Credit CDC
# 6339
An eye-opening report from The Lancet today, which indicates that a large percentage of the anti-malarial drugs used in Asia and sub-Saharan Africa are either fake, or are of inferior quality.
Ominously, using drugs that contain too little of their intended active ingredient can contribute to pathogens developing increased and widespread resistance over time.
The problem isn’t new, but is apparently more widespread than previously thought. The authors divided `Poor Quality’ drugs into three categories.
- Falsified (fraudulently manufactured with fake packaging and usually no or a wrong active pharmaceutical ingredient)
- Substandard (products resulting from poor manufacturing with no intent to deceive, usually with inadequate or too much active pharmaceutical ingredient);
- Degraded (good-quality drugs that are degraded by poor storage after leaving the factory)
Follow the link to the Lancet article (full access with free registration) is below.
Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa
Gaurvika ML Nayyar BS , Joel G Breman MD , Paul N Newton MRCP , James Herrington PhD
Summary
Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand—Cambodia border makes protection of the effectiveness of the drug supply imperative.
We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified.
A problem of longstanding, the CDC’s website has more on the problem of fake Malaria drugs, and what steps travelers should take if the must purchase medication abroad.
Counterfeit and Substandard Antimalarial Drugs
What Are They?
Counterfeit (fake) antimalarial or other drugs are deliberately made to look like brand name drugs. However, they may have no active ingredients, they may have less than the required amount of active ingredient, or they may contain ingredients which are not what is described on the package label. Counterfeiters tend to focus on the more expensive brands. Substandard drugs are found even among cheaper products, because some manufacturers try to avoid costly quality control and good manufacturing practices.
The quality of commercially available drugs varies greatly in malaria-endemic countries:
- The amount of the active ingredient can vary due to lack of regulations and poor quality control practices in many of these countries.
- Some pills may release very little if any drug due to poor formulation techniques.
- Chemical break-down of some drugs can occur due to poor storage conditions, especially in warm and humid tropical climates.
- Some drugs may be contaminated with other substances.
- Counterfeiters may also obtain expired drugs and repackage them with new expiration dates.
Where Do You Find Them?
Worldwide prevalence of counterfeit and substandard products is summarized in a Drug Quality Report matrix by the U.S. Pharmacopeia Drug Quality and Information (USP DQI) Program. Information on domestic (U.S.) issues regarding counterfeit and poor-quality drugs is provided by the U.S. Food and Drug Administration.
For example, in Cambodia in 1999, counterfeit antimalarial drugs were responsible for the deaths of at least 30 people. A 2001 survey in Southeast Asia showed that among 104 tablets presented as the antimalarial drug artesunate, 38% did not contain any artesunate.
When Buying Drugs, Take the Following Precautions
- Travelers should buy in their home country all the medicines they will need before their trip.
- Travelers should write down the drug's generic and brand names as well as the name of the manufacturer. In case they run out, they can look for the correct product.
- Make sure that the drug is in its original packaging.
- Inspect the packaging because many times poor quality printing indicates a counterfeited product.
- Be suspicious of tablets that have a peculiar odor, taste, or color, or that are extremely brittle
