This summer in Ghana an antimalarial drug came under suspicion; presumably, this medication was counterfeit. After chemical analyses, the drug sold under the name “Coartem” confirmed these doubts, lacking any active ingredient. This incident exposes a threat that is not common in the United States, but wide-spread and under-addressed in the developing world. Counterfeit drugs pose a threat to public health on an individual level as well as an international scale and often bias the poor socio-economic classes. Although there are regulatory frameworks in place, further pursuit of imitation and ineffective drugs are necessary to decrease the incidence of malaria.
Counterfeit artesunate anti-malarial tablet with fake 'X-52' stamp as seen under UV light. From www.worldvisionreport.org
Counterfeit drugs pose a major barrier in combating malaria throughout much of the underdeveloped world. The most direct reason why fakes are dangerous is those persons relying on a drug for protection against malaria presume they are safe, often ignoring other pathways for protection. To make an analogy within another spectrum of public health- it’s like protecting yourself against pregnancy without using birth control pills because you’re already using a condom… with holes in it.
Counterfeit drug makers have also learned how to thwart the system by adding minimal levels of active ingredients so that quality-screening tests reveal a false-positive. Not only are these types of counterfeits ineffective at killing the parasite infection but they also increase the likelihood of mutation and resistance. Several studies have already indicated that the prevalence of counterfeit drugs has is induced some strains of malaria to become resistant (How? Some counterfeits do have small traces of the active ingredient, but not a heavy enough dose to kill the parasite completely. The strains that survive this ineffective dose may replicate and pass on their drug-resistant genome to all following progeny. Whatever doesn’t kill them makes them stronger…).
The prevalence of counterfeit drugs has increased over the past decade. At the end of the 20th century in southeast Asia, 38% of over-the-counter counterfeit artesunate tablets containing no active ingredient; in 2004 this percentage rose to 53%. In certain countries, mainly in Africa, over a half of the available medications are fake (compare this to developed nations, like the USA, where only 1% of all medications are counterfeit) . The WHO estimates that counterfeits contribute to nearly 200,000 preventable deaths each year from malaria.
A recent study conducted a quality assessment test of available antimalarials in six urban or rural setting of southeast Nigeria. Their findings? Thirty seven percent of the tested drugs did not meet USP standards. Furthermore, this study implied that drug quality in rural settings was significantly worse than in urban settings, where 66% of quinine medications were substandard as compared to 43%, respectively. The private and low-level providers observed in this study were predominantly used by low socio-economic status (SES) individuals. This suggests that the poor SES groups often receive the lowest quality of treatment, perpetuating a cycle of poverty in endemic areas.
To understand why this large discrepancy exists in a developing country and not developed countries, we must look at how these citizens go about obtaining their drugs and how this is different than the process in the USA.
A drug dealing holding a counterfeit medication. From NYTimes.com
A majority of malaria cases in Nigeria are usually treated by private providers, purchasing drugs through shops and/or peddlers – we’ll call this the “informal private sector.” These providers do not have to hold standards or requirements (the USA has the FDA to do this); this is where counterfeits or poor drugs are often obtained. But these vendors may not have any choice but to sell faulty products. It is the drug makers who ultimately receive the most economic incentive to fudge-up their product. Medicine has relatively high production costs and when legislation (or a lack thereof) provides minimal penalties, counterfeiters are given an economic incentive to produce fakes. The providers, whether it be vendors or pharmacists, often lack awareness of the existence and/or consequence of counterfeits. The peddlers are victim to competition; they have to buy the cheapest drug marketed to them to stay in business. Public providers, such as pharmacies or retail outlets, may also have pitfalls in dispensing the correct medication. Their gaps in quality assurance result from the lack of quality control during manufacture and faulty storage environments.
There is some framework to catch these counterfeits – the U.S. Pharmacopeial (USP) Convention is a nonprofit scientific organization who develops international standards for medicine quality. They have been supported by USAID to create a Drug Quality and Information (DQI) program for developing countries to ‘verify, assure, and improve the quality of medicines intended to treat life-threatening neglected diseases.’ The recent seizure of the Ghanaian counterfeits strengthens the USP’s DQI reputation as a way to regulate fake drugs, yet the statistics prove there is a lot of ground to make up .
Other movements throughout the world are also effective in combating the market of counterfeit drugs. In China, collaboration between public health advocates, scientists, and law regulators has developed a technique called forensic palynology to track down the location of manufacture. They study the chemical makeup of the pollen contaminants in the medicine; in their studies, some of the pollen had traces of the mineral calcite which is commonly mined in southern China. This lead brought officials to a suspect in the Yunnan Province of China, eventually seizing over 24,000 doses of fake medications in 2008.
Where can we move from here? A report published in the PLoS Medicine Journal suggests ways to decrease the prevalence of counterfeit drugs. It sets out some goals; 1) the provision of effective, available, and inexpensive drugs, 2) effective drug regulatory networks, 3) openness of governments on the severity of counterfeit drug prevalence (many governments have often denied the problem), 4) cooperation between countries where counterfeit drugs are crossing borders, and 5) improved education of patients, drug sellers, and health workers. It is quite obvious from these suggestions that we cannot rely on developing nations to individually attack or pursue fraudulent manufacturers. Instead, the drug regulation and standardization process must be the responsibility of non-governmental industry manufacturers, governments, and the international community. Ultimately, if counterfeits induce drug resistance, the mutant malaria strain does not discriminate and will cross country borders whenever given the chance. By that time, the infection will be more than a local or national issue, but a looming threat to the international community.
References:
http://www.eurekalert.org/pub_releases/2009-07/up-cad072209.php
http://www.sciencedaily.com/releases/2006/06/060619005440.htm
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3115
http://www.malariajournal.com/content/8/1/22
http://www.sciencedaily.com/releases/2008/02/080212085828.htm
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020100#s1
