Should Statins become OTC?

[Caverject]

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Why or why not?

 

[GravyRPH]

No, livers are hard to come by. Muscles are even harder.

 

[bananaface]

If they ever do, I want "DO NOT TAKE IF PREGNANT" pasted predominitely on the packaging.

The FDA's guidelines require a person of normal inelligence to be able to use the product safely off the shelves. Since there is bloodwork involved in choosing the dose and product, I don't know how the the case for OTC statins could be made in the US.

For those of you who don't already know, the statins are currently OTC in the UK.

 

[Caverject]

No, livers are hard to come by. Muscles are even harder.

You stole that from your astra article! LOL

 

[MNnaloxone]

No way, no how. Think about this:

The vast majority of the OTC preps are made for short-term use. You have a stuffy nose, a headache, dyspepsia, etc. You take the OTC, you feel better, you stop the OTC. There are few OTCs I can think of that are supposed to be taken chronically (ASA is one. Prilosec OTC is shady like that, anything else? Claritin maybe.). The average idiot can tell when his HA goes away or his Kleenex use decreases.

Statins are drugs that take at least a month to have any real effect, and are unable to be self-monitored (like banana said). And the real bad S/E are often confised with other things (I've seen it. The light bulb comes on when you tell the patient that it might be the statin that is making his muscles cramp. They're ok with blood draws at that point, too 😉 )

 

[Caverject]

I ask because in Pharmacy Today magazine, I read this....(sorry if there are any typo's I couldnt find this online)

Study: Most Pharmacists support OTC statins

Pharmacists are interested in supporting patients who wish to self-asminister OTC statins, accoring to a study published in the september/october Journal of the American Pharmacists Association. As reported in the July issue of Pharmacy Today, the United Kingdon has moved Zocor to a pharmacists only nonprescription category. In the United States, Johnson and Johnson-Merck is studying the feasibility of offering OTC lovastatin 20mg.

The study reported in JAPhA, led by James McKenney, looked at the beliefs and attitudes of 104 independent pharmacists and 169 chain pharmacists regarding coronary heart disease, high blood cholesterol lowering OTC statin theapy, and the role of the pharmacist in helping patients lower cholesterol. The study was sponsored by APhA and the National Lipid Association and funed by a grant from J&J Merck.

Overall 75% of pharmacists strongly believed that CHD is a significant health problem. The majority of pharmacists surveyed 68%, would consumers interested in purchasing an OTC statin, and 79% had a high level of interest in giving advice about OTC statins. Of the 273 pharmacists, 68% were interested in monitoring patients response to an OTC statin for adverse effects and drug interactions.

 

[CosmoDaNP]

Only if the package includes a mini LFT test with a guide on how to read the results.

Even then I think it's a HORRIBLE idea!

Cosmo

 

[Caverject]

Only if the package includes a mini LFT test with a guide on how to read the results.

Even then I think it's a HORRIBLE idea!

Cosmo

Agreed

 

[LVPharm]

We just had this discussion the other day during a conference with a clinical pharmacist, a roomfull of pharm students and a few pharmacy practice residents.

No, it should not be available OTC, purchased with no questions asked. The only possible way I can see it safely dispensed without a prescription is through a type of pharmacist-run dyslipidemia clinic, where the patient would be seen, LFTs ordered, monitored for ADRs, etc. If this were the case, this would be a good opportunity for pharmacists to expand their practice. Statins are only effective when the patient is compliant...re: President Clinton. Even then, I can see those few people who do develop rhabdo, putting off that "muscle ache" as no big deal, until it's too late. You can't trust the general public to take this medication safely and correctly on their own. I can see some idiot taking this PRN chili dog.

 

[MNnaloxone]

Only if the package includes a mini LFT test with a guide on how to read the results.

I can just see it now: "Is it positive, is it negative, I can't read these damn things! (husband: Why'd you pee on my hand? No that's definitely a minus sign...) Argh! Gimmie another testing stick..." Just make sure you don't collect your bloodstick in a wax cup...

But you did set me off on an idea...I wonder how much effort would have to go into a portable lipid monitor (think Accucheck). Would make it easier on clinic practicioners...

 

[CosmoDaNP]

Actually there is a portable cholesterol monitor. I believe it just gives a total count but none the less one is availble. Runs about $100 at the pharmacy and will do three tests before it needs more supplies.

If having that machine availble OTC is what's pushing statins closer to OTC, one must consider that there is now a machine availble OTC which will let you test you HgBA1c. So if we go with THAT theory then won't we need to put Actos, Avanadia, Glucophage, ect... OTC?

I certainly hope not!
Think of how much more liver damage we'd see THEN.

Cosmo

 

[Caverject]

Giving a cholesterol test at a pharmacy is increasingly becoming a common practice. LFT tests are not, and never should be. I do not believe that we should be responsible for an LFT test since it is a little more than a simple diagnostic test like cholesterol.

