Drugs and medical products are essential to treat, prevent and save the lives of millions of people globally. Hence, they must be safe, effective and of good quality. Pharmaceutical products that do not meet stringent regulatory standards of quality threaten the health of the population.
Medicines are rigorously tested and approved as safe and effective by regulatory authorities before becoming available to the public. Once on the market, pharmaceutical manufacturers and drug regulatory authorities continue to monitor the medicines for unforeseen problems. When an issue develops that questions the safety or effectiveness of a medication, a recall may be initiated.
Every year, thousands of drugs and medical products are recalled from the drug market globally. It is reported that the last few years have seen a drastic increase in the number of drug recalls.
Owing to the COVID-19 pandemic, globally, there has been a surge of substandard and falsified medical products, putting a huge burden on health systems particularly in low-and-middle-income countries (LMICs) like those in Africa where there is poor surveillance of medicine supply chains and inadequate pharmacovigilance systems. Drug recalls are therefore critical to protect the public from the consequences of defective or potentially harmful products.
Why are drugs recalled?
Low-quality medicines or medical products are recalled from the market by manufacturing companies voluntarily or by the order of national or international drug regulatory bodies.
A drug can be recalled for several reasons, such as when it is found to cause health hazards. Unfortunately, some health risks associated with certain drugs are not known until after they become widely used. For example, in 2010, the weight loss drug sibutramine (Meridia) was recalled from the US market after it was found to increase a person’s risk of heart attack and stroke.
Other reasons for drug recalls include mislabelling or poor packaging leading to erroneous or confusing dosing instructions, contamination by unwanted or harmful ingredients during production or distribution, and manufacturing defects affecting a product’s quality, purity, and potency, amongst others.
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Drug recalls in Africa: Challenges and implications
Africa is no exception to the increase in drug recalls occurring globally. In 2018, South Africa recalled several high blood pressure and heart drugs (valsartan-containing medicines) produced by a Chinese company. The recall occurred because of the detection of an impurity, N-nitrosodimethylamine (NDMA) which is classified as a probable human carcinogen, in the valsartan active substance the company supplied.
Unfortunately, achieving successful drug recalls in Africa is enormously challenging. Many pharmaceutical companies have inefficient reverse logistics- that is how goods are sent back from the retailer or consumer to the manufacturer. The fundamental complexities of reverse logistic operations, such as uncertainty in quality, quantity, and the timing of returns, make the product-return process complicated.
There is also the challenge of pharmaceutical waste management of recalled products. When drugs are recalled because of defects or damages, they must be destroyed. But recalled drugs can’t be disposed of like other consumer products, as they are harmful to the environment. However, in Africa, there is limited capacity for waste elimination and transportation of product recalls within the pharmaceutical industry.
Another critical challenge is the poor technical know-how and skill set for handling drug recalls among personnel in the pharma industry.
Poor drug recalls in Africa not only pose significant risks to public health, they also weaken the credibility of pharmaceutical companies and decrease confidence in the pharma industry.
Strategies to address drug recall challenges in Africa
There is an urgent need to address the financial, technical, and human resource challenges confronting drug recalls in Africa. To achieve this, Bloom Public Health proposes the following strategies:
• Development of sustainable drug recall policies and processes: Pharmaceutical manufacturing companies must develop their current drug recall strategies to be sustainable and comply with the strict guidelines and requirements of national medicine regulatory authorities (NMRAs). NMRAs must also strengthen their capacity to oversee companies’ strategies and assess the adequacy of recalls
• Increasing pharma workforce capacity for drug recalls: Bloom Public Health strongly proposes to establish a pharmaceutical training academy that will deliver training to new graduates in Sub-Saharan Africa. Amongst other relevant training areas, the Academy will provide in-depth training on Good Pharmacovigilance Practice (GPvP), pharmaceutical recall regulations, guidelines and best practices, pharmaceutical risk and crisis management, reverse logistics operations, amongst others.
This will ensure sustainable availability of personnel who are confident in handling drug recalls and reverse logistics challenges. Bloom Public Health is actively working to engage relevant stakeholders and deploy strategic partnerships to achieve the establishment of this academy.
Conclusion
Drug recalls play a crucial role in protecting Africa’s public health sector. However, given the huge financial cost of drug recalls, it is essential that African pharmaceutical companies fully align with Good Manufacturing Practice (GMP) guidelines of their respective NMRAs to minimise the risk of product recalls.
To support this, Bloom Public Health has partnered the National Institute for Pharmaceutical Research and Development (NIPRD) in a World Bank-funded project to support Nigerian pharmaceutical manufacturing companies in the attainment of cGMP and WHO Prequalification (WHO PQ).
Anyakora is the CEO of Bloom Public Health and a public health expert &
Odibeli is a pharmacist and the regional communications manager at Bloom Public Health
