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FDA Considers Easier Drug Access

Once upon a time you could buy just about anything at the neighborhood drug store. “Doc,” as the pharmacist was called a century ago, could dispense medications like marijuana or opium. The neighborhood pharmacist was frequently consulted about a range of health problems and provided advice on how to use the remedies he dispensed.

Eventually the Food, Drug and Cosmetic act of 1938 limited the sale of dangerous drugs to prescription-only status. But the definition of dangerous is surprisingly arbitrary.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen were prescription drugs for years. Such pain relievers can cause serious side effects such as bleeding ulcers or high blood pressure and may even increase the risk for heart attacks or strokes.

These NSAIDs were eventually given the green light to go over the counter under brand names such as Advil and Motrin IB (ibuprofen) and Aleve (naproxen). Now anyone can buy these drugs in huge quantities.

With the stroke of a bureaucratic pen, the FDA changed the public perception of these medications. One day they were potent prescription pain relievers with serious side effects. The next day they were mild nonprescription headache remedies.

Americans tend to think of over-the-counter drugs as wimpy. They are not perceived as powerful as their prescription cousins and they’re also not seen as potentially dangerous.

Surveys have shown that less than one out of five consumers actually reads the information on NSAID drug labels. As a result, many people are unaware of the proper dose and possible side effects.

The FDA faces a difficult balance between making helpful drugs more easily available and making sure people know how to use them safely. That’s why the agency is beginning to look around the world to see how other countries handle this dilemma.

The solution appears to be a return to the old days when the pharmacist played a far more active role in dispensing drugs. Many countries including Australia, Britain, Canada, Denmark, France, and New Zealand allow pharmacists to dispense certain medications from behind the counter.

For example, the cholesterol-lowering drug simvastatin (Zocor) is available in England without a prescription. Pharmacists can perform a blood test in the pharmacy to see if a person would benefit from this medication. Advice and warnings are given in person and the pharmacist is available to answer questions.

If the FDA adopts this model, it could open the door to behind-the-counter sale of antiviral herpes medicines such as Zovirax (acyclovir) or Valtrex (valacyclovir). Other possibilities could include drugs for the flu such as Tamiflu (oseltamivir) or Flumadine (rimantadine).

In truth, this system has already begun. Decongestants containing pseudoephedrine do not require a prescription but can only be purchased by speaking with a pharmacist. The morning after pill (Plan B) is also only available from behind the counter.

If pharmacists actually counseled people on how to use medications properly, there might be fewer complications. Behind-the-counter dispensing could make many useful medicines readily available in a safer fashion.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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