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Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent and relevant healthcare issues. Direct oral anticoagulants (DOACs) are now the first-choice for anticoagulant treatment of these conditions displaying a better efficacy/safety profile than vitamin-K antagonists, mainly due to significantly reduced risk of major bleeding, especially of intracranial haemorrhage. Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in developed countries showing a continuously growing prevalence. Nonalcoholic steatohepatitis (NASH), its evolutive form, will be the leading cause for liver transplantation by 2020. NAFLD is independently associated with an increased risk of abnormalities of cardiac structure and function, including cardiac rhythm disorders (mainly AF). Moreover, data suggest an increased risk of unprovoked VTE associated with NAFLD/NASH. Therefore, a growing number of patients with chronic liver disease (CLD) will be candidate for anticoagulant therapy in the near future. Cirrhosis of any etiology is characterized by an unstable thrombosis/bleeding haemostatic balance, making anticoagulant therapy particularly challenging in this condition. Given that patients with significant active liver disease and cirrhosis were excluded from all pivotal randomized controlled trials on DOACs, this comprehensive review aims at critically discussing real-world evidence, including the latest population studies, regarding the use of DOACs in patients with CLD/cirrhosis. [ABSTRACT FROM AUTHOR]

Nowadays, the intensity of care organizational model has been adopted in several Italian hospitals in order to create specific areas dedicated to patients reporting homogeneous needs of care. The present paper aims at describing the organizational intervention Inside the change, designed to explore the context and assess the impact of the implementation of the Intensity of cure model in an Italian hospital. Inside the change was composed of two segments: i) the evaluation of attitudes toward change and workers' well-being (quantitative phase); ii) the conduction of a consulting process aimed to identify critical issues and the related improvement actions (qualitative phase). The results showed that workers (i.e., physicians, nurses, healthcare assistants) involved in the change process showed higher levels of work-related well-being symptoms. In line with this result, the second stage of the intervention had the goal of improving workers' involvement in organizational change, together with the identification of suitable improvement actions. Data collected one year after the intervention suggest that the whole performance of healthcare organizations may be enhanced by investments in monitoring and improving organizational processes, particularly for those focused on HR management. [ABSTRACT FROM AUTHOR]

Background: Clostridium difficile (CD) is a leading cause of diarrhoea among hospitalized patients. The objective of this study was to evaluate the rate, the optimal diagnostic work-up, and outcome of CD infections (CDI) in Internal Medicine (IM) wards in Italy. Methods: PRACTICE is an observational prospective study, involving 40 IM Units and evaluating all consecutive patients hospitalized during a 4-month period. CDI were defined in case of diarrhoea when both enzyme immunoassay for GDH, and test for A/B toxin were positive. Patients with CDI were followed-up for recurrences for 4 weeks after the end of therapy. Results: Among the 10,780 patients observed, 103 (0.96 %) showed CDI, at admission or during hospitalization. A positive history for CD, antibiotics in the previous 4 weeks, recent hospitalization, female gender and age were significantly associated with CDI (multivariable analysis). In-hospital mortality was 16.5 % in CD group vs 6.7 % in No-CD group (p < 0.001), whereas median length of hospital stay was 16 (IQR = 13) vs 8 (IQR = 8) days (p < 0.001) among patients with or without CDI, respectively. Rate of CD recurrences was 14.6 %. As a post-hoc evaluation, 23 out of 34 GDH+/Tox- samples were toxin positive, when analysed by molecular method (a real-time PCR assay). The overall CD incidence rate was 5.3/10,000 patient-days. Conclusions: Our results confirm the severity of CDI in medical wards, showing high in-hospital mortality, prolonged hospitalization and frequent short-term recurrences. Further, our survey supports a 2-3 step algorithm for CD diagnosis: EIA for detecting GDH, A and B toxin, followed by a molecular method in case of toxin-negative samples. [ABSTRACT FROM AUTHOR]

There are several clinical areas or types of drugs that make prescribing branded drugs preferable, because of potential therapeutic inequivalence or confusion. Bioequivalence criteria may be fine for most drugs, but some conditions may require drug levels with modified variations, like in the case of narrow therapeutic index and critical dose drugs, highly variable drugs and modified-release formulations. Moreover, substitution with generics can be problematic in some patient subpopulations, such as elderly frail people, immunocompromised and transplant patients and patients with epilepsy. We include a list of branded drugs that are considered safer, more effective or with a lower risk of error. The therapeutic substitution is markedly different from therapeutic interchange. The replacement of a brand product with an equivalent has to occur under the control of the physician. At some point in their interaction with individual patients, physicians should let them know that generics are available as substitutes for the more expensive brand-name medications and are equivalent in terms of efficacy and safety. Finally, we hope that a tool like the American Orange book will be also implemented in Italy: it would serve as an accurate reference, that can be useful both to physicians for prescription appropriateness and to patients for their own informed consent. [ABSTRACT FROM AUTHOR]

