

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Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 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

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3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Florence MargraffDélégation à la Recherche Clinique et à l'Innovation, Hospices Civils de Lyon, 3, quai des Célestins, 69229, Lyon Cedex 02, France.
Delphine Bertram

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe modalities and contributions to drug safety of patient adverse drug reaction reporting systems in 50 countries have been reviewed and analysed.

methodsThe means made available by National Health Competent Authorities (NCAs) for patients to report drug side effects were compared through literature review and questionnaire.

resultsAmong the 50 countries included in this study, we found that direct patient reporting systems exist in 44 countries and represent 9 % of total reports, the rest coming from healthcare professionals. Australia was the first, in 1964, and the United States has the system in which patients are the most involved. A total of 27 countries have a patient-specific reporting form, and 31 countries provide a form to complete online. In order to help patients, four countries constrain the description of the reaction and 12 constrain the choice of drug on the reporting form. Most of the surveyed countries request the patient's medical history (30 countries) and concomitant therapies (41 countries). The total number of fields per form ranges from 6 to 59, with a mean of 36 items.

conclusionsMost of the surveyed countries have implemented a patient adverse drug reaction reporting system. From this study, it seems that an online reporting form increases the rate of reporting. Currently, many different forms exist worldwide; these should be harmonized by considering the strengths and weaknesses of all existing forms. But above all, to increase the number of reports, each country should promote NCA-initiated adverse drug reactions reporting systems.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsHealth PersonnelHumans

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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.