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FDA Considers Moving Migraine Medications to OTC Status

The Food & Drug Administration recently announced it will study a proposal to move certain medications for treatment of chronic diseases like migraine and diabetes to over the counter status.

This means those medications would no longer require a doctor’s prescription or perhaps only require a prescription the first time the patient uses the medication or a consultation with a pharmacist. This change would be years in the works and each medication would have to separately apply to be moved to over the counter status. In anticpation of the FDA’s planned two day public hearing on this issue, there are some significant pros and cons to such a decision that you should be aware of as an informed, engaged migraine patient.

 

Pros:

Improved access.

There are thousands, if not millions, of patients with chronic diseases like ours who are unable to access readily available treatments because they don’t have insurance and can’t afford the cost of a doctor’s appointment. For example, experts estimate as many as 7 million people have diabetes, but are as yet undiagnosed and not receiving treatment because they don’t have access to a doctor.

Convenience.

Rather than having to see their doctors, take a prescription to the pharmacy and come back to pick it up, patients could buy what they need right off the shelf, the same way you buy something to treat a cold or constipation.

Cost savings to medical system.

We all know we have to find ways to maximize health care options on a shoe string budget or the cost of access may soon be beyond the reach of most Americans. This change would save insurance companies money, and, so the thought goes, consumers, too.

 

Cons:

Safety.

Although the FDA has acknowledged they might still require some kind of intermediate step short of requiring a prescription, but more than offering these medications on the shelf, there are still significant safety concerns. Who will warn patients about side effects? Who will make sure patients aren’t taking other medications that will cause dangerous interactions?

Insurance coverage.

Insurance companies would no longer pay for your prescriptions or any part of them. You could use an FSA (flexible savings account) if your employer offers one. But considering how expensive triptans are (even the copays can be outrageous), this would be a big drawback for patients and may undermine the intention of increasing access.

The reality of cost savings.

Do cost savings to insurance companies actually translate to cost savings for consumers? This is a controversial question without a straightforward answer. Insurance companies are mostly for-profit businesses. Can we really expect them to forgo profit increases to pass the savings on to their customers? I honestly don’t know, and I doubt it.

Added burden to pharmacists.

I don’t know if you’ve noticed, but pharmacists are expected to do a lot more than prepare prescription orders and counsel patients. Navigating the red tape of insurance alone seems to occupy hours of their time each day. Adding another task to their already full plates may not be the right move.

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.

1. http://the-scientist.com/2012/03/13/self-prescribing-patients/- 2. http://www.bloomberg.com/news/2012-03-08/fda-weighing-non-prescription-status-for-chronic-disease-drugs.html- 3. http://www.npr.org/templates/story/story.php?storyId=148177565-

Comments

  • tucker
    7 years ago

    And if it is the treatments meds, there is MOH to consider. My coworker was “addicted” to excedrin. (not really, but she took 6-8 every day) before she saw a doc. I did the same with advil. Think of all the folks who would take imitrex every day. It’s such a hard disease to live with – you do ANYTHING to get rid of the pain….

  • Chad Whyte
    7 years ago

    I think this is a bad idea. Look how many people abuse acetaminophen and ibuprofen. Now they are talking about triptans, which overusing them can cause more distressing issues such as increased blood pressure (then potential heart attack, stroke…). Also regarding the cost issue, OTC Prilosec is still more expensive then prescription and is a lessened dosage. So I don’t know whose idea this was but it’s not good.

  • Danielle Howell
    7 years ago

    I do not think that making them OTC is a good idea for the simple fact that my dr monitors fairly closly what I am taking, how much I am taking, and if my migraines are getting better or worse. Plus, she runs tests to check for side effects and I think making the meds OTC would allow patients to mix meds that they shouldn’t much easier, possibly end up with more side effects, and possibly skip dr appointments which could later cause bigger issues down the road.

  • Ellen Schnakenberg
    7 years ago

    At first I thought “This is great!” then I thought about it, coming up with a lot of the pros and cons you mentioned here Diana Lee. I guess I’m shaking my head at the fact they were considering removing acetaminophen from OTC status, and here we are looking at Triptans as OTC’s. Even if I could take triptans, I’m afraid I’d find the cost prohibitive. As some are moved to OTC status I’d be afraid that some of the patients I work with who need a specific triptan might find themselves denied for it because insurance companies feel you should be able to take the OTC version. It will be interesting to see what they come up with on this… Keep us informed Diana! 🙂

  • Louise M. Houle
    7 years ago

    Ellen Schnakenberg What if the Triptans stay behind the counter and patients have to ask the pharmacist for it, still not needing a RX? They do that here in Montreal (perhaps all of Canada?) for Gravol. I ask my pharmacist and he/she notes in my file that I’ve pruchased x-amount (without a RX). That way he/she can tell if I’m taking too much in a month. There would have to be safeguards against people going to several different pharamcies, but thought I’d throw the idea into the mix. Will be interesting to see where this goes. Thanks for the update Diana Lee.

