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Preventing Accidental Poisoning

by Audrey T. Hingley

Audrey T. Hingley is a writer in Mechanicsville, Va.

Protect Yourself Against Tampering

With FDA's new proposed regulations regarding packaging of high-dose, iron-containing pills in mind, it's important to remember that no packaging or warnings can protect without your involvement. Nonprescription OTC drugs sold in the United States are among the most safely packaged consumer products in the world, but "child-resistant" and "tamper-resistant" do not mean "childproof" and "tamperproof." FDA adopted "tamper-resistant" packaging requirements after seven people in the Chicago area died from taking cyanide-laced Extra-Strength Tylenol capsules in 1982. Although the product met all FDA requirements at the time, it wasn't designed so tampering would leave visible evidence. FDA swiftly enacted new regulations requiring most OTC drug products to be packaged in "tamper-resistant" packaging, defined as "packaging having an indicator or barrier to entry that could reasonably be expected to provide visible evidence that tampering had occurred," and required OTC product labeling to alert consumers to tamper-resistant packaging. In 1989, FDA regulations were amended to require two-piece hard gelatin capsules to be packaged using at least two tamper-resistant features unless sealed with a tamper-resistant technology.

"Consumer vigilance is part of the equation," says Lana Ragazinsky, consumer safety officer with FDA's Center for Drug Evaluation and Research, division of drug quality evaluation, office of compliance. "The consumer is being led into a false sense of security because they see 'tamper-resistant'... 'tamper evident' means you, the consumer, need to look for evidence of tampering." FDA has proposed changing the term "tamper-resistant" to "tamper-evident" to underscore the fact that no package design is tamperproof. The most important tool to detect tampering is you! Here are a few tips to help protect against tampering:

  • Read the label. OTC medicines with tamper-evident packages tell you what seals and features to look for.

  • Inspect the outer packaging before you buy.

  • Inspect the medicine when you open the package, and look again before you take it. If it looks suspicious: be suspicious.

  • Look for capsules or tablets different in any way from others in the package.

  • Don't use any medicine from a package with cuts, tears, slices, or other imperfections.

  • Never take medicine in the dark. Read the label and look at the medicine every time you take a dose.


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