A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call innovator products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between prescribability (equivalence when prescribing a drug to a patient for the first time) and switchability (interchangeability of drugs for a patient already in treatment) considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: duplicate applications for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines. [ABSTRACT FROM AUTHOR]

Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability. A summary of the methods adopted to define bioequivalence (pharmacokinetic studies; pharmacodynamic studies; comparative clinical trials; in vitro studies) is also included. [ABSTRACT FROM AUTHOR]

The article reports the results of an observational study conducted in 53 internal medicine departments of the Emilia Romagna region based on the answers to 54 questions administered in a questionnaire, submitted electronically, based on the type of center (large >250 beds, small <250 beds), laboratory equipment, management aspects, pharmacological and clinical/economic aspects and use of antibiotics in the empirical treatment of severe infections. The result is a snapshot of the existing situation which shows a substantial availability of resources and a good level of expertise in the field of infectious disease management, despite some areas still need improvement. It also highlights some differences in terms of procedures amongst large hospitals, where infectious diseases are treated by an ad hoc specialized staff, and the small ones, where the internist is generally involved, being responsible for both direct management of severe infections and giving advice to other departments (emergency or surgery). It emerged that, both in small and large hospitals, more discussion and continuous assessment are needed to apply the appropriate protocols based on reference checklists. [ABSTRACT FROM AUTHOR]

Glucose intolerance often occurs in liver cirrhosis; therefore a long-term control of plasma glucose levels appears to be important. For this purpose glycated hemoglobin A (HbA) determination is proposed as a suitable method, while no data are available on fructosamine test. In 98 cirrhotic patients serum fructosamine and HbA levels were compared with those of normal controls and among cirrhotic patients grouped in non glucose-intolerant and with non insulin-dependent (NIDDM) or insulin-dependent diabetes mellitus (IDDM). The mean HbA values of cirrhotic patients with normal glycemic control were significantly lower than normal, and only a few IDDM and NIDDM cirrhotic patients showed high values of HbA, indicating that HbA is often underestimated in these patients. On the contrary, serum fructosamine levels were on the average higher than normal in nondiabetic patients, but they were significantly higher in IDDM and NIDDM patients than in nondiabetics, and the 72% of NIDDM and 85% of IDDM patients had fructosamine levels higher than the upper normal value. In conclusion, in diabetic patients with liver cirrhosis fructosamine seems to be a more suitable test than HbA for monitoring blood glucose levels. [ABSTRACT FROM AUTHOR]

Background: Clostridium difficile (CD) is a leading cause of diarrhoea among hospitalized patients. The objective of this study was to evaluate the rate, the optimal diagnostic work-up, and outcome of CD infections (CDI) in Internal Medicine (IM) wards in Italy.Methods: PRACTICE is an observational prospective study, involving 40 IM Units and evaluating all consecutive patients hospitalized during a 4-month period. CDI were defined in case of diarrhoea when both enzyme immunoassay for GDH, and test for A/B toxin were positive. Patients with CDI were followed-up for recurrences for 4 weeks after the end of therapy.Results: Among the 10,780 patients observed, 103 (0.96 %) showed CDI, at admission or during hospitalization. A positive history for CD, antibiotics in the previous 4 weeks, recent hospitalization, female gender and age were significantly associated with CDI (multivariable analysis). In-hospital mortality was 16.5 % in CD group vs 6.7 % in No-CD group (p < 0.001), whereas median length of hospital stay was 16 (IQR = 13) vs 8 (IQR = 8) days (p < 0.001) among patients with or without CDI, respectively. Rate of CD recurrences was 14.6 %. As a post-hoc evaluation, 23 out of 34 GDH+/Tox- samples were toxin positive, when analysed by molecular method (a real-time PCR assay). The overall CD incidence rate was 5.3/10,000 patient-days.Conclusions: Our results confirm the severity of CDI in medical wards, showing high in-hospital mortality, prolonged hospitalization and frequent short-term recurrences. Further, our survey supports a 2-3 step algorithm for CD diagnosis: EIA for detecting GDH, A and B toxin, followed by a molecular method in case of toxin-negative samples. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor about the application of portal flow velocity test in the prevention of variceal bleeding.