Members present: President Steve Statz, Arvid Liebe, Jeff Nielsen, and Marla Hayes. Excused: Arlene Ham-Burr.
Staff present: Executive Secretary Ron Huether; Inspectors Earl McKinstry and Randy Jones, Senior Secretary Rene Hixon.
Others present: Gary Karel, Mark O’Brien, and Doug Smith, Sanford Medical Center; Brian Lounsbery and Al Carter, Walgreens; Jodi Treharne and Chris Jones, McKesson; Chris Sonnenschein and Sue Schaefer, SD Pharmacists Association; Dennis Hedge, SDSU College of Pharmacy; Lisa Rave, CIGNA Tel-Drug; Megan Leloux, Andrea Darr, and Bob Lewis, Avera McKennan Hospital; Bill Ladwig, Lewis Drug; Ann Oberg, SD Association of Pharmacy Technicians; Miranda Reinert, Joan Baird, Bret Gabert, and Carla May, National American University Technician Program; Mark Mora, WalMart.
The meeting was called to order by President Statz at 9:30 a.m. with introductions of board members and others in attendance. He also thanked Gary Karel and Sanford Health for hosting the meeting.
The meeting agenda was approved by the board members.
Minutes from the December 11, 2009 meeting were reviewed. These have been posted on the Board of Pharmacy website after preliminary electronic approval by the board members. Liebe moved to approve. Seconded by Nielsen. Motion approved.
The financial reports for the current fiscal year were reviewed. Revenues and operating expenses are on budget. Huether reported that the FY2011 operating budget has been approved.
The Inspector’s Activity Reports were reviewed. Huether and McKinstry reported on their visit to Fall River Hospital in Hot Springs. This new facility is very impressive and the pharmacy department has adequate space and an efficient design.
The Statistical Report of licensing activities was reviewed and discussed.
SD Pharmacists Assn. –Sue Schaefer, Executive Director, discussed the activity and financial reports of SDPhA. Chris Sonnenschein reported that education sessions at the SDPhA Convention will include round-table discussions on PDMP, pharmacist’s immunization authority and medication “take back” programs.
Dean Dennis Hedge, SDSU College of Pharmacy, reported on current activities. The West River faculty has been increased to accommodate more Advanced Practical Pharmacy Experience (APPE) opportunities for P4 students. Final interviews have been completed and 80 students have been accepted into the P1 class for next year. The new Avera Health Sciences Building is nearing completion and will be ready for the fall semester. Dean Hedge requested that the Board consider an increase in the funding support for the integrated software that documents internship hours for APPEs. He also invited the Board to hold the October 1st meeting in the new building.
Ann Oberg, past-president, reported for the South Dakota Association of Pharmacy Technicians. A technician certification review was held April 9, and the fall meeting will be held in Pierre.
Andrea Darr, Avera Health, requested approval for the after hours remote order entry services that will be provided at Avera McKennan to Avera DeSmet Memorial Hospital, Avera St. Benedict’s Hopsital, Avera Weskota Memorial Medical Center, Avera Hand County Memorial Hospital, Dells Area Health Center/Avera Health, Flandrea Medical Center, and Platte Community Memorial Hospital. This service will comply with the guidelines established by the Board and will be expanded to other Avera facilities in the future. Hayes moved for approval. Liebe seconded. Motion passed with a unanimous vote.
Doug Smith, Sanford Health, reported the Sanford Health System is also planning to provide after hours remote order entry to their facilities. That service will be provided by Cardinal Health from a location in Illinois. Huether stated that the Cardinal Health pharmacy is licensed with our Board and the pharmacists who will be providing the service are in the process of obtaining licensure.
Bob Lewis, Avera McKennan Hospital Pharmacy, presented a policy for dispensing starter packs from an AMDD at the new Avera Surgery Center which will open this summer. After questions and discussion the Board directed Huether to work with Lewis to make appropriate changes in the policy to assure compliance with counseling and packaging regulations.
Other approvals: Technician Ratio: Medicap South – Compounding area, Rapid City.
Policies and procedures for return and credit of unit dose medications: Prairie Pharmacy, Corsica, and Genoa Healthcare Pharmacy, Watertown.
Gary Karl and Mark O’Brien, Sanford Health described the plan to provide medications to dialysis centers in Chamberlain, Madison and Wagner using Pyxis medication stations. Order entry and inventory will be provided through the central pharmacy at Sanford Health. Huether requested that the Board approve the plan as a variance. Board staff will work with Sanford staff to develop guidelines appropriate for this and other similar situations. Liebe moved for approval. Seconded by Nielsen. Motion carried.
Huether reported that the board-mandated Health Professionals Assistance Program participation and probationary periods have expired for pharmacists Mark Tokach and Jay Wickre. Char Skovlund, Executive Director, SD HPAP has submitted letters affirming compliance and recommending dismissal from the program. Nielsen moved that licensure status for these pharmacists be restored to “Licensed in good standing”. Seconded by Hayes. Motion carried by unanimous vote.
The group discussed the recent letter from CVS Caremark regarding inappropriate filling of expired prescriptions. The Board members expressed concern that the letter was not clear in stating that all follow-up was properly completed. The Board instructed Huether to send a letter requesting complete information on this situation (including names and phone numbers of patients, the medications dispensed and the prescribers). Board staff will conduct our own investigation.
