Chronic Non Cancer Pain Clinical Trial
Official title:
Pharmacists in Detecting Opioid Misuse Using the Prescription Opioid Misuse Index (POMI): Survey in a Region in the South of France, Occitanie-Est
| NCT number | NCT04544696 |
| Other study ID # | RECHMPL20_0433 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 17, 2019 |
| Est. completion date | June 1, 2019 |
| Verified date | September 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Opioid use is increasing in Western countries and is associated with harms as
hospitalization, addiction and deaths(1). Community pharmacists interact frequently with
patients, giving them the opportunity to identify and prevent the risk of prescribed opioid
misuse. The purpose of this study was therefore to assess the risk of prescribed opioids
misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community
pharmacies.
Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed
to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est,
in April 2019. Eligible patients were adults with CNCP that consented to participate.
A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains
were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7
[IQR25-75: 5-8]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol
(35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were
oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram
equivalent (MME) was 40 mg/day [IQR25-75: 20-80].
POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question
were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and
need to early renew opioid medication earlier (30.8%).
Patients with POMI score > 4 were younger (49 years versus 55.9; p<0.01), more urban (78.1%
versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p<0.01), received higher median MME
(112 mg versus 64.9 mg; p<0.01), and consumed more strong opioid (45.3% versus 27.3%;
p=0.04).
| Status | Completed |
| Enrollment | 414 |
| Est. completion date | June 1, 2019 |
| Est. primary completion date | June 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - -Collection of the questionnaire in a community pharmacy of the area of investigation East-Occitania) - Patient over 18 years of age - Suffering from pain (CNCP) (> 3 months old) - Treated with weak or strong opioids Exclusion criteria: - Collection of the questionnaire in a community pharmacy outside Eastern Occitania - Patient under 18 years of age - Suffering from acute pain (< 3 months old) or cancerous pain |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients with POMI test "Prescribed Opioid Misuse Index"> 2 | Patients with POMI test > 2 A score >2, may be associated with a risk of misuse of opioid medication. It is recommended to discuss this with the physician | 1 day |