International Journal of Clinical Pharmacy

, Volume 38, Issue 4, pp 829–837 | Cite as

Adherence with regulatory resolutions on prevention of NSAIDs-related gastrointestinal injury in Italy

  • Sabrina MontagnaniEmail author
  • Marco Tuccori
  • Arianna Testi
  • Michele Cristofano
  • Tiberio Corona
  • Stefano Salvadori
  • Carmelo Scarpignato
  • Corrado Blandizzi
Research Article


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.


Gastrointestinal injury Italy Misoprostol Prescription data Proton pump inhibitors 



This research did not receive specific funding.

Conflicts of interest

No conflicts of interest to declare.


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Copyright information

© Springer International Publishing 2016

Authors and Affiliations

  • Sabrina Montagnani
    • 1
    Email author
  • Marco Tuccori
    • 2
    • 3
  • Arianna Testi
    • 4
  • Michele Cristofano
    • 5
  • Tiberio Corona
    • 4
  • Stefano Salvadori
    • 6
  • Carmelo Scarpignato
    • 7
  • Corrado Blandizzi
    • 1
    • 2
  1. 1.Department of Clinical and Experimental MedicineUniversity of PisaPisaItaly
  2. 2.Unit of Adverse Drug Reactions MonitoringUniversity Hospital of PisaPisaItaly
  3. 3.Tuscan Regional Centre of PharmacovigilanceFlorenceItaly
  4. 4.Health District of PisaPisaItaly
  5. 5.Medical DirectionUniversity Hospital of PisaPisaItaly
  6. 6.Institute of Clinical PhysiologyNational Research Council, PisaPisaItaly
  7. 7.Clinical Pharmacology and Digestive Pathophysiology Unit, Department of Clinical and Experimental MedicineUniversity of ParmaParmaItaly

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