Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries

Margraff, Florence; Bertram, D. S.

doi:10.1007/s40264-014-0162-y

Cited by 81 publications

(74 citation statements)

References 19 publications

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“…Some studies, for example, have suggested using administrative data or mining EMRs for signals to identify harmful events [26,27], although validation studies have indicated that these methods have poor sensitivity for identifying relevant ADE outcomes [28,29]. Other studies have pointed to the value of expanding the role of patient reports, yet there has been little formal evaluation of patient reporting, and reporting rates among patients remain low [30,31]. Studies that have examined underreporting and initiatives to improve reporting have rarely scrutinized systems issues, instead focusing on the users.…”

Section: Discussionmentioning

confidence: 99%

Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design

Peddie¹,

Small²,

Badke³

et al. 2016

JMIR Res Protoc

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BackgroundAdverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs.ObjectiveWe aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada.MethodsTo develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting.ResultsThis is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs.ConclusionsWe take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers’ failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians’ workflow, and design the system to optimize its uptake into practice.

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Section: Discussionmentioning

confidence: 99%

Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design

Peddie¹,

Small²,

Badke³

et al. 2016

JMIR Res Protoc

View full text Add to dashboard Cite

show abstract

“…The systems in place for collecting ADR data differ between nations, and is inevitably influenced by the pattern of clinical practice and the culture of the country, especially where spontaneous reporting is concerned (Vallano et al 2005; Margraff and Bertram 2014). In a Korean tertiary children’s hospital, under a medical practice pattern that emphasizes efficiency, it is difficult to gather sufficient information and to properly report ADRs.…”

Section: Discussionmentioning

confidence: 99%

Multidisciplinary approach to improve spontaneous ADR reporting in the pediatric outpatient setting: a single-institute experience in Korea

et al. 2016

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In order to improve the reporting of adverse drug reactions (ADRs) as part of the routine practice at the pediatric outpatient department (OPD), we modified our ADR reporting strategy into one that facilitates the reporting process by means of a multi-disciplinary approach. In this study, we retrospectively reviewed ADR records during the period from March to September 2014 when we changed our reporting process as a part of institutional quality assurance (QA) activity. Yearly differences in the number and composition of ADRs were compared, and the descriptive analyses were done for cases reported from OPD during the QA activity in terms of the suspected drugs, type, causality, and severity of ADRs. There were 1211 pediatric ADR reports including 520 cases with underlying hemato-oncologic diseases during the period of 2014. Among the 691 non-oncologic cases, 76 were reported from the OPD, which was a significant increase (347 %) from the 17 cases reported during the previous year. Further analyses of these 76 cases revealed that the caregivers (47.4 %) initiated about half of the reports, the most frequently affected organ was the skin (32.9 %), and the most frequent suspected drugs were anticonvulsants (14.5 %). In contrast to the in-ward system, moderate cases were more frequent (51.3 %) than mild ones. In conclusion, this study provides a profile of pediatric ADRs in the OPD, which were largely under-reported during the usual clinical practice. A multi-disciplinary approach would improve spontaneous ADR reporting at the pediatric OPD.

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“…Three studies [27][28][29] assessed the situation of patients reporting in different countries through self-administered questionnaires, interviews or phone calls to the national regulatory authorities in different countries. Table 1 shows the distribution of countries covered in these studies according to the year of country's acceptance of patients' reporting, and the methods of reporting.…”

Section: Subjects: National Regulatory Authorities/ Organizationsmentioning

confidence: 99%