Case Study - Preserving life-saving drugs: the regulator role

Women are making great strides in the AMR field; whether it is in laboratories or health policy, they are helping to strengthen and sustain surveillance systems. The Fleming Fund Fellowship Scheme supports the development of expertise in-country, giving the tools to improve laboratory networks and generate and share surveillance data to inform policymakers.

Marking International Women's Day, Dr Sabrina Yesmin, Fleming Fund Policy Fellow, has spent the last ten years working in the Directorate General of Drug Administration (DGDA) under the Ministry of Health and Family Welfare in Bangladesh, who has been actively involved in antimicrobial resistance (AMR) related activities since 2015.

Image shows: Dr Yesmin presenting at 'Current AMR Patterns and AMU Trends in Bangladesh' dissemination programme of CAPTURA, 17-18 May, 2022.

Concrete evidence

In my regulator role at the DGDA in pharmaceuticals and healthcare, I ensure compliance with new drug registration, overseeing clinical trials for pharmaceutical product approval, manufacturing quality, and medical device inspections. I am also completing a Master of Public Health at North South University.

" … to make a significant impact on public health and contribute to the global fight against AMR is what continues to drive my passion …"

It was when I had the opportunity to become a Fleming Fellow, supported by Host Institute, the International Livestock Research Institute, that my interest in the AMR field deepened. Through attending several international workshops, participating in training sessions, and conferences, I gained exposure to global perspectives on AMR and discovered the significant gaps that existed in Bangladesh to reduce drug resistance.

Acquiring a wealth of AMR knowledge and skills through my Fleming Fellowship, I learnt about the over-the-counter sale of antibiotics, the need for a National AMC system, and the insufficient evidence of AMC patterns in Bangladesh from existing surveillance data.

I led advocacy programmes to raise awareness and implement antimicrobial consumption (AMC) surveillance to monitor and analyse the use of antimicrobial drugs in Bangladesh. Considering feasible and practical solutions to strengthen drug regulatory measures, I had an increased interest in establishing concrete evidence and translating it into robust policies.

The potential to make a significant impact on public health and contribute to the global fight against AMR is what continues to drive my passion for this work.

Advocacy Programme: Baseline survey on the level of awareness about antimicrobials, antimicrobial resistance (AMR), and its impacts on self-medication in Barisal District, Bangladesh.

In her Fleming Fellowship, Dr Yesmin advocated the importance of AMC surveillance - meeting with AMR mentors and coordinators in Bangladesh.

Perpetual problem

As a developing country, a major challenge is the higher burden of infectious diseases presenting significant health risks in Bangladesh. The living conditions, including water, sanitation, and hygiene at non-optimal levels, create an environment conducive to the growth and spread of microbes, further exacerbated by the hot and humid climate.

Frequent and excessive use of antimicrobial drugs is also a primary contributor to AMR. Antibiotics are often used indiscriminately without adequate diagnosis, and patients frequently fail to adhere to prescribed treatment courses. This is coupled with the significant concern of over-the-counter antibiotic sales by often unqualified individuals prescribing and selling antimicrobials without appropriate oversight.

The role of pharmacies and drug stores as primary healthcare providers is crucial in Bangladesh, but many lack qualified pharmacists and promote self-medication and informal consultations. Such limited knowledge perpetuates the misuse of antimicrobials, especially among poorer communities.

National AMC surveillance

Establishing a centralised National AMC surveillance system in Bangladesh was essential to understanding and effectively addressing the lack of AMC patterns. At the DGDA, the National Centre for AMC Surveillance in Bangladesh, I developed a standard operating procedure (SOP) as part of the National Guideline on Antimicrobial Consumption Surveillance in Bangladesh – featured in the National Gazette and the WHO website.

This was approved by the Ministry of Health and Family Welfare to help ensure the surveillance system’s sustainability. The comprehensive guideline and robust regulatory framework for monitoring and analysing AMU (antimicrobial use) and AMC in-country provided a foundation for an evidence-based pathway for health officials to act.

Dr Yesmin (second right-front) attending meeting between the Directorate General of Drug Administration (DGDA) and the Bangladesh Association of Pharmaceutical Industries (BAPI) on January 30, 2022 for the decision of Red Label.

Image shows: Dr Yesmin presenting at 'Current AMR Patterns and AMU Trends in Bangladesh' dissemination programme of CAPTURA, 17-18 May, 2022.

Effective interventions

Successful active surveillance in Bangladesh generated valuable data on AMC patterns and was a vital tool for understanding the extent of the AMR problem and formulating effective interventions.

This resulted in the milestone accomplishment of enrollment to the WHO Global Antimicrobial Resistance Surveillance System in November 2022, with surveillance data from Bangladesh influencing global policy change and informing decision-making.

The baseline data survey and Key Informant Interviews (KII) on antimicrobials and AMR awareness in Bangladesh confirmed cases of self-medication and irrational use of antibiotics, including a substantial lack of knowledge among pharma.

Providing insight into AMR knowledge gaps, the survey data also helped further targeted interventions and educational initiatives to improve understanding and responsible use of antibiotics.

Baseline survey on the level of awareness about antimicrobials, AMR, and its impacts on self-medication in Dhaka, Bangladesh.

Red Label

The KII study of health professionals from public and private sectors aimed to understand the preferences for antibiotic labelling and incorporating identification marks. Examining the labelling of antibiotics in Bangladesh and implementation challenges led to improving labelling practices of antimicrobial products and enhanced consumer awareness.

The regulatory decision to include red identification marks prominently on the label was endorsed by the Drug Control Committee. This research was published on the WHO website and implemented by pharmaceutical companies in November 2022.

Dr Yesmin spearheaded new AMC guidelines in Bangladesh, including implementing red labelling on antibiotics packaging to inform dispensers and consumers.

Driving change

Through my Fellowship, leveraging digital technology, conducting research, generating evidence, and fostering partnerships, I have helped find solutions and raised awareness about responsible AMU.

Supporting the development of guidelines and improved surveillance systems has led to health policy changes in Bangladesh. Equipping countries with drug resistance data promotes appropriate antibiotic use among clinicians and urges Governments to prioritise and invest in AMR. This mitigates the global health impact and preserves the effectiveness of life-saving drugs.

Drug Control Committee meeting on March 20, 2022 for the decision of Red Label.

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