A new regulatory debate about whether certain medications should require prescriptions makes me reflect on how good things used to be when it comes to obtaining my own diabetes meds over-the-counter.
Insulin, in particular.
Two decades ago when I was on second-generation insulin like Regular and Lente, I could walk into a pharmacy and pick up a bottle of insulin without needing a prescription. That was helpful during those times when I forgot my insulin vial at home. Or dropped the last bottle in just the right way for it to shatter, just when it was needed the most.
Yes, back before I was constantly connected to a continuous drip of insulin via my pump, and before the days of rapid-acting insulin or the many pens that are now available with a doc’s Rx, I could just buy insulin at the drugstore; no doctor’s orders were needed to just pick up an extra bottle.
I thought that was a good thing. So it made me happy to hear not long ago that the Food and Drug Administration (FDA) announced it was exploring the idea of “expanding the availability” of certain medications, like modern insulin — possibly opening them up to the over-the-counter (OTC) market where you wouldn’t need a doc’s prescription to get this stuff.
You probably know that there are two types of drugs at the moment: those that require a doctor’s prescription and those that don’t. The latter are assumed to be safe enough for patients to treat themselves without a doctor’s guidance. What the FDA is proposing now is that a third class be created, allowing those drugs that would normally require an Rx to be sold OTC under the condition of “safe use.” That term could mean a pharmacist assessing whether a patient might need or can use a particular medication, and in certain cases the FDA might require a doctor’s visit after a patient obtains a refill or small initial amount of the medication.
To those of us in the Diabetes Community, one of the big questions comes down to what this might mean for access to insulin, which is mostly a prescription-required medication despite some older-generation insulin still being offered OTC.
For those without an endo or who aren’t frequent visitors of their regular docs, and especially for those people without insurance coverage, this expanded availability of a life-sustaining medication would be a very welcome change.
Of course, opinions vary and not everyone is open to this change. The American Medical Association (AMA) and other medical societies offered the FDA plenty of comments opposing this move, basically claiming in not so many words that this could be the beginning of an end-run around physician authority. They’re pushing back hard.
Surprisingly, the other group of doctors pushing back equally hard is endocrinologists, via the Endocrine Society – representing roughly 15,000 endos worldwide. They also provided the FDA with an earful of protest. Not singling out insulin, the Society states that all diabetes drugs are tricky with respect to “conditions of safe use” because patients may suffer from, or develop, complications. Huh? So why shouldn’t they have easier access to the meds they need?
And I quote…
“The Society appreciates that the FDA is evaluating which drugs might be appropriate to designate as nonprescription in an effort to improve access and health outcomes, but strongly believes that diabetes medications should not be considered under these new paradigms.”
A recent discussion among the Diabetes Advocates group had quite a few folks riled up about this. After all, shouldn’t endocrinologists, supposedly passionate about diabetes care, be at the forefront of making sure people with diabetes can easily access the medications they need to survive?
The Society goes on to state that since “diabetes is an extraordinarily complex disease,” only docs are qualified to assess what meds are needed, not the PWD thanks to a whole host of factors such as medical history, lifestyle considerations and more. And any non-physician or pharmacist might not understand the full picture, or be able to offer additional advice if and when it’s needed.
So only the endos are qualified to prescribe insulin and no one else — in any situation — is able to make that assessment? No matter what length of time someone has been living with diabetes, and regardless of the type?
Their statement reads like an obvious play of self-preservation — in which the Endocrine Society is basically trying to ensure that people who need insulin and other diabetes drugs can only get access to it by coming through their offices. This resembled moves by the AADE, in not doing enough to allow more people become certified as educators, and the school nurses who pushed for policies mandating that only they are qualified to administer insulin and no one else can be trained to give necessary injections at school because of the “complex medical knowledge” one needs.
I scoffed, and solidified my negative thoughts about the Endocrine Society.
But then, I had a conversation with Dr. Jason Wexler that changed my views to some degree.
This endo at Washington Hospital Center in D.C. chairs the clinical affairs core committee studying these kind of issues, and he says the opposition was not about protecting endos’ status. “Self-preservation arguments don’t hold, that isn’t where this comes from,” Wexler said.
Rather, the Society is pushing for safeguards to “make sure people with diabetes aren’t making decisions in isolation and there’s an ongoing dialogue with their endo or primary care physician.”
So there are people out there who just might think they need certain meds or insulin, and go out and buy them without a diagnosis or doctor’s consult? Is that really a concern? I asked. Wexler answered: Yes, it is.
He told me about how a half-dozen times a year, he gets patients in his office that say they have a grandmother or parent at home who has some type of diabetes. That individual uses a glucometer and sees a higher-than-recommended number, and decides to just start taking medication or insulin. This kind of medication-sharing is one example of behaviors that could become more common with relaxed FDA regulation on prescriptions, Wexler worries.
