By Betha Igbinosun
This blog post was submitted as a contribution to the Tabula project, an international and comparative research collaboration carried out over the summer of 2021.
In 2003, Adebayo Alonge’s father purchased salbutamol, a drug to treat Alonge’s asthma, from a chemist in Ibadan, Nigeria. It turned out that the package was falsely labeled: instead of salbutamol, it contained fatal levels of diazepam. The drug put Alonge in a coma for three weeks.
In 2008, Hannah Ikem purchased a paracetamol-based syrup known as My Pikin Baby Teething Mixture for her seven-month-old son, who was experiencing teething-related discomfort. The medicine was counterfeit: instead of glycerin, a harmless additive, it contained diethylene glycol, a less-expensive, toxic industrial solvent often used as brake fluid. Her son died, as did 83 other Nigerian children who ingested the syrup.
In Togo, in 2016, Ayawo Hievi was diagnosed with malaria and typhoid, and he commenced taking the medicines prescribed by his doctor for treatment. After four days, he became worse, and two weeks later he needed to be hospitalized. An investigation revealed that the quinine and antibiotics used to treat him were fake. Hievi sustained chronic kidney failure and now needs regular dialysis.
Drug counterfeiting is a pervasive phenomenon that continues to plague health systems in Africa. A counterfeit drug is one “that has been deliberately or fraudulently mislabeled with respect to identity and/or source”; it might contain incorrect ingredients, falsely state the amount of its active ingredients (or omit them altogether), or be produced without quality control. Beyond the waste and expense incurred by the individuals and health systems that purchase them, counterfeit medicines are dangerous, with the potential to injure or even kill patients. The World Health Organization estimates that about 100,000 deaths per year in Africa are linked to the counterfeit drug trade.
In 2015, all United Nations member states adopted the 2030 Agenda for Sustainable Development, central to which are 17 Sustainable Development Goals (SDGs) that serve as a “blueprint to achieve a better and more sustainable future for all.” SDG number 3 is: “Ensure healthy lives and promote well-being for all at all ages,” and a global indicator framework adopted in 2017 for the SDGs expanded this to denote, among other indicators, universal health coverage, defined to include access to “safe, effective, quality and affordable essential medicines and vaccines for all.” This is clearly still just a dream, however, in many health systems within Africa.
Counterfeit drugs thrive in the absence of optimal regulation and governance; uncoordinated distribution and supply channels allow them to flourish. Public sector distribution is often directed through the Ministries of Health, but private sector distribution channels are not well defined and are difficult to track. Prescription drugs, many of which are counterfeit, are available for purchase in unregulated open markets, and in countries like Nigeria, medicines are openly sold on street corners and at kiosks by unlicensed drug vendors. Unethical practices are also extensive, and in cities across Africa, people working in obscure warehouses are engaged in the business of repackaging pharmaceuticals and tampering with expiry dates.
The most effective way to avoid counterfeit drugs is to purchase needed medication from approved pharmacies. Sustainable financing of medicines is lacking in many countries within the region, however, as extant National Health Insurance Schemes (NHIS) do not offer sufficient coverage for most of the population and, in any event, do not cover prescription medicines on an outpatient basis. As a result, many people pay for medicines and other healthcare services wholly out-of-pocket, with the monthly cost of medicines in most cases greater than the disposable income of patients. For example, a seven-day treatment course of ciprofloxacin antibiotic in Kenya can cost about a month’s income, and treating a child for malaria in Uganda with artemisinin combination therapy is estimated to cost the equivalent of 11 days’ wages. In general, out-of-pocket expenses for pharmaceuticals are especially burdensome for poorer populations.
In addition, since a significant number of the medicines used in the region are imported, local manufacturers often use active ingredients brought in from countries like India or China, making the cost of medicines susceptible to fluctuation in the exchange rate of currencies. It is noteworthy that this vulnerability was the impetus behind the decisions of countries like Brazil, China, India, and Bangladesh to develop their domestic pharmaceutical industries. Beyond importation costs, other domestic add-ons in the form of taxes and tariffs, as well as wholesale and retail margins, also impact the ultimate cost to patients. Governments within the region have failed to implement price controls, instead choosing to lean toward a free market regime. The resultant inability to afford medicines sold in licensed pharmacies has led people to patronize unlicensed street vendors and open drug markets, many of which sell adulterated medicines, for first-line treatment.
