UNVEILING ANTIMICROBIAL QUALITY WITH MINILAB DETECTION

 Ecumenical Pharmaceutical Network(EPN) will focus on scaling the  surveillance  and detection of Substandard and Falsified antimicrobials in regions near the borders of Cameroon and Malawi using the Global Pharma Health Fund (GPHF) Minilab technique

Judith Asin will be the lead for this solution

The Sub-Saharan region is grappling with a grave issue as the prevalence of substandard and falsified (S/F) antimicrobials is alarmingly high.  In Africa, the proliferation of falsified and substandard medicines is a public health emergency that can no longer be ignored. There is an 18.7% prevalence of S/F amongst low-and middle-income countries worldwide and up to half a million people due to the intake of these medicines.  They may have the incorrect or wrong dose of pharmaceutical ingredients, or no active ingredients and may result in death, prolonged illness, loss of trust in healthcare systems and are key drivers of antimicrobial resistance (AMR). The recent expansions in industrialization and trade have aggravated the scale of the problem. In addition, there has been poor drug traceability, inadequate post-marketing surveillance programs which is often restricted to sporadic sampling and testing exercises with poor tracking across borders .Though the issue is widely acknowledged, its complexities are poorly understood. On top of that, Africa has no official data collection for S/F medicines. If adherence to good pharmaceutical manufacture, distribution & trading practice cannot be assumed, a greater number of samples have to be tested in order to maintain an appropriate assurance of drug quality.

EPN focuses its efforts on underserved and rural communities served by the church health organizations.The solution aims to help the members of the communities inclusive of women, men and children in border regions of Cameroon and Malawi by testing for quality of antimicrobials  supplied in those regions, the data collected will inform the government to initiate product call and remove the substandard/falsified antimicrobials from the market and ultimately improving the quality of products circulating in the market. This ensures that the community has access to quality medications that can effectively treat their medical conditions addressing the needs of the population for safe and effective treatments. In addition, it helps in building trust in the healthcare system by improving patient confidence in healthcare providers. Lastly, detecting and removing S/F from the market helps protect the public from potential health risks associated with consuming these products. This can prevent adverse reactions, treatment failures, and the development of antimicrobial resistance. Currently EPN, through its minilab partners in Malawi and Cameroon is testing for medicines, however, with the small sample size , EPN plans to scale up the sampling size and well as areas in order to increase coverage and produce more reliable data

Our initiative provides several public goods by informing policies, and safeguarding public health against the threat of antimicrobial resistance. Our solution also protects the public from harm by ensuring access to quality medications through Minilab tests. By increasing the sample size and sampling areas, the area covered will be broad and hence producing substantial data on quality of antimicrobials circulating in the community. Following detection of a S/F, this will facilitate product recall thereby halting the circulation of these medicines including stocking them in community pharmacies/retail outlets. 

Integration of data generated will enable comprehensive analysis and the development of targeted interventions to mitigate the spread of AMR. By sharing data with policymakers, we will contribute to evidence-based decision-making, informing and reinforcing surveillance  Furthermore, we uphold transparency and collaboration by publishing our findings as open-source publications and conducting information-sharing sessions with stakeholders.

Through this solution, EPN aims to scale- up the surveillance and detection of S/F antimicrobials in regions near the borders of Cameroon and Malawi using the  Minilab

By testing for quality of antimicrobials being supplied in those regions, the data collected will inform the government to initiate product recall and remove the substandard/falsified antimicrobials from the market and ultimately improving the quality of products circulating in the market. This will ensure that the community has access to quality medications that can effectively treat their medical conditions addressing the needs of the population for safe and effective treatments and achieve better health outcomes. S/F medicines can also result in wasted resources as community members may have to seek alternative treatments or face increased healthcare costs due to prolonged illness. By detecting these products, communities are protected from unnecessary financial burdens.

The main sub-goals will be as follows;

Sub-Goal 1: Expansion of sample collection efforts & Testing to produce more data on quality of antimicrobials using the GPHF Minilab 

Sub-Goal 2 : Improve real-time data visualization of the sampling area and test results using a dashboard to inform decision making

Sub-Goal 3: Support regulatory enforcement through improved report and dissemination of findings

The data generated from this solution will be made available to the NRA and it will assist the policy makers in; Identifying hotspots/key areas in which this problem is most prevalent. The data will also help track trends in the prevalence of S/F over time. The analysis of data generated will inform on the root causes of the problem and develop long-term strategies to combat poor quality antimicrobials. This will  strengthen surveillance and motivate the NRA to scale up /expand the risk-based sampling strategies to the most affected regions, outlets and antimicrobials.

