Tuesday, November 19, 2013

Iowa State Board of Pharmacy Charges Against Bauder Pharmacy, Des Moines, Iowa and status of case

Bauder Pharmacy, Des Moines, Iowa, pharmacy license #222, CSA registration #110280
The Board issued a Statement of Charges and Emergency Order in May 2012 for 19 counts including:
Failing to maintain adequate control over and accountability for controlled substances
Failure to establish effective controls against diversion of controlled substances
Failure to maintain records as required by the Controlled Substances Act
Failure to properly sign and date invoices for controlled substances
Dispensing Schedule II controlled substances in quantities exceeding prescriber authorization
Failure to comply with requirements for the partial filling of Schedule II controlled substances
Failure to maintain complete and accurate perpetual inventories of Schedule II controlled substances
Failure to maintain a complete and accurate inventory of controlled substances
Failure to document verification of controlled substances refills
Failure to properly supervise dispensing functions that are delegated to non-pharmacists
Failure to maintain complete patient records
Failure to ensure that all pharmacy technicians have a current and active technician registration
Failure to maintain required policies and procedures for the operation of the pharmacy
Failure to provide proper security for prescription medications and pharmacy records stored in the basement
Failure to have required policies, procedures and documentation for pharmacy technician training
Failure to have a continuous quality improvement program
Failure to meet minimum standards for sterile compounding
Failure to provide labeling and record keeping for patient med paks
Failure to provide adequate patient counseling to patients
Charges were initiated following two secret shopper surveys of the pharmacy, a routine inspection of the pharmacy, as well as an audit of controlled substances (looking at the DEA ARCOS report and PMP dispensing records) which found significant areas of non-compliance and the likelihood of diversion of hydrocodone-containing products.  The Emergency Order immediately and indefinitely suspended the pharmacy's CSA registration prohibiting it from handling controlled substances.  An administrative hearing was held in February 2013.  The Board ordered revocation of the pharmacy's CSA registration.  The Order assessed the pharmacy a $25,000 civil penalty, placed its license on indefinite probation, and required the submission of a corrective action plan, policies and procedures and a CQI program within 30 days.   The pharmacy was barred from providing sterile compounded products until approved by the Board.  The pharmacy is required to obtain Board approval for every pharmacist in charge of the pharmacy and is not allowed to give Mark Graziano access to the prescription department or the prescription drugs.  The pharmacy was also ordered to submit to quarterly inspections by a Board approved consultant, at the pharmacy's expense, and provide quarterly reports for the duration of the indefinite probation.          [2013]
Following a partial remand order from Polk County District Court, the Board held an administrative hearing in October 2013 to hear additional evidence related to the pharmacy's policy and procedure manual to determine if its April 2013 Order would require any change.                 [PEND]
source Iowa State Board of Pharmacy

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