A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients

Autor: Sara Di Pede, Alberto Gandolfi, Daniela Zoboli, Morena Pellati, Daniela Riccò, Corrado Busani, Pamela Mancuso, Massimo Vicentini, Paolo Giorgi Rossi, Alessandra Ferretti
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Male
Drug
medicine.medical_specialty
medicine.drug_class
Proton pump inhibitors
media_common.quotation_subject
Drug prescription
Proton-pump inhibitor
Osteoarthritis
Drug Costs
Anti-inflammatory
03 medical and health sciences
0302 clinical medicine
General Practitioners
Internal medicine
medicine
Humans
030212 general & internal medicine
Cluster randomised controlled trial
Practice Patterns
Physicians'
Medical prescription
Acetaminophen
Aged
media_common
Aged
80 and over
lcsh:R5-920
business.industry
030503 health policy & services
Anti-Inflammatory Agents
Non-Steroidal
Nonsteroidal anti-inflammatory drugs
Analgesics
Non-Narcotic
medicine.disease
Opioids
Defined daily dose
Paracetamol
Italy
Opioid
Female
0305 other medical science
Family Practice
business
lcsh:Medicine (General)
Research Article
medicine.drug
Zdroj: BMC Family Practice, Vol 20, Iss 1, Pp 1-9 (2019)
BMC Family Practice
ISSN: 1471-2296
Popis: Background Paracetamol is recommended as first-line treatment for pain control in osteoarthritis because it has fewer side effects than do other therapeutic options, including nonsteroidal anti-inflammatory drugs (NSAIDs). Prescribing proton pump inhibitors (PPIs) as gastric bleeding prophylaxis in chronic NSAID users is also common, although not recommended. In Italy, paracetamol is not reimbursed by the National Health System. The aim of this trial was to test whether the availability to osteoarthritis patients of free paracetamol would decrease their use of NSAIDs and, as a secondary objective, whether opioid and PPI consumption would also decrease. Methods Eight general practitioners (GPs) (59 patients) were randomized to usual care and 8 (58 patients) to the experimental arm, where prescribed paracetamol was directly distributed for free by the local hospital. After 6 months, paracetamol was also available for free in the control arm. The main outcome was the pre/post difference in average NSAID and PPI consumption. Differences between experimental and control arms in pre/post differences are reported, as registered by the drug prescription information system. Results Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067). No changes were observed for PPIs (from 11.27 to 14.65 DDD and from 9.74 to 12.58 DDD in experimental and control arms, respectively, p = 0.788) or opioids (from 1.61 to 1.14 DDD and from 1.41 to 1.56 DDD in experimental and control arms, respectively, p = 0.419). When the intervention was extended to the control arm, no decrease in NSAID consumption was observed (from 2.46 to 2.43 DDD, p = 0.521). Conclusions Removing small economic barriers had small or no effect on the appropriateness of opioid or PPI prescribing to patients with osteoarthritis; a reduction in NSAID consumption cannot be ruled out. Trial registration number NCT02691754 (Approved February 24, 2016).
Databáze: OpenAIRE
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