Caution Urged in Moving More Drugs OTC



Although expanding nonprescription access to some medications could be beneficial, patients with a wide array of chronic conditions need regular medical attention.

That was the message physicians and nurses gave to the Food and Drug Administration at a hearing March 22-23 to explore moving more medications to nonprescription status.

Photo courtesy Debbie Kutka/National Community Pharmacists Association Pharmacist John Motsko of Apple Discount Drugs in Salisbury, Md., counsels a patient about her diabetes care.

In an early March notice in the Federal Register, the FDA outlined possible scenarios for moving drugs to nonprescription status with added requirements for safe use, including the following:

Lengthen the time between follow-up visits. Under this scenario, patients would see their physician or other health care provider for an initial prescription, and the prescriber would authorize refills beyond what normally are currently allowed before a follow-up visit is required. In addition, conditions of safe use would be set for the refills. In its proposal, FDA officials noted that this approach could be used for rescue inhalers to treat asthma, or epinephrine for allergic reactions.

Make use of new technology. A patient could use a pharmacy kiosk or website to self-screen for a particular condition; an associated algorithm would help the patient determine whether a particular medication is appropriate or contraindicated.

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Increase the role of the pharmacist. Certain drugs would be switched to OTC status, but in order to purchase the drug, the patient would need to visit with the pharmacist. Pharmacists could potentially be involved in conducting and interpreting diagnostics, including blood tests or liver function tests. Based on the results of those tests, pharmacists could help determine if a particular drug is appropriate or contraindicated.

Dr. Sandra Adamson Fryhofer, an internist and chair-elect of the American Medical Association’s Council on Science and Public Health, said that the FDA proposals for increasing OTC access to medications such as epinephrine autoinjectors for allergic reactions likely would be beneficial. But, she said, she is skeptical that chronic conditions could be managed that way. Since the disease progression changes over time and new comorbidities may appear, a lack of interaction with a physician is problematic, she said.

Pharmacists have done well in administering immunizations over the past several years, she said. But bypassing the physicians in treating chronic disease would be a "mistake."

Dr. Fryhofer also raised concerns about the FDA’s plans to use kiosks or computer programs to allow patients to self-diagnose and to determine if certain medications are appropriate. For instance, in the case of treatments for hyperlipidemia, patients may be able get access to an appropriate drug through a kiosk. However, without regular care by a physician, such patients could progress to heart disease or experience a cardiac event, yet not have a connection to the health care system in the event of an emergency, she said.

"The patient is sort of left out in the cold," Dr. Fryhofer said.

The proposed OTC option could also undermine efforts to create accountable care organizations (ACOs), in which a team of health care providers in the inpatient and outpatient settings work together on the care of patients.

Greater usage of OTC medications that isn’t captured, monitored, and shared with the members of the ACO would make it harder for the team to manage a patient’s health care, she said.

FDA officials acknowledged the concerns. But Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that the agency is looking toward the future, when pharmacists, physicians, and patients will all be better connected through the use of electronic health records and patient portals. Greater pharmacist involvement also has the potential to bring nonadherent patients back into the health care system, she said.

"I strongly believe that medicine needs to take medical care to where the patients are," Dr. Woodcock said. "This is one way that we will really improve both access and adherence."

The FDA is not considering any fundamental changes to the scientific process for reclassifying products from prescription to OTC, Dr. Woodcock said. "This is more about how the information would be made available to the consumer, not what quantity of evidence would be used to decide that the product could be nonprescription."

Making the change will require rule making from the FDA, Dr. Woodcock said, so the agency is gathering public input. In addition to the testimony at the 2-day hearing, the agency is accepting public comments until May 7.


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