July 2005
South Dakota State Board of Pharmacy
4305 S Louise Ave, Suite 104, Sioux Falls, SD 57106
NEW REGISTERED PHARMACISTS
The following pharmacists were recently registered in South Dakota having satisfactorily met licensure requirements: Jerrad Aman, Jessie Boehm, Kimberly Bollinger, James Buttke, Shelly Clayton, Stephanie Cone, Jeff DeRouchey, Kimberly Edsen, Kenneth Fosheim, Erin Haver, Clinton Hoffman, Kristin Horning, Yvonne Hotchkiss, Lindsey Hoyer, Amy Huntimer, Jodi Hurd, Carmen Hutchison, Susan Kollars, Kim Kortje, Casey Lesnar, Janelle Louwagie, Melanie Lunn, Emily Maydew, Matthew McClung, Amanda McClung, Stacie Neal, Jaclyn Plamp, Anita Preheim, Justin Richter, Shane Schuster, Michelle Shepherd, Tyler Turek, and Amanda Weber.
PHARMACISTS – Your license must be renewed by September 30. You will need to have 12 hours of continuing education credits by that date. |
PHARMACY LICENSES
Pharmacy licenses issued during the past quarter went to: Renee Sutton, Burke Community Pharmacy, Burke (change of ownership); Terrence Hoffman, Eastern Dakota Health Co. d/b/a Avera Doctors Plaza 2 Pharmacy, Sioux Falls; Tamara Van Roekel, Graham Drug, Corsica (change of ownership); Julie Ford, Medicap Pharmacy, Sioux Falls; Joe Rex, Rex Enterprises d/b/a Thornton Drug, Wessington Springs (change of ownership); Ron Schwans, Family Thrift Center Quality Care Pharmacy #258, Belle Fourche (change of ownership); and Vince Reilly, Medicap Pharmacy, Hartford.
ARVID LIEBE DISTINGUISHED COLLEGE OF PHARMACY ALUMNUS 2005
Arvid Liebe, pharmacist from Milbank, South Dakota, and owner of Liebe Drug in Milbank was recently presented with the Distinguished College of Pharmacy Alumnus Award 2005 by the South Dakota State University College of Pharmacy. Liebe is a 1965 graduate of South Dakota State University College of Pharmacy and currently serving on the Board of Pharmacy. Congratulations, Arvid!
DON’T BITE
Many pharmacists have received faxed messages that say, “become a part of a leading mail order pharmacy network that spans the entire United States” or “Pharmacy seeks pharmacies who would like to have 50-200 extra scripts to fill per day.
Don’t bite! Or you will break your teeth! These offers are almost always scams. Neither Discount Pharmacy Direct of Pharmacyby-fax.com are licensed to do business in the State of South Dakota. They should not be using the words “pharmacy” or “drug store” to solicit business in South Dakota (SDCL 36-11-31) from you or from South Dakota consumers.
The South Dakota Board of Pharmacy expects you to evaluate each prescription for its legitimacy. Any prescription written by a physician who has never seen the patient is not legitimate.
The scenarios usually work by these companies soliciting doctors to write or overwrite prescriptions and then soliciting pharmacies to fill these prescriptions. The company can then claim they did nothing wrong, it was only the physician and pharmacy who did not perform their professional responsibilities. All the company did was connect the two together.
The Board of Pharmacy, the Drug Enforcement Administration and the other state boards where these people might be located do pursue them and have active investigations underway.
Please don’t become part of the investigation.
NEW RESTRICTIONS ON OVER-THE-COUNTER SALES OF PSEUDOEPHEDRINE AND EPHEDRINE PRODUCTS
The South Dakota 2005 Legislature passed legislation to establish certain restrictions regarding the sale and purchase of products containing pseudoephedrine or ephedrine. The law will become effective July 1, 2005, and will require that no retailer may sell in a single transaction, more than two packages containing pseudoephedrine or ephedrine as an active ingredient.
Products containing pseudoephedrine as the sole active ingredient shall not be displayed and/or offered for sale, except as otherwise provided, behind a counter where the public is not permitted or in a locked case so the customer must ask a store employee for assistance. If the retailer uses any type of anti-theft device system such as a tag and detection alarm to prevent theft, they may offer these products without restriction. Products containing pseudoephedrine as a sole active ingredient which are in liquid, liquid capsules, or gel capsule or products intended to administration to children are not restricted to behind the counter sales.
Combination products may be sold and displayed within 20 feet of a counter which allows the attendant to view the products unobstructed. Any combination product may be offered for sale without restrictions if the product uses anti-theft tag system devices. Although these restrictions on the sale of products containing pseudoephedrine and ephedrine are minimal, pharmacists are encouraged to make every effort to prevent the theft or abuse of these products.
The South Dakota law will also require posting a notice that informs the public that no more than two packages containing pseudoephedrine or ephedrine may be purchased.
There is no civil liability to employees or retailers due to injury including wrongful death because of the sale of these products.
No county or municipality may establish a penalty that is higher or more stringent than established by this Act.
REGISTERED PHARMACY TECHNICIAN
“Registered pharmacy technician,” is defined in SDCL 36-11-2(22A) as a person registered y 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 that 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 new regulation SDCL 36-11-29 at http://pharmacy.sd.gov. 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. 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.
COMPOUNDING OR MANUFACTURING
Compounding drug products that are commercially unavailable in the marketplace or that are essentially copies of commercially available drug products would not be consistent with Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG). In certain circumstances it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. However, in these circumstances FDA and the Board of Pharmacy would consider whether or not there was sufficient documentation of the medical need for the particular variation of the compound for that particular patient.
In the United States Pharmacopeia—National Formulary there is a section on pharmacy compounding. In that section the differences between compounding and manufacturing are discussed at some length. Some of the characteristics that differentiate compounding from manufacturing include the existence of specific practitioner-patient-pharmacist relationships, including the quantity of medication prepared in anticipation of receiving prescriptions and the conditions of sale, which are limited to patient-specific prescription orders. Both FDA and the Board of Pharmacy would consider a pharmacy to be manufacturing if the pharmacy were selling compounded products to a practitioner for his or her own office use. A facility that acquires stock medications in this manner is considered to be receiving drugs from unlicensed or improperly licensed sources. For additional information on compounding, the CPG may be downloaded at www.fda.gov/cder/pharmcomp under “Guidance for Industry.”
FDA URGES CONSUMER EDUCATION ABOUT COUNTERFEIT DRUGS
In an interim report, FDA’s Anti-Counterfeiting Task Force stressed the importance of increasing awareness and education of stakeholders including the public concerning counterfeit drugs. The report called for increasing efforts of FDA and other government agencies to educate consumers and health care professionals on how to reduce the risk of obtaining counterfeit drugs before the event occurs; educating consumers and health care professionals on how to identify counterfeit drugs; and improving and coordinating FDA and industry messages and efforts to address and contain a counterfeit event. At press time, FDA had available on its Web site (www.fda.gov/cder/consumerinfo/counterfeit_all_resources.htm) public service announcements that can be printed for consumers as well as educational articles to inform the public.
