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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
Author(s) -
Sessa Maurizio,
Bernardi Francesca Futura,
Vitale Andrea,
Schiavone Beniamino,
Gritti Giulia,
Mascolo Annamaria,
Bertini Michele,
Scavone Cristina,
Sportiello Liberata,
Rossi Francesco,
Capuano Annalisa
Publication year - 2018
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12744
Subject(s) - discontinuation , medicine , adverse effect , drug , drug reaction , hepatitis c , adverse drug reaction , pharmacology , intensive care medicine , hepatitis , surgery
Summary What is known and Objective Medication errors, such as unnecessary treatment discontinuation during treatment with direct‐acting antivirals ( DAA s), can lead to imbalances in the benefit‐to‐risk ratio. This risk is especially high when the medication error leads to adverse drug reactions ( ADR s). However, to date, evidence on the frequency of this phenomenon is scarce. This study aims to provide better insight into ADR s 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 ( ICSR s) generated from July 2012 to March 2017 via the Campania Region (Italy) spontaneous reporting system. ICSR s 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 ICSR s. 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 DAA s due to ADR s, 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 ADR s 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 ADR s.