The Impact of Fake Drugs on Public Health

In most cases, counterfeit drugs are not equivalent in safety, efficacy and quality to their genuine counterparts. Even if they are of the correct quality or contain the correct amount of active substance, their production and distribution are not within the control of the drug regulatory authority of the country concerned. This means that any associated defects and adverse reactions will not be easily recognized or monitored and, if needed, an effective product recall would not be possible.

So far counterfeit drugs that have been discovered have rarely been efficacious. In many cases they have been found to be without active ingredients, or with wrong ingredients or with incorrect quantities of active ingredients. The use of such drugs can prolong treatment periods as patients may not respond as quickly as they should and exacerbate conditions being treated. Treatment with ineffective counterfeit drugs such as antibiotics can lead to the emergence of resistant organisms and may have а deleterious effect on а wide section of the population. 1n extreme cases, counterfeit drugs may even cause death.

As а consequence of such damaging effects, counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities (DRAs). Incorrect labeling as to the source can also be detrimental to the reputation and financial standing of the original and/or current manufacturer whose name has been fraudulently used.

There is no simple solution or remedy that can be applied to eliminate counterfeit medicines nor can the problem be solved by an individual company or government. The problem has reached а global dimension and needs а global approach.

Health cost of counterfeiting

The cost of counterfeiting of pharmaceuticals cannot simply be analyzed in terms of cost implications. It is also vital that the health costs are considered, as counterfeit drugs are a serious threat to people’s health. Cases include antimalarial drugs containing no active ingredient, a meningitis vaccine made from tap water and contraceptive pills that consisted of nothing but wheat flour. These drugs can be dangerous, are not sterile, may be supplied in reused vials containing human material, and will give the patient a false sense of security in terms of treatment or immunity to disease. More serious cases of counterfeiting have been reported where drugs either intentionally or unintentionally contained toxic materials that proved to be lethal.

The cases highlighted below are in developing regions of Asia, Africa and South America. Counterfeiting in Africa tends to be more crude and on a larger scale, with drugs such as painkillers and antibiotics being common targets. This makes instances of counterfeiting easier to detect because crude copies are easier to recognize. In industrialized nations like the US and in Europe, counterfeiting tends to be more sophisticated and these drugs are often sold through the Internet, making it more difficult to police.

Dr Akunyili of Nigeria’s National Agency for Food and Drug Administration and Control has commented that in Nigeria fake drugs are implicated in kidney failure, liver damage, heart failure, and other organ dysfunctions, as well as in worsening of chronic disease conditions, such as hypertension. Additionally, patients receiving genuine antibiotics may fail to respond due to resistance induced from previously taken fake versions of the antibiotics. During the meningitis epidemic in the West Africa state of Niger in 1995 over 50,000 people were inoculated with fake vaccines containing only tap water, resulting in 2,500 deaths. This shipment was received as gift from the international community, via the WHO, in response to the epidemic.

In contrast to the industrialized nations, the drugs most often targeted by counterfeiters in developing countries are common prescription drugs, such as antibiotics, painkillers, antimalarials and HIV antivirals (TIME Asia Magazine, 06/04).

• Antibiotics (e.g. amoxicillin);
• Painkillers (e.g. acetaminophen);
• Antimalarials (e.g. Artensunate);
• HIV antivirals (e.g. Combivir, Epivir).