Pharmacy Malpractice Case Involving Wrong Dose Highlights Need for Regulation
By Attorney Fred Pritzker
I recently settled a wrongful death case involving a compounding pharmacy. An elderly woman died a horrible death within twenty-fours after ingesting a medication produced by a compounding pharmacy that was eight to ten times stronger than was prescribed by her doctor and labeled on the medication vial. The overly-strong medication was the result of a simple weighing and labeling error by the compounding pharmacy that would have easily been prevented/detected if rudimentary quality control measures were followed.
Unlike the large chain drug stores (or the corner drug store), compounding pharmacies manufacture small doses of rare and unusual drugs that are not otherwise available from major drug companies.
People with rare disorders or those who have a good therapeutic response to rarely used medications depend on compounding pharmacies for prescription drugs not otherwise available from more traditional pharmacies and drug companies.
The problem is that compounding pharmacies operate in a gray area far less regulated than traditional drug companies. This means they are not subject to regulation by the United States Food and Drug Administration (FDA) and do not have to comply with the very strict statutes and regulations governing the development, formulation and testing of prescription drugs.
This lack of oversight can have disastrous consequences as exemplified by the case discussed above.
It is time for the FDA to regulate compounding pharmacies and manufacturers and processors of all medicinal products, including vitamins and other health products. These products should be safety-tested, inspected by the FDA, and subject to immediate recall be the FDA. The compounding pharmacies and other companies should be required to follow quality control measures approved by the FDA, be subject to FDA plant inspections and be required to file relevant safety documents with the FDA.
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Tags: Pharmacy Malpractice MN, Wrong Dose Malpractice Lawyer MN
