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thelabdude
05-15-2012, 09:57 PM
Ok, I am a big mess physically. I have Neff tubes, they run from my kidneys to bags strapped to my legs. Twice a day, they need backflushed, injecting 10 ccs of 0.9 saline. We are about out and my wife check with Walgreens today. She was told she would have to have a prescription. Now I can understand prescriptions for some stuff. My PCP just advised me to cut my dose of Lisinapril in half lest I collapse. But salt water?

running coach
05-15-2012, 10:06 PM
Isn't it supposed to be sterile?

dexter
05-15-2012, 10:20 PM
First, my sympathies offered for your health issues.
As to the script for the saline, if you're in the US and you have insurance, it can kind of be a good thing, in that at least it can be applied to your insurance. I wouldn't think sterility in and of itself would be a factor. I mean, bandages are generally sterile without a script.

Mangetout
05-16-2012, 02:39 AM
Emergency eyewash bottles are a)saline b)sterile and c)cheap but check with your doc before using something other than the specified solution(ha!) In case the composition or packaging makes it unsuitable.

thelabdude
05-16-2012, 09:57 AM
Since it is going to be squirted a sensitive part of my body, yes I want good stuff. Still, it seems to me the public should be able to trusted with salt water.

robert_columbia
05-16-2012, 10:22 AM
...Still, it seems to me the public should be able to trusted with salt water.

I, for one, welcome our new salt water abusing overlords. I'm gonna be on the phone with my broker buying call options on some new salt water rehab facility.

purplehorseshoe
05-16-2012, 11:12 AM
How did you previously obtain the saline? Was it over-the-counter? And will your PCP write a scrip so Walgreens can do their thing?

mnemosyne
05-16-2012, 01:32 PM
Since it is going to be squirted a sensitive part of my body, yes I want good stuff. Still, it seems to me the public should be able to trusted with salt water.

The first part of this quote more or less negates the second part.

Medical saline goes through the same manufacturing and quality control issues as any other drug; it went through regulatory approval, SOP and method development and validation, it has particular techniques and cleaning protocols associated with the manufacturing equipment, requires trained workers to manufacture, it is tested for pH, purity, dosage (that 0.9% probably is accurate to within +/- 2.0% of the label value), microbial content (minimal/non-existent), impurities (no other salts, medical products, preservatives, etc), it must pass release and identity testing before shipping and must undergo ongoing long-term stability testing to ensure quality (in addition to the original stability it went through to verify the manufacturing procedure and packaging).

Heck, the water used to make the saline is tested independently first, and I can tell you for an absolute fact that it's a PITA testing protocol and takes anywhere from 1 to 1.5 days' work, before documentation and review, and that's just the easy wet chemistry. The microbial stuff takes longer (for reasons that I hope are obvious).

It is a drug, as much as any other drug, and so it's not a matter of "trusting the public with salt water" because if that's really all it is, go ahead and grab some table salt (hope you grab the right amount) and put some into a Ziploc baggie full of tap water. Only you wouldn't dare, because it is for a sensitive part of your body, and you expect a certain medical quality that you know you won't get, unless you really want to see what iodine does to your medical condition.

See the contradiction?



The FDA does not allow normal saline to be dispensed without a prescription (other than wash saline, which is not suitable for your needs). I admit to not knowing why, though.

elbows
05-16-2012, 01:36 PM
You may find it's actually distilled water, that's then salinated.

tdn
05-16-2012, 01:40 PM
I, for one, welcome our new salt water abusing overlords. I'm gonna be on the phone with my broker buying call options on some new salt water rehab facility.

I'm trying desperately to come up with a quip involving kids today, meth labs, and tropical fish tanks. I'm failing miserably.

thelabdude
05-16-2012, 01:50 PM
How did you previously obtain the saline? Was it over-the-counter? And will your PCP write a scrip so Walgreens can do their thing?

I was sent home with a liter bottle. I have a call into my PCP and if it is returned, expect no trouble getting a script. I also may call the practice that did the tubes. They and already given me more urine collection bags after what I was sent home with started to leak.

