January 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: Rachell Case, David Doane, Kent Kennon, Andrea Schopp, Melissa Sharp, and Liudmyla Zamulko.
PHARMACY INSPECTOR
Pharmacy inspector Jack Jones has decided to take life a little easier and is hanging up his “inspector hat”. The Board of Pharmacy members and staff have enjoyed working with Jack and want to thank him for his many years of dedicated service to the people of South Dakota. We wish Jack and his wife Wilma all the best during their retirement years.
SAFETY CAPS
The Poison Prevention Packaging Act (PPPA) was enacted in 1970 by Congress. This act provided the Consumer Product Safety Commission (CPSC) with the authority to establish child resistant packaging standards. These regulations subsequently required that prescription drugs, with some specific exceptions, be dispensed in packages that meet the child resistant effectiveness requirements of the regulation. The CPSC believes that state boards of pharmacy can be of great assistance to the agency in monitoring and enforcing its PPPA regulations at the pharmacy level.
The South Dakota State Board of Pharmacy inspectors have been granted special authority by the CPSC to conduct unannounced inspections at pharmacies to determine compliance with and to document any potential violations of the PPPA. The long-range goal of these inspections is to ensure that pharmacists are complying with the PPPA and, if violations are occurring, that the pharmacy take corrective action to remedy the problem.
The Board wishes to clarify that pharmacists are required under the PPPA to provide and dispense oral medications in packaging that meets the child resistant effectiveness requirements (safety caps). Some specific exemptions are allowed only if the pharmacist documents in the computer and/or on a signed statement that the patient is requesting the exemption because of medical reasons and is unable to open the safety-capped vials. For liability reasons the Board recommends pharmacists collect the patient’s signature to verify their request for non-safety caps for their medications. These exemptions must be maintained and available for inspection to prevent a violation of the PPPA. The Board encourages and hopes that pharmacists will familiarize themselves with the requirements of PPPA and understand the great job pharmacists have done to prevent thousands of children from being harmed.
MISSTATEMENT REGARDING REFILLS OF SCHEDULE II PRESCRIPTIONS
The August 2004 FAQ of the Federal Register stated: “Schedule II prescriptions may not be refilled; however, a physician may prepare multiple prescriptions on the same day with instructions to fill on different dates.” (Italics added.) The first part of this statement is correct, as the Controlled Substance Act (CSA) expressly states: “No prescription for a controlled substance in schedule II may be refilled.” 21 U.S.C. 829(a). However, the second part of the sentence (italicized above) is incorrect. For a physician to prepare multiple prescriptions on the same day with instructions to fill on different dates is tantamount to writing a prescription authorizing refills of a schedule II controlled substance. To do so conflicts with one of the fundamental purposes of section 829(a). Writing multiple prescriptions on the same day with instructions to fill on different dates is a recurring tactic among physicians who seek to avoid detection when dispensing controlled substances for unlawful (nonmedical) purposes. It is worth noting here that the DEA regulations setting forth the requirements for the issuance of a controlled substance prescription are set forth in 21 CFR 1306.01-13-6.27 (Federal Register, November 16, 2004).
If you have any questions regarding this, please contact the Board’s pharmacy inspectors or call the Board Office.
PROFESSIONAL INVENTORY SERVICES ALERT
The Board wishes to advise any pharmacy that contracts with a professional inventory service that the pharmacist-in-charge is responsible for all activities in the pharmacy area. It has been brought to the Board’s attention that theft of controlled drugs occurred at a pharmacy that used a professional inventory service. Any pharmacist that identifies a theft of controlled or non-controlled drugs should report this to the police, Board of Pharmacy, State Department of Health, and DEA immediately.
