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[e-drug] Two drug systems in the U.S. (3)

E-DRUG: Two drug systems in the U.S. (3)

Dear E-Druggers:
This issue is complex and does indeed call into question pharmacy ethics.  
Pharmaceutical manufacturing under the guise of pharmacy compounding in the 
U.S. is a supplier-driven, pharmacy-owned and operated industry. Over the past 
several years, reports in the media, warning letters issued by the FDA, 
congressional testimony and records from legal cases chronicle the history, 
scope and public health implications of this growing public health problem--now 
considered out of control by public health experts.  
Consider the following. On Sept 17 2004, pharmacy Delta Pharma, Inc. received a 
warning letter which alleges the manufacturing of sub-standard injections under 
the guise of compounding (accessible at 
www.fda.gov/foi/warning_letters/g4965d.htm). The warning letter notes that 
products made at the pharmacy included copies of commercially available 
products, and that no documentation existed to establish the medical necessity 
for making the drugs from scratch. This is just one example of many letters 
issued over the past several years--some to pharmacies manufacturing massive 
quantities of drugs, some to smaller operations making unsafe  drugs, and some 
to repackagers who supply the industry with questionable chemicals. The FDA has 
noted certain products (including nebulizer medications and injectables) are 
compounded in massive quantities that far exceed amounts consistent with 
traditional and necessary pharmacy compounding (some pharmacies produce more 
drug than licensed manufacturers). Other federal agencies have now become 
involved. After deaths and injuries were associated with compounded drugs, the 
U.S. Centers fro Disease Control reviewed the matter and issued an alert 
instructing physicians to include exposure to substandard drugs in their 
differentials for unexplained infection following certain injection procedures 
and noted that health systems may not even realize they are purchasing 
compounded injectables (Exophiala Infection from contaminated injectable 
steroids prepared by a compounding pharmacy MMWR Weekly December 13, 2002/51 
(49); 1109-1112). 
The volumes of compounded drugs in the marketplace are unknown. U.S. does not 
track sales of compounded drugs or even the amounts of bulk chemicals/APIs that 
are purchased, imported and repackaged for pharmacy compounding.  Compounded 
drugs have been recalled for contamination and potency issues, but because 
there is no formal surveillance of the industry and because pedigree 
requirements have not been implemented under the 1987 U.S. PDMA, known problems 
are considered tip of the iceberg by public health experts. 
My comments may be considered harsh with respect to conflicting U.S. policies, 
but increasing patient populations are being exposed to substandard products 
without their knowledge and in many cases through misleading doctors into 
authorizing substitutions--the U.S. governement knows about the problem, but 
has yet to address the issue in a meaningful way.  It's political. The words of 
a scientist, colleague and friend from Russia haunt me on this one-- "politics 
always win". I hope politics can join policy on this one. 


Sarah Sellers, PharmD MPH 

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