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.
regards
Sarah Sellers, PharmD MPH
ssellers@jhsph.edu