Is the U.S. the only country that requires a prescription for anticoagulation testers?

[Protimenow]

We've probably gone through some of this before, but probably not looking for an answer to this question:

The United States Food and Drug Administration, in its infinite wisdom, decided that you can't get an INR tester (CoaguChek XS or Coag-Sense, or probably supplies) without a prescription. Of course, this makes little sense because these meters just give you information - just like the blood glucose monitors and other testers that are available without a prescription.

I might send a letter to the FDA and my local Representative (and probably a Senator or two) to see if they can consider changing the requirements for these devices.

What I'm looking for, in a nutshell, is whether or not YOUR country (give me the name) requires a prescription for these items.

Perhaps even referring to papers or practices in these other countries that advocate weekly testing and promote self testing would also be very persuasive.

Thanks in advance

 

[LondonAndy]

As you know, I regularly post this document, where our "National Institute of Clinical Excellence" recommends self-testing with a CoaguChek XS machine, and there's also this document I found, from a regional health authority. I am sure I could find others, too, but suspect some from other countries would be more useful.

 

[tom in MO]

A few years ago I contacted the FDA about prescriptions and INR testers and supplies. I was told by an FDA representative that a prescription is not required by the FDA. It is usually required by your insurance provider.

 

[Protimenow]

Hmm.

I don't really need ANOTHER meter - my XS and XS Pro work fine. I really don't need an InRange.

My insurance carrier told me that Medicare will pay 80% and they would pick up the 20%. I didn't think to ask if I could buy it myself (I can't - it takes MONEY to do this) and submit the bills to Medicare and Blue Shield. I don't know if the features in the InRange are really of much value - there's no need to communicate with a testing service (I do my own management), and from what I've seen, the firmware updates are pretty minor and don't have any impact on the test results.

I'll probably give up my senseless attempt to get a 'free' meter and strips and stay as I am -- especially if getting an unnecessary meter will be a hassle to do.

 

[tommyboy14]

In the UK, anybody can buy the Coagucheck. You dont need a prescription. There is only one approved company selling them new and I just ordered mine and they send it to me. No doctors involved. Coagucheck is the only machine available.

At the clinic, they use their own Caogucheck to check against mine everytime I go. Every six months, the clinic does a blood test to test both their and mine coagucheck. The latest result was: My Coagucheck: 2.5, Theirs 2.4 Blood test 2.3. These are so close within each other it is pretty much the same.

I know in Germany and Switzerland they normally give you the machine before you leave hospital. I dont know if you need to get a prescription, but it is so normal there to self-test that everyone gets the machine before they leave the hospital.

I think it is the same in France.

There is no medical reason for why you cant just buy your own machine without prescription.

 

[Standardvelocity]

Script required in Canada, l believe for health care reimbursement. Seems like they can be purchased without.

 

[Protimenow]

Thanks Tommyboy.

I'll look a bit further into global requirements.

It doesn't make sense to me why a prescription would be required for the tester or supplies. Just like the blood glucose meters (which I've seen for FREE because the manufacturers expect you to buy THEIR strips - the old razor and blades approach) - which only give you test results. You can't act on the results without a prescription for insulin (blood glucose testers) or something with sugar in it, or warfarin (INR testing).

Maybe you could look at it kind of like a gas gauge in your car -- you probably COULD drive your car without a gauge, predicting how much fuel is left, and refilling your tank (usually) before you run out of gas - and you can get by without it -- but it sure helps to have an idea what the status of your gas tank is. Requiring a prescription for a fuel gauge (or INR test meter, or blood glucose meter) that just gives you a 'photograph' of your current blood glucose or INR status so you can respond to the information seems, to me, somewhat similar.

Why should a meter - that only gives you instant status information - be controlled, if the actual control is the doctor who is involved in actual prescriptions for insulin or warfarin?

 

[oo0My_Valve0oo]

deleted

 

[RAS]

A few years ago I contacted the FDA about prescriptions and INR testers and supplies. I was told by an FDA representative that a prescription is not required by the FDA. It is usually required by your insurance provider.

I wish that were true! Your FDA contact was incorrect though.

CoaguChek Systems require a prescription in the US per the FDA. There are many documents available in the FDA device database. The 510k decision document gives a good summary. Here are links to Vantus and XS Plus System PT 510k summary docs.

They are class II systems and the documents state a prescription is required. Unfortunately that includes the strips too.
We're stuck with the current situation unless these can somehow be reclassified.

 

[MdaPA]

CoaguChek Systems require a prescription in the US per the FDA.

