Guideline proposal for pharma companies to manage pharmacovigilance activities in digital media

Internet has become a central part of our everyday lives. Digital media are integrated in our daily routines and play a critical role in the dissemination of public health information and disease prevention guidelines. For this reason, digital activities are becoming more and more impacting in pharma company activities and this is an increasing trend after the pandemic period. Managing digital activities from pharmacovigilance (PV) perspective may have challenges linked to correct assessment of the activities and application of PV rules: this was underlined in recent publications, where the need to have more specific guidelines linked to digital activities management was evidenced. Considering this scenario and the continuous evolution of the digital activities, the SIMEF PV working group decided to work on a proposal guideline to provide support to PV departments in pharma companies, suggesting a framework to manage sponsored digital activities (i.e., website, web apps, social media webpage, chatbots) impacting potential collection of adverse events (AEs). The purpose of this guideline is to provide useful instructions on how to manage PV requirements for digital activities, suggesting potential solutions for assessing initiatives, creating governance framework, conducting a correct vendor management, and suggesting practical approaches for AEs reporting and follow-up. The aim of this document is also to trigger a broader discussion among relevant stakeholders on which PV guidelines may be useful and appropriate considering this continuous evolving scenario

Il farmaco: ricerca, sviluppo e applicazione in terapia

[Italiano]:Il farmaco: ricerca, sviluppo e applicazione in terapia si propone l’obiettivo di offrire una panoramica sul processo di Ricerca e Sviluppo che un farmaco compie a partire dal momento in cui viene progettato fino alla sua pratica utilizzazione. Quando una molecola è ritenuta potenzialmente adatta per creare un medicinale, si attiva un lungo percorso che ha come traguardo la realizzazione di un nuovo mezzo terapeutico e la sua approvazione per l’immissione in commercio. Un percorso scandito dalla rigorosa osservanza di regolamenti e leggi che si sono evoluti nel tempo di pari passo con il progresso scientifico e tecnologico, ma spesso anche a seguito di reazioni avverse o eventi dannosi irreversibili che hanno innescato processi di revisione delle norme e dei protocolli sperimentali. Questo libro parte con una densa ricognizione sulla storia della farmacologia occidentale, al fine di agevolare la comprensione del coacervo di vicende e circostanze che nel tempo hanno fatto da sfondo a tutte quelle dinamiche attraverso cui il processo di Ricerca e Sviluppo si è gradualmente affermato e consolidato. Notevole attenzione è stata poi dedicata ad alcuni risvolti divenuti oramai cruciali all’interno dell’articolato universo normativo in cui il farmaco è collocato, quali le terapie avanzate e i nuovi approcci per la ricerca clinica. Inoltre, gli autori si sono concentrati sulla prescrizione dei cosiddetti off-label e sulle tematiche di farmacoutilizzazione e farmacovigilanza che, nel giro di pochi decenni, sono assurte a sfere di conoscenza sempre più significative e influenti nelle prospettive presenti e future, non solo delle scienze farmaceutiche ma dell’intera società. Lo sforzo compiuto per redigere questo volume trova la sua ragion d’essere proprio nel voler mettere a disposizione dei lettori uno sguardo d’insieme sul farmaco e sulle complesse sfide che ancora lo attendono./ [English]:“The drug: research, development and application in therapy” is an in-depth study on the Research and Development process that a drug performs from the moment it is designed up to its practical use. When a molecule is considered suitable for a medicine, a long process is activated which has as its goal the creation of a new therapeutic tool and its approval for marketing. A path marked by the strict observance of regulations and laws that have evolved over time in step with scientific and technological progress. A path that however has often been determined also by tragic events following damaging adverse reactions that have triggered processes of revision of the norms and experimental protocols. This book starts with a summary on the history of Western pharmacology, written to allow the reader to understand the circumstances that have been the background to those dynamics through which the Research and Development process has gradually consolidated. An important part of the book is dedicated to some aspects that are crucial in the normative universe in which the drug is placed, such as the advanced therapies and new approaches for clinical research. The authors also focused on the prescriptions of off-label drugs and on the issues of pharmacoutilization and pharmacovigilance, two disciplines that, in a few years, have become increasingly influential in the present and future perspectives, not only of the pharmaceutical sciences but of the entire society

Antidiabetic Drug Prescription Pattern in Hospitalized Older Patients with Diabetes

