Improving the quality of medicines in Africa

                              •Dr. Patrick Lukulay

The problem of counterfeit and substandard medicines in Africa is huge. It is estimated that up to one-third of medicines in some parts of the continent are counterfeit and even more are substandard – meaning they are either ineffective, of subpar quality or, worst of all, harmful to patients. Every year, 122,000 African children under the age of five die because of counterfeit antimalarials alone. Beyond deaths, poor-quality medicines place an enormous economic strain on families and health systems and are also contributing to the rise of drug resistant strains of various diseases, including malaria, tuberculosis and other common infections.

The Centre for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, is an incredible example of an Africa-led solution to this major public health challenge in Africa. It aims to help build a cadre of well-trained regulatory and pharmaceutical professionals that can help detect counterfeit and substandard medicines in Africa and advocate for their removal from the market. In this piece, Dr. Patrick Lukulay, USP’s Vice President for Global Health Impact Programmes in Africa, highlights the importance of improving quality of medicines in Africa through expansion of this Centre.

 When we are unwell and visit our local pharmacies or dispensaries, we expect to get safe and effective medicines that make us feel better. That is, after all, what medicines are supposed to do. However, for far too many people living in Africa, this is not the reality. Fake and substandard medicines are flooding our markets. In fact, it is estimated that up to one-third of medicines used in some parts of Africa are counterfeit and even more are of poor quality. In effect, this means many Africans have more than a 30 percent chance of getting medicines that are partially effective, completely ineffective, or downright harmful to their health. Growing up in Sierra Leone, I saw this reality all too often. The effects of poor-quality medicines are many and massive. It is estimated that at least 122,000 African children under the age of five lose their lives every year as a result of counterfeit antimalarials alone.

Poor quality medicines also place an enormous economic strain on families who must pay additional money for more (hopefully) effective medicines or pay for hospitalizations as a result of ineffective or harmful medicines. At a broader level, counterfeit and substandard medicines are contributing to the rise of drug-resistant strains of deadly diseases, such as malaria, tuberculosis and common infections. When medicines contain too little of an active ingredient, they do not fully kill the disease-causing bacteria or parasite, leaving the most resistant to multiply within the infected individual – and likely infect others. The development of drug resistance will ultimately make even high-quality medicines ineffective over time, posing a major threat to global public health. Counterfeit and substandard medicines are so pervasive because, unfortunately, they are difficult to detect, particularly in low-resource settings in Africa.

Many governments have quality standards in place but are ultimately unable to enforce them. Customs procedures are often quite lax, and most regulatory agencies and laboratories simply do not have the equipment or the technical skills required to conduct rigorous quality control tests. That is why, in 2013, the United States Pharmacopeial Convention (USP) launched the Centre for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana. Our aim is to build a well-trained cadre of regulatory professionals across the African continent that can assess compliance with and enforce quality standards to ensure that effective, beneficial medicines reach the people who need them most. Over the past three years, we have trained 190 professionals from 32 countries, including 31 from Nigeria. Many of our trainees have in turn helped train additional scientists and regulators back home. In addition to training, CePAT has also screened pharmaceuticals from Ghana and across Africa with the goal of identifying poor-quality medicines before they are on the market and advocating for higher standards at the policy level. 

 In 2013, USP and the Ghanaian Food and Drugs Authority (GFDA) conducted testing in Ghana and found that around 90% of oxytocin — used to prevent massive bleeding in mothers, post-delivery — was substandard. We then successfully worked with the Ministry of Health to ensure that all oxytocin must now be vetted and registered by the GFDA before reaching Ghanaian women. This week, CePAT is further expanding its offerings by opening a microbiology lab, which will enable us to train regulatory professionals across Africa to identify medicines that have been contaminated by micro-organisms such as bacteria. This type of testing has historically been extremely difficult in Africa due to its complexity and the resources needed to conduct the tests.

However, this particular pre-assembled microbiology laboratory was designed specifically for use in low-resource settings, making it a potential model for other countries across the continent to replicate. Our success with training and medicines quality screening in Ghana has shown us what is possible when the right resources are in place. What we need – and urgently – is for stakeholders across the continent to make quality assurance a priority. At the national level, we need governments to put strict policies around medicine quality in place and ensure these policies are stringently enforced.

 Governments also need to equip their laboratories with suitable laboratory equipment and invest in training their regulatory personnel on how to properly detect counterfeit and substandard medicines. In some countries, donor support will be needed to help fund the modernization of regulatory laboratories and build local capacity. At CePAT, we are ready and willing to accept more trainees at our facilities. We are currently sponsoring 12 trainees from six countries every two months, but we could do much more with additional resources for scholarships. It is also important for communities to get involved because ultimately every day, people in Africa are bearing the brunt of the counterfeit and substandard medicine situation. Communities must hold their governments accountable for ensuring quality and keeping poor-quality medicines out of pharmacies and out of homes.