Counterfeit and Substandard Antimalarial Drugs

What are counterfeit and substandard antimalarial drugs, and why are they important to public health?

Counterfeit (fake) and substandard antimalarial drugs  may contain no active ingredients, less than the required amount of active ingredients, or ingredients not described on the package label. Manufacturers of counterfeit drugs tend to copy more expensive brands of drugs and make them look like brand-name drugs. They may also repackage expired products and substitute a later expiration date, or they may package another drug or alternative substance as if it were an active product. Substandard drugs are made by manufacturers trying to avoid costly quality control and good manufacturing practices; these can result from deliberate or unintended lapses in the manufacturing process. These medicines may have too little or too much of the active ingredients and may not be absorbed properly by the body. If they are taken to treat an illness like malaria, they may be incompletely effective or altogether useless. A counterfeit or substandard treatment can prolong illness and increase the risk of severe disease or death. If substandard medicines are widely used, they can also select for drug-resistant parasites.

Where can they be found?

They can be found anywhere, but they are especially prevalent in developing countries lacking effective drug regulatory agencies as well as resources required to effectively evaluate drug quality or enforce drug quality regulations.

What types of antimalarial drug quality issues can be found?

• Drugs with too little, too much, or absolutely no active ingredient, due to intentional fraud or poor manufacturing and quality control practice.
• A tablet’s inability to release drug, due to poor formulation techniques.
• Chemical breakdown of drugs caused by storage conditions, especially in warm, humid climates.
• Contamination with other substances due to poor manufacturing procedures.
• Incomplete, inaccurate or misleading packaging and labeling.

How can I avoid buying counterfeit or substandard antimalarial drugs to prevent malaria when I travel to an area with malaria transmission?

• Buy the antimalarial drugs you need in your home country and keep the original packaging.
• Write down the drug's generic and brand names as well as the name of the manufacturer so in case you run out, you can look for the correct product.
• If you need to purchase medicine in the country you are visiting, inspect and compare the packaging of the medicine available for sale in that country with the original. Many times poor quality printing or paper indicates a counterfeited product.
• Be suspicious of tablets that have a peculiar odor, taste, or color, or ones that are extremely brittle. Ill-defined imprints on the tablet may indicate a counterfeit.

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.
• 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 false or missing expiration dates.

What are countries with malaria transmission doing about this problem?

With help from the Global Fund to Fight HIV/ AIDS, Tuberculosis and Malaria, the U.S. Agency for International Development, the U.S. Pharmacopeia (USP), and CDC, countries are improving their capacity to monitor the appearance of counterfeit drugs and to execute their regulatory functions.

How is CDC (or CDC and its partners) addressing this issue?

CDC is currently collaborating with the London School of Hygiene and Tropical Medicine and the Georgia Institute of Technology on a project surveying and evaluating the quality of ACTs in Africa. CDC is also working with the U.S. Food and Drug Administration and Georgia Institute of Technology to evaluate new techniques to quickly identify counterfeit medicines. We are also assisting our collaborators in Kenya, Tanzania, the Lao People’s Democratic Republic and Burma by collecting samples and performing chemical analysis of suspect pharmaceuticals.

More on: FDA.gov: Counterfeit Medicine

More on: WHO: General Information on Counterfeit Medicines

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