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FDA Mulls Expanding Patients' Access to Certain Drugs
Agency is in 2 days of hearings on whether some prescription meds shift to 'conditional' OTC status
By Amanda Gardner
HealthDay Reporter

THURSDAY, March 22 (HealthDay News) -- Americans troubled by a range of ailments might someday more easily obtain medications that are now only available by prescription.

On Thursday and Friday, experts at the U.S. Food and Drug Administration (FDA) are holding hearings on whether to expand the availability of certain prescription drugs by giving them "conditional" over-the-counter, or OTC, status.

The details of the new plan are sketchy, but certain drugs used to treat such conditions as high blood pressure, high cholesterol, diabetes, asthma and migraine may no longer require a prescription.

Dispensing of these drugs would vary on a case-by-case basis and would include "conditions of safe use," possibly to be determined by the consumer with the help of a pharmacist.

"There are a lot of unanswered questions right now but we're advocating that the pharmacist would be involved with the patient as they . . . determine if the product is right for them," explained pharmacist Ronna Hauser, vice president of policy and regulatory affairs at the National Community Pharmacists Association. "The information would be relayed back to a physician if necessary."

According to Brian Gallagher, senior vice president of government affairs at the American Pharmacists Association, many of the discussions that have taken place with the FDA on the issue so far have involved emergency medications, such as asthma inhalers.

For example, he said, "if someone had already had an inhaler [prescribed] and they had it confiscated at the airport, they could go in, talk to their pharmacist who has access to medical records and get a refill on their inhaler," he said.

Farther down the road, the plan might give pharmacists the ability to screen a person who has already been diagnosed with high blood pressure by their doctor and restart them on medication if needed.

"The pharmacist could urge them to go see a physician before they get into a really bad situation," Gallagher added.

The idea behind the plan is to get millions of untreated or undertreated Americans back into the health care system, experts said.

The move is being driven partly by computer technology, such as the touch-screen kiosks found in pharmacies that help patients self-diagnose common diseases, an idea that has raised inevitable concerns about patient safety.

But the kiosks, said Gallagher, would be less for self-diagnosing than for making decisions in conjunction with a pharmacist in the drug store.

"It might say 'You need to see a doctor right away' rather than 'I've made a diagnosis. Here's some medication,'" Gallagher said.

In particular, concerns about drug interactions, specifically interactions that would lessen the effectiveness of certain cancer drugs, have been voiced.

Without knowing details of the new initiative, Diane Pinakiewicz, president of the National Patient Safety Foundation, said the intent of making it easier for patients to obtain certain types of medications for certain types of conditions is "reasonable."

"Patients today are better informed and want to play a more active role and that's what we're trying to encourage patients to do," she said. "Patient engagement is a key piece of patient care."

But coordination of care with a physician is still critical, she added.

Dr. Sandra Adamson Fryhofer, chair-elect of the American Medical Association's Council on Science and Public Health, testified at the hearing Thursday and expressed concern about the potential lack of physician involvement.

"A patient's confidence in their physician and the prescriber's emphasis on the need to take the medicine as prescribed is one of the most motivating influences in promoting medication adherence," she explained in a statement. "For a program to be successful on this front, it must be delivered by a trusted source, be personalized to the patient's situation, reinforce medical need and expected outcomes, segment and target at-risk populations and reinforce and reward initiation and maintenance of treatment," Fryhofer added.

"We also have concerns about patients taking certain drugs without physician involvement, especially for patients with chronic disease," she continued.

"While the increased availability of certain prescription-based antidotes, such as Epi-Pens [which administer adrenaline for severe allergic reaction], appear to have few if any safety concerns, the FDA has not offered evidence that patients with hypertension [high blood pressure], hyperlipidemia [high cholesterol], asthma or migraine headaches can self-diagnose and manage these serious chronic medical conditions safely on their own," Fryhofer stated.

More information

The U.S. Food and Drug Administration has more on prescription drugs and over-the-counter drugs.

SOURCES: Brian Gallagher, R.Ph., J.D., senior vice president, government affairs, American Pharmacists Association; Ronna Hauser, Pharm.D., vice president of policy and regulatory affairs, National Community Pharmacists Association; Diane Pinakiewicz, president, National Patient Safety Foundation; statement of Sandra Adamson Fryhofer, M.D., chair-elect, Council on Science and Public Health, American Medical Association
Agency is in 2 days of hearings on whether some prescription meds shift to 'conditional' OTC status.
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