Dataset Information

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System.

ABSTRACT: Background:Despite the risk of bleeding is a well-known adverse effect of oral anticoagulants, there is scarce evidence on the preventability of oral anticoagulant-induced bleedings. Therefore, we investigated the potential risk factors related to preventable cases of oral anticoagulant-induced bleedings. Methods:We performed a study using Individual Case Safety Reports (ICSRs) with an oral anticoagulant as suspected drug among those reported through the spontaneous reporting system of Campania Region from 1 July 2012 to 31 December 2017. The P-method was used for the preventability assessment of all cases of bleeding. Results:In total, 58 cases out of 253 (22.9%) were preventable, and the most reported suspected drug was an indirect oral anticoagulant (warfarin). Sixty-eight critical criteria for preventability were identified, all related to healthcare professionals' practices. The most detected risk factor related to healthcare professionals' practices was the labeled drug-drug interaction for both direct and indirect oral anticoagulants. Conclusion:Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription.

SUBMITTER: Mascolo A

PROVIDER: S-EPMC6503045 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System.

Mascolo Annamaria A Ruggiero Rosanna R Sessa Maurizio M Scavone Cristina C Sportiello Liberata L Rafaniello Concetta C Rossi Francesco F Capuano Annalisa A

Frontiers in pharmacology 20190430

<h4>Background</h4>Despite the risk of bleeding is a well-known adverse effect of oral anticoagulants, there is scarce evidence on the preventability of oral anticoagulant-induced bleedings. Therefore, we investigated the potential risk factors related to preventable cases of oral anticoagulant-induced bleedings.<h4>Methods</h4>We performed a study using Individual Case Safety Reports (ICSRs) with an oral anticoagulant as suspected drug among those reported through the spontaneous reporting syst ...[more]

PMID: 31114497

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Project description:ObjectiveTo estimate the association between untreated, community acquired, respiratory tract infections and bleeding in oral anticoagulant users.DesignSelf-controlled case series.SettingGeneral practices in England contributing data to the Clinical Practice Research Datalink GOLD.Participants1208 adult users of warfarin or direct oral anticoagulants with a general practice or hospital admission record of a bleeding event between January 2010 and December 2019, and a general practice record of a consultation for a community acquired respiratory tract infection for which immediate antibiotics were not prescribed (that is, untreated).Main outcome measuresRelative incidence of major bleeding and clinically relevant non-major bleeding in the 0-14 days after an untreated respiratory tract infection, compared to unexposed time periods.ResultsOf 1208 study participants, 58% (n=701) were male, median age at time of first bleed was 79 years (interquartile range 72-85), with a median observation period of 2.4 years (interquartile range 1.3-3.8). 292 major bleeds occurred during unexposed time periods and 41 in the 0-14 days after consultation for a respiratory tract infection. 1003 clinically relevant non-major bleeds occurred during unexposed time periods and 81 in the 0-14 days after consultation for a respiratory tract infection. After adjustment for age, season, and calendar year, the relative incidence of major bleeding (incidence rate ratio 2.68, 95% confidence interval 1.83 to 3.93) and clinically relevant non-major bleeding (2.32, 1.82 to 2.94) increased in the 0-14 days after an untreated respiratory tract infection. Findings were robust to several sensitivity analyses and did not differ by sex or type of oral anticoagulant.ConclusionsThis study observed a greater than twofold increase in the risk of bleeding during the 0-14 days after an untreated respiratory tract infection. These findings have potential implications for how patients and clinicians manage oral anticoagulant use during an acute intercurrent illness and warrant further investigation into the potential risks and how they might be mitigated.

Project description:BACKGROUND: Monitoring oral anticoagulants is logistically challenging for both patients and medical staff. We evaluated the effect of adding an interactive voice response system to computerized decision support for oral anticoagulant management. METHODS: We developed an interactive voice response system to communicate to patients the results of international normalized ratio testing and their dosage schedules for anticoagulation therapy. The system also reminded patients of upcoming and missed appointments for blood tests. We recruited patients whose anticoagulation control was stable after at least 3 months of warfarin therapy. We prospectively examined clinical data and outcomes for these patients for an intervention period of at least 3 months. We also collected retrospective data for each patient for the 3 months before study enrolment. RESULTS: We recruited 226 patients between Nov. 23, 2006, and Aug. 1, 2007. The mean duration of the intervention period (prospective data collection) was 4.2 months. Anticoagulation control was similar for the periods during and preceding the intervention (mean time within the therapeutic range 80.3%, 95% confidence interval [CI] 77.5% to 83.1% v. 79.9%, 95% CI 77.3% to 82.6%). The interactive voice response system delivered 1211 (77.8%) of 1557 scheduled dosage messages, with no further input required from clinic staff. The most common reason for clinic staff having to deliver the remaining messages (accounting for 143 [9.2%] of all messages) was an international normalized ratio that was excessively high or low, (i.e., 0.5 or more outside the therapeutic range). When given the option, 76.6% of patients (164/214) chose to continue with the interactive voice response system for management of their anticoagulation after the study was completed. The system reduced staff workload for monitoring anticoagulation therapy by 48 min/wk, a 33% reduction from the baseline of 2.4 hours. INTERPRETATION: Interactive voice response systems have a potential role in improving the monitoring of patients taking oral anticoagulants. Further work is required to determine the generalizability and cost-effectiveness of these results.

Dataset Information

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System.

Publications

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System.

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