Tuesday, April 21, 2015

AJTMH/NIH: The Threat From Fake & Substandard Pharmaceuticals



# 9964


A topic we’ve touched on in the past, and coincidentally mentioned last Saturday (see Early Signs Of Artemisinin-Resistant Malaria In Africa), is the proliferation of fake or substandard pharmaceuticals around the globe; everything from antimalarials, to antibiotics, to chemotherapy agents.


Three years ago, in Interpol & FDA: Operation Pangea V, we looked at a consortium of 100 nations engaged in a crackdown on illegal pharmaceutical sales via the Internet. That marked the fifth year that Operation Pangea has been run, and according to Interpol, thousands of illegal websites have been targeted.


Some of these drugs may have none of the promised active ingredients, while others may be less potent than advertised, or are laced with potentially dangerous substitutes or fillers. Often more money is spent trying to duplicate the packaging of a legitimate product, than is spent producing the medicine itself.


And the end result can not only be tragic for the user – but also to society – as using substandard medicines is one of the ways that drug resistant bacteria, viruses, and parasites can be created and spread.


Yesterday the NIH, in concert with the publication of a series of reports in the AJTMH (The American Journal of Tropical Medicine and Hygiene), released the following statement.


For Immediate Release: Monday, April 20, 2015

Global pandemic of fake medicines poses urgent risk, scientists say

Poor quality medicines are a real and urgent threat that could undermine decades of successful efforts to combat HIV/AIDS, malaria and tuberculosis, according to the editors of a collection of journal articles published today. Scientists report up to 41 percent of specimens failed to meet quality standards in global studies of about 17,000 drug samples. Among the collection is an article describing the discovery of falsified and substandard malaria drugs that caused an estimated 122,350 deaths in African children in 2013. Other studies identified poor quality antibiotics, which may harm health and increase antimicrobial resistance. However, new methodologies are being developed to detect problem drugs at the point of purchase and show some promise, scientists say.

Seventeen articles in all, detailing various aspects of the issue and proposing possible solutions, are included in a special journal supplement “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” published online ahead of print by The American Journal of Tropical Medicine and Hygiene. Several articles suggest policy interventions, including an international framework and the adoption of stricter national laws against drug counterfeiting.

“This problem continues to spread globally, creating an even greater challenge to cooperation among stakeholders, many with limited resources,” noted the supplement’s co-editor, Joel Breman, M.D., M.P.H., senior scientist emeritus at the National Institutes of Health’s Fogarty International Center. “The need is urgent for collaboration among those with expertise in policy, science, technology, surveillance, epidemiology and logistics, in order to secure global supply chains.”


An urgent and coordinated international response is required to address the pandemic of poor quality drugs, the scientists maintain. Policy proposals include a global agreement, similar to the Framework Convention on Tobacco Control External Web Site Policy, and stricter national laws to prosecute those who knowingly sell counterfeit medicines.

In addition to Fogarty, the supplement is sponsored by the Bill and Melinda Gates Foundation and the New Venture Fund.

The individual articles will be published online at: http://www.ajtmh.org/content/early/recent External Web Site Policy

(Continue . . . )


While bogus medicines – devoid of any therapeutic benefit - have been reported around the globe, researchers at the London School of Hygiene & Tropical Medicine analyzed 2,028 antimalarials from Tanzania and Cambodia and found that while as many as  31% were substandard, none sampled were completely fake.

From another related press release (Fake malaria drugs not as common as previously reported) we get the following summations:


Dr Harparkash Kaur from the London School of Hygiene & Tropical Medicine, lead investigator of the drug quality programme of the ACT Consortium, said: "Although there have been alarming reports about the prevalence of fake antimalarials, our study provides ample data showing that the quality of drugs is not so bad based on comprehensive sampling and analysis presented here. This type of study is very cost intensive, both for the purchase and analysis of drugs. The lack of falsified medicines in Cambodia and Tanzania are reassuring, but the presence of substandard medicines is definitely a concern."

Dr Shunmay Yeung from the London School of Hygiene & Tropical Medicine, lead author of the study in Cambodia - one of the epicentres of resistance to artemisinin - said: "Falsified medicines have received much attention globally, but substandard drugs are far more prevalent and of great concern. Not only do they leave patients with malaria undertreated, which could be fatal, but they may also contribute to the development of resistance to ACTs, the most effective drugs for malaria. Generally, the fact that no falsified antimalarials were identified reflects the positive impact of the country's effort to control drug quality."

But whether wholly bogus, adulterated, or simply substandard – these counterfeit medications represent a serious threat to global health.


Unless you are buying your prescription drugs from an unscrupulous online pharmacy, Americans are most likely to encounter these fake or substandard medications while traveling to developing countries.  The CDC’s Traveler’s Health website offers the following advice.


Counterfeit Drugs

Bottle of pills

Counterfeit (or fake) medicines are manufactured using incorrect or harmful ingredients. These medicines are then packaged and labeled to look like real brand-name and generic drugs. Counterfeit medicines are unsafe because they may not be effective or may even harm you.

Counterfeiting occurs throughout the world, but it is most common in countries where there are few or no rules about making drugs. An estimated 10%–30% of medicines sold in developing countries are counterfeit. In the industrialized world (countries such as the United States, Australia, Japan, Canada, New Zealand, and those in the European Union), estimates suggest that less than 1% of medicines sold are counterfeit.

The only way to know if a drug is counterfeit is through chemical analysis done in a laboratory. Counterfeit drugs may look strange or be in poor-quality packaging, but they often seem identical to the real thing. The only way to make sure you have the real thing is to bring all the drugs you will need during your trip with you from the United States, rather than buying them while you are traveling.

Pills being manufactured

If an emergency occurs and you must buy drugs during your trip, you can reduce your chances of buying drugs that are counterfeit:

  • Buy medicines only from licensed pharmacies and get a receipt. Do not buy medicines from open markets.
  • Ask the pharmacist whether the drug has the same active ingredient as the one that you were taking.
  • Make sure that the medicine is in its original packaging.
  • Look closely at the packaging. Sometimes poor-quality printing or otherwise strange-looking packaging will indicate a counterfeit product.
  • If you buy drugs online, visit Buying Prescription Medicines Online: A Consumer Safety Guide to learn how to buy safely.

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