An 8-year-old died, it was
suspected, after receiving methadone instead of methylphenidate, a drug
used to treat attention deficit disorders. A 19-year-old man showed
signs of potentially fatal complications after he was given clozapine
instead of olanzapine, two drugs used to treat schizophrenia. And a
50-year-old woman was hospitalized after taking Flomax, used to treat
the symptoms of an enlarged prostate, instead of Volmax, used to
relieve bronchospasm.
In each of these cases reported to the Food and Drug Administration, the names of the dispensed drugs looked or sounded like those that were prescribed. There have been others: Serzone, an antidepressant, for Seroquel, used to treat schizophrenia, and iodine for Lodine, a non-steroidal anti-inflammatory drug.
Adverse events that can occur when drugs are dispensed as the wrong medications underscore the need for clear interpretation and better communication between the doctors who write prescriptions and the pharmacists who fill them. The FDA says that about 10 percent of all medication errors reported result from drug name confusion.
In each of these cases reported to the Food and Drug Administration, the names of the dispensed drugs looked or sounded like those that were prescribed. There have been others: Serzone, an antidepressant, for Seroquel, used to treat schizophrenia, and iodine for Lodine, a non-steroidal anti-inflammatory drug.
Adverse events that can occur when drugs are dispensed as the wrong medications underscore the need for clear interpretation and better communication between the doctors who write prescriptions and the pharmacists who fill them. The FDA says that about 10 percent of all medication errors reported result from drug name confusion.
Now, the FDA is guilty of a similar error that sounds like the one they are trying to prevent.
FDA
mixed up drug plant names
Confusion prevented China factory inspection
By Bruce Japsen and David GreisingTRIBUNE REPORTERS
February 19, 2008
The Chinese factory involved in the production of possibly tainted blood-thinning drugs for export to America was not inspected by the U.S. Food and Drug Administration because of a paperwork error in which Washington regulators confused the factory's name with another that already had U.S. approval, the FDA said Monday.
The FDA's explanation, by Joseph Famulare, deputy director of compliance for the FDA's center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA's inspection procedures for drugs entering the U.S. from China.
More than 300 people have reported potentially deadly allergic reactions after taking the blood-thinning drug heparin, which includes a key active ingredient produced in China for Deerfield-based Baxter International Inc. by Scientific Protein Laboratories of Waunakee, Wis.
While the cause of the allergic reactions remains unknown, the FDA said it plans to visit the Chinese plant this week as part of an investigation that the agency on Monday deemed "one of its top priorities."
Confusion prevented China factory inspection
By Bruce Japsen and David GreisingTRIBUNE REPORTERS
February 19, 2008
The Chinese factory involved in the production of possibly tainted blood-thinning drugs for export to America was not inspected by the U.S. Food and Drug Administration because of a paperwork error in which Washington regulators confused the factory's name with another that already had U.S. approval, the FDA said Monday.
The FDA's explanation, by Joseph Famulare, deputy director of compliance for the FDA's center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA's inspection procedures for drugs entering the U.S. from China.
More than 300 people have reported potentially deadly allergic reactions after taking the blood-thinning drug heparin, which includes a key active ingredient produced in China for Deerfield-based Baxter International Inc. by Scientific Protein Laboratories of Waunakee, Wis.
While the cause of the allergic reactions remains unknown, the FDA said it plans to visit the Chinese plant this week as part of an investigation that the agency on Monday deemed "one of its top priorities."
Drug names often sound like a foreign language, so it is easy to mix them up. I guess that drug factories in China have names that sound foreign, too.
We need to keep in mind that the cause of the problem with heparin remains unknown, so we don't want to conclude automatically that this is a "China problem." Nonetheless, it underscores the problem with name confusion.
Medicine & Health
Comments
Seems to me like the easiest solution for differentiating manufacturers would be to set up "establishment" numbers in the same way that the USDA handles all the food production facilities. That would also serve to differentiate different plants operated by the same company.
Posted by: chezjake | February 19, 2008 10:02 PM
I agree, they do need to come up with a better system. Using numbers would work very well.
Posted by: Joseph j7uy5 | February 20, 2008 12:59 AM
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http://blog.logtar.com/2008/02/18/bodies-revealed-boycott/
Posted by: logtar | February 20, 2008 10:55 AM
I think it's already been done...
All military medical units in Nato track medications using a NATO Stock Number...
http://en.wikipedia.org/wiki/NATO_Stock_Number
I recall combined Ex's (in the 80's) when we would admit from German (or Norwegian, or?) units and the only thing we could get off the patient's tag were the ICD codes and the NSN for medications given...(not the best system, but at least it was all make believe)
So now I'll bet they use Google translator...
Posted by: ian | February 20, 2008 10:44 PM
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Posted by: Oyun | February 22, 2008 11:26 PM