title: Adherence with regulatory resolutions on prevention of NSAIDS-related gastrointestinal injury in Italy.
abstract: Background The rate of gastrointestinal (GI) complications with non-steroidal antiinflammatory drugs (NSAIDs) or low-dose aspirin (LD-ASA) varies according to risk factors. For at risk patients, the Italian regulatory resolution enforce prophylaxis with proton pump inhibitors (PPIs) or misoprostol. Objective This study evaluated the consistency with such resolution in patients receiving NSAIDs or LD-ASA and assessed whether patients continued to receive GI protection with PPIs for an adequate time following NSAID discontinuation. Setting An observational retrospective study was conducted using data from Health District of Pisa. Methods The analysis was performed on patients receiving prescription of NSAIDs or LD-ASA, with or without concomitant PPIs or misoprostol, accordingly with the presence of risk factors (2008-2010). Prescription data were retrieved from the database of reimbursement claims for dispensed drugs, while history of past GI diseases was obtained from primary or secondary discharge diagnosis. Main outcome measure The consistency rates of PPI and misoprostol prescriptions with Italian regulatory rules in patients receiving chronic NSAIDs or LD-ASA. Results 6869 patients, receiving NSAIDs or LD-ASA during the observation period, were eligible for the analysis. For NSAIDs or LD-ASA, gastroprotection rates in patients without risk factors were: 8 and 6 % in 2008; 10 and 8 % in 2009; 9 and 6 % in 2010; while the proportions of patients with one or more risk factors not receiving gastroprotection were: 12 and 17 % in 2008; 25 and 22 % in 2009; 15 and 17 % in 2010. In patients discontinuing chronic NSAIDs, 62 % were maintained on protection with PPIs, but only 28 % continued the PPI treatment for an adequate time (60 ± 7 days). Conclusions The present analysis, although restricted to prescription patterns in a single health district, suggests scarce levels of consistency with Italian regulatory resolution on the prophylaxis of GI adverse events associated with chronic NSAIDs or LDASA.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 55, 56126, Pisa, Italy. montagnani.pisa@gmail.com.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Montagnani
authors.affiliation: Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Via Roma 55, 56126, Pisa, Italy.|Tuscan Regional Centre of Pharmacovigilance, Via Taddeo Alderotti 26/N, 50139, Florence, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Tuccori
authors.affiliation: Health District of Pisa, Via Cocchi n.7/9, 56100, Pisa, Italy.
authors.forename: Arianna
authors.initials: A
authors.lastname: Testi
authors.affiliation: Medical Direction, University Hospital of Pisa, Via Cocchi n.7/9, 56100, Pisa, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Cristofano
authors.affiliation: Health District of Pisa, Via Cocchi n.7/9, 56100, Pisa, Italy.
authors.forename: Tiberio
authors.initials: T
authors.lastname: Corona
authors.affiliation: Institute of Clinical Physiology, National Research Council, Pisa, Via Moruzzi, 1, 56124, Pisa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Salvadori
authors.affiliation: Clinical Pharmacology and Digestive Pathophysiology Unit, Department of Clinical and Experimental Medicine, University of Parma, Via Università, 12, 43121, Parma, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Scarpignato
authors.affiliation: Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 55, 56126, Pisa, Italy.|Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Via Roma 55, 56126, Pisa, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Blandizzi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D004363:Drug Utilization / Q000639:trends*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000517:prevention & control*; D019983:Guideline Adherence; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D054328:Proton Pump Inhibitors; D016595:Misoprostol; D001241:Aspirin
keywords: Gastrointestinal injury; Italy; Misoprostol; Prescription data; Proton pump inhibitors