OTC medication regulation?

[DrMom]

http://www.newscientist.com/article.ns?id=mg18825295.000

'Safe' painkiller is leading cause of liver failure
08 December 2005
NewScientist.com news service
Alison Motluk
A POPULAR over-the-counter painkiller is now the leading cause of acute liver failure in the US - and almost half of those cases are accidental overdoses.

Paracetamol (or acetaminophen as it is known in the US) is used by millions of Americans each year, and is commonly thought to be safe. Until 1980, paracetamol was not even listed as a cause of acute liver failure. But between 1998 and 2003, the proportion of cases of liver failure caused by the drug nearly doubled.

William Lee at the University of Texas Southwestern Medical Center in Dallas and his colleagues followed patients with acute liver failure who were in a coma. Of the 275 people with paracetamol poisoning, 8 per cent received a liver transplant, 65 per cent survived without one and 27 per cent died.

Initially the researchers had suspected a direct relationship between how much of the drug is in the liver and for how long, and the extent of the damage. But people who intentionally overdosed, who tend to be identified and treated more quickly, had similar damage to those who overdosed accidentally. That suggests a clear threshold for what constitutes a safe dose of the drug.

Many of the people who had accidentally poisoned themselves did so by taking just 10 grams of the medication each day for about three days - the equivalent of about 20 pills per day instead of the recommended eight, an overdose that might be less serious with other drugs. Other people had unwittingly taken two products that both contained the drug (Hepatology, vol 42, p 1364).

Lee thinks American drug enforcers should follow the lead of the UK, which requires products that contain acetaminophen to be packaged in blister packets and sold in small quantities. "I think we should talk about limiting package size," says Lee. "You can buy 500 at a time. They're like M&Ms."

From issue 2529 of New Scientist magazine, 08 December 2005, page 19

What do you guys think?

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[mustangsally65]

It's a double-edged sword. Since pseudophedrine and most other decongestants has been placed behind the counter, people have complained. I was in the pharmacy picking up a prescription for my mom a couple of months ago, and an older lady came up and asked where the cold medicine was. She had to get in line with everyone else and wait until it was her turn to get her cold medicine. She was confused, and asked why it was behind the counter. The person working there feigned innocence, but someone else in line volunteered the information about people make methamphetamines from these drugs. Anyway, the prescription line is bad enough where I live, and I could feel the lady's frustration when she had a cold and had to wait in line to get an OTC med.

I realize this is for medical safety instead of to prevent crime, but the principal is the same. I don't think it will keep people from taking too much if they really want to, just like someone running a meth lab can pay different people to buy Sudafed for them. Education is probably the best prevention of liver disease caused by Tylenol, but there will still be people who take too much. Some do it out of misinformation, others do it because one or two pills don't work anymore so they feel like if they take more it will help the pain.

Pain is a big problem. There are lots of people who can't afford treatment for the underlying problem so they pop ibuprofen, acetaminophen, aspirin and others to keep the pain down to a bearable level. At the same time, we all hear stories about narcotic addicts coming to the ED and faking a symptom to get pain meds. It's a tough call, and until there's a way to measure the amount of pain a patient is perceiving, it's going to be a problem.

No one should have to suffer in pain that could be alleviated/reduced by easily accessible and affordable OTC pain relievers. But no one should suffer liver damage because of a few mistakes or oversights, either.

There is a huge amount of misinformation and, quite frankly, ignorance, out there about health and medicine. I had one person tell me she saw a patient who came in with a UTI who said she'd tried Monistat and it hadn't cleared up the problem. Patient education and prevention is key.

 

[bananaface]

Such a measure would increase cost and perhaps keep people from buying acetaminophen. Plus, many of the elderly can't deal with blister packs. We may just end up with a bunch of people on chronic NSAIDS, which would do more harm in the end the with the increase in cardiotoxicity, bleeding ulcers, and kidney toxicity greatly surpassing the harm from APAP mishandling.

The big issues with acetaminophen are labeling of content and patient comprehension of safe dosing. We get combination products where patients do not appreciate that acetaminophen is included and branded products where patients do not realize the active ingredient. Then, some pharmacies use APAP as an abbreviation on bottles, so patients may have prescription medications containing acetaminophen and not realize it. It's trouble waiting to happen. The key to getting people to use things safely is adequate labeling and patient education. It hasn't been that long since we figured out there was a problem, so not all healthcare providers are fully informed. It's too common for patients to receive Vicodin and Percocet together and not be counseled to cap at 4g/day and to avoid OTC APAP use. Additionally, most healthcare providers don't realize that for chronic use the maximum should be 2.6 g/ day, not 4g.

There are so many OTC and Rx products that would never be approved if they were submitted to the FDA today. And, oodles of drug interactions looming amongst both groups. OTC does not equal safe, and we should never try to convince ourselves or consumers that it does.

 

[Law2Doc]

Such a measure would increase cost and perhaps keep people from buying acetaminophen. Plus, many of the elderly can't deal with blister packs. We may just end up with a bunch of people on chronic NSAIDS, which would do more harm in the end the with the increase in cardiotoxicity, bleeding ulcers, and kidney toxicity greatly surpassing the harm from APAP mishandling.

The big issues with acetaminophen are labeling of content and patient comprehension of safe dosing. We get combination products where patients do not appreciate that acetaminophen is included and branded products where patients do not realize the active ingredient. Then, some pharmacies use APAP as an abbreviation on bottles, so patients may have prescription medications containing acetaminophen and not realize it. It's trouble waiting to happen. The key to getting people to use things safely is adequate labeling and patient education. It hasn't been that long since we figured out there was a problem, so not all healthcare providers are fully informed. It's too common for patients to receive Vicodin and Percocet together and not be counseled to cap at 4g/day and to avoid OTC APAP use. Additionally, most healthcare providers don't realize that for chronic use the maximum should be 2.6 g/ day, not 4g.

There are so many OTC and Rx products that would never be approved if they were submitted to the FDA today. And, oodles of drug interactions looming amongst both groups. OTC does not equal safe, and we should never try to convince ourselves or consumers that it does.

While I agree with what you are saying, OTC drugs mean cheaper drugs, because the free market dictates what drug companies can charge. For those people educated and savvy enough to understand the labels, OTC is actually a very good thing. There are lots of things people can go to the store and buy that, if used improperly, can kill them (eg. alcohol, cutlery). There are even things on the market that cannot be used safely (eg. cigarettes). Given these social norms, I'm not sure the government should play parent to adults making adult decisions.
(And for what it's worth, taking Dr. Lee's quote out of context, I'm not sure eating 500 M&Ms would be any smarter than some OTC drugs -- obesity is a big killer too. Everything needs to be done smartly and in moderation).