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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.

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In an early March notice in the Federal Register, the FDA outlined possible scenarios for making drugs available over the counter. (See box.)

* 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 at www.regulations.gov until May 7.

Jan Towers, Ph.D., the director of health policy and federal government and professional affairs for the American Academy of Nurse Practitioners, also urged the FDA to proceed with caution. Although moving certain drugs to OTC status is in many cases beneficial, the model that the agency is proposing would work best in a closed system like an HMO, or in retail clinics where pharmacists and physicians interact directly, she said.

She also urged FDA officials to consider whether a given disease or condition requires clinician oversight and how much, what kind, and how often. The major concern, Dr. Towers said, is that patients could fall through the cracks because too many different people are doing too many different things.

But not every health care provider at the hearing threw up the yellow caution flag. Some physician-researchers in ob.gyn, urged the FDA to consider moving oral contraceptives over the counter.

Dr. Daniel Grossman of the University of California San Francisco and a senior associate at Ibis Reproductive Health, said that the current data strongly support the safety of progestin-only oral contraception over the counter. These drugs have no significant toxicity, they are not addictive, users can self-diagnose, and users can safely take the drug without a doctor's screening, he said.

Not surprisingly, pharmacists are eager to move forward with the FDA's proposed options. Tom Menighan, executive vice president and CEO of the American Pharmacists Association, said that increasing the role of pharmacists will actually get patients back into the health care system by getting patients who have dropped their therapies back on medication. Pharmacists also would refer patients back to their physicians when appropriate, he said.

Mr. Menighan said that pharmacists' role in administering immunizations can be a model for expanding their role in medications. Over the last decade, states have enacted laws allowing pharmacists to immunize, and now more than 175,000 pharmacists have completed certificate training programs to administer vaccines, he said, adding that in the 2010-2011 influenza season, pharmacists administered approximately 20 million influenza vaccines.

To move forward, pharmacists would need appropriate algorithms, standards of care, and documentation for specific products, but those are achievable, he said.

Beverly Schaefer, a pharmacist and pharmacy owner in Seattle, agreed that pharmacists are well positioned to take on an expanded role if the FDA decides to make more drugs available OTC with conditions of safe use. "Pharmacists are the most accessible health care provider," she said.

Patients who might most benefit from the FDA proposal would be those seeking symptomatic relief from acute conditions, such as antivirals for shingles or a cold sore outbreak. "When this happens on Friday night, what's going to happen if you have to wait until Monday? Trouble," she said.

Ms. Schaefer highlighted other medicines that would be a good fit for the proposed new paradigm such as rescue inhalers for asthma attacks, burn ointment for minor burns, steroid nasal sprays to reduce sinus inflammations, epinephrine autoinjectors for allergic reactions, and antihistamine eye drops for allergy relief.

Dr. Bobby Q. Lanier, executive medical director for the American College of Allergy, Asthma, and Immunology, disagreed.

He called the FDA proposals "chilling and a little scary." Drugs such as albuterol inhalers require physician oversight because some patients are skilled at gaming the system to simply obtain their usual prescription and move on, he said.

And he added that he didn't know of any evidence that moving these types of drugs over the counter would improve compliance, adherence, or patient care.

Ms. Schaefer pointed out that pharmacists are already helping patients to be more adherent to their medicines, she said. Many community pharmacists offer medication reconciliation and medication therapy management programs, and pharmacists are assisting patients to correctly use, adhere to, and gain control of their medication regimen.

"We help patients understand why they are taking these medications," she said.

Possible Nonprescription Scenarios

In announcing the potential changes, the FDA explained some of the scenarios it is considering 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.

* 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.

BY MARY ELLEN SCHNEIDER FROM A HEARING HELD BY THE FOOD AND DRUG ADMINISTRATION
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Author:Schneider, Mary Ellen
Publication:Family Practice News
Date:Apr 1, 2012
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