Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial

BackgroundProton pump inhibitors (PPIs) are among the most commonly and inappropriately prescribed drugs by general practitioners (GPs), resulting in increased risk of adverse outcomes for patients and in avoidable costs for Italy’s National Health Service (NHS). This study aims to assess the effect...

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Main Authors: Manuela Casula, Ilaria Ardoino, Laura Pierini, Lara Perrella, Stefano Scotti, Sara Mucherino, Valentina Orlando, Enrica Menditto, Carlotta Franchi
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2024.1430879/full
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author Manuela Casula
Manuela Casula
Ilaria Ardoino
Laura Pierini
Lara Perrella
Stefano Scotti
Sara Mucherino
Valentina Orlando
Enrica Menditto
Carlotta Franchi
author_facet Manuela Casula
Manuela Casula
Ilaria Ardoino
Laura Pierini
Lara Perrella
Stefano Scotti
Sara Mucherino
Valentina Orlando
Enrica Menditto
Carlotta Franchi
author_sort Manuela Casula
collection DOAJ
description BackgroundProton pump inhibitors (PPIs) are among the most commonly and inappropriately prescribed drugs by general practitioners (GPs), resulting in increased risk of adverse outcomes for patients and in avoidable costs for Italy’s National Health Service (NHS). This study aims to assess the effectiveness of a low-cost and easily implementable informative intervention directed at GPs to enhance the appropriate prescription of PPIs.MethodsThe LAPTOP-PPI study is a pragmatic, cluster-randomized controlled trial designed to improve the appropriateness of PPI prescriptions among community-dwelling individuals aged ≥65 years. In June 2021, GPs in the Local Health Units (LHUs) of Bergamo (Northern Italy) and Caserta (Southern Italy) were randomly allocated to either an intervention group (summary reports on prescribing habits, scientific documents on the Italian Medicine Agency’s therapeutic indications, strategies for PPI de-prescribing, along with educational materials for patients), and a control group (standard practice). PPI appropriateness was assessed through an algorithm specifically designed and based on NHS prescription appropriateness and reimbursement criteria. Intervention efficacy was evaluated by comparing data from the baseline period (July 1 to 31 December 2019) with those from the follow-up period (July 1 to 31 December 2021), 6 months after randomization. The analysis was performed on the intention-to-treat principle and according to GP level. To estimate the effectiveness of the intervention, we used a difference-in-differences (DID) approach.ResultsOverall, 942 GPs (540 from Bergamo and 402 from Caserta LHUs) were included in the analysis. At baseline, 171,978 patients aged ≥65 received drug prescriptions for acid-related diseases and were assessable for evaluation of appropriateness. At follow-up, this number was 137,699. The overall inappropriateness rate at baseline among GPs included in the analysis was 57.4% (std.dev. 8.4%) in the intervention arm and 57.6% (std.dev. 8.8%) in the control arm; 6 months after the intervention delivery, they were 59.2% (std.dev. 8.0%) and 58.5% (std.dev. 7.3%), respectively.ConclusionGiven their widespread use, improving the prescription quality of PPIs is a major concern. Educational interventions for GPs and patients are routine strategies to address inappropriateness, but they appear to be insufficient for independently improving prescribing practice, especially in a critical situation such as the post-pandemic period.
