Background: When Fight the Fakes heard the great news of how the percentage of falsified anti-malarials had dropped from 31% in 2009 to 1.5-2% in 2018 in Ghana, we wanted to know more. USP Ghana country manager, Mr Kwasi Boateng tells how the work of many hands had led to achieving this great result.
The success in reducing falsified anti-malarials in Ghana was made possible thanks to the Food and Drugs Authority (FDA) in Ghana and the USAID Funded Promoting the Quality of Medicines Programme implemented by US Pharmacopeia (USP), partner in the Fight the Fakes campaign. Together they worked on the programme promoting access to quality medicines. The programme kicked off in 2009 when the partners started monitoring and supporting measures to increase access to good quality anti-malarials. According to WHO’s World malaria report 2017, there are around 10 million cases of confirmed malaria in Ghana and almost the entire population is at risk of contracting the disease. Therefore getting the real treatment rather than a fake one is essential and life-saving. Nine years ago, there was a one in three chances you might be taking a falsified anti-malarial, fast-forward nine years and our latest monitoring report shows the percentage of falsified anti-malarials to be less than 2%. This is hugely good news.
Testing for fake medicines is essential – It’s been a long personal journey. Between 2011 and 2015, I was the PQM country consultant working on the monitoring programme directly with Ghana’s FDA team. We actively contributed to the USP Medicines Quality Database, a great resource which gave the World Health Organizations (WHO) almost 30% of the cases used to analyze for the WHO study on substandard and falsified medicines.
In 2015, I started working on different USP projects, but thankfully, I could continue my work on quality medicines. My work allowed me to go with the team around the country to take samples from the medicines distribution channels, from warehouses, public and private hospitals, retail pharmacies, over the counter sellers, mission hospitals, basically across the whole medicines supply chain. In addition, we were able to take samples from the informal sector.
To test the sample, we would put it through what we call a three-level approach. The first level was the visual and physical inspection of the product to see whether we could identify anything that would suggest quality issues. We would especially look at the packaging and the information on it. The second level involved using a GPHF-Minilab which employed Thin-layer chromatography, Colorimetric methods, and a disintegration test to check the identity of drugs and their approximate content. And finally, the third level would determine drug quality according to the compendial standards of the Medicines Control Laboratory. Over the years we have adopted also other screening methods such as “True Scan” which helps identify the quality standards of the products, as well as CD3 – the Counterfeit Detection Device nr.3, developed by America’s FDA, as additional tools for the second level screening, which is mainly carried out on the field. We used all three methods to see how they could complement each other. When irregular samples were found recommendations were made to Ghana’s FDA management, to take the necessary regulatory actions. Although the FDA does not have prosecution power, they can still recall products and impose fines.
The way we see it is that there are two types of samples that need to be signaled to the FDA. If we find out that the active pharmaceutical ingredients (API) are missing from the samples it is considered that the medicines have been deliberately falsified. When substandard medicines are found this could be attributed to potential mistakes in the manufacturing. Worryingly, this was a common occurrence for locally manufactured medicines. To solve this, Ghana’s FDA has put in place a Good Manufacturing Practice (GMP) roadmap for the local manufacturers, giving them guidance and helping them to become compliant with international standards.
Capacity building helps secure gains for the future – What is very rewarding is that our work goes beyond testing. USP Ghana trains and builds capacity. The more competent regulatory staff are in dealing with quality medicine, the better it is for the patients and the health system to ensure that quality products reach them. To date, USP has trained around 320 medicine regulators as well as local manufacturers and academics in 40 countries of Sub Saharan Africa. We are looking at ways to ensure we have good regulators in the future. For this reason, we are looking at ways to build capacity when regulators are being schooled, before they get on the field. We have piloted a project along with the University of Ghana School of Pharmacy, where we introduced lessons to final year students. It was great to see the results of our work in Mauritius for instance, where they now have their own medicines regulatory laws. We have also carried out testing on behalf of the countries that do not have the capacity for it.
Part of the successful achievement of lowering the percentage of falsified anti-malarials in Ghana was that the regulators were willing to tackle these issues. USP stepping up to support this through capacity building will have also contributed to the success. Today, the will is spreading across Africa and tackling falsified anti-malarials and medicines more generally, is a key objective for the New Partnership for Africa’s Development (NEPAD) African Medicines Regulatory Harmonization programme. I have been working for the Regulatory Capacity Development sub-committee of NEPAD focusing on harmonizing the curricula for training of regulatory staff across Africa. In addition, USP is a key actor and the technical partner of the African Medicines Quality Forum that gathers the network of laboratories in Africa aimed at reducing substandard and falsified medicines together in Africa.
The story does not end here – Together with anti-malarials, antibiotics are amongst the most commonly reported substandard and falsified medical products. Substandard and falsified medical products contribute to antimicrobial resistance and drug-resistant infections. Tackling falsified antibiotics is a major issue on the public health agenda but it doesn’t command as much attention, because the focus of funding is on solving the 3 major global health pandemics of HIV, Tuberculosis and Malaria. HIV medicines are considered safe from substandard and falsified medicines because the treatments come through the Ghana AIDS Control Programme. Anti-retrovirals to treat the condition come through a safe channel secured by the Global Fund. What we can test are the specific antibiotics used to treat TB but unfortunately, we cannot extend the screening to all antibiotics. So, while a great deal has been done to address the public health challenge of falsified anti-malarials, there is still plenty of work ahead.
Staying vigilant – In the meantime, what can people do to protect themselves from falsified medicines: We need to be aware. In my experience, in Ghana I would say that there is a kind of invisible consent that there are fake medicines out there. The level of awareness among citizens is very difficult to quantify but I feel reassured because people talk about the problem despite not having much evidence for them to point to. Raising awareness further can help encourage people to procure medicines from licensed outlets, wholesalers, distributors, with granted authorization from Ghana’s FDA. There is a strong incentive also for local manufacturers to step up the quality of their medicines. I get the general feeling that people usually perceive that local manufacturers in Ghana produce medicine that are of lower quality than international brands. The threat of a local manufacturer being found out to have supplied poor quality medicines should increasingly become an incentive to do better, or risk losing its reputation and having consumers shun their products.
My agenda going forwards – We can support more awareness about falsified medicines, and further help eliminate them by using the WHO Medical Product Alert System and this is very rewarding. This system channels the notifications about suspicious medical products and further alerts other Member States about the potential dangers of that product on the market. Furthermore, I think that linking falsified medicines and pharmacovigilance could be interesting. Pharmacovigilance is the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. This goes on today without patients knowing. Many of the systems are in place, so it could be easy to add collecting information on falsified medicines.
What makes me happy is that consumers are increasingly making wise decisions that take into account the quality of products and manufacturers and regulators are increasingly showing that they want to do things right. I am confident about that future.
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