Dumb pharm question

[nancysinatra]

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Does anyone know what qualities a drug has to have in order to be sold OTC? I wonder if some of the SSRIs could be OTC? I mean, why not? Any good reason? People can diagnose themselves with toothaches and yeast infections so why can't they diagnose themselves with depression or anxiety? This might really help ease up the psychiatrist shortage.

 

[st2205]

St. John's Wort?

 

[OldPsychDoc]

Does anyone know what qualities a drug has to have in order to be sold OTC? I wonder if some of the SSRIs could be OTC? I mean, why not? Any good reason? People can diagnose themselves with toothaches and yeast infections so why can't they diagnose themselves with depression or anxiety? This might really help ease up the psychiatrist shortage.

That ought to reassure folks on this board. No more worries about being replaced by NPs. We can be replaced by anybody with a google account! 👍

 

[F0nzie]

Don't forget free online CBT. I tried it once. It was pretty good.

 

[billypilgrim37]

A drug with a black box warning for suicidality probably isn't going to be sold over the counter any time soon.

 

[shan564]

St. John's Wort?

Yeah, that's what I was going to say...

 

[psychattending]

Does anyone know what qualities a drug has to have in order to be sold OTC? I wonder if some of the SSRIs could be OTC? I mean, why not? Any good reason? People can diagnose themselves with toothaches and yeast infections so why can't they diagnose themselves with depression or anxiety? This might really help ease up the psychiatrist shortage.

I believe that FDA also considers the illness being treated and whether it is something that needs a physician for Dx or longterm care. Given that people die from major depression, I would not anticipate any antidepressant being approved if the FDA factors in the disease.

 

[nancysinatra]

A drug with a black box warning for suicidality probably isn't going to be sold over the counter any time soon.

Yeah, I was thinking that would be the main thing. But isn't there some amount of arbitrariness in how the FDA decides to put black box warnings on drugs? Really my question is more basic. Why are some drugs OTC but not others? What are the criteria? Tylenol and ASA will kill you if you take too much. You can buy caffeine pills, and that would be bad during pregnancy. You can buy cigarettes and alcohol. Some people even buy absinthe!

If someone has a headache every morning for 3 years and all they do is take ibuprofin (whether it helps or not), and it turns out they have a brain tumor and they die, you could argue that they should have seen a doctor much earlier and they have a long term potentially fatal condition. You can self diagnose constipation and diarrhea, both of which can have serious causes. Is there a specific reason why people should not self-diagnose depression?

I suppose one reason might be that there are no truly benign causes for depression? There are certainly benign causes for pain, constipation, etc.

At some level it must be political, because some drugs that are OTC in other countries, like benzos, require a prescription here.

 

[michaelrack]

Really my question is more basic. Why are some drugs OTC but not others? What are the criteria? .

It's hard to meet the current criteria (partially described by psychattending). That's why most of the OTC's are old drugs. Tylenol, aspirin and ibuprofen would never be approved as OTC's if they were developed today.

 

[DebDynamite]

5HTP

5-0-300 mg daily, various brands/labels, increases serotonin (?):

http://www.vitacost.com/natrol-5-htp-tr-time-release


People pay for this on their own, all day long. I think you could also sell citalopram OTC, black box and all, and we would stay just as busy. Job security in this economy is a good thing.

 

[nancysinatra]

It's hard to meet the current criteria (partially described by psychattending). That's why most of the OTC's are old drugs. Tylenol, aspirin and ibuprofen would never be approved as OTC's if they were developed today.

That would be terrible!

The FDA is both good and bad. It regulates drugs so there is less risk to consumers. But they slow down developments and restrict access to things. No wonder there are always new "herbal" treatments appearing.

 

[nitemagi]

Try reading:
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs
by Avorn.

Covers many things including the history of FDA and how we've gotten where we are in our regulation. Includes things like that if tylenol was released now it probably wouldn't be OTC (kinda got grandfathered in)

 

[nancysinatra]

Try reading:
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs
by Avorn.

Covers many things including the history of FDA and how we've gotten where we are in our regulation. Includes things like that if tylenol was released now it probably wouldn't be OTC (kinda got grandfathered in)

Thanks! Sounds very interesting. I recall hearing that some of the current prescription meds also got grandfathered in, not as OTC but when the FDA created the current system for approving rx meds. I think phenobarbital was one--it has never been tested.

Something I understand about the FDA is that the current prescription drug approval process takes so long that companies' patents expire during the process, or shortly after approval, which means they can only profit from a new drug for a few years, and that may be why the drug companies are always trying to cough up the newest copycat drug--because they can get a patent and profit off of it without having to start from scratch with the research and approval process.

 

[DOC PENGUIN]

Try reading:
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs
by Avorn.

Covers many things including the history of FDA and how we've gotten where we are in our regulation. Includes things like that if tylenol was released now it probably wouldn't be OTC (kinda got grandfathered in)

Its great that your back.

 

[J ROD]

They usually look at the side effect profile and the potential for harm.

Psy meds will not make the cut. Black box warnings as mentioned and most have nasty side effect profiles that would make them not suitable for the general public to manage.

 

[SuperSoccer19]

Some how I have a feeling money is behind this decision more so then safety, efficacy or common sense.

I wonder how making a drug OTC affects pharm co. profits? There seem to be so many factors at play ranging from price to competition to allowing the consumer/patient make decisions over physicians, etc.

 

[nancysinatra]

They usually look at the side effect profile and the potential for harm.

Psy meds will not make the cut. Black box warnings as mentioned and most have nasty side effect profiles that would make them not suitable for the general public to manage.

Buspar, anyone?

 

[Armadillos]

slight aside, but somewhat related. What are the main important studies people are generally referring to when they say that SSRI's are or are not more effective than placebo for depression? I feel like so often I hear both sides of this statement, so presumably there is some conflicting data out there?

 

[DynamicDidactic]

slight aside, but somewhat related. What are the main important studies people are generally referring to when they say that SSRI's are or are not more effective than placebo for depression? I feel like so often I hear both sides of this statement, so presumably there is some conflicting data out there?

can of worms opened?

here is a big article and one of the biggest critics
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2253608/?tool=pubmed

 

[Armadillos]

can of worms opened?

Not really?

I assume like most things in medicine there are a couple famous studies on each side and the results from both sides get overgeneralized and taken out of context to prove points the studies didn't actually prove.