Why are some drugs deemed safe for OTC when others of no greater risk require a Rx? I’ll have to come back and post a few examples which came to mind. (Where did Rx come from, anyhow?)
“They’re coming to take me away ha-ha, ho-ho, hee-hee, to the funny farm where life is beautiful all the time… :)” - Napoleon IV
Rx isn’t really Rx. It’s an R with a slash through its leg. That looks a bit like Rx, so that’s how it’s spelled when using a keyboard. It’s an abbreviation for Latin “recipe” (take), as in Rx 2 aspirin.
I don’t know the answer to your first question, except for some older medications. Meds that were already on the market got a bye when the legislation was passed that created the FDA. Aspirin and phenolphthalein (former ingredient in Ex-lax) never went through the approval process. Unfortunately, phenolphthalein has since been shown to be a carcinogen. As of a few years ago the FDA was planning to start testing all the older drugs for safety.
Work is the curse of the drinking classes. (Oscar Wilde)
What does the pharmacist’s symbol “Rx” mean?
OTC drugs are usually not as strong as prescription. E.g., ibuprofen is usually dispensed in 600 mg tablets for prescription and 200 mg OTC (Motrin). It’s technecally illegal to take 3 OTC Motrins to get the same dose as a prescription. But unless you live with an FDA agent, you’ll probably get away with it. If you get ill from taking the OTC stuff, you can’t sue because they have a warning on the package about not using the product as directed or without a doctor’s approval to use it that way.
Other drugs that aren’t OTC yet have been approved for specific use when prescribed by a doctor. If the drug is determined to be safe and effective at reduced levels, it may be allowed to be sold OTC.
Still other drugs have been determined not to be safe when overused, so they’ll never be sold OTC.
You must unlearn what you have learned. – Yoda
It’s funny because I can recall signs outside drugstores using “Rx” prior to the problem of ASCII characters as Cecil suggests. While the same problem still existed with the typewriter, I think sign makers and print shops must have moved away from the funny “R” to a “Rx” symbol. In fact, I WAG more people would think the funny “R” symbol was just “short hand” or a cute way of writing “Rx”. (Now I know better!)
“They’re coming to take me away ha-ha, ho-ho, hee-hee, to the funny farm where life is beautiful all the time… :)” - Napoleon IV
There was a cover story in USA Today last week about the fact that three medications currently hot in the US for allergy relief (including Claritin) are OTC medications most everywhere else in the world, but have the requirement of prescriptions here. Guess what the relative prices are in OTC countries (like Canada) for Claritin versus the US?
Blue Cross has a petition before the FDA to have the three drugs put on OTC status on the basis that they have no known significantly harmful side effects (one of the drugs involved doesn’t have a known lethal dose). According to the law governing the issue, anyone can petition to have a drug declared available OTC; in fact this is the first time the petitioner hasn’t been the manufacturer of the drug. Usually, the petitions aren’t made until the patent on the drug expires, whereupon the manufacturer moves the drug to OTC and tries to corner market share with the still well-known name. According to the article, the manufacturers of the three drugs in question, having convinced the various other regulatory agencies in the foreign countries that the medications are safe enough to be sold OTC there have argued strenuously that the medications are not safe to be sold OTC here.
With Claritin costing something around $70 for 30 pills here in the US and only $15 for the same thing in Canada, and with millions of advertising conscious Americans suffering runny noses all spring and summer, I don’t think it’s any wonder that Shering-Plough is aproaching the issue this way. 
You might also want to bear in mind that just because a prescription drug’s patent has expired doesn’t mean you’ll be able to go down to the corner Walgreen’s and get it the next day. It will certainly become a generic, but that just means the cost to your HMO will get cheaper. Many drugs that have dangerous side effects, commonly interact with other drugs, or have norrow indexes of indication (i.e. the right amount works but just slightly more than that is dangerous) will continue to stay on a pharmacist’s shelf.
As already mentioned, they will sometimes lower the dose and reformuate the product though (witness Tagamet —> Tagamet HB)
“Generic” is not the same as OTC. A brand-name drug doesn’t “become generic” when the patent expires. generic forms of the drug may become available, but that’s not the same thing, and that can happen before the expiration of the patent.
(Dat was my column, not Cecil’s. But tanks - Jill)
An interesting side note from a pharmacist friend. In Illionis, you should always have your doctor write the prescription out for the name brand and check may subsitute generic.
