A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues

Hasford, Joerg; Bruchmann, F; Lutz, Mark F.; Thürmann, Petra A.; Schmiedl, Sven

doi:10.1007/s00228-021-03134-9

Cited by 9 publications

(7 citation statements)

References 12 publications

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“…It is well‐known that women report more side effects. 30 , 31 A multitude of potential reasons exist for this difference, for example a higher polypharmacy rate, reaching a higher age, different baseline characteristics and risks (e.g. longer QT interval, higher prevalence of depression), physiological differences that can lead to higher average drug exposures, receiving different care, a different perception of healthcare professionals, and a different attitude towards drugs in women.…”

Section: Discussionmentioning

confidence: 99%

“…This higher number probably derived from the twice higher total number of drug reports in comparison to men. It is well‐known that women report more side effects 30,31 . A multitude of potential reasons exist for this difference, for example a higher polypharmacy rate, reaching a higher age, different baseline characteristics and risks (e.g.…”

Section: Discussionmentioning

confidence: 99%

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Patient reporting of sexual adverse events on an online platform for medication experiences

Gordijn

Wessels

Kriek

et al. 2022

Brit J Clinical Pharma

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Aims For >300 drugs, sexual side effects are included in the drug information leaflet. As sexual adverse events (sAEs) may be more easily shared at online medication platforms, patient‐reported drug experiences may add to the current knowledge on sAE experiences. This study evaluated patient reports from the online platform mijnmedicijn.nl for the frequency of sAE reporting, sex differences concerning sAEs and to assess drugs with disproportional sAE reporting. Methods On the online platform, terms for sAEs as used by patients were collected with a poll. Subsequently, drug reports posted between 2008 and 2020 were searched for sAEs with the identified terms. From the retrieved reports, the sAE frequencies and complaints and reporting odds ratios (ROR) were calculated, stratified for sex and drug (class). sAE reporting was considered disproportional frequent if the lower 95% confidence interval bound of the ROR >2.0. Results For 189 drugs, sAEs were identified in 2408 reports (3.9%). Women posted 1383 reports (3.5% of all female reports) and men 1025 (4.7%). Almost half of the sAE reports addressed antidepressants: 586 reports of women (ROR 4.2; 95%CI 3.8–4.7) and 510 reports of men (ROR 7.5; 95%CI 6.6–8.5). Disproportional high numbers of sAE reports were found for 27 drugs, mostly antidepressants, hormonal contraceptives and drugs used in benign prostatic hyperplasia. Of these drugs with frequent sAEs, 7 had low sAE risks in their professional drug information. Conclusion One in 25 drug reports on mijnmedicijn.nl included sAEs. The sAEs were reported frequently for antidepressants, contraceptives and drugs used in benign prostatic hyperplasia.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Patient reporting of sexual adverse events on an online platform for medication experiences

Gordijn

Wessels

Kriek

et al. 2022

Brit J Clinical Pharma

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“…10 Consumers often detect AMEs before their healthcare professionals notice them 11 , and, where patient engagement is implemented, consumer self-report of AMEs alert regulators to new and previously unknown reactions prior to health professional reports. 12,13 In Australia, however, the number of reports to regulators from consumers is disproportionately low compared to those made by healthcare professionals and pharmaceutical manufacturers 14 , partly because of consumers' limited awareness of the reporting system, and perceived absence of benefits of reporting. 15 The AME reporting system, developed by the medicine regulatory body, the Therapeutic Goods Administration (TGA), 14 has seen limited consumer uptake in Australia.…”

Section: Introductionmentioning

confidence: 99%

Co-designing a consumer-focused digital reporting health platform to improve adverse medicine event reporting: Protocol for a multi-method research project (the ReMedi project) (Preprint)