Objective: To describe the prescription pattern of antidiabetic and cardiovascular drugs in a cohort of hospitalized older patients with diabetes. Methods: Patients with diabetes aged 65 years or older hospitalized in internal medicine and/or geriatric wards throughout Italy and enrolled in the REPOSI (REgistro POliterapuie SIMI—Società Italiana di Medicina Interna) registry from 2010 to 2019 and discharged alive were included. Results: Among 1703 patients with diabetes, 1433 (84.2%) were on treatment with at least one antidiabetic drug at hospital admission, mainly prescribed as monotherapy with insulin (28.3%) or metformin (19.2%). The proportion of treated patients decreased at discharge (N = 1309, 76.9%), with a significant reduction over time. Among those prescribed, the proportion of those with insulin alone increased over time (p = 0.0066), while the proportion of those prescribed sulfonylureas decreased (p < 0.0001). Among patients receiving antidiabetic therapy at discharge, 1063 (81.2%) were also prescribed cardiovascular drugs, mainly with an antihypertensive drug alone or in combination (N = 777, 73.1%). Conclusion: The management of older patients with diabetes in a hospital setting is often sub-optimal, as shown by the increasing trend in insulin at discharge, even if an overall improvement has been highlighted by the prevalent decrease in sulfonylureas prescription

The “Diabetes Comorbidome”: A Different Way for Health Professionals to Approach the Comorbidity Burden of Diabetes

(1) Background: The disease burden related to diabetes is increasing greatly, particularly in older subjects. A more comprehensive approach towards the assessment and management of diabetes’ comorbidities is necessary. The aim of this study was to implement our previous data identifying and representing the prevalence of the comorbidities, their association with mortality, and the strength of their relationship in hospitalized elderly patients with diabetes, developing, at the same time, a new graphic representation model of the comorbidome called “Diabetes Comorbidome”. (2) Methods: Data were collected from the RePoSi register. Comorbidities, socio-demographic data, severity and comorbidity indexes (Cumulative Illness rating Scale CIRS-SI and CIRS-CI), and functional status (Barthel Index), were recorded. Mortality rates were assessed in hospital and 3 and 12 months after discharge. (3) Results: Of the 4714 hospitalized elderly patients, 1378 had diabetes. The comorbidities distribution showed that arterial hypertension (57.1%), ischemic heart disease (31.4%), chronic renal failure (28.8%), atrial fibrillation (25.6%), and COPD (22.7%), were the more frequent in subjects with diabetes. The graphic comorbidome showed that the strongest predictors of death at in hospital and at the 3-month follow-up were dementia and cancer. At the 1-year follow-up, cancer was the first comorbidity independently associated with mortality. (4) Conclusions: The “Diabetes Comorbidome” represents the perfect instrument for determining the prevalence of comorbidities and the strength of their relationship with risk of death, as well as the need for an effective treatment for improving clinical outcomes

Clinical features and outcomes of elderly hospitalised patients with chronic obstructive pulmonary disease, heart failure or both

Background and objective: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) mutually increase the risk of being present in the same patient, especially if older. Whether or not this coexistence may be associated with a worse prognosis is debated. Therefore, employing data derived from the REPOSI register, we evaluated the clinical features and outcomes in a population of elderly patients admitted to internal medicine wards and having COPD, HF or COPD + HF. Methods: We measured socio-demographic and anthropometric characteristics, severity and prevalence of comorbidities, clinical and laboratory features during hospitalization, mood disorders, functional independence, drug prescriptions and discharge destination. The primary study outcome was the risk of death. Results: We considered 2,343 elderly hospitalized patients (median age 81 years), of whom 1,154 (49%) had COPD, 813 (35%) HF, and 376 (16%) COPD + HF. Patients with COPD + HF had different characteristics than those with COPD or HF, such as a higher prevalence of previous hospitalizations, comorbidities (especially chronic kidney disease), higher respiratory rate at admission and number of prescribed drugs. Patients with COPD + HF (hazard ratio HR 1.74, 95% confidence intervals CI 1.16-2.61) and patients with dementia (HR 1.75, 95% CI 1.06-2.90) had a higher risk of death at one year. The Kaplan-Meier curves showed a higher mortality risk in the group of patients with COPD + HF for all causes (p = 0.010), respiratory causes (p = 0.006), cardiovascular causes (p = 0.046) and respiratory plus cardiovascular causes (p = 0.009). Conclusion: In this real-life cohort of hospitalized elderly patients, the coexistence of COPD and HF significantly worsened prognosis at one year. This finding may help to better define the care needs of this population

