Articles

Rx, OTC, BTC – Wading into Pharmacy’s Alphabet Soup

Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.

Should Drug A be available without a prescription?

Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.

Should Drug B be available without a prescription?

What factors influence if a drug can be purchased without a prescription? Drug A is acetaminophen (Tylenol), a safe drug when used at appropriate doses, but highly toxic in overdose – one in three overdoses are fatal, and linked to 500 deaths per year (USA). Drug B is aspirin (acetylsalicylic acid/ASA), with well established benefits for a number of conditions, but also an impressive side effect profile, including stomach ulcers, multiple drug interactions, and an associated risk of Reye’s syndrome when given to children.

Acetaminophen and aspirin are among the oldest drugs that continue in regular use. Both were first marketed long before the current drug licensing standards were implemented. And both have side effect profiles and toxicities that rival some prescription drugs. But they’re hardly alone in the over-the-counter (OTC) marketplace, which is a collection of drug products with varying levels of effectiveness and safety. When it comes to decisions about access, science informs, but does not determine, your ability to buy a drug without a prescription.

FACTORS INFLUENCING ACCESS

In the United States, as in most other countries, drug regulation has evolved over time. Oversight started in 1906, with standards set for strength and purity. Safety standards were introduced in 1938, but existing drugs, which were generally recognized as safe, were exempted from this requirement. It was recognized that some drugs required specific expertise to use, and the concept of prescription-restricted drugs was introduced at that time. Safety and efficacy standards didn’t arrive until 1962, following the thalidomide tragedy, and again, drugs that were generally recognized as safe and effective were exempted from these new requirements. The U.S. regulatory framework is largely unchanged since that time. Despite retroactive evaluations of efficacy that have been applied since the 1960′s to evaluate older drugs, the reality is that older drugs with a long history of use may not be supported by the robust clinical data that would be demanded for newly marketed drugs.

Today, regulators like the FDA determine a drug’s prescription status. Prescription-only drugs require physician diagnosis, and are for conditions that cannot be self-diagnosed. These drugs may have the potential to produce dependency, have significant drug interactions, or have the potential to cause resistant organisms to develop. For a drug to be considered for OTC status, the FDA states that consumers need to be able to self-diagnose, self-treat, and self-manage the condition in question. OTC products are expected to offer a wider margin of safety over prescription drugs, in the event that they are used inappropriately.

Some countries have a sizable “behind the counter” (BTC) category, for drugs which can be purchased without a prescription, but require a pharmacist’s authorization for sale. BTC drugs may have a dependency potential, or a complicated dosing schedule. Or, the drug may have the characteristics of a prescription drug, but the need for emergency access outweighs prescription controls, such as insulin, nitroglycerin, or Epi-pens. Proponents of BTC argue it offers greater consumer access to drugs that do not require physician consultation, but benefit from pharmacist consultation. Detractors cite the lack of physician oversight, or possible attempts by manufacturers to circumvent more strict prescription drug regulatory and marketing requirements. In some countries, even cholesterol-lowering medications like simvastatin (Zocor) are BTC, clearly pushing the limits on what can reasonably be regarded as self-managed conditions. Drugs can move both directions: In the United States, emergency contraception (Plan B) recently moved BTC for women 18 years of age and older. Pseudoephedrine (Sudafed) was an OTC drug for years until it moved BTC in many countries: not because of safety reasons, but because it’s a key ingredient in manufacturing methamphetamine.

Where the prescription/non-prescription line gets fascinating (to pharmacists, anyway) is when you start comparing between countries. Pharmacy “tourists” engage in a kind of drug arbitrage, stocking up on products they can’t get back home. Canadian visitors to the United States load up on omeprazole (Prilosec/Losec) for stomach problems, Neosporin antibiotic eye drops, 1% hydrocortisone cream, Primatene Mist, and until recently, naproxen (Aleve). American visitors to Canada are renowned for buying large supplies of 222′s (codeine, aspirin, and caffeine), Tylenol #1 (codeine, acetaminophen, and caffeine) and until recently, antihistamines like Reactine and Claritin. Fluconazole tablets (for yeast infections) are OTC in Canada, but prescription in the USA. It’s clear, even comparing between two countries with similar regulatory frameworks, like Canada and the USA, that there are different factors under consideration.