Gebreyohannes,

Thornton,

Thiessen

et al. 2024

Preprint

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BACKGROUND Adverse medicine events (AMEs) are unintended effects that occur following administration of medicines. Up to 70% of AMEs are not reported to, and hence remain undetected by, healthcare professionals and only 6% of AMEs are reported to regulators. Increased reporting by consumers, healthcare professionals, and pharmaceutical companies to medicine regulatory authorities is needed to increase the safety of medicines. OBJECTIVE We describe a project that aims to co-design a digital reporting platform to improve detection and management of AMEs by consumers and healthcare professionals and improve reporting to regulators. METHODS The project will be conducted in three phases and employs a co-design methodology that prioritises equity in designing with stakeholders. Our project is guided by the Consolidated Framework for Implementation Research. In Phase 1, we will engage with three stakeholder groups: consumers, healthcare professionals and regulators to define digital platform development standards. We will conduct a series of individual interviews, focus group discussions, and co-design workshops with the stakeholder groups. In Phase 2, we will work with a software developer and user interaction design experts to prototype, test and develop the digital reporting platform based on findings from Phase 1. In Phase 3, we will implement and trial the digital reporting platform in South Australia through general practices and pharmacies. Consumers who have recently started using medicines new to them will be recruited to use the digital reporting platform to report any apparent, suspected or possible AMEs since starting the new medicine. Process and outcome evaluations will be conducted to assess the implementation process, and to determine whether the new platform has increased AME detection and reporting. RESULTS This project is currently underway, and we will publish findings progressively as we complete our analyses. CONCLUSIONS This project adopts a co-design methodology to develop a new digital reporting platform for AME detection and reporting, considering the perspectives and lived experience of stakeholders and addressing their requirements throughout the entire process. The overarching goal of the project is to leverage the potential of both consumers and technology, to address the existing challenges of under-detection and under-reporting of AMEs to healthcare professionals and regulators. The project potentially will improve individual patient safety and generate new data for regulatory purposes related to medicine safety and effectiveness.

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“…Reports from patients are increasingly recognized as important sources of information about ADRs [ 14 ]. Previous studies have shown that patients are able to detect ADRs first [ 15 , 16 ], and that patient ADR reports alert regulatory authorities to new and previously unknown ADRs [ 17 ]. However, barriers such as lack of awareness of the importance of ADR reporting, difficulty using existing reporting systems due to complicated language and cumbersome interfaces, and negative reporting experiences mean that ADR reporting rates from patients remain very low [ 11 , 18 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Lim¹,

Thornton²,

Staněk³

et al. 2022

JMIR Form Res

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Background Medicine use is the most common intervention in health care. The frequency with which medicines are used means medication-related problems are very common. One common type of medication-related problems is adverse drug events, which are unintended and harmful effects associated with use of medicines. Reporting of adverse drug events to regulatory authorities is important for evaluation of safety of medicines; however, these adverse effects are frequently unreported due to various factors, including lack of consumer-friendly reporting tools. Objective The aim of this study was to develop a user-friendly digital tool for consumers to report medication-related adverse effects. Methods The project consisted of 3 parts: (1) content development, including a systematic literature search; (2) iterative system development; and (3) usability testing. The project was guided by participatory design principles, which suggest involving key stakeholders throughout the design process. The first 2 versions were developed as a mobile app and were tested with end users in 2 workshops. The third version was developed as a web application and was tested with consumers who were taking regular medicines. Consumers were asked to complete a modified version of the mHealth app usability questionnaire (MAUQ), an 18-item questionnaire with each item scored using a 7-point Likert scale ranging from 0 (strongly disagree) to 7 (strongly agree). The MAUQ assessed 3 subscales including ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Continuous variables were reported as mean (SD) values, whereas categorical variables were presented as frequencies (percentages). Data analysis was conducted in Microsoft Excel. Results The content for the system was based on a systematic literature search and short-listing of questions, followed by feedback from project team members and consumers. Feedback from consumers in the 2 workshops were incorporated to improve the functionality, visual design, and stability of the third (current) version. The third version of the system was tested with 26 consumers. A total of 79% (N=307/390) of all responses on the MAUQ were scored 6 or 7, indicating that users generally strongly agree with the usability of the system. When looking at the individual domains, the system had an average score of 6.3 (SD 0.9) for “ease of use,” 6.3 (SD 0.8) for “interface and satisfaction,” and 5.2 (SD 1.4) for “usefulness.” Conclusions The web-based system for medicine adverse effects reporting is a user-friendly tool developed using an iterative participatory design approach. Future research includes further improving the system, particularly the usefulness of the system, as well as testing the scalability and performance of the system in practice.

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A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues

Cited by 9 publications

References 12 publications

Patient reporting of sexual adverse events on an online platform for medication experiences

Patient reporting of sexual adverse events on an online platform for medication experiences

Co-designing a consumer-focused digital reporting health platform to improve adverse medicine event reporting: Protocol for a multi-method research project (the ReMedi project) (Preprint)

Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

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