Clinical features and outcomes of elderly hospitalised patients with chronic obstructive pulmonary disease, heart failure or both

Background and objective: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) mutually increase the risk of being present in the same patient, especially if older. Whether or not this coexistence may be associated with a worse prognosis is debated. Therefore, employing data derived from the REPOSI register, we evaluated the clinical features and outcomes in a population of elderly patients admitted to internal medicine wards and having COPD, HF or COPD + HF. Methods: We measured socio-demographic and anthropometric characteristics, severity and prevalence of comorbidities, clinical and laboratory features during hospitalization, mood disorders, functional independence, drug prescriptions and discharge destination. The primary study outcome was the risk of death. Results: We considered 2,343 elderly hospitalized patients (median age 81 years), of whom 1,154 (49%) had COPD, 813 (35%) HF, and 376 (16%) COPD + HF. Patients with COPD + HF had different characteristics than those with COPD or HF, such as a higher prevalence of previous hospitalizations, comorbidities (especially chronic kidney disease), higher respiratory rate at admission and number of prescribed drugs. Patients with COPD + HF (hazard ratio HR 1.74, 95% confidence intervals CI 1.16-2.61) and patients with dementia (HR 1.75, 95% CI 1.06-2.90) had a higher risk of death at one year. The Kaplan-Meier curves showed a higher mortality risk in the group of patients with COPD + HF for all causes (p = 0.010), respiratory causes (p = 0.006), cardiovascular causes (p = 0.046) and respiratory plus cardiovascular causes (p = 0.009). Conclusion: In this real-life cohort of hospitalized elderly patients, the coexistence of COPD and HF significantly worsened prognosis at one year. This finding may help to better define the care needs of this population

Hospital Care of Older Patients With COPD: Adherence to International Guidelines for Use of Inhaled Bronchodilators and Corticosteroids

