Board of Pharmacy Meeting Updates



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These updates are provided by IPA and are not an official record of the Board of Pharmacy's activities. The updates provided are selected portions of the meeting that are of general interest.  

 

Meeting Updates for 2022:

January:

 

Election of Officers:
Mark Smosna, R.Ph. was elected as President.  Mark is the Senior Pharmacist in Charge - Indianapolis, Amazon.
Mark Bunton, R.Ph. was elected as Vice President. Mark is a Senior Advisor, Professional Practice for CVS and Past President of IACP. 
Both are members of IPA.

Disciplinary Case of Note:
Inaccurate Labeling: An independent pharmacy purchased another pharmacy.  Prior to this purchase, the original pharmacy received a prescription for Juluca for a patient. This pharmacy filled other prescriptions for this patient, packaging them in a DosePak.  However, the pharmacy did not have Juluca in stock.  The original pharmacy believed that they adequately communicated to the patient the need for the patient to source Juluca from another pharmacy.  However, the patient did not understand this and went for a year before a healthcare provider notified the pharmacy that the patient's viral load was not controlled.  By this time, multiple DosePaks had been provided which included a label for Juluca, by both the original pharmacy and the new owner, even though the package did not actually contain Juluca.  In a settlement agreement, the pharmacy agreed that it provided a misbranded product and agreed to a term of probation for nine months.   This case highlights the importance of accurate labeling, checking DosePak packaging and communication with patients. 

 

February:

 

Disciplinary Case of Note:
Prescription Misfill: An incorrectly compounded ivermectin prescription resulted in a serious adverse event in 2013. The pharmacy received a script for 15 g of ivermectin powder, and the only instructions were “use as directed.” The pharmacist dispensed 3 vials of 5 g of ivermectin. The pharmacist was supposed to compound the powder into 3 mg pills. The medications were ingested by the patient, the patient was found unconscious, and spent 9 days in the ICU. This complaint was filed in 2020. A settlement was reached and the pharmacist license was placed on probation. This case emphasizes the importance of exercising appropriate professional judgment, especially in clarifying directions on prescriptions that are vague or incomplete. 

Licensing of Pharmacy Areas not Physically Adjacent to Each Other:
A pharmacy asked the Board for clarification on whether an additional pharmacy license was needed for an area of he business that was on the same property.  The spaces were not physically connected, but were separated by a 10 foot outdoor space.  The Board decided that since the two areas were not physically joined together that separate licenses were needed for each space. 
 
Extension of Technician-in-Training Permits:
Pursuant to authorities granted because of COVID-19, the Board extended all technician-in-training permits for an additional six months. 

Emergency Drug Scheduling:
Through an emergency rule, tianeptine was scheduled as a schedule I controlled substance.

 

March:

INSPECT Update:
The state INSPECT Director discussed development of an "alert tool" within the INSPECT platform that would provide alerts to pharmacies to possible fraudulent prescriptions. This could be used in instances where a prescription pad has been stolen or a DEA license number has been compromised.  The alert could create a warning that a pharmacist should contact the prescriber to verify the prescription.  A development and implementation timeline however was not provided. 

Compliance Update:
The Board of Pharmacy's Compliance Director indicated that the chief issue they were noting in inspections were expired drug products on active inventory shelves.  The Board has seen several cases recently from the Attorney General's office seeking disciplinary action against pharmacies for having expired medication.  It is imperative that if pharmacies want to avoid scrutiny that they have systems in place to rotate out expired or near-expired stock. 

The Compliance Director also reviewed their inspection results process.  There are three possible outcomes following a pharmacy inspection: Pass, Corrective Action Plan, and Fail. 

  • Pass - No issues noted, or issues that are easily and quickly resolved

  • Corrective Action Plan - Used for most inspection issues; provides an opportunity to correct, generally within 30 days. The pharmacy would submit the CAP and the Board would conduct a re-inspection within 30 days.  A re-inspection will result in either a Pass or Fail. If the pharmacy fails the re-inspection, a complaint is filed with the Attorney General's for possible disciplinary action.  If the fail also concerns controlled substance issues, the DEA is also notified. 

  • Fail - Generally, pharmacies must be provided an opportunity to submit a CAP prior to receiving a Fail.  However, there are exceptions to this.  These include intentional misconduct or fraud, the issue cannot be corrected in a reasonable amount of time, violations constitute a pattern of willful disregard, or constitutes an immediate health risk.  A pharmacy does not automatically have to close based on a Fail inspection, but a complaint will be filed with the Attorney General's office.  These inspections are most likely to result in summary suspensions of the pharmacy license. 

Disciplinary Cases of Note:
Inaccurate Labeling: Pursuant to a settlement agreement, a pharmacy was reprimanded and fined $1,000 for providing inadequate label directions.  The prescription was for a dog for "meloxicam 7.5mg #30 1/2-3/4 tab POSID PRN pain."  The pharmacist confirmed that the directions were for 1/2-3/4 of a 7.5mg SID.  SID means once a day; however, the label directions were 1/2-3/4 tablets by mouth six times daily as needed for pain.  QD is generally used for once a day, while SID is an older abbreviation not in common use.  This case highlights the need for pharmacists to be certain of all directions on a prescription, especially terms or abbreviations used irregularly. 

