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.