May 2, 2012 — Imagine a patient walking into a pharmacy, self-diagnosing a cough at a kiosk with medical software, and then getting a drug from a pharmacist in the back of the store, all without a physician's prescription.
The US Food and Drug Administration (FDA) is imagining this scenario, much to the alarm of the American Medical Association (AMA) and other medical societies, which see the beginnings of an end-run around physician authority.
Since February, the FDA has been soliciting opinions on creating a new paradigm for drug approval. Right now there are 2 types of drugs — those that require a clinician's prescription, and those that can be sold over the counter (OTC) without a script, because patients are considered able to safely treat themselves with the product. Under the new paradigm, the agency would approve drugs in a third class — those that ordinarily would require a prescription, but which would be sold OTC under conditions of "safe use." Such conditions of safe use, specific for each drug, could include reliance on FDA-approved technology, such as medical software for self-diagnosis and blood tests administered by a patient or pharmacist, according to an FDA notice of a public hearing on the issue on March 22. The FDA document, published in February, also solicited written comments.
Safe use also could mean a pharmacist assessing whether a patient has any condition or risk factor that would contraindicate the use of a particular drug, or helping a patient choose between different drugs. With some medications, the FDA would require an initial visit to a clinician for a prescription but allow more automatic refills than usual before a follow-up visit.
Safe-use medications, the agency states, could benefit many Americans who go untreated or undertreated for their conditions because they are deterred from visiting a clinician by the "cost and time required." The deterrence factor of making one or more visits to get a prescription "may contribute to the undertreatment of certain common medical conditions including hyperlipidemia, hypertension, migraine headaches, and asthma."
"There Is No Substitute for a Clinician"
At the FDA hearing on March 22, 2 medical societies went on record objecting to the proposal for OTC safe-use drugs.
Sandra Fryhofer, MD, chair-elect of the AMA Council on Science and Public Health, said her group continues to "strongly support" the status quo of 2 drug classes — prescription and traditional OTC. In exploring how new technologies and new roles for pharmacists might expand the portfolio of OTC drugs, the FDA should not "undermine the relationship that a patient has with his or her physician."
"In our view, lack of oversight from a practitioner could be a serious concern," said Dr. Fryhofer.
The FDA has not provided any evidence showing that patients with hypertension, hyperlipidemia, or asthma can diagnose and manage these conditions by themselves, she noted. "The balance of medical evidence strongly suggests otherwise." She also estimated that patients would pay more out-of-pocket for drugs that insurers would shift into the OTC safe-use category.
Bobby Lanier, MD, speaking for the American College of Allergy, Asthma and Immunology (ACAAI), raised similar concerns, but more pointedly.
"The new proposals here being discussed are chilling and scary," said Dr. Lanier. "You are facilitating bad behavior by not having (patients) talk to a clinician. In our mind, there is no substitute for a clinician."
The FDA heard more objections like these from organized medicine in written responses to its notice. "Allowing the pharmacist authority to dispense medication without consulting the patient's physician first could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients," said Roland Goertz, MD, president of the American Academy of Family Physicians.
The Endocrine Society told the FDA that whatever it does, it should exclude diabetes drugs from a new safe-use category. "Diabetes is an extraordinarily complex disease," said Endocrine Society President Janet Hall, MD. The ability to prescribe drugs for this condition "should rest with the primary care physician or endocrinologist."
Pharmacists Tout Easy Accessibility Compared to Physicians
The notion of OTC safe-use drugs has its supporters, particularly among pharmacists. They say this hybrid of prescription and OTC drugs will increase consumer access to healthcare. Pharmacist groups lined up behind the proposal include the American Pharmacists Association (APA), the National Community Pharmacists Association, the Academy of Managed Care Pharmacy, and the National Association of Boards of Pharmacy.
These organizations tout the ability of pharmacists to make the new safe-use model a success. Pharmacists are "the medication experts," and for many Americans, more accessible than physicians, they claim. Through their frequent conversations with patients, pharmacists are in a good position to help them stick to their medication regimens — improving health outcomes and reducing costs. At the same time, the pharmacist groups recognize the need for their members to collaborate with physicians, and refer patients who need more in-depth treatment.
And it is not as if pharmacists would be filling a brand new role. The APA says that pharmacists are authorized to independently administer influenza immunizations in all 50 states.
In a letter to the FDA, the Arkansas Pharmacists Association noted that members of their profession in the United Kingdom and Australia dispense "pharmacist-only" medications without a clinician's prescription. The group also said this model has worked in Arkansas with the nasal decongestant pseudoephedrine. Instead of making the drug prescription-only — and requiring a physician's appointment — to keep it out of the hands of methamphetamine makers, the state legislature recently made pseudoephedrine pharmacist-only. Patients now can buy it if a pharmacist determines that they have a legitimate medical need.
The ability of pharmacists to dispense safe-use drugs will become even more important in 2014 when the Affordable Care Act brings a host of newly insured Americans into the healthcare system, writes Mark Riley, PharmD, the executive vice president of the Arkansas association. The new paradigm is needed, Dr. Riley said, "for healthcare to remain affordable and accessible."
The FDA has yet to propose specific regulations that would create the OTC safe use drug class. The deadline for submitting comments on what the agency set forth in its February 2012 notice is May 7. The notice explains several ways to submit comments.
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Cite this: Robert Lowes. Pharmacists Dispensing Without Rx 'Scary,' Say Med Societies - Medscape - May 02, 2012.