Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system

Maurizio Sessa; Francesca Futura Bernardi; Andrea Vitale; Beniamino Schiavone; Giulia Gritti; Annamaria Mascolo; Michele Bertini; Cristina Scavone; Liberata Sportiello; Francesco Rossi; Annalisa Capuano

doi:10.1111/jcpt.12744

Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system

Maurizio Sessa, Francesca Futura Bernardi, Andrea Vitale, Beniamino Schiavone, Giulia Gritti, Annamaria Mascolo, Michele Bertini, Cristina Scavone, Liberata Sportiello, Francesco Rossi, Annalisa Capuano

2 Citations (Scopus)

Abstract

WHAT IS KNOWN AND OBJECTIVE: Medication errors, such as unnecessary treatment discontinuation during treatment with direct-acting antivirals (DAAs), can lead to imbalances in the benefit-to-risk ratio. This risk is especially high when the medication error leads to adverse drug reactions (ADRs). However, to date, evidence on the frequency of this phenomenon is scarce. This study aims to provide better insight into ADRs possibly due to medication errors leading to DAA discontinuation and their preventability.

METHODS: The Italian Pharmacovigilance Network database was used to extract individual case safety reports (ICSRs) generated from July 2012 to March 2017 via the Campania Region (Italy) spontaneous reporting system. ICSRs that included ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir, dasabuvir, daclatasvir, sofosbuvir, simeprevir or elbasvir/grazoprevir as suspected drugs were included in this study. A preventability assessment was then performed utilizing the "P-Method," an algorithm that evaluates known risk factors due to medication errors that can be detected in ICSRs.

RESULTS AND DISCUSSION: Of the 355 cases included in this study, 6 (1.69%) were classified as preventable and 52 (14.6%) were classified as potentially preventable. The most frequently identified critical criteria (risk factor) for preventable or potentially preventable cases were drug-drug interactions and incorrect drug dosing as part of the antiviral treatment scheme. In total, 89 of the 355 cases (25.1%) discontinued use of the DAAs due to ADRs, of which 20 of the 89 cases (22.5%) were due to an unimportant medical event as classified by the European Medicine Agency important medical event list.

WHAT IS NEW AND CONCLUSION: This study found a proportion of preventable/potentially preventable ADRs involving DAA, which could be improved in the Campania Region (Italy). Additionally, the study identified a high proportion of seemingly unnecessary DAA discontinuations among patients who experienced ADRs.

Original language	English
Journal	Journal of Clinical Pharmacy and Therapeutics
Volume	43
Issue number	6
Pages (from-to)	867-876
ISSN	0269-4727
DOIs	https://doi.org/10.1111/jcpt.12744
Publication status	Published - Dec 2018

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Sessa, M., Bernardi, F. F., Vitale, A., Schiavone, B., Gritti, G., Mascolo, A., Bertini, M., Scavone, C., Sportiello, L., Rossi, F., & Capuano, A. (2018). Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system. Journal of Clinical Pharmacy and Therapeutics, 43(6), 867-876. https://doi.org/10.1111/jcpt.12744

Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system. / Sessa, Maurizio; Bernardi, Francesca Futura; Vitale, Andrea et al.
In: Journal of Clinical Pharmacy and Therapeutics, Vol. 43, No. 6, 12.2018, p. 867-876.

Research output: Contribution to journal › Journal article › Research › peer-review

Sessa, M, Bernardi, FF, Vitale, A, Schiavone, B, Gritti, G, Mascolo, A, Bertini, M, Scavone, C, Sportiello, L, Rossi, F & Capuano, A 2018, 'Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system', Journal of Clinical Pharmacy and Therapeutics, vol. 43, no. 6, pp. 867-876. https://doi.org/10.1111/jcpt.12744

Sessa M, Bernardi FF, Vitale A, Schiavone B, Gritti G, Mascolo A et al. Adverse drug reactions during hepatitis C treatment with direct-acting antivirals: The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system. Journal of Clinical Pharmacy and Therapeutics. 2018 Dec;43(6):867-876. doi: 10.1111/jcpt.12744

Sessa, Maurizio ; Bernardi, Francesca Futura ; Vitale, Andrea et al. / Adverse drug reactions during hepatitis C treatment with direct-acting antivirals : The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system. In: Journal of Clinical Pharmacy and Therapeutics. 2018 ; Vol. 43, No. 6. pp. 867-876.

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abstract = "WHAT IS KNOWN AND OBJECTIVE: Medication errors, such as unnecessary treatment discontinuation during treatment with direct-acting antivirals (DAAs), can lead to imbalances in the benefit-to-risk ratio. This risk is especially high when the medication error leads to adverse drug reactions (ADRs). However, to date, evidence on the frequency of this phenomenon is scarce. This study aims to provide better insight into ADRs possibly due to medication errors leading to DAA discontinuation and their preventability.METHODS: The Italian Pharmacovigilance Network database was used to extract individual case safety reports (ICSRs) generated from July 2012 to March 2017 via the Campania Region (Italy) spontaneous reporting system. ICSRs that included ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir, dasabuvir, daclatasvir, sofosbuvir, simeprevir or elbasvir/grazoprevir as suspected drugs were included in this study. A preventability assessment was then performed utilizing the {"}P-Method,{"} an algorithm that evaluates known risk factors due to medication errors that can be detected in ICSRs.RESULTS AND DISCUSSION: Of the 355 cases included in this study, 6 (1.69%) were classified as preventable and 52 (14.6%) were classified as potentially preventable. The most frequently identified critical criteria (risk factor) for preventable or potentially preventable cases were drug-drug interactions and incorrect drug dosing as part of the antiviral treatment scheme. In total, 89 of the 355 cases (25.1%) discontinued use of the DAAs due to ADRs, of which 20 of the 89 cases (22.5%) were due to an unimportant medical event as classified by the European Medicine Agency important medical event list.WHAT IS NEW AND CONCLUSION: This study found a proportion of preventable/potentially preventable ADRs involving DAA, which could be improved in the Campania Region (Italy). Additionally, the study identified a high proportion of seemingly unnecessary DAA discontinuations among patients who experienced ADRs.",

