44:69:07:01.  Pharmaceutical services. The requirements for pharmaceutical services in birth centers include the following:

 

          (1)  There shall be written orders signed by a practitioner legally authorized to prescribe for all drugs administered to mother and infant within the birth center;

 

          (2)  There shall be policies and procedures addressing the receiving, transcribing, issuance, storage, control, accountability, administration, and disposal of medications or drugs in each birth center;

 

          (3)  Each birth center shall keep a list of the following in the drug storage area for reference:

 

               (a)  Generic and trade names for drugs substituted within the birth center;

               (b)  Drugs with unique requirements for administration used within the birth center, including enteric coatings, sublingual, buccal, and sustained release dosage forms; and

               (c)  Drugs controlled under SDCL chapter 34-20B that are used within the birth center;

 

          (4)  Written policies shall be established addressing the type and intended use of any drug to be used by clients within the birth center;

 

          (5)  Drugs, medications, biologicals, and chemicals kept in the birth center shall be labeled with the drug name, strength, and expiration date;

 

          (6)  Drug cabinets shall be accessible only to the nurse in charge, the practitioner, or the pharmacist. All drugs controlled pursuant to SDCL chapter 34-20B shall be kept in a securely locked box, accessible only to the nurse in charge, the practitioner, or the pharmacist;

 

          (7)  Each birth center having narcotics shall maintain a narcotic administration record so the disposition of any particular controlled substance can be readily traced. The date, time administered, name of administering practitioner or nurse, the name and strength of the narcotic, the name of the client, and the balance remaining shall be documented in the record;

 

          (8)  Drugs may not be stored in a refrigerator used for food storage for clients, families, and employees;

 

          (9)  Anesthetic agents and techniques to be used in any birth center shall be determined by its governing board;

 

          (10)  General and conduction anesthesia may not be administered at the birth center. Local anesthesia for pudendal block and episiotomy repair may be performed if procedures are outlined by the clinical staff. Systemic analgesia may be administered but pain control should depend primarily on close emotional support and adequate preparation for the birth experience;

 

          (11)  Drugs shall be administered only by personnel or staff licensed to administer drugs;

 

          (12)  The birth center shall be in conformance with any applicable federal, state, and local laws and regulations relating to drug and to controlled substances;

 

          (13)  A physician, pharmacist, or certified nurse midwife shall be responsible for the supervision of drug stocks in the birth center; and

 

          (14)  Self-administration of medications may not be permitted by clients admitted to the birth center.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:02.  Written orders for medication required. All medications or drugs administered to clients shall be ordered in writing and signed by the prescribing practitioner. Telephone orders for medications or drugs may be taken only when there is an urgent need to initiate or change an order and accepted only by a pharmacist, licensed nurse, or certified nurse midwife in the birth center. The practitioner shall sign or initial the orders for birth center clients on the next visit to the birth center.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:03.  Storage and labeling of medications and drugs. All drugs or medications shall be stored in a well illuminated, locked storage area that is well ventilated, maintained at a temperature appropriate for drug storage, and inaccessible to individuals, clients, or visitors at all times.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:04.  Control and accountability of medications and drugs. Medications brought from home may be used if ordered by the attending practitioner and, if prior to administration, is identified as the prescribed drug.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:05.  Documentation of drug disposal. If a birth center has a licensed pharmacy, outdated or discontinued medications shall be returned to the pharmacy for disposition. In the absence of a licensed pharmacy, the method of disposition of outdated or discontinued medications shall be handled and recorded in the client's medical record as follows:

 

          (1)  Legend drugs not controlled under SDCL chapter 34-20B shall be destroyed by a nurse and another witness;

 

          (2)  Destruction or disposal of medications controlled under SDCL chapter 34-20B shall be witnessed by two persons, both of whom are either a nurse, certified nurse midwife, or pharmacist, as designed by facility policy; and

 

          (3)  Medications, excluding controlled substances listed in SDCL chapter 34-20B, in unit dose packaging that meets packaging standards in § 20:51:13:02.01 may be returned to the pharmacy pursuant to § 20:51:13:02.01.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).