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spelling doaj-art-dd1b8a287ec34c118f089ff2c2bcf6e22025-01-03T06:46:47ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.14308791430879Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trialManuela Casula0Manuela Casula1Ilaria Ardoino2Laura Pierini3Lara Perrella4Stefano Scotti5Sara Mucherino6Valentina Orlando7Enrica Menditto8Carlotta Franchi9Epidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, ItalyIRCCS MultiMedica, Sesto San Giovanni, Milan, ItalyLaboratory of Pharmacoepidemiology and Human Nutrition, Department of Health Policy, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, ItalyLaboratory of Pharmacoepidemiology and Human Nutrition, Department of Health Policy, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, ItalyDepartment of Pharmacy, Center of Pharmacoeconomics and Drug Utilization Research (CIRFF), University of Naples Federico II, Naples, ItalyIRCCS MultiMedica, Sesto San Giovanni, Milan, ItalyDepartment of Pharmacy, Center of Pharmacoeconomics and Drug Utilization Research (CIRFF), University of Naples Federico II, Naples, ItalyDepartment of Pharmacy, Center of Pharmacoeconomics and Drug Utilization Research (CIRFF), University of Naples Federico II, Naples, ItalyDepartment of Pharmacy, Center of Pharmacoeconomics and Drug Utilization Research (CIRFF), University of Naples Federico II, Naples, ItalyLaboratory of Pharmacoepidemiology and Human Nutrition, Department of Health Policy, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, ItalyBackgroundProton pump inhibitors (PPIs) are among the most commonly and inappropriately prescribed drugs by general practitioners (GPs), resulting in increased risk of adverse outcomes for patients and in avoidable costs for Italy’s National Health Service (NHS). This study aims to assess the effectiveness of a low-cost and easily implementable informative intervention directed at GPs to enhance the appropriate prescription of PPIs.MethodsThe LAPTOP-PPI study is a pragmatic, cluster-randomized controlled trial designed to improve the appropriateness of PPI prescriptions among community-dwelling individuals aged ≥65 years. In June 2021, GPs in the Local Health Units (LHUs) of Bergamo (Northern Italy) and Caserta (Southern Italy) were randomly allocated to either an intervention group (summary reports on prescribing habits, scientific documents on the Italian Medicine Agency’s therapeutic indications, strategies for PPI de-prescribing, along with educational materials for patients), and a control group (standard practice). PPI appropriateness was assessed through an algorithm specifically designed and based on NHS prescription appropriateness and reimbursement criteria. Intervention efficacy was evaluated by comparing data from the baseline period (July 1 to 31 December 2019) with those from the follow-up period (July 1 to 31 December 2021), 6 months after randomization. The analysis was performed on the intention-to-treat principle and according to GP level. To estimate the effectiveness of the intervention, we used a difference-in-differences (DID) approach.ResultsOverall, 942 GPs (540 from Bergamo and 402 from Caserta LHUs) were included in the analysis. At baseline, 171,978 patients aged ≥65 received drug prescriptions for acid-related diseases and were assessable for evaluation of appropriateness. At follow-up, this number was 137,699. The overall inappropriateness rate at baseline among GPs included in the analysis was 57.4% (std.dev. 8.4%) in the intervention arm and 57.6% (std.dev. 8.8%) in the control arm; 6 months after the intervention delivery, they were 59.2% (std.dev. 8.0%) and 58.5% (std.dev. 7.3%), respectively.ConclusionGiven their widespread use, improving the prescription quality of PPIs is a major concern. Educational interventions for GPs and patients are routine strategies to address inappropriateness, but they appear to be insufficient for independently improving prescribing practice, especially in a critical situation such as the post-pandemic period.https://www.frontiersin.org/articles/10.3389/fphar.2024.1430879/fullproton pump inhibitorsinappropriate prescriptionalgorithmpragmatic trialinformative intervention
spellingShingle Manuela Casula
Manuela Casula
Ilaria Ardoino
Laura Pierini
Lara Perrella
Stefano Scotti
Sara Mucherino
Valentina Orlando
Enrica Menditto
Carlotta Franchi
Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
Frontiers in Pharmacology
proton pump inhibitors
inappropriate prescription
algorithm
pragmatic trial
informative intervention
title Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
title_full Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
title_fullStr Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
title_full_unstemmed Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
title_short Inappropriate prescribing of drugs for peptic ulcer and gastro-esophageal reflux disease remains a matter of concern: Results from the LAPTOP-PPI cluster randomized trial
title_sort inappropriate prescribing of drugs for peptic ulcer and gastro esophageal reflux disease remains a matter of concern results from the laptop ppi cluster randomized trial
topic proton pump inhibitors
inappropriate prescription
algorithm
pragmatic trial
informative intervention
url https://www.frontiersin.org/articles/10.3389/fphar.2024.1430879/full
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