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. 2025 Jun 14.
doi: 10.1007/s40264-025-01571-4. Online ahead of print.

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  1 , Henk-Jan Guchelaar  2 , Lisanne E N Manson  1 , Jesse J Swen  1 , Agnes C Kant  1   3 , Stefan Böhringer  1   4
Affiliations

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 et al. Drug Saf. .

Abstract

Background: Adverse 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.

Objective: Patient-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.

Methods: Patients 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.

Results: Patients (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.

Conclusions: Our 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).

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Conflict of interest statement

Declarations. Funding: The PREPARE study was funded by the EU Horizon 2020 Programme (grant agreement number 668353 [U-PGx]). Conflict of interest: Henok D. Habtemariam, Henk-Jan Guchelaar, Lisanne E.N. Manson, Jesse J. Swen, Agnes C. Kant, and Stefan Böhringer have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in this article. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Ethics approval: The data were collected as part of the PREPARE study and ethical approval was therefore provided by the Leiden University Medical Center and other participating centers of the prior study. Ethical approval was granted by the Leiden University Medical Center Institutional Review Board and the Medical Ethics Review Committee (P16.298). Consent to participate: Informed consent, including consent to participate, was given by participants as part of the PREPARE study. This analysis was based on data provisioning by the PREPARE study according to the data-sharing rules of the project. Consent for publication: Consent for publication was given by participants as part of the PREPARE study. Availability of data and material: Data from the PREPARE study are not publicly available but are planned to be made available after preplanned analyses have been completed. A complete deidentified dataset will be made accessible, together with a data dictionary, for a minimum of 5 years. Requests for access to the data can be made by sending an e-mail together with a research plan to the corresponding author and will be evaluated by and require authorization from the Ubiquitous Pharmacogenomics Consortium executive board. The criteria for data access (e.g., who will be granted access, for what types of analyses, and by what mechanism) have yet to be determined; the procedure is under development by the consortium’s executive board and will be published separately. Code availability: The code will be provided upon request. Author contributions: HDH, H-JG, and SB were involved in the conception, design, analysis of the data, and drafting of the article. All the authors were involved in revising the article and all authors read and approved the final version.

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