Drug Shortages Spark Use of Compounders
Are the bureaucrats blaming others when they may be at the root of the problem..
It was Congress back in the 70’s that established MAC ( Maximum Allowable Costs) for Medicaid and generics… They are also the ones who mandated REBATES from the brand name medications for Medicaid prescriptions.
They have allowed the PBM’s industry to share the Insurance industry’s Sherman Anti trust exemption by the Mc Carren Ferguson Act .. thus the rebates/kick backs that they receive from the Pharma’s are legal…
All of this “squeezing of allowables” .. was it the underlying cause of all the consolidation in the Pharma industry… particularly the generic industry.. to where we have only one or two companies producing a particular product.. or line of products… and if/when there is a production problem… we have a shortage of one or more drugs.
As is with human psychology .. we can sometime do irrational things when we are desperate… we don’t do our due diligence … have these hundreds of compounding pharmacies that are doing “high risk” compounding seizing on a opportunity.. in a area that they are pushing the envelope of both ethics and legalities?
Do the various BOP inspectors know enough.. or care enough.. to peruse these companies websites… where they show were they will be having “displays” at various medical conventions… do they even ask .. how many salesmen do you have… look at their promotional literature. If they are acting like a manufacturer.. shouldn’t more questions be asked .. or ask the opinion of the FDA to do an inspection and make a decision if the compounding pharmacy is acting like a manufacturer.
Look at this issue with NECC/Ameridose… a VP/RPH of Ameridose was on the MA BOP… both of these entities were miles apart… the same ownership.. it is against MA practice act to produce medication in bulk without being licensed by the FDA.. Ameridose was licensed by the FDA. Who believes that this person who was a VP at Ameridose was not aware of what was going on at NECC in regards to bulk compounding…
As a member of the MA BOP … should this VP/RPH have both a ethical and legal responsibility to make the MA BOP aware of what was going on?… The failure to do so.. should it be considered UNPROFESSIONAL CONDUCT?
What about all the RPH’s that worked in these two entities that knew or should have known what was going on… UNETHICAL ??? … UNPROFESSIONAL??.. have a liability of all the collateral damage?
Or is this the typical attitude of many BOP’s… go along to get along…
This whole issue could be a turning point for the entire profession… where our legal system holds us to a higher standard… and holding us legally liable for “going along” with what corporate pharmacy management demands that we do.. when we find it questionable.
Filed under: General Problems
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