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
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
-
-
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.
|
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.
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
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.