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Enrolling by invitation NCT06521892

Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

No phase Interventional Non-Prescription Drug Misuse Acute Respiratory Tract Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: social surveillance and health education interventions.
Who it may be relevant to
Registry conditions: Non-Prescription Drug Misuse, Acute Respiratory Tract Infection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Proportion of antibiotics dispensing without a prescription [Time frame: baseline, First month after intervention, 3, 6, and 12 months after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Hubei Provincial Drug Administration — Wuhan

Identifiers

NCT: NCT06521892 · HuazhongU20240720

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