Monitoring safety and use of old and new treatment options for type 2 diabetic patients: a two-year (2013–2016) analysis

<p><b>Objective</b>: To compare patients’ and physicians’ perceptions regarding effectiveness and tolerability of non-insulin hypoglycemic drugs in a cohort of type 2 diabetic patients; to verify whether a possible tridimensional link between effectiveness, tolerability, and adherence affects long-term therapeutic outcomes.</p> <p><b>Methods</b>: A two-year observational study was performed in 1389 Type 2 diabetic patients by involving general practitioner clinics and Diabetes Centers. A decimal scale and the Morisky questionnaire were used, respectively, to assess effectiveness and tolerability perceptions, and medication adherence.</p> <p><b>Results</b>: Physicians perceived therapy as more efficacious compared to their patients: perceived effectiveness was steady for physicians during the study whereas patients’ perception not significantly decreased (mean score from >8 to 7.84 ± 1.69). Physicians assigned higher tolerability scores compared to patients but only at the beginning of the study; interestingly, physicians’ tolerability perception was poorer than patients’ perception at last follow-up (mean score = 7.57 ± 1.40 vs. 7.88 ± 1.84). Favorable (score >7) patients’ perceptions about treatment effectiveness and tolerability were associated with higher adherence. Patients showed medium adherence across the study.</p> <p><b>Conclusions</b>: A mutual relationship between clinical effectiveness, adverse drug reactions, and adherence has been established, significantly impacting the clinical management of diabetic patients. A careful monitoring of this link by clinicians appears therefore necessary.</p

Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation

<p><b>Background</b>: The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines’ use. Based on this background, we investigated the trend of ADRs in Calabria in 2011–2014, trying to analyze the possible entailments of the new law.</p> <p><b>Methods</b>: Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014.</p> <p><b>Results</b>: A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years.</p> <p><b>Conclusions</b>: These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.</p