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

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.

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

Journal of Medical Internet Research ◽

10.2196/27188 ◽

2021 ◽

Author(s):

Erina Chan ◽

Serena S Small ◽

Maeve E Wickham ◽

Vicki Cheng ◽

Ellen Balka ◽

...

Keyword(s):

Mixed Methods ◽

Adverse Drug Event ◽

Mixed Methods Study ◽

Drug Event ◽

Data Standards

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Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05061-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jeffrey P. Hau ◽

Penelope M. A. Brasher ◽

Amber Cragg ◽

Serena Small ◽

Maeve Wickham ◽

...

Keyword(s):

Health Information ◽

Adverse Drug Event ◽

Primary Outcome ◽

Adverse Drug Events ◽

Primary Objective ◽

Drug Event ◽

Controlled Trials ◽

Drug Reactions ◽

Main Trial ◽

Randomized Controlled

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

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Drug-related problems with targeted/immunotherapies at an oncology outpatient clinic

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155219861679 ◽

2019 ◽

Vol 26 (3) ◽

pp. 595-602

Author(s):

Esra Kucuk ◽

Aygin Bayraktar-Ekincioglu ◽

Mustafa Erman ◽

Saadettin Kilickap

Keyword(s):

Adverse Drug Event ◽

Clinical Pharmacist ◽

Adverse Drug Events ◽

Drug Event ◽

Targeted Chemotherapy ◽

Drug Related Problems ◽

Patients With Cancer ◽

Common Drug ◽

Oncology Care ◽

The Impact

Background Some studies in the literature describe drug-related problems in patients with cancer, although few studies focused on patients receiving targeted chemotherapy and/or immunotherapy. To identify the incidence of drug-related problems in patients receiving targeted chemotherapy and/or immunotherapy, and demonstrate the impact of a clinical pharmacist in an outpatient oncology care setting. Methods Prospective study was conducted in a hospital outpatient oncology clinic between October 2015 and March 2016. Patients greater than 18 years old receiving cetuximab, nivolumab, ipilimumab, or pembrolizumab were included in the study and monitored over a three-month period by a clinical pharmacist. Drug-related problems were analyzed using the Pharmaceutical Care Network Europe classification system. The main outcome measures were the frequency and causes of drug-related problems and the degree of resolution achieved through the involvement of a clinical pharmacist. Results A total of 54 patients (mean age: 57 ± 12 years) were included. There were 105 drug-related problems and 159 associated causes. Among the planned interventions (n = 149), 92 interventions were at the patient-level with 88 (96%) being accepted by the doctors. This resulted in 68 (65%) drug-related problems being completely resolved and 9 (8.6%) being partially resolved. The most common drug-related problem identified was “adverse drug event” (n = 38, 36%). Of the 105 drug-related problems, 63 (60%) related to targeted chemotherapy and/or immunotherapy with 34 (54%) classified as an “adverse drug event.” Conclusion Adverse drug events were the most common drug-related problems in patients with cancer. The involvement of a clinical pharmacist improved the identification of drug-related problems and helped optimize treatment outcomes in patients receiving targeted chemotherapy/immunotherapy.

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

10.2196/preprints.10248 ◽

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.

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A Survey of Nursing Home Physicians to Determine Laboratory Monitoring Adverse Drug Event Alert Preferences

Applied Clinical Informatics ◽

10.4338/aci-2014-06-ra-0053 ◽

2014 ◽

Vol 05 (04) ◽

pp. 895-906 ◽

Cited By ~ 4

Author(s):

S. Perera ◽

D.A. Nace ◽

C.M. Culley ◽

S.M. Handler ◽

R.D. Boyce

Keyword(s):

Nursing Home ◽

Adverse Drug Event ◽

Adverse Drug Events ◽

Clinical Event ◽

Drug Event ◽

Specific Information ◽

Laboratory Monitoring ◽

Term Care ◽

Home Setting ◽

Communication Modalities

SummaryObjective: We conducted a survey of nursing home physicians to learn about (1) the laboratory value thresholds that clinical event monitors should use to generate alerts about potential adverse drug events (ADEs); (2) the specific information to be included in the alerts; and (3) the communication modality that should be used for communicating them.Methods: Nursing home physician attendees of the 2010 Conference of AMDA: The Society for Post-Acute and Long-Term Care Medicine.Results: A total of 800 surveys were distributed; 565 completed surveys were returned and seven surveys were excluded due to inability to verify that the respondents were physicians (a 70% net valid response rate). Alerting threshold preferences were identified for eight laboratory tests. For example, the majority of respondents selected thresholds of ≥ 5.5 mEq/L for hyperkalemia (63%) and ≤ 3.5 without symptoms for hypokalemia (54%). The majority of surveyed physicians thought alerts should include the complete active medication list, current vital signs, previous value of the triggering lab, medication change in the past 30 days, and medication allergies. Most surveyed physicians felt the best way to communicate an ADE alert was by direct phone/voice communication (64%), followed by email to a mobile device (59%).Conclusions: This survey of nursing home physicians suggests that the majority prefer alerting thresholds that would generally lead to fewer alerts than if widely accepted standardized laboratory ranges were used. It also suggests a subset of information items to include in alerts, and the physicians’ preferred communication modalities. This information might improve the acceptance of clinical event monitoring systems to detect ADEs in the nursing home setting.Citation: Boyce RD, Perera S, Nace DA, Culley CM, Handler SM. A survey of nursing home physicians to determine laboratory monitoring adverse drug event alert preferences. Appl Clin Inf 2014; 5: 895–906http://dx.doi.org/10.4338/ACI-2014-06-RA-0053