“It’s about empowering patients to make their own informed decisions, not about getting one more patient in the door,” he says.
With a large amount of the population poor and under-insured, Wexler says the danger of blindly taking drugs without a doctor’s consultation is even greater – particularly during tougher economic times.
Still, Wexler says the FDA comment period was just a starting point. More information and recommendations could come down the road. Maybe the Endocrine Society would be open to discussing certain exceptions, allowing some restrictions or “safe use conditions” on certain medications, like insulin. At least until a person is able to get with a doctor to talk.
Protocols could be established between pharmacies and clinics where this medication is available, so that consumers have an ongoing
dialogue with their doctors.
Nothing’s official, as these rules would have to go up the ranks of the Endocrine Society and also be considered by the FDA, of course. But the possibility is there and at least they’re willing to talk about it.
This was a useful conversation for me, as I realized I’d been looking at this issue only through the lens of a longtime type 1 whose been taking insulin as long as I can remember and who regularly visits an endo. But there’s the other side, of those who might actually be self-medicating based on little knowledge about life with diabetes.
Unfortunately, this whole debate came up after the FDA docket closed May 7, so public comments are no longer being accepted. Jay Leno joked (at the 4:05 mark) about the issue a few days before the docket closed, taking it to the mainstream but offering little time for interested people to object if they hadn’t known about it earlier.
The process is still underway, as the FDA hasn’t made any decision. The agency isn’t obligated to listen to the Endocrine Society, or even to holding a public hearing on this issue. But it could.
And that’s where we come in. Taking this discussion to the Endocrine Society (and others who have similar views) is the next move on the chessboard here. So, we in the DOC should let them know what we think on this!
The Endocrine Society’s comments to the FDA are available to review online in PDF form here. Their PR guy Aaron Lohr tells us we can all submit our own reaction and comments to them by sending emails to societyservices@endo-society.
After all, this is about eliminating barriers — in a safe way — to restrictive health care and policies and practices, and giving PWDs more access to the meds they need to manage their health.
You don’t need a prescription to pick up insulin anywhere in Canada. It has nothing to do with a ‘safe’ versus ‘non-safe’ designation; rather, it’s scheduled as ‘life-sustaining medication’ for people with diabetes and, therefore, something that needs to be accessible. The system hasn’t crumbled and people still see their physicians for guidance.
It seems over-simplistic to me to argue that access to such life-sustaining medication would pre-empt a visit to the doctor’s office. People making decisions about diabetes management without the guidance of healthcare practitioners might have more to do with other larger systemic issues (e.g., financial or physical access to care)?
I am for releasing all forms of insulin to OTC but with a qualifying status that comsumers MUST have an official documented diagnosis of Diabetes that requires Insulin. Easy solution to a complex problem.
Once a diagnosis is made access to insulin can be made without a prescription. Diabetes is a fatal progressive incurable disease. Bottom line. Death comes quickly to those who require insulin but don’t have it.
Thank you for this article and comments regarding the availablity of all types of insulins to Diabetics. My own history with type one diabetes have been a roller coster. Access to this drug is crucial to keep my condition in check, when out of work or when conflicting schedules make it hard to talk with an endo. A strict diet and exercise is just not enough. My hope is that all insulins will become more obtainable in the future without a perscription.
P.S. Kathy you have a brillant idea!
I guess I am on the fence with this one. However, I am not so sure that prescriptions are a barrier to insulin. I would say cost is a barrier and I don’t know what making it OTC lowers the cost. In fact, would I have to buy it over the counter at retail if this happened, rather than pay a copay? Lots to consider.
Access to physicians is the problem. The reason that OTC insulin seems to help patients is that they don’t have to go to the doctor to get a prescription, and getting to a doctor is hard and expensive. The FDA is attempting to circumvent the problem in a more cost effective way by taking the doctor out of the loop. Yes, they have meds available in Canada and other countries without a prescription, but these countries have universal access health care so that any patient on any day can go to a primary care physician and seek help without paying anything.
Though I can see why patients could view physician opposition to this as self-preservation, our concern is really that the government is promoting cheaper and (in my opinion) inferior care.
What I would like to see is that the real problem gets solved. Patients, especially diabetics, need a strong relationship with doctors and a health care team that they can turn to on a regular basis easily without significan financial burden.
In addition, you probably realize that your insurance doesn’t cover over the counter medicines. If Lantus or any other branded insulin is OTC, and the government/insurance companies choose not to pay for this, who do you think will be stuck with the bill?
#no2OTC
You obviously haven’t priced the cost of insulin in Canada lately. Almost $200 a bottle for OTC Humulin and Novalin R, NPH, and 70/30 that Walmart sells it for $24.99
Lantus is super cheap at $150 in Canada compared to US prices, but it requires a prescription.
