Clinically important drug-drug interactions in poly-treated elderly outpatients: a campaign to improve appropriateness in general practice.

AIMS: The aim was to assess the impact of a campaign for general practitioners (GPs) to reduce clinically-important drug-drug interactions (DDIs) in poly-treated elderly patients. METHODS: We compiled a list of 53 DDIs and analyzed reimbursed prescriptions dispensed to poly-treated (≥four drugs) elderly (>65 years) patients in the Emilia Romagna region during January 2011-June 2011 (first pre-intervention period), January 2012-June 2012 (second pre-intervention period) and January 2013-June 2013 (post-intervention period). Educational initiatives to GPs were completed in July 2012-December 2012. Pre-test/post-test analysis (2013 vs. 2012) was performed, also using predicted 2013 data (P < 0.01 for statistical significance). RESULTS: Despite the slight increase in poly-therapy rate (16% in 2013, +1.5% from 2011), we found a stable or slightly declining number of potential DDIs for each elderly poly-treated patient (~1.5). In 2013, 11 DDIs exceeded 5% of prevalence rate: antidiabetics-ß-adrenoceptor blockers ranked first (20.3%), followed by ACE Inhibitors (ACEIs)/sartans-non steroidal anti-inflammatory drugs (NSAIDs) (16.4%), diuretics-NSAIDs (13.6%), selective serotonin re-uptake inhibitors (SSRIs)-NSAIDs/acetyl salicylic acid (ASA) (12.7%) and corticosteroids-NSAIDs/ASA (9.7%). A remarkable reduction emerged for NSAID-related DDIs (diuretics-NSAIDs peaked -14.5%; P < 0.01), whereas prevalence of antidiabetics-ß-adrenoceptor blockers increased (+7.9%; P < 0.01). When using predicted values, the statistical significance disappeared for antidiabetics-ß-adrenoceptor blockers (+1.3%; P = 0.04), whereas it persisted for almost all NSAIDs-related DDIs: ACEIs/sartans-NSAIDs (-3.0%), diuretics-NSAIDs (-6.0%), SSRIs-NSAIDs/ASA (-5.9%). CONCLUSIONS: This campaign contained the burden of DDIs in poly-treated elderly patients by 1) reducing most prevalent DDIs, especially NSAIDs-related DDIs and 2) balancing the observed rise in poly-therapy rate with stable rate in overall prescriptions of potentially interacting drugs per patient.

Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.

OBJECTIVE: New incretin-mimetics increased the treatment options for type 2 diabetes mellitus. Studies on the safety of incretin-based therapy showed a risk of hypersensitivity reactions, acute pancreatitis, renal failure, infection, thyroid and pancreas cancer. We contributed to safety assessment of these new drugs by evaluating the spontaneous adverse drug reactions (ADRs) reporting in Italy. RESEARCH AND METHODS: Reports of suspected ADRs associated with incretin-mimetics were selected from the Italian Spontaneous ADR Reporting Database. For a subgroup of cases belonging to the Hospital of Cento (Ferrara), levels of pancreatic enzymes, amylase and lipase, before and after the therapy with the incretin-mimetics were available. RESULTS: As of December 2012, the reports of ADR associated with hypoglycemic drugs (excluding insulin) were 2443, 1169 (47.85%) concerned the incretin-mimetics. A total of 90 reports described pancreatitis (44) and elevated pancreatic enzymes (46). Out of 90 cases, 34 were serious (37%). Data on amylase/lipase values for 10 patients were provided and an analysis of the published literature was performed. CONCLUSIONS: Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.