This is because in IL the generic equivilent of a drug must be IDENTICAL to the chemical make up of the name drug. However if the doctor prescribes the generic that stipulation doesn’t apply
Jinx, I can’t seem to locate my pharmaceutical textbook (I do have one - paid a bunch of money for it, too!), so I can’t give a real precise answer, but I can add some more to what has already been said. Especially since we were just having a discussion along these lines at the vet clinic where I work!
As others have said, many drugs are prescription only because of the potential for harm - side effects, overdoses, drug interactions, etc. Also remember that we are facing some pretty scary problems with antibiotic-resistant bacteria - bacteria mutate rapidly, and improper and/or unnecessary antibiotic therapy CREATES resistant bacteria. (I can give a brief explanation for how, if you’re interested.)
However, one criteria for control of drugs is the abuse potential. (I’ll have to wing this, so my classifications may be a little off.) Drugs are divided into different classes - Class I, Class II, Class III, and Class IV. Class III (I think) are tightly controlled addictive and/or poisonous substances with a known medical use. This includes drugs like Valium, Phenobarbital, Ketomine, Codeine, etc. Class IV (again, I think) are drugs with the same potential for abuse/harm, but with no known medical benefit.
At the clinic where I work, we are required to keep Class III drugs in a locked cabinet at all times. A usage log must be kept, showing the date, amount, and animal the drug was used on, with a running total of stock on hand. The DEA inspects these logs and compares the usage amounts to the stock on hand, the amount purchased by the clinic, etc. Having a bottle of, say, Ketamine, missing and unaccounted for can get you into big trouble!
We also have a very sophisticated alarm system to try to prevent burglaries committed for the sole purpose of obtaining drugs.
Maybe there is a nurse, EMT, MD or some such on here who can give you a more accurate rundown on the classes, etc., but what I’ve said is correct in general. Or maybe in internet search for ‘drug classifications’ or something will produce a webpage with the info.
God is love. Love is blind. Ray Charles is blind. Therefore, Ray Charles is God.
Schedule I drugs have a high abuse potential and no approved medical use, such as heroin or marijuana.
Schedule II drugs have a high abuse potential but have legitimate medical use, such as cocaine or morphine. It doesn’t always have much to do with potential harm–Ritalin is a schedule II, and it’s an incredibly safe drug (unless you snort it). It is commonly abused, though, so it’s a II. These you can prescribe only a month at a time (no refills).
Schedule III and IV drugs require a prescription, but don’t have much abuse potential. I’m not sure what the difference between the two is. Schedule V drugs are over-the-counter.
Generic drugs are almost always just as good as the name-brand. At our hospital, even if the doc does write you for the name brand, the pharmacy will give you the “cheapest generic alternative that is therapeutically identical”. Some doctors believe that some drugs show a greater consistency from pill to pill in the name-brand form. This was long believed to be the case with Synthroid (synthetic thyroid hormone, usually the #2 or 3 prescribed drug in America), but later studies have differed.
A prof once gave me a patient’s list of meds, which were numerous and many of which had “Do not substitute” written next to them. He asked me why I thought that was. When I guessed wrong, he said to note what they were–Valium, pain pills, etc. It almost always means they’re selling them. People know what an actual Valium looks like, and won’t buy a generic diazepam. Makes sense–how would you know he’s not just selling you his unused antibiotics?
Dr. J
“Seriously, baby, I can prescribe anything I want!” -Dr. Nick Riviera
Thanks, DrJ - I knew I had it screwed up, didn’t know I had it backwards! Anyway, I did a little internet research to correct my ignorance, and thought I’d share the following sites with everyone, if you’re interested:
drug schedules Brief, clear listing of drug schedules with some examples
University of Buffalo Addiction Research More comprehensive information and examples
Federal Controlled Substances Act, Part B - Authority to Control; Standards and Schedules Official FDA info.
Schedule I substances have a high abuse liability and no approved medical use. Examples: marijuana, LSD, mescaline, peyote, heroin.
Schedule II - IV substances have decreasing abuse liabilities (II is the highest) and approved medical uses. They require a prescription. Examples: Sch. II - amphetamine, methamphetamine, cocaine, codeine, morphine, opium, pentobarbital; Sch. III - Tylenol w/codeine, paregoric, anabolic steroids; Sch. IV - chloral hydrate, diazepam (Valium), phenobarbital.
Schedule V substances have a recognized abuse liability (and approved medical uses) but are generally not regulated (e.g. are available without prescription). Example: Robitussin A-C (contains less than 100 mg codeine per 100 ml).
God is love. Love is blind. Ray Charles is blind. Therefore, Ray Charles is God.