313noObjectives: We aimed to analyze the prevalence and impact of COPD in older patients hospitalized in internal medicine or geriatric wards, and to investigate adherence to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, associated clinical factors, and outcomes. Design: Data were obtained from REgistro POliterapie SIMI (REPOSI), a prospective multicenter observational registry that enrolls inpatients aged 65 years. Setting and Participants: Older hospitalized patients enrolled from 2008 to 2016 with a diagnosis of COPD. Measures: We evaluated adherence to the 2018 GOLD guidelines at admission and discharge, by examining the prescription of inhaled bronchodilators and corticosteroids in COPD patients. We also evaluated the occurrence of outcomes and its association with COPD and guideline adherence. Results: At hospital admission, COPD was diagnosed in 1302 (21.5%) of 6046 registered patients. COPD patients were older, with more impaired clinical and functional status and multiple comorbidities. Overall, 34.3% of COPD patients at admission and 35.6% at discharge were adherent to the GOLD guidelines. Polypharmacy (5 drugs) at admission [odds ratio (OR): 3.28, 95% confidence interval (CI): 2.24-4.81], a history of acute COPD exacerbation (OR: 2.65, 95% CI: 1.44-4.88) at admission, smoking habit (OR: 1.45, 95% CI: 1.08-1.94), and polypharmacy at discharge (OR: 6.76, 95% CI: 4.15-11.0) were associated with adherence to guidelines. COPD was independently associated with the risk of cardiovascular and respiratory death and rehospitalization occurrence compared to patients without COPD during follow-up. Adherence to guidelines was inversely associated with the occurrence of death from all causes (OR: 0.12, 95% CI: 0.02-0.90). Conclusions/Implications: COPD was common in older patients acutely hospitalized, showing an impaired functional and clinical status. Prescriptions for older COPD patients were often not adherent to GOLD guidelines. Poor adherence to guidelines was associated with a worse clinical status. There is a need to improve adherence to guidelines in treating COPD patients, with the ultimate goal of reducing clinical events.reservedmixedProietti, Marco; Agosti, Pasquale; Lonati, Chiara; Corrao, Salvatore; Perticone, Francesco; Mannucci, Pier Mannuccio; Nobili, Alessandro; Harari, Sergio; Tettamanti, Mauro; Pasina, Luca; Franchi, Carlotta; Marengoni, Alessandra; Salerno, Francesco; Cesari, Matteo; Licata, Giuseppe; Violi, Francesco; Corazza, Gino Roberto; Cortesi, Laura; Ardoino, Ilaria; Prisco, Domenico; Silvestri, Elena; Cenci, Caterina; Emmi, Giacomo; Biolo, Gianni; Zanetti, Michela; Guadagni, Martina; Zaccari, Michele; Vanoli, Massimo; Grignani, Giulia; Pulixi, Edoardo Alessandro; Bernardi, Mauro; Bassi, Silvia Li; Santi, Luca; Zaccherini, Giacomo; Mannarino, Elmo; Lupattelli, Graziana; Bianconi, Vanessa; Paciullo, Francesco; Nuti, Ranuccio; Valenti, Roberto; Ruvio, Martina; Cappelli, Silvia; Palazzuoli, Alberto; Olivieri, Oliviero; Girelli, Domenico; Matteazzi, Thomas; Barbagallo, Mario; Dominguez, Ligia; Cocita, Floriana; Beneduce, Vincenza; Plances, Lidia; Zoli, Marco; Lazzari, Ilaria; Brunori, Mattia; Pasini, Franco Laghi; Capecchi, Pier Leopoldo; Palasciano, Giuseppe; Modeo, Maria Ester; Di Gennaro, Carla; Cappellini, Maria Domenica; Maira, Diletta; Di Stefano, Valeria; Fabio, Giovanna; Seghezzi, Sonia; Mancarella, Marta; Rossi, Paolo Dionigi; Damanti, Sarah; Clerici, Marta; Conti, Federica; Miceli, Emanuela; Lenti, Marco Vincenzo; Pisati, Martina; Dominioni, Costanza Caccia; Murialdo, Giovanni; Marra, Alessio; Cattaneo, Federico; Pontremoli, Roberto; Secchi, Maria Beatrice; Ghelfi, Davide; Anastasio, Luigi; Sofia, Lucia; Carbone, Maria; Cipollone, Francesco; Guagnano, Maria Teresa; Angelucci, Ermanno; Valeriani, Emanuele; Mancuso, Gerardo; Calipari, Daniela; Bartone, Mosè; Delitala, Giuseppe; Berria, Maria; Muscaritoli, Maurizio; Molfino, Alessio; Petrillo, Enrico; Zuccalà, Giuseppe; D'Aurizio, Gabriella; Romanelli, Giuseppe; Zucchelli, Alberto; Picardi, Antonio; Gentilucci, Umberto Vespasiani; Gallo, Paolo; Dell'Unto, Chiara; Annoni, Giorgio; Corsi, Maurizio; Bellelli, Giuseppe; Zazzetta, Sara; Mazzola, Paolo; Szabo, Hajnalka; Bonfanti, Alessandra; Arturi, Franco; Succurro, Elena; Rubino, Mariangela; Serra, Maria Grazia; Bleve, Maria Antonietta; Gasbarrone, Laura; Sajeva, Maria Rosaria; Brucato, Antonio; Ghidoni, Silvia; Fabris, Fabrizio; Bertozzi, Irene; Bogoni, Giulia; Rabuini, Maria Victoria; Cosi, Elisabetta; Manfredini, Roberto; Fabbian, Fabio; Boari, Benedetta; De Giorgi, Alfredo; Tiseo, Ruana; Paolisso, Giuseppe; Rizzo, Maria