UNDERSTANDING THE VARIATION

Beyond the regulations themselves, how evidence is interpreted seems to play a large factor in influencing decisions about prescription status. Consider cough and cold products in children: A handful of ingredients have been used for decades, and were approved long before current standards were in place. Clinical data supporting pediatric use is either of poor methodologic quality, or lacking altogether. Over the past few years, reports of (sometimes fatal) side effects in children prompted several countries to review this group of products:

  • An FDA advisory panel concluded that cough and cold products in children were ineffective and potentially hazardous. The panel recommended that they should be relabelled to indicate “do not use” in children under the age of six. Following this announcement, product manufacturers voluntarily relabelled their products to state “do not use” in children under the age of four.
  • Around the same time, Health Canada announced that cough and cold products would be relabelled to caution against use in children under the age of six. Products developed just for this age group will be no longer be sold. This extends an earlier decision to remove from the market any products intended for children under the age of two.
  • In Australia, cough and cold products are now labelled “do not use” for those under the age of 2, but remain available by prescription. They continue to be marketed and sold with labelling for children aged 2 – 12.
  • In the United Kingdom, products for children under the age of six were withdrawn. Medication for children aged 6 – 12 will continue to be available, with new warnings on the label.

Four regulators. Same data. Four different decisions. Each regulator had to weigh issues such as the mild and self-limiting nature of the illness, the consequences of rare but sometimes serious side effects, the perceived effectiveness of restrictions/relabelling, and the general philosophy about minimum safety standards for licensed drug products.

BALANCING RISK AND BENEFIT

Prescription or OTC, no drug is absolutely safe under all circumstances. In order to have a meaningful therapeutic effect, any drug can be expected to cause some sort of side effects. And all have a toxicity profile that must be evaluated, and weighed against the benefit that is expected. Old drugs have a long history of use, which helps us understand their side effect profile, as well as the prevalence of any rare adverse effects. But the trade-off can be that these drugs may never have been adequately assessed for efficacy, particularly for the way they are being used. It’s one reason why different regulators routinely make different decisions on prescription / non-prescription status: Balancing access with safety, and the implications of possible widespread use of a drug, with sometimes very limited clinical data.  Science informs this decision, but it’s one factor among many that are considered. Decisions are made that reflect this balance.

What does this mean for science-based medicine advocates? Understanding the factors that influence regulatory decisions force us to stay vigilant, and bring the evidence to bear even on seemingly straightforward health interventions. A non-prescription drug isn’t necessarily effective, or safer than prescription alternatives. If data emerges to suggest a drug causes more harm than good, then we should stop using it. Where the evidence suggests that drugs can be safely and effectively used without the need for physician intervention, we should support their move to OTC status.

It’s not a perfect process, as the cases show. Regulatory systems consider a number of issues when evaluating drugs, of which the underlying science is just one factor. There is a considerable grey area, and it reinforces the importance of considering OTC drugs just as we do for other health interventions: evaluating risk and benefit, and ensuring there’s evidence to support the decisions we make.

Posted in: Pharmaceuticals, Politics and Regulation

Leave a Comment (34) ↓

34 thoughts on “Rx, OTC, BTC – Wading into Pharmacy’s Alphabet Soup

  1. davidp says:

    OTC medicines seem to include quite a few ineffective substances. I am told there are no effective OTC cough suppressants.

    There is a strong drive by parents to do something for sick kids. Having nothing OTC might lead people towards worse options, such as splitting adult tablets.

    I feel that Acetaminophen should be sold combined with the antidote Methionine – that would minimize the liver problems. What is the cost benefit for this?

