9:00 AM --- FRIDAY, FEBRUARY 18, 2005
BOARD OF PHARMACY OFFICE, SIOUX FALLS, SD
Members Present: President Duncan Murdy; board members Arvid Liebe, Stephen Statz, Nora Hussey; and Executive Secretary Dennis M. Jones.
Others Present: Board Inspector, Ronald Huether; Attorney Robert Mayer, Attorney Generals Office; Mark Tokach, pharmacist.
The Board of Pharmacy members toured Tel-Drug of Sioux Falls, South Dakota in the morning. Tel-Drug is a mail-order pharmacy owned by CIGNA Health Insurance and provides mail-order medications to patients covered by CIGNA Insurance Pharmaceutical Health Plan. Tel-Drug is a very automated facility providing pharmaceuticals mainly to people living outside of South Dakota.
President Murdy opened the meeting at 11 a.m.
OLD BUSINESS
Motion by Liebe to grant P4 and P3 pharmacy students authority to administer influenza vaccine to patients eighteen years of age and older provided the pharmacy students: 1) have completed the educational requirements of the College of Pharmacy; 2) are certified by the Board of Pharmacy. 3) are enrolled by the College of Pharmacy and completing internship/externship rotations; and 4) are directly supervised by a pharmacist also certified by the Board to administer influenza vaccine. Seconded by Statz.
Motion by Liebe for Secretary Jones to draft a letter to Tel-Drug advising the Pharmacist-in-Charge that the Board has decided Tel-Drug needs to petition the Board of Pharmacy for the use of additional technician personnel. The burden of persuasion is on the pharmacist-in-charge. The petition for use of additional personnel must be based on evidence that patient care and safety will be maintained. The petition must identify where the technicians will work and the ratio of technicians to pharmacist in that specific area. The pharmacist-in-charge must request the specific ratio for a specific area where the pharmacist-in-charge feels additional technicians could be used. No blanket ratio for the entire Tel-Drug area would be approved by the Board. The technician duties must meet all requirements for technicians as described in ARSD 20:51:29.
ADDITION TO PREVIOUS BOARD MINUTES
Statz recommended that goals discussed by the board at the last meeting be included.
Fining – The board needs the authority to fine for violations of pharmacy laws, especially for repeat violators. Most state boards possess this authority and the board members feel that the board should attempt to find a sponsor to introduce a bill in the next legislature.
Inspectors Education—The Board would like to send our two inspectors to a meeting specific to their work area.
Counseling—The board will work toward improvement of pharmacist compliance with the counseling regulations.
Canadian Drug Violations—Advise the public of the risk of purchasing unapproved drugs.
NEW BUSINESS
Attorney Robert Mayer of the South Dakota Attorney Generals Office represented the Board at a disciplinary hearing for pharmacist Mark Tokach for violations of pharmacy regulations and diverting prescription drugs for his own use. Mr. Tokach represented himself and has agreed to stipulations outlined by the Board and will serve five years probation.
Budget
The members reviewed the latest budget numbers and asked questions about recent capital expenditures. Secretary Jones will inquire about the cost and purchase of a lap-top computer for inspector Thomas. The board believes some reports could be reviewed sooner if reports can be sent to the board’s office electronically. Motion to approve budget report by Hussey; seconded by Liebe.
United States Pharmacopeia/National Formulary-Chapter 797
The USP/NF Committee has adopted and made recommendations for guidelines to control and regulate all levels of manufacturing and compounding of parenteral products. The board previously discussed the formation of an ad-hoc committee composed of interested South Dakota pharmacist practitioners involved with the compounding of I.V. parenteral products. Several pharmacists have already contacted the board’s office and offered to serve on the ad-hoc committee.
Secretary Jones will select this committee with the goal of finding mutual language that will be adopted and used to regulate preparation of all parenteral products that are compounded by pharmacists and not approved by the FDA. Jones will contact NABP and other boards for any information or regulations adopted in their states. Such information will be provided to members of the ad-hoc committee. The goal would be to adopt regulations in 2006. Statz made a motion to proceed; seconded by Liebe.
NABP’s 101st Annual Meeting
The annual meeting with be held May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, Louisiana. NABP has put together a superb blend of educational programs and special events specifically designed to help board members and staff keep current on patient safety issues facing the practice of pharmacy today. This meeting also will be reporting and voting on constitution and by-laws and resolutions as well as election of new officers.
Motion by Statz that President Murdy will be the voting delegate and Secretary Jones will be the alternate. Seconded by Hussey.
Motion: Liebe made a motion that Secretary Jones submit a request for the members and Inspector Huether to attend this annual meeting and that expenses and four days per-diem be paid for the board members. Seconded by Murdy.
Inspector’s Report
Inspector Huether provided the board with a report of pharmacies inspected. He also handed out some forms he is providing to pharmacies to record perpetual inventories and audits.
Center for Medicare and Medicaid (CMS)
The CMS new proposals under the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 will include requirements for the use of electronic systems to help pharmacists use
Medicare drug benefits and coordinate the amount that beneficiaries pay for their drugs with other drug benefits they may have are supposed to be in place when the Medicare Part D prescription drug benefits take effect January 1, 2006. Comments can be sent to the CMS by April 5, 2005.
NABP has been closely monitoring the development of these electronic prescribing regulations and is working with CMS to address federal preemption of state regulations. The electronic “coordination of benefits “ system will ensure that what seniors pay at the pharmacy’s counter takes into account the proper level of their Medicare coverage, according to CMS. The beneficiaries should be able to walk up to the pharmacy counter at any drug store in their drug plan’s network and be assured that their coverage will work smoothly, even if they don’t have any of their drug benefit information with them. The idea is not to use the pharmacist’s time solving insurance matters for beneficiaries according to Mark McClellan, CMS Administrator. Every pharmacist hopes he right!
Deadline for New HIPAA Rule
HIPAA security rule takes effect April 20, 2005. This part of HIPAA regulations deal with security of private health information stored in computers and how employees understand and handle that information if transmitted.
Pharmacists that have questions on how to meet the requirements should contact the National Community Pharmacists Association, National Association of Chain Drugstores or HIPAA directly.
New Product Warning
Secretary Jones has posted a “WARNING” on the board’s web site for a new product called Palladone® manufactured by Purdue Pharma, LP. All pharmacists should thoroughly read the package insert before dispensing this product. It is intended for treating chronic pain and can only be used on adults who are tolerant to opiates. It is time released and should not be crushed or taken with alcohol. It would be fatal to small children.
SureScripts
The manufacturer of SureScripts is seeking approval of their software for use in South Dakota. The Board members are asked to review material provided and discuss at April meeting.
Next Meeting Date
The next board meeting will be scheduled for April 1, 2005, in Sturgis, South Dakota.
President Murdy Adjourned the meeting at 5:30 p.m.