I just checked this a few days ago and was shocked at what I found. The drug industry is literally killing people with these prices. Insurance companies need to tell the pharmeceutical industry they will NOT pay enormous prices for insulin. That is the ONLY thing that will bring the price down.
As a point of clarity, at present, only analogues (third-generation insulins) are Rx today, and we can actually thank Eli Lilly & Co. for pushing the FDA on that issue back in the late 1990s when they attained approval for Humalog. Canada went it’s own way (lucky for them). One final point: although the official docket is now closed, any American Citizen, by Federal law, may submit comments to any docket from any public agency (like the FDA) at anytime. So I would dare say it’s not too late to chime in …
I say no. This is not a good idea because if insurance will not cover the cost of insulin then the full cost will go to the patient. This is a cost that people without insurance face now and many people just barely able to afford insurance could not afford if insulin goes OTC. Price may decline slightly, but I doubt that.
If medical insurance will continue to cover, then I see this as maybe workable if pharmacists are in control and it is not out on the shelves.
With insulin, I still would feel more comfortable if it is not readily available as this could be the next medication of choice for suicide.
The full cost already goes to the uninsured. Insurance is the cause of the high cost of health care in the US. The average cost of health insurance for those that acutually pay for it themselves is over $1200.. A MONTH for one person!
If R insulin is OTC why not the rest? All insulins will cause hypoglycemia in the patient who uses it long enough (one day? one week?). Or at least I believe they should be available in urgent situations (which can be assessed by a pharmacist, who has an advanced medical degree anyway) without a prescription. It’s the same logic in making insulin syringes available OTC.
Just like you are required to have a doctor’s prescription to go overseas and get insulin, Type 1 diabetics should be given a prescription from their doctor the day they are diagnosed, and they should always keep it with them.
Then they could get a pre-determined “emergency” amount of insulin from a pharmacy if the need arose.
As parent of two children with Type 1, it sounds like a way for insurance companies to make more money by covering even less. They already restrict which brand of insulin, number and brand of strips, pump necessity, and supplies. If their insulin was OTC, insurance companies would try to pay for none of it, or make us go through even more hoops and still pay for less. Already, with “good” insurance, we can barely pay for all the costs.
Additionally, I have had many discussions at group endo appointments with other parents who have children with T1D. One parent still did not really understand how the insulin worked in her child; this was not a newly diagnosed child. The disease is complicated, and not everyone tries to or can educate themselves. Endos and the CDEs are essential for my children’s care.
Call me cynical but comments by others have me worried that this is a ploy on part of insurance companies to not cover insulin
My first thought was if insulin is made OTC, insurance won’t pay for it anymore . . . but there are other products that are OTC and are still paid for by insurance; some generic brands of medications have OTC counterparts. But if it were to go OTC and NOT be covered, that would definitely be a hardship for people on fixed incomes, like me. After I pay my rent, I have about $400 left to pay for everything else I need. If I have to pay about $250 for insulin (the going rate in my area for one bottle of Lantus and one bottle of NovoLog), and then who knows how much for syringes, etc., my quality of life would definitely suffer. I am very pessimistic about this situation; we with diabetes seem to get the short end of the stick quite often where insurance companies are concerned.
As a nurse, I think this is an unsafe practice. When working in the Intensive Care Unit, Insulin had to be “double checked”…checked by two RNs before administration. Insulin can kill if used incorrectly. It would be unsafe to have it OTC in my humble opinion.
The only products that get double checked in an ICU are blood products and floor stock controlled substances. You may be a student or a pharmacuetical plant but you are not an RN. Tim 30 year RN.
Would it be safe for a diabetic not to have access to insulin? Is this all about the insured diabetic? A diagnosis of diabetes makes you ineligible for health insurance. I know this because it happened to me. This is not about insurance. It is about having access to a life sustaining substance for EVERYONE. What do you think will happen to the price of drugs if there was no health insurance? I think it would drop like a rock so that everyone could pay for it and not have to worry about dying in a couple of days in a very unpleasant way.
Rx in the US are typically only valid for a maximum of 365 days or 12 months. Chain pharmacies also typically do not like to fill Rx that are more than 3 months old.
Furthermore, many states require that the Rx be ‘generic’ unless the patient agrees for the Brand and agrees to pay any additional $ for the brand.
Narcotics used to be dispensed without an Rx back before 1915. When Congress decided that they must be Rx.
Also, the Original Humalog Pens were discontinued ca. 2010 so they would not be available ‘generic’ or ‘off-patent’.
Hopefully, the agencies can let the Pharmacist make decisions regarding medication like this. As the states have basically regulated them to get Doctoral degrees now a days to be a R.Ph. instead of Bachelor degrees. One would think that with more ‘education and internship experience’. A R.Ph. can be able to make a good decision regarding this. As most people typically see the same pharmacist for years.
