scholarly journals Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset

10.2196/10248 ◽  
2018 ◽  
Vol 6 (2) ◽  
pp. e10248 ◽  
Author(s):  
David Peddie ◽  
Serena S Small ◽  
Katherin Badke ◽  
Chantelle Bailey ◽  
Ellen Balka ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Drug Event ◽  
Clinical Care ◽  
Drug Event ◽  
Event Reporting

scholarly journals Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset (Preprint)

2018 ◽  
Author(s):  
David Peddie ◽  
Serena S Small ◽  
Katherin Badke ◽  
Chantelle Bailey ◽  
Ellen Balka ◽  
...  
Keyword(s):  
Systematic Review ◽  
Patient Safety ◽  
Mixed Methods ◽  
Adverse Drug Event ◽  
Improve Patient Safety ◽  
Clinical Care ◽  
Drug Event ◽  
Care Providers ◽  
Event Reporting ◽  
Improve Patient

BACKGROUND Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized. OBJECTIVE The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety. METHODS We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format. RESULTS We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations. CONCLUSIONS By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.

Organizational implications of implementing a new adverse drug event reporting system for care providers and integrating it with provincial health information systems

2019 ◽  
Vol 32 (4) ◽  
pp. 208-212 ◽  
Author(s):  
Serena S. Small ◽  
Corinne M. Hohl ◽  
Ellen Balka
Keyword(s):  
Health Information ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Clinical Care ◽  
Drug Event ◽  
Care Providers ◽  
Private Industry ◽  
Event Reporting ◽  
Health Delivery ◽  
Beneficial Impact

Cross-sector collaborations between academia, government, and private industry, known as Triple Helix configurations, are increasingly common. In the health Information Technology (IT) sector, such configurations often also include health delivery organizations where technology is implemented and used. The complexity of collaborating within and between multiple organizations can present hurdles for innovators that are seldom discussed in the literature. We outline challenges we encountered in cross-sector collaboration and offer some guiding principles for decision-makers, academics, industry partners, and health delivery organizations to successfully negotiate divergent approaches to innovation and implementation. We discuss an innovative project that aims to implement a researcher-designed adverse drug event reporting system into clinical care and integrate it with provincial and health authority IT systems. Based on our experience, implementing an interoperable health IT system must extend beyond technical integration to encompass meaningful stakeholder engagement to ensure utility for end-users and beneficial impact for participating organizations.

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting

2010 ◽  
Vol 19 (12) ◽  
pp. 1211-1215 ◽  
Author(s):  
Jeffrey A. Linder ◽  
Jennifer S. Haas ◽  
Aarthi Iyer ◽  
Michael A. Labuzetta ◽  
Michael Ibara ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Event Reporting ◽  
Secondary Use ◽  
Record Data ◽  
Electronic Health

Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: A Mixed Methods Study (Preprint)

2021 ◽  
Author(s):  
Erina Chan ◽  
Serena S Small ◽  
Maeve E Wickham ◽  
Vicki Cheng ◽  
Ellen Balka ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Drug Event ◽  
Adverse Drug Events ◽  
Retrospective Chart Review ◽  
Drug Event ◽  
Free Text ◽  
Snomed Ct ◽  
Data Standards ◽  
Data Standard ◽  
Research Assistants

BACKGROUND Existing systems to document adverse drug events often use free text data entry, producing non-standardized, unstructured data prone to misinterpretation. Standardized terminology may improve data quality, but it is unclear which data standard is most appropriate to document adverse drug event symptoms and diagnoses. OBJECTIVE Our objective was to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. METHODS We performed a mixed-methods sub-study of a multicenter retrospective chart review. We reviewed research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. Two pharmacy research assistants independently entered symptoms and/or diagnoses for adverse drug events using 4 standards: MedDRA, SNOMED CT, SNOMED Adverse Reaction, and ICD-11. Disagreements between research assistants regarding case-specific utility of data standards were discussed until reaching consensus. We used consensus ratings to determine proportion of adverse drug events covered by a data standard, and coded and analyzed field notes from consensus sessions. RESULTS We reviewed 573 adverse drug events and found MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and/or diagnoses. While MedDRA had the highest number of matches between the research assistants, ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. Research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, and least likely with MedDRA. CONCLUSIONS Usability, comprehensiveness, and accuracy are important features of data standards for documenting ADE symptoms and diagnoses. Based on our results, we would recommend the use of MedDRA.

Impact of nurse case manager-pharmacist collaboration on adverse-drug-event reporting

2004 ◽  
Vol 61 (5) ◽  
pp. 483-487 ◽  
Author(s):  
Paul F. Lata ◽  
Marianne Mainhardt ◽  
Curtis A. Johnson
Keyword(s):  
Adverse Drug Event ◽  
Case Manager ◽  
Drug Event ◽  
Event Reporting ◽  
Nurse Case Manager

Adverse Drug Event Reporting

2012 ◽  
Vol 31 (8) ◽  
pp. 1911-1911
Author(s):  
William Vaughan
Keyword(s):  
Adverse Drug Event ◽  
Drug Event ◽  
Event Reporting

scholarly journals Adverse drug event reporting systems: a systematic review

2016 ◽  
Vol 82 (1) ◽  
pp. 17-29 ◽  
Author(s):  
Chantelle Bailey ◽  
David Peddie ◽  
Maeve E. Wickham ◽  
Katherin Badke ◽  
Serena S. Small ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Drug Event ◽  
Drug Event ◽  
Event Reporting ◽  
Reporting Systems
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