We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement, and that it could have an impact on the deprescribing of BZD/Z in adult patients.
Two primary objectives will be evaluated in a sequential hierarchical manner, with two primary endpoints analysed one after the other, without alpha risk adjustment, but the second can only be analysed if the null hypothesis is rejected for the first:
1. Evaluate the impact of brief motivational intervention (BMI) on reducing the daily dose of BZD/Z prescribed at 6 months (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies. 2. Evaluate the impact of BMI on clinical worsening at 6 months (non-inferiority hypothesis) in comparison with the usual practice of dispensing BZD/Z in pharmacies.
Continuous treatment (at least once daily) with BZD/Z for at least 6 months, after verification of 6 months' supply.
Signed informed consent
Patient able to understand the survey and complete a questionnaire in French.
Affiliation with the French social security system
The following oral antipsychotics: risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, flupentixol, pimozide, chlorpromazine, sulpiride, zuclopenthixol, loxapine, cyamemazine (>100mg/D), sulpiride (>150mg/D),
Injectable medium- and long-acting antipsychotics
Thymoregulatory treatment with lithium
Treatments for alcohol use disorders: baclofen, nalmefene, naltrexone, acamprosate, disulfiram
Parallel
Brief motivational intervention
Other interventionidentification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (≥ 6 months).
Change of the Daily dose of BZD/Z drug
Change of at least 50% of the Defined Daily Dose (DDD) initially prescribed (reduction), 6 months after the BPMI (during the last 4 weeks prior to the assessment)
Worsening of the clinical symptoms of anxiety and/or sleep disorders
Clinical worsening is defined as: * An increase in anxiety ≥ 3 points of the HAD-A sub-score (the minimum clinically significant difference being estimated at 3.2 +/- 4. * and/or an increase ≥ 8 points in the ISI (the minimum difference corresponding to a moderate improvement being estimated at \> 7 points.
change of the prescribed daily dose of BZD/Z without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
1\. Proportion of patients with a change (reduction) of at least 50% of the initially prescribed Defined Daily Dose (DDD), without clinical worsening, during the last 4 weeks prior to assessment.
complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
Proportion of patients whose BZD/Z prescription was stopped, without clinical worsening. Discontinuation is defined as no prescriptions or dispensing identified in the last 4 weeks prior to assessment.
declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies
declared average daily dose consumed and the number of days without consumption during the 7 days preceding the patient's visit
anxiety symptoms
Worsening of anxiety at 12 months is considered to be an increase in anxiety ≥ 3 points on the Hospital anxiety and depression scale (HAD-A sub-score). HAD-A is from 0 (no anxiety) to 21(max of anxiety)
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