Why does insulin require a prescription in the US?

#1

I’ve heard some countries don’t require a prescription to buy insulin and it made me wonder why its required in the US.

It really bothers me that something I need to stay alive I have to ask permission to buy. For example if I was out of town and lost my travel supply it would be great to buy one insulin pen without having to get proof I’m allowed to have it.

Is anyone aware of any efforts to change this in the US?

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#2

some insulins (analogs) require an Rx. you can purchase a number of insulins “OTC”.

FYI, there are many prescriptions that people need to survive. Just because they are necessary for you to maintain your health, doesn’t mean they are available over the counter (OTC).

#3

They should all be no rx. The newer insulins aren’t so they can continue to make huge amounts of money.

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#4

One of my major Asian corporate headquarters is in South India where there are a lot of highly educated people and many medications including insulin and all associated supplies are available over the counter (OTC) and by mail as well. My staff often complains that drugs which are prescription based in the US should be in India as well as too many uneducated people die in India from trying out medications that are readily available to them without medical assistance.

In Canada Insulin, however, is also OTC and I have never heard a similar complaint.

Not sure how best to give easier access without putting people at greater risk. Perhaps an initial prescription should be required with an extended, maybe 5 year date of expiration?

#5

I get that, but OTC insulin is available in the U.S. without a prescription as well in all states but Indiana (no idea why they’re the holdout). It is old-school insulin and not the fancy new stuff, and I suspect it is more dangerous than the analog insulins commonly in use now.

I can’t really see any reason why the US requires prescriptions for modern insulin analogs unless it’s to protect profits. The non-prescription model works in the vast majority of the world, and the only people I’ve ever heard of abusing insulin are a vanishingly small fraction of bodybuilders. Safety (regardless of the issues in India) doesn’t seem like the driving force here in the U.S. People don’t purchase insulin from Walmart to experiment with (according to the linked paper), they purchase it from Walmart without a prescription because they can’t afford copays or list price of modern analogs.

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#6

Chris - insulin was around before the FDA started regulating. When the recombinant human insulin was invented the FDA grandfathered it in because it was human insulin even though it was the porcine and bovine which required no prescription. Today you can walk into Walmart and buy NPH or regular for $25.

The analogs are not insulin. They are analogs. If you look at the molecular structure of each - lantus, humalog, novolog, tresiba, etc. they are all different. They are engineered to do different things. One concern with the engineered molecules is long term effects.

The exception is afrezza - which is human insulin. The concern with this was impact on lung function. At the 4 year mark afrezza users are not seeing decreased lung function and some are showing better lung function. Their RELs was recently lifted so this one has a chance of being available without prescription. It also requires no needles.

BTW - the way they use to control insulin was requiring prescriptions for the needles. This was lifted after the introduction of plastic needles which could not be sterilized but were being reused and were spreading HIV and Hepatitis.

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#7

Thats interesting to know the older insulin was grandfathered in. Still I think human or analog insulin should be treated the same. I agree with another’s statement that the older insulin is likely more dangerous.

I suspect the reason comes back to money and profits not safety. I appreciate this discussion and highlighting some details I was not aware of.

#8

Actually Indiana used to have the older insulin with no prescription. This changed in 2014 with the strong backing of the state AMA. Making sales tax collection greater in IL, OH, KY and MI. Go figure.

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#9

Because it’s a dangerous drug that can cause major side effects up to and including death quite easily, and so the regulations require that it can only be dispensed with the approval of a doctor.

Just look how many people who don’t even actually have diabetes have joined this forum over the years, absolutely certain that they had type 1 diabetes, even though their doctors were telling them that nothing was wrong with them… some of them might be dead if analog insulin was available without a prescription.

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#10

If that were the case, we would see more evidence of this from the rest of the world. Insulin can be dangerous, but it can also be used safely OTC with a doctor or without. I see a greater risk from imposing more hurtles to the people with diabetes.

