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FDA Steps Reluctantly Behind the Counter

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The Food and Drug Administration is being dragged kicking and screaming toward a whole new category of medications. Until the recent approval of Plan B, the FDA allowed only two kinds of drugs: those that require a physician’s prescription and those that you can buy over the counter.

Because the emergency contraceptive Plan B was a political hot potato, the FDA had to come up with a third approach—“behind the counter��? drugs. Any woman who wants to purchase Plan B must ask the pharmacist and establish that she is at least 18 years old. Only then can the pharmacist sell this medication to her.

For reasons that are unclear to us, the FDA has resisted the concept of behind-the-counter dispensing for decades. Even when the decongestant pseudoephedrine was being widely used to make illicit methamphetamine, the FDA took no action.

State and federal legislators passed laws restricting the sale of this drug to try to reduce the availability of meth. Now, if you want to buy an allergy or cold medicine such as Advil Allergy Sinus Caplets, Claritin-D or Sudafed Nasal Decongestant Tablets, you must ask the pharmacist for it. Drugs containing pseudoephedrine are kept behind the counter.

Though you don’t need a prescription to buy such medicines, you do need a photo ID and you will need to sign for them. In this respect, buying cold medicine resembles getting codeine cough medicine in some states.

Although codeine is considered an effective cough remedy, it is also a narcotic. Many states permit cough syrup containing low-dose codeine to be sold without a prescription, as long as the person signs a register that shows name and address.

The FDA has long resisted the idea of behind-the-counter drugs even though this practice is not unusual in many other countries. In Great Britain, for example, you can buy the cholesterol-lowering drug simvastatin (Zocor) without a prescription. You will have to talk to a pharmacist, however, and if there is any doubt whether you need it, the pharmacy is often equipped to do a cholesterol test on the spot.

The FDA refused to allow over-the-counter sale of simvastatin in the U.S. and also rejected OTC sale of the antiviral drug acyclovir (Zovirax) against cold sores. On the other hand, the agency has allowed unrestricted sale of NSAID pain relievers such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve). This often surprises visitors from other countries where NSAIDs are often sold from behind the counter or only in small quantities (16 pills per pack).

There is a growing recognition that NSAIDs not only cause severe digestive tract irritation, but they may also increase the risk of hypertension or heart attack. A survey found that only one in five consumers actually read the label on these OTC drugs. Almost half took more than the recommended dose.

If pharmacists controlled the dispensing of such medications and counseled people on their proper use, the rate of complications might drop. Behind-the-counter dispensing could make more treatments available without a prescription, if the precedent that the FDA has set with Plan B leads the agency to include other medicines in this new category.

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As of last summer, a prescription IS required in Oregon to purchase pseudoephedrine.

Oregon was either the first or one of the first states to require pseudoephedrine to be kept behind the counter, and then took it a step further.

I cannot see how any of the issues raised by the preparations mentioned in the editorial above apply to the distribution of glucose tablets for the safe and effective relief of dangerous low blood sugars in diabetics. The ingredients are not too different from the cornucopia available on the candy aisle, yet to purchase them at some stores involves standing in line at the pharmacy and making special inquiry. It's just glucose!

If it were a product requiring more controlled distribution we would have to put sales from most bakery and sweets sections under the pharmacist's discretion. I object to the inconvenience and also the presumption that the store can charge more just because it is sold from behind the counter. I doubt the FDA would care one way or another. But I do, and I am not going to buy glucose tablets from stores that make it difficult. I'll save my money. I hope others will join me.

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