44:76:07:01.  Pharmaceutical services. The requirements for pharmaceutical services in ambulatory surgery centers are as follows:

          (1)  A physician, pharmacist, or registered nurse is responsible for the supervision of drug stocks in the facility;

          (2)  Records shall be kept of stock supplies of all drugs and shall give an accounting for all items purchased and dispensed;

          (3)  Policies and procedures on drug handling, storing, labeling, and dispensing shall be in writing and available to personnel; and

          (4)  All drugs in the facility shall be labeled with drug name, strength, and expiration date and shall be stored in specially designated, well illuminated cabinets, closets, or storerooms. Drug cabinets shall be accessible only to authorized individuals as outlined in the facilities policies and procedures. All drugs controlled pursuant to SDCL chapter 34-20B shall be securely locked and shall be accessible only to authorized individuals.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:02.  Policies and procedures. Each facility shall establish and practice methods and procedures for medication control that include the following:

          (1)  A requirement that each patient's prescribing physician, physician assistant, or nurse practitioner provide to the facility electronic or written signed orders for any medications taken by the patient; authorization for medications or drugs kept on the person or in the room of the patient; and release of medications;

          (2)  Provisions for proper storage of prescribed medications so that the medications are inaccessible to patients or visitors with requirements for:

               (a)  Separate storage of poisons, topical medications, and oral medications;

               (b)  Each patient's medication to be stored in the container in which it was originally received and not transferred to another container; and

               (c)  A medication prescribed for one patient not to be administered to any other patient;

          (3)  Self-administration of medications to be accomplished with the supervision and within the scope of practice by a designated employee of the facility to include:

               (a)  A description of the responsibilities of the patient, the patient's family members, and the facility staff; and

               (b)  The provision of written educational material explaining to the patient and the patient's family the patient's rights and responsibilities associated with self-administration; and

          (4)  The proper disposition of medicines that are discontinued because of the discharge or death of the patient, because the drug is outdated, or because the prescription is no longer appropriate to the care of the patient.

          Methods and written policies and procedures shall be established to include the manner of issuance, proper storage, control, accountability, and administration of medications or drugs in accordance with pharmaceutical and nursing practices as well as professional standards.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:03.  Written orders for medication required. All medications or drugs administered to patients shall be ordered electronically or in writing and authenticated by the prescriber. Verbal 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 or licensed nurse in facility. The prescriber shall date, time, and authenticate the orders for patients promptly. The practitioner shall date, time, and authenticate the orders for patients as soon as promptly. A policy on stop orders for antibiotics, anticoagulants, and controlled drugs shall be established based on recommendations of the medical staff.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:04.  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 patients, or visitors at all times. Medications suitable for storage at room temperature shall be maintained between 59 and 86 degrees Fahrenheit (15 and 30 degrees centigrade). Medications that require refrigeration shall be maintained between 36 and 46 degrees Fahrenheit (2 and 8 degrees centigrade). Poisons and medications prescribed for external use shall be stored separately from internal medications, locked and made inaccessible to patients.

          The medications or drugs of each patient for whom medications are facility-administered shall be stored in the containers in which they were originally received and may not be transferred to another container. Special modification of this requirement may be made if single dose packaging is used. Each prescription drug container, including manufacturer's complimentary samples, shall be labeled with the patient's name, physician, physician assistant, or nurse practitioner's name, drug name and strength, directions for use, and prescription date.

          Containers with contents that will not be used within 30 days of issue or with contents that expire in less than 30 days of issue shall bear an expiration date. If a single dose system is used, the drug name and strength, expiration date, and a control number shall be on the unit dose packet.

