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-   -   reporting to FDA - medwatch--Mrs D? (https://www.neurotalk.org/peripheral-neuropathy/29918-reporting-fda-medwatch.html)

LizaJane 10-11-2007 07:53 PM

reporting to FDA - medwatch--Mrs D?
 
I've just filed on online report on Forteo, reporting that I have increased neuropathic pain since taking it. I figure it's important to do.

But now I'm wondering---mrs D???---do pharmacists have to fill out any kind of report if they dispense the wrong medication? because that happened to me, and I'm wondering if they are supposed to do this?

Yorkiemom 10-11-2007 08:27 PM

LizaJane:

What is this about? I don't know if I just missed a post on problems you had with this or what. Could you please explain? Also, if you are not taking it any longer, what alternative is there?

Cathie

mrsD 10-11-2007 08:33 PM

Liza....
 
compounding pharmacies are another breed.

YOu should sue them. That is your only recourse. Other than reporting to the
NY board of Pharmacy for professional discipline. If you wait too long the statute of limitations will pass, 2 yrs typically.

The high calcium influx after the shot, is probably causing the side effects you
feel. You might try taking magnesium (if you aren't already). Calcium stimulates the NMDA channels and increases pain. Magnesium closes the channels.

Some people get cramping too.

You could try calling Lilly up...they have a toll free number..their professional line, see if they can help (I have little confidence that they will help you however).
Here is a list of reported reactions:
http://www.patientsville.com/medicat...de_effects.htm

BEGLET 10-13-2007 09:44 AM

Drug Reporting
 
Liza Jane - good to hear you reported to FDA - I dont think the docs do much of anything to report to drug companies unless they see lots of instances.... (until they see a pattern)... I took one tablet once of seldayne (it was an allergy med) (the only one I ever had), but was also at the end of a week long bout of the flu so couldnt really isolate an incident - and went into heart failure - my effective heart rate was around 29 bpm for almost a whole day - and after finally going to urgent care was rushed by ambulance to UCLA CCU - they had no idea what was going on -especially since I'd just had a cardiac workup few months earlier and all was fine.... (this is when I was healthy).... it slowly got back to normal as the med wore off - but - no connection was made at the time... I saw several years later it had been taken off the market for just this reason.... couple months ago I accidently sprayed nasonex (nose spray for allergies) right into my eye (I was tired - duh) and called the manufacturer to see what if any damage I might/could do... they told me first what to do (go soak your head)... then took my personal information and sent me a release to send to my doc to follow up and make sure there was no lasting damage.... I was surpised at their vigilance on that one.....

Hope you feel better.:)

HeyJoe 10-13-2007 10:35 AM

I have noticed over the years that people here including myself take as little as possible of medications and as much as possible try to do vitamins or other therapies like electrical, massage, exercize etc. As you all well know all of these medications have some side effects and as Joan says the interaction potentials become mind boggling at times. Even those who have to take more than others because of their extreme pain or number of conditions still take no more than necessary. This includes people here who i often think of and say a prayer for because of how valiantly they continue the battle, despite long term excruciating pain and limitations in their life. This is a very informed and intelligent group and felt its positive to remember that at times.

LizaJane 10-16-2007 01:02 PM

Mrs D
 
Do you know if there are any mandatory mechanisms that pharmacies are supposed to have when they dispense an incorrect medication? I know hospitals make out "incident reports" that get some sort of oversight. But what are pharmacies suppoesd to do when they give out the wrong drug?

Are there rules?

mrsD 10-16-2007 03:24 PM

???
 
Quote:

Originally Posted by LizaJane (Post 158431)
Do you know if there are any mandatory mechanisms that pharmacies are supposed to have when they dispense an incorrect medication? I know hospitals make out "incident reports" that get some sort of oversight. But what are pharmacies suppoesd to do when they give out the wrong drug?

Are there rules?

I thought we had been over this subject thru email in the recent past?

An incident report is only used by lawyers and insurance companies. A private pharmacy can do whatever it wants to. It can be very careful, or sloppy and pay the price.
How does it pay a price? It gets sued. Or it loses its license.

A private pharmacy answers only to the Board of Pharmacy in its state.
That is it, in regards to errors. The board does not know if any pharmacy is doing sloppy things unless people report it. In a corporate situation in a chain, there is a heirarchy to which you report. They then go to their insurance carrier, who tries to settle you out. This may be done without State Board interference, if no complaint is made. Not all patients complain of an error, but if they do, the company expects an incident report to be there.

The State board governs all health professions. It is the premier place to make a complaint.

I think what is at stake here is your contribution to the situation. You did not notice your labels were wrong. So you hesitate to make the complaint.
In a liability situation this may reduce your claim. But in a complaint to the State, it will have no if any bearing.

A private pharmacy may or may not fill out an incident report. A corporate chain requires a report as part of the job description, but that does not mean it will be done. I have seen many things... Rxs mysteriously disappear, false reports, you name it. If you do not have PROOF that you were given the wrong thing....and I recall recommending that you SAVE all your receipts and bottles... then you have no legal standing. And very little back up to a formal complaint to the Board in your state.

There is NO recourse for an error to a private pharmacy other than the State Board. The State determines the license of the place. Without a license there is no pharmacy.

There is a movement in Congress right now to tighten controls over compounding pharmacies. This is to ensure that illegal drugs are not used, inappropriately in compounds. Some believe that compounding pharmacies are loose cannons. Others believe that they perform custom services for patients that are necessary.

In your case, a drug which is not FDA approved for nasal application, because of harm, was ordered for you and you used it. I think you should seek an attorney with experience in malpractice for complete answers. Statute of limitations is typically two years. After that no liability recourse is available.
There may be still valid the complaint to the State. That depends on the public health laws of your state.

Also you might have a claim against the doctor, who used a dangerous substance to treat you. If he exceeded normal level of care, he is culpable, as well. That would be a civil tort action, and you would have to start it.

edit to add: If this pharmacy has no other complaints against it, typically they will be reprimanded and perhaps a fine levied.
If there are numerous complaints, and you are not the only one, then stricter actions may result. Having a written reprimand in the file protects others of the public down the road.

dahlek 10-16-2007 09:22 PM

Try the site below
 
http://www.op.nysed.gov/pharm.htm
It's a start, tho I'm not familiar with NYS organizations....

In my case I reported to the state licensing board and the med MFR as it was an issue in a hospital setting...Within 5 weeks all professionals involved received 'refresher-updated training' by both the MFR and by the appropriate credentialing sources...Imagine...a major hospital infusion clinic being closed for a week for 'training'?
Possible statutes of limitations may have expired, but the negligence has not. The records have to be kept for one heck of a very long time...
Hint? Request a copy of what the pharmacy 'billed' your insurance company for that specific med? Ask your insurance company for all prescription meds issued from X to Y points in time...ask for the detail on meds and doses. Betcha any wrinkles should show up there? As in they billed your insurance for the 'quantity' that wasn't quite what you wanted? Computer billing is very literal in that respect. You get it IN PRINT, then well, you got them! What can be done about it? Different animal completely.
Hope this helps - j


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