Prof Wants Ibuprofen Pulled Off Store Shelves
By George Anderson
A professor of pharmacy at the University of Tasmania says many of the problems that led to Vioxx being withdrawn from the market can be found in a popular anti-inflammatory drug that consumers purchase everyday right off the shelf in retail stores.
According to Gregory Peterson, the use of ibuprofen has been linked to an increased risk of heart attacks, asthma, gastrointestinal problems and miscarriages.
While medicines contain ibuprofen contain warning labels, Professor Peterson says many consumers in Australia either do not read them or discount them as not being applicable to their personal case. The mere fact the product is sold on store shelves gives at-risk consumers the sense that it is safe for them to use, he argued in an opinion piece published in the Australian Journal of Pharmacy.
“This is the real problem – you’ve got to catch one-in-five of the adult population that have these risk factors and aren’t sufficiently aware of the problems and there’s no safeguards in place in a supermarket,” he wrote.
Professor Peterson is not calling for ibuprofen to be taken off the market, simply reclassified. “It’s certainly a safe drug for short periods in relatively fit young people [but] probably the other consumer is at risk – the older patient – those on multiple medications, those with underlying cardiac or other diseases or an increased risk of adverse events from ibuprofen.”
As with other drug controversies, Prof. Peterson believes there are issues with some of the studies used to support the case for approving ibuprofen for OTC sale in Australia in the first place.
“The original study in which a lot of the case was built to make ibuprofen over the counter was the study supported by the manufacturer of that drug and in hindsight, there are a number of flaws with that study,” he wrote.
Moderator’s Comment: Will the call for reclassifying of ibuprofen in Australia have any impact elsewhere? Does the U.S. need a third class of drug sales
designation beyond OTC and Rx to protect consumers while not unduly restricting their access to them? –
George Anderson – Moderator
There should be a reasonable a type size minimum for drug labels and inserts. The font used is often so small that many people can’t read the words. Putting more drugs behind the counter, even if prescriptions aren’t required, is not likely to increase patient education significantly. People staffing prescription counters are pretty busy already, and they can’t easily counsel people in private.
A goodly chunk of any Australian pharmacist’s earnings comes from sales of products where availability is limited to pharmacies. Some non-prescription medicines may be sold only in pharmacies; others can be sold in supermarkets, but only in small pack sizes. The pharmacists have traditionally argued that they provide essential advice and play a role in preventing abuse and misuse of pharmaceuticals. However, I suspect the argument is specious.
I quote from personal experience.
Ibuprofen is a non steroidal anti inflammatory, at the safer end of that group of drugs. For many years, in Australia, it was only available on prescription. Several years ago, it was made available as an over-the-counter medicine in pharmacies and, in early 2004, to the horror of the pharmacists, it became available in supermarkets.
Some people should NOT take ibuprofen, including those with a history of gastric bleeding or ulcers.
For some time, my aging right knee has required me to consume ibuprofen from time to time. At one stage, I feared it had become a food group. Each time I have bought it in a pharmacy, I have walked up, asked for it, paid for it and walked out with the parting words: “This is the best thing I have ever taken for my ulcer pain.” Every time, except one, this remark went either unchallenged, or worse, was greeted with words to the effect of, “That’s good.” To her credit, a young pharmacist stopped me and told me of the dangers.
I know this is mischievous, and some might claim unfair. However, my point is that while pharmacists seem keen to claim they are protecting consumers, it is probably not the case. A very large proportion of the sales of these pharmacy-only over the counter products are being made by people little more qualified than those in the supermarkets.
Pharmacists are without doubt Australia’s most protected retail species, but still they seek further protection. Manage the risks of medication by education and labelling, not by further protecting the apothecaries.
Tasmania, Tasmania – oh, isn’t that where DeBakie did the first heart transplant?… No, no it was Salk that worked in Tasmania on the Polio vaccine… that’s not it… it was Curie who founded the Tasmanian school of Medical Opinion where doctors, not pharmacists review and comment on medications and receive a worldwide audience because competing 24 hour news channels couldn’t find a terrorist inspired explosion to report so they had to come up with almost anything to fill the time. GIVE US A BREAK!
Why not create a standard testing format including specific, at risk groups (say the top 10 medical conditions – heart problems, diabetes, etc.) and test for safety when used alone and other frequent OTC/Prescription drugs (e.g. with the top 5 OTC and the top 5 prescription drugs)
Based on testing, classify OTC into color coded classes, e.g. green: safe for most – see limited special conditions and amber or yellow: use with care – multiple condition and interaction warnings.
Ah, Tasmamia, birthplace of Errol Flynn, King of Hormones in the 1930s, 40s and 50s, has arisen spectacularly once again.
While Professor Peterson works hard to substantiate his point, there is nobody as complicating as somebody with either more intelligence or less common sense than we have. To wit:
I once had a mania
To go to Tasmania
For medical curds and whey
To tell you the vivid truth
There’s more knowledge in Duluth
Where ibuprofen stays on display.
Having spent a great deal of ’00-’03 traveling back and forth to New Zealand, I was always asked by my Kiwi friends to bring back two items from the U.S.: Big Red gum and Ibuprofen. I never researched why these two products weren’t available there, but dutifully did as I was asked. (I also took a small bottle of Heinz Ketchup with me each trip to NZ, for personal consumption only. For some reason, the formulation there was not the same as the one we enjoy.)
In retrospect, it seems that Ibuprofen was regulated and expensive in NZ, yet the population was aware of its palliative properties. Perhaps the regulations were right all along. (No reports yet on Big Red, however.)
Anyone purchasing OTC drugs knows that the usage instructions are vague and writ small, very small. Most of us are familiar with the peel-back, accordianed manuals attached to many OTC drug containers and, interestingly, to containers of weed killer – go figure. Coincidentally, those whose eyesight is worst usually need drugs the most. If a new drug classification is designated in the U.S., perhaps something as simple as understandable, readable instructions could be stipulated.
Once again, we are back to individual responsibility. If the packaging says “don’t take this medication if you do thus and so and be sure your primary physician knows that you are taking this and any other OTC drug or supplement.”
Then you have on your own think if 2 will do the job, 4 should really do the job. You then take the medications outside the normal dosage and you get a stomach ache or worse; whose fault is that?
I suppose the good doctor would prefer you go to the pharmacy and would be dispensed individual dosages each day?
The dosage/usage instructions are there. If you want to know any side effects get on the Net or ask the pharmacist, but don’t make me get a lecture on how to take aspirin. Maybe it gets lonesome in Tasmania?
Unlike foods, virtually all medications involve the balancing of the benefits versus the risks of consuming the product, and as we all know, different people in different societies have different levels of risk tolerance.
We’d hope that the impact of this call for action wouldn’t have a broader effect, but it’s also clear that we live in an increasingly fearful world. So, it’s hard to anticipate what will happen.
Just one more thing to think about.
Oh, please, not a third class of drugs. We need less regulation, not more. Will this have any impact in the U.S.? Certainly not, unless the FDA finds out, which is unlikely.
Since laws regarding the sales of pseudoephedrine have taken effect, we have to deal with taking a card up to the counter, standing in line waiting to receive the item we want to purchase. Most of these items are kept in the pharmacy and are not available at all if the pharmacy is closed. Imagine the lost revenue. This problem will on double if the pain category is put behind the counter. There has been a lot of action, lately, to take personal responsibility away from the consumer. I find it annoying that someone feels that we, as consumers can’t follow directions, call our doctors or ask the pharmacist questions, without help. With all that is going on behind the pharmacy counter these days, we don’t need another reason to stand in line.