Poor-quality medicines are on the rise worldwide, with the market for falsified and substandard medicines being estimated to be worth US$65–200 billion each year globally. The problem is rife in low- and middle-income countries, where more than 13 percent of the essential medicines that satisfy the priority healthcare needs of the population are of poor quality. The African region, however, has the highest prevalence of poor-quality medicines, with an 18.7% prevalence of falsified and substandard medicines among low- and middle-income countries worldwide.
Poor-quality medicines are either falsified medicines, that is, medical products that deliberately and fraudulently misrepresent their identity, composition, or source, or substandard medicines, which are real medical products that fail to meet quality standards or specifications for a variety of reasons, including poor manufacturing, shipping, or storage conditions, or because the drug is sold beyond its expiration date. Regardless of the source, the negative consequences of poor-quality medicines are recognized as a major threat to the integrity of public health systems worldwide.
In Africa, while great effort is being placed on reducing disease burdens, the circulation of falsified and substandard medicines on the continent can potentially reverse the hard-won gains and threaten to undermine progress towards achieving the Sustainable Development Goals in the region.
The growing number of poor-quality medicines in Africa constitutes a major hazard to the prevalent diseases in the region, such as malaria, HIV, hypertension, diabetes, and tuberculosis
The fate of poor-quality medicines in Africa
Although falsified and substandard medicines exist in every region of the world, Africa bears a significant burden of this problem worldwide. The WHO reported that between 2013 and 2017, 42% of all fake medicines reported to them were from Africa, with 50% of drugs for sale on the internet being counterfeit. Another report found that approximately 1 million patients die annually, with 450,000 preventable malaria deaths caused by toxic counterfeit pharmaceuticals.
A study on ten sub-Saharan African countries showed that nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality, which could have deleterious consequences for the population. Similar results were also seen in a study that evaluated anti-tuberculosis drugs in Africa, with the percentage of substandard medicines being 16.6%.
Public health impacts of poor-quality medicines
The growing number of poor-quality medicines in Africa constitutes a major hazard to the prevalent diseases in the region, such as malaria, HIV, hypertension, diabetes, and tuberculosis. A significant public health impact is the problem of antimicrobial resistance.
Substandard and falsified antimicrobials expose pathogens to subtherapeutic doses of medicines, selectively allowing the growth of resistant organisms. Poor-quality drugs have contributed to the rise of drug-resistant tuberculosis and antimalarial resistance, which threatens to undo the good that artemisinin therapies have done, threatening global malaria control programmes.
A further potential impact of substandard and falsified medical products is the loss of public confidence in medication and in health systems. Doubts about the quality of medicines can lead people to stay away from particular health facilities, refuse vaccination for their children, or fail to take treatment as prescribed, leading to untoward health consequences.
Challenges driving poor-quality medicines in Africa and recommendations
Major drivers of substandard and falsified medicines on the continent are poor pharmaceutical governance, weak technical capacity with poor supply-chain management, poor affordability of quality medicines and out-of-pocket payments, weak and fragmented health regulations, limited access to health services and technologies, recurrent disasters, conflicts, and disease outbreaks, global supply chain disruptions, poor management of health resources, and extreme poverty. Most of the burden of these effects is seen in rural areas, which often lie beyond the reach of regulations, policies, services, and technological innovations in medicine security.
Tackling the problem of poor-quality medicines in Africa requires a coherent, multi-sectorial, and government-led strategy. There is an urgent need for a fundamental rethink of approaches towards stronger regulations and policies, community-based approaches, collaborations, and investments, which all must be scaled up to effectively control this situation.
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A key strategy is to tackle the poor local pharmaceutical manufacturing on the continent. Significant progress towards curtailing the problem of falsified and substandard medicines in Africa requires that more investment be made to strengthen local production to serve as conduits for increasing the availability of quality essential medicines on the continent.
An indigenous public health think-tank, Bloom Public Health, has risen to this challenge. Bloom Public Health has partnered with Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) in a World Bank-funded initiative to support local pharmaceutical manufacturers in Nigeria towards the attainment of Good Manufacturing Practices (GMP) and WHO prequalification.
This WHO prequalification programme will have a huge public health impact in Nigeria by ensuring increased availability of quality, efficacious, and safe medicines and reducing overreliance on imports for public health interventions, among several other benefits.
In conclusion
Despite decades of control efforts from multiple angles and converging efforts of the regional governments, the WHO, the Global Funds, and various international non-profit organisations, poor-quality medicines present a huge setback to the global fight against diseases of major public health concern in Africa.
A paradigm shift is therefore necessary, and concerted efforts must be made towards tackling this silent epidemic to improve access to quality, accessible, and affordable medicines and reduce the disease burden on the continent.
