Update on FDA Proposal to Move Certain Migraine Meds to OTC

How nice would be be if someday you could access a kiosk to get your migraine treatment medication refilled 24 hours a day whether you've had time for a doctor's appointment or not? This could come to pass eventually under a proposal being considered by the FDA to utilize technology to increase patient access to over the counter (OTC) medications.

That type of access to treatment medications could be helpful for a segment of migraine patients, but carries with it some serious possible drawbacks. The good news is that people with migraines aren't the only ones who share those concerns.

At the two day FDA hearing on this proposal in March, FDA representatives said they are envisioning two ways technology could be incorporated into the distribution of OTC medications:

(1) Technology would provide an interactive process to help make more information for self diagnosis and selection of treatment option available to patients than just what they receive in package inserts.

(2) Pharmacists would assist patients with confirming the diagnosis and selection of appropriate treatment option using tools made available to them or by verifying the results of tools used by patients. Pharmacists would also reinforce directions for appropriate use.

The FDA representatives said the proposal will not change the process for determining whether a prescription medication should be switched to OTC status. Instead the goals include developing ways to use technology to make more information available to patients, using technology and pharmacists to increase adherence rates among already diagnosed patients and dealing with specific situations that may not need a physician's involvement. For example, if a patient loses her Epi-Pen, could she get it filled through the pharmacist instead of needing her doctor's participation?

Pharmacists testified about the need for financial reimbursement for pharmacists if more demands are put on their time. Like physicians and patients, they wonder whether insurance companies will continue to cover the cost of medications involved or if patients will be on the hook for those costs. They also want to be sure the proposal avoids creating confusion among patients about which medications are prescription and which are OTC.

Physicians and the AMA said this proposal would shift costs, rather than increase access, and undermine primary care. They said it will not address the growing shortage of primary care physicians and will have no impact on the number of emergency department visits. They said something that can be addressed by an OTC medication would rarely lead to an emergency department visit anyway. They do not believe chronic diseases can be handled the same way as immunizations, which have become readily available in pharmacies across the United States. They stressed that chronic diseases change, often becoming worse, and development of the doctor patient relationship over time is an important component of successful chronic disease management.

Although no migraine patients and no one who treats migraine patients testified at the hearing, patients were represented. The president of Allergy & Asthma Network: Mothers of Asthmatics, an organization for parents of kids with asthma and allergies, raised concerns common to many patients. She challenged myths that have been often raised as reasons to adopt the proposal: (1) patients have to see the doctor every time they need a refill; (2) patients who use OTC medications cannot afford to see a doctor; and (3) patients who use OTC medications cannot afford prescription medications. She pointed out that the more common it becomes to be helped by a pharmacy technician rather than a pharmacist during a transaction, the more worrisome the idea of trusting the pharmacy with other aspects of our health care becomes.

The most important thing for Migraine.com readers to take away from this update article is that this proposal is in very early stages. Any mention of a specific drug or medical condition, such as migraine, doesn't seem to mean much right now and seems to be used as an example of how the proposed systems and technologies could work. But keeping up with the proposal as it moves forward and sharing our thoughts and concerns will continue to be important to making sure our interests as migraine patients are properly addressed.