Newsletter


January 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:  Mary Andrawis, Nelle Balsiger, Grant Schmalz, and Alina Viziteu.

PHARMACY LICENSES
    
New pharmacy licenses were recently issued to Justin Richter, Lewis Drug at 57th and Cliff, Sioux Falls, SD; and Nichole Metzinger, Walgreens #10572, Pierre, SD.

SPECIAL NOTICE ABOUT NEWSLETTERS
     The South Dakota Board of Pharmacy Newsletter is the official method of notification to pharmacists licensed by the South Dakota Board of Pharmacy.  Please read each newsletter and keep it for future reference.  The newsletters will be used as proof of notification in hearings conducted by the Board of Pharmacy. 

     You should also have your pharmacy technicians read each newsletter.  This is one of the methods you can use to keep them informed and to document ongoing education for your technicians.  

     Please contact the board office (605-362-2737) if you have questions about any article in the newsletter.  Past newsletters can also be viewed on the Board of Pharmacy web site http://pharmacy.sd.gov.

SANITARY CONDITIONS REQUIRED IN PHARMACIES
    
SDCL 36-11-42 – “Any permit to conduct a pharmacy issued by the Board of Pharmacy shall be void and subject to cancellation by the State Board of Pharmacy, unless such pharmacy is maintained in a clean and sanitary condition, free from unhealthful, foreign, or injurious contamination.”

     This statute requires the Board to make sure that all pharmacies are clean and safe for the public. Patient medication safety is at risk when a pharmacy is cluttered and disorganized.  The image of the profession is enhanced by pharmacies that are neat and orderly.  The Board of Pharmacy inspectors are instructed to identify any pharmacy that does not maintain an environment that enhances accuracy in dispensing and patient safety. 

     Pharmacists, please look at the professional services area of your pharmacy. If you are not proud of the appearance, you know what to do before the inspector arrives.

FDA RECOMMENDATION
     This article was published in the November-December NABP Newsletter and the Board believes it is worth passing on.

INHALER CAPSULE PRECAUTIONS
    
Food and Drug Administration is recommending several precautions to avoid accidental ingestion of capsules intended for use with inhalers that resemble oral medication. While the manufacturers are working on making changes to labeling and packaging to prevent further instances, FDA has issued several precautions for the interim:

DEA FORM 106 - LOSS OF CONTROLLED SUBSTANCES
     The Board of Pharmacy wants to remind you that Drug Enforcement Administration Form 106 must be completed and submitted to the South Dakota Board of Pharmacy Office; Bob Coolidge, Department of Health Licensure and Certification; and to the DEA in accordance with 21 Code of Federal Regulations (CFR) 1301.74(c) for any theft or significant loss of controlled substances.  Section 1301.74(c) states “The registrant shall notify the Field Division Office of the Administration in his area, in writing, of any theft or significant loss of any controlled substance within one business day of discovery of such theft or loss. The Supplier is responsible for reporting in-transit losses of controlled substances of this section, within one business day of discovery of such theft or loss. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them.  

     When determining whether a loss is significant, a registrant should consider, among others, the following factors:

  1. The actual quantity of controlled substances lost in relation to the type of business;
  2. The specific controlled substance lost;
  3. Whether the loss of the controlled substance can be associated with access to those controlled substances by specific individuals, or whether or not the loss can be attributed to unique activities that may take place involving the controlled substance.
  4. A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
  5. Whether the specific controlled substances are likely candidates for diversion;
  6. Local trends and other indicators of the diversion potential of the missing controlled substance.”

     The DEA Field Division Office for South Dakota is in Des Moines, Iowa -- phone number 515-284-4709.  The contact number for Bob Coolidge, Department of Health Licensure and Certification, 615 East 4th Street, Pierre, South Dakota 57501, is 605-773-3356.

     The Board also encourages all pharmacies to install an alarm system which, upon unauthorized entry, shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond. The alarm should have a backup system, such as a cellular telephone, that will report the unauthorized entry in the event the telephone lines are cut.

WHAT TO DO WHEN THE DOCTOR PASSES AWAY, RETIRES, OR RELOCATES PRACTICE
Good Advice from the Kansas State Board Newsletter

     How do you handle refill requests when a prescriber passes away, retires, or relocates his or her practice? The South Dakota Board of Pharmacy and South Dakota Board of Medical and Osteopathic Examiners have no regulations pertaining to the number of refills allowed under these circumstances.

     The following response to the issue was provided by the Office of Drugs, the National Center for Drugs, and the Biologics, Food and Drug Administration.

It is well established that a prescription of a practitioner given to a patient signifies generally that a physician/patient relationship exists. This relationship also connotes that during the life of that prescription, the patient is under the practitioner’s professional care and includes the number of authorized refills. It is our opinion that once a physician/patient relationship is broken, the prescription loses its validity since the physician is no longer available to treat the patient and oversee his [or] her use of the prescribed drug(s).

     The South Dakota Board of Pharmacy recommends that if the pharmacist is aware of the situation, the pharmacist should counsel the patient to seek a new physician immediately. The patient should be able to obtain a sufficient amount of prescribed drug of any unexpired prescription to carry over until the services of another physician are obtained. In some cases, obtaining the services of another physician may take 60 days or longer.

     The key to this issue is the pharmacist’s professional judgment. The pharmacist can refuse to refill any prescription, if, in the pharmacist’s professional judgment and discretion, the prescription should not be refilled.

SELLING CONTROLLED SUBSTANCES TO ANOTHER PHARMACY OR PRACTITIONER’S OFFICE
    
Remember that all Schedule II sales/transactions must be completed utilizing a Drug Enforcement Administration Form 222 supplied by the pharmacy or practitioner requesting the Schedule II item. All Schedule III-V transactions must be documented by invoice with a copy provided to the buyer and a copy retained by the seller. These transactions are treated the same as if they were purchased from a wholesaler.

     Contact the Board office if you have any questions about this record-keeping requirement.

TECHNICIAN TRAINING
     In the last issue of the South Dakota Board of Pharmacy Newsletter, a short message was written about the pharmacist-in-charge’s responsibility for developing an appropriate training program for pharmacy technicians. The Board has reviewed several manuals that would be appropriate.  Please ask your pharmacy inspector or call the Board office for further information.

NOTIFICATION OF CHANGE OF ADDRESS
    
Board of Pharmacy regulations require pharmacists and pharmacy technicians to report any change of address or employment to the Board of Pharmacy. Please make sure you are compliant with this regulation.