My Walgreens has an extensive selection of drugs people depend on to be properly made. It seems to me the criterion for script/OTC is how much trouble you can get into with unsupervised use. Saline is commonly use for a number of things.

redtail23
05-16-2012, 02:01 PM
Right, I think the OP's complaint is not that the saline solution is regulated and treated more-or-less like a drug.

It's that it requires a prescription instead of being OTC.

I can buy contact saline solution or eyewash OTC, and it meets a lot of the same standards. I can (so far) still buy pseudoephedrine without a prescription, even though they keep it behind the counter, require an ID for purchase, and track your purchases. I can purchase all sorts of FDA-regulated drugs OTC.

So why the Rx for this particular type of saline solution?

mnemosyne
05-16-2012, 03:12 PM
Normal saline (sterile) is distilled and deionized water ("USP Sterile Water for Injection", IIRC) and pure NaCl added to it. It is then sterilized and packaged. Naturally, once open, the package is no longer sterile. It is easier to remove everything from water then add back what you want than to selectively keep what you want while removing everything else.

I can assure you that the standards are in fact different: the purity levels for preparations of eye washes are different than that of Sterile Water for Injection (there's something like 4 or 5 different levels of USP standards for different pharmaceutical uses of water, IIRC. It's been a while, so forget the details). On the surface, these types of products might seem to be the same, but they really aren't when it comes to how they are made.


WAGS for the lack of OTC approval:

Is saline typically (or ideally) used for illegal drug use? I honestly have no idea; it might be a matter of making it harder to obtain in order to deal with the illegal use of something? Steroids or cocaine or something?

Improper use for irrigation could also lead to infection and other issues, I would think. It might be a public-health thing; prescribing it ensures that patients see a doctor regularly, and are well-trained in how to use it, in order to prevent infections and more costly complications.

A quick but unreliable google search suggests additional risks for kidney or heart patients - who may be the very ones using it? Perhaps it is, again, to ensure regular monitoring of at-risk patients, who make up a significant enough percentage of users that it's worth it to just make it a prescription and be done with it.

Then you probably also get into cost issues: this is a generic, but by no means a low-cost thing to manufacture (nothing sterile is low-cost) and so there might be reasons no manufacturer wants to file the ANDA to get OTC approval. One may one day do it, and the rest would follow, but market conditions might not ever make it worthwhile (just filing the paperwork costs a small fortune).

thelabdude
05-16-2012, 09:55 PM
Then you probably also get into cost issues: this is a generic, but by no means a low-cost thing to manufacture (nothing sterile is low-cost) and so there might be reasons no manufacturer wants to file the ANDA to get OTC approval. One may one day do it, and the rest would follow, but market conditions might not ever make it worthwhile (just filing the paperwork costs a small fortune).

Makes the most sense to me. You would have to prove beyond doubt that it is as safe as it obviously is. You would then never recover your costs in a limited market.

The Neff tube practice is calling a prescription to my Walgreens in the morning. Fortunately my wife had the foresight not to wait until we were out.

mnemosyne
05-16-2012, 11:14 PM
Adding to that idea, how many people are doing these sorts of procedures on their own? If the vast majority of saline is being used in hospital/clinic/outpatient situations, and only a small number of people need it for home use (without having a home care worker come in and treat the patient), then there may never have been the numbers to even bother looking into making it OTC.

IIRC, the original drug approval is always for prescription use only, and a considerable amount of data - and consequently, time - goes into filing the ANDA to get OTC approval. If there haven't been enough patients to even "ask" for it, there is really no point pursuing it for the manufacturer.


A few years ago, my sister lived in PEI. She has been on a medication for several years, which costs in the range of $25 000 a year (medicine isn't covered in Canada, though pretty much any full-time employer has plans for it, or it's on government aid lists for students/children/elderly/etc). Anyways, prior to her, no one on PEI had ever used this medicine: the population of the province is such that no one had her disease, or, at least, no one was being treated with this drug for it. So the government couldn't help her cover the cost of the drug, since it wasn't on their list. In the end, they found a way, but that first month of trying to sort out what to do was a little weird!

grude
05-17-2012, 02:01 AM
Well to put some reality back into the speculations pharmacies here in Trinidad sell bags of Baxter brand IV saline solution OTC and the cost is around two to five US dollars, so I think the idea that sterile saline is costly are misfounded.