 

Controlled Substance Issue: A pharmacy was placed on probation for a minimum of one year after entering into a MOU with the DEA.  The MOU cited several violations:
  • Failure to provide effective controls or procedures to guard against theft or diversion

  • Failure to maintain complete and accurate inventory records

  • Failure to execute a Power of Attorney Revocation Notice for an ex-employee

  • Failure to maintain a proper DEA Form 222 Official Order Form, and other violations related to execution of DEA Form 222

  • Illegal shipment of C2s to a location other than that specified on the DEA Form 222

  • Failure to maintain complete and accurate receiving records

This pharmacy was fined $75,000 by the DEA and subject to further oversight by the DEA. 

Expired Medication: Pursuant to a settlement agreement, a pharmacy fined $1,000 and placed on probation for a miminum of six months for dispensing a prescription product that was expired for seven months. 

 

April:

 

Technician Licensing:
The Board filed a complaint with the Attorney General's Office against a pharmacy who allowed an individual to work as a technician-in-training without a license.  This highlights the importance of pharmacies having systems in place to ensure all individuals are properly licensed. 

Disciplinary Cases of Note:
Controlled Substance Issue: Two related pharmacies were placed on probation for a minimum of three years after entering into a MOU with the DEA.  The MOU cited several violations:

  • Failure to maintain complete and accurate inventory records

  • Failure to properly execute DEA Form 222s

  • Filling prescriptions without the signature of the prescriber or address of the patient

  • Receiving previously dispensed controlled substances without registering as a collector

  • Failure to maintain complete and accurate receiving records

 

May:

 

INSPECT Update:
The INSPECT Director reported that after July 1, 2022, all pharmacists must be registered with INSPECT to access INSPECT through integrated EHR systems. While no resolution was provided, the Board discussed with the INSPECT Director the issue of wholesale limits on suboxone distribution while at the same time there are more providers eligible to prescribe suboxone. 

Disciplinary Cases of Note:
Misfill: Pursuant to a settlement agreement, a pharmacy was fined $1,000 for misfilling a prescription. The pharmacy received a prescription for 120 mg Sotalol, but dispensed 160 mg. According to the patient's physician, this wrong dose was the cause of a four day hospitalization stay. 

Inspection Issues:Pursuant to a settlement agreement, a pharmacy was placed on probation for a minimum of 18 months as a result of two failed inspections.  The issues identified in the inspection were:

  • Expired drug product on active inventory shelves

  • Dust and debris in the pharmacy area

  • Mislabeled or unlabeled drug products

  • Offers for counseling not being made consistently

 

June:

 

No information available
 

July:

 

INSPECT Update:
The INSPECT Director reported that suspcious orders by wholesalers can now be reported online to the Board of Pharmacy. The Board of Pharmacy voted to require online submission of all suspicious order reports. 

Disciplinary Cases of Note:
Misfill: Pursuant to a settlement agreement, a pharmacy was placed on probation for a minimum of six months as a result of a misfilled prescription. The two misfills were for one patient, who reported adverse events as a result.  The misfills though occurred in 2016 and 2017. 

Temperature Logs: A pharmacy servicing a long term care facility holding a remote location license was reprimanded and fined $1,000 for failing to keep temperature logs of the room where an automated dispensing system was kept.  The Board of Pharmacy in its inspection of long-term care facilities, has been particularly focused on temperature controls in the rooms where automated dispensing systems are located. 

August:

Remote Dispensing Facility Application/Telepharmacy:
CVS Health appeared before the Board to request that their Culver, Indiana location be converted to a remote dispensing facility, staffed by a pharmacy technician who was remotely supervised by a pharmacist at its North Judson, Indiana location. This was the first time a major retail chain pharmacy had requested conversion of an existing pharmacy to a remote dispensing facility. The Board ultimately tabled its decision to gather more information, particularly around store hours, prescription volume, staffing levels, security concerns, and how many other locations CVS Health may seek to convert. 

The Board also approved a remote dispensing facility application for Herbst Pharmacy, even though the location would be within ten miles of another retail pharmacy.  The Board approved the application under the "public health" exception to the "ten-mile rule" based on the geographic division of the area by U.S. 31 and a significant Amish population that would have difficulty traveling to another town to have their prescriptions filled. 


Pharmacy Technician Immunization Emergency Rule:
The Board of Pharmacy voted to amend its emergency rule to expand the immunizations that pharmacy technicians can administer from just COVID-19 and influenza to any immunization a pharmacist can administered.  This will take effect once the amended emergency rule is officially filed. 


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To be the voice and advocate for the profession of pharmacy in Indiana.

Our Vision:

To lead the advancement of Indiana Pharmacy by promoting legislation and innovations that optimize patient care, safety, and the health of our communities.