Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy

NCT03961789 | Completed

• 1 other identifier: CHU-434
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management. Thus, the satisfaction of an individual in their interview with the pharmacist is a very important element. The pharmacist in his professional activity may have to manage patients with opioid related disorders. Pharmacist activity will result in the dispensing of opioid replacement therapy (ORT), single-use syringes, harm reduction kits and prevention advices for the reduction of toxicity and infection risks. Since the 1990s, the consumption of ORT has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients undergoing ORT is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed ORT in France. Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with patient suffering of opioid related disorders, which can have an impact on patient's satisfaction. The objective of this study will be to assess the satisfaction of patients undergoing ORT regarding their management by community pharmacists.

Conditions

Opioid-Related Disorders

Keywords

Opioid-Related Disorders; Opiate replacement therapy; Community Pharmacy Services; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Score of satisfaction

  visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?" 0: not satisfied - 100: totally satisfied

  day 1

Secondary Outcomes (10)

• Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions

  day 1

• Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy

  day 1

• Perception of the profile / behaviour of pharmacists: welcoming and open to discussion

  day 1

• Perception of the profile / behaviour of pharmacists: respect for confidentiality

  day 1

• Perception of the profile / behaviour of pharmacists: competent

  day 1

Study Arms (1)

cohorte 1

patients undergoing opioid replacement therapy

Other: patients undergoing opioid replacement therapy

Interventions

patients undergoing opioid replacement therapy OTHER

patients undergoing opioid replacement therapy

Also known as: no intervention or other

cohorte 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing opioid replacement therapy

You may qualify if:

• Patient undergoing opioid replacement therapy

You may not qualify if:

• Age \<18 years
• Patient unable to understand or write in French

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• UFR de Pharmacie (Clermont-Ferrand): collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Balayssac

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: January 29, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

FR (1)