Rosaria; Borghi, Claudio; Strocchi, Enrico; De Sando, Valeria; Pareo, Ilenia; Sabbà, Carlo; Vella, Francesco Saverio; Suppressa, Patrizia; Schilardi, Andrea; Loparco, Francesca; Fenoglio, Luigi; Bracco, Christian; Giraudo, Alessia Valentina; Fargion, Silvia; Periti, Giulia; Porzio, Marianna; Tiraboschi, Slivia; Peyvandi, Flora; Rossio, Raffaella; Ferrari, Barbara; Colombo, Giulia; Monzani, Valter; Savojardo, Valeria; Folli, Christian; Ceriani, Giuliana; Pallini, Giada; Dallegri, Franco; Ottonello, Luciano; Liberale, Luca; Caserza, Lara; Salam, Kassem; Liberato, Nicola Lucio; Tognin, Tiziana; Bianchi, Giovanni Battista; Giaquinto, Sabrina; Purrello, Francesco; Di Pino, Antonino; Piro, Salvatore; Rozzini, Renzo; Falanga, Lina; Spazzini, Elena; Ferrandina, Camillo; Montrucchio, Giuseppe; Petitti, Paolo; Salmi, Raffaella; Gaudenzi, Piergiorgio; Perri, Ludovica; Landolfi, Raffaele; Montalto, Massimo; Mirijello, Antonio; Guasti, Luigina; Castiglioni, Luana; Maresca, Andrea; Squizzato, Alessandro; Molaro, Marta; Grossi, Alessandra; Bertolotti, Marco; Mussi, Chiara; Libbra, Maria Vittoria; Dondi, Giulia; Pellegrini, Elisa; Carulli, Lucia; Colangelo, Lidia; Falbo, Tania; Stanghellini, Vincenzo; De Giorgio, Roberto; Ruggeri, Eugenio; Vecchio, Sara del; Salvi, Andrea; Leonardi, Roberto; Damiani, Giampaolo; Gabrielli, Armando; Capeci, William; Mattioli, Massimo; Martino, Giuseppe Pio; Biondi, Lorenzo; Pettinari, Pietro; Ghio, Riccardo; Col, Anna Dal; Minisola, Salvatore; Colangelo, Luciano; Afeltra, Antonella; Marigliano, Benedetta; Pipita, Maria Elena; Castellino, Pietro; Blanco, Julien; Zanoli, Luca; Pignataro, Samuele; Saracco, Valter; Fogliati, Marisa; Bussolino, Carlo; Mete, Francesca; Gino, Miriam; Cittadini, Antonio; Vigorito, Carlo; Arcopinto, Michele; Salzano, Andrea; Bobbio, Emanuele; Marra, Alberto Maria; Sirico, Domenico; Moreo, Guido; Gasparini, Francesca; Prolo, Silvia; Pina, Gloria; Ballestrero, Alberto; Ferrando, Fabio; Berra, Sergio; Dassi, Simonetta; Nava, Maria Cristina; Graziella, Bruno; Baldassarre, Stefano; Fragapani, Salvatore; Gruden, Gabriella; Galanti, Giorgio; Mascherini, Gabriele; Petri, Cristian; Stefani, Laura; Girino, Margherita; Piccinelli, Valeria; Nasso, Francesco; Gioffrè, Vincenza; Pasquale, Maria; Scattolin, Giuseppe; Martinelli, Sergio; Turrin, Mauro; Sechi, Leonardo; Catena, Cristina; Colussi, Gianluca; Passariello, Nicola; Rinaldi, Luca; Berti, Franco; Famularo, Giuseppe; Patrizia, Tarsitani; Castello, Roberto; Pasino, Michela; Ceda, Gian Paolo; Maggio, Marcello Giuseppe; Morganti, Simonetta; Artoni, Andrea; Del Giacco, Stefano; Firinu, Davide; Losa, Francesca; Paoletti, Giovanni; Montalto, Giuseppe; Licata, Anna; Malerba, Valentina; Antonino, Lasco; Basile, Giorgio; Antonino, Catalano; Malatino, Lorenzo; Stancanelli, Benedetta; Terranova, Valentina; Di Marca, Salvatore; Mecocci, Patrizia; Ruggiero, Carmelinda; Boccardi, Virginia; Meschi, Tiziana; Lauretani, Fulvio; Ticinesi, Andrea; Minuz, Pietro; Fondrieschi, Luigi; Pirisi, Mario; Fra, Gian Paolo; Sola, Daniele; Porta, Massimo; Riva, Piero; Quadri, Roberto; Scanzi, Giorgio; Mengoli, Caterina; Provini, Stella; Ricevuti, Laura; Simeone, Emilio; Scurti, Rosa; Tolloso, Fabio; Tarquini, Roberto; Valoriani, Alice; Dolenti, Silvia; Vannini, Giulia; Tedeschi, Alberto; Trotta, Lucia; Volpi, Riccardo; Bocchi, Pietro; Vignali, Alessandro; Cattaneo, MaraProietti, Marco; Agosti, Pasquale; Lonati, Chiara; Corrao, Salvatore; Perticone, Francesco; Mannucci, Pier Mannuccio; Nobili, Alessandro; Harari, Sergio; Tettamanti, Mauro; Pasina, Luca; Franchi, Carlotta; Marengoni, Alessandra; Salerno, Francesco; Cesari, Matteo; Licata, Giuseppe; Violi, Francesco; Corazza, Gino Roberto; Cortesi, Laura; Ardoino, Ilaria; Prisco, Domenico; Silvestri, Elena; Cenci, Caterina; Emmi, Giacomo; Biolo, Gianni; Zanetti, Michela; Guadagni, Martina; Zaccari, Michele; Vanoli, Massimo; Grignani, Giulia; Pulixi, Edoardo Alessandro; Bernardi, Mauro; Bassi, Silvia Li; Santi, Luca; Zaccherini, Giacomo; Mannarino, Elmo; Lupattelli, Graziana; Bianconi, Vanessa; Paciullo, Francesco; Nuti, Ranuccio; Valenti, Roberto; Ruvio, Martina; Cappelli, Silvia; Palazzuoli, Alberto; Olivieri, Oliviero; Girelli, Domenico; Matteazzi, Thomas; Barbagallo, Mario; Dominguez, Ligia; Cocita, Floriana; Beneduce, Vincenza; Plances, Lidia; Zoli, Marco; Lazzari, Ilaria; Brunori, Mattia; Pasini, Franco Laghi; Capecchi, Pier Leopoldo; Palasciano, Giuseppe; Modeo, Maria Ester; Di Gennaro, Carla; Cappellini, Maria Domenica; Maira, Diletta; Di Stefano, Valeria; Fabio, Giovanna; Seghezzi, Sonia; Mancarella, Marta; Rossi, Paolo