I have to question APhA's motives for publishing such an article with such a small sample. I wonder if there is more behind this than what meets the eye because any pharmacist with common sense will say that statins should NOT be OTC, especially if the only choice is some shi++y drug like Mevacor. Then when Mevacor goes over the counter, all insurance plans will not cover statins because of the OTC variant and patients access to medicine is then limited. (Remember Claritan or Prilosec?)

 

[ultracet]

i'm going for FDA 3rd class of drugs on this one...


interestingly enough here in AL pseudoephedrine (i really need to learn to spell) is behind the counter now. It irritates the crap out of me as a patient because the pharmacy is never open when i need it.

On that note...
I would have to say where ever i work the statins would definitely be pulled behind the counter with a nice sign that said "Ask your pharmacist!"

I can't imagine that most think it is a good idea for these to go OTC but then again.... tagamet is still out there..

 

[LVPharm]

The counter argument is the potential public health benefits of being able to reach all those folks with undiagnosed dyslipidemias...that it could save that many more lives from CHD in comparison to the relative handful that end up with liver damage or rhabdo.

Given the tough lobbying effort big pharma will utilize to get statins OTC, maybe the only real compromise would be to make this a 3rd class.

 

[LVPharm]

Giving a cholesterol test at a pharmacy is increasingly becoming a common practice. LFT tests are not, and never should be. I do not believe that we should be responsible for an LFT test since it is a little more than a simple diagnostic test like cholesterol.

I don't know how much of a blood draw would be necessary to run LFTs, but I presume that it would be too much for a community pharmacist's clinic, or home use 😉 This would have to be performed by a medical laboratory with licensed med techs. In other words, you would have to have a nurse (?) do the draw, and send it out for processing.

 

[MNnaloxone]

I've run that countertop lipid meter, Cholestech myself. I wasn't too impressed. I'm certain that LFT testing is not going to be CLIA-waved in its current manifestation. Was thinking better technology on these. Was also thinking easier on clinic practitioners...so they wouldn't have to send out the lab work. No way would I trust the public with these things. I meant Accucheck in the context of a ward nurse doing a BG. Not grandpa bitching about sore fingers. Sorry for the confusion.

Why is Mevacor a bad drug? When you look at the 1000's on Lipitor 10mg that could save $$$ by going on Mevacor 40... Although I definitely see your point about PBMs playing the OTC card. I'm surprised that APhA is pushing this as well.

 

[DrugDealer]

The vast majority of the OTC preps are made for short-term use. You have a stuffy nose, a headache, dyspepsia, etc. You take the OTC, you feel better, you stop the OTC. There are few OTCs I can think of that are supposed to be taken chronically (ASA is one. Prilosec OTC is shady like that, anything else? Claritin maybe.). The average idiot can tell when his HA goes away or his Kleenex use decreases.

Exactly. And what about all the people who think, "If a little is good, a lot is better" and decide to take 2 statin pills thinking it will lower their cholesterol twice as much, or pop an extra one after their eggs benedict at weekend brunch and their Big Mac twice a week. This might be tolerable for short-term meds, but not so much for the chronic ones.

 

[nikkai]

Those OTC cholesterol tests aren't worth the boxes they come in.

Statins go OTC = screw the indigent people on public aid who need them

LFT's are important, but typical family doctor won't do that routinely (as suggested by the PI) - and really, not toooooo bad... You figure a person is more likely to surpass the 4mg Tylenol limit than the statin limit as there isn't as fast of an effect.

I'll correct grammar when I'm more awake...

 

[sdn1977]

I just had a young woman today call me to ask about Plan B (ok....no - I'm not going off topic here). She had a "condom slippage issue" (her wording) on Thurs night & got Plan B Friday (good for her👍 ) & took her first pill. She told me....it then slipped her mind to take the next one (another "slippage" issue😱 ) & didn't take the second one until Sunday AM.

Now....this is a 20-something & highly movtivated young woman to not get pregnant and she can't even get the instructions right.

Can you imagine trying to explain how to monitor an 80-something's cholesterol or god-forbid lfts (really - the doctor said to drink 2 glasses of scotch - it improves my appetite😛 )? And....she takes Celebrex & Fosamax - what is causing that muscle pain I wonder???? Would the MD/DO really know if she started taking it? Likewise, what if she didn't need it, but her bridge club group were all taking it so it must be good???

While we are mulling over this issue.....the FDA is considering stronger lettering & possible restrictions on otc analgesics - while I have to sign out each & every pseudoephedrine to every Tom, Dick & Harry who might have a meth lab (or NOT) in their bathtub!

What a crazy healthcare policy we have and the public who only chooses to read what they want (or perhaps there is just too much to read, so they don't read any of it)😕 .

