MEREAFaPS: uno Studio di Farmacovigilanza Attiva e Farmacoepidemiologia in Pronto Soccorso

Adverse drug reactions (ADRs) have a significant impact on the patient’s health. The purpose of this PhD thesis was to analyse the impact of ADRs on the admissions to the emergency room, using the data obtained from the MEREAFaPS study. Elderly patients resulted the most exposed group to ADRs. Gastrointestinal disorders were the most commonly reported adverse reactions. Acetylsalicylic acid and warfarin were the most reported drugs. 17% of serious ADRs and 32% of the resulting deaths were classified as avoidable. Elderly age was found to be the main risk factor associated with ADRs. It is therefore important to underline the need for a more careful use of drugs in this group of patients

Real-World Safety of Anticoagulants

The aim of the present chapter is to characterize the management of anticoagulation in the real-world clinical setting, describing all pharmacological aspects of anticoagulant medications, in particular safety aspects. The chapter is structured into three main sections. Within the first two sections, active principles are classified on the basis of their pharmacological properties (pharmacodynamic and pharmacokinetic characteristic) in old and new molecules (or first and second generation class). In the third one, we discuss safety issues of anticoagulants using available data from postmarketing evidences. Furthermore, we also provide some essential information on the use of this kind of medications in special populations (i.e., elderly, coronary artery disease, diabetics, chronic kidney disease, etc.) in clinical practice

A novel CFA+EFA model to detect aberrant respondents

Aberrant respondents are common but yet extremely detrimental to the quality of social surveys or questionnaires. Recently, factor mixture models have been employed to identify individuals providing deceptive or careless responses. We propose a comprehensive factor mixture model that combines confirmatory and exploratory factor models to represent both the non-aberrant and aberrant components of the responses. The flexibility of the proposed solution allows for the identification of two of the most common aberant response styles, namely faking and careless responding. We validated our approach by means of two simulations and two case studies. The results indicate the effectiveness of the proposed model in handling with aberrant responses in social and behavioral surveys.Comment: 24 pages, 5 figures, 7 table

A psychometric modeling approach to fuzzy rating data

Modeling fuzziness and imprecision in human rating data is a crucial problem in many research areas, including applied statistics, behavioral, social, and health sciences. Because of the interplay between cognitive, affective, and contextual factors, the process of answering survey questions is a complex task, which can barely be captured by standard (crisp) rating responses. Fuzzy rating scales have progressively been adopted to overcome some of the limitations of standard rating scales, including their inability to disentangle decision uncertainty from individual responses. The aim of this article is to provide a novel fuzzy scaling procedure which uses Item Response Theory trees (IRTrees) as a psychometric model for the stage-wise latent response process. In so doing, fuzziness of rating data is modeled using the overall rater's pattern of responses instead of being computed using a single-item based approach. This offers a consistent system for interpreting fuzziness in terms of individual-based decision uncertainty. A simulation study and two empirical applications are adopted to assess the characteristics of the proposed model and provide converging results about its effectiveness in modeling fuzziness and imprecision in rating data

Risk of bone fractures among users of oral anticoagulants: An administrative database cohort study

Occurrence of osteoporotic fracture in patients treated with oral anticoagulants was investigated. •Risk of fractures was comparable for warfarin and non vitamin K oral anticoagulants. •Independently from which OAC is used, female and elderly subjects were at higher risk of fractures

Ticagrelor safety profile in real-life setting of acute coronary syndrome patients

Ticagrelor safety profile in real-life setting of acute coronary syndrome patient

Local complications associated with labial salivary gland biopsy for diagnosis of Sjögren?s Syndrome : a retrospective cohort study

