January 2006
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: Phyllis Bennett-Mobley, Donna Christensen, Kimberly Freudenthal, Kim So-Young, Martha Meg Mellecker, and James Schott.
PHARMACY LICENSES
Pharmacy license were recently issued to: Jocelyn Prang, Medicap Pharmacy, Black Hawk; Rebecca Johnson, Lewis Family Drug, Sioux Falls; David Dyball, WalMart, Vermillion; Anne Nopens, Lewis Family Pharmacy, Lake Preston (change of ownership); and Mary Thoennes, Genoa Healthcare of South Dakota, Watertown; Ken Jones, Yankton Medical Clinic, Yankton.
EMERGENCY ROOM DISPENSING
Many pharmacists have questions regarding dispensing of emergency room medications.
The Department of Health requires that licensed health care facilities ensure that their employees and contracted providers comply with their respective professional practice acts as well as other state statutes and regulations.
ARSD 44:04:08:03 states that all medication or drugs administered to patients in hospitals or nursing facilities must be ordered in writing and signed by the prescribing practitioners.
Telephone orders for medication may be taken only where there is an urgent need to initiate or change an order, and the telephone orders may only be accepted by a pharmacist or licensed nurse in the hospital or nursing facility. The practitioner must sign the verbal order at the next visit to the hospital or nursing facility.
ARSD 44:04:08:02 states that policies and procedures shall be established to direct the manner of issuance, storage, control, accountability, and procedure for administering medication or drugs to patients in each hospital or nursing facility.
ARSD 44:04:08:06 addresses the pharmaceutical services of all state licensed hospital or nursing facility with a full or part-time pharmacy license. It further states that only prepackaged drugs or a single unit-dose may be removed from the pharmacy when the pharmacist is not available.
ARSD 20:51:15:13 addresses the procedure that must be followed when the pharmacist is not available. Most hospitals and nursing facilities do not have 24-hour pharmacy coverage and must follow these regulations when a medication is needed when the pharmacist is not available and the pharmacy is closed.
ARSD 20:51:15:15 clarifies the responsibility of the pharmacist and procedure for supplying emergency drugs to meet the immediate therapeutic needs of patients so as to prevent harm or delay of treatment. The hospital pharmacist may provide medications or drugs in limited quantities that are properly labeled, supplied and stored in an emergency room of the hospital. In a nursing facility the quantity and types of medication provided for emergency kits is discussed in ARSD 20:51:15:15.01.
It is in the best interest of patients to begin many medications at the time of an emergency room visit. Since most South Dakota hospitals do not have overnight and/or weekend pharmacy coverage, the pharmacist responsible for medication provision should develop a list of potential take-home medications in collaboration with the hospital medical staff. Any take-home medications should be limited to 48-72 hour quantities where possible, properly labeled, and placed in appropriate safety containers. If the on-site prescriber wants the patient to have additional quantities of medication, they should provide a written prescription to the patient.
The Boards of Medical Examiners, Nursing, and Pharmacy agreed that no violation of rule or statute occurs when the on-site licensed practitioner gives a licensed nurse an order to issue prepackaged, properly labeled medication to a patient registered and examined in the emergency room.
Practitioners with prescriptive authority are permitted to dispense drugs in an emergency setting, and may label medication for the licensed nurse to hand to a patient under certain circumstances. The nurse may not package or label drugs for the patient. This would be considered dispensing and a violation of the nurse’s practice act, which does not permit a nurse to dispense medications.
A licensed emergency room nurse may not prepare and dispense medications to a patient pursuant to an after-hours phone call from an off-site practitioner.
If you have any questions pertaining to this topic, please contact the Board of Pharmacy office.
PSEUDOEPHEDRINE/EDPHEDRINE LAW
During the 2005 Legislative Session a bill was introduced to restrict the sale of non-prescription products containing pseudoephedrine or ephedrine. The Legislature passed this bill and enacted statute SDCL 34-20D which limits the retail sale to a single transaction of not more than two packages containing pseudoephedrine or ephedrine as an active ingredient.
The retailer must restrict products with pseudoephedrine or ephedrine as the sole active ingredient to behind-the-counter sales where the consumer must ask a store employee for assistance.
A retailer may display combination products containing pseudoephedrine or ephedrine as an active ingredient without restrictions if the products are displayed within twenty feet of the checkout counter to allow the clerk visual contact with the products. If anti-theft devices are employed, combination products can be displayed anywhere in the store.
The pharmacist or retailer shall post a notice at the location to inform the public of package limit requirements of SDCL 34-20D(1-7). The South Dakota Board of Pharmacy encourages each pharmacist to review the law in its entirety at http://legis.state.sd.us/statutes. Go to “Statutes” and click “Quick Find”. Type 34-20D in the box and click on “Get Chapter.”
Pharmacists can help reduce the abuse of these products and have been requested by Governor Rounds, the state legislators and law enforcement to help. Pharmacists are in a position to help make a difference controlling the availability of these products to those who misuse them.
SALE OR TRANSFER OF DRUGS
The sale of drugs from one licensed pharmacy to another pharmacy or a prescriber’s office is allowed by law. Some physicians believe they can write on a prescription “for office use” and the pharmacist can sell them legend medications. Not so.
When the pharmacist makes a sale or transfer of legend drugs, including Schedules III-V of controlled substances, to another DEA registered site, the pharmacist shall document the drug name, strength, quantity, and date of sale or transfer. The invoice must include the names, addresses and DEA registration numbers of the parties involved in the sale/transfer of all controlled substances III-V. To transfer Schedule II substances, the receiving registrant must issue an Official Order Form (DEA Form 222) to the registrant transferring/selling the drugs.
Any pharmacy engaged in the sale or transfer of drugs in this state equivalent to five percent of the total gross sales is required to be licensed as a pharmacy distributor (SDCL 36-11A-4).
PROVISIONS FOR PHARMACIST ABSENCE
Pharmacist owners have been given authority by regulations to be temporarily absent from their pharmacy without closing the entire store (ARSD 20:51:06:10). Temporary absence is a short absence of no more than one to two hours. The absence can be for eating, banking, visit to nursing homes, hospital, or any legitimate personal business.
It has become more frequent for store owners to leave their pharmacy and store open for extended periods without a pharmacist present. The Board inspectors have been instructed to identify such operations and to instruct the pharmacist owner that they have two options:
The Board is giving notice to pharmacists to be compliant with this regulation (ARSD 20:51:06:10). If your business is in violation of this regulation the board will expect compliance by September 30, 2006, before taking action. If you have any questions, please contact the Board office.