    Aspirin wrecks the blood clotting effects of platelets – I have also heard it said that whenever you take aspirin you get stomach bleeding. Aspirin might well be appropriately removed from the OTC painkiller market now that generic ibuprofen (Neurofen) tablets are widely available.

  2. windriven says:

    It seems to me that there are unassailable reasons to dispense antibiotics by prescription only. There are also any number of vasoactives and psychotropics that clearly should not be self-administered.

    But faced with mounting health care costs how do we justify insisting on prescriptions for, as an example, statins? Once titrated and instructed on the symptoms of statin toxicity, what is the point of having to return to a physician every 60 or 90 days to have the prescription renewed? It is a waste of both the physician’s and the patient’s time and of someone’s money (patient, insurer, government).

  3. cervantes says:

    Actually acetaminophen is considerably more dangerous than that. It can cause liver damage when used in combination with moderate ETOH consumption, even at recommended doses. I don’t think it should be sold at all, frankly.

    And the side effects of aspirin are kind of overhyped. Except for the Reyes syndrome problem, they are largely reversible. You have gastric complications, just stop taking it. Fatal overdose is only possible intentionally, i.e. suicide. People can easily find other, easier and better ways than trying to OD on aspirin — which is actually quite difficult to do.

  4. Todd W. says:

    @windriven

    Once titrated and instructed on the symptoms of statin toxicity, what is the point of having to return to a physician every 60 or 90 days to have the prescription renewed?

    My guess, and someone correct me if I’m wrong, is to keep an eye on blood pressure and other vitals that are affected by statins and to adjust the prescription as necessary.

  5. JerryM says:

    Welcome to SBM, Scott Gavura!

    .

    .

    (psst, there’s a few typos. i’m on a #languagepeeve bender, sorry.)

  6. Necandum says:

    I second that welcome. Nice article!

  7. windriven says:

    @Todd W.

    Perhaps. But this only reinforces my point. Doesn’t everyone have a responsibility to keep track of their vital signs and general health? I’m not suggesting that people don’t visit their physicians as required; only that there are a lot of wasted visits. If we indeed are to bring 30 million people into the health care system without magically creating 30,000 new primary care physicians overnight, doesn’t that suggest that we will have to use the available physician resources a little more wisely?

  8. Todd W. says:

    @windriven

    There are certain vitals that a person can reasonably keep an eye on at home: temperature, heart rate, weight. I’m not so certain about blood pressure (added equipment requirements, training in the use of that equipment, education on what the numbers mean). Then there are blood labs (not sure how often these are taken for individuals on statins), which a person cannot do at home.

    Yet even if a person can keep track of things on their own, regulators also need to consider how likely it is that patients will do so.

  9. Lawrence C. says:

    Thank you for this excellent overview of the drug regulatory process and all the variation it produces. Even with all the different outcomes in various countries, I think today’s system is better than what it once was. I am old enough to remember when one could walk into a pharmacy and walk out with medicinal whiskey, morphine and a wide variety of compounded preparations containing various narcotics. Much of that was either sold over the counter or effectively so as one could simply pay a doctor a few dollars for an ongoing prescription. (Apparently that last thing is still going on these days!)

    I hope that continuing advances in science will lead to a greater understanding of both old and new drugs and a clearer path for regulators to follow.

  10. colli037 says:

    Speaking of concerning differences between contries, You might want to comment on propoxyphene (sold as Darvocette N-100 in the US combined with tylenol). This supposed pain medication (an opioid) doesn’t even beat Tylenol in a placebo controlled trial.

    It causes significant dizziness/balance problems in the elderly, but is the most commonly prescribed pain medication in the nursing home population.

    Its major metabolite is a known cardiotoxin, and some authors in the US suggest many or most of the “overdoses” of propoxyphene are due to arrythmia caused by taking a normal dose with alcohol.

    It is off the market in the UK, and a recent FDA advisory board suggested limitations here in the US.

