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Chapter 2The Pre-Travel ConsultationCounseling & Advice for Travelers

Perspectives: Pharmaceutical Quality & Counterfeit Drugs

Michael D. Green

GENERAL INFORMATION

Counterfeit and substandard drugs are an international problem contributing to illness, death, toxicity, and drug resistance. A counterfeit drug is a compound that is not made by an authorized manufacturer but is presented to the consumer as if it were. Both the packaging and pill construction of counterfeit drugs are often virtually identical to the authentic medication. Substandard drugs are medicines made by a licensed manufacturer but fail to comply with pharmaceutical regulatory standards. These drugs may not contain the proper proportion of ingredients and are consequently less effective or may cause an adverse reaction. Regulatory agencies in the United States, such as the Food and Drug Administration (FDA), protect citizens from products that are inherently unsafe. In developing countries, regulatory controls are much less effective or even nonexistent, leading to conditions that allow proliferation of counterfeit and substandard drugs. Overall, global estimates of drug counterfeiting are ambiguous, depending on region, but proportions range from 1% of sales in developed countries to >10% in developing countries. In specific regions in Africa, Asia, and Latin America, chances of purchasing a counterfeit drug may be >30%.

Since counterfeit drugs are not made by the legitimate manufacturer and are produced under unlawful circumstances, toxic contaminants or lack of proper ingredients may result in serious harm. For example, the active pharmaceutical ingredient may be completely lacking, present in small quantities, or substituted by a less-effective compound. In addition, the wrong inactive ingredients (excipients) can contribute to poor drug dissolution and bioavailability. As a result, a patient may not respond to treatment or may have adverse reactions to unknown substituted or toxic ingredients.

Before international departure, travel health providers should alert travelers to the dangers of counterfeit and substandard drugs and provide suggestions on how to avoid them.

HOW TO AVOID COUNTERFEIT DRUGS WHEN TRAVELING

The best way to avoid counterfeit drugs is to reduce the need to purchase medications abroad. Anticipated amounts of medications for chronic conditions (such as hypertension, sinusitis, arthritis, and hay fever); medications for gastroenteritis (travelers’ diarrhea); and prophylactic medications for infectious diseases (such as malaria) should all be purchased before traveling.

Before departure, travelers should do the following:

  • Purchase all medicines needed for the trip in advance. Prescriptions written in the United States usually cannot be filled overseas, and over-the-counter medicines may not be available in many foreign countries. Checked baggage can get lost; therefore, travelers should pack as much as possible in a carry-on bag and bring extra medicine in case of travel delays.
  • Make sure medicines are in their original containers. If the drug is a prescription, the patient’s name and dose regimen should be on the container.
  • Bring the “patient prescription information” sheet. This sheet provides information on common generic and brand names, use, side effects, precautions, and drug interactions.

If travelers run out and require additional medications, they should take steps to ensure the medicines they buy are safe:

  • Purchase medicines from a legitimate pharmacy. Patients should not buy from open markets, street vendors, or suspicious-looking pharmacies; they should request a receipt when making the purchase. The US embassy may be able to help find a legitimate pharmacy in the area.
  • Do not buy medicines that are substantially cheaper than the typical price. Although generics are usually less expensive, many counterfeited brand names are sold at prices substantially below the normal price for that particular brand.
  • Make sure the medicines are in their original packages or containers. If travelers receive medicines as loose tablets or capsules supplied in a plastic bag or envelope, they should ask the pharmacist to see the container from which the medicine was originally dispensed. The traveler should record the brand, batch number, and expiration date. Sometimes a wary consumer will prompt the seller into supplying quality medicine.
  • Be familiar with medications. The size, shape, color, and taste of counterfeit medicines may be different from the authentic. Discoloration, splits, cracks, spots, and stickiness of the tablets or capsules are indications of a possible counterfeit. Travelers should keep examples of authentic medications to compare if they purchase the same brand.
  • Be familiar with the packaging. Different color inks, poor-quality print or packaging material, and misspelled words are clues to counterfeit drugs. Travelers should keep an example of packaging for comparison, and observe the expiration date to make sure the medicine has not expired.

USEFUL WEBSITES

General Information about Counterfeit Drugs

Traveling and Customs Guidelines

Researching what travelers can pack and bring back into the United States, especially for travelers with disabilities and medical conditions, is helpful in preparing for travel.

Reporting Counterfeit Cases

BIBLIOGRAPHY

  1. Bate R, Jin GZ, Mathur A. Does price reveal poor-quality drugs? Evidence from 17 countries. J Health Econ. 2011 Dec;30(6):1150–63.
  2. Nayyar GM, Breman JG, Newton PN, Herrington J. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis. 2012 Jun;12(6):488–96.
  3. Newton P, Fernandez F, Green M. Counterfeit and substandard antimalarial drugs. In: Schlagenhauf-Lawlor P, editor. Travelers’ Malaria. 2nd ed. Hamilton, ON: BC Decker; 2008. p. 331–42.
  4. Newton PN, Green MD, Fernandez FM, Day NP, White NJ. Counterfeit anti-infective drugs. Lancet Infect Dis. 2006 Sep;6(9):602–13.
  5. World Health Organization. Medicines: counterfeit medicines [fact sheet no. 275]. Geneva: World Health Organization; 2012 [cited 2012 Sep 18]. Available from: http://www.who.int/mediacentre/factsheets/fs275/en/.
 
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