          If a stock bottle system is used in a facility with a licensed pharmacy, the container shall be labeled with the drug name and strength, expiration date, and a control number. Any container with a worn, illegible, or missing label shall be destroyed pursuant to § 44:73:08:06. Licensed pharmacists are responsible for the labeling, relabeling, or altering of labels on medication containers.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:05.  Control and accountability of medications and drugs. A patient may self-administer medications brought from home during their treatment or these medications may be administered by the facility staff if ordered by the attending physician, physician assistant, or nurse practitioner and, if prior to administration, is identified as the prescribed drug. Medications prescribed for one patient may not be administered to another. Patients may not keep medications on their person without a physician's, physician assistant, or nurse practitioner's order allowing self-administration. Written authorization by the patient's physician, physician assistant, or nurse practitioner shall be secured for the release of any medication to a patient upon discharge from the facility. The release of medication shall be documented in the patient's record, indicating quantity, drug name, and strength. The facility shall maintain records that account for all medications and drugs from their receipt through administration, destruction, or return.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:06.  Documentation of drug disposal. Legend drugs not controlled under SDCL chapter 34-20B shall be destroyed or disposed of by a nurse and another witness. Destruction or disposal of medications controlled under SDCL chapter 34-20B shall be witnessed by two persons, both of whom are a nurse or pharmacist, as designated by facility policy. Methods of destruction or disposal may include:

          (1)  Disposal by using a professional waste hauler to take the medications to a permitted medical waste facility or by facility disposal at a permitted municipal solid waste landfill. Prior to disposal all medications shall be removed from original containers and made unpalatable by the addition of adulterants and alteration of solid dosage forms by dissolving or combination into a solid mass;

          (2)  Return to the dispensing pharmacy for destruction or dispose according to federal and state regulations;

          (3)  Return to an authorized reverse distributor company licensed by the South Dakota Board of Pharmacy; or

          (4)  Release to patient upon discharge after authorization by the patient's prescribing practitioner.

          Documentation of destruction or disposal of medications shall be included in the patient's record. The documentation shall include the method of disposition (destruction, disposal, return to pharmacy, or release to patient); the medication name, strength, prescription number (as applicable), quantity, and date of disposition; and the name of any person who witnessed the destruction or disposal.

          Medications, excluding those controlled under SDCL chapter 34-20B, contained in unit dose packaging meeting the requirements of § 20:51:13:02.01 may be returned to the dispensing pharmacy for credit and redispensing.

          Any medication held for disposal shall be physically separated from the medications being used in the facility, locked with access limited, in an area with a system to reconcile, audit, or monitor them to prevent diversion.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:07.  Medication administration. Each medication administered shall be recorded in the patient's medical record and signed by the person responsible. Medication errors and drug reactions shall be reported to the patient's physician, physician assistant, or nurse practitioner and an entry made in the patient's medical record. Orders involving abbreviations and chemical symbols may be carried out only if the facility has a standard list of abbreviations and symbols approved by the medical staff or, in the absence of an organized medical staff, by the medical director and the list is available to the nursing staff. All medications shall be administered to patients by personnel acting under delegation of a licensed nurse, or licensed to administer medications.

          A person may not administer medications that have been prepared by another person, other than a pharmacist.

          Medication administration shall comply with §§ 44:76:08:02 to 44:76:08:05, inclusive, and with the requirements for training in §§ 20:48:04.01:14 and 20:48:04.01:15 and for supervision in § 20:48:04.01:02. The supervising nurse shall provide an orientation to the unlicensed assistive personnel who will administer medications. The orientation shall be specific to the facility and relevant to the patients receiving administered medications.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:08.  Medication records. Medication administration records shall be used and regularly checked against the practitioner's orders. Each medication administered shall be recorded in the patient's medical record and signed by the individual responsible.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).

          44:76:07:09.  Administration of facility pharmacy. The pharmaceutical service of each facility with a licensed full or part-time pharmacy shall be directed by a licensed pharmacist accountable to the administration of the facility. Only prepackaged drugs or a single dose unit may be removed from the pharmacy when the pharmacist is not available. These drugs may be removed only by a designated registered nurse or physician, physician assistant, or nurse practitioner in amounts sufficient only for immediate therapeutic needs. A record of such withdrawals shall be made by the designated nurse or the physician, physician assistant, or nurse practitioner making the withdrawal.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(9).

          Law Implemented: SDCL 34-12-13(9).