Monday, December 30, 2013

South Dakota Board of Pharmacy Minutes from December 6, 2013 Meeting

Friday, December 6, 2013, 9:00 A.M.
Avera Prairie Center Building - Presentation Room; 1000 E. 23rd St., Sioux Falls, SD 
 
Members Present: Lisa Rave, Jeff Nielsen, Diane Dady, and Lenny Petrik
Staff Present: Executive Director Randy Jones; PDMP Director Kari Shanard-Koenders; Inspectors Gary Karel; and Senior Secretary Rita Schulz
Others Present: Andrea Darr, Avera ePharmacy; Sue Schaefer, SD Pharmacist’s Association; Dennis Hedge, SDSU College of Pharmacy; Lora VanDyke, Pharmacy Specialties, Inc.; Scott Setzepfandt, Genentech; Bill Ladwig, Lewis Drug; and Tom Johnson, Avera McKennan Pharmacy
Present by Phone: Arlene Ham-Burr (Board Member) and Paula Stotz (Staff Member)
                                                           
The meeting was called to order by Lisa Rave at 9:00 a.m. with introductions of Board members, staff, and others in attendance.
A. Minutes 
Jeff Nielsen moved for approval of the September 12th, 2013 meeting minutes.  Seconded by Diane Dady.  Motion carried. 
B. Financial Report 
The Board Financial Report was reviewed and approved.  Executive Director Randy Jones provided an overview and highlighted remaining balance.  
The status of salaries in the PDMP program due to the government shut-down was discussed along with additional information needed to acquire grant funds awarded.  
C. Staff Reports
1.
Employee Update:
Director Jones requested the minutes reflect the passing of inspector Ron Johnson on October 25th.   A brief conversation was held in regards to the open position which will be discussed at a future Board meeting.  
2.
Inspector Reports
Inspector:  Gary Karel
 
Education to PICs on the following:
  • HIPAA – New Guidelines
  • Electronic Retention of Health Records
  • Sterile Compounding – working with the various facilities to remodel pharmacies to conduct compounding for hazardous drugs (chemo) and nonhazardous drugs. 
  • New pharmacies at Avera Sacred Heart and SDHSC in Yankton.
  • Reinforce CS record keeping.  Encourage annual audits.  Lewis is conducting six-month audits.
  • AMDD – working with PIC to have on file Board of Pharmacy approval letter.
Discussion introduced by Bill Ladwig was held on spot inventory checks, cameras, and other security precautions in pharmacies.  Also discussed was Medicaid D and prescription storage.

 Inspector:  Paula Stotz
 
  • Encouraged audits be completed more often and noted her inspections reflected items noted in Gary’s report.
 PDMP Report:  Kari Shanard– Koenders-PDMP Director
 
  • Education letters were mailed out.  An education letter is a letter sent to prescribers and dispensers who met criteria of a patient being prescribed or dispensed to over a course of 90 days.  Letters will go out in January, April, July, and October. 
  • Discussion was held on method of payments.  Also, discussion was held on DCI contacts for pharmacies and this information will be made available.
  
3.
Statistical Reports
 Licensing activities were reviewed and discussion followed.
 
D. Approvals – 60% now have automation and this number will increase.  Kessler’s Pharmacy and Medicine Shoppe Advanced Care now have letter reflecting approvals but approvals had been in place for some time.
1.
2.
3.
4.
5.
Regional Health; AMDD Revised
Kessler’s Pharmacy; Aberdeen – AMDD*
Regional Outpatient Pharmacy; Rapid City – AMDD Revised        
Medicine Shoppe Advanced Care; Rapid City – AMDD*
Randall Pharmacy; Redfield – Credit Return of Unit Dose
 
E. Variances – 3:1 ratio variances are increasing.  Discussion was held on this ratio and further discussion will be put on Board’s future agenda.
1.
2.
3.
4.
Wal-Mart; Brookings  - 3:1 Technician Ratio
Hy-Vee (S. Minn); Sioux Falls – 3:1 Technician Ratio
Omnicare; Sioux Falls – 3:1 Technician Ratio
Wal-Mart; Spearfish – 3:1 Technician Ration (renewal)
 
F. Complaints, Investigations, Disciplinary Actions, Loss / Theft Reports – Explanation of Complaint was provided and followed by discussion.
1.
2.
3.
4.
5.
6.
7.
8.
Medicap Pharmacy; Rapid City – Complaint
Wal-Mart Pharmacy; Rapid City – Compliant         
Haisch Pharmacy; Canton – Complaint
Family Pharmacy (Clinic); Mobridge – Loss / Theft
Family Pharmacy (Downtown); Mobridge – Loss / Theft
Hy-Vee Pharmacy; Watertown – Loss / Theft
Murdy Pharmacy; Aberdeen – Loss / Theft
Omnicare; Loss/Theft
 
G. SD Pharmacists Association – Sue Schaefer
1.



 
 