  • Ellen Schnakenberg
    7 years ago

    I guess one other important thing to mention is the prevalence of Medication Overuse Headache and the overuse of triptans. I’ve seen it estimated that as much as 80% of those diagnosed with chronic Migraine have MOH involvement which may have led to their chronification. I truly don’t want to see more patients in MOH because nobody explained those dangers to them…

  • taralane
    7 years ago

    The pros you mentioned are all valid, but they become nightmares when the OTC drug costs over a $100 per month which used to have a co-pay of $5.00 under Medicare, Medicaid or an insurance program. Considering the number of people in this country with migraines, it sounds like a good way for insurance companies to stop paying for medications that migraineurs need and let them pay the full retail cost, making the rescue pain medications unaffordable to most people. I think this is something that has to be watched very carefully, and some research needs to be done on who is behind this idea and is pushing it through the FDA as a way to cut Medical costs. We are in a Presidential election year, and I don’t think this is a co-incidence.

  • Diana-Lee author
    7 years ago

    The FDA notice of hearing did not specify which migraine medications, unfortunately. The hearing is scheduled for Thursday and Friday, so hopefully we’ll soon know more. From the context of their announcement I would say they’re referring to treatment medications.

  • MandaLuu
    7 years ago

    Thanks very much for the info. Does this address those medications identified as specifically for Migraine, such as abortives (Relpax, Axert, Maxalt)…or preventatives that originally came to the market to treat other illnesses but adopted for treatment migraine (Topomax, Amitriptyline, etc.)?

  • Elaine Gross
    7 years ago

    I also believe taking the doctor out of the monitoring picture is a very bad idea. Migraines are too complicated and dangerous for us to be treating ourselves, I think, but that’s just my opinion. Triptans are serious meds, and I don’t think they should be sold over the counter. If someone is overusing them and there is no doctor prescribing them, who’s monitoring?

  • Abby Dirge
    7 years ago

    OTC meds lead to reduced prices. If the drug companies can’t charge insurance exorbitant prices then they have to market their wares to consumers. If consumers can’t afford the price the drug companies won’t make any money. Believe me, making money is the first priority of Big Drug.

  • Tara Wade
    7 years ago

    I am not saying the industry is perfect, far from it; CEOs make insane wages. But there is no simple fix, and forcing the marketplace to be cheaper will only take out the drug innovation. Is that the answer? Stop invention and development? Speaking of Economics, companies exist to make money. Without it, they die.

  • Abby Dirge
    7 years ago

    Simple economics is not vilification. And you might want to look into the marketing departments of these companies that have decided that it is cheaper to pay fines for marketing the drugs for unapproved uses than actually not break the law.
    http://www.washingtonpost.com/wp-dyn/content/article/2010/03/19/AR2010031905578.html

  • Tara Wade
    7 years ago

    Before you vilify “Big Drug,” do some research. Look into how many molecules/protein syntheses are studied in R&D. Of those thousands only a handful make it to Clinical Trials. One in 5 of those successfully make it to market. Then the Federal Government, namely the FDA, is there to increase regulation at every turn (not saying this is all bad). It is expensive, very expensive.

  • Lindsey Melnyk
    7 years ago

    I’ve had major, bad side effects from most tritan class meds and do NOT take them at all! so this wouldn’t directly affect me, but seeing as how much those suckers are it would be impossible for me to afford them OTC! as I’ve done in the past, but then I hear that an FDA advisory panel is proposing a ban on vicodin and percoset b/c of the acetaminophen contained in them! they say that when people take things containing acetaminophen then take vicodin or percoset along with it then that will eventually lead to liver failure…..i say they should take acetaminophen off the market B/C it does so much damage, and apparently they think we’re all stupid and don’t read labels that we will overdose ourselves! and I dunno about any one else here, but taking tylenol for my migraines is like eating a habenero pepper then trying to cool your mouth off with a glass of water…..IT JUST DOESN’T WORK!

  • Muffy Godwin
    7 years ago

    I am sensitive to them as well. I tried them about ten years ago and it was a nightmare, but at least the doctor was able to help me out. If I bought it OTC I don’t know. Not to mention that so many people don’t know what a real migraine is compared to a headache. I agree about tylenol as well the stuff is toxic and overused.

  • Lindsey Melnyk
    7 years ago

    i meant i paid for those tritans out of my own pocket way back in the day, sorry to be a lil’ bit confusing….

  • Paula Joanne Albers
    7 years ago

    Diana, Do you think this possible change would include triptans? I can think of some pros, but one of the cons: insurance not paying for these meds at almost $30.00 each, would make purchasing these meds almost impossible for many people (especially chronic).

  • Barbara Collins
    7 years ago

    This is NOT good news for the affordability to consumers. I can’t believe triptans will not require a doctor’s monitoring and prescription knowing their potential side effects and risk of over use.

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