Wednesday, August 13, 2014

Exserohilum and the compounding pharmacy: pushing the envelope of virulence

It is 77 years since the sulfanilamide disaster precipitated the Food, Drug and Cosmetic Act aimed at protecting the American public from such incidents. Without aggressive legislation to ensure that the compounding pharmacy industry can produce medications with the expected sterility and potency, over- and underdosing illnesses, blindness, and deaths will continue to occur. This is particularly true of ‘industrialized’ compounders, which manufacture large quantities of supposedly sterile medications that are distributed widely.
As stated by Mikosz et al. in a report on fungal endophthalmitis linked to compounded products, “Clinicians should be aware that the availability of a compounded medication in the United States is not a guarantee of its quality or of FDA approval. Disclosure of a medication's FDA approval status should be encouraged at all stages of purchase and use. This information might enable clinicians to make informed decisions about the medications they purchase for patient use and to educate patients about the status of medications to which they are exposed. Maintenance of the safety and integrity of sterile compounded drugs in the United States demands a thorough review and improvement of compounding pharmacy regulatory practices.”19
 
more information here

No comments: