Evidence map›Paper›PMID 16180936›Full record

ReviewDrug safety2005

Clarification of terminology in drug safety.

Jeffrey K Aronson, Robin E Ferner

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 14 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

111 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  6. Drug-related deaths among inpatients: a meta-analysis.European journal of clinical pharmacology · 2022
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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Jeffrey K AronsonDepartment of Clinical Pharmacology, Radcliffe Infirmary, Oxford, UK. jeffrey.aronson@clinpharm.ox.ac.uk
Robin E Ferner

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nomenclature surrounding drug safety needs to be clear and unambiguous, so that patients, prescribers, manufacturers, and regulators can all understand each other. In particular, it needs to make it clear how adverse events and drug therapy are related to one another, how they are best classified, and their frequency, intensity and seriousness. In this article, we therefore discuss and define terms used in the field of drug safety, particularly terms that are sometimes misunderstood or misused, including medicinal product, pharmaceutical formulation, excipient, adverse event (or experience) and adverse drug reaction (or effect). We also discuss terms used to define the seriousness, intensity, and risk of adverse reactions, and their classification. Instead of creating definitions from scratch, as is commonly done, we have taken the novel approach of critically examining definitions that have been proposed or widely used and have formulated new or modified definitions based on a logical appraisal of their merits and demerits. We hope that these definitions will lead to discussion that will allow a corpus of satisfactory definitions to be widely agreed.

Indexed as

Drug-Related Side Effects and Adverse ReactionsTerminology as TopicChemistry, PharmaceuticalDose-Response Relationship, DrugExcipientsHumansSafetyExcipients

Identifiers

PMID16180936

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.