South Dakota Board of Pharmacy Minutes from July 12, 2013 Meeting

BOARD MEETING MINUTES

 

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Friday, July 12, 2013, 8:00 A.M.
Capital Building, Room 413, Pierre SD

Members Present:  Jeff Nielsen, Arlene Ham-Burr, Diane Dady, Lenny Petrik.  Excused:  Lisa Rave

Staff Present:  Executive Director Randy Jones; PDMP Director Kari Shanard-Koenders; Inspectors, Gary Karel and Paula Stotz, and Senior Secretary Rita Schulz.

Others Present:  Mark Dady, Sue Schaefer, Else Umbreit, Brenda Jensen, and Brian Zeeb.

The meeting was called to order by Jeff Nielsen at 8:00 a.m. with introductions of Board members, staff, and others in attendance.

A. Minutes

     Arlene Ham-Burr  moved for approval of December 7, 2012 meeting minutes.  Seconded by Diane Dady.
     Motion carried.

B. Financial Report

     The Board Financial Report was reviewed and approved.  Director Randy Jones provided the overview and
     highlighted salaries overage and the rationale along with the budget in the contractual category. The license fees
     will be transferred to the SD Pharmacist’s Association on December 31^st and June 30^th. Revenue reports did
     show “0” which was due to waiting for the grant extension for the PDMP program.  The extension was granted,
     however, future funding will be needed to maintain the program.

C. Staff Reports

     1. Employee Update:  We currently have 1.75 FTE’S for inspectors with .25 FTE currently unused.  It is suggested
         to have a .25 FTE in the NE area of the state.  This would enable someone to complete inspections in the area and
         decrease travel costs for current inspectors to travel to this area.

        Arlene Ham-Burr motioned to explore a .25 position in the NE area.  Seconded by Jeff Nielsen.  Motion carried.

     2. Inspector Report:  Gary Karel

• Lack of temp logs for freezers in Pharmacies storing Zostavax
• Immunization certificates not displayed
• Security cameras being installed
• Sterile compounding continue to see challenges HEPA Filter Leaks and Room Air Exchanges
• Concentrated Electrolytes (KCI) found KCI Vial 2mEg/ml 250 ml bottles stocked in Critical Access Hospital
  Pharmacy Dept.
• Remote Order Entry – we continue to push for medication orders to be reviewed for appropriateness by pharmacist
  before first dose administered.

         Inspector Report:  Paula Stotz

• Small critical access hospital pharmacies have difficulties with after-hours access and no electronic records.  They
  are doing the best they can.
• Auditing controlled substances continues to be a concern.  Strongly encourage to complete a  yearly audit even
  though Federal rule is two years. 

         PDMP Report:  Kari Shanard-Koenders-PDMP Director

• Grant Writing has taken a majority of time since the last meeting.  It will be necessary to look into future program
  funding and options such as an increase in wholesaler’s licensing.
• PDMP Exhibit booths at various meetings have not really been helpful.  Presentations have a better outcome to
  heighten awareness of the PDMP.  In addition, providing presentations in the schools, such as the Medical School
  may be a better tool to explain the opiate problem.   Providing the message in high schools using education pieces
  such as SAMSA will increase awareness.
• PDMP Program Graphs were shown and discussed along with the status of sharing information with other states
  and the progress of the PDMP Program.

     3. Statistical Reports of licensing activities were reviewed and discussion followed.

 D. Approvals - Approvals have been submitted and the following sites have been approved.

1.  Shane’s Pharmacy-Ft. Pierre; AMDD
2. Lewis & Clark Specialty Hospital: AMDD
3. Walgreen’s Mt. View; Rapid City: AMDD
4. Shopko Pharmacy; Winner; AMDD
5. Dunes Family Pharmacy; Dakota Dunes; AMDD
6. Hy-Vee Pharmacy: Watertown;  AMDD
7. Madison Community Pharmacy; AMDD
8. Faulkton Area Medical Center: AMDD
9. DT Pharmacy; Aberdeen; AMDD
10. Redfield Community Hospital; AMDD
11. Bon Homme / Avon Clinic; Starter Packs
12. Jackrabbit Pharmacy / Wellness Clinic: Brookings; Remote Pickup
13. Regional pharmacy / Remote Pickup – Newell Clinic

 E. Variances  - The following variances have been approved.  (*Note- There are 14 compliance points that are necessary

in order to be approved for a 3:1 ratio.)

1.  Lewis LTC Pharmacy; E-Kit County Jail (renewal)
2. Sam’s Club Pharmacy; SF – 3:1 Ratio
3. Wal-Mart Pharmacy; Aberdeen – 3:1 Ratio
4. Wal-Mart Pharmacy; Vermillion – 3:1 Ratio

 F. Complaints, Investigations, Disciplinary Actions, Loss / Theft – Reports were reviewed.

1.  Walgreen’s; Rapid City (diazepam) - Dosage miscommunicated with prescription transfer
2.  CIGNA Home Delivery  - Patient concern 
3. Varney Pharmacy; Parkston-Loss / Theft
4. Avera McKennan Hospital – Sioux Falls; Loss / Theft
5. Avera Sacred Heart Hospital (Pain Clinic) – Yankton; Loss / Theft
6. Shopko Pharmacy – Sturgis; Loss / Theft
7. Shopko Pharmacy – Hot Springs: Loss / Theft
8. Hoffman Drug, Platte; Loss / Theft
9. Prairie Lakes Hospital Pharmacy; Watertown; Loss / Theft
10. Redler’s Long Term Care –  Long Term Care Contract
11. Wollman’s Pharmacy – Loss / Theft

G. SD Pharmacists Association – Sue Schaefer – Written report provided to the Board.

     1. Activity Report  

• Retreat was held in the Hills in June.  The Association is enhancing membership, educational activities including
  technician CE’s, collaborating with regional activities such as a partnership in the Winter Expo. 
• Two student ex officio members:  Amber Olson and Eric Grocott
• No longer contracting with Midwest Solutions; students will assist with duties
• Engage in Foundation for Medical Care (SDFMC) to reduce readmissions
• PBM audit bill became law on July 1, 2013
• Contest to create ways to promote pharmacy and patient care during Pharmacists Awareness Week in October.
• Working with Iowa Pharmacists  Association to promote their Winter Conference
• Discussing review of Association Bylaws
• Continued Medicaid Expansion meetings throughout the State of South Dakota
• The Annual Meeting is in Sioux Falls, September 13-14, 2013.

