The dangers of counterfeit anti-infectives

The impact of counterfeit anti-infectives is highlighted in an upcoming article in The Lancet Infectious Diseases. This article underscores the fact that the increasingly widespread production and distribution of counterfeit drugs is a growing problem, causing significant morbidity and mortality, an increase in drug resistance and toxicity, and reducing the effectiveness of healthcare provision. The fake drugs often closely resemble legitimate drugs yet may contain only inactive, incorrect, sub-potent or super-potent ingredients, improper dosages, or contaminations. Worryingly, the World Health Organisation (WHO) estimates that up to 10% of medicines worldwide are counterfeit.

However, the true extent of the problem is difficult to ascertain: the production of counterfeit medicines, anti-infectives in particular, is more prevalent in poorer, developing countries, especially Africa and . Anti-malarials are the most widely taken anti-infective drugs in tropical countries and, therefore, are an obvious target for counterfeiters.

In fact, recent reports have indicated that eight of the 12 major anti-malarials are being counterfeited. One study found that 38% of anti-malarial drugs for sale in pharmacies in did not contain any active ingredients, causing numerous preventable deaths from the disease.

In addition, counterfeit mefloquine and artesunate, two more expensive anti-malaria drugs, were first noticed in in 1998, where artesunate preparations contained 6% chloroquine but no artesunate, while mefloquine-labeled pills contained sulphadoxine-pyrimethamine but no mefloquine. Neither replacement compound is effective in this region.

Another aspect of drug fakes is the mix of potentially toxic ingredients or pathogenic contaminants, making counterfeits a huge safety concern. The imitations may cause serious side effects, possibly even death, as well as fail to treat or prevent the actual condition they are sold for. In addition, anti-infective medicines containing sub-therapeutic amounts of the active ingredient increase the risk of spreading drug resistance.

Use of counterfeits can also have a huge commercial and financial impact on companies producing the genuine drugs: analysts estimate the cost of counterfeit drugs to the pharmaceutical industry to approach $40 billion per year. Furthermore health-related adverse effects of counterfeits can damage the reputation of the brand/company enormously, such that patients lose confidence in the legitimate product and switch to different brands.  

Unfortunately, drug faking has a long history, showing the difficulties involved in tackling the issue. Regulatory authorities in the West have proposed high-tech solutions such as radio tagging and barcoding each packet, but such measures are of limited use in environments with a less developed infrastructure.

Instead, increased patient awareness, inexpensive genuine medicines, political support for domestic drug regulatory authorities, vigorous law enforcement, and more international cooperation with determined political leadership in countries with a high prevalence of counterfeit drugs are the measures proposed by the authors of the Lancet article.

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