Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, October 24, 2014
Observation: There is no way to compare recalls of compounded medications to recalls of commercially available that is fair; all adverse results from compounds are not tracked, not required to be reported, the adverse result may not be known because of lack of studies and trials, adverse results may be covered up with no consequence etc. Commercially available drugs are and have been regulated for sometimes, thus allowing for immediate recall when a problem is discovered
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This is very important, and underscores the statistical reality that "absence of evidence is not evidence of absence." Not only are pharmacies not required to conduct surveillance, in most states they are also not required to report, track or analyze quality complaints or adverse events. All the more problematic because as laypersons (i.e. consumers/patients) we are unable to identify flaws and reject products at the user level. Impossible, even to detect Pyrimethamine, 2380% of its declared concentration, a recall that would have saved the lives of horses http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410141.htm.
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