Dionigi; Damanti, Sarah; Clerici, Marta; Conti, Federica; Miceli, Emanuela; Lenti, Marco Vincenzo; Pisati, Martina; Dominioni, Costanza Caccia; Murialdo, Giovanni; Marra, Alessio; Cattaneo, Federico; Pontremoli, Roberto; Secchi, Maria Beatrice; Ghelfi, Davide; Anastasio, Luigi; Sofia, Lucia; Carbone, Maria; Cipollone, Francesco; Guagnano, Maria Teresa; Angelucci, Ermanno; Valeriani, Emanuele; Mancuso, Gerardo; Calipari, Daniela; Bartone, Mosè; Delitala, Giuseppe; Berria, Maria; Muscaritoli, Maurizio; Molfino, Alessio; Petrillo, Enrico; Zuccalà, Giuseppe; D'Aurizio, Gabriella; Romanelli, Giuseppe; Zucchelli, Alberto; Picardi, Antonio; Gentilucci, Umberto Vespasiani; Gallo, Paolo; Dell'Unto, Chiara; Annoni, Giorgio; Corsi, Maurizio; Bellelli, Giuseppe; Zazzetta, Sara; Mazzola, Paolo; Szabo, Hajnalka; Bonfanti, Alessandra; Arturi, Franco; Succurro, Elena; Rubino, Mariangela; Serra, Maria Grazia; Bleve, Maria Antonietta; Gasbarrone, Laura; Sajeva, Maria Rosaria; Brucato, Antonio; Ghidoni, Silvia; Fabris, Fabrizio; Bertozzi, Irene; Bogoni, Giulia; Rabuini, Maria Victoria; Cosi, Elisabetta; Manfredini, Roberto; Fabbian, Fabio; Boari, Benedetta; De Giorgi, Alfredo; Tiseo, Ruana; Paolisso, Giuseppe; Rizzo, Maria Rosaria; Borghi, Claudio; Strocchi, Enrico; De Sando, Valeria; Pareo, Ilenia; Sabbà, Carlo; Vella, Francesco Saverio; Suppressa, Patrizia; Schilardi, Andrea; Loparco, Francesca; Fenoglio, Luigi; Bracco, Christian; Giraudo, Alessia Valentina; Fargion, Silvia; Periti, Giulia; Porzio, Marianna; Tiraboschi, Slivia; Peyvandi, Flora; Rossio, Raffaella; Ferrari, Barbara; Colombo, Giulia; Monzani, Valter; Savojardo, Valeria; Folli, Christian; Ceriani, Giuliana; Pallini, Giada; Dallegri, Franco; Ottonello, Luciano; Liberale, Luca; Caserza, Lara; Salam, Kassem; Liberato, Nicola Lucio; Tognin, Tiziana; Bianchi, Giovanni Battista; Giaquinto, Sabrina; Purrello, Francesco; Di Pino, Antonino; Piro, Salvatore; Rozzini, Renzo; Falanga, Lina; Spazzini, Elena; Ferrandina, Camillo; Montrucchio, Giuseppe; Petitti, Paolo; Salmi, Raffaella; Gaudenzi, Piergiorgio; Perri, Ludovica; Landolfi, Raffaele; Montalto, Massimo; Mirijello, Antonio; Guasti, Luigina; Castiglioni, Luana; Maresca, Andrea; Squizzato, Alessandro; Molaro, Marta; Grossi, Alessandra; Bertolotti, Marco; Mussi, Chiara; Libbra, Maria Vittoria; Dondi, Giulia; Pellegrini, Elisa; Carulli, Lucia; Colangelo, Lidia; Falbo, Tania; Stanghellini, Vincenzo; De Giorgio, Roberto; Ruggeri, Eugenio; Vecchio, Sara del; Salvi, Andrea; Leonardi, Roberto; Damiani, Giampaolo; Gabrielli, Armando; Capeci, William; Mattioli, Massimo; Martino, Giuseppe Pio; Biondi, Lorenzo; Pettinari, Pietro; Ghio, Riccardo; Col, Anna Dal; Minisola, Salvatore; Colangelo, Luciano; Afeltra, Antonella; Marigliano, Benedetta; Pipita, Maria Elena; Castellino, Pietro; Blanco, Julien; Zanoli, Luca; Pignataro, Samuele; Saracco, Valter; Fogliati, Marisa; Bussolino, Carlo; Mete, Francesca; Gino, Miriam; Cittadini, Antonio; Vigorito, Carlo; Arcopinto, Michele; Salzano, Andrea; Bobbio, Emanuele; Marra, Alberto Maria; Sirico, Domenico; Moreo, Guido; Gasparini, Francesca; Prolo, Silvia; Pina, Gloria; Ballestrero, Alberto; Ferrando, Fabio; Berra, Sergio; Dassi, Simonetta; Nava, Maria Cristina; Graziella, Bruno; Baldassarre, Stefano; Fragapani, Salvatore; Gruden, Gabriella; Galanti, Giorgio; Mascherini, Gabriele; Petri, Cristian; Stefani, Laura; Girino, Margherita; Piccinelli, Valeria; Nasso, Francesco; Gioffrè, Vincenza; Pasquale, Maria; Scattolin, Giuseppe; Martinelli, Sergio; Turrin, Mauro; Sechi, Leonardo; Catena, Cristina; Colussi, Gianluca; Passariello, Nicola; Rinaldi, Luca; Berti, Franco; Famularo, Giuseppe; Patrizia, Tarsitani; Castello, Roberto; Pasino, Michela; Ceda, Gian Paolo; Maggio, Marcello Giuseppe; Morganti, Simonetta; Artoni, Andrea; Del Giacco, Stefano; Firinu, Davide; Losa, Francesca; Paoletti, Giovanni; Montalto, Giuseppe; Licata, Anna; Malerba, Valentina; Antonino, Lasco; Basile, Giorgio; Antonino, Catalano; Malatino, Lorenzo; Stancanelli, Benedetta; Terranova, Valentina; Di Marca, Salvatore; Mecocci, Patrizia; Ruggiero, Carmelinda; Boccardi, Virginia; Meschi, Tiziana; Lauretani, Fulvio; Ticinesi, Andrea; Minuz, Pietro; Fondrieschi, Luigi; Pirisi, Mario; Fra, Gian Paolo; Sola, Daniele; Porta, Massimo; Riva, Piero; Quadri, Roberto; Scanzi, Giorgio; Mengoli, Caterina; Provini, Stella; Ricevuti, Laura; Simeone, Emilio; Scurti, Rosa; Tolloso, Fabio; Tarquini, Roberto; Valoriani, Alice; Dolenti, Silvia; Vannini, Giulia; Tedeschi, Alberto; Trotta, Lucia; Volpi, Riccardo; Bocchi, Pietro; Vignali, Alessandro; Cattaneo, Mar

