Performance of the Adverse Drug Event Trigger Tool and the Global Trigger Tool for Identifying Adverse Drug Events: Experience in a Belgian Hospital

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

10.2196/preprints.27188 ◽

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.

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Establishment of a pediatric trigger tool based on Global Trigger Tool to identify adverse drug events of children: experience in a Chinese hospital

BMC Pediatrics ◽

10.1186/s12887-020-02354-9 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Yi Liu ◽

Junfeng Yan ◽

Yunfei Xie ◽

Yuan Bian

Keyword(s):

Cohort Study ◽

Retrospective Review ◽

Retrospective Cohort ◽

Literature Search ◽

Adverse Drug Events ◽

Trigger Tool ◽

Trigger Rate ◽

Global Trigger Tool ◽

Pediatric Inpatient ◽

Grade 3

Abstract Background The Global Trigger Tool (GTT),which is a method using “triggers” to review medical record retrospectively to identify possible adverse events. Several studies showed that the GTT was effective. However, there were only a few localized trigger tools that had been established to detect pediatric adverse drug events (ADEs) in China. This study aimed to establish a pediatric trigger tool based on GTT, to examine the performance by detecting pediatric inpatients ADEs in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of ADEs. Methods The triggers were established by three steps including literature search, triggers extraction and revision, and experts investigation. A retrospective cohort study was conducted to detect ADEs by using 200 pediatric inpatient records of Sichuan Provincial People’s Hospital. Results Thirty-three preliminary triggers were established, and 2 rounds of experts investigation were conducted. Finally, 33 triggers were established. In the retrospective review, the positive trigger rate was 64.0%, while the positive predictive value (PPV) was 24.9%. The occurrence of inpatients with ADEs was 20.5%. ADEs/100 admissions were 49.0. ADEs/1000 patient days were 46.89. The most common ADE categories were leukocyte disorders, skin disorders and platelet disorders. The severity of 39 ADEs was grade 1, 55 ADEs was grade 2, 4 ADEs was grade 3. The highest frequency of ADE-related drugs was antineoplastic, followed by antibacterial. The length of stay and the leukemia in the diagnosed diseases were positively correlated with ADEs. Conclusions The 33 pediatric triggers may detect ADEs effectively, but still need to be optimized. This study may provide some references for further research in order to improve the rationality and safety of medication.

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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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Patient-specific risk factors of adverse drug events in adult inpatients - evidence detected using the Global Trigger Tool method

Journal of Clinical Nursing ◽

10.1111/jocn.12714 ◽

2014 ◽

Vol 24 (3-4) ◽

pp. 582-591 ◽

Cited By ~ 19

Author(s):

Marja Härkänen ◽

Marjo Kervinen ◽

Jouni Ahonen ◽

Ari Voutilainen ◽

Hannele Turunen ◽

...

Keyword(s):

Risk Factors ◽

Adverse Drug Events ◽

Patient Specific ◽

Trigger Tool ◽

Specific Risk ◽

Global Trigger Tool

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Evaluation of Trigger Tool Methodology Related to Adverse Drug Events in Hospitalized Patients

Patient Safety ◽

10.33940/med/2019.12.2 ◽

2019 ◽

pp. 20-29

Author(s):

Sara Kolc Brown ◽

Jacob Peterson ◽

Shayne Harris Schiedel ◽

Kari Vavra Janes

Keyword(s):

Renal Function ◽

Adverse Drug Events ◽

Dose Range ◽

Common Factor ◽

International Normalized Ratio ◽

Drug Event ◽

Contributing Factors ◽

Trigger Tool ◽

Naloxone Administration ◽

The Future

Purpose: To determine why an inpatient has had one of the following occurrences in the electronic health record due to an adverse drug event (ADE): international normalized ratio (INR) > 6, plasma blood glucose ≤ 50 mg/dL, or naloxone administration use. Utilizing the Institute for Healthcare Improvement (IHI) Global Trigger Tool, the information gathered will be used to determine how to prevent these events from occurring in the future. Summary: The positive predictive value (PPV) for elevated INR was 35% (confidence interval [CI] 21–53%), hypoglycemia was 70.4% (CI 62–78%), and 53% for naloxone administration (CI 45–60%). Drug interactions were the most common factor that may have contributed to an elevated INR, with a mean INR of 7.9. Basal insulin monotherapy, recent diet changes, decreases in renal function, and discontinuation/tapering of corticosteroids were all observed to be contributing factors to hypoglycemia events. The mean trigger glucose level was 42.98 mg/dL. Dose range order sets, high morphine milligram equivalents (MME), and decreased renal function may have contributed to naloxone administration. Polypharmacy was attributed to some of these adverse events, with the average inpatient MME of 100.5 mg. Conclusion: The use of trigger tool methodology was useful for identifying ADEs related to hypoglycemia with insulin, moderately useful for naloxone administration, and least successful for elevated INR with warfarin. The ADEs that were identified revealed a wide variety of contributing factors that can be used as areas of interest when creating new policies and procedures to reduce ADEs in the future.

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Establishment of a Pediatric Trigger Tool Based on Global Trigger Tool to Identify Adverse Drug Events of Children: Experience in a Chinese hospital

10.21203/rs.3.rs-24648/v1 ◽

2020 ◽

Author(s):

YI LIU ◽

JUN FENG YAN ◽

YUN FEI XIE ◽

YUAN BIAN

Keyword(s):

Retrospective Review ◽

Retrospective Cohort ◽

Literature Search ◽

Adverse Drug Events ◽

Skin Lesions ◽

Trigger Tool ◽

Trigger Rate ◽

Global Trigger Tool ◽

Pediatric Inpatient ◽

Grade 3

Abstract Background: The Global Trigger Tool (GTT)，which is a method using “triggers” to review medical record retrospectively to identify possible adverse events. Several studies showed that the GTT was effective. However, there were only a few localized trigger tools that had been established to detect pediatric adverse drug events (ADEs) in China. This study aimed to establish a pediatric trigger tool based on GTT, to examine the performance by detecting pediatric inpatients ADEs in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of ADEs. Methods: The triggers were established by three steps including literature search, triggers extraction and revision, and experts investigation. A retrospective cohort study was conducted to detect ADEs by using 200 pediatric inpatient records of Sichuan Provincial People's Hospital. Results: 33 preliminary triggers were established, and 2 rounds of experts investigation were conducted. Finally, 33 triggers were established. In the retrospective review, the positive trigger rate was 64.0%, while the positive predictive value (PPV) was 24.9%. The occurrence of inpatients with ADEs was 20.5%. ADEs/100 patients were 49.0. ADEs/1000 patients days were 46.89. The most common ADE categories were leukocyte abnormalities, skin lesions and platelet abnormalities. The severity of 39 ADEs was grade 1, 55 ADEs was grade 2, 4 ADEs was grade 3. The highest frequency of ADE-related drugs was antineoplastic, followed by antibacterial. The length of stay and the leukemia in the diagnosed diseases were positively correlated with ADEs . Conclusion : The 33 pediatric triggers may detect ADEs effectively, but still need to be optimized. This study may provide some references for further research in order to improve the rationality and safety of medication.

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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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