Pharmacists could get prescription power
By Gary Haber
(Wilmington, Del.) News Journal
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Someday soon, you may be able to walk out of your local pharmacy with prescription-strength drugs without ever having seen a doctor.
The U.S. Food and Drug Administration is considering creating a new category of medicines, midway between prescription and non-prescription, that would no longer require a doctor's prescription but be accessible only after consulting with a pharmacist.
While no drugs have been identified as candidates, experts think medicines such as birth-control pills and migraine pain relievers, which patients already take with little physician supervision, could be among the first considered.
Even the idea of the "behind-the-counter" classification is stirring up controversy. 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 safety concerns in lining up against the proposal.
At least 11 other countries, including Canada, the United Kingdom and Germany, already allow pharmacists to dispense some prescription drugs without a doctor's involvement. In the U.S., some non-prescription medications, such as certain cold medicines and the Plan B "morning after" contraceptive, are kept behind the counter.
But those cases are different from the proposed behind-the-counter category because the pharmacist doesn't advise the patient on those medication choices, but acts more like a gatekeeper, said Kristina Lunner, vice president of government affairs for the American Pharmacists Association.
The FDA held a hearing Wednesday to examine what it called "the public health benefit" of the proposed new drug category and is soliciting public comment until Nov. 28. The agency hasn't set a timetable for a decision.
"There's no proposal," said Ilisa Bernstein, director of pharmacy affairs for the FDA. "It's just an informational meeting."
Even before the hearing, groups are staking out their positions.
The American Medical Association opposes the process of letting patients skip a physician's input.
"When a drug product is considered to be unsafe without supervision, a physician should be responsible for supervising the use of that drug," said a statement from Dr. Rebecca Patchin, an AMA board member.
The potential for patients' diagnosing themselves troubles Dr. Stephen Permut, who chairs the department of family and community medicine at Temple University School of Medicine.
"They might be having tension headaches, or they might be having a brain tumor," Permut said.
He also worries that if doctors aren't doing the prescribing, they won't know which medications patients are taking, leading to the possibility of dangerous drug interactions.
But the American Pharmacists Association's Lunner said the "behind-the-counter" proposal is worth considering.
The association supports "increasing the role of pharmacists" who are "the best equipped to help a patient choose medication and manage that medication," Lunner said.
The FDA hasn't said exactly what role pharmacists would play.
Pharmacist Calvin Freedman said the proposed regulation could mean more work for pharmacists, but most would welcome the idea.
Some over-the-counter medications that patients can now get without review by any health care professional "really should have some professionals making recommendations about them," said Freedman, owner of SaveWay Compounding Pharmacy in Newark, Del.
One key factor is how insurers would treat the new category of drugs. If insurance companies consider behind-the-counter drugs the same as over-the-counter drugs, they won't pay for them, leaving patients to pay the entire cost. But if behind-the-counter drugs were less expensive than prescription drugs, insurers could encourage wider use by reducing or eliminating co-payments.