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Feds Propose 'Behind-the-Counter' Drugs

Pharmacists could dispense drugs without a doctor's prescription

By Mark Huffman
ConsumerAffairs.com

October 4, 2007

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Currently, consumers seeking medication have two choices – getting a prescription from their doctor or settling for something less potent, sold over the counter. The U.S. Food and Drug Administration says it may give consumers a third choice.

The agency this week floated a proposal to create a new category of drugs – stronger than over-the-counter medication but available without a prescription. Under the plan, these drugs could be purchased only after consultation with a pharmacist.

The American Medical Association has not yet commented on the proposal, but physicians are likely to bristle at any intrusion onto their prescription-writing turf.

“It is a terrible idea for a number of reasons,” said Dr. Henry Fishman, ConsumerAffairs.com’s health advisor. “First of all, many over the counter drugs are already causing problem.

'Terrible' idea

"For example, 100 people a year die from a driving off the road from taking sedating antihistamines. Decongestants can cause high blood pressure. Aspirin allergy kills 500-1000 people per year,” Fishman said.

Only a doctor can know patient's total health picture, from diseases, to diets, to medications and allergies, Fishman argues. Only a doctor, he says, can determine if a medicine is proper for the patient and whether its benefits outweigh its risks.

“Pharmacists may know a bit more about a medication but they do not know enough about the patient to know what is right and safe for the patient,” Fishman said.

In addition, he says, pharmacists will be opening themselves up to increased liability and are likely to face a significant increase in lawsuits. Even so, pharmacists already seem to like the idea.

“We think it's a very wise thing to do,” said Charlie Sewell, senior vice president of government affairs for the National Community Pharmacists Association. “Other countries have this approach and it's worked fairly well.”

Which drugs?

What kind of drugs would fall into this third category, which the FDA refers to as “behind-the-counter” medication?

Under the FDA plan, a number of drugs now dispensed only with a doctor’s prescription. However, the agency did not suggest which drugs might be included in the new category.

The next step in the process is a November 14 public meeting, where the FDA will solicit feedback.

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