FDA Mulls Expanding Patients’ Access to Certain Drugs

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.

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