In addition to a prescription/order from a Doctor, per Roche, a patient also needs to subscribe to a "paid" service through one of the authorized companies, not through a point-of-sale/medical equipment distributor, in order to "officially"obtain a CoaguChek XS and/or strips.

 

[Unicusp]

In addition to a prescription/order from a Doctor, per Roche, a patient also needs to subscribe to a "paid" service through one of the authorized companies, not through a point-of-sale/medical equipment distributor, in order to "officially"obtain a CoaguChek XS and/or strips.

Yeah it's a strange and corrupt system in the US to enable Companies to charge more and require services that may not be truly needed. I believe that through lobbying, Roche was successful in this requirement. Cannot buy any Roche equipment or supplies without the script. Yet, ironically one can buy the Coag-Sense meter and supplies without a script. That is what I do. Less expensive without insurance mark-up and cost out-of-pocket.

 

[RAS]

I'm not surprised Coagusense can be bought without a script, but Coagusense is a class 2 device and requires a script per the FDA. However they do wholesale to medical device companies who then sell direct to patients. Appears to be up to the medical device seller to enforce (or not enforce) the prescription requirement. As an example, Wilburn Medical has this statement in their Product Disclaimer terms: "All patients or home users should have a valid prescription for any medical supplies or devices that require one" But do they actually ask for a script or just leave it to the patient to self-police? Years ago when I had an Alere InRatio device the supplier (now out of business) I used for test strips had similar language in their terms, but never asked to see a prescription.

Roche has chosen to restrict sales to INR testing service providers and other medical providers. Apparently this has been successful at limiting options for a patient to directly buy Coaguchek devices and strips. It's a business decision that each of these companies made. They don't need permission from the FDA for this sales strategy. I don't know which strategy is more profitable.

 

[Protimenow]

Roche sells so many meters and strips that they probably don't care if the sales is actually restricted to services, or even if they limit sales to the gray market.

Coagusense (the company) is probably not in a position where they can afford to restrict the sales of their devices and strips. Although these are also class II, they can (probably) leave it up to their distributors to do the prescription enforcement. Also - requiring that patients can ONLY get their device and supplies from a service might even further limit their sales.

 

[Cris N]

Thanks Tommyboy.

I'll look a bit further into global requirements.

It doesn't make sense to me why a prescription would be required for the tester or supplies. Just like the blood glucose meters (which I've seen for FREE because the manufacturers expect you to buy THEIR strips - the old razor and blades approach) - which only give you test results. You can't act on the results without a prescription for insulin (blood glucose testers) or something with sugar in it, or warfarin (INR testing).

Maybe you could look at it kind of like a gas gauge in your car -- you probably COULD drive your car without a gauge, predicting how much fuel is left, and refilling your tank (usually) before you run out of gas - and you can get by without it -- but it sure helps to have an idea what the status of your gas tank is. Requiring a prescription for a fuel gauge (or INR test meter, or blood glucose meter) that just gives you a 'photograph' of your current blood glucose or INR status so you can respond to the information seems, to me, somewhat similar.

Why should a meter - that only gives you instant status information - be controlled, if the actual control is the doctor who is involved in actual prescriptions for insulin or warfarin?

In case you have not seen this https://wayback.archive-it.org/7993...NewsEvents/WorkshopsConferences/ucm476561.htm

 

[Protimenow]

Thanks.
I wasn't aware of this.

I'll read this today.

 

[tom in MO]

I wish that were true! Your FDA contact was incorrect though.

CoaguChek Systems require a prescription in the US per the FDA. There are many documents available in the FDA device database. The 510k decision document gives a good summary. Here are links to Vantus and XS Plus System PT 510k summary docs.

They are class II systems and the documents state a prescription is required. Unfortunately that includes the strips too.
We're stuck with the current situation unless these can somehow be reclassified.

Those documents state the requirement for a prescription comes from the manufacturer, not the FDA (see Section H of K110960). That's why you can buy strips from places that don't require a prescription and you can buy used meters. If FDA required a prescription those activities would be disallowed and FDA would take enforcement actions. Requiring a prescription is a restriction placed on the device and strips by Roche .

 

[Protimenow]

So, basically, eBay is being too careful.

I'm beginning to see some new listings (that may have gotten past eBay's filters) for strips and meters on eBay. I hope this keeps up and sanity will return.

I probably won't bother to get a prescription for an InRange - my XS meters work fine. It probably won't be worth the hassle if I HAVE to get a service in order to get a meter and strips.