E-drug: Products recalled in Australia (cont'd)
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Dear Libby,
Thank you for this important information concerning substandard
drug manufacturing in Australia. The US has seen a recent flurry of
recalls of purportedly sterile dosage forms distributed throughout
the US which have been found to be contaminated with fungus
and/or bacteria; and, just yesterday, some which have been found
to be sub-potent. The recent recalls involve millions of doses of
drugs manufactured by pharmacies in the absence of US FDA
oversight. As the result of a Supreme Court ruling in April 2002,
regulations which provided federal oversight for "pharmacy
compounding" have been nullified - currently the practice is
regulated by states which have limited and discrepant rules for
pharmacy drug manufacturing.
Some of the recalls have been associated with patient deaths and
cases of meningitis - though morbidity/mortality from substandard
drug exposure is largely unknown - pharmacies are not required to
report adverse events associated with drugs they make.
The recent recalls can be viewed at:
http://www.safetyalerts.com/recall/f/02.2/f0002502.htm
http://www.safetyalerts.com/recall/f/02.2/f0002500.htm
http://www.safetyalerts.com/recall/f/02.2/f0002498.htm
http://www.safetyalerts.com/recall/f/02.2/f0002570.htm
http://www.safetyalerts.com/recall/f/02.2/f0001732.htm
http://www.safetyalerts.com/recall/f/02.2/f0000444.htm
Sarah Sellers, PharmD
MPH candidate
Johns Hopkins School of Public Health
e-mail: ssellers@jhsph.edu
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