It might very well be due to drug use worries, the availability of even syringes OTC varies between the states in the USA(ironically every agricultural supply usually has a bucket of 1cc syringes by the counter in the USA, while the pharmacy next door might require a RX:confused:).

I really hate the theory many in the health care profession in the USA have that by making everything RX only will ensure patients see a physician, this same reasoning was put forward as a reason to remove Primatene Mist from the market many times. This theory doesn't pan out, in the case of asthma it will lead to poor kids being told to relax and drink this herb tea that grandma says will cure you because we can't afford a ER visit.:smack:

mnemosyne
05-17-2012, 11:14 AM
I don't know: I consider 2-5 USD for a litre of water and a few grains of NaCl to be quite expensive. There are no other ingredients; you are paying for the process. There is, of course, the manufacturing advantage of rather easily being able to make massive lots of product at a time (compared to things like tablets or small vials of morphine), but the process itself it still costly, particularly for the company. I expect that normal saline isn't Baxter's big money-maker (aren't they the syringe makers too? That's where the money's at!)

Syringe availability is, in general, a response to illegal drug use rather than medical patient safety. The War on Drugs, I guess.

As for your last point: valid for the USA, but makes sense in places with UHC. The idea of healthcare should be to provide as much preventative care as acute/emergency care, and the sheer idea of going to the ER to renew a prescription for chronic asthma is kind of crazy. Systems should have easy access to GPs and walk-in clinics at no cost (ideally) and drug plans should make common medication as affordable as possible (if not free as well, which would be one hell of an ideal).

The idea of making everything prescription only has a benefit of ensuring that patients see doctors more often, but it isn't the scientific cause. Getting to OTC requires data, and some of that data needs to come from real-world users, simply because that's how you get all the long-term data, etc. Sure, there are cynical reasons too: keeping things under patent and at higher costs in order to make profits, but that's the reality of the economic world we live in. Any drug with proven safety can go OTC: it's just costly to bother and the burden falls on the manufacturer, and they don't do it.




In the years I worked in pharmaceuticals, I never once saw someone cackling evilly...well, other than the lucky SOB who got to use the bunsen burner on any given day. Lab geeks love bunsen burners.

wheresmymind
05-17-2012, 11:34 AM
As others have said, there are many different OTC products that are essentially "sterile 0.9% saline solution." The reason this particular product is prescription is to ensure that the patient gets exactly what they need. It's not hard to imagine someone browsing through the drugstore and saying to themselves "Hmm, this injectable saline solution costs a lot more than this eyewash. But they both have identical ingredients, so I'll just buy the eyewash and use that." They could be forgiven for thinking this, because we're taught (by our doctors no less) that for most OTC drugs the cheap generic version is just as good as the expensive name-brand version as long as the active ingredients are the same. But it's already been pointed out that in this case, it's not the ingredients but rather the manufacturing process that matters.

It's not that they don't trust the public with saline, it's that they don't always trust the public to pick the right saline.

mnemosyne
05-17-2012, 11:52 AM
I'll always defend generics: it's not the doctors making claims, it's the entire process of approving generics that result in the generic of a product being just as good as the brand name (determined, as all things, on a statistically significant population). There is nothing special about the cookies I make in my kitchen vs in yours: that's essentially the difference between brand name and generics.


Baush & Lomb eye wash, as a random example that I happen to have in my house, is "essentially sterile saline solution" but it also contains buffering agents and preservatives: boric acid, sodium borate, HCl or NaOH (for pH balancing), EDTA and Sorbic Acid.

It is most definitely NOT the same as Normal Saline, used for IV or irrigation, which is water and NaCl only. In many cases, people won't think twice to look for preservatives, but their presence or absence does matter. You're right - choosing the correct saline would perhaps come secondary to choosing the least expensive saline, but in this case, these two products are NOT generics of one another. They are different products, with different treatments in mind.

wheresmymind
05-17-2012, 12:11 PM
[...]You're right - choosing the correct saline would perhaps come secondary to choosing the least expensive saline, but in this case, these two products are NOT generics of one another. They are different products, with different treatments in mind.

Agreed. I wasn't trying to imply that eyewash is a generic version of injectable saline, just that thinking so would be an easy mistake to make.

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