Compound drugs strikes again…

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/36621?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2012-12-27&eun=g578717d0r&userid=578717&

 

From the article…

The FDA has issued a class I recall of two infusion pumps citing motor failure when used with drugs not specifically approved for them.

Device manufacturer Medtronic noted in a letter sent to healthcare professionals that the device failure rate went from 2.4% when used with approved drugs to 7% when used with unapproved drugs. The company cautioned healthcare professionals to avoid using compounded drugs, unapproved concentrations, and unapproved formulations with these pumps.

“Pain clinic” and other MD’s that routinely use these implanted pumps… would put compounded drugs in them.. with pain pts.. they couldn’t legally get Morphine compounded since there was a commercially available product ( Infumorph).. so many would add a Lidocaine type drug to what was put into the pump.. which typically adds little/nothing to the therapeutic benefits… but  since this was not commercially available .. it became “legal” to have it compounded.. WHY?… because places like NECC and others would sell these compounded products at 10%-25% of the cost of the commercial product.  Since these pain clinics bill the insurance carrier via HCPCS codes… there is no such thing as brand/generic pricing…  Think of it like being able to sell a generic and charging the insurance company for the brand name…

On top of that .. the commercial product ( Infumorph) had been tested by Metronic to be stable for six months in vivo… most/all compounding pharmacies put a 30-90 days stability date on their product.. which meant the MD was able to provide and charge for more procedures per year… refilling the pumps.  Of course, these pumps put drugs directly into spinal fluid.. so they have to be both sterile and preservative free.. and refilling these pumps poses a huge potential for spinal fluid contamination .. that usually results in meningitis .. which can result from anything from paralysis to death for the patient… but the MDs’ were able to generate more revenue…

 

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