Thursday, November 8, 2012

How many other Complaints Against Bad Compounding Pharmacies Have Been Filed Where State Boards Have Failed to Take Action or the Proper Action?

In light of the recent discovery that the Colorado State Board of Pharmacy had filed with the Massachusetts' Board of Pharmacy  a 34-page complaint alleging NECC had distributed manufactured drugs to their state without patient-specific prescriptions, which was a  violation of NECC’s Colorado and Massachusetts’ licenses.  This complaint was sent to the Director of the Massachusetts' Board of Pharmacy, James Coffey and  the board's attorney Susan Manning, who would have been responsible for ordering an investigation. Neither did so according to news reports.  Coffey has been fired, and Manning has been placed on administrative leave.

These event in Massachusetts make me wonder how many other state boards of pharmacy have:

1)  taken no action or not strong enough action on complaints against compounding  pharmacies and pharmacist who pose a health and safety risk;

2)  received a complaint from another state and done nothing with it;

3)  referred the complaint to the FDA or another state with nothing having been done;

4)  inspected the pharmacy once and written it up, but not reinspected it to determine if it took corrective measures; (i.e., written up a compounding pharmacy or pharmacist for a  violation, but the pharmacy or  pharmacy and pharmacist are still doing the same thing).

Are state boards being proactive and examining the complaints that they have received within the last couple of years regarding compounding pharmacies and pharmacists?   In light of potential liability issues and health risk, not to mention the possibility of being fired, if I were on a state board of pharmacy or an inspector for a state board of pharmacy, I would be reviewing the complaints and inspections of compounding pharmacies and pharmacists for at least the last two years and making sure I had all my i's dotted and my t's crossed.

If the proper course of action had not been taken on a complaint or inspection, then I would get busy trying to figure out how to fix it before it becomes another NECC nightmare.  If no action has been taken on a complaint, take the appropriate action.  If the proper or not strong enough action was taken, reinspect or figure out a way to fix the health and safety risk.  If a complaint has been received from another state, take the appropriate action on that complaint.  If a complaint has been referred to the FDA or another state, followup with the FDA or that state to make sure they received the complaint, inquire if they need any additional information from your state, and find out what has or will happen to the pharmacy or pharmacist.  Reinspect any pharmacies that have been written up for violations and determine if corrective measures are in place; if not take immediate action to fine or close down the pharmacy.  By being proactive and taking the proper actions, state boards of pharmacy members and employees can not only limit potential exposure to liability (even though most states have statutory limits on this already in place), but they can also less the risk to the health and safety of the public.  
         

 

          
              

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