FDA eyes "behind the counter" drug category with greater clinical role for pharmacists
■ Pharmacists argue it will increase access to health care, but physicians say it could endanger patients.
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.
"Given that new technology, it seems like an appropriate time to ask now whether or not there are ways of improving public health through increased access by behind-the-counter availability," said Randall Lutter, PhD, the FDA Deputy Commissioner for Policy.
It is unknown what drugs might fall into the BTC category or how dispensing them might work, although two examples currently exist. Emergency contraception is behind the counter because of the need for age verification. Over-the-counter medicines with pseudoephedrine also are handled in this manner in an effort to reduce their diversion to the manufacture of methamphetamine. These two examples, however, are not what pharmacists, who tend to support this step, have in mind.
"This class should not be used to enforce age or quantity-based limits on certain medications or otherwise restrict access," Mary Ann Wagner, RPh, senior vice president of policy and pharmacy regulatory affairs at the National Assn. of Chain Drug Stores, said during the hearing.
Rather, if created, the category would allow pharmacists to perform a clinical evaluation of a patient before deciding to dispense a drug or refer that patient to a physician. Those who support the creation of this third category argue that it would increase access, improve patient compliance, reduce health care costs and allow for more postmarketing surveillance.
"This does have a lot of merit. There are many prescription drugs that have been around long enough to be used without as much medical supervision but still need a little bit more supervision than over the counter would allow," said Stephen Giroux, PD, president of the National Community Pharmacists Assn. "Many times a patient can see a pharmacist far more frequently than a physician, and pharmacists can keep the physician informed so that they have better information when they do see the patient."
Lining up in opposition
While pharmacists tend to be most in favor of the BTC category, physicians argue it would make an already fragmented health care system even more so. They also say the need to see a doctor first is not the most significant barrier to patients getting needed care.
"Patients need a medical home. They don't just need a medication," said Jim King, MD, president of the American Academy of Family Physicians. "What's limiting access is the cost of medications, not access to a physician. And there may be a good reason why patients should not be able to get some medications."
Concerns about a third class of drugs focus on other themes, too. First, many argue that it would not reduce costs and improve access. Medications that otherwise would be sold over the counter could end up behind it, making them less available to consumers. In addition, pharmacists are calling for the establishment of mechanisms that would allow them to bill for clinical services on top of charging for the drug, thereby making it possible that a BTC category wouldn't so much save money as move it around. Also, another cost burden for patients could result if some third-party payers, many of which do not pay for OTC medications, decide not to pay for those that shift from prescription to BTC.
"This may decrease access because patients may not have enough resources to pay for a medication no longer covered by insurance," Dr. Patchin said.
In addition, questions arise as to whether the FDA has authority to make this change without congressional action, and many are unconvinced patients are better educated.
"Just because people have more information doesn't mean people are better informed. They have more access to misinformation as well," said Bruce Bouts, MD, RPh, an internist and chair of the Pharmacy and Therapeutics Committee at Blanchard Valley Medical Associates in Findlay, Ohio.
And while the category exists elsewhere in the world, an August 1995 Government Accountability Office report -- considered to be the most definitive on this subject -- concluded that there was little evidence BTC had any public health benefit or had increased access.
The FDA is considering all input and is expected to reach a conclusion soon.