October 2007
South Dakota State Board of Pharmacy
4305 S Louise Ave, Suite 104, Sioux Falls, SD 57106
NEW REGISTERED PHARMACISTS
The following candidates recently met licensure requirements and were registered as pharmacists in South Dakota: Bradley Beck, Brett Bieber, Dustin Brinkman, Michael Cookston, Margaret Haberman, Justin Hora, Alison Jensen, Mandy Kappel, John Kappes, Michael Kuchta, Rebecca Meyer, Katie Mires, April Owen, Suzette Rolling, Sarah Rothi, Daniel Sneedon, Sara Spilde, and Sarah Van Eaton.
PHARMACY LICENSES
New pharmacy licenses were recently issued to Janice Smith, Your Daily Dose, Harrisburg, SD; and Jeanie Stahl, Lewis Family Drug #70, Flandreau (change of ownership).
NEW BOARD MEMBER
Governor M. Michael Rounds has appointed pharmacist Jeffrey L. Nielsen to the State Board of Pharmacy pursuant to Chapter 36-11 of the South Dakota Codified Laws. Pharmacist Nielsen’s appointment is effective July 19, 2007, and shall continue until October 1, 2010.
Jeff graduated from SDSU in 1993 with a BS degree in Pharmacy. He has worked for CIGNA Tel-Drug in Sioux Falls for the last 13 years and currently is Chief Pharmacist and AVP of Clinical Operations and Specialty Pharmacy. Jeff has also served as advisor for the technician training program at Southeast Technical Institute. He is married to Julie and has two children, Sterling and Chandler. Jeff enjoys sports, especially basketball and football.
Jeff became the fifth member of the Board of Pharmacy. The 2006 Legislature passed legislation setting term limits and the number of members of various boards. The Board of Pharmacy is now composed of four pharmacists and one public member.
BOARD MEMBER REAPPOINTMENT
Board member Stephen Statz has been a member of the Board of Pharmacy since 1997 and was reappointed to the State Board of Pharmacy effective October 1, 2007, continuing until October 1, 2010. Steve resides in Sioux Falls with his wife Julie and children, Michael and Mary Beth. He is Senior Vice-President of Business Development at Avera Health.
DEA ELECTRONIC VERSION OF FORM 106
An electronic version of DEA Form 106 for Reporting Theft or Loss of Controlled Substances is now available. The electronic form may be completed online and submitted to the DEA. The new form may be accessed at www.deadiversion.usdoj.gov.
DUTY TO DISPENSE AS WRITTEN
When a prescriber writes a prescription for a medication, the quantity written on the prescription is the quantity that must be dispensed unless the pharmacist contacts the prescriber and receives permission to increase the quantity dispensed. This applies regardless of the number of refills that are indicated on the prescription.
A pharmacist may not automatically take a prescription written for 30 tablets with two refills and dispense 90 tablets without getting the prior approval of the prescriber. It has come to our attention that some pharmacists are filling more than what is written on the prescription because the insurance company will pay for a 90-day supply. Insurance companies do not dictate the quantity you may dispense without the permission of the prescriber. If you want to help the patient, call the prescriber and get permission. Ninety-day quantities are okay for some patients on maintenance drugs, but oftentimes can be very wasteful. Drug disposal is a concern to the state’s Environmental and Natural Resource Agency because of the effect to our water supply. Many prescribers do not want the patient to receive a 90-day supply. This applies to both controlled and non-controlled drugs.
PHARMACY TECHNICIAN REGISTRATION RENEWAL
Each year during the month of October pharmacists are reminded to make sure their pharmacy technicians renew their registration with the Board of Pharmacy.
“Registered pharmacy technician” is defined in SDCL 36-11-2(22A) as a person registered by the South Dakota State Board of Pharmacy who is employed by a pharmacy to assist licensed pharmacists in the practice of pharmacy by performing specific tasks delegated by and under the immediate personal supervision and control of a licensed pharmacist, as permitted by the Board.
A pharmacy technician cannot work in the capacity of a pharmacy technician for anyone other than a licensed pharmacist.
The Board would like to remind pharmacists that an employee who receives and handles bulk drugs or is working in the pharmacy dispensing area is to be registered as a pharmacy technician.
