Niccolò Lombardi1, Alfredo Vannacci1, Alessandra Bettiol1, Ettore Marconi2, Serena Pecchioli2, Alberto Magni3, Claudio Cricelli3, Francesco Lapi4. 1. Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50139, Florence, Italy. 2. Health Search, Italian College of General Practitioners and Primary Care, Via Sestese,61, 50141, Florence, Italy. 3. Italian College of General Practitioners and Primary Care, 50142, Florence, Italy. 4. Health Search, Italian College of General Practitioners and Primary Care, Via Sestese,61, 50141, Florence, Italy. lapi.francesco@simg.it.
Abstract
BACKGROUND AND OBJECTIVES: In 2014, the Italian Medicines Agency (AIFA) amended the summary of product characteristics of codeine-containing medications limiting their use for maximum three days. This study attempted to clarify the impact of AIFA intervention on prescribing trends and appropriateness of use of codeine-containing medications and other opioids. METHODS: Using the Health Search Database, a quasi-experimental interrupted time series analysis was conducted to evaluate changes in prescribing trends and appropriateness of use of codeine-containing medications and opioids between 2013 and 2015. RESULTS: Prescribing trends of codeine-containing medications significantly decreased (on average, - 352 days of treatment per month of observation), while long-acting opioids (LAOs) had an overall increase. Trends of inappropriate prescriptions significantly increased for two LAOs (i.e. tapentadol, naloxone-oxycodone), both before and after AIFA intervention. CONCLUSION: The use of paracetamol-codeine combination was effectively decreased in Italy because of AIFA intervention. Instead, prescriptions of tapentadol and oxycodone-naloxone stably increased over the study period irrespective of regulatory intervention. Given that the choice of the most appropriate opioid therapy is not straightforward, especially in elderly and/or comorbid patients, general practitioners should consider carefully alternative therapies on the bases of regulatory interventions.
BACKGROUND AND OBJECTIVES: In 2014, the Italian Medicines Agency (AIFA) amended the summary of product characteristics of codeine-containing medications limiting their use for maximum three days. This study attempted to clarify the impact of AIFA intervention on prescribing trends and appropriateness of use of codeine-containing medications and other opioids. METHODS: Using the Health Search Database, a quasi-experimental interrupted time series analysis was conducted to evaluate changes in prescribing trends and appropriateness of use of codeine-containing medications and opioids between 2013 and 2015. RESULTS: Prescribing trends of codeine-containing medications significantly decreased (on average, - 352 days of treatment per month of observation), while long-acting opioids (LAOs) had an overall increase. Trends of inappropriate prescriptions significantly increased for two LAOs (i.e. tapentadol, naloxone-oxycodone), both before and after AIFA intervention. CONCLUSION: The use of paracetamol-codeine combination was effectively decreased in Italy because of AIFA intervention. Instead, prescriptions of tapentadol and oxycodone-naloxone stably increased over the study period irrespective of regulatory intervention. Given that the choice of the most appropriate opioid therapy is not straightforward, especially in elderly and/or comorbid patients, general practitioners should consider carefully alternative therapies on the bases of regulatory interventions.
Authors: Catherine Ciszkowski; Parvaz Madadi; Michael S Phillips; Albert E Lauwers; Gideon Koren Journal: N Engl J Med Date: 2009-08-20 Impact factor: 91.245
Authors: Lauren E Kelly; Michael Rieder; John van den Anker; Becky Malkin; Colin Ross; Michael N Neely; Bruce Carleton; Michael R Hayden; Parvaz Madadi; Gideon Koren Journal: Pediatrics Date: 2012-04-09 Impact factor: 7.124
Authors: Claudio Cricelli; Giampiero Mazzaglia; Fabio Samani; Marco Marchi; Andrea Sabatini; Roberto Nardi; Giuseppe Ventriglia; Achille P Caputi Journal: J Public Health Med Date: 2003-09