Safety Concerns with Drugs Imported from Foreign Countries

Written by Brad Conley Pharm D Candidate, St. Louis College of Pharmacy

As reported by the FDA Consumer¹, several years ago Salena Rios was 18 months old and her family was illegal immigrants from Mexico that feared their alien status would be revealed if they sought healthcare at a hospital or clinic. For this reason Salena's family decided to have her treated in an illegal backroom clinic in Tustin, California. She was administered a drug known as Neo-Melubrina (dipyrone), which was previously banned in the United States because of a high risk for potentially fatal side effects, which include a drop in white blood cells that greatly reduces the body's ability to fight infections. She would soon die after complications from the illegal treatment given. Her death sparked a movement to stop the smuggling of drugs from Mexico that would be sold in retail establishments in Southern California.

The movement began with the development of the Health Authority Law Enforcement Task force located in Los Angeles, also known as HALT. HALT consisted of a collaboration of law enforcement officials that were specially trained in pharmaceuticals. Since its development, HALT has confiscated large amounts of prescription drugs being sold illegally. The success of HALT in the United States continues to remind of us the uncontrolled and unregulated access to prescription drugs from Mexico.

The use of imported drugs from foreign countries is accompanied by a long list of safety concerns. The primary problem is that prescription drugs are being used without the supervision of a doctor or other healthcare provider. There is also an immense danger in buying drugs of unknown origin and quality. The drugs could be old, expired, contaminated, or counterfeit in which it may have no active ingredient at all. Additionally, if you were to suffer an allergic reaction or other side effect with one of these medications, it would be very difficult determine the exact cause and therefore the best method to resolve the problem.

The Federal Food and Drug Administration (FDA)--the agency that tests and regulates drug products in the U.S. to ensure their safety and effectiveness--warns against the use of imported drugs if you are trying to get cheaper drug prices or avoid a doctor's office visit. Something else to keep in mind is that while a drug may be approved in a foreign country it may not be approved in the United States and in some cases may be banned in this country altogether. The bottom line is--if you buy drugs from foreign countries such as Canada or Mexico you do not completely know what you're getting and safety becomes as serious issue.

These imported drugs could present several problems such as:

• Quality Assurance Concerns: Medications that have not been approved for sale in the United States may not have been manufactured under strict quality assurance programs that can assure a safe and effective product.

• Counterfeit Potential: Some imported medications, even those that bear the U.S. brand name, in fact, are counterfeit versions, which are unsafe or even completely ineffective.

• Presence of Untested Substances: Imported medications and their ingredients, although legal in other countries, may not have been evaluated for safety and effectiveness in the United States. It is possible for these medications to contain dangerous substances.

• Risk of Unsupervised Use: Many medications, even those that may not be imported, are considered unsafe if not administered under the supervision of a trained healthcare professional. It may be necessary to have a medical evaluation to assure the drug is appropriate for you and your condition. It may also be necessary to have frequent medical checkups to make sure you are taking the medication properly, that it is working, and that you have not had any dangerous side effects.

• Labeling and Language Issues: Many imported drugs are labeled in a foreign language, which means potential side effects and directions for use cannot be read by the person using them. Often times these medications will make medical claims and suggest specific uses that have not been extensively studied.

• Lack of Information: Imported medications may be missing crucial information relating to quickly and correctly treating dangerous side effects.

It is important to know that acquiring medications from foreign countries may also be illegal. Under the Federal Food, Drug, and Cosmetic Act it is illegal to have interstate shipment of any prescription drug that lacks FDA approval. Interstate shipment would include importation of drugs into the United States from foreign countries.²

Mexico is not the only foreign country that consumers should be concerned with importing drugs from. There is a common misconception that drugs manufactured and sold in Canada are exactly the same as drugs sold in the United States and in some cases made in the same manufacturing plants. The FDA acknowledges that some may be while others are not.¹

The manufacturing facilities responsible for drugs to be sold to Canadians have been approved and registered with Health Canada's Health Products and Food Branch, which has similar functions to the FDA in the United States. However, the FDA does not have any jurisdiction to approve drugs sold in Canada. Another important aspect is that if a company in Canada is selling drugs only for export and not to Canadian citizens, then Health Canada may not regulate the company or the drugs they produce at all.

In many cases the drugs claiming to be coming from Canada can be coming from other foreign countries and just passing through Canada before they are sent to the United States. The FDA performed an investigation to examine many pharmaceuticals that were being imported into the United States allegedly from Canada. The FDA discovered that almost half of the imported drugs they had intercepted from four select countries were shipped to fill orders that consumers believed they were placing with Canadian pharmacies. The results of the investigation concluded that 85 percent actually came from 27 other countries around the globe. Additionally, numerous products were found to be counterfeit.³

The investigation was carried out in August 2005 in airports across the U.S. including JKF Airport in New York City, Miami International Airport, and Los Angeles International Airport. The FDA examined parcels that were suspected of containing pharmaceutical products sent from four countries including India, Israel, Costa Rica, and Vanuatu. It was previously noticed by the FDA that these were sources of drugs allegedly ordered from Canadian pharmacies. In total, 4,000 packages were examined, about 43 percent had been ordered from Canadian internet pharmacies and were claimed to be of Canada origin. However, only 15 percent of these packages actually were from Canada.³

The FDA is closely working with the Canadian drug regulatory and law enforcement agency to get these matters resolved. The FDA will continue to take courses of action to keep this from continuing so that counterfeit products are kept out of the U.S. drug supply. The agency will continue to take legal actions against those that violate the rules and regulations set forth regarding importation of drugs into the U.S.

In a nut shell, while it may be cheaper to purchase drugs from foreign online companies and doctor's office visits are avoided, it can be very dangerous. Many health conditions require proper monitoring of health related issues in addition to drug treatment. If the foreign medication is not up to the standards set forth here in the U.S. many health conditions that can be controlled easily may become fatal. While it may be appealing to purchase medications at cheaper cost, is it really worth the potentially serious side effects and sometimes fatalities that could result?

References:

1. Meadows M. Imported Drugs Raise Safety Concerns. FDA Consumer Magazine. 2002.
2. Importation of Prescription Medicines/Drugs. US Food and Drug Administration. Available at: http://www.fda.gov/ora/import/traveler_alert.htm. Accessed March 2008.
3. McDermott C. Many Canadian Drugs Really From Other Countries. FDA News. Available at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01277.html. Accessed March 2008.

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