Background: Adverse drug reactions (ADRs) are an important public health problem, representing a major cause of morbidity and mortality. However, several countries have no recent studies available. Since 2014, a prospective active pharmacovigilance project, aimed to improve ADRs monitoring in hospital wards (FORWARD) was performed in Sicily. This study, as part of FORWARD project, was aimed to describe ADRs occurred during the hospital stay in Internal Medicine wards. ADRs related to hospital admission, characteristics and preventability of ADRs were also evaluated.Methods: Demographic, clinical, and pharmacological data on patients admitted to six wards of Internal Medicine, from 2014 to 2015, were collected by trained, qualified monitors, who screened all medical records. The rate of ADRs occurred during hospital stay and those leading to hospitalization were analyzed. A descriptive analysis of the reactions, suspected drugs, and associated factors was performed according to the setting analyzed.Results: During the study period, 4,802 admissions were recorded; in 3.2% of them ADRs occurred during hospital stay while in 6.2%, admission was due to ADRs. The duration of hospital stay was longer in patients who experienced ADRs during hospitalization, compared to patients without ADRs [median days 12 (Q1–Q3: 8–17) vs. 9 (6–13)]; p < 0.001). Females [OR1.39 (95% CI 1.03–1.93)] and patients taking ≥ 4 drugs [OR1.46 (95% CI 1.06–2.03)] were more likely to experience ADRs during hospital stay, as well as to be admitted because of ADRs [female: OR1.75 (95% CI 1.37–2.24); ≥ 4 drugs: OR2.14 (95% CI 1.67–2.74)]. The most frequent ADRs occurred during hospital stay were cutaneous (26.8%), general (13.4%), vascular (13.4%), and cardiac (11.5%) disorders and the drug classes mainly involved were anti-bacterials (38.2%) and antithrombotic agents (21.7%). ADRs were serious in 44.6% and probably preventable in 69.4%. Gastrointestinal (27.7%), hematological (26.5%), metabolic (18.1%), and nervous (16.1%) disorders were the main ADRs cause of hospitalization, primarily due to antithrombotic agents (39.0%) RAS-inhibitors (13.9%), NSAIDs (11.9%), and diuretics (9.0%). Only 12.9% of them was not preventable.Conclusion: Adverse drug reactions occurred during hospitalization or contributing to admission to Internal Medicine wards were considerable and most of them were preventable. Females and patients taking many medications were more likely to present ADRs both during hospital stay or as cause of admission.

AIMSThe aim of the study was to analyze the prescribing pattern of both newer and older AEDs. METHODSA population of almost 150 000 individuals registered with 123 general practitioners was included in this study. Patients who received at least one AED prescription over 2005-2011 were identified. The 1 year prevalence and cumulative incidence of AED use, by drug class and individual drug, were calculated over the study period. Potential predictors of starting therapy with newer AEDs were also investigated. RESULTSThe prevalence of use per 1000 inhabitants of older AEDs increased from 10.7 (95% CI10.1, 11.2) in 2005 to 13.0 (95% CI12.4, 13.6) in 2011, while the incidence remained stable. Newer AED incidence decreased from 9.4 (95% CI 8.9, 9.9) in 2005 to 7.0 (95% CI 6.6, 7.5) in 2011, with a peak of 15.5 (95% CI 14.8, 16.1) in 2006. Phenobarbital and valproic acid were the most commonly prescribed AEDs as starting therapy for epilepsy. Gabapentin and pregabalin accounted for most new pain-related prescriptions, while valproic acid and lamotrigine were increasingly used for mood disorders. Female gender (OR 1.36, 95% CI 1.20, 1.53), age ranging between 45-54 years (OR 1.39, 95% CI 1.16, 1.66) and pain as an indication (OR 16.7, 95% CI, 13.1,21.2) were associated with newer AEDs starting therapy. CONCLUSIONSOlder AEDs were mainly used for epileptic and mood disorders, while newer drugs were preferred for neuropathic pain. Gender, age, indication of use and year of starting therapy influenced the choice of AED type. The decrease of newer AED use during 2007 is probably related to the restricted reimbursement criteria for gabapentin and pregabalin.