Antibiotic use and associated factors in a large sample of hospitalised older people.

OBJECTIVES: The aims of this study were to assess (i) the prevalence of antibiotic use, (ii) factors associated with their use and (iii) the association with in-hospital mortality in a large sample of hospitalised older people in Italy. METHODS: Data were obtained from the 2010-2017 REPOSI register held in more than 100 internal medicine and geriatric wards in Italy. Patients aged ≥65 years with at least one antibiotic prescription during their hospitalisation were selected. Multivariable logistic regression models were used to determine factors associated with antibiotic use. RESULTS: A total of 5442 older patients were included in the analysis, of whom 2786 (51.2%) were prescribed antibiotics during their hospitalisation. The most frequently prescribed antibiotic class was β- lactams, accounting for 50% of the total prescriptions. Poor physical independence, corticosteroid use and being hospitalised in Northern Italy were factors associated with a higher likelihood of being prescribed antibiotics. Antibiotic use was associated with an increased risk of in-hospital mortality (odds ratio=2.52, 95% confidence interval 1.82-3.48) also when accounting for factors associated with their use. CONCLUSION: Hospitalised older people are often prescribed antibiotics. Factors related to poor physical independence and corticosteroid use are associated with increased antibiotic use. Being prescribed antibiotics is also associated with an increased risk of in-hospital death. These results demand the implementation of specific stewardship programmes to improve the correct use of antibiotics in hospital settings and to reduce the risk of antimicrobial resistance

