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.

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.

Underreported Risk of Lisinopril-Induced Angioedema in a Veteran Population

2021 ◽  
pp. 106002802110324
Author(s):  
Whitley J. Whitehead ◽  
Jennifer Meyer Reid
Keyword(s):  
Adverse Drug Event ◽  
Chart Review ◽  
Reporting System ◽  
Veterans Health Administration ◽  
Veterans Affairs ◽  
Drug Event ◽  
Veterans Health ◽  
Health Administration ◽  
Local Chart ◽  
Event Reporting

Background: Lisinopril-induced angioedema (LIA) is a rare but serious adverse drug event (ADE) with a published incidence of 0.1% to 0.7%. It is well known that ADEs are widely underreported; however, LIA is one of the most reported ADEs within the Veterans Health Administration (VHA). Objective: To estimate the effect of underreporting on the risk of LIA within VHA. Methods: The reported risk of LIA was calculated from reports submitted to the Veterans Affairs (VA) Adverse Drug Event Reporting System (VA ADERS) and the number of veterans prescribed lisinopril. To estimate underreporting, local chart review identified cases of LIA that were compared to reports submitted. The underreporting rate was then applied to the national reported risk. Results: Locally, 68 reports of LIA were submitted of the 21 262 patients prescribed lisinopril, for a reported risk of 0.32%. Nationwide, 14 289 reports of LIA were submitted of the 3 109 661 patients prescribed lisinopril, for a crude reported risk of 0.46%. Of the 324 patients identified for chart review, 240 patients were diagnosed with LIA, suggesting that at least 71.7% of cases were unreported. When this underreporting rate is extrapolated to the national reported risk, a better estimate of the risk of LIA within VHA could increase to 1.6%. Conclusion and Relevance: When estimating the effect of underreporting, the risk of LIA increases to approximately 1.6% or 1 in 63 patients. Because this ADE may affect more patients than previously understood, providers may wish to take LIA into consideration when prescribing lisinopril.

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

2016 ◽  
Vol 5 (3) ◽  
pp. e169 ◽  
Author(s):  
David Peddie ◽  
Serena S Small ◽  
Katherin Badke ◽  
Maeve E Wickham ◽  
Chantelle Bailey ◽  
...  
Keyword(s):  
Study Protocol ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Drug Event ◽  
Multiple Methods ◽  
Event Reporting

scholarly journals Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260980
Author(s):  
Junko Nagai ◽  
Yoichi Ishikawa
Keyword(s):  
Adverse Event ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Beers Criteria ◽  
Event Report ◽  
Event Reporting ◽  
The Us

Introduction Anticholinergic adverse effects (AEs) are a problem for elderly people. This study aimed to answer the following questions. First, is an analysis of anticholinergic AEs using spontaneous adverse drug event databases possible? Second, what is the main drug suspected of inducing anticholinergic AEs in the databases? Third, do database differences yield different results? Methods We used two databases: the US Food and Drug Administration Adverse Event Reporting System database (FAERS) and the Japanese Adverse Drug Event Report database (JADER) recorded from 2004 to 2020. We defined three types of anticholinergic AEs: central nervous system (CNS) AEs, peripheral nervous system (PNS) AEs, and a combination of these AEs. We counted the number of cases and evaluated the ratio of drug–anticholinergic AE pairs between FAERS and JADER. We computed reporting odds ratios (RORs) and assessed the drugs using Beers Criteria®. Results Constipation was the most reported AE in FAERS. The ratio of drug–anticholinergic AE pairs was statistically significantly larger in FAERS than JADER. Overactive bladder agents were suspected drugs common to both databases. Other drugs differed between the two databases. CNS AEs were associated with antidementia drugs in FAERS and opioids in JADER. In the assessment using Beers Criteria®, signals were detected for almost all drugs. Between the two databases, a significantly higher positive correlation was observed for PNS AEs (correlation coefficient 0.85, P = 0.0001). The ROR was significantly greater in JADER. Conclusions There are many methods to investigate AEs. This study shows that the analysis of anticholinergic AEs using spontaneous adverse drug event databases is possible. From this analysis, various suspected drugs were detected. In particular, FAERS had many cases. The differences in the results between the two databases may reflect differences in the reporting countries. Further study of the relationship between drugs and CNS AEs should be conducted.

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
Sign in / Sign up

Export Citation Format

Share Document