For now - I vote no. There is just not enough communication with prescibers & too many ways it can cause problems.

 

[BMBiology]

The National Lipid Association (NLA) is lobbying the FDA to remove the requirement for liver function test from statin labeling. Reports of liver failure due to statin are only 1 out of 1 million prescriptions. While statins increase liver enzymes (AST, ALT), many experts believe the increase is not associated with liver dysfunction.

Overdose on tylenol, however, causes about 50% of acute liver failure in the U.S.

Reference: McKenney JM, Davidson MH, Jacobson TA, Guyton JR. Final conclusions and recommendations of the national lipid association statin safety assessment task force. Am J Cardiol 2006; 97(8A):89C-94C.

 

[genesis09]

I don't think statins so go OTC or BTC. Statins need to be carefully monitored. It is not uncommon for people to change their dose several times before optimal is found. Also, this is a chronic drug. Almost every OTC is for an acute condition. For the FDA to approve them as OTC/BTC, will be against their normal take on the matter. People will also think, oh, I had a high cholesterol meal, and so, taking a statin will make it all better. I just don't feel confortable with them going OTC/BTC.

 

[sdn1977]

The National Lipid Association (NLA) is lobbying the FDA to remove the requirement for liver function test from statin labeling. Reports of liver failure due to statin are only 1 out of 1 million prescriptions. While statins increase liver enzymes (AST, ALT), many experts believe the increase is not associated with liver dysfunction.

Overdose on tylenol, however, causes about 50% of acute liver failure in the U.S.

Reference: McKenney JM, Davidson MH, Jacobson TA, Guyton JR. Final conclusions and recommendations of the national lipid association statin safety assessment task force. Am J Cardiol 2006; 97(8A):89C-94C.

I never even knew there was a National Lipid Association!

Your citations speak of liver dysfunction - which is not necessarily disease - just a change. And....tylenol overdose, which is also rare & causes ACUTE liver failure.

The issue with acetaminophen is not so much acute as it is chronic toxicity, IMO and what is causing labeling change discussions.

Likewise, with the statins, altho it may not in the long term cause enough of a dysfunction to cause disease, it may cause enough harm - either thru increasing lfts or mucle pain to require further workup, particularly if the pt hasn't shared that they're taking the drug with the md.

Then....there is the whole issue of monitoring if the drug is really working & to what extent is it working? The otc cholesterol check systems are awful now, but they will get better with time. However, until they are more reliable, they aren't anything many of us would base a decision on - whether to increase or decrease the dose.

Then....there is the whole idea of "fractionating" cardiovascular care - or all medical care. A previous poster mentioned....otcs - altho mostly for acute illnesses, are often used for chronic conditions - prilosec, ibupofen...but they all come labeled with the caveat - if your condition does not improve in 2 weeks - see your physician.

Wouldn't you want your family & pts to see their physician for continuing cardiovascular care since it involves more than just the statin??? Are there enough of us - pharmacists with enough training, time, leadership skills, etc.....to intervene with those pts who really do need to see a physician when they come to ask us which (potential) statin is better? I know I could - given enough time with them.......but I think of all the days when I don't have that kind of time to devote to really finding out about that individual's concern & if they are really better served by seeing a physician rather than seeking out something they've seen on late night TV (which we all know happens). At this point in time, unless I fill an rx.....I don't have any way of getting back to the pt to remind them to come back in to be monitored.

These are not insurmountable issues....just ones which need to be hashed out & developed on our side of healthcare. I'm not sure where the medical community stands - particularly the cardiologists - does anyone have that citation to the FDA? But...for now..I'd have to stay on the cautious side.

 

[BMBiology]

The study Caverject mentioned in his post was sponsored by The APhA and the National Lipid Association. It was published in JAPhA.

You are right about being cautious but we should first look at the data. I would argue requiring liver function tests when they are not necessary may cause patients to be fearful of statins and to discontinue the medications. If anyone is interested in the safety of statins, here are additional references:

Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006;97:77C-81C.

Bays H. Statin safety: an overview and assessment of the data-2005. Am J Cardiol 2006;97:6C-26C.

Jacobson TA. Statin safety: lessons from new drug applications for marketed statins. Am J Cardiol 2006;97:44C-51C.

Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006;97(8A):52C-60C.

 

[Farmercyst]

The other concern I would have is, if these are OTC, when does the patient go to the doctor to see if changes are required. Not just changes in med levels, but diet, exercise, improving/worsening related conditions (cardiovascular disease). Or does the pt assume since he can just pull the box off the shelf that these checkups are no longer required. Isn't that like making psych meds OTC so that the patient can just pick his pills off the shelf. Afterall, all he needs to know is the dose, right. If he feels a little worse he can take a little more. Then he won't have to waste his money going back for continuous psych evaluations.