     2. Financial Report – Closed out fiscal year and we are in the black. 

H. Other Reports

SDSU College of Pharmacy –Dean Hedge provided written report

• The College of Pharmacy (COP) had 69 students graduate with the Doctor of Pharmacy degree.  All but four
  students have accepted employment offers to date.
• The COP has admitted 80 students into the P1 Class beginning this August.  Applications were steady at about
  230. Academic statistics remain consistent with an average ACT score of 27 and an average GPA of 3.7.
• Dr. Dwivedi retired as Dept. Head of Pharmaceutical Sciences on June 21, 2013 and Dr. Omathanu Perumal
  has replaced him in this position.
• COP filled both community pharmacy residency program slots with Hartford Pharmacy, LLC in Hartford, SD and
  Liebe Drug in Milbank, SD.
• The COP has completed work on a new strategic plan which will provide a vision for the next five years.
• COP has started work on its next ACPE  accreditation self-study.  ACPE will have a site visit in October of 2014.

SD Society of Health System Pharmacists – Kelley Oehlke provided written report

• The 37^th Annual Conference was held at the Rushmore Plaza Holiday Inn in Rapid City on April 12 and 13^th. 
  Despite the weather conditions  47 pharmacists, 12 pharmacy technicians, 14 pharmacy residents and 6 pharmacy
  students attended the conference.
• Brian Kaatz was awarded the Gary W. Karel Lifetime Achievement Award.  Veronica Lesselyoung was awarded
  the SDSHP Pharmacist of the Year and Megan Oltman was recognized as the SDSHP Pharmacy Technician of
  the Year.
• Upcoming Event…12^th Annual Gary Van Riper Society Open Golf Classic at Bakker Crossing Golf Course on July 26, 2103.

SD Association of Pharmacy Technicians report unavailable.

Health Professional Assistant Program – Maria Eining was unable to attend.

Old Business

A.  NECC / FDA update

Jones reported on the sterile compounding issues nationally.  Improvements continue to be made in this area. 
Proper ventilation of hoods is needed and additional inspection forms are being utilized to ensure this is done.  We are
one of few states completing yearly inspections. Randy and Gary participated with NABP surveyors to conduct
inspections for Iowa nonresident pharmacies located in SD. This process provided beneficial information in regards to
inspections. Gary Karel provided additional information in regards to the inspections and compounding concerns.

B.  Background check expiration

Discussion was held on background check expiration and Jones shared the conversation he had with the Board of
Nursing.  They have a six month expiration limit on background checks.  Diane Dady motioned for six-month expiration
date on background checks. Seconded by Arlene Ham-Burr.  Motion carried.

C.  Recap of NABP Annual Meeting – St. Louis

Information was shared by Randy Jones.  Biosimilars seems to be the major topic right now and discussion was held on
issues in regards to these. Some states have taken legislation on this.  It was suggested we wait for more
communication in regards to this as the FDA further considers the matter.  Lenny Petrik reported the meeting had
good CE’s and provided networking opportunities. Lisa Rave also attended the meeting.

New Business

 A. Electronic Storage of Prescription Drug Orders – Interim Rules Committee schedule was noted.  Hearing will be
held at 1:00 p.m. today.

Other Business

A.  Prescription Drug Monitoring Program updates – Kari Shanard-Koenders

The PDMP Program has now been operating over a year.  There are two million prescriptions.  Accessibility, accuracy
and sustainable funding are needed to maintain and increase the PDMP use. The stories will be the best means to
increase usage and awareness of the program.  A survey of the system will be given to users which will provide important
feedback. Additional Law Enforcement training will be provided. Alerts will also be provided to prescribers and dispensers
for patients that have received prescriptions from six physicians and six pharmacies within a 90 day time frame.  The
alerts are slated for implementation next month. PDMP Integration with Rapid City’s Regional Healthcare System is also
being researched as a potential pilot. 

B. Reporting of Pseudoephedrine – Brian Zeeb

Brian Zeeb, Assistant Director of Criminal Investigation (DCI), reported the potential use an electronic format in order to
have real time information on pseudoephedrine purchases.  Meth stats are up again and the best possible solution to
improve SD Pseudoephedrine is a tracking system.  The system will include current information & requirements /
maintain limits that are required in current laws / certify that a signature was captured.  This also will provide real time
access and feedback/recommendations for sale with automatic limits.  SD DCI has the option to contract with a private
vendor at no cost to retailers or tax payers.  Following Brian’s presentation discussion was held on the benefits for
NADDI (National Association of Drug Diversion Investigators) using the NPLEx (National Precursor Log Exchange)
system. This is the best way to prevent the continued usage of Meth and stop the point of sale.  The Board agrees that
methamphetamine continues to be major concern.  Jones advised the board that if a legislative act is required for
utilization of an electronic format, the proposed changes would need review by the Department of Health before
rendering a formal opinion.