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.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.
View References
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs Accessed May 2012.

Comments

View Comments (7)
  • Donna Parsons
    7 years ago

    Yes, if, like my son, who doesn’t have insurance, I think this would be great, especially if he’s going to get into the situation he did with his doctor, who wouldn’t right him multiple refills, said he was needing them too much as it was and then eventually ended up dismissing him as a patient. However, yes, I’d be concerned as well about pharmacy “techs” giving medical advice, but that’s why you wouldn’t get it from them but from the pharmacist him/herself, like I grew up with my mother/grandmother doing; might have to go back to a locally owned/compounding pharmacy but there are still places like that that have more time to talk to you about that than typicallly the doctors do anyway!

  • tucker
    7 years ago

    I was at the pharmacy today (a grocery store) and when someone has a question, they get the pharmacist. There was a long line at 7pm after work but they still took time to talk to a mom with a child in front of me and the man behind me (while I had something else filled that was missed).

    Techs can answer simple questions like pill color changes, etc. But they’ve always gotten the pharmacist at my pharmacy if the bag has a stamp “see pharmacist” or a paper attached ” drug interaction”. I’ve also been called at home by the pharmacist one time for a lengthy conversation over a new RX I had dropped off. I’ve even seen the pharmacist out in the OTC section helping people and this is a pretty busy store. So I would hope that techs wouldn’t be counseling except over pretty simple stuff.

  • Megan Oltman
    7 years ago

    When my daily allergy med, Zyrtec, went OTC, it went form being a $10 copay for me to being $20 OTC. Triptans, which are expensive, I imagine would be similar – not a cost savings, although if people don’t have prescription coverage, they might be more accessible.. I agree with you Diana that there must be big money for pharma in this. I’m also concerned about pharmacy techs giving medical advice – if you knew how often my pharmacy messes up a prescription!

  • Megan Oltman
    7 years ago

    Exactly, Cathy. And they’re contraidincated for certain cardiovascular issues too.

  • Cathy Bertinuson
    7 years ago

    Not to mention that Triptans can have dangerous drug drug interactions with SSRIs – when you buy stuff OTC , who is going to advise you of stuff like that ?

  • Kathy Lowery
    7 years ago

    It would be good for you to get them easier, I’m wondering which drugs they are. Triptians would be good to be able to just buy but I think the american insurance agencies would make it very difficult for that happen in the US. They would loose so much money. Everything else is prescribed off label so probobly not going to happen. I wouldn’t mind being able to buy it OTC here but they would then be taken off the government subsidy and cost a lot more. Surely you can get repeats of your scripts? I get 4 tablets per $30 script and 5 reapeats. So I can have 20 more beofre seeing a GP.

  • Diana Lee
    7 years ago

    Yes, we absolutely can get more than one refill on a prescription and it is almost unheard of for a doctor to not write your triptans for multiple refills without needing to see the doctor or get a new prescription. Honestly, I think the pharma companies are pushing this. So they must be HUGE dollar signs. 🙂 I think the insurance companies would probably prefer it because patients would most likely end up paying for our meds ourselves if they switch to OTC. They’d be off the hook.

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