CPAP Prescription

[Gary L Wyatt]

I have been using a CPAP for over ten years and it is about to shoot the bucket. I am unemployed and can't afford a new sleep study. The pressure on the old CPAP is fine and I don't get fatigued in the afternoon. Should I ge able to get a copy of the original prescription and would a vendor honor a prescription that old?

[-SWS]

https://www.cpap.com/cpap-faq/Prescriptions.html#221

[tomjax]

The answer quoted is further proof that its author does not know the law.

It states that a prescription does not expire which is not according to drug laws.
All rx in the US expire after one year.
Controled subsatnces are 6 months.

My recent dme in Jax said I needed a new Rx every year and I told her she was wrong.
She was.

An ORDER does not expire unless it is timely.

Yet the confusion continues

and I am still waiting for the statute that says a PAP requires a RX.

[6PtStar]

My Script said good for lifetime. My DME informed me that I had to have a new one for every new mask no matter what the script said. I am having a real problem with this kind of BS. I thought DME's were in it to make money. How can they make money if they keep refusing to sell us things we need? They also had a clause in the contract that they did not supply small items unless they were combined with a large item. I could not get a new hose or filters unless I was getting it at the same time as I got a new mask.

Jerry

[ricochetv1]

"Hey, Jim-Bob-Jo-Jimmy-Bob-Jim! Come over 'ere 'n smell'er!"

"Yee-haw! That smells worse than my Aunt's nickers after a bullfight!"

"What the hell kinda steer you suppose left that pile uh crap on the road?!"

"I dunno, Bubba, but it must'a been one helluva big 'un!"

[-SWS]

and I am still waiting for the statute that says a PAP requires a RX.

Tomjax, we've been hearing your adamant legal position about CPAP prescription status for years now. However, the central question here is what the FDA legally maintains regarding CPAP prescription status.

Bear in mind I'm neither pharmacist, lawyer, nor government bureaucrat. But I just went to the FDA website and randomly pulled
an FDA approval letter for the first CPAP machine that my mouse happened to click on at random:
http://www.accessdata.fda.gov/cdrh_docs ... 053486.pdf

Page 5 of that FDA approval letter clearly designates "Prescription Use _X_ (Part 21 CFR 801 Subpart D)".

Bear in mind that's not a third-party legal opinion. Rather, that's a letter written by the FDA in 2006 stating exactly which federal law THEY think mandates prescription status for that CPAP machine. If the FDA agreed with you, Tomjax, they would have put a big "X" by the "Part 21 CFR 807 Subpart C" section of that same page.

Yet the confusion continues

Apparently not on the part of all those DME's who are legally required to demand a CPAP prescription--- because of the FDA's "Prescription Use (Part 21 CFR 801 Subpart D)" legal requirement. End of confusion I hope.

[Guest]

obviously you folks know nothing about the possible harm an improperly adjusted CPAP machine could do to people with ALS or other types of breathing disorders or pulmonary conditions. These are medical devices that require a doctor's order for dispensing.

[-SWS]

My Script said good for lifetime. My DME informed me that I had to have a new one for every new mask no matter what the script said. I am having a real problem with this kind of BS.

obviously you folks know nothing about the possible harm an improperly adjusted CPAP machine could do to people with ALS or other types of breathing disorders or pulmonary conditions. These are medical devices that require a doctor's order for dispensing.

What does your irrelevant and trollish answer have to do with either the original poster's purpose of this thread or even the majority of discussion occurring in this thread?

Obviously many industrialized nations that DO NOT require a CPAP prescription disagree with your decree, guest. But that's not to say the consensus discussion in this thread maintains that CPAP machines shouldn't need a prescription. Obviously trolls don't know how to read.

[Muse-Inc]

...I am unemployed and can't afford a new sleep study...

You have my sympathy; I'm in the same boat 'cept I have an ongoing relationship with my sleep doc who did my PSG in '07. I too need a new study but finances preclude one, so my doc loaned me an APAP and recording oximeter a week ago to gather 5 night's of data. He should have analyzed it today and I see him tomorrow to discuss the results. He and I both agree something's gotta change as my current CPAP therapy is not getting me where I need and want to be after nearly 2 yrs. I do have insurance so for me there is help with whatever the costs of improving my therapy is going to cost.

