How to Protect Yourself Against Drug Tampering : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Alert and Aware

But while FDA laid down the law concerning tamper-resistant features, its regulations stress that these features cannot prevent tampering; they simply help to alert the consumer if tampering has occurred.

"It's very important that there be some consumer vigilance," said FDA Commissioner David Kessler, M.D. "I don't want people to have a false sense of confidence.

"In the instance of the 12-hour Sudafed capsule, there were three barriers," said Kessler. "The safety tab on the carton, the blister pack with its tinfoil backing, and the capsule itself, which was safety banded. [A blue band sealed the halves of each Sudafed capsule together.] All we're asking is that consumers look twice before they take any product."

Said Bradley: "The Sudafed 12-hour, tamper-resistant packaging did all that it was supposed to do. Its tamper-resistant packaging was violated in a way that left evidence to the naked eye."

Not only was Sudafed's packaging violated, but the tainted capsules themselves looked different than the other capsules in the tampered blister packs:

• They did not have Sudafed's characteristic blue safety band.
• They did not have the company logo or product name printed on them.
• They contained a yellowish powder instead of the familiar white time-release beads.
• And, finally, the tinfoil that secures each capsule in its individual "blister" had been obviously cut.

"In today's environment, unfortunately, a crude product tampering can go undetected," said Bradley. "If the public does not look at OTC packaging, then no amount of tamper-resistant packaging, in and of itself, can protect the public."

The disturbing fact is that a determined tamperer simply cannot be stopped, according to Richard Swanson, director of FDA's Division of Emergency and Epidemiological Operations.

"We aren't going to be able to stop the person who wants to kill someone," Swanson said. "If that person wants to do it, he's going to find a way to do it."

Swanson, who has spent 23 years investigating tampering incidents for FDA, said tamperers can be divided into general categories. First there are the criminals, the out-and-out murderers whose tampering is aimed at a specific victim, or whose victims are random, as was apparently the case in the 1982 Tylenol tragedy.

Then there are the "pranksters" (who find product tampering amusing), the disgruntled (such as an angry employee seeking revenge on an employer), and the profiteers (who seek to gain financially from their tampering), according to Swanson.

"Man invented tampering a very long time ago," Swanson said. "The ancient monarchs used to have their own food tasters to make sure someone wasn't trying to poison them.

"We're never going to be able to completely stop it," he continued. "But with cooperation and a team effort, we can provide control. The consumer ultimately is the last step in the quality assurance chain. They have the responsibility to look twice at the product to make sure it's in the same condition it was in when it left the manufacturer."

Be Observant

Lana Ragazinsky, a consumer safety officer with FDA's Center for Drug Evaluation and Research, said consumers need to be more observant when they buy OTC drugs, and should check products carefully for rips, tears, or other packaging damage before purchasing them.

"If there's something on the package that looks suspicious, take it back to the store manager, or to the store's pharmacist," said Ragazinsky. "And you have to read the label. The label tells you what tamper-evident features are on the package." For example, a product may be labeled, "Tamper-Evident Bottle Cap. If breakable ring is separated, Do Not Use."

And the scrutiny shouldn't stop once you bring the product home, either, Ragazinsky warned. When it's time to actually take your medicine, continue to examine the product closely as you're removing it from its various layers of protective packaging, she said.

"Sometimes that's hard to do," admitted Duane Sylvia, another consumer safety officer with FDA's Center for Drug Research and Evaluation. "People will open medicine in the middle of the night, when they're still half asleep, or when they're in pain and looking for some fast relief. You tend not to be real observant at moments like these."

Sylvia emphasized the need to be cautious.

"Would you sit down to dinner in the dark, unable to see what you're eating?" he asked. "The same goes for taking medication. You have to look, and look twice."

"We can make all the rules and regulations we want, but it can't replace consumer awareness," said Ragazinsky. "You have to look at the package. You have to read the label. If the consumer doesn't look, there's nothing we can do."

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.