  11. mr. grieves says:

    @cervantes

    Actually Scott’s assessment is essentially accurate. There is no increased risk of acetaminophen toxicity with acute ingestion of alcohol. In fact, acute alcohol ingestion is likely protective of acetaminophen-induced liver toxicity (See Thummel et al, JPET. 1988).

    There may be an increased risk of liver toxicity from acetaminophen in alcoholics however even this is not clear.

    Your assesment of ASA is a bit of a whitewash. “You have gastric complications, just stop taking it.” – sure, as long as its not a fatal GI bleed. You also completely neglect the numerous drug interactions that can occur with ASA. I don’t think I have ever heard an argument that ASA is safer than acetaminophen (other than from those who think that ASA is ‘natural’ (not really) and is therefore inherently safer than ‘chemicals’ like acetaminophen).

  12. Wolfy says:

    Gavura: great article :)

    @ Todd and Windriven: statin toxicity is important to follow, but doesn’t require more than the primary care setting. In particular, we monitor liver toxicity and rhabdomyolysis, among other issues. While these toxicities are relatively infrequent in the most serious of cases, they do occur and the best way to follow these toxicities is by history, physical exam, and labs–naturally, this requires periodic physician visits.

    I agree that we need to use physician resources better and it will be difficult to bring ~16% of the uninsured population into the healthcare system without overburdeoning physicians, nurses, etc.

    @cervantes: one can pretty easily overdose on ASA–can’t recall what the LD50 is, but perhaps one of the pharmacy posters could comment. in any case, you may recall the young female marathon runner a few years ago who overdosed on transdermal salicyates.

  13. weing says:

    “There is no increased risk of acetaminophen toxicity with acute ingestion of alcohol. In fact, acute alcohol ingestion is likely protective of acetaminophen-induced liver toxicity (See Thummel et al, JPET. 1988). ”

    That’s not what I read.

    http://www.nature.com/clpt/journal/v67/n6/abs/clpt200062a.html

  14. cervantes says:

    Mr. Grieves — you are mistaken, although I agree it’s a bit more complicated.

    Of 71 patients treated at a Dallas medical center for acetaminophen overdose, 50 were attempted suicides and 21 were victims of an accidental overdose (Schiodt et al, New England Journal of Medicine, October 1997). The would-be suicides on average took twice as much of the drug as the accidental victims. Yet far more of the latter went into a coma (seven versus three) and died (four versus one). Why? Because most of the accidental victims were alcoholics. Five people–three accidental victims, two attempted suicides–overdosed on less than four grams, the claimed safe dosage for 24 hours.

    Regular alcohol drinking “induces” a metabolic pathway in the liver called P-450 2E1, making the liver more efficient at breaking down alcohol with this 2E1 enzyme. This happens within a few days of drinking 2 or 3 or 4 drinks a day. That’s why steady drinkers can “hold” their liquor better, because they are breaking it down faster and so less alcohol gets in the blood. When you stop drinking for a few days, the liver reverts back to its old self and so the first time you drink again, your liver is less efficient at breaking down the alcohol so you get a “buzz” with the first drink. Here’s how this relates to acetaminophen: The same 2E1 enzyme turns acetaminophen into the toxic byproduct (called NAPQI) that can destroy the liver. So regular drinking produces more 2E1 and hence more NAPQI, and the more acetaminophen you take, the more the NAPQI can overwhelm the liver’s other defense mechanisms and cause liver cell death. But here’s the twist: drinking alcohol at the same time as you take acetaminophen puts both drugs into the liver at the same time, competing for the same 2E1, and thus drinking at the same time actually can protect against liver damage. The deadly pattern is when a drinker gets sick, with the flu for instance, stops drinking and starts taking acetaminophen near the maximum 4 grams a day, and that can cause catastrophic liver failure (because the 2E1 has nothing else to do but turn the acetaminophen into the NAPQI).

  15. Scott says:

    @ cervantes:

    Very, very interesting. It’s always good to know more about these things. Do you have any references/citations for those interested to read a bit more on the subject?

