Sunday, July 6, 2014

Kudos to the Nevada Board of Pharmacy: More Evidence of More Problems in the Compounding Pharmacy World--Nevada Board of Pharmacy took Strong and Swift Action in the Pathway case



 


July 2012 Board case:
Pathway was inspected at the end of August 2011.

Facility did not have a certified ante room and were instructed to not use the sterile area for compounding until an ante room was build and certified.


 


In October 2011 Pathway compounded 100ml preservative free Ca Gluconate vials in the unapproved area (from anhydrous, which is not approved for parental compounding, and was purchased on-line from China).

The Ca Gluconate vials were sold to a practitioner, through his nurse, who administered them in 10ml aliquots put into 11 vitamin mini-bags.


 


All 11 Patients become ill with a gram positive sepsis; presented to emergency rooms, and 2 were hospitalized.
Information is shared with both the practitioner’s and nurse’s licensing boards for their review/action.


 


July 2012 hearing.
Of the three pharmacists named in the case, two appeared, as well as the pharmacy itself.

The third pharmacist surrendered his license and moved to New Jersey . . .


 

Pharmacist A ordered to:

Complete "Your Success Rx".

Attend Star Center in Colorado prior to compounding again.

Pay fees for both of the above programs.

Pass proficiency tests.

Probation for two years.


 

Pharmacist B ordered to:

Pay fine.

Attend Star Center as well.

Pass proficiency tests.

Probation for two years.


 


Pathway Pharmacy:
Probation for 3 years.

Train all pharmacists and technicians on procedures recommended by Star Center

All individuals doing high risk sterile compounding must pass competency testing.


Revise policy and procedure manual to the approval of Board staff.


 


Bring antiquated computer system into compliance with our regulations.
Any new staff involved in sterile compounding shall be approved by the board to ensure proper training.

A designated representative, other than Pharmacist A, shall complete successfully "Your Success Rx" Program


 


Pharmacist C:
Surrender of certification of registration in Nevada.

Is not eligible to reapply with Board in Nevada for 5 years from date of order.

Cannot work in any capacity for any other entity licensed with the Nevada Board of Pharmacy until relicensed by the Board.
Quoted from here


 

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