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FDA Concept Would Mean Fewer Prescriptions, More Over-the-Counter Drugs

FDA Concept Would Mean Fewer Prescriptions, More Over-the-Counter Drugs [Ventura County Star, Calif.]

From Ventura County Star (CA) (May 12, 2012)

May 12--In the paradigm pitched by the Food and Drug Administration, people who won’t see doctors for high blood pressure or diabetes may have another way to get their meds: Go straight to a pharmacy and buy them.

Officials of the federal agency want to make some relatively low-risk medications that currently require a prescription available over the counter. It’s unclear what drugs would be included, but treatments for certain chronic illnesses would likely be in the mix.

Supporters of the concept, targeted for public comments in a forum that ended this week, predict it would mean lower costs, fewer delays and a way for people who go without meds to get them.

Doctors, drug companies and some pharmacists, however, worry the plan would jeopardize safety and push patients away from physicians. The initiative has stirred so many concerns that an FDA official acknowledged Friday that more work is needed. She said a plan that would require new laws or regulation changes is more than two years away.

"But I do think it will happen," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. She said the challenge is in convincing doctors and others that the changes won’t put people in harm’s way but will propel them toward medication to control their illnesses.

"About a third of the people are untreated," she said, singling out those with hypertension. "A third of the people who are under the care of a physician are under-treated."

In the FDA concept still being developed, pharmacists would likely play a greater role in dispensing certain medications. People might need to go through a diagnostic test or get a doctor’s OK for an initial prescription but not refills.

People would likely self-diagnose, using Internet tools to discern symptoms and assess needed medication. They might use pharmacy kiosks set up to allow patients to screen themselves for conditions, perhaps employing tools like blood-pressure monitors.

Maybe it would drive down costs and make it easier to get medications, said Dr. Stan Frochtzwajg, a Ventura family doctor. But the plan also makes him think of three patients he admitted into the hospital recently. Each had internal bleeding because of over-the-counter medications they didn’t take properly.

"Every one of those medications (the FDA is) looking to put over the counter can cause a person to go into shock, can cause a person to go into liver failure, can go into a wide array of side effects," he said, asserting the risks overshadow the gains.

Woodcock said medications available without a prescription would be determined on a case-by-case basis. Drugs that carried higher risks wouldn’t be on the list. Patients with numerous conditions, elevating the chance of side effects or other risks, would not be good candidates.

In many parts of the world, people can get medications over-the-counter that require prescriptions in the United States, said Umesh Manglani, a Ventura pharmacist. Risks can be minimized by carefully picking which medications are available and also reducing recommended dosages.

Making drugs available over the counter not only improves access but can dramatically drive down the price of pills, particularly brand-name drugs that would be available as over-the-counter generics, Manglani said. A $200 prescription drug might go for $10.

"It saves people money and time," he said.

Woodcock said it’s unclear how much money the plan would save consumers. She said the FDA is working with insurers to make sure coverage of medications would not be affected.

Some pharmacists argue they could play a greater role in dispensing medications for hypertension. Others reject the plan.

Even with a doctor’s help, people don’t follow a doctor’s instructions in taking medications, said John Skovmand, a pharmacist and owner of Seeber’s United Drug in Santa Paula. Take away that expert advice and things would get worse.

"It’s going to cause more illness," he said, suggesting risks for diabetics would include "more blindness, more amputations, more kidney disease. Not something to mess with."

As he walked out of a CVS Pharmacy in Ventura, World War II veteran Larry Almack admitted he forgot to ask his doctor for more cholesterol medication. It means he’ll have to go without for a week, maybe longer, while his doctor and the Department of Veterans Affairs processes the order.

"When you get over 90, you tend to forget when to order them," said the 90-year-old Venturan, noting the FDA plan could make his life simpler. He could just walk back into the pharmacy and buy what he needed.

Dan Norton, 56, of Ventura sees his doctor every six months for high blood pressure and to see if his medication is working.

"It keeps you in touch with the doctor," he said, expressing his distrust of a plan that would allow people to sit at a computer, diagnose themselves and pick their own meds.

"They’ll get out of it what they want to get out of it," he said.

But people self-diagnose all the time when they use aspirin, sunscreen or other over-the-counter drugs, said Woodcock. She said the FDA plan would be set up in a way that would push people toward care, not away from it.

She compared the opposition to the resistance against allowing pharmacies to give flu vaccines. Now it’s clear that giving pharmacies a greater role increases access to flu shots.

Online assessment tools give health care professionals a way to dispense information that can help people figure out which medications will treat an illness, she said. Blood pressure screening machines tell people when they need to worry about hypertension.

The technology is there. The over-the-counter plan is one way to use it, she said.

"We shouldn’t be locked in the ‘70s," she said.


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Posted: May 2012