Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

Not Applicable

• Conditions: Non-Prescription Drug Misuse; Acute Respiratory Tract Infection
• Interventions: Behavioral: social surveillance and health education interventions

• Registration Number: NCT06521892
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-26
• Study Start: 2024-08-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-08-25
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	social surveillance and health education interventions	Participants in intervention group will receive social supervision and health education interventions.

Primary Outcome Measures

Name	Time	Method
Proportion of antibiotics dispensing without a prescription	baseline, First month after intervention, 3, 6, and 12 months after intervention	Proportion of antibiotics dispensing without a prescription measured by standardized patients

Trial Locations

Locations (1)

Hubei Provincial Drug Administration; 🇨🇳 Wuhan, Hubei, China