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#11

I don’t necessarily disagree… but that’s the logic with it and all other prescription drugs here in the USA… that someone who knows what they’re talking about (a doctor) has to determine that the benefits outweigh the risks…

Unfortunately with the payer system here in the USA that leads to all kinds of pricing games…

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#12

Many over the counter medications can be deadly if taken improperly.

Diabetes requires us to manage our selfs. Doctors are advisors but we are responsible for our self between visits. In the 3+ months between my doctor’s appointments I make thousands of care decisions without their input.

The first day I was diagnosed I was told to start at 40 units per-day (20 units of Basaglar morning and night). I thought that sounded high so I took 20 units (first day). I then set an alarm to wake up every 2 hours all night long each time with a sugar between 50-60. If I hadn’t done what I thought was safe I might have died my first day on insulin.

Over a few days I figured out my self I actually needed closer to 12 units per-day.

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#13

Yeah… but had you not gotten the advice to take 40, maybe if you didn’t know anything about it would have asked some guy you work with how much he takes… and maybe he takes 100u / day… and maybe you would have thought… “well my blood sugars are really high, and I weigh at least 30 lbs more than him… i must need at least 150u” or something like that

And yes otc drugs can be dangerous if taken improperly as you say… but what differentiates them is that they are so easy to describe how to take properly that they can print it in one-size-fits-all instructions on a little tiny label with no need whatsoever for individualized guidance

Also you have to realize that these things are designed for the lowest common denominator sort of people. You may be an intelligent person capable of making many well informed decisions every day about how to titrate your insulin doses, but not everyone is so fortunate, and some couldn’t even comprehend the idea of thinking for themselves…

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#14

You make solid points.

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#15

Chris - there no no doubt money is a HUGE driver in the pharma industry, just look at all the non-insulin T2 meds with highly questionable safety history.

The initial issue with the analogs was safety. Initial development of the analogs did not go well. By the end of the 1980’s Eli Lilly and Novo Nordisk were both working on a “Rapid” acting analog. Initially, Novo Nordisk took the lead and they were working on an AspB10 analogue. The goal was to develop a monomer insulin. The “Holy Grail”of insulins.

Their approach was to alter the amino-acid composition in such a way that the insulin molecule would no longer self-associate to hexamers around a zinc atom. The amino-acid at position B10, a histidine, was known to be involved in zinc binding and so it seemed rational to replace this with the negatively charged amino acid aspartic acid which is where the name AspB10.

The first tests of this new insulin analogue were promising. Absorption after subcutaneous injection was indeed twice as fast as absorption of human insulin. The first clinical study in humans demonstrated that postprandial glucose peaks decreased compared to regular human insulin.

It was the first “Rapid”analogue tested in humans. However, while the phase 2 trials in humans were underway the scientists back in the lab revealed a dose-dependent increase in mammary tumors in female rats. In simple words, they killed the rats back in the lab.

After that everyone got gun shy of the long term effects. Twenty years later the argument goes on http://care.diabetesjournals.org/content/early/2016/01/05/dc15-1816

#16

Can you please decode, “REL”?

#17

Quite a few drugs that start out as perscription only are converted to OTC. The synthetic human insulin’s are a good example. The FDA has two formal processes for doing so. Here’s a one-page article from the FDA website describing the process.

https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143547.htm

I’m not sure why analogs haven’t been converted to OTC while animal and human insulin have been. One of the processes requires the manufacturer to submit a new drug application (NDA) to start the review. My guess is Lily and Novo won’t do so until their patents expire. The other process is an internal FDA-initiated review. Not sure whether the analogs have ever been reviewed. I imagine you could dig through the FDA website and find out.

#18

If insulin went OTC would it still be covered by insurance? Think about it!

#19

Exactly. In Canada, where a prescription is not required to buy insulin, a prescription is required for coverage by private or public insurance or to be eligible as a medical expense for tax purposes. Therefore, very few Canadians buy insulin without a prescription. We leave that to our American visitors. :grinning:

#20

I’m one of those in Canada who pays as I go (All meds are out of pocket purchases)