Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

NCT06521892 | Enrolling By Invitation

• 1 other identifier: HuazhongU20240720
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Prescription Drug Misuse; Acute Respiratory Tract Infection

Keywords

antibiotic; community pharmacy; non-prescription; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Proportion of antibiotics dispensing without a prescription

  Proportion of antibiotics dispensing without a prescription measured by standardized patients

  baseline, First month after intervention, 3, 6, and 12 months after intervention

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: social surveillance and health education interventions

control group

NO INTERVENTION

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

Interventions

social surveillance and health education interventions 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.

intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Hubei Provincial Drug Administration

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Drug Misuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Social Medicne and Health Management Department

Model Details: 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

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 26, 2024
• Study Start: August 25, 2024
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)