Evidence map›Paper›PMID 40517185›Full record

ArticleDrug safety2025

Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands.

Henok D Habtemariam, Henk-Jan Guchelaar, Lisanne E N Manson, Jesse J Swen, Agnes C Kant, Stefan Böhringer

Registry-linked trialAbstract readComparative StudyMulticenter Study
In one paragraph

Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03093818 (PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03093818 nacompletednot on this map

PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

TypeinterventionalSponsorJ.J.SwenRan2017 to 2021Enrolled6,950ConditionsAdverse Drug ReactionArmsPharmacogenomic testing
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Henok D HabtemariamDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.ORCID http://orcid.org/0000-0003-1542-7616
Henk-Jan GuchelaarDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands. h.j.guchelaar@lumc.nl.ORCID http://orcid.org/0000-0002-7085-1383
Lisanne E N MansonDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.
Jesse J SwenDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.
Agnes C KantDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.
Stefan BöhringerDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2300 RC, Leiden, The Netherlands.

Funding

Horizon 2020 Framework Programme 668353
6 · The paper itself

Abstract

backgroundAdverse drug events (ADEs) are events occurring after the administration of a drug. Several authorities are involved in capturing these ADEs to improve pharmacovigilance. These ADEs are reported directly to healthcare professionals or via the telephone, online, or e-mail and are crucial for maintaining drug safety.

objectivePatient-reported adverse drug events (ADEs) are collected using various tools, though not much is known with regard to the comparability of these different methodologies. It is known that telephone-based surveys result in a higher report rate, although it is not known if this has an effect on the type of ADEs that are reported. In this prospective study, we aimed to investigate if there are differences in the number, type, and severity of ADEs reported via telephone and online in an event monitoring setting.

methodsPatients included in Dutch community pharmacies were asked whether they experienced any ADEs via telephone and online (Lareb Intensive Monitoring) surveys as part of the PREPARE study. The PREPARE study was a multicenter study, researching the effect of genotype-guided dosing on the incidence of clinically relevant adverse drug reactions. With the paired data acquired in the PREPARE study, we investigated differences in the number, type, and severity of the reported ADEs.

resultsPatients (N = 525) completed both the telephone and online surveys. Of the 525 patients who completed both surveys, 326 reported ADEs via telephone and 239 online. A visual comparison showed a similar distribution in the type of ADEs among the methods except for less commonly reported types of ADEs and cardiac disorders. The perceived severity of ADEs were proportionally reported as more severe during the telephone survey versus the online survey.

conclusionsOur study showed a clear difference in the number of ADEs reported during telephone and online monitoring. Additionally, the differences in the type of ADEs and the severity distribution of both tools shows that the tools are not exchangeable (CT.gov identifier: NCT03093818).

Indexed as

Adverse Drug Reaction Reporting SystemsCommunity Pharmacy ServicesDrug-Related Side Effects and Adverse ReactionsTelephoneAdultAgedFemaleHumansInternetMaleMiddle AgedNetherlandsPharmacovigilanceProspective StudiesSurveys and Questionnaires

Identifiers

PMID40517185
PMCPMC12515233

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Registered trials

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.