  16. Calli Arcale says:

    Ditto ^ Scott! That was fascinating, cervantes, and cleared up my confusion on the subject as well!

  17. Maybe I’m being picky, but I wish that hospital staff and doctors would give a bit more information when suggesting a OTC. A while back my son had surgery. They prescribed Tylenol with codeine for pain and advised OTC Tylenol after a few days when the Tylenol with codeine wasn’t needed. The codeine gave my son some poor side-effects, anxiety, night terrorish type symptoms. The Tylenol didn’t seem to work well. I switched to Ibuprophen at the advice of a family member. This worked quite well for pain, but I found out later that the Doctor expressly did NOT want me to use Ibuprophen due to bleeding risks. Luckily, we had no problems with bleeding.

    I know this was my fault. but I can’t help but wonder how often that sort of thing happens when patients are not told “don’t take this.”

  18. windriven says:

    @Todd W and Wolfy

    I don’t want to get too far into the weeds with this but I do a blood panel complete with liver enzymes annually. If anything is outside of norms or shows a marked departure from earlier years’ measures, I schedule a visit with my internist. I don’t think that is beyond the capabilities of most people. Same with BP. I have a clinical NIBP (because I’m in the medical manufacturing business) and use that. But I find excellent correlation with NIBP kiosks that are ubiquitous in pharmacies. And as to rhabdomyolysis, I noted that alerting the patient to symptoms is and should be part of the prescribing and titrating process. Beyond that, if the patient is going to succumb it won’t be while he happens to be in the physician’s office.

    But statins are just an example; maybe not even a good one. We had a significant shortage of primary care physicians before the current round of health care reform. Bringing 30M additional patients into the system will critically exacerbate the problem. Squandering physician time on routine stuff that could be handled by a PA or a nurse or the patient is unsupportable.

    People need to take some responsibility for their health and well-being.

  19. mr. grieves says:

    @cervantes

    Thanks for the reply, I am very familiar with the theoretical mechanism for enhanced toxicity in the setting of alcohol use. The study you quote is interesting, however the conclusions that can be drawn are minimal due to its small size (71 patients) and single-center setting.

    Two much more informative studies found NO association between ethanol use and extent of hepatotoxicity or worsened outcome: Malkin et al, Gastroenterology, 1995 (single-center, 560 patients) and Smilkstein et al, JT:CT, 1998 (multi-center, 2540 patients). Admittedly, a few studies HAVE noted an increased risk (such as Schmidt et al, Hepatology, 2002). However, this is why I said increased risk in this population is uncertain and I think this is a MUCH fairer assesment of the data than your statement that moderate EtOH consumption increases risk. I do not think you have evidence to back this up (if you do, please share). In any event, you haven’t demonstrated that I am in fact “mistaken”.

    Furthermore, the crux of your initial post was the implication that ASA is safer than acetaminophen, as myself and several other posters have pointed out I think you are way off the mark there.

  20. Dave Ruddell says:

    Nice to see some Canadian Content at SBM.

    I’m proud of myself for figuring out what Drug A and B were before your reveal. OK, so they weren’t exactly tough, but I still want my validation!

    I laughed when you brought up the differences in what’s OTC in Canada vs USA. I used to ‘import’ 222′s for my thesis supervisor; he thought that OTC codeine was a fine idea.

  21. Geekoid says:

    @weing -
    from the link:
    “However, this possibility is at odds with previous clinical studies that showed that acute ethanol ingestion could protect against hepatotoxicity by inhibiting CYP-mediated acetaminophen oxidation.”

    AND
    results: “P < .03"

    Coupled with it's tiny sample size that study is ,at best, and interesting data point.

    Lets see a reasonable sized study that also shows result, preferable better the less then .03.

  22. BillyJoe says:

    windriven,

    “And as to rhabdomyolysis, I noted that alerting the patient to symptoms is and should be part of the prescribing and titrating process.”

