Look Twice; How to Protect Yourself against Drug Tampering

By Cramer, Tom | FDA Consumer, October 1991 | Go to article overview

Look Twice; How to Protect Yourself against Drug Tampering


Cramer, Tom, FDA Consumer


Mom and dad taught you to look both ways before crossing the street, and now the Food and Drug Administration is urging you to look twice when you buy over-the-counter (OTC) drug products like cold medicines and pain relievers.

For nearly a decade, most of these products have been coming to us securely enclosed within sealed layers of plastic, tinfoil, and other forms of safety packaging, but FDA is growing concerned that all this "tamper-resistant" technology has made us just a little too complacent for our own good.

"People shouldn't be lulled into a false sense of security," said Daniel Michels, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research. "Just because you see that a product is safety sealed, don't assume you shouldn't examine the product carefully. No product is tamper-proof."

Michels, who has been involved in responding to tampering incidents, pointed out that any OTC drug product can be tampered with--no matter how many safety features it has. And it is this diturbing fact that has many FDA officials shying away from the term "tamper-resistant" when they discuss safety packaging, aaa embracing instead the term "tamper-evident."

Michels said the latter term is not only more accurate, but also sends a subtle message to consumers that they are ultimately responsible for their own safety.

That sobering point was driven home last February when two people in Washington state died shortly after swallowing 12-hour Sudafed capsules that had been laced with cyanide. Ironically, the tamperer did not do a particularly sophisticated job when penetrating Sudafed's various tamper-evident features, but apparently neither victim noticed anything suspicious.

"Sudafed offered state-of-the-art tamper-evident technology," said Michels. "And still the product was tampered with.

"The drug manufacturing industry, FDA, and the consumer need to work together as a team to prevent future tragedies like this. Consumer vigilance is perhaps the most important part of the whole equation."

Safety Issue Emerges

For years, most OTC drug products came in containers that were easy to open. Then, during the 1960s and 1970s, safety features began appearing on certain medicines to prevent children from accidentally poisoning themselves.

For the most part, however, safety was regarded as a side issue by many packagers. The emphasis remained on coming up with creative packaging that would attract the attention of consumers, not protect them from cold-blooded killers. Tampering wasn't unheard of, but it wasn't exactly a household word either.

All that changed abruptly in 1982 when seven Chicago-area residents died after swallowing cyanide-laced Tylenol capsules. Shortly after that tragedy, FDA issued regulations requiring certain OTC drugs and some other medical and cosmetic products to be marketed in tamper-resistant packaging.

Packaging Helps

FDA regulations require tamper-resistant packaging for certain OTC human drug products, cosmetic liquid oral hygiene products, vaginal products, and contact lens solutions and tablets.

Excluded from the regulations are products applied topically to the skin, dentifrices (such as toothpaste), insulin (which is usually kept behind the pharmacy counter), and lozenges (cough drops, for example). These items are not regulated because they are less vulnerable to tampering or, even if tampered with, would likely cause you considerably less injury than something that you swallow whole, inhale, insert, or use in your eyes.

A tamper-resistant package, according to FDA's regulations, "is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred."

Over-the-counter drugs must have at least one--and in some cases two--of these indicators or barriers. …

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

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

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.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

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 article

Look Twice; How to Protect Yourself against Drug Tampering
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?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now 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

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

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.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.