South Dakota State Board of Pharmacy
4305 S Louise Ave, Suite 104, Sioux Falls, SD 57106
NEWS FROM THE BOARD
Board meeting dates: Board meetings are scheduled for April 16 in Sioux Falls and June 3 in Pierre. Please check our website for the time, location and agenda.
NEW REGISTERED PHARMACISTS
The following candidates recently met licensure requirements and were registered as pharmacists in South Dakota: Katherine Chiu, Beth Graham, and Jeanne Leoni.
Pharmacy licenses have been issued recently to: James Stephens, pharmacist-in-charge, Vilas Pharmacy, 100 Main Street, Faith, SD; and Marla Hayes, pharmacist-in-charge, The Remedy Shoppe – Mission, 153 Main Street, Mission, SD. Both of these locations will serve as telepharmacies.
PARTIAL FILLING OF CONTROLLED SUBSTANCES
Our inspectors often receive questions related to partial filling of controlled substances in schedules III, IV and V. The Code of Federal Regulations (21 CFR) § 1306.23 states the partial filling of controlled substances listed in schedule II, IV, and V is permissible, provided that:
Each partial filling is recorded in the same manner as a refilling,
The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and
No dispensing occurs after 6 months from the date on which the prescription was issued.
AUTOMATED MECHANICAL DISTRIBUTION DEVICES
Our inspectors find that some pharmacies utilizing devices such as Pyxis, Omnicell, ScriptPro, Parata, Baker, etc. do not maintain proper documentation or supervision by the pharmacist. Administrative Rule 20:51:17:02 states:
(2) The automated mechanical distribution device shall be stocked with a limited supply of drugs only by a health care facility pharmacist or a person authorized by the pharmacist permittee. The health care facility pharmacist shall maintain electronic or written stocking records which contain the following information in the pharmacy for two years:
(a) The name of the person stocking the drug or medicine;
(b) The name, quantity, and strength of the drug or medicine; and
(c) The date of stocking;
Please ensure as the pharmacist permittee, all necessary documentation is being captured by the staff you have designated with access to the device.
CONTROLLED SUBSTANCES AND PATIENT IDENTIFICATION
As recently as 10 years ago (data from 1995-2004) controlled substances prescriptions consisted of approximately nine percent of all prescriptions written by prescribers. More recent statistics suggest that percentage has risen to 23 percent; almost one in four prescription orders are for a controlled substance medication.
A certain percentage of these orders are obtained by drug shoppers and diverters. Are we as pharmacists, being as diligent as possible to guard against this growing problem? Many pharmacies have implemented policies and procedures requiring patients to present a valid photo ID when presenting prescriptions for controlled substances. This process is very similar or identical to requirements for purchasing pseudoephedrine. A simple sign is posted at the “pick up area” stating something similar to “Our pharmacy verifies positive identification on all prescriptions for controlled substance medications”. Is it reasonable to assume if we ask even our most familiar patients to provide identification to purchase a package of Sudafed, we should also ask an unfamiliar patient for positive identification before obtaining a prescription for Oxycodone or any other controlled substance?
PHARMACEUTICAL TAKE-BACK PROGRAMS
A number of South Dakota pharmacists have expressed interest in pharmaceutical take-back programs, which are designed so that members of the public can bring unused or expired drugs to a central location for appropriate disposal. The South Dakota Board of Pharmacy reminds pharmacists to be aware of several things.
Federal controlled substance laws and rules prohibit a pharmacy from receiving controlled substances from anyone who is not a registrant of the United States Drug Enforcement Administration (DEA). (With limited exceptions involving drugs that are the subject of a manufacturer’s recall or that were dispensed by the pharmacy in error.) This means accepting controlled substances from patients or members of the public is prohibited except for the two examples listed.
DEA does have a process in place through which a local law enforcement agency can get permission to conduct take-back programs. The law enforcement agency may then work with a pharmacy or pharmacist to conduct the take-back program. Law enforcement officials must be present during a take-back event because there is no way to guarantee that controlled substances will not be brought to the collection site. Pharmacists may assist by identifying controlled substances so that they can be handled separately from other drugs collected.
Pharmacists can also help determine the proper method of disposal. Drugs such as warfarin, hormones, chemotherapy agents, etc. should not be disposed of by flushing or placing in landfills because of environmental concerns.
The Board encourages pharmacists to work with local law enforcement help organize these programs. We ask that you keep our office informed of your participation and so we share information with other pharmacists who are interested in providing this service in their community.
SPECIAL NOTICE ABOUT THIS NEWSLETTER
The South Dakota Board of Pharmacy Newsletter has been designated as an official method of notification to pharmacists licensed by the South Dakota State Board of Pharmacy. Please read all Newsletters and keep them for future reference. The Newsletters will be used in hearings as proof of notification. Please contact the Board office at 605-362-2737 if you have questions about any article in the Newsletter. Past Newsletters are also available on the Board’s Website.
BOARD OF PHARMACY STAFF DIRECTORY
|Office Phone 605-362-2737||FAX 605-362-2738|
|Ron Huether, Executive Secretaryfirstname.lastname@example.org|
|Rene Hixon, Senior Secretaryemail@example.com|
|Kim Kocmick-Burden, Secretaryfirstname.lastname@example.org|
|Earl McKinstry, Pharmacy Inspectoremail@example.com|
|Randy Jones, Pharmacy Inspectorfirstname.lastname@example.org|
|Board of Pharmacy Website||www.pharmacy.sd.gov|