Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

NCT ID: NCT06521892

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-25

Study Completion Date

2025-08-25

Brief Summary

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This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.

Detailed Description

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Conditions

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Non-Prescription Drug Misuse Acute Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Pharmacies participating in the study did not know which group they were assigned to. Standardized patient surveyors also did not know which group of pharmacies they surveyed.

Study Groups

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intervention group

Participants in intervention group will receive social supervision and health education interventions.

Group Type EXPERIMENTAL

social surveillance and health education interventions

Intervention Type BEHAVIORAL

Social surveillance: In the intervention group retail pharmacies posted or hung signs "antibiotics need to be purchased by prescription, if found without prescription sales, welcome to call 12315 hotline to report", to form social supervision intervention.

Health education: On-site training for retail pharmacy staff, inviting respiratory physicians and pediatricians to give health education lectures on disease diagnosis, treatment and medication.

control group

Participants in control group will receive routine drug supervision and management measures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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social surveillance and health education interventions

Social surveillance: In the intervention group retail pharmacies posted or hung signs "antibiotics need to be purchased by prescription, if found without prescription sales, welcome to call 12315 hotline to report", to form social supervision intervention.

Health education: On-site training for retail pharmacy staff, inviting respiratory physicians and pediatricians to give health education lectures on disease diagnosis, treatment and medication.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The qualification of retail pharmacies to sell antimicrobial drugs complies with relevant regulations and requirements, ensuring that the study participants operate legally within the regulatory framework.
* Pharmacies located in Hubei Province.

Exclusion Criteria

* The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;
* Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;
* Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;
* Subjects withdrew from the study on their own or were lost to follow-up.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xiaoxv Yin, PhD

Professor and Head of Social Medicne and Health Management Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hubei Provincial Drug Administration

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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HuazhongU20240720

Identifier Type: -

Identifier Source: org_study_id

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