How to Protect Yourself Against Drug Tampering

by Food and Drug Administration (FDA)

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 disturbing fact that has many FDA officials shying away from the term "tamper-resistant" when they discuss safety packaging, and 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.

To prevent a tamperer from substituting the tamper-resistant feature (such as a shrink band or film wrap), the indicator or barrier to entry must be distinctive by design, or it must employ an identifying characteristic, such as a pattern, name, registered trademark, logo, or picture.

"Distinctive by design" means that the tamper-resistant feature is designed from material not readily available to the public, and therefore can't be easily duplicated. Blister packs, aerosol containers, and individual foil pouches fall into the "distinctive by design" category.

On the other hand, materials such as plain tape and clear plastic or paper seals are considered "readily available." Indicators or barriers using these materials must therefore have an identifying characteristic so that the substitution of the material could easily be detected by a consumer. (One brand of children's cold medicine, for example, uses a shrink band featuring rows of tiny blue soldiers.)

The massive conversion to tamper-resistant packaging cost the drug manufacturing industry somewhere between $500 million and $1 billion, according to Bill Bradley, director of technical affairs at the Nonprescription Drug Manufacturers Association in Washington, D.C.

Packaging had to be redesigned. New equipment had to be obtained, and in, some cases, new personnel and new buildings. But no one was grumbling.

"Companies were very anxious to comply as quickly as possible," Bradley said. "Consumer confidence was down."

It took about three months before consumers started feeling comfortable again about OTC drugs, Bradley said.

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.