Has anyone asked if their insulin is available OTC? I am a Type 2 on Humilin 70/30 with no insurance. I can get it OTC anytime I need it. No questions asked at my pharmacy.
Can you tell me what state you live in? It may vary state to state,as I also use 70 /30 humulin. I live in Florida
how much does it cost
Walmart sells 70/30 HUMULIN insulin for $24.99 a bottle without a script.
I thought internists could prescribe insulin, too. No?
Personally, I wish they would make it prescription only. My friend’s boyfriend claims he’s a diabetic, but has never tested himself. He was told by someone that he was and he needed insulin. No doctor was ever consulted. So, now he takes insulin and eats whole boxes of cookies (not sugar free cookies), ice cream, and huge meals.
Another friend knows he’s abusing insulin because he’s using it to stay thin. Taking way too much. So, yes, prescriptions should be mandatory! Besides that what is to stop drug addicts from getting needles?
Not that I don’t agree with the sentiments behind your comment, but I think the push is not towards insulin becoming OTC, but BTC (behind the counter). BTC is not a formal drug class, but I personally feel like it should be.
There would be regulations in place for the sale of insulin so that situations like your boyfriend and friend’s won’t occur. For example, the pharmacists would need to counsel, get lab tests, or have a diagnosis from a physician before they can sell the insulin.
(Needles would fall under similar rules, you have to be purchasing insulin/have diagnosis of diabetes in order to buy them)
Insulin will always be behind the counter because it requires refridgeration.
BTC have a different connotation than simply behind the counter. Yes, physically it’ll probably be in a refrigerator in the pharmacy, but right now, you can technically go and buy some forms of insulin just like any other product in the store (you just have to tell the pharmacist/tech to get it for you).
Making it BTC would legally require some sort of consultation, diagnosis, or other pharmacist/doctor intervention to make sure the person actually has diabetes and is using the insulin correctly.
I only need it to stay alive, no ins.,little hope, dept of human services claims my disability pays to much for medicaid, and I have not made the two year mark yet for medicare, maybe I will die soon and they can spend the money elsewhere!
There are programs for people like you. check it out at your local hosptial. They will know where to send you. Make too many trips to the ER and they will make SURE you know how to appy for assistance. In the meantime, buy your insulin at Walmart.
I have way to much income to qualify for any assistance so that is where I buy my in insulin.
No mention of cause, no mention of GMO in food supply either, at least someone observed the gross profit margin! {for maintenance not for a cure.
I buy R and N Insulin over the counter at Illinois Wal-Marts. Yes, it is old fashioned Insulin maintenance, but my HBa1C is never oever 6 in the fifteen years I have used this. In addition Wal-Mart brand Insulin (Reli-On) is only $25 per vial. It is made by Lilly or Novo-Nordisk and I can manage my Insulin within my budget easily. Reli-On test strips are only 100 for $35 ….so I am happy! I have no insurance btw.
Hot topic!
IMHO:
If you are a type one diabetic you shouldn’t have to to continually renew your prescription for insulin. It’s obvious to anyone that without it you’d, like, die. Surely they can figure out some way to certify that you are a legit “consumer” or insulin and not have to continually renew your legitimacy as a sufferer of a supposedly incurable disease.
For this same reason, insurance companies should have no business (pun intended) NOT covering it, and this should be obvious too.
One of the most frustrating things about having to purchase my insulin by prescription is that I can never stock up for emergencies. I’m often refilling at the last moment possible. I think it is also obvious that a substance without which you will die quite quickly should be kept at the home of the potential “die-ee” in abundance–in case of emergencies such as outages, breakages hurricanes, any and all unforeseen circumstances, but this basic requirement is not even considered and can only be dealt with through subterfuge—-over-prescribing and stocking up over time. Something I’m never able to manage, unfortunately.
With insulin pumps like omnipod, for instance, it’s easy to use more than the “prescribed” amount—malfunctions happen all the time and lots of insulin gets wasted, leading to running out before the next refill is due. I’ve emailed my doc so many times for this very reason, and of course she responds by caling the pharmacy right away.
Any barrier to a life-sustaining medication is highly unethical, and those who seek to establish them are exhibiting extremely unethical behavior. Don’t physicians take an oath regarding harm to a patient? Is death not harmful? Is kidney failure not harmful? Are amputations not harmful? Is blindness not harmful? Are those acceptable prices to pay to control distribution of life-sustaining medications?
If you think they are, you might be a sociopath. Only a sociopath would maim or kill to attain some kind of goal other than sustaining a patient’s life. Denying insulin is tantamount to maiming or killing, as that is the outcome of that practice.