Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Hubei Provincial Drug Administration — Ухань

Идентификаторы

NCT: NCT06521892 · HuazhongU20240720

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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