Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it is not included in list of drugs than can be prescribed in charge of National Health System by General Practitioners. The hypothesis is that removing this economical barrier the investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome, opioids use was also monitored to see.
Aim of the study is to test if allowing prescription of free paracetamol decreases the prescription of NSAID in osteoarthritic patients.
The trial was conducted in two primary care units of the province of Reggio Emilia. The units have about 34.000 inhabitants. In this units 16 General Practitioners are active, the average beneficiaries per General Practitioner are 1500, about one fourth over 65 years old.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| free paracetamol | Experimental | the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital |
|
| standard drug prescription | No Intervention | Paracetamol is not included in the list of drugs than can be prescribed in charge of National Health System by General Practitioners. The General Practitioners can prescribe other drugs or recommend paracetamol payed by the patient (out of pocket) at the chemistry. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| free paracetamol | Other | General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of NSAID | Difference in defined daily dose (DDD) per patient between the control and the intervention | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of PPI | Difference in defined daily dose (DDD) per patient between the control and the intervention | one year |
| Consumption of opioids | Difference in defined daily dose (DDD) per patient between the control and the intervention |
Not provided
Inclusion Criteria:
Exclusion critera:
- none
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandra Ferretti, MSc | Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31810456 | Derived | Vicentini M, Mancuso P, Giorgi Rossi P, Di Pede S, Pellati M, Gandolfi A, Zoboli D, Ricco D, Busani C, Ferretti A. 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. BMC Fam Pract. 2019 Dec 6;20(1):169. doi: 10.1186/s12875-019-1050-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| one year |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided