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New FDA drug safety projects rely on IT

FDA takes the pain out of Rx info

BY Ferris

Published on Dec. 6, 2006

The Food and Drug Administration plans to improve the Web portal so that

anyone can report adverse drug effects and will try data mining to learn

more about any problems with regulated medicines.

The agency, which has been criticized for paying too little attention to

prescription drugs after they are approved for sale, also will offer a

downloadable software module that doctors and other practitioners can

use to report on drugs. The module will work with existing electronic

medical records, making reporting easier for those with EMR systems.

snip

Today’s MedWatch portal “is a valuable tool, but we know that it is not

being used as effectively as it ought to be,” Gottlieb said in his

speech. The agency gets only about 10 percent of the adverse-event

reports that it would find helpful, he said, and few of the reports

come from doctors and patients.

snip

The FDA also will begin producing a regular, perhaps weekly, report to

the public so that everyone can find out what kinds of problems are

being reported, he said. The report may prompt more health

professionals to contribute data on drugs’ effects, he added.

http://www.govhealthit.com/article97031-12-06-06-Web

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Hi Kathy,

A small step in the right direction.

I am aware that Americans are more likely to complain than the British, but will it be well enough publicised and will it result in side effects being printed on all bottles of medication and will the printing be big enough for anyone to read.

I would also like it to be a requirement that all doctors should be required to point out all side effects to all their patients for whom they make a prescription.

Larry

New FDA drug safety projects rely on IT FDA takes the pain out of Rx infoBY FerrisPublished on Dec. 6, 2006The Food and Drug Administration plans to improve the Web portal so thatanyone can report adverse drug effects and will try data mining to learnmore about any problems with regulated medicines.The agency, which has been criticised for paying too little attention toprescription drugs after they are approved for sale, also will offer adownloadable software module that doctors and other practitioners canuse to report on drugs. The module will work with existing electronicmedical records, making reporting easier for those with EMR systems.snipToday's MedWatch portal “is a valuable tool, but we know that it is notbeing used as effectively as it ought to be,†Gottlieb said in hisspeech. The agency gets only about 10 percent of the adverse-eventreports that it would find helpful, he said, and few of the reportscome from doctors and patients.snipThe FDA also will begin producing a regular, perhaps weekly, report tothe public so that everyone can find out what kinds of problems arebeing reported, he said. The report may prompt more healthprofessionals to contribute data on drugs’ effects, he added.http://www.govhealthit.com/article97031-12-06-06-WebThere are just two rules for this group 1 No Spam 2 Be kind to othersPlease recognise that Prostate Cancer has different guises and needs different levels of treatment and in some cases no treatment at all. Some men even with all options offered chose radical options that you would not choose. We only ask that people be informed before choice is made, we cannot and should not tell other members what to do, other than look at other options. Try to delete old material that is no longer applying when clicking replyTry to change the title if the content requires it

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I think it is very important that side effects are well documented and discussed with patients prior to them starting them. I find myself addicted to a prescription medication (Anti-Depressants) with a number of symptoms that affect day to day life. Despite being told there was none and it was not addictive. Anyway I digress, In Britain we can report problems via a Yellow Card Scheme either through our doctors or on the MRHA website directly. Although its not much publicised and most people don't know about it. Take care, Clare hotlamb@... wrote: Hi Kathy, A small step in the right direction. I am aware that Americans are more likely to complain than the British, but will it be well enough publicised and will it result in side effects being printed on all bottles of medication and will the printing be big enough for anyone to read. I would also like it to be a requirement that all doctors should be required to point out all side effects to all their patients for whom they make a prescription. Larry In a message dated 12/12/2006 16:05:23 GMT Standard Time, kmeadelistaec225 writes: New FDA drug

safety projects rely on IT FDA takes the pain out of Rx infoBY FerrisPublished on Dec. 6, 2006The Food and Drug Administration plans to improve the Web portal so thatanyone can report adverse drug effects and will try data mining to learnmore about any problems with regulated medicines.The agency, which has been criticised for paying too little attention toprescription drugs after they are approved for sale, also will offer adownloadable software module that doctors and other practitioners canuse to report on drugs. The module will work with existing electronicmedical records, making reporting easier for those with EMR systems.snipToday's MedWatch portal “is a valuable tool, but we know that it is notbeing used as effectively as it ought to be,†Gottlieb said in hisspeech. The agency gets only about 10 percent of the adverse-eventreports that it

would find helpful, he said, and few of the reportscome from doctors and patients.snipThe FDA also will begin producing a regular, perhaps weekly, report tothe public so that everyone can find out what kinds of problems arebeing reported, he said. The report may prompt more healthprofessionals to contribute data on drugs’ effects, he added.http://www.govhealthit.com/article97031-12-06-06-WebThere are just two rules for this group 1 No Spam 2 Be kind to othersPlease recognise that Prostate Cancer has different guises and needs different levels of treatment and in some cases no treatment at all. Some men even with all options offered chose radical options that you would not choose. We only ask that people be informed before choice is made, we cannot and should not tell other members what to do, other than look at other options. Try to delete old material that is no longer

applying when clicking replyTry to change the title if the content requires it

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