Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)

Lombardi, Niccolò; Crescioli, Giada; Bettiol, Alessandra; Tuccori, Marco; Capuano, Annalisa; Bonaiuti, Roberto; Mugelli, Alessandro; Venegoni, Mauro; Vighi, Giuseppe

doi:10.3389/fphar.2020.00412

Cited by 27 publications

(45 citation statements)

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“…Off-label drug utilisation and DDIs are well known causes of ADRs in the general population [ 25 ], and the risk of DDI-related ADRs typically increases in patients exposed to c drugs, such as those aged ≥ 65 years [ 24 ]. In the case of COVID-19 pandemic, lacking of specific pharmacological treatments forced clinicians and regulatory agencies to resort to currently available drugs.…”

Section: Discussionmentioning

confidence: 99%

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Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions

et al. 2020

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Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug–drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients’ demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.

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Section: Discussionmentioning

confidence: 99%

“…Suspected drugs and concomitant medications were classified according to the Anatomical Therapeutic Chemical (ATC) classification system. ADR description according to diagnosis and symptoms was coded using the Medical Dictionary for Regulatory Activities (MedDRA) and organised by Preferred Term (PT) [ 23 , 24 ].…”

Section: Methodsmentioning

confidence: 99%

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions

et al. 2020

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“…This is an observational retrospective study performed on data retrieved by pharmacovigilance reports of suspected ADE collected between January 1, 2007 and December 31, 2018 in the 94 EDs participating to the MEREAFaPS Study, an on-going multicentre study of active pharmacovigilance whose features have already been extensively described ( Lombardi et al, 2020b ). The involved hospitals belong to the territories of five Italian Regions: Lombardy and Piedmont (north), Tuscany and Emilia-Romagna (center), and Campania (south).…”

Section: Methodsmentioning

confidence: 99%

“…In evaluating real-world safety aspects of CV medications in the elderly, EDs can certainly represent a valuable observatory to perform pharmacovigilance active investigations about the clinical impact of ADEs in outpatients ( Lombardi et al, 2018 ; Lombardi et al, 2020a ; Lombardi et al, 2020b ). Numerous investigations have been published on ED visits related to ADEs, but none of those found in the scientific literature have focused on CV medications in elderly.…”

Section: Introductionmentioning

confidence: 99%

Risk of Hospitalization Associated with Cardiovascular Medications in the Elderly Italian Population: A Nationwide Multicenter Study in Emergency Departments

et al. 2021

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Background: There is a significant gap in knowledge addressing cardiovascular (CV) medications safety in elderly. In this context, our purposes were to define clinical and pharmacological characteristics of outpatients’ adverse drug events (ADEs) related to CV medications leading to emergency department (ED) visits in the elderly Italian patients according to different age groups, and to evaluate the risk of hospitalization associated to ADEs in this population.Methods: A multicentre, retrospective study was performed on reports of suspected ADEs collected between 2007–2018 in 94 EDs involved in the MEREAFaPS Study. Elderly patients who experienced one or more CV medications-related ADEs leading to ED visit were selected. Patients’ characteristics, suspected (ATC classes B and C) and concomitant drugs, and ADE description were collected. Elderly patients were stratified into three age groups (65–74, 75–84, and ≥85 years) and compared to adults (18–64 years). Logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization adjusting for sex, presence of two or more suspected drugs, concomitant drugs, and one or more comorbidities.Results: Among elderly, 16,926 reports of suspected ADE related to CV medications were collected, and 6,694 (39.5%) resulted in hospitalization. Patients were mostly female, Caucasians, and middle-old (75–84). 78.9% of patients were treated with only one suspected drug, and 71.9% and 47.1% reported concomitant medications and comorbidities, respectively. Compared to adults, risk of hospitalization was significantly higher for middle-old and oldest-old patients exposed to vitamin K antagonists (1.29 [1.09–1.52] and 1.56 [1.30–187]), direct thrombin inhibitors (3.41 [1.44–8.08] and 4.12 [1.67–10.17]), antiplatelets (1.51 [1.26–1.81] and 2.09 [1.71–2.57]), and beta-blockers (1.89 [1.38–2.59 and 2.31 [1.60–3.35]). Overall, a higher risk of hospitalization was observed for renin-angiotensin system inhibitors (1.32 [1.04–1.68], 1.65 [1.32–2.06], and 2.20 [1.70–2.85]), presence of two or more concomitant drugs, and concomitant conditions.Conclusion: Our real-world findings underline relevant safety aspects of CV medications in the elderly Italian population. ED clinicians must always consider the higher risk of hospitalization related to the use of CV drugs in elderly, particularly in oldest-old ones, for antiarrhythmics, beta-blocking agents, renin-angiotensin system inhibitors, antiplatelets, and anticoagulants.

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“…Pharmacovigilance specialists and the other healthcare professionals should always take into consideration all clinical covariates and risk factors of each patient, and this was done in our case, during the pharmaco-toxicological consultation. Nevertheless, for a better general understanding and a wide comparability between settings, Naranjo scale still plays a role, although, as stated in several pharmacovigilance studies, the scale presents numerous well-known application limits [5]. Finally, as reported in Table 2 [2], none of adverse drug reactions described in our study were assessed as "certainly" associated with the suspected drugs.…”

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confidence: 68%

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions-reply

et al. 2021

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We read with great interest the comment written by Pardo-Cabello and colleagues [1], replying to our original article entitled "Adverse drug reactions in SARS-COV-2 hospitalised patients: a case series with a focus on drug-drug interactions" [2] and we would like to make some comments regarding their considerations. As the authors correctly point out, data on the overall number of patients hospitalised for COVID-19 during the study period were not available at the time of writing. For this reason, only those patients for whom a pharmacological and toxicological counselling was requested by clinicians working in COVID-19 Units were considered. Of course, knowing the overall number of patients treated, and consequently, the prevalence rate of adverse drug reactions, could improve the assessment of burden due to pharmacological treatments in COVID-19 inpatients. Currently, we are able to retrieve the total number of patients hospitalised in the COVID-19 Units during the different phases of the SARS-CoV-2 pandemic, from the last Smart Consensus Conference organised by Careggi University Hospital, Florence (Italy) available online [3]. In particular, during the first wave (I semester 2020), a total of 472 patients were hospitalised, with a mean age of 72 years and an average hospital stay of 14.2 days. Of them, 27% (n = 127) were managed in the intensive care units, with an overall mortality of 25.6% (mean age of 77 years) [3]. Considering that all

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Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)

Cited by 27 publications

References 23 publications

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions

Risk of Hospitalization Associated with Cardiovascular Medications in the Elderly Italian Population: A Nationwide Multicenter Study in Emergency Departments

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions-reply

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