FDA eyes 'behind the counter' drug category with greater clinical role for pharmacists

From the American Medical News:
The Food and Drug Administration is contemplating the establishment of a class of medications that would be available only after counseling from a pharmacist but without a physician's prescription. Physicians widely oppose the development, arguing that it could disrupt continuity of care and put patients at risk.

"We're concerned about patient safety," said Rebecca J. Patchin, MD, an American Medical Association trustee. "If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." The AMA testified in opposition to this action at the FDA's Nov. 14 hearing on the subject.

Known as "behind the counter," this category exists in many other countries in various forms. The FDA is considering the possibility for the fourth time since the 1970s because agency officials feel the emergence of the Internet means that consumers are more informed than ever and the time may be right to make this change in the United States. ...more

FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales

From Forbes:
During a day-long public hearing Wednesday on whether to allow certain drugs to be sold by pharmacists without a prescription, U.S. Food and Drug Administration officials listened to arguments for and against the proposal by representatives of various medical and public interest groups.

But at the day's end, the FDA officials said they weren't ready to make a decision on whether to create a new class of drugs that pharmacists could sell "behind-the-counter." And, they wouldn't speculate on a timetable for such a decision. ...more

FDA Weighs Behind-the-Counter Drugs

I've already posted a few articles regarding the "behind the counter" issue in the States. I thought I'd add this one as well as it has some information I haven't seen elsewhere.

From WebMD:
For at least the fourth time, federal regulators are considering whether pharmacists should be allowed to regularly dispense medications without a doctor's prescription.

Three times since the 1970s, the FDA has rejected the idea of adding a new "behind the counter" class of drugs to existing prescription-only and over-the-counter medication, which can be bought with no professional supervision.

But the new class is once again on the FDA's docket, spurred in part by big drug companies looking for a new way to sell prescription products that the agency has rejected for nonprescription sales. ...more

FDA Mulls Direct Pharmacist-to-Patient Drug Sales

From the Washington Post:
Experts at the U.S. Food and Drug Administration are meeting Wednesday to hear arguments on whether or not pharmacists might someday bypass doctors and directly provide consumers with certain drugs that now require a prescription.

If this plan were to go ahead, it would create a new class of drugs that could be sold by pharmacists "behind-the-counter." Such drugs might include birth control pills, cholesterol drugs and migraine medicine, experts said. Their sales would require that patients discuss these purchases with the pharmacist first.

"We believe having certain drugs behind the counter, but available only after a consultation with a pharmacist, could significantly increase patient access," Ilisa Bernstein, the FDA's director of pharmacy affairs, told theLos Angeles Times.

Wednesday's hearing marks another chapter in the behind-the-counter saga. In 2005, the agency rejected a proposal to allow the cholesterol-lowering drug Mevacor to be sold without a prescription. At the time, however, some of the FDA's scientific advisers said it might be possible for pharmacists to sell the drug if they could help select which customers bought the pills. ...more

Prescription power from the pharmacist

Look for a lot more news regarding "behind the counter" status in the United States next week as the FDA starts hearings on November 14. I noticed that the same concerns that physicians have voiced re: pharmacist prescribing in Canada are mentioned in this American debate.

From the Wilmington (DE) News Journal:
Someday soon, you may be able to walk into your local pharmacy and walk out with prescription-strength drugs without ever having seen a doctor.

The Food and Drug Administration is considering creating a new category of drugs that would no longer require a doctor's prescription. The category -- midway between prescription and non-prescription drugs -- would be accessible only after consulting with a pharmacist.

It's far from clear how the FDA's proposed "behind-the-counter" classification would work, but even the idea is stirring up controversy in the health care field. While no drugs have been identified as candidates, experts think drugs such as birth-control pills and migraine pain relievers -- those that patients already take with little physician supervision -- could be among the first to be considered.

Some consumer groups and pharmacists say not having to go through a physician would make it more convenient for patients to get needed drugs. Physicians' groups, on the other hand, have raised patient safety concerns in lining up against the proposal. ...more

FDA proposes new class of medicines

This is an old article, but I thought it was interesting to see that the FDA is considering a "behind the counter" status, much as we have in Canada.

From the Dallas Morning News:
Physicians might be losing their lock on Americans' medicine cabinets.

For years, consumers either showed up at the drugstore with a doctor's prescription or settled for less powerful medications sold over the counter.

Now the U.S. Food and Drug Administration is considering creating a class of medicines dubbed "behind the counter." It would let consumers buy routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription – as long as they discuss it with a pharmacist first.

Pharmacists and drug companies like the idea; doctors think it's dangerous. If approved, the new drug classification could go into effect as early as next year.

"We believe having certain drugs behind the counter but available only after a consultation with a pharmacist could significantly increase patient access," said Ilisa Bernstein, the FDA's director of pharmacy affairs. ...more