The Application for Permit to Conduct a Pharmacy for Eureka Pharmacy and Gift Shop dba Ipswich Pharmacy was reviewed. Owner Jim Stephens and pharmacist-in-charge Judy Waldman will operate the Ipswich location as a Telepharmacy with the Eureka location serving the central pharmacy. The planned opening date is several months away and Stephens has requested approval at this time prior to construction of a new building. Liebe moved to approve the permit with the restriction that a detailed design plan be submitted to the Board for approval and that a pharmacy technician meeting Board requirements be identified before the pharmacy opens for business. Seconded by Nielsen. Motion carried.
Brian Lounsbery and Al Carter, Walgreens gave a presentation on the Walgreens “Stickerless Program”. The term “stickerless” refers to a new procedure whereby pharmacy personnel no longer place a sticker on the back of the hard copy prescription. The electronic record is utilized to satisfy all record keeping requirements. This change will not apply to CII prescriptions. Hayes moved for approval. Seconded by Liebe. Motion carried.
Chris Jones and Jodi Treharne, McKesson Automation Solutions, and Gary Karel, Sanford Medical Center Pharmacy, gave a presentation on a new robotic pharmacy dispensing system that will be implemented at Sanford later this year. The use of automation and bar coding has demonstrated many benefits, including: fewer medication errors; faster medication turn-around time and better medication therapy as pharmacists move from distribution tasks to more direct patient care. This system is being used in other hospitals and has been approved in several other state boards of pharmacy. Huether indicated that the Board may need to consider changes or additions to our current rules for Automated Mechanical Distribution Devices (ARSD 20:51:17) in order to recognize advancements in automation that improve patient safety. Nielsen moved to approve implementation of this dispensing system at Sanford. Seconded by Hayes. Motion carried.
President Statz called a lunch recess of the regular board meeting at 12 noon. After lunch Sanford Pharmacist Linda Oyen provided a tour of the pharmacy and several other areas at the Sanford Children’s Hospital.
The board meeting resumed at 1:15 p.m.
Prescription Drug Monitoring – Huether reviewed the timeline and the responsibilities of the staff in planning and implementing prescription drug monitoring. HB1231, passed by the legislature and signed by Governor Rounds, places the responsibility for implementing and administering a Prescription Drug Monitoring Program (PDMP) with the Board of Pharmacy. Huether wrote and submitted a request to US DOJ Bureau of Justice Assistance for a $400,000 grant to fund the program for the period of October 1, 2010 through September 20, 2012. During the next several months we will work on the administrative rules that define and support this law. If the grant is approved we hope to hire a half-time pharmacist and a full-time administrative assistant to oversee this program.
Technician Ratio Rules – In response to requests for approval of technician ratios greater that 2:1 as defined in ARSD 20:51:29:19, the compliance staff has prepared a “checklist” to be used during inspections. The form was discussed and the Board agreed that inspectors need to monitor compliance with the ratio.
Software Updates – Huether provided an update on our plans to improve our licensing and registration software. There are specific requirements that must be followed as we work toward selecting a vendor. Staff will continue to work with Bureau of Information Technology and Department of Health on this project.
Support for Educational Programs - Huether reported that we continue to provide support for educational programs. Board staff provide presentations on laws and rules when asked (SD Association of Pharmacy Technicians, SDSHP, SDPhA, College of Pharmacy, NAU, SETI, WDT, District Pharmacist meetings, HyVee Pharmacy Managers, etc.). We also provide financial assistance for some meetings. The Board members agreed that we continue provide this support. The Board encouraged the SDPhA to present proposals at board meetings for supporting specific educational activities that meet the mission of the Board of Pharmacy in protecting the health and welfare of SD citizens. The Board is also interested in providing funding for SDSU scholarships or tuition reimbursement for pharmacy students who plan to return to underserved areas of our state.
DEA Correspondence – Staff reported that we have been receiving good information from the DEA with copies of DEA responses to questions. Our inspectors frequently get questions on the same issues. This information is especially useful as we try to assist pharmacists in maintaining good compliance with all laws, rules and regulations. Some of the recent information that has been very timely to current inquiries includes: Return of Controlled Substances for Destruction and Automated Dispensing Devices in Nursing Facilities
NABP Task Force on Technician Education and Certification – Inspector Earl McKinstry presented a position paper for potential rule changes which propose mandating education requirements for pharmacy technicians. Discussion was held on how to approach implementation of technician certification and formal education requirements.
MPJE Item Writing Workshop - Inspector Randy Jones reported on the NABP workshop on updating and adding new questions to the Multistate Jurisprudence Exam. Representatives from 32 state boards of pharmacy attended. Our participation in this annual program helps to ensure that the exam for our new licensees (initial registration and reciprocity) is accurate and appropriate.
Meeting Dates -- The next board meeting is set for Friday, June 4, 2010, at 9:00 a.m. in conjunction with the South Dakota Pharmacists Association convention in Chamberlain. Other meeting dates in 2010 are October 1 in Brookings, and December 10 in Sioux Falls.
Nielsen made a motion, seconded by Hayes, for approval of per diem and expenses for upcoming district and national meetings which will require board and staff attendance. Grant funds will provide support for meeting related to PDMP. Board funds will only be used if necessary. The meetings are:
SDSHP Annual Conference – April 9-10, Rapid City
SDPHA Annual Meeting – June 4-6, Chamberlain
PMP Alliance Regional Conference – May 10-11, Portland, OR
NABP Annual Meeting – May 22-25, Anaheim, CA
National Harold Rogers PDMP Meeting – June 28-30, Washington, D.C.
District V NABP/AACP Meeting – August 5-7, Williamsburg, IA
NASCSA Conference – October 19-22, Charleston, SC
Meeting was adjourned at 3:15 p.m. by President Statz.