Clinical trial NCT04544696: Pharmacist for Detecting Opioid Misuse
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Non Cancer Pain
Keywords: Opioid
Misuse
Community pharmacy
POMI test
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic non cancer pain

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).


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

Primary outcomes:
measure: Patients with POMI test "Prescribed Opioid Misuse Index"> 2
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Hélène Peyrière, PH
role: PRINCIPAL_INVESTIGATOR
References: