People seek treatment for malaria from public sector facilities and a range of formal and informal private sector facilities [1, 2]. Around 60% of all malaria episodes in sub-Saharan Africa (SSA) are initially treated by private providers, mainly through the purchase of drugs from shops and drug peddlers [1]. The "informal private sector", such as patent medicine dealers, is a main source of anti-malarial drugs [3, 4], but the quality of treatment that they provide is suspect [1]. However, these treatments are often inconsistent with national treatment guidelines: they may include counterfeit drugs, drugs of poor quality, as well as incorrect dosing and irrational prescription practices [4]. A counterfeit formulation is one that is "deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeits may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging" [5]
Drug quality in public and private outlets may be problematic. A previous study in Nigeria assessed the quality of drugs from retail outlets and pharmacies, and attributed problems to a lack of quality control in manufacture and degradation during storage [6].
A major problem with the treatment of malaria is the high level of treatment failures resulting in the large part from the high prevalence of counterfeit drugs bought by the patients [7–9]. Anti-malarials, are among the most widely consumed drugs in tropical countries that have been particularly targeted by counterfeiters and of the 12 anti-malarial drugs used in the world today, eight have been counterfeited [7]. Published estimates of the global prevalence of counterfeit drugs range from 1% to 50% and there is evidence of 206 cases of counterfeit anti-infectives from 38 countries [8]. The widespread prevalence of counterfeit anti-malarials is of great public health concern [7, 8]. Also, lack of knowledge of counterfeits and appropriate preventive measures, together with poor dissemination of information among health workers and the public, make their detection difficult [8].
Although the official treatment policy has been changed as per WHO recommendations to the use of artemisinin-based combination therapy (ACT) as first-line treatment for malaria in Nigeria, the reality on the ground is the continued production, deployment and use of monotherapies, such as chloroquine (CQ), sulphadoxine-pyrimethamine (SP), quinine (QU), artesunate and dihydroartemisinin, in both public and private facilities, especially by patent medicine dealers (vendors) in Nigeria and other African countries. Artemisinin monotherapy remains common in Africa [9]. Researchers have evaluated the quality of CQ, quinine, SP, amodiaquine and proguanil formulations sold in the market in various parts of Africa, including eastern part of Congo DR and Kenya [10–12]. Good quality anti-malarial drugs are often misused in treating malaria because of under-dosing and poor adherence, which could lead to treatment failures and development of drug resistance. The use of counterfeit or substandard monotherapies further endangers malaria chemotherapy.
There is paucity of information about the quality of anti-malarials in many sub-Saharan African (SSA) countries, such as Nigeria. Most of the evidence about quality of anti-malarials has come from South-East Asia. However, in a six-country study that highlighted the availability and relative quality of anti-malarials in Africa's private sector, found that over 35% (73/210) of tested samples were substandard [9]. In Nigeria, 36% of sampled anti-infectives contained quantities of active ingredients outside pharmacopoeial limits [6, 8]. Also, from a random sample of 5% (n = 581) of Nigerian pharmacies, 48% of anti-infectives contained active ingredients outside pharmacopoieal limits [6, 8]. In some cases, the drugs may contain more of the stated active ingredients, which could lead to adverse events as was found in Nigeria where 94 of 160 (59%) of anti-malarials tested contained 110% or more of the stated active ingredients [8, 13].
There is little existing knowledge about actual quality of drugs provided by different providers in Nigeria and in many SSA countries. A search of the medical literature yielded only 43 primary published research reports concerning counterfeit drugs in the world [8]. Some researchers found 21 peer-reviewed articles and three reports on the quality of anti-malarial drugs in Africa [14]. Failing products more often originated or were claimed to originate from poorer parts of the world with weaker regulatory systems [9]. The critical finding by some researchers was that most anti-malarial drugs pass the basic tests for pharmaceutical dosage forms such as the uniformity of weight for tablets and the content test, but that in vitro product dissolution is the main problem [12, 14].
Over the past decade, the massive public health problem of counterfeit and substandard drugs has become more manifest, leading to serious clinical consequences to patients, such as increased morbidity, mortality, and drug resistance, which leads to spurious reporting of resistance and toxicity and loss of confidence in healthcare systems [8, 15, 16]. Other studies looking at a broader range of diseases in Nigeria found widespread inappropriate drug use, low quality of treatment, and ineffective regulation [17–21].
The information generated by this study will help design policy measures to strengthen the treatment component of the malaria control strategy. Such information is especially important for improving malaria treatment, especially in light of the change of first-line drug to ACT in the country. The information will also lead to the development and implementation of targeted actions designed to remedy problems found with respect to quality of treatment. These remedial actions could include improved training of public and private sector providers, strengthened regulation, and consumer education.