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.