    Hopefully the patient won’t stop taking it the first time he gets a sore muscle. This can happen where pharmacists warn patients to stop the drug and see their doctor if they experience any sore muscles. They stop the drug but they don’t go back to see their doctor who prescribed the nasty med. Most of the time they’ve simply suffered a simple muscle strain.

    micheleinmichigan,

    “The codeine gave my son some poor side-effects, anxiety, night terrorish type symptoms.”

    Your son will never make a good drug addict.
    (I have the same reaction and ditto – some of my old friends became drug addicts)

    “I switched to Ibuprophen at the advice of a family member. This worked quite well for pain, but I found out later that the Doctor expressly did NOT want me to use Ibuprophen due to bleeding risks. Luckily, we had no problems with bleeding.”

    Fortunately, after two days or so the risk of bleeding had probably passed.

  23. Wolfy says:

    for windriven

    As an ex-primary care physicain, I agree with you that much of the stuff that PCPs end up doing is routine and could be easily taken care of by a PA or a well trained nurse–this is especially the case for patients with few or “minor” medical problems. In many medical practices, this “cost saving” method has already been employed.

    I agree that people need to take some medical responsibility and the medical establishment can’t “keep tabs” all the time on everything the patient does. That said, since we are prescribing chemicals (all the effects of which cannot be known in every individual) we are obligated to keep close watch over the prescribed therapies.

    Clearly, you are a very complient and educated patient and may need only one yearly visit with your physician and can touch base periodically with him/her by phone. However, this simply cannot be done for every patient because every patient has individual needs. Many patients have long medical problem lists which result in very long medication lists and need to be followed more closely with longer appointment durations or at shorter intervals. In my opinion, our health care system falls apart here because we operate under a business model that is interested in turning out “widgits.” Problem is that patients are not widgits.

    The physician-patient relationship needs to be tailored to the needs and medical problems of the patient. Thus, you may only need a yearly visit, but other people may need 2-3 visits (maybe more) per year.

  24. “Fortunately, after two days or so the risk of bleeding had probably passed.”

    Hmm, He’s having a second palate surgery again next month. I will have to ask our plastic surgeon when he feels ibuprofen is okay. My guess is he’s say nada til healing is complete. I’m hoping his reaction to the tylenol/codeine is better now that he’s bigger, since I don’t know of an alternative.

    As to addiction, that’s looking on the bright side. I have a similar reaction to Ambien, . Unfortunately I don’t think that predicts a similar distaste for the opiates (vicodin, etc) that seem to be popular these days and far too easy to get.

  25. Whoops, should have said “other opiates” since codeine is in that family.

  26. redplanet says:

    “In order to have a meaningful therapeutic effect, any drug can be expected to cause some sort of side effects.”

    Not true. Look at naltrexone at low doses. Most drugs work by blocking some process. Naltrexone works by IMPROVING the immune system (normalizing it – not dampening it or activating.) It works through opioid receptors/immune interaction.

    This is difficult to swallow because the medical paradigm is not accustomed to something that works as systems theory. Bringing homestasis to the body is not what pharmaceuticals are all about. This drug is given the heave ho because it works on so many fronts (most autoimmune illness and some cancers). That’s not acceptable by most and is labeled snake oil.

    Only, it isn’t. And there is nothing scientific about ranting about snake oil that is making huge and dramatic changes in the lives of people with chronic illness and in quite a few cases, terminal cancer. To see it use in cancer: MD/PhD speaking at USC on his terminal pts (now cured) using LDN. He presents PET scans of pancreatic cancer pts. He is a former investigator with the FDA There are more in this series.
    http://www.YouTube.com/watch?v=WqRwXEnPYKk

    It’s time to change the paradigm because it is ineffective and creates a hurdle that some people don’t have the time left to jump over.

  27. Wolfy says:

    to redplanet:

    “It’s time to change the paradigm because it is ineffective”

    I’m not sure I would go so far as to say that. The paradigm is effective, it’s just not perfect.