ObjectivesWe sought to evaluate the prescribing pattern of statins according to national and regional health policy interventions and to assess specifically the adherence to the therapy in outpatient setting in Southern Italy.MethodsA population-based study was performed on persons ≥15 years old, living in the catchment area of Caserta (Southern Italy), and registered in Arianna database between 2004 and 2010. Prevalence and incidence of new treatments with statins were calculated for each year and stratified by drug. Adherence to therapy was measured by Medication Possession Ratio. Sub-analyses by individual compound and type of cardiovascular prevention were performed.ResultsFrom 2004 to 2010, the one-year prevalence of statin use increased from 44.9/1,000 inhabitants to 79.8/1,000, respectively, consistently with the incidence of new use from 16.2/1,000 to 19.5/1,000, except a slight decrease after criteria reimbursement revision on 2005 (13.3/1,000). The incidence of new treatments decreased for atorvastatin, and increased for simvastatin over the study years. Overall, 43% of new users were still highly adherent to the treatment (MPR≥80%) after six months, while 26% after 4-years of follow-up. As compared with highly adherent patients, the probability to be non-adherent (MPR≤25%) at 4-years of follow-up was 26% higher for women than for men (full adj. odds ratio: 1.26; 95% CI: 1.10–1.45), and 64% higher in patients who started on primary rather than on secondary prevention (1.64; 1.29–2.07).ConclusionsPrevalence and incidence of statin use increased consistently with health policy interventions. Only one-fourth of patients who newly initiated a statin were adherent to the treatment after 4-year of follow-up. Since the benefits of statins in terms of cardiovascular outcome and costs are associated with their chronic use, the identification of patient-related predictors of non-adherence such as gender, primary prevention could be suitable for physicians to improve the patients' compliance.

Use of levothyroxine oral liquid formulations is increasing over time even though their use is still limited in a general population of Southern Italy. Our exploratory analysis showed that the frequency of thyroid-stimulating hormone measurement was reduced in patients switching from levothyroxine tablet to new formulations.

Lowering blood cholesterol levels reduces the risk of coronary heart disease. However, the effect of interventions depends on the patients' adherence to treatment. Primary care plays an important role in the detection, treatment and monitoring of disease, therefore different educational programs (EP) have been implemented to improve disease management in general practice. The present study is aimed to assess whether a general practitioner auditing and feedback EP may improve dyslipidaemia management in a primary care setting and to evaluate patients' adherence to prescribed lipid-lowering treatment. The quality of cardiovascular and cerebrovascular disease prevention before and after the implementation of an EP offered to 25 general practitioners (GPs), was evaluated. Clinical and prescription data on patients receiving at least one lipid-lowering treatment was collected. To evaluate the quality of the healthcare service provided, clinical and biochemical outcomes, and drug-utilization, process indicators were set up. Adherence was evaluated before and after the EP as the "Medication Possession Ratio" (MPR). A correlation analysis was carried out to estimate the effect of the MPR in achieving pre-defined clinical end-points. Prescription data for lipid-lowering drugs was collected in a sample of 839 patients. While no differences in the achievement of blood lipid targets were observed, a slight but significant improvement ofthe MPR was registered after the EP (MPR >0.8=64.2% vs 60.6%, p=0.0426). Moreover, high levels of statin adherence were associated with the achievement of total blood cholesterol target (OR=3.3 for MPR >0.8 vs MPR <0.5, 95% CI:1.7-6.7) or LDL therapeutic goal (OR=3.3 for MPR >0.8 vs MPR <0.5, 95% CI:1.5-7.2). The EP partially improved the defined clinical targets; probably, a more patient-based approach could be more appropriate to achieve the defined target. Further studies are needed to identify how healthcare services can be improved. Cardio-cerebrovascular (CCV) diseases have a major impact on patient morbidity and mortality, and are associated with significant costs to healthcare budgets worldwide. CCV diseases are the most