[rogelah]

obviously you folks know nothing about the possible harm an improperly adjusted CPAP machine could do to people with ALS or other types of breathing disorders or pulmonary conditions. These are medical devices that require a doctor's order for dispensing.

II certainly do because I have FSHD. I might also point out that the folks here have had a PSG and a titration or two which resulted in a doctor writing a prescription indicating how the machine should be enabled.

You probably take medicine on a daily basis and have had a doctor or two tell you to take an aspirin or acetaminophen or ibuprofen and it said on the prescription PRN and you decide when within the parameters for the medication such as no more than 3 times in 24 hours.

Well, Guest, we have machines that have been properly prescribed and set up. But instead of waiting 3 weeks or more before we return to the doctor we take an interest in our improvement or non-improvement on a regular basis such as daily.

We are not adjusting other people's machines but sharing our experiences as we adjust our own.

If you would like to share your story there are plenty of sympathetic ears here to help or just commiserate with you. Otherwise, begone!

[apnez]

obviously you folks know nothing about the possible harm an improperly adjusted CPAP machine could do to people with ALS or other types of breathing disorders or pulmonary conditions. These are medical devices that require a doctor's order for dispensing.

And YOU are surely not aware that doctor's prescriptions about CPAP or APAP are generaly flimsy opinions on what should be ok. I would qualify their prescriptions as a generally educated guess. I would also say that 90% of the time we have to fine tune or adapt their guess to our real needs and find by ourself the optimal settings.... As a matter of fact, we are paying them thousands of dollars for their guess. As a matter of fact also you are speaking, here, to people who know a lot more on the matter than the vast majority of those who have the legal right to prescribe. The fact that those machines are named medical devices and require a doctor's order for dispensing in USA has nothing to do with patient security. This is B.S. it has it's fundamental in money making. Period.

[raylo]

obviously you folks know nothing about the possible harm an improperly adjusted CPAP machine could do to people with ALS or other types of breathing disorders or pulmonary conditions. These are medical devices that require a doctor's order for dispensing.

And YOU are surely not aware that doctor's prescriptions about CPAP or APAP are generaly flimsy opinions on what should be ok. I would qualify their prescriptions as a generally educated guess. I would also say that 90% of the time we have to fine tune or adapt their guess to our real needs and find by ourself the optimal settings.... As a matter of fact, we are paying them thousands of dollars for their guess. As a matter of fact also you are speaking, here, to people who know a lot more on the matter than the vast majority of those who have the legal right to prescribe. The fact that those machines are named medical devices and require a doctor's order for dispensing in USA has nothing to do with patient security. This is B.S. it has it's fundamental in money making. Period.

My board certified Sleep Doc, with all the letters behind his name, told me in so many words, just what apnez said. He told me that he believes that our (humans) collective knowledge of how to treat sleep problems is in its infancy. We don't much know about sleep period.

He knows more about the medical side of sleep than I do, but I know more about current machines and their capabilities. I have had to help his techs change settings on my machine and I have pointed out when my machine was set improperly or contrary to explicit terms in the prescription.

He has listened to me and expressed his pleasant surprise at my knowledge (most of which was gathered here). He has changed my prescribed pressure a couple of times after consultation with me. We have talked about what are safe/reasonable adjustments I can make. When I talked about getting an APAP we discussed the ranges I might set it at. He did not use absolute terms.

I think that this is how it should be with any patient. We should all know the safe parameters of this therapy, and we should be informed enough to be able to make small, safe changes to improve our therapy. We should not be kept in the dark like so many of us are. We are lucky if we are shown how to use the darn machine and are often told not to try to understand it more deeply than "slap it on and sleep."

If xPAP is prescribed, but the patient has some condition that could make an improperly adjusted machine harm them, they should be fully informed and warned of that. The technicians who set the machine should capable, and careful, enough to set it properly. The patient should be informed on how to double check the settings and of warning signs that something isn't right. They should have extra, timely follow up with the physician and/or knowledgeable staff to ensure all is as it should be. They shouldn't be left so uninformed as to consider making an unsafe change.

One of the dangers of keeping people uninformed is that they may unitentionally do something wrong.

[LinkC]

Methinks polysomno-freak has reared his ugly head once again.

Only now he's finally figured out how to manage the "Also posted as..." feature.

Welcome back! We need a few laughs...

[klockemy]

Anyone care to share the polysomno....whatever, story? Some of us new folks haven't been endowed with this knowledge.

I will start a new thread as not to hijack this one.