E-DRUG: Two drug systems in the U.S. (10)
-----------------------------------------
Dear e-druggers,
With all due respect to David Newton's assessment--the morbidity and mortality associated with compounded drugs is unknown--there is no surveillance. Compounders love to make this comparison, but one cannot compare drugs that are subjected to extensive surveillance and reporting requirements with drugs which fly under the radar screen.
Just yesterday I received a message from a physician whose patient called to report that her pharmacy dispensed an unregulated drug--she was told that Medicare would pay only for a compounded product. The patient complained the medication was not working well and irritating her throat. Unfortunately I have many similar stories, but they are not part of a formal review system.
As to the state issue, I have been phoned by inspectors who are uncertain how to even inspect a compounding pharmacy--they ask me what to look for that would indicate drugs are being made safely. When I have filed complaints with states about pharmacies churning out massive quantities of substandard injections "for office use," some complaints have gone unanswered. Others have come back "no violation"--later to be cited by federal authorities. For respiratory drugs, I have recently learned that some states do not require compounded respiratory drugs to be sterile, and furthermore that pharmacists are not required to disclose this information to prescribers or patients. That effectively removes the ability of physicians to act as "learned intermediaries" for the purposes of communicating risks to patients.
Compounders claim a "right to compound drugs," however, they do not have a right to expose patients to substandard products without their consent for profit reasons.
I am simply appalled by the inaction on this issue.
Sarah Sellers, PharmD MPH
ssellers@jhsph.edu