Clinical trial NCT06521892: Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies
Official title: The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Non-Prescription Drug Misuse
Acute Respiratory Tract Infection
Keywords: antibiotic
community pharmacy
non-prescription
randomized controlled trial
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Proportion of antibiotics dispensing without a prescription
timeFrame: baseline, First month after intervention, 3, 6, and 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Drug Administration
state: Hubei
Study officials:
References: