Imported Drugs Raise Safety Concerns: With an Unapproved Drug, You Can't Sure That It Has Been Shipped, Handled, and Stored under Conditions That Meet U.S. Requirements.

By Meadows, Michelle | FDA Consumer, September-October 2002 | Go to article overview

Imported Drugs Raise Safety Concerns: With an Unapproved Drug, You Can't Sure That It Has Been Shipped, Handled, and Stored under Conditions That Meet U.S. Requirements.


Meadows, Michelle, FDA Consumer


Selene Seguros Rios was 18 months old in 1999 when she received two injections of a pain and fever drug called Neo-Melubrina (dipyrone) in an illegal backroom clinic in Tustin, Calif. That was 20 years after the Food and Drug Administration had banned the drug in the United States because of potentially fatal side effects, including a drop in white blood cells that hampers the body's ability to fight off infections.

Selene died soon after the shots. Her death set off a crackdown in December 2000 on smuggling drugs from Mexico and selling them at swap meets, gift stores, clothing stores, meat markets and other retail establishments in Southern California.

"We've found drugs that were stored in tin containers and car trunks," says Daniel Hancz, Pharm.D., a pharmacist with the Health Authority Law Enforcement Task Force (HALT) in Los Angeles, an organization of police officers and other law enforcement personnel with special training in pharmaceuticals. HALT was launched as part of the crackdown, and task force members have confiscated a variety of prescription drugs being sold illegally.

Experts say the problem mirrors what goes on in nearby Mexico, where easy access to prescription drugs is common. Marv Shepherd, Ph.D., director of the Pharmacoeconomic Center at the University of Texas at Austin, places drugs available in Mexico into two categories. "Plenty of drugs that require a prescription in the United States--like antibiotics, cardiac drugs, and birth control pills--are available over the counter in Mexico," he says. "Then there are controlled substances like Valium, which you do need a prescription for in Mexico."

The FDA's Office of Criminal Investigations in Los Angeles has teamed with HALT to uncover major black market pharmacy rings selling Spanish-labeled pharmaceuticals. Ring members have been arrested and accused of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Local lawmakers have stiffened penalties, and many illegal pharmacies have been shut down. Other drug sellers have taken their businesses underground, moving from storefronts to private homes in an attempt to hide.

As in Selene's case, some criminals have falsely claimed to have a medical background and not only illegally sold drugs, but administered injections. Hancz says that HALT has seized prescription drugs found mostly in Latino, Asian, and Russian immigrant communities, where some undocumented immigrants, fearing that their immigration status may be discovered, have sought health care in back rooms. The U.S. Attorney's Office in the Central District of California has indicated that legitimate or state-licensed clinics exist where immigrants can be treated safely regardless of immigration status.

The list of safety risks is long, but the principal problems involve the use of prescription drugs without a physician's supervision, and the danger of buying drugs of unknown origin and quality. "I've seen eye medications that look like they're 20 years old," Hancz says. "The drugs could be old, contaminated, or counterfeit. And if you experience some kind of allergic reaction or other side effect, it's hard to trace the problem and treat it."

Whether you're searching for a cheaper price or dodging the doctor's office, the FDA warns against using unapproved drugs. And just because a drug is approved in a foreign country, that doesn't mean it's approved in the United States. Drug standards and regulations vary from country to country and the FDA is responsible only for those marketed and sold inside the United States.

Joe McCallion, a consumer safety officer in the FDA's Office of Regulatory Affairs, sums it up this way: "If you buy drugs that come from outside the U.S., the FDA doesn't know what you're getting, which means safety can't be assured."

Benefits of a Closed System

Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Imported Drugs Raise Safety Concerns: With an Unapproved Drug, You Can't Sure That It Has Been Shipped, Handled, and Stored under Conditions That Meet U.S. Requirements.
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.