South Dakota Board of Pharmacy
Friday, December 9, 2011 – 8:00 a.m.
Avera Behavioral Health
Sioux Falls, SD
Members present: President Arvid Liebe, Arlene Ham-Burr, Lisa Rave, Jeff Nielsen and Diane Dady
Staff present: Executive Director Randy Jones, PDMP Director Ron Huether, Inspectors Gary Karel and Paula Stotz, and Secretary Melanie Houg.
Others present: Paul Athey, Shopko; Jillian Tucek, SDSU P4 student; Bernie Hendricks, SDSU; Sue Schafer, Executive Director of South Dakota Pharmacists Association, Bill Ladwig, Lewis.
The meeting was called to order by Board Member Jeff Nielson at 8:15 a.m. with introductions of board members and others in attendance.
Minutes from the September 16, 2011 were introduced. Rave moved to approve the minutes of the September 16th meeting, seconded by Nielson. Motion approved.
The financial reports through November 30, 2011 were reviewed. On the second page, Randy Jones brought to the board’s attention that $172,200 had been spent. A transfer to the Pharmacist Association had been made which encompassed fees from May 2011 to October 2011. Also noted was there were more candidates that had reciprocated than usual. The capital outlay of $3,200 for the printer replacement should have been pulled out of #901 instead of #900. There is a contract item of $20,000 for the intern electronic program that will be completed by the next board meeting.
On the Revenue Reports by Month, a line item reflecting the grant funding was added. Ron Huether explained to the board that $400,000 over the next two years is available and an extension of those funds can be asked for. It is expected there is a three to four year operating costs that can be expected from this grant.
Diane Dady was welcomed as the newest board member with her term beginning on November 1, 2011. Paula Stotz was introduced as the West River inspector replacing Earl McKinstry who will retire at the end of 2011. Melanie Houg was also introduced as the part-time secretary.
The Inspectors’ Activity Reports were reviewed. Stotz accompanied McKinstry during the month of November to be trained in the inspector’s position. Gary Karel reminded that pharmacies need to be in compliance with 20:51:31 by the end of the year. There has been issues with the refrigerator/freezer monitoring documents. The bieannual inventory is not always completed for controlled substances III, IV, and V.
The License Summary was reviewed and the numbers recapped. Noted was an increase in wholesale permits partially due to Medicare requiring the licensure for billing purposes. Brought to the attention of the Board was Levon Drugs LLC dba Troy Pharmacy non-resident pharmacy license. Troy Pharmacy is not in good standing due to an insufficient funds check. The Non-prescription drug licenses might also be repealed during the next legislative session.
Applications have been submitted and the following sites have been approved:
Lewis Family Pharmacy, Mitchell
Sanford Aberdeen Medical Center, Aberdeen
MedVantx, Sioux Falls – off-site storage extension
Milbank Area Hospital - AMDD
Regional Pharmacy, Spearfish
A variance was given to Regional Health with regards to the Telepharmacy 1:3 ratio. Due to an illness this was approved, a short range plan was given to fill the need with a long term plan being developed and implemented to prevent a future issue.
HyVee was given a variance for the daily printouts of controlled substances. A one-page report will be used and signed off by each pharmacist for the controlled substances.
Pamida Pharmacy in Madison was dispensing an incorrect dose of Warfarin. The issue was resolved with the pharmacy putting methods into place to correct the issue.
Lewis Pharmacy in MB 3 in Sioux Falls has put procedures into place to improve patient counseling.
SD Pharmacists Association Report
The Association is in good fiscal condition. The Association appreciates the support of the Board of Pharmacy. Technicians have been encouraged to become members and membership is increasing among the technicians. SDPhA is on task for endorsements from providers who serve members. Advertising in the journal is down as there is less support from the vendors. Various grants have been applied for but very few were received. The convention is most affected by budget as it is being pared down to one and a half days.
September 21-22 in Deadwood is the convention. The schedule as well as the continuing education was reviewed with suggestions made to offset the immunization CE with an alternate program or putting the immunization CE at the end of the conference. Other topics were suggested as well. Intended is to finish the programs/awards by noon on Saturday.
Board Meeting was suspended at 10:00 AM to conduct Rules Hearing.
Dean Hedge, SDSU College of Pharmacy, reported that NAPLEX results for the first time in five years was not a 100% pass rate. Although they are still above the national average, immediate changes were made. Next week the P4 students will take a NAPLEX assessment to give a better benchmark as to where identified students and test areas may need more attention. Dean Hedge also expressed there is a very high student satisfaction. Beginning in the Summer of 2012, Liebe Drug in Milbank will begin a community residency program with SDSU. SDSU requested from the board a $400 grant to support the beginning of a CPE monitoring/identification program. Ham-Burr motioned for approval, seconded by Dady. Motion approved.
