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 syste

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

doi:10.1111/jcpt.12744

Cited by 4 publications

(5 citation statements)

References 37 publications

(76 reference statements)

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“…In our study population, the prevalence of skin complaints and gastrointestinal effects was higher than that found by Villani et al in a recent meta-analysis [24]. Anemia was frequent in our population, which is typically associated with RBV use, similar to other studies [14,24,56]. In 47% of patients, RBV dose reduction or discontinuation was needed, which is a higher proportion of cases than reported by Conti et al [15].…”

Section: Discussionsupporting

confidence: 64%

“…However, as suggested by Hanlon et al, anticholinergic risk scales are easy and useful for identifying patients at risk of adverse effects, regardless of the scale used [41]. Sessa et al, found a proportion of preventable adverse drug reactions involving DAAs, suggesting that it would be a target for improvement [56]. Anticholinergic medications are a potentially modifiable risk factor for the prevention of adverse events and one may hypothesize that recognizing the use of anticholinergic drugs-and therefore potentially inappropriate polypharmacy-by means of these scales, could help in identifying older patients with comorbidities at risk of adverse events when starting antiviral therapy [57].…”

Section: Discussionmentioning

confidence: 99%

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Anticholinergic Burden and Safety Outcomes in Older Patients with Chronic Hepatitis C: A Retrospective Cohort Study

Amoros-Reboredo

Soy

Hernández

et al. 2020

IJERPH

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Aim: Older patients with chronic hepatitis C infection starting direct-acting antivirals (DAAs) are frequently prescribed multiple medications that may be categorized as inappropriate. Anticholinergic burden has been shown to be a predictor of adverse health and functional outcomes. Different scales are available to calculate anticholinergic burden. The aim of this study was to determine the prevalence of anticholinergic medication among older patients treated with DAAs and the risk factors associated using the Anticholinergic Cognitive Burden (ACB) scale, the Anticholinergic Risk Scale (ARS) and the Anticholinergic Drug Scale (ADS) and analyze the resulting safety consequences. Methods: Observational, retrospective cohort study of consecutive patients ≥65 years old receiving DAAs and taking concomitant medication. This study was conducted in accordance with the Strengthening the Reporting of observational studies in Epidemiology Statement. Results: 236 patients were included. The average age was 71.7 years, 73.3% cirrhotic, and 47% patients took ≥5 medicines. According to the ACB, ARS and ADS scales, 35.2% (n = 83), 10.6% (n = 25) and 34.3% (n = 81) of the patients were treated with anticholinergic medication. Two hundred-and-six (86%) patients presented any adverse events (AEs) during therapy. ARS scale showed a significant relationship between presence of anticholinergic medication and AEs. A large number of patients suffered anticholinergic events, with more events per patient in patients taking anticholinergic drugs. Conclusions: Older hepatitis C chronic patients are exposed to potentially inappropriate polypharmacy and anticholinergic risk, according to the ACB, ARS and ADS scales. The three scales showed different results. Only the ARS scale was associated with AEs, but the rate of anticholinergic effects per patient was significantly higher in patients with anticholinergic drugs, regardless of the scale used. Consider quality of pharmacotherapy when starting DAA with a multidisciplinary approach could improve health outcomes.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Anticholinergic Burden and Safety Outcomes in Older Patients with Chronic Hepatitis C: A Retrospective Cohort Study

Amoros-Reboredo

Soy

Hernández

et al. 2020

IJERPH

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“…Generally, doctors, followed by nurses and other health workers, represent the primary sources of spontaneous reports, especially in South Italy [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ]. Several initiatives have been implemented, and others are still necessary to implement a pharmacovigilance culture among all healthcare professionals and the general population [ 32 , 33 , 34 , 35 , 36 , 37 ]. The pressure to which healthcare personnel have been subjected during the COVID-19 emergency is well known.…”

Section: Discussionmentioning

confidence: 99%

Did the COVID-19 Pandemic Affect Contrast Media-Induced Adverse Drug Reaction’s Reporting? A Pharmacovigilance Study in Southern Italy

Rossi

Ruggiero

Sportiello

et al. 2022

JCM

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Medical imaging is required for a complete clinical evaluation to identify lung involvement or pulmonary embolism during SARS-CoV-2 infection or pulmonary and cardiovascular sequelae. Contrast media (CM) have undoubtedly been useful in clinical practice due to their ability to improve medical imaging in COVID-19 patients. Considering their important use, especially in hospitalized COVID-19 patients, and that increased use of a medical tool could also be associated with its deeper knowledge, we chose to explore if new information emerged regarding CM safety profiles. We analyzed all Individual Case Safety Reports (ICSRs) validated by Campania Pharmacovigilance Regional Centre from 1 January 2018 to 31 December 2021 and reported a CM (ATC code V08) as a suspected drug. We compared CM-related reporting between 2 years before (period 1) and 2 years during (period 2) the COVID-19 pandemic. From our analysis, it emerged that, during the COVID-19 pandemic, CM-related ADR reporting decreased, but a significant increase in reporting of serious cases emerged. Serious ADRs were mainly related to iodinated CM (V08A ATC) compared to magnetic resonance imaging CM (V08C ATC). Cutaneous and respiratory disorders were the most frequently reported in both periods. No new or unknown ADRs were reported in the overall study period.

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“…There is still no compelling evidence at present to sustain the conclusion that the use of DAAs for the treatment of HCV is associated with an increased risk of HCC occurrence [25,26]. Labelled DDIs of co-administered drugs were found to be the most common preventable criterion of ADRs related to DAAs [27]. It is known that especially the medicines that alter the activity of the enzymes CYP3A4 or CYP2C8 are contraindicated in patients treated with Om/Pa/Ri+Da [16].…”

Section: Discussionmentioning

confidence: 99%

Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO

Cazacu

Stroe²,

Dondera³

et al. 2020

JGLD

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Background and Aims: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen. Methods: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase® on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex® tool. Results: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p<0.001). Most commonly reported ADRs were pruritus (6.8%), fatigue (5.4%), dizziness (4.3%) and headache (3.8%). For the serious ICSRs, a significant relationship was found between age and renal and urinary disorders, and between gender and neoplasms, injury, poisonings and procedural complications. Hepatotoxicity was identified in six ICSRs, four of them being serious. Potential contraindicated DDIs were identified in 1.9% of all ICSRs and major DDIs in 20.4%. Conclusions: About a third of the ICSRs related to Om/Pa/Ri+Da regimen were serious. Pruritus, fatigue, dizziness and headache were the most commonly reported ADRs. The frequent use of multiple co- medications in HCV-infected patients requires the consideration of potential DDIs when using the Om/ Pa/Ri+Da regimen.

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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 syste

Abstract: 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.

Cited by 4 publications

References 37 publications

Anticholinergic Burden and Safety Outcomes in Older Patients with Chronic Hepatitis C: A Retrospective Cohort Study

Anticholinergic Burden and Safety Outcomes in Older Patients with Chronic Hepatitis C: A Retrospective Cohort Study

Did the COVID-19 Pandemic Affect Contrast Media-Induced Adverse Drug Reaction’s Reporting? A Pharmacovigilance Study in Southern Italy

Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO

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