FDA weighs prescriptions without medical visits
■ Physician organizations cite safety concerns in opposing technology that lets patients self-diagnose and assess their medication needs.
The U.S. Food and Drug Administration is considering a move that would allow patients to obtain prescription medications without ever seeing a doctor. Instead, patients would use technology to evaluate their needs.
The new model of drug distribution being considered by the FDA would allow some drugs for chronic conditions, such as asthma and allergies, to be sold under “conditions of safe use,” a proposed category that would describe prescription drugs sold over the counter. To determine whether patients meet conditions of safe use of the drug, the FDA is recommending the development of new technology to help diagnose and assess patients’ needs. The model would expand the role of pharmacists while reducing that of physicians.The FDA is considering the new model due to changes in both technology and the health care system, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said at a March 22 hearing.
“Consumers of tomorrow will have access to all sorts of media and sources of information that simply weren’t available 20, 30 years ago,” she said. “And so it is clear that there are now many interactive mechanisms that can step the consumer through the process of self-diagnosing and medication selection in a much more comprehensive manner than would happen by them reading the drug fact box.”
She said the rise of health information technology and the increased use of electronic health records have resulted in a health care system that links patients, physicians and pharmacists.
“Greater pharmacist involvement could provide an avenue to bring nonadherent individuals back to health care and get them involved back in their health care. And methods to inform and link providers back from the pharmacy could be developed,” she said.
Though some in the pharmacy business think the plan has potential, some patient advocacy and physician groups, including the American Medical Association, express concern that the technology would remove physicians from the equation and result in patient safety issues.
Under the proposal, criteria of safe conditions would be measured using technology such as patient kiosks, remote diagnostic tools and online questionnaires that determine patients’ needs and help match them to the right medication. The proposal also would expand the role of pharmacists, who would help determine patients’ needs for certain medications and help verify their self-diagnoses.
The FDA said there could be drugs that require an initial prescription from a physician, or there could be some that are simultaneously available by prescription and over the counter.
“Dual availability could help ensure greater access to needed medications, making obtaining them more flexible,” the FDA wrote in its notice of public hearing on the issue.
The FDA argues that many patients do not seek medical care or prescriptions for certain conditions because of the time and cost associated with seeing a doctor and obtaining a prescription.
Sandra Adamson Fryhofer, MD, chair-elect of the AMA’s Council on Science and Public Health, said in testimony that one of the most motivating influencers of patients’ medication adherence is “their confidence in their physician and the prescriber’s emphasis in the need to take the medication as prescribed.”
Dr. Fryhofer said while some prescription antidotes, such as epinephrine autoinjectors for use in allergic emergencies, appear to have few safety concerns, the FDA has offered no evidence that other conditions such as hypertension, hyperlipidemia and migraine headaches can be self-diagnosed and managed safely by patients alone.
Bobby Quentin Lanier, MD, an allergist and executive director of the American College of Allergy, Asthma and Immunology, said the FDA is sending mixed signals about the dangers of medications.
He said one branch of the FDA is sending such strong warnings about the dangers of some inhalers that prescribers have to sign a consent before recommending them to patients. Now, “you want to make this class of drug easier to get. We’re just flat-out confused,” he said.
Eric Juhl, director of federal public policy with the National Assn. of Chain Drug Stores, said the association is “cautiously optimistic” about the FDA’s proposal.
He said pharmacists are not only qualified to help educate patients, they also are more accessible than any other health care professional due to the number of drugstores in the U.S. and their extended hours. “Pharmacists are already one of the most trusted and accessible health care providers and experts in appropriate use of medications and are uniquely qualified to take on this new role,” Juhl said in his testimony. However, he said the NACDS is concerned about whether the changes would give pharmacists an overwhelming workload.
Nancy Sander, president of the Allergy and Asthma Network Mothers of Asthmatics, said in testimony against the FDA’s proposal that her asthmatic daughter spent her first six years in and out of the hospital until “we got the care, the coordinated care that was needed, and she never needed to go back to a hospital again. How does that happen? It’s not by do-it-yourself medicine.”
Sander said many people, including parents of asthmatic children, underestimate the seriousness of the condition.
“Too little or too much medication administered at the wrong time is also associated with increased symptoms, emergency visits, hospitalizations, missed work and school days, poor performance, higher health care cost and oh, yes, death 3,600 times a year,” she said.
The FDA accepted written testimony on the issue until May 7. The agency said there will be more opportunities for public input before the issue moves forward with rule-making proposals.