Erin Christensen submitted information on behalf of the South Dakota Society of Health-System Pharmacists. SDSHP Reported that the American Society of Health-system Pharmacists Midyear Clinical Meeting was in New Orleans on December 5th. SDPhA and SDSU College of Pharmacy will be co-sponsoring a CE event on Saturday, February 4th providing 4/5 hours of CE (ACPE credit has been applied for) with a Jacks basketball game vs. Southern Utah that evening. The SDSHP Annual Conference will be held March 30th and 31st at the Sioux Falls Convention Center.
Prescription Drug Monitoring Program (PDMP) – Ron Huether reported that the first week of submission of reports will be information from 12/5/11 due by 12/12/11. By mid-February information retroactive to July 1, 2011 is to be submitted. This will provide enough data to begin seeing trends and to be able to provide information to persons who may request reports. October 1, 2011 a letter was sent to pharmacies to advise each pharmacy on how to report information or apply for a waiver. Of the approximately 430 non-resident licenses, 105 waivers have been approved. Most that have been approved specialize in hemophilia or respiratory products or services. There are 47 part-time licenses in South Dakota of which few controlled substances are given. These part-time facilities will need to submit written reports when a controlled substance is prescribed – the Board of Pharmacy will work with these facilities to educate them on the proper procedures. Of the 247 full-time licenses in South Dakota, approximately 10-20 will qualify for waivers. Waivers will be valid until June 30, 2012 with a ‘box’ to be on the renewal application to extend the waiver through the next licensing year. 170-180 pharmacies have logged in and set up accounts with HID with as many as 500 to yet setup their accounts. HID will have a listing the week of December 12th as to who has or has not set up their account for submission of reports. Two hundred data submissions have been completed with one that has sent information from July 1, 2011. South Dakota is the 14th state to use this vendor and it will take two to three months to get all of the information submitted. There is no penalization for late reporting during initial set-up period. In January, practitioners will be educated on how to view profile reports. After a year it is expected to have about one-third of practitioners with access to reports. To access data, there are two options. Option #1 is to get online approval by submitting a request through the South Dakota Board of Pharmacy. Option #2 is submit a profile report to the office directly. Law enforcement such as DCI, Minnehaha County Sheriff, and Sioux Falls Police Department will also be able to have access. Law officers may submit requests through the DCI. There are penalties in place for misuse of this information. A designated agent for a practitioner was discussed with the recommendation that only one designated agent to allowed initially. HID will be coming February 5-7 for training with data access opening February 15th. A part-time PDMP secretary should be on board in January.
Sean Harms was introduced as doing an externship in the Board of Pharmacy office. Randy Jones expressed the benefit to students and hopes to have students in a couple of times a year. Sean thanked the Board for the opportunity saying he enjoyed taking part in the inspections, assisting with the PDMP waiver forms, and presenting a lecture to the P1 students.
Randy Jones advised that the current administration has asked that law or rule which may not be relevant any longer be reviewed with the possibility for repeal. Suggested from the Board of Pharmacy is the repeal of the Poison license as it is not enforced due to the reformulation to be environmentally safe. The non-prescription permits may also be repealed. Surrounding states do not issue these permits. The non-prescription permits will go to the LRC in January.
USP / NF 797 (Sterile Compounding and Compliance) is enforceable by January 1, 2012. Many critical access hospitals have a plan in place but have not completed. A discussion as to whether the Board of Pharmacy will give latitude was had. Suggestions were made to send out a self-inspection letter regarding this issue. If there is a deficiency, ask for a plan including the number of days for plan to be in place. A follow-up letter from the Board of Pharmacy will go to the PIC as well as the administration.
Future Meetings – Board member and staff will participate in upcoming meetings:
April 20, 2012, Sioux Falls
July 13, Aberdeen
September 21, Deadwood
December 7, Sioux Falls
A one-hour conference call will be schedule in February
Recent Meetings – Board members and/or staff that attended recent meetings gave brief reports on those meetings:
ANSCA 27th Annual Meeting – Portland, ME, October 18-21 (Huether)
NABP Task Force on the Control and Accountability of Prescription Medications, October 26-27 (Karel)
NABP Compliance officer Interactive Forum, Chicago, December 1-2 (Karel)
The meeting was adjourned at 12:32 p.m. A tour was conducted of the Avera Behavioral Health facility.