According to a study published in the Journal of Pharmaceutical Policy and Practice, an estimated 1 in 5 medicines in Africa is either substandard or falsified. The paper also estimates that 34.2% of medicines sold in the region are unregistered/unlicensed.
Though still high, this figure demonstrates an improved outlook for the continent, as it is lower than the estimate highlighted by the World Health Organization (WHO) in 2018, which approximated that 2 in 3 medicines sold in Africa were either substandard or counterfeit.
Substandard medicines are licensed products that fail to meet their quality standards and/or specification while falsified medicines are those that purposefully or fraudulently misrepresents their origin, identity, or composition.
Unregistered are medicines that are sold, distributed, or used in a market without first being evaluated and/or approved by a national or regional regulatory authority.
Impact of substandard, counterfeit and unregistered medicines can be profound.
From treatment failure, increased length of hospital stays, high healthcare costs, antimicrobial resistance to even death.
The study, a systematic review of articles published between April 2014 and March 2024, found that antibiotics were the most frequently falsified and substandard in Africa, holding a prevalence rate of 44%.
With amoxicillin being the antibiotic experiencing the highest rates of counterfeiting or being out of specification.
Other classes of medicines commonly affected in Africa included antimalarials and antihypertensive medicines.
According to the study, after antibiotics, substandard or falsified antimalarials had the second highest prevalence in Africa at 15.6%. This was attributed to the high prevalence of malaria in the region.
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Research carried out in ten African nations (Benin, Burkina Faso, Congo-Brazzaville, DRC, Niger, Senegal, Togo, Côte d’Ivoire, Guinea, and Mauritania) revealed that as much as 16.3% of the cases involved substandard or counterfeit antihypertensive medications.
The authors noted that unregistered medicines were more likely to be substandard or falsified compared to legally licensed products. From their results, unregistered products experienced a higher “failure rate” (48.2%), significantly less than properly licensed medicines (6.6%).
The study also showed that imported medicines had higher rates of substandard quality and counterfeiting compared to locally manufactured products.
Additionally, the paper highlighted several reasons why substandard, falsified, and unregistered medicines are more prevalent in African countries than other parts of the world, including:
- Lack of strong and effective drug regulatory authorities.
- High cost of medicines.
- Lack of effective collaboration between national, regional, and global stakeholders.
- Local companies are not achieving GMP compliance.
The authors concluded by stating that sensitization of health professionals and other stakeholders is a key strategy in the fight against unregistered, substandard, and falsified medicines.
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Source: Journal of Pharmaceutical Policy and Practice.
