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 ◽  
...  

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.

2019 ◽  
Vol 32 (4) ◽  
pp. 208-212 ◽  
Author(s):  
Serena S. Small ◽  
Corinne M. Hohl ◽  
Ellen Balka

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.


10.2196/10248 ◽  
2018 ◽  
Vol 6 (2) ◽  
pp. e10248 ◽  
Author(s):  
David Peddie ◽  
Serena S Small ◽  
Katherin Badke ◽  
Chantelle Bailey ◽  
Ellen Balka ◽  
...  

2017 ◽  
Vol 16 (4) ◽  
pp. 294-298 ◽  
Author(s):  
Sarah E. Tevis ◽  
Ryan K. Schmocker ◽  
Tosha B. Wetterneck

2016 ◽  
Vol 82 (1) ◽  
pp. 17-29 ◽  
Author(s):  
Chantelle Bailey ◽  
David Peddie ◽  
Maeve E. Wickham ◽  
Katherin Badke ◽  
Serena S. Small ◽  
...  

Author(s):  
Seham Sahal Aloufi

Patient safety is considered as an essential feature of healthcare system. Many trials have been conducted in order to find ways to improve patient safety, and many reports indicate that medication errors pose a threat to patient safety. Thus, some studies have investigated the impact of bar code medication administration (BCMA) system on medication error reduction during the medication administration procedure. This systematic review (SR) reports the impact of BCMA system on reducing medication errors to improve patient safety; it also compares traditional medication administration with the BCMA system. The review concentrates on the effectiveness of BCMA technology on medication administration errors, and on the accuracy of medication administration. This review also focused on different designs of quantitative studies, as they are more effective at investigating the impact of the intervention than qualitative studies. The findings from this systematic review show various results depending on the nature of the hospital setting. Most of the studies agree that the BCMA system enhances compliance with the 'five rights’' requirement (right drug, right patient, right dose, right time and right route) of medication administration. In addition, BCMA technology identified medication error types that could not be identified with the traditional approach which is applying the 'five rights' of medication administration. The findings of this systematic review also confirm the impact of BCMA system in reducing medication error, preventing adverse events and increasing the accuracy of the medication administration rate. However, BCMA technology did not consistently reduce the overall errors of medication administration. Keyword: Patient Safety, Impact, BCMA, eMAR


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044563
Author(s):  
Christy Burden ◽  
Danya Bakhbakhi ◽  
Alexander Edward Heazell ◽  
Mary Lynch ◽  
Laura Timlin ◽  
...  

ObjectiveWhen a formal review of care takes places after the death of a baby, parents are largely unaware it takes place and are often not meaningfully involved in the review process. Parent engagement in the process is likely to be essential for a successful review and to improve patient safety. This study aimed to evaluate an intervention process of parental engagement in perinatal mortality review (PNMR) and to identify barriers and facilitators to its implementation.DesignMixed-methods study of parents’ engagement in PNMR.SettingSingle tertiary maternity unit in the UK.ParticipantsBereaved parents and healthcare professionals (HCPs).InterventionsParent engagement in the PNMR (intervention) was based on principles derived through national consensus and qualitative research with parents, HCPs and stakeholders in the UK.OutcomesRecruitment rates, bereaved parents and HCPs’ perceptions.ResultsEighty-one per cent of bereaved parents approached (13/16) agreed to participate in the study. Two focus groups with bereaved parents (n=11) and HCP (n=7) were carried out postimplementation to investigate their perceptions of the process.Overarching findings were improved dialogue and continuity of care with parents, and improvements in the PNMR process and patient safety. Bereaved parents agreed that engagement in the PNMR process was invaluable and helped them in their grieving. HCP perceived that parent involvement improved the review process and lessons learnt from the deaths; information to understand the impact of aspects of care on the baby’s death were often only found in the parents’ recollections.ConclusionsParental engagement in the PNMR process is achievable and useful for parents and HCP alike, and critically can improve patient safety and future care for mothers and babies. To learn and prevent perinatal deaths effectively, all hospitals should give parents the option to engage with the review of their baby’s death.


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