(Page 4 of 4)

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.

Antidotes

If you suspect childhood poisoning, call the nearest poison control center or your physician first, and follow their instructions precisely.

To induce vomiting in case of accidental poisoning, experts recommend keeping on hand syrup of ipecac — safely stored away from children, of course! Syrup of ipecac induces vomiting, thus ridding the body of the swallowed poison. It usually works within a half-hour of ingestion.

Some medical experts also recommend that parents keep activated charcoal on hand as well: You may have to ask your druggist for it, because it may not be on store shelves. Although some poison control experts recommend having activated charcoal on hand, there is a difference of opinion on its use by consumers. The U.S. Consumer Product Safety Commission, for example, does not recommend that consumers use activated charcoal because it is less palatable to young children.

Activated charcoal (or charcoal treated with substances that increase its absorption abilities) absorbs poison, preventing it from spreading throughout the body. One advantage of activated charcoal is that it can be effective for a considerable time after the poison is swallowed. But activated charcoal should never be used at the same time you administer syrup of ipecac: The charcoal will absorb the ipecac.

For children ages 1 to 12, give one tablespoon of syrup of ipecac followed by one or two glasses of water. Children ages 12 and over should get two tablespoons, followed by one or two glasses of water.

Activated charcoal is usually found in drugstores in liquid form in 30-gram doses. For children under 5, give one gram per every two pounds of body weight. Older children and adults may require much higher doses.

Both antidotes should only be used on conscious poison victims; an unconscious victim should always be treated by professionals.

"Remember to call your local poison control center first before giving your child any at-home antidote," says Robert Mueller, poison information specialist at the Virginia Poison Center in Richmond, Va.

Tags: Pediatrics

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.