Prescription appropriateness of anticoagulant drugs for prophylaxis of venous thromboembolism in hospitalized multimorbid older patients

The aims were to assess: the prescription prevalence of anticoagulant drugs for thromboprophylaxis (TP) in hospitalized older patients; the appropriateness of their prescription or non-prescription; the in-hospital mortality in appropriately versus non-appropriately prescribed or not prescribed patients. 4836 patients aged 65 or older, admitted to the Italian internal medicine and geriatric wards participating to the REPOSI register from 2012 to 2019 were assessed for prescription of anticoagulant drugs for TP at admission and/or during hospital stay. The Padua Prediction Score (PPS) and the IMPROVE score were used to assess the thrombotic and bleeding risk. Patients were considered to be appropriately prescribed when had PPS ≥ 4 and IMPROVE < 7, and appropriately not prescribed when PPS < 4. Logistic regression model was used to assess whether appropriateness was associated with in-hospital mortality. Among 4836 patients included, anticoagulants were prescribed for TP in 1233 (25.5%). In all, 4461 patients were assessable for appropriateness: 3136 (70.3%) were appropriately prescribed or non-prescribed according to their thrombotic and bleeding risk. Among 1138 patients receiving prophylaxis, only 360 (31.7%) were appropriately prescribed, while among 3323 non-prescribed patients, 2776 (83.5%) were appropriately non-prescribed. The in-hospital mortality rate was lower in patients appropriately prescribed or non-prescribed than in those inappropriately prescribed or non-prescribed (OR: 0.63; 95% CI: 0.46-0.83). In conclusion, a high prevalence of multimorbid hospitalized patients were appropriately prescribed or non-prescribed for TP with anticoagulants, appropriate non-prescription being mainly driven by a high bleeding risk. The appropriateness of prescription or non-prescription was associated with lower in-hospital mortality

Low serum albumin is associated with mortality and arterial and venous ischemic events in acutely ill medical patients. Results of a retrospective observational study

Background: In general population hypoalbuminemia is associated with poor survival. Aim of this study was to assess the impact of hypoalbuminemia on mortality and venous and arterial ischemic events in hospitalized acutely ill medical patients. Patients and methods: Retrospective observational analysis from the "REgistro POliterapie SIMI" (REPOSI). Patients were followed up to 12 months. Serum albumin was obtained in each patient. Mortality and ischemic events were registered throughout the follow-up period. Results: In the entire population including 4152 patients, median levels of serum albumin were 3.4 g/dL and 2193 patients (52.8 %) had levels ≤3.4 g/dL. Cases with albumin ≤3.4 g/dL were older, frailer, had more comorbidities and were most frequently underweight than those with serum albumin >3.4 g/dL. During the 12-month follow-up, all-cause mortality was 14.8 % (613 patients), with a higher rate in cases with serum albumin ≤3.4 g/dL (459, 20.9 % vs 154, 7.9 % in those with serum albumin >3.4 g/dL; p < 0.0001). During follow-up 121 ischemic events (2.9 %) were registered, 86 (71.1) arterial and 35 (28.9 %) venous. Proportional hazard analysis showed that patients with albumin ≤3.4 g/dL had a higher chance of dying. Furthermore, patients with albumin ≤3.4 g/dL had a higher likelihood of experiencing ischemic events. Conclusions: Acutely ill hospitalized medical patients with serum levels ≤3.4 g/dL are at higher risk of all-cause mortality and ischemic events, measurement of albumin may help to identify hospitalized patients with a poorer prognosis