Pharmacist for Detecting Opioid Misuse

NCT ID: NCT04544696

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 414 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2019-06-01

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).

Conditions

Chronic Non Cancer Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with chronic non cancer pain

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène Peyrière, PH

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0433

Identifier Type: -

Identifier Source: org_study_id