USING OF THE ORANGE BOOK
Every pharmacist needs to know how to use the information contained in the Orange Book – Approved Drug Products With Therapeutic Equivalency Evaluations – to legally substitute an equivalent drug product. The Board recommends that every pharmacist add to your internet “favorites” the following web site maintained by the US Food and Drug Administration www.fda.gov. At this site select and click on Drugs, then click on Orange Book. Click on Orange Book 24th Annual Editions, then click on “Orange Book Query”. This will allow you to check on medications that have been rated at least AB (see South Dakota Codified Law 36-11-46.4 and Administrative Rules of South Dakota 20:51:14:04—Requirements for substitution of equivalent products). At Orange Book Query you can search by Active Ingredients or the Proprietary Name. If a drug is not listed with a generic equivalent rating of AB, the drug is not substitutable by state law.
Pharmacists shall follow the law. Identifying products that do not meet FDA AB approval will help deter medications that are not approved for sale in this state. If you have questions about how to use the Orange Book, contact the Board of Pharmacy office.
AUTHORIZATION TO PICK UP MEDICATIONS
How many times have you handed a package of medication to a complete stranger that says “I am here to pick up Mrs. Johnson’s prescription. I am a friend and she is sick at home and wanted me to deliver the medication to her.”? Does this sound familiar?
Pharmacists and those working in the pharmacy need to ask for identification and should check with the patient to make sure they have approved this person to pick up their medications.
If a stranger picks up a medication and uses the medication themselves and is then harmed, is the pharmacist liable? Can the patient be held responsible for any harm to the person that picks up the medication? These are questions that are being asked today because of such an incident. Pharmacists and employees must always protect patients and their business from liability that may come their way unknowingly.
USP CHAPTER 797 – PHARMACEUTICAL COMPOUNDING – STERILE PREPS
The United States Pharmacopeia (USP) standards determine what a pharmacist may compound, dispense, sell or offer for sale in the State of South Dakota (SDCL 36-11-46). Recent published revisions to USP’s sterile products chapter have greatly expanded its recommendations for processes and procedures under which sterile products are compounded. This revision addresses several topics in sterile product preparation including contamination risk levels, personnel training, clean rooms, and quality assurance.
While these revisions are not addressed in statute or rule and are not enforceable by the Board, they are a realistic model for future pharmacy practice. The Board already has some rules dealing with compounding, but they are in need of major revision due to increased compounding by pharmacists and the new UPS standards.
As has been discussed at previous board meetings, new rules will need to be considered by the Board. The Board will most likely form an ad hoc committee on rules review. While the committee may not recommend and the Board may not adopt everything in USP Chapter 797, it will give serious consideration to the revised USP chapter as it considers rules updates and changes.
The Board’s final determination on any rule proposal will be done in 2005 with final rules adopted and effective, most likely, in early 2006. Pharmacists wishing to serve on the ad hoc committee should contact the Board office by February 2005.
PHARMACY TECHNICIAN REGISTRATION
The first registration of pharmacy technicians started October 1, 2004, and for the most part has gone smoothly. There still seems to be some confusion as to who needs to register with the Board as a technician. The South Dakota State Board of Pharmacy has ruled that any person who is in the pharmacy department and is handling medications, whether putting up stock, packaging unit dose, assisting in the filling of a prescription, working for a technician who is sick, or only working in the pharmacy department an hour a day must be registered with the Board.
Any individual who solely acts as a cashier and never performs any functions in the pharmacy is not required to be registered as a technician. These support persons are not to handle any medications unless they are packaged and ready to be sold and handed to the patient. If you are unsure whether or not a person needs to be registered, please call the Board office and we will be glad to assist you.
The pharmacist-in-charge will be responsible for any person working in the pharmacy department and is reminded state law prohibits a technician from working without being properly registered with the Board of Pharmacy. The pharmacist-in-charge should review all regulations with the pharmacy technicians. These regulations can be viewed at http://pharmacy.sd.gov under ARSD chapter 20:51:29.
If a new pharmacy technician is hired, they have 30 days to get registered with the Board of Pharmacy. Technicians will be required to renew registration yearly and are responsible to keep the Board informed of any changes in home or work address and phone number.
Inspectors for the Board are on the lookout for violations whenever they walk into a pharmacy and the pharmacist-in-charge, or supervising pharmacist, is responsible for making sure all staff are properly registered and identified with the Board.