Be sure to review regulation SDCL 36-11-29 at www.doh.sd.gov/boards/pharmacy. Each pharmacy utilizing pharmacy technicians shall develop, implement, and review written policies and procedures for training and utilizing pharmacy technicians appropriate to the practice of pharmacy. Every registered pharmacy technician should review the South Dakota Board of Pharmacy rules for Technicians (ARSD 20:51:29 Registered Pharmacy Technicians) yearly. A very good time for this to take place is October – during the time when registered technicians are submitting their renewal applications. The pharmacist-in-charge should make sure that all technicians and pharmacists understand these rules and carry out all tasks in compliance.
The technician and pharmacist-in-charge must notify the Board of any changes in technician status within 10 days. The Board’s inspectors will be checking for compliance.
Pharmacists are required to sign all technician registration renewal forms.
TAMPER-PROOF PRESCRIPTION PADS
The Centers for Medicare and Medicaid Services (CMS) has provided partial guidance and background information on the requirements to use tamper-proof prescription pads.
Beginning on October 1, 2007, in order for Medicaid outpatient drugs to be reimbursable by the federal government, all written, non-electronic prescriptions must be executed on tamper-resistant pads. This requirement was included in section 7002(b) of the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007. On August 17, 2007, the CMS issued a letter to State Medicaid Directors with guidance on implementing the new requirement.
CMS has outlined three baseline characteristics of tamper-resistant prescription pads, but each state will define which features it will require to meet those characteristics in order to be considered tamper-resistant. The baseline characteristics are one or more industry-recognized features that: (1) prevent unauthorized copying of a completed or blank prescription form; (2) prevent the erasure or modification of information written on the prescription by the prescriber; (3) and prevent the use of counterfeit prescription forms. On October 1, 2007, states must require at least one of these baseline requirements. After October 1, 2008, states must require all three characteristics on prescription pads in order to be considered tamper-resistant.
The letter to State Medicaid Directors outlines situations where the new requirement does and does not apply. The requirement does not apply: when the prescription is electronic, faxed, or verbal; when a managed care entity pays for the prescription; or in most situations when drugs are provided in certain institutional and clinical facilities. The letter also allows emergency fills as long as a prescriber provides a verbal, faxed, electronic, or compliant prescription within 72 hours. This restriction applies to all outpatient drugs, including over-the-counter drugs in states that reimburse for prescriptions for such items.
The South Dakota Pharmacists Association has requested a meeting with the Department of Social Services Medicaid Division regarding further clarification and will update members as information becomes available.
The State of South Dakota and State Board of Pharmacy currently do not have requirements for tamper-proof prescription pads, but the federal law has precedence. Therefore, prescribers should be looking at secure pads to meet the law.
NDC PRODUCTS CODE
Pharmacists should be aware that the National Drug Code (NDC) is a system used to identify products approved by the FDA. Most pharmacists recognize this 11-digit NDC number as a means to properly identify a manufacturer’s product.
The NDC format is divided into three distinct segments (i.e., 12345-6780-05). This format typically is used in computer systems and printed labels. The first segment is the labeler code, next is the product code, and last the packaging code.
A number of instances reported in a recent Institute for Safe Medical Practice (ISMP) article (Vol. 6, Issue 8, August 2007) indicates a serious problem and pharmacists need to be aware. If only the middle four numbers are checked, the product may not be what the pharmacist thinks he is dispensing.
Some examples reported are: quinidine gluconate 324 mg (NDC-00677-0675-01) and quinine sulfate 325 mg (NDC-13279-0675-10); Synthroid® 75 mcg (NDC-00074-5182-13) and generic levothyroxine sodium 75 mcg (NDC-00781-5182-01); Inderal LA® 60 mg (NDC-00046-0470-81) and propranolol 60 mg immediate release (NDC-50111-0470-01)
In all of the above examples the pharmacist only looked at the middle four digits.
Another safety issue mentioned in this article was a mix-up between Lantus® (long-acting insulin) and Apidra® (rapid-acting insulin). The report attributes this error to the similar appearance of the drug vials and solutions. The manufacturer of Lantus® and Aprida® has been asked to investigate ways to better differentiate these products.
The above problems are good reminders for pharmacists to be on the watch for any possible product problems including packaging, labels, number and dosage forms.
