Thursday, June 23, 2011

Adverse Event Reporting System...a dirty little secret

I live in the southeast of the US and we have just entered the dreaded hurricane season here. Now add to that the recent outbursts of terrible tornadoes that have devastated many regions of this country and you can understand why I am very concerned about the various warning systems set in place. They do a terrific job here where I live.

This got me to thinking about what medical warning systems we have in place here in the U.S.. So off I went to do my research. The first and foremost top dog here is the FDA which stands for our Federal Drug Administration. They pretty much govern it all: food, drugs, medical devices, vaccines/blood/biologics, animal & veterinary, cosmetics, radiation-emitting products, and tobacco products. I would put this link under one of your favorites.

Why? Well we don't always get notified of things that maybe we should be notified about. If you check back frequently on their home page you can then become an empowered consumer and stay atop of what "alerts" may impact you. OK...I am getting sidetracked here.

My main intent for today is to talk about how side effects of medications are reported in this country. Upon first undertaking the looksie into this, I was expecting a very clear cut path by which doctors, hospitals would be reporting any adverse drug reaction or even any side effect of concern.  I was figuring (falsely so) that our government had a tight reign on this reporting system. You all know by now I love the KISS system of things (Keep It Simple Stupid) and as a patient consuming many, many medications (some relatively new) I was under the false impression that big government had this little pony show under a very tight reign. WRONG!!! I almost puked when I read this...

The Adverse Event Reporting System is a VOLUNTARY system! Are you kidding me! So, let me get this straight oh wonderful FDA of ours...all those adverse reactions that I have been having on a regular basis with methotrexate, plaquinil,  enbrel, humira, mobic, celebrex, etc. etc. probably were not reported? How the heck can this be happening? So for the past 13 years I have been under the false security that while I was consuming my ra medications I thought that all reactions to any of the medications I was taking was being reported, tallied and that our FDA was watching over me.  I was under the impression that when I read side effects on any website (including the manufacturers) that all adverse reactions where being reported, computed and thereby feed back to us as consumers.

And what about my internet friends that have passed away while on medications, often a large amount of medications? Where their deaths reported at all?  Did anyone even consider that maybe their medication combination might have played into their demise at all or maybe even a single medication? I am sure their families were not aware that THEY should have reported their deaths! And I am not saying any medication did contribute to their passing but how do we know?

Now should I be over reacting here? Please check out this link which stipulates that ADVERSE REACTIONS is a voluntary system..I am posting word for word here...

Reporting Serious Problems to FDA

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse eventproduct quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.  You can also report suspected counterfeit medical products to FDA through MedWatch.

Submit Your Report Online

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products.  Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

I am ending this now. What can be done about this? My only answer at this point (my BP is so high right now I can't really think to straight!) is for YOU to report YOUR OWN REACTIONS TO ANY MEDICATION YOU ARE TAKING AND MUST STOP!! Did you read that correctly. If not, let me repeat it for you...YOU MUST REPORT IT YOURSELF TO ENSURE IT HAS BEEN REPORTED AT ALL!!

Here is the link to do just that and please bookmark this link. I am counting on you...why? You may very well save my life in the future.

Where to report an adverse drug reaction.

Breath in...breath out....slowly...slowly....slowly. I am now going to take some medication for nausea...oh wait...can I be sure it is safe?


Jan said...

How ridculous! Thanks for reporting what I should have already known. Dismal.

Deb aka AbcsOfra said...

I often hesitate to post "dismal" type posts because ra is so hard to deal with already but on this one if we don't do our own reporting then it may nit get reported at all. I have had ra for 13 years and I DIDN'T know either and I do alot of reading to be informed. I was floored when I found this out myself. I was assuming that all along my doc was reporting. I am now going to read my drug inserts next time I get my scripts refilled to see if this reporting information is on them. I don't remember seeing it there but I could be wrong. My doctor never told me about reporting any adverse incidents could we know? And how can we possible know everything Jan? That is why we need each help walk down this path together. Thank you for your comment here.

Anonymous said...

I haven't been a huge lover of the FDA since they started harassing the meat/milk coop I belong to. They conficated all of their computers as well as their truck full of meat, eggs, and milk several years ago. When small farmers who are providing foods for individuals who have carefully thought through their food choices are harassed by the FDA, it makes me sick, especially when you can walk into any store and buy tons of foods that do nothing but add to obseity and disease. "Okay Cathy, stop there. No need to rant on someone elses blog." Sorry. I am just not impressed with the FDA at all.

Thanks for sharing this information with us. It does make one want to throw up, doesn't it?

Cathy (who can only comment as an anonymous blogger once again.)

Deb aka AbcsOfra said...

I can truly understand your frustration with a small coop being infiltrated by the FDA. Sad. I just want a mandatory reporting system put in place immediately so we know what is going on with meds out in use among the public. Now how do we do this...get a mandatory reporting system?

Anonymous said...

Our government fails us yet again. This is truly disheartening, maddening. I am at a loss for words. I assumed the the doctors reported those kinds of things. Thanks for posting.

Deb aka AbcsOfra said...

Cammie - me too...I wrongly thought the same thing. I am one of the unlucky ones that for some reason medications give me allergic reactions alot. I assumed that my doctor(s) reported it all. Now I don't have a clue what was reported if any of it. I do know that the Humira reaction I did report on my own because I called the FDA to see if anyone else had my reaction to it. They told me nothing at all which didn't help me at all but did take my allergic reaction report. Thank you for your comment.

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