In addition, the data generated can also be used to raise public awareness and advocacy  about the issue and educate consumers about the risks associated with using these products. This can help empower individuals to make informed choices and avoid falling victim to S/F

 EPN also plans to conduct a regional minilab workshop which will be a platform for sharing of best practices and lessons learnt. The minilab partners from the two countries will be able to illustrate the positive impact of utilizing the real-time dashboard which is a new concept in the network and can be scaled up to the other minilab users in the different countries.

EPN uses key indicators to monitor the performance of the project which will include;  Number of samples tested by the minilab partners, in-country dashboard developed,100% of minilab test results reports shared, Number of minilab workshops conducted.  EPN usually develops a project dashboard in which the indicator worksheet, implementation plan , budget, and log frame are embedded to it  as well as an M&E plan outlining  how progress will be monitored and evaluated throughout the project.

Performance of the project is usually reviewed during bi-weekly Monitoring & Evaluation meetings(M&E). In addition, the EPN secretariat  conducts monthly update meetings with the implementing partners in order to collect updates as well as  joining  them  on the ground for support supervision in which challenges are discussed and success stories are also collected. In this solution, there will also be minilab workshops which will engage with key stakeholders including NRAs throughout the project to gather feedback on the effectiveness of the mini labs in detecting substandard and falsified medicines. 

In addition, data  from the tests conducted will be collected regularly throughout the project will allow for real-time monitoring of progress and early identification of any challenges or issues that may arise.

Monitoring quality of medicines is a collaborative effort in the country, however, taking action to recall the identified SF medicine and raise alert is an exclusive mandate of NRAs. It takes time to raise alert, to recall the product and protect the community. There is need to continue advocating for sustainable collaboration, transparency and dialogue to ensure that the trust is built the actions are taken on tile.

GPHF Minilabs require replenishment of reference standards and reagents (chemicals). Stock out might lead to delays in performing testing. A close monitoring of stocks will be conducted to ensure that all implementing partners are supplied on time and in-full to avoid delays.

The dashboard for data entry, analysis and reporting will be developed in collaboration with key in-country partners identified in Cameroon and Malawi. The design of the Dashboard and MoH buy-in for future ownership is critical. This harmonization process can be delayed with the bureaucracy in the country. Close monitoring and involvement of targeted MoH staff from the inception will be necessary to overcome this challenge.    

The Minilab has helped EPN raise awareness on the quality of medicines in the faith-based health system. Most of facilities are located in rural areas, serving communities who pay their health care expenses out-of-pocket. It has been a challenge to convince healthcare workers, especially those involved in decision-making that quality should prevail price. Seeking for cheaper prices has led to the introduction of poor quality antimicrobials in the facilities.

With more data generated with this support from Trinity Challenge, EPN will be able to showcase incidence of SF and the need for more responsible supply chain decision-making.

In some countries, the collaboration among Minilab Members and MoH still faces challenges. The success story of this strong partnership which will be developed in Cameroon and Malawi will serve in our advocacy efforts in those countries.

We also believe that the impact of this solution will provide opportunities to EPN to attract more funding and partners to scale up and extend this solution to other Minilab member countries. Our objective is also to expand the Minilab Network in other countries in sub-Saharan Africa.

Our experience will also inform Merck and GPHF on new antimicrobials without a Minilab Monograph to be developed.

Primary beneficiaries are our members in Cameroon and Malawi

Christian Health Association of Malawi (CHAM), Cameroon Baptist Convention (CBC), Presbyterian Church in Cameroon (PCC) and Christian Health Association of Kenya (CHAK). 

Our secondary beneficiaries are the EPN network members. https://www.epnetwork.org/members/ 

This solution will enhance our commitment as a network to fight substandards and falsified products. It will create more commitment, more cases for experience sharing and strengthen our members collaboration with NRAs in monitoring quality of medicines in the countries