    I must admit that I don’t know much about this Dr Burt Berkson guy, but a quick Google search suggests he and his organization may be wrought with woo:

    http://www.cancercontrolsociety.com/

    http://www.cancercontrolsociety.com/bios-old/Berkson.htm

    http://www.drberkson.com/

    http://www.ncbi.nlm.nih.gov/pubmed/20042414

    Please enlighten me, those who study the woo and the anti-woo.

  28. Charon says:

    redplanet: I assume you read http://www.sciencebasedmedicine.org/?p=4997 , because you commented on it, but… perhaps you ought to read it again?

  29. Mark P says:

    Aspirin might well be appropriately removed from the OTC painkiller market now that generic ibuprofen (Neurofen) tablets are widely available.

    Ibuprofen gave my daughter a very serious asthmatic attack. We were in hospital for three days as a result.

    On the very rare occasions she needs something, she gets Panadol (acetaminophen) thanks.

  30. weing says:

    @Geekoid,

    I think that was just a test of their hypothesis. It’s been a long time since I worked in an ICU setting dealing with acetaminophen toxicity, so what I remember may be a bit out of date. The important thing I remember is that it becomes more toxic with glutathione depletion. That’s why we treated acetaminophen overdose with acetylcysteine as it would replenish glutathione. The metabolism of alcohol leads to glutathione depletion, so it makes sense to me that anything that depletes gluathione will increase the toxicity of acetaminophen. Correct me if I am wrong.

  31. BillyJoe says:

    micheleinmichigan,

    “Hmm, He’s having a second palate surgery again next month. I will have to ask our plastic surgeon when he feels ibuprofen is okay. My guess is he’s say nada til healing is complete.”

    Oh, I don’t know, if I was guessing I’d go for something much more interesting…. ;)

    Some surgeons use it immediately after surgery.
    Others say you should not use it for a week before to a week after surgery. Some even say for 2 weeks before and after. There is apparently no evidence base for any of these opinions. Studies, on the other hand, show that the antiplatelet effects of ibuprofen last only 24 hours making it safe to use up to 24 hours before surgery. I remember one trial (though, inconveniently, I can’t find it now) that showed no statistical difference in blood loss during surgery in patients who took ibuprofen right up to the time of their surgery (it might have been right up to 24 hours before suregery).
    I cannot find any trials showing when it is safe to use after surgery. So it seems, my opinion was not evidence-based either Damn.

  32. AlexisT says:

    One of my favorites in this vein is domperidone. Available BTC in the UK, FDA approval withdrawn in the USA.

    The UK controls the quantities of ibuprofen and acetaminophen (paracetamol) that can be purchased at any one time–I believe 16 tablets/capsules when no pharmacist is present, and 32 when one is, and they are sold in blister packs to make them more difficult to take. I used to buy Costco bottles of Advil and Tylenol when I visited my parents in the US.

  33. BillyJoe “Oh, I don’t know, if I was guessing I’d go for something much more interesting…. ;)”

    Yup, I deserved that! Sadly (or happily) plastic surgery appointments just don’t spark my imagination. Not an alien or leading man to be seen.

    Thanks for checking into the ibuprofen, BillyJoe.

    I wonder if there is some thought that less clotting could lead to slower healing. With this surgery the skin in the palate is kinda stretched, then stitched. One concern seems to be that if stitches open before healing, things don’t heal the way you want them to. This could mean a fistula or shorter palate which would not give the speech results hoped for.

    I don’t know that ibuprofen would slow healing though, that’s just layperson conjecture.

  34. Welcome, Scott! What a great post to start off with here. It’s really valuable for all of us that you are a practicing pharmacist and have the international perspective on drug usage and regulation (plus, I love my Canadian colleagues).

    I never really thought about how odd it was for the US and Canada to have a similar regulatory structure but then have some drugs BTC or OTC in one country but not the other. I look forward to learning more from you.

Comments are closed.