FDA considering drug overhaul
Doctors’ prescription pads might see a lot less ink in the future.
The U.S. Food and Drug Administration is enlisting public feedback on the possibility of creating a “behind-the-counter” category for certain medicines, the agency recently announced. These drugs would not require a prescription, but would be available directly from the pharmacist, according to a notice the FDA published in the Federal Register. Customers could only buy “behind-the-counter” medications after consulting with a pharmacist. The agency is holding a hearing on the issue Nov. 14 in Washington, D.C.
“The public meeting is designed to get input from all groups to see the feasibility of the idea,” said Chris Kelly, FDA spokesman. “There’s been a lot of interest, and now’s the time to listen in.”
Some doctors and even pharmacists, however, are worried that moving selected drugs behind the counter could do more harm than good.
“I think there’s a problem with making too many of these drugs available,” said Dr. Charles Austin, a Mission family-practice physician. “You need a physician who is familiar with the patient, who is aware of the patient’s medical history, monitoring the drugs.”
Kelly said the agency hasn’t yet identified particular drugs that could be moved to the new category, but it’s possible the U.S.’s list of behind-the-counter drugs could be similar to a list of “pharmacist-only” drugs available in other countries. The cholesterol-lowering drug Zocor, for example, recently became available without a prescription in the United Kingdom; in several countries, birth-control pills are available over the counter.
Only a few medications currently are accessible behind the counter in the United States, including the “Plan B” contraceptive, which became available without a prescription last year.
Medications like cholesterol drugs and birth-control pills could prove dangerous for patients who aren’t being closely monitored, Austin said.
In some cases, cholesterol-lowering medicines can cause liver damage or kidney problems, according to the Mayo Clinic. Birth-control pills can increase the risk of blood clots and breast cancer is some patients, experts report.
These are some of the reasons why a doctor should stay involved in patients’ care, said Dr. William Hinchey, president of Texas Medical Association.
“Convenience doesn’t always equal safety,” Hinchey said. “People on prescription medications need to be monitored appropriately … pharmacists would have to do clinical evaluations and consultations, and I think the evaluation of a patient’s clinical situation is something a physician needs to do.”
Some pharmacists said they were worried that patients would forego needed visits to the doctor if more drugs were available behind the counter.
“What if they developed a problem? It could go unnoticed,” said Robert De Lachica, pharmacist at Los Ebanos Pharmacy in Brownsville. “I think it would be more beneficial to keep (these drugs) the way they are, as prescriptions.”
Proponents of the creation of a behind-the-counter category argue that it could improve patients’ access to needed medications. If a doctor’s visit isn’t required, it will save the patient money and time, they said.
“If it’s well-monitored, it’s a good idea,” said Lisa Camooso Miller, spokeswoman for the National Community Pharmacists Association, which represents pharmacists at independently owned stores. “It would be a more affordable way for patients to get these drugs.”
Pharmacist Amy Schaefer, who works at MacPherson’s Pharmacy in Harlingen, said she thinks some drugs, like earache medicines for children, would be safe for behind-the-counter. Others are too risky, she said.
“It really depends on the medicine,” Schaefer said.
In determining whether a drug is suitable for behind-the-counter status, the FDA will be considering issues like the drugs’ safety, the risk of side effects and the potential for abuse, according to the Federal Register announcement.
Questions the FDA will ask at the public meeting include: Should there be behind-the-counter availability of certain medications? How would offering drugs behind the counter improve access to needed medicines? What criteria should be considered when determining which drugs should be in the new category?
“We’re trying to remain neutral … and just listen in,” Kelly of the FDA said.
GET INVOLVED
To submit written comments on the proposition write to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For more information go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-19329.pdf