author = "Maurizio Sessa and Bernardi, {Francesca Futura} and Andrea Vitale and Beniamino Schiavone and Giulia Gritti and Annamaria Mascolo and Michele Bertini and Cristina Scavone and Liberata Sportiello and Francesco Rossi and Annalisa Capuano",

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T1 - Adverse drug reactions during hepatitis C treatment with direct-acting antivirals

T2 - The role of medication errors, their impact on treatment discontinuation and their preventability. New insights from the Campania Region (Italy) spontaneous reporting system

AU - Sessa, Maurizio

AU - Bernardi, Francesca Futura

AU - Vitale, Andrea

AU - Schiavone, Beniamino

AU - Gritti, Giulia

AU - Mascolo, Annamaria

AU - Bertini, Michele

AU - Scavone, Cristina

AU - Sportiello, Liberata

AU - Rossi, Francesco

AU - Capuano, Annalisa

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N2 - WHAT IS KNOWN AND OBJECTIVE: Medication errors, such as unnecessary treatment discontinuation during treatment with direct-acting antivirals (DAAs), can lead to imbalances in the benefit-to-risk ratio. This risk is especially high when the medication error leads to adverse drug reactions (ADRs). However, to date, evidence on the frequency of this phenomenon is scarce. This study aims to provide better insight into ADRs possibly due to medication errors leading to DAA discontinuation and their preventability.METHODS: The Italian Pharmacovigilance Network database was used to extract individual case safety reports (ICSRs) generated from July 2012 to March 2017 via the Campania Region (Italy) spontaneous reporting system. ICSRs that included ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir, dasabuvir, daclatasvir, sofosbuvir, simeprevir or elbasvir/grazoprevir as suspected drugs were included in this study. A preventability assessment was then performed utilizing the "P-Method," an algorithm that evaluates known risk factors due to medication errors that can be detected in ICSRs.RESULTS AND DISCUSSION: Of the 355 cases included in this study, 6 (1.69%) were classified as preventable and 52 (14.6%) were classified as potentially preventable. The most frequently identified critical criteria (risk factor) for preventable or potentially preventable cases were drug-drug interactions and incorrect drug dosing as part of the antiviral treatment scheme. In total, 89 of the 355 cases (25.1%) discontinued use of the DAAs due to ADRs, of which 20 of the 89 cases (22.5%) were due to an unimportant medical event as classified by the European Medicine Agency important medical event list.WHAT IS NEW AND CONCLUSION: This study found a proportion of preventable/potentially preventable ADRs involving DAA, which could be improved in the Campania Region (Italy). Additionally, the study identified a high proportion of seemingly unnecessary DAA discontinuations among patients who experienced ADRs.

AB - WHAT IS KNOWN AND OBJECTIVE: Medication errors, such as unnecessary treatment discontinuation during treatment with direct-acting antivirals (DAAs), can lead to imbalances in the benefit-to-risk ratio. This risk is especially high when the medication error leads to adverse drug reactions (ADRs). However, to date, evidence on the frequency of this phenomenon is scarce. This study aims to provide better insight into ADRs possibly due to medication errors leading to DAA discontinuation and their preventability.METHODS: The Italian Pharmacovigilance Network database was used to extract individual case safety reports (ICSRs) generated from July 2012 to March 2017 via the Campania Region (Italy) spontaneous reporting system. ICSRs that included ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir, dasabuvir, daclatasvir, sofosbuvir, simeprevir or elbasvir/grazoprevir as suspected drugs were included in this study. A preventability assessment was then performed utilizing the "P-Method," an algorithm that evaluates known risk factors due to medication errors that can be detected in ICSRs.RESULTS AND DISCUSSION: Of the 355 cases included in this study, 6 (1.69%) were classified as preventable and 52 (14.6%) were classified as potentially preventable. The most frequently identified critical criteria (risk factor) for preventable or potentially preventable cases were drug-drug interactions and incorrect drug dosing as part of the antiviral treatment scheme. In total, 89 of the 355 cases (25.1%) discontinued use of the DAAs due to ADRs, of which 20 of the 89 cases (22.5%) were due to an unimportant medical event as classified by the European Medicine Agency important medical event list.WHAT IS NEW AND CONCLUSION: This study found a proportion of preventable/potentially preventable ADRs involving DAA, which could be improved in the Campania Region (Italy). Additionally, the study identified a high proportion of seemingly unnecessary DAA discontinuations among patients who experienced ADRs.

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