Although there have been calls to dismantle these open drug markets and prohibit the operations of street vendors, it is important to highlight that in many parts of Africa, these are often the only means by which the rural poor are able to access needed medicines. In this regard, the extant accredited drug-dispensing outlet (ADDO) program launched in the United Republic of Tanzania provides useful pointers. In Tanzania, most people rely on private drugstores (termed duka la dawa baridi, or DLDB) to access medicines. However, DLDB often sell prescription medicines illegally, stock low-quality drugs, and have inadequately trained staff. In 2003, the ADDO program was launched by the Tanzania Food and Drugs Authority, in collaboration with the Ministry of Health and Social Welfare, DLDB owners, and other stakeholders. The program focused on improving government oversight over the operations of DLDB through several interventions, including accreditation standards, a code of ethics, and other quality-control mechanisms established in consultation with government officials, medical officers, and DLDB owners. Capacity-building for DLDB owners was another essential feature of the program, fundamentally through trainings and credit assistance to enable them to meet accreditation standards.
In 2007, Tanzania’s NHIS integrated the ADDO program into its operations, and in 2010, an ADDO professional association was established to harmonize the operations of DLDB owners and enable the joint procurement of drugs to reduce purchase prices, among other things. By 2013, ADDOs were found in every region of the country, in both rural and urban areas, with the availability and quality of medicines continuing to improve. Though the political, legal, social, economic, and other factors in countries within the region may vary, the ADDO program presents a useful case study in improving access to quality medicines, especially for the rural poor.
Weak health information systems that inhibit effective communication and knowledge-sharing within the region, as well as the absence of sufficient infrastructure for drug traceability, also heighten the counterfeiting menace. In addressing the latter, technology has proved a viable solution for countries like Nigeria. In 2012, the Nigerian National Agency for Food and Drugs Administration introduced a Mobile Authentication Service (MAS) for use on antimalarial and antibiotic medicines to enable consumers to verify the authenticity of medicines at the point of purchase. Through the MAS, consumers can scratch off a panel on the packaging of a medication to reveal a unique, one-time use number. By texting this code to a toll-free number, the buyer can be notified whether the medication is genuine or a suspected fake. Technological devices such as this are undoubtedly helpful, but it is important to adapt their use to individuals who reside in rural areas, many of whom are illiterate farmers and petty traders.
Furthermore, more than 90 percent of fake drugs in Africa are attributable to international sources. In July 2020, for example, millions of counterfeit tablets from India, the majority of which were fake dexamethasone (a medicine thought to alleviate severe COVID-19 symptoms), and 920,000 of which were fake tramadol (an medication similar to an opioid), were confiscated by the Nigerian Customs Service. This indicates how essential it is to set up proper regulations and collaborations built on transparency and accountability at a broader international level. Moreover, to improve access to quality drugs and reduce the cost of medicines in Africa, there is a clear need to amplify the capacity for pharmaceutical research and development and local drug production within the region.
Other relevant factors contributing to the flourishing of counterfeit pharmaceuticals that need to be addressed include the lack of vigilance and advocacy by health care providers, the absence of political will, illegal drug importation, insufficient penalties for convicted drug counterfeiters, and low levels of health care financing. The establishment of National Medicines Regulatory Authorities tasked with ensuring that only safe, effective, quality medicines are imported or locally manufactured and distributed can be an important strategy in reducing access to and reliance on counterfeit medicines. Innovative regulatory strategies like that adopted under the ADDO program in Tanzania are also instructive. Ultimately, the inclusive and participatory approach utilized to secure the buy-in of DLDB owners and other stakeholders, as well as a supportive regulatory environment jointly operated to engender appropriate incentives for the supply of safe and effective medicines within the country, proffer useful lessons for other countries within the region.