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

Annamaria Mascolo; Rosanna Ruggiero; Maurizio Sessa; Cristina Scavone; Liberata Sportiello; Concetta Rafaniello; Francesco Rossi; Annalisa Capuano

doi:10.3389/fphar.2019.00425

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

Annamaria Mascolo, Rosanna Ruggiero, Maurizio Sessa, Cristina Scavone, Liberata Sportiello, Concetta Rafaniello, Francesco Rossi, Annalisa Capuano

7 Citations (Scopus)

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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.

Original language	English
Article number	425
Journal	Frontiers in Pharmacology
Volume	10
Number of pages	12
ISSN	1663-9812
DOIs	https://doi.org/10.3389/fphar.2019.00425
Publication status	Published - 2019

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title = "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.",

author = "Annamaria Mascolo and Rosanna Ruggiero and Maurizio Sessa and Cristina Scavone and Liberata Sportiello and Concetta Rafaniello and Francesco Rossi and Annalisa Capuano",

year = "2019",

doi = "10.3389/fphar.2019.00425",

language = "English",

volume = "10",

journal = "Frontiers in Pharmacology",

issn = "1663-9812",

publisher = "Frontiers Research Foundation",

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TY - JOUR

T1 - Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System

AU - Mascolo, Annamaria

AU - Ruggiero, Rosanna

AU - Sessa, Maurizio

AU - Scavone, Cristina

AU - Sportiello, Liberata

AU - Rafaniello, Concetta

AU - Rossi, Francesco

AU - Capuano, Annalisa

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

U2 - 10.3389/fphar.2019.00425

DO - 10.3389/fphar.2019.00425

M3 - Journal article

C2 - 31114497

SN - 1663-9812

VL - 10

JO - Frontiers in Pharmacology

JF - Frontiers in Pharmacology

M1 - 425

ER -

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

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