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

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Other: patients undergoing opioid replacement therapy

• Registration Number: NCT03961789
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Patients will be recruited in addiction departments, associations for risk management and general practitioners, and a paper questionnaire will be sent to the patients. The questionnaire is anonymous.

Study Timeline

• Study Start: 2018-01-29
• Primary Completion: 2019-05-21
• Study Completion: 2019-05-21
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Patient undergoing opioid replacement therapy

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohorte 1	patients undergoing opioid replacement therapy	patients undergoing opioid replacement therapy

Primary Outcome Measures

Name	Time	Method
Score of satisfaction	day 1	visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?" 0: not satisfied - 100: totally satisfied

Secondary Outcome Measures

Name	Time	Method
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion	day 1	VAS, 0: not at all - 100 : totally
duration of opioid use disorder	day 1	number of years/months
Perception of the profile / behaviour of pharmacists: respect for confidentiality	day 1	VAS, 0: not at all - 100 : totally
Perception of the profile / behaviour of pharmacists: competent	day 1	VAS, 0: not at all - 100 : totally
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy	day 1	yes/no
Demographic information	day 1	: age, sex, study level, marital status, health care insurance, monthly income, type of housing
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions	day 1	yes/no
Number of community pharmacy consulted for the last 6 months	day 1	number
Number of physician consulted for the last 6 months	day 1	number
opioid replacement therapy	day 1	name, dose, route

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France