Activity Report – Sue provided a handout with Association Updates  and reported on the  following:
  • A working group will be developed to review and update necessary sections of the current Pharmacy Practice Act, and present such findings to SDPhA’s membership for discussion.  The first meeting is scheduled for January 28th.
  • The Fall District Meetings are all completed.
  • SD LECC Conference was held which provided networking opportunities with law enforcement and physicians.  Marc Gonzales with Purdue Pharma on Prescription Drug Abuse & Identification provided a training session.  Over 25 pharmacists registered for the event and the LECC Committee was very pleased with the outcome.
  • President Shannon Gutzmer will attend the ASHP Midyear meeting in Orlando.
  • The Association will soon be implementing a new website which is more social media friendly.
  • SDPhA Legislative Days is slated for January 28 and 29th, 2014 in Pierre.  The event has been moved to the Clubhouse Suites in Pierre.  Wednesday, January 29th, health screenings will be provided by SDSU College of Pharmacy students for legislators. 
2.
Financial Report – A financial report was provided.
 
H.  Other Reports 
 



 
 
SDSU College of Pharmacy - Dean Hedge provided the following report:
  • Rolling Admission is going well.  The demand for the program remains strong.  All students taking the NAPLEX passed.  The College changed assessment strategies to strengthen and enhance the program.  All students passed the in-state MPJE. 
  • The College is now tracking residency information.  25% of the graduating class goes on to residencies.  In-state residencies have grown.  Using metric analysis, student match rate has done very well.
  • A self-study is currently in process for accreditation.  Accreditation projected visit will occur in late October.  The college is having a major retreat in January in preparation and all is going well.
  • There continues to be faculty turnover for various reasons. Recruitment will be done at the midyear meeting.
  • Inter professional work is being implemented and students are enjoying the opportunities.  Gary Karel and Randy Jones were able to participate in the inter-professional activity with nursing/pharmacy and found the process very interesting. 
  • Dennis is also on a Health Science Task Force with hopes to provide a Masters in Public Health next year. 
  • Legislative Days will be attended by students and a bus has been reserved.
  • As a sad note, Joye Billow, Professor Emeritus, passed away.  She contributed greatly to the college and profession.

SD Society of Health System Pharmacists - no report was available at this meeting but is available from the Association meeting.
 SD Association of Pharmacy Technicians – No report.
 
Old Business
A.


 
USP / NF <797>; Sterile Compounding Legislative Update
  • An article from Drug Topics was provided.  Discussion was held on the following statement:

    The legislation distinguishes between compounders who are engaged in traditional pharmacy practice and compounders who practice outside the scope of traditional practice.  The latter group can voluntarily register with FDA as an outsourcing facility and is subjected to similar FDA oversight as traditional manufacturers.  Traditional pharmacies will still be overseen by State Boards of Pharmacy.

    Director Jones felt reputable outsourcing facilities will register with FDA as it will provide them an advantage. The Board of Pharmacy will continue to monitor this process. 

 
New Business
A.
Hy-Vee Central Fill overview – Kristin Williams PIC
  • A power point was provided to the Board on the system and discussion was held throughout the presentation.
B. 
Appointments – Executive Director Jones reviewed Board Member Appointments
  • Governor reappointed Lisa Rave and Jeff Nielsen.  Lisa is in her 2nd year of three year appointment; Jeff and Arlene are in their 3rd year of their three-year appointment; Lenny and Diane are in their 1st year of three-year appointment.
 
Other Business
1. 
Prescription Drug Monitoring Program updates.   Handouts were provided on the PDMP program.
  • The Pharmacist and prescribers queries have increased since implementation.  It has helped that some pharmacies are enforcing registration.   
  • The PDMP process is going to be improved so the system is more user-friendly.  Discussion was held on the program and education is important to increase users.  We are now connected with 20 states and two or more hubs are being developed.   Handouts were provided on PDMP usage and top 20 controlled substances.
2.   
NABP Executive Officer Interactive Forum-NABP (recap Jones)
  • Jones provided an overview of the meeting which was an interactive forum.  The meeting was excellent.  NABP domain will provide the ability to see which mail-order pharmacies are ethical.  Inspections will also be available on the portal.
3.  
NABP Sterile Training Meeting – October 8-10th (recap Stotz)
  • The meeting was excellent and she is currently taking the Critical Point – 31 Units Training. 
     
4. 
NABP Compliance Officer Interactive Forum-NABP; December 5-6 (recap Stotz)
  • This was a collaborative meeting and provided excellent networking opportunities.
5. 
Board Meeting Dates for 2014 – Board members requested to respond with the dates they are available
  • March 14 or 21 – Rapid City?
  • June 6 or 13 – Sioux Falls?
  • September 18 – Chamberlain      
  • December 5 or 13 – Sioux Falls?
 
Other Meetings – Future dates of meeting were announced.
  • SDSHP Annual Meeting – April 11 & 12; Sioux Falls
  • District V NABP / AACP – August 2014; South Dakota
  • SDPHA Annual Meeting – September 19 & 20; Chamberlain
Adjourn - Diane Dady moved to adjourn the meeting.  Seconded by Jeff Nielsen.  Motion carried, meeting adjourned at 12:25 p.m.
A Tour of Avera Prairie Center Facility was provided following lunch
quoted from here

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