Sunday, July 5, 2009

Clarifying My Position

In the heat of being pissed over the FDA panels recommendations on Acetaminophen, I didn't really clarify my position, and so got all kinds of comments and email from both sides of the aisle.

To summarize my worthless viewpoints:

1. I stand by my point about regulating cars, pools, alcohol, and tobacco. The bottom line is that no amount of guidance, laws, and regulations will EVER protect people from their own stupidity and misuse (intentional or unintentional) of ANYTHING! People such as The Angry Pharmacist's "Cracky McCrackhead Addict" will continue to do whatever the hell they want.

2. I have no problem with regulating Acetaminophen (or APAP for short) to smaller doses and/or cutting out the combo meds. I'm not sure the APAP component really does much compared to the narc, and it falsely gives the impression these drugs are less addictive.

I understand the risks of hepatic toxicity (and, from a more practical viewpoint, rebound headaches), and have counseled patients about this for years. APAP is in a HUGE number of both OTC and prescription drugs, where it's existence isn't well listed. Many of these are "me too" crap, where the public buys them without reading the ingredients, and ends up unintentionally taking too much APAP. Getting half of this junk off the shelves would be nice.

3. Pain is a serious issue. Especially for people who are suffering from terminal illness. None of us want to die in misery. In a perfect world we wouldn't need pain medications. But we don't live in one.

And that's all, folks!


MarcoRPh said...

Hi Dr. Grumpy and everyone,

I've been reading posts here for a while but this is the first response I'm posting. The reduction in Tylenol maximum doses shouldn't really effect pain control in patients. I agree with the good Dr. that the APAP doesn't add significantly to the effectiveness of the dual component pain meds....but Tylenol doses > 4 grams/24 hours over time can have serious adverse effects to the liver.

I'll give you an example how we handle these dual component narcotic drugs in the hospital where I work. If the physician orders Percocet 5/325 they will receive that. If the physician orders a Percocet strength with more APAP (7.5/500 or 10/650) the patient will *only* receive the oxycodone component of Percocet and *no* Tylenol at all. We have had no problems at all with this substitution.

Now, if a person decides to go to their local Wal-Mart and buy extra strength Tylenol and take a dozen of em in a day there is no way to control that. There is no law that states the patient has to follow the label direction or follow the advice of a physician, nurse or pharmacist. I guy I used to work with had a great saying for something like this.... "You can't legislate stupidity". That pretty much sums it up.

Anonymous said...

I recall one of my shifts in a drugstore not long ago that started with a customer showing me two boxes of bottles of regular-strength nAPAP; one brand name with the words 'non-aspirin containing' or some such, and the other one that just was labeled acetaminophen 325 mg, so the patient asks me about the generic. Does this one contain aspirin? Classic. Part of the OTC problem is advertising/labeling. If the label was bare like Mallinkrodt's stock chemical bottle of XX USP, or just plain, and stating 'acetaminophen 325 mg tablets' (compare to Tylenol 325 mg tablets), I think patients should be able to figure it out on their own. But, some of the labeling IS confusing. Thank heavens that certain elements of proper labeling is required to be sold in the US, or I fear that companies would get away with the minimum altogether. (If I look at the label long enough I just know that the information is on it somewhere!) Right now, labels often have very small print, or covered by extraneous colors, designs, wording that it is sometimes difficult to find the part about the strength of the active ingredient (which evidently doesn't have to be on the part that includes the rest of information, for some dumb reason I don't know).

My concern about nAPAP combo vs. single-ingredient narcotics is based on the argument that a narc-abusing patient might have concern about preserving liver function so including nAPAP was a 'self-imposed' limit to ingesting opioids to incredibly high tolerance levels. However, it is a backhanded argument, and apparently the 400 people that died from liver failure last year due to nAPAP toxicities either weren't aware or did not 'care' about limits on nAPAP ingestion, or do 'care' and are deliberately overdoing it for a final sendoff.

KT said...

Medicine shouldn't be available in supermarkets where idiots can just buy them. The reason infant cold and flu medicines in Australia were rescheduled to prescription only medicines is because parents in America were overdosing their kids because they could buy it off the shelf (you couldn't do that in Australia anyway, so it definitely makes perfect sense). My point is, people shouldn't be able to just run down to their local supermarkets and buy any form of medicine (including vitamins!). Because the ones who aren't idiots genuinely don't know. Any medicine should be sold in a pharmacy where a patient can be (shoud be!) advised on the correct dose and counselled on side effects etc. There are always people who are too stupid, and do what they want, but then, if you've been informed not to take more than 8 500mg paracetemol (APAP) per day, and continually take in excess of 8 500mg tablets of paracetemol per probably deserve what you get.

ladyk73 said...

The OTC medications are out of control. Many college educated people I know get confused. Alot of people think Advil and Motrin are different meds. Is is crazy. And so easy to OD on APAP.

I just did a lecture on self-directed violence, and surprised a room full of mental health workers that someone can have a fatal OD with 14 pills of APAP

Anonymous said...

I'm with Dr. G on this one, I believe. The FDA action is a pretty clear case of confusing a need for awareness with a need for action.

I'm not a medical professional but I think of myself as a reasonably well-informed person. Yet it wasn't until a couple of years ago that I realized just how toxic APAP could be--on its own, in combination with booze, etc. The average pharmacy-goer doesn't know that.

So curbing the amounts and ways someone can unintentionally get too much (or any at all) seems like it would be a plus, as well as getting the word out that NO SERIOUSLY TYLENOL CAN KILL YOU. (That'll take some doing--don't forget, the Tylenol people have been running ads for years talking about how safe it is, hospitals prefer, blah blah.)

But the FDA seems to want to go further than that, in ways which look like they'll cost a lot of money for extremely little benefit.

Anonymous said...

You could have left it at one sentence, "The bottom line is that no amount of guidance, laws, and regulations will EVER protect people from their own stupidity and misuse (intentional or unintentional) of ANYTHING!". So true.

In France, they sell paracetamol (APAP) in 1000mg sister-in-law grabbed some from the cabinet when my husband complained of a headache and my take on it was that it's a standard household stock item. It comes in what I refer to as a fizz tab - drop it in water, etc - my husband insists works better that way. OK...getting off track here...the label states in a sort of shockingly casual manner something like you really shouldn't need more than three of these in one day. NOTHING about the MDD and/or consequences of od. Apparently there aren't as many morons over there...or maybe they consider it a kinder, gentler form of natural selection...and maybe the FDA should take that into consideration too!

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