The use of unregulated, pharmacy-compounded dosage forms has been associated with morbidity and mortality throughout the nation:
quoted from Dr. Sarah Seller's 2003 Testimony before Congress.
- An outbreak of bacterial meningitis in California was associated with compounded spinal injections—three patients died and eight were hospitalized.
- warned physicians and health systems to consider substandard, compounded drug exposures in cases of unexplained infections following intraspinal or intra-articular injections after an outbreak of fungal meningitis was associated with compounded drugs— further cautioned that health systems may not be aware that they are purchasing compounded drugs, thus actually requiring vigilance to prevent compounded drugs from inadvertently entering supply chains.
- Compounded spinal injections were associated with neurologic complications including paralysis in an epidemiologic cohort study of patients who received unapproved, pharmacy-compounded continuous intrathecal infusions [23].
- Three cases of poisonings in children have been associated with unapproved drugs compounded for Attention Deficit Hyperactivity Disorder [35,36].
- A 5-year-old died as a direct result of receiving an unapproved compounded drug for bed-wetting [37].
- Two patients developed septicemia and were hospitalized after receiving compounded vitamin injections contaminated with bacteria [38].
- Three patients were hospitalized in critical condition after receiving compounded thyroid remedies [39].
- A cancer patient died after receiving a compounded injection of herbal tea [40].
- A patient became blind after using compounded eye-drops that were not sterile [20].
- A study comparing a compounded prostaglandin dosage form with a licensed product found a higher incidence of cesarean delivery associated with the compounded drug [41].
- An estimated 4,000 cancer patients received diluted, sub- therapeutic chemotherapeutic agents compounded in Missouri [31].
quoted from Dr. Sarah Seller's 2003 Testimony before Congress.
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