Pharmacist for Detecting Opioid Misuse

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04544696
Collaborator
(none)
414
1
1.5
280

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    414 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    Apr 17, 2019
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with chronic non cancer pain

    Patients with chronic non cancer pain, treated with opioids and having completed the POMi questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Patients with POMI test "Prescribed Opioid Misuse Index"> 2 [1 day]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34290

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Hélène Peyrière, PH, UH Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04544696
    Other Study ID Numbers:
    • RECHMPL20_0433
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Sep 14, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2020