Saturday, July 5, 2014

Seventh Question of the Day July 5, 2014 How much of this is still true? Do most US patient, even after NECC, have no awareness or understanding when they are receiving FDA approved drugs and when they are not?

More than 80 percent of the raw active pharmaceutical ingredients (APIs) come into the United States from overseas. FDA has found that some of these APIs are not produced in FDA-registered and inspected facilities. These APIs are not produced under cGMP requirements. The Pharmacy Compounding team has seen problems such as contamination, adulteration or lack of purity with these APIs. An example found was the contaminated heparin API. Produced and distributed from China, it resulted in numerous deaths and hundreds of adverse reactions.
The Pharmacy Compounding team cannot inspect every pharmacy, identify every Web site selling unsafe or ineffective compounded products or test every API coming into the United States. To aid its mission, the Pharmacy Compounding team tries to increase public awareness and understanding regarding compounded drugs and the potential risks. Many patients do not know that a compounded drug is not an FDA-approved drug and therefore the safety and efficacy are unknown. Unlike drug manufacturers, pharmacies are not required to report adverse events related to compounded drugs, so adverse events are often undocumented and unreported.

quoted from here

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