Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program

NCT ID: NCT06313619

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2024-10-31

Brief Summary

We developed 'SmartAMR', a digital pharmacy system featuring real-time records, symptom checks, telemedicine, counselling, and medication reminders. This study aims to assess its feasibility, acceptability, and effectiveness within community pharmacy settings in Bangladesh.

A before-after designed pilot quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample. For qualitative part, the sample will be selected purposively until data saturation and a total of 8 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding effectiveness, acceptability, adoption, feasibility, and cost of the intervention.

Detailed Description

The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).

This is a pioneering study in Bangladesh that introduces a comprehensive digital pharmacy management system, demonstrating its feasibility and acceptability while highlighting potential challenges. The intervention showed promise in improving record-keeping, raising awareness, and promoting rational antibiotic use. The cloud-based server of this system allows its integration with existing government data systems, providing it the privilege to scale up to a nationwide level and achieve sustainability. With adequate support and strategies to mitigate profit-driven noncompliance, such pharmacy-based interventions can play a vital role in national efforts to combat AMR.

The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced and piloted to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs.

Conditions

Resistance Bacterial; Increased Drug Resistance; Drug Resistance, Microbial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Digital Pharmacy Intervention

A total of 39 pharmacy will be included in the intervention. The digital intervention named "SmartAMR" will be introduced among them. The participants will install the mobile app and use it to keep record of the antimicrobial sales in a central database.

Group Type: EXPERIMENTAL

SmartAMR

Intervention Type: COMBINATION_PRODUCT

"SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service.

Interventions

SmartAMR

"SmartAMR" is a digital system including a mobile app that helps keeping record of medicine sales, sending auto-generated messages to the consumers to remind them about medicine taking time and completing doses. It also poses a symptom checker driven by artificial intelligence and a telemedicine service.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and above
• Registered drug seller/pharmacist
• Permanent residents of the study areas
• Willing to participate

Exclusion Criteria

• Disoriented or critically ill

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Md Atiqul Haque

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M Atiqul Haque, PhD

Role: STUDY_DIRECTOR

Bangladesh Medical University

Locations

Bangladesh Medical University

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/20236831

Identifier Type: -

Identifier Source: org_study_id