CHAPTER 44:75:08
MEDICATION CONTROL
Section
44:75:08:01 Policies and procedures.
44:75:08:02 Written orders for medication required.
44:75:08:03 Repealed.
44:75:08:04 Storage and labeling of medications.
44:75:08:05 Control and accountability of medications.
44:75:08:06 Documentation of medication disposal.
44:75:08:07 Medication administration.
44:75:08:08 Medication records.
44:75:08:09 Administration of facility pharmacy.
44:75:08:01. Policies and procedures. Each facility shall establish and implement written policies and procedures for medication control that include:
(1) A requirement that each patient's prescribing physician, physician assistant, or nurse practitioner provide to the facility electronic or written signed orders for:
(a) Any medications taken by the patient;
(b) Authorization for medications kept on the patient or in the room of the patient; and
(c) Release of medications;
(2) Provisions for proper storage of prescribed medications so that the medications are inaccessible to patients and 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 that is not to be administered to any