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Why some cold medicines have moved behind the counter

Some over-the-counter (OTC) cold and allergy medicines are being moved behind the counter at pharmacies nationwide as part of the fight against illegal drug production. Under the Patriot Act signed by President Bush on March 9, 2006, all drug products that contain the ingredient pseudoephedrine must be kept behind the pharmacy counter and must be sold in limited quantities to consumers after they show identification and sign a logbook.
Pseudoephedrine is a drug found in both OTC and prescription products used to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory allergies. The drug is also a key ingredient in making methamphetamine--a powerful, highly addictive stimulant often produced illegally by "meth cooks" in home laboratories.

The new legal provisions for selling and purchasing pseudoephedrine-containing products are part of the Combat Methamphetamine Epidemic Act of 2005, which was incorporated into the Patriot Act. These "anti-meth" provisions introduce safeguards to make certain ingredients used in methamphetamine manufacturing more difficult to obtain in bulk and easier for law enforcement to track.

According to the National Institute on Drug Abuse, methamphetamine use and abuse is associated with serious health conditions including memory loss, aggression, violence, paranoia, hallucinations, and potential heart and brain damage. The Drug Enforcement Administration says there is a direct relationship between methamphetamine abuse and increased incidents of domestic violence and child abuse.

Meth users ingest the substance by swallowing, inhaling, injecting, or smoking it. There are currently no safe and tested medications for treating methamphetamine addiction.

The new law affects several hundred OTC products for children and adults, such as Sudafed Nasal Decongestant Tablets, Advil Allergy Sinus Caplets, TheraFlu Daytime Severe Cold SoftGels, Tylenol Flu NightTime Gelcaps, and Children's Vicks NyQuil Cold/Cough Relief. "There are very few decongestants on the market that don't contain pseudoephedrine," says Charles Ganley, M.D., director of the Food and Drug Administration's Office of Nonprescription Products.

Ganley says that products containing pseudoephedrine are still available without a prescription and that they are packaged the same way as any OTC drug. "The only difference is that people will have to go to the pharmacist to buy them," he says. "They just need to ask for them and show ID, and know that there's a limit to the amount they can purchase."

Buyers must show a government-issued photo ID, such as a driver's license, and sign a logbook. Stores are required to keep a record about purchases, which includes the product name, quantity sold, name and address of purchaser, and date and time of the sale, for at least two years. Single-dose packages containing 60 milligrams or less of pseudoephedrine are excluded from the recordkeeping requirement, but must still be stored behind the counter.

The federal law limits the amount of pseudoephedrine an individual can purchase to 3.6 grams in a single day and 9 grams in a month at a retail store. For example, a person may buy Advil Allergy Sinus Caplets, which contain pseudoephedrine and other ingredients, in quantities of up to 146 tablets in one day and 366 tablets in one month. The number of pills or amount of liquid medicine allowable will vary depending on the type of product and its strength.

The limits on the amount an individual can purchase became effective April 8, 2006. The requirements to place products behind the counter and to keep a logbook take effect Sept. 30, 2006. Many drug stores are already complying voluntarily or because some state laws require similar controls.

Drug companies are reformulating some of their products to eliminate pseudoephedrine. Pfizer, for example, while still offering Sudafed nasal decongestants, which contain pseudoephedrine, also markets a line called Sudafed PE as an "on the shelf" alternative. Sudafed PE contains the active ingredient phenylephrine, which is not used to make methamphetamine, and so is not under the same restrictions as pseudoephedrine.

"Drugs that contain phenylephrine are also safe and effective," says Ganley. "The dosing is a little different--you have to take them a little more frequently than the pseudoephedrine-containing drugs because their effects are not as long-lasting."

The anti-meth provisions of the Patriot Act restrict the sale of two other drug ingredients, ephedrine and phenylpropanolamine, because of their potential to be used illegally to make methamphetamine. Like pseudoephedrine, drugs containing these ingredients must be placed behind the counter, and buyers must show identification to purchase a limited quantity.

Synthetic ephedrine is used in some topical drugs, such as nose drops, to temporarily relieve congestion due to colds, hay fever, sinusitis, or other upper respiratory allergies. It is also used orally for temporary relief of asthma symptoms.

Phenylpropanolamine was commonly used in OTC decongestants and weight-loss drugs. Today, it is unlikely that consumers will find phenylpropanolamine in their drug stores, says Ganley. In 2000, the FDA asked drug manufacturers to discontinue marketing products containing phenylpropanolamine because of an increased risk of bleeding in the brain (hemorrhagic stroke) associated with the ingredient. The FDA has taken regulatory actions to remove phenylpropanolamine from all drug products.

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