Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

October 3, 2024 updated by: Xiaoxv Yin, PhD, Huazhong University of Science and Technology

The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Hubei Provincial Drug Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Participants in intervention group will receive social supervision and health education interventions.
Behavioral: 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.
No Intervention: control group
Participants in control group will receive routine drug supervision and management measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of antibiotics dispensing without a prescription
Time Frame: baseline, First month after intervention, 3, 6, and 12 months after intervention
Proportion of antibiotics dispensing without a prescription measured by standardized patients
baseline, First month after intervention, 3, 6, and 12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2024

Primary Completion (Estimated)

August 25, 2025

Study Completion (Estimated)

August 25, 2025

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HuazhongU20240720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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