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PP88 Intravenous Medication Delivery System Cost-Effectiveness Analysis

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318002350 ◽

2018 ◽

Vol 34 (S1) ◽

pp. 99-99

Author(s):

Antonio Peregrino ◽

Roberto Silva ◽

Alexander Itria ◽

Carlos Silva ◽

Ana Tolentino ◽

...

Keyword(s):

Cost Effectiveness ◽

Adverse Drug Event ◽

Adverse Drug Events ◽

Cost Effective ◽

Drug Event ◽

Base Case ◽

Infusion Pumps ◽

System Perspective ◽

Medication Delivery ◽

Intravenous Medication

Introduction:Medication delivery is one of the most common interventions in clinical practice. It requires the direct involvement of nurses and high precision infusion pumps in order to increase the infusion accuracy. Any mistake in the medication delivery process can lead to a medication error, resulting in adverse events with considerable increases in hospital length of stay and cost. Research studies should analyze this area more in emerging countries, as their realities differ from the realities of developed countries, where most of the literature of this area has been developed. This research study analyses this area in Brazil, a leading emerging country. The incorporation of these technologies in health services have caused two major problems: uncertainty around its effectiveness in reducing adverse drug event rates related to infusion dose errors, and the high cost of their inputs. The objective of this study was to analyze the cost-effectiveness of intelligent drug library infusion pumps to reduce adverse drug events during intravenous medication delivery in pediatric and neonatal patients.Methods:Cost-effectiveness was evaluated using a decision-tree framework, considering two scenarios as the base case: the reference one, which uses conventional infusion pumps for intravenous medication delivery with a volume greater than 60 mL, and an alternative one, which uses the drug library infusion pumps. The analysis is with the Unified Health System (Brazil's publicly funded health care system) perspective. The Monte Carlo simulations addressed the uncertainties of the framework. The effectiveness measure was avoidance of adverse drug events.Results:The probabilistic analysis showed the drug library infusion pumps to be more cost-effective than conventional pumps. This ratified what had already been revealed by acceptance curve, which demonstrated that the drug library infusion pumps are more likely to be cost-effective compared to the conventional infusion pumps (with a minimum of the incremental cost-effectiveness of USD 1,501.28).Conclusions:The study demonstrated that the use of the drug library infusion pumps in the pediatric and the neonatal intensive care unit can improve the results of the adverse drug event reduction strategy.

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Why Clinicians Don�t Report Adverse Drug Events: Qualitative Study (Preprint)

10.2196/preprints.9282 ◽

2017 ◽

Author(s):

Corinne M Hohl ◽

Serena S Small ◽

David Peddie ◽

Katherin Badke ◽

Chantelle Bailey ◽

...

Keyword(s):

Qualitative Study ◽

Adverse Drug Event ◽

Adverse Drug Events ◽

Community Pharmacists ◽

Care Quality ◽

Drug Event ◽

Complex Nature ◽

Safety Research ◽

Patient Care Quality ◽

Field Notes

BACKGROUND Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. OBJECTIVE Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. RESULTS We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. CONCLUSIONS Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.

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

JMIR Medical Informatics ◽

10.2196/10248 ◽

2018 ◽

Vol 6 (2) ◽

pp. e10248 ◽

Cited By ~ 4

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

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Drug Prescribing to the Elderly Patients

International Journal of Human and Health Sciences (IJHHS) ◽

10.31344/ijhhs.v1i2.12 ◽

2018 ◽

Vol 1 (2) ◽

pp. 65

Author(s):

Misha’l Aly A

Keyword(s):

Elderly Patients ◽

Drug Interactions ◽

Adverse Drug Event ◽

Older Patients ◽

Adverse Drug Events ◽

The Elderly ◽

Health Sciences ◽

Drug Event ◽

Drug Prescribing ◽

Age Related

Age-related physiologic and anatomic changes in various body systems are accompanied by significant pharmacokinetic and pharmacodynamic alterations that make it mandatory for treating physicians to adjust types and dosages of medications for their older patients. Moreover, physicians should be always alert for adverse drug events, and consider any new symptoms as drug-related until proven otherwise. Other issues addressed include prescribing cascades, polypharmacy, drug-drug interactions, and the need to review all medications used by the elderly patients, with special attention to non-prescription and herbetic drugs. This review aims at maximizing safe medicine prescribing, and minimizing adverse drug event in caring for older subjects.International Journal of Human and Health Sciences Vol. 01 No. 02 July’17. Page : 65-69

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