To describe local or systemic complications related to the labial salivary glands biopsy (LSGB) used as diagnostic tool for the diagnosis of Sjögren?s Syndrome (SS). Clinical databases from a cohort of patients, who underwent LSGB with provisional clinical diagnosis of Sjögren?s Syndrome, were retrospectively reviewed. Pain, assessed by registering the intake of analgesic drugs in the first week following the biopsy, and any further relevant clinical information regarding complications after biopsy were recorded. 50 patients received LSGB. 10 of them (9 women and 1 man) showed histopathological findings compatible with SS. Ten patient (20%) receiving labial biopsy developed local complications: three of them (6%) reported a sensory defect at the surgical site that lasted at most few weeks; three patients (6%) reported pain sensation needing the assumption of analgesic drugs, while one patient (2%) described a transient local burning sensation, which resolved in few days. Three patients (6%) showed cutaneous haematoma in the surgical area and two patients (4%) showed mild mucosal inflammation at the biopsy site. LSGB is associated with to few and mild complications and it is a useful tool in the diagnosis of SS. The complications usually resolved in few weeks after the biopsy

Knowledge and training of Italian students in Healthcare Settings on COVID-19 vaccines and vaccination strategies, one year after the immunization campaign

Abstract Introduction: COVID-19 vaccines represent an important opportunity for defeating the disease, as long as high vaccination acceptance rates are achieved. Healthcare workers (HCWs) have a relevant role in the promotion of immunization. The aim of the study is to assess the knowledge of medical and pharmaceutical area students regarding COVID-19 vaccination and the impact of a specific Elective Teaching Activity (ETA), one year after the immunization campaign in Italy. Methods: Students’ knowledge was tested with a questionnaire before and after attending the course. Descriptive statistical methods were used to analyse the results obtained. Student’s t-tests for paired data were used. Results: Overall, 387 students at the University of Florence attended the course and took the same test before and after the ETA on COVID-19 vaccines. Despite achieving satisfactory average scores in the pre-course test (26/32±4.0), all students were able to significantly enhance their final score (+17.1%; p<0.001), indicating that the ETA was highly effective in improving their knowledge of COVID-19 vaccination. Medical students demonstrated a better comprehension of the role of the medical specialist in public health in the COVID-19 vaccination campaign, while some uncertainties were revealed regarding the role of pharmacists.  Conclusions: The results of this study confirm that specific training activities on vaccination are effective for implementing the knowledge of future health professionals

Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications

Introduction: Magistral preparations of therapeutic cannabis are extracted from standardized products imported from Holland or from the Florence Military Pharmaceutical Chemical Works, but extraction protocols differ among galenic laboratories. This study assessed the inter-laboratory variability in concentrations of cannabidiol (CBD), cannabinol (CBN), tetrahydrocannabinol (THC), and tetrahydrocannabinolic acid (THCA) among different magistral oil preparations.Methods: 219 samples of Bediol, Bedrobinol, Bedrolite or FM-2 70 or 100 mg/ml in oil were collected from 3 laboratories. Concentrations of CBD, CBN, THC, and THCA were quantified by high-pressure liquid chromatography; inter-laboratories variability was assessed using the Kruskal–Wallis test.Results: A significant variability in CBD and THC concentrations was found for Bediol 70 mg/ml samples from 2 laboratories [for CBD: median 5.4 (range 4.8–6.6) vs. 6.1 (4.9–7.2) mg/ml, p = 0.033; for THC: 3.6 (3.1–3.9) vs. 4.0 (2.6–5.1) mg/ml, p = 0.020]. As for Bediol 100 mg/ml, a significant variability emerged in THC concentrations among the three considered laboratories [5.7 (-) vs. 4.2 (1.5–4.8) vs. 5.2 (4.2–6.9), p = 0.030]. No significant inter-laboratory variability emerged for Bedrocan and Bedrolite. Concentrations of CBD, CBN, and THC were <LOQ in all Bedrocan samples, and CBN and THCA were <LOQ in all Bedrolite samples. As for FM-2, a significant inter-laboratories variability was found for CBD concentrations.Conclusion: Quantitative variability of cannabinoids in magistral preparations might impact on the efficacy and safety of therapeutic cannabis. A standardized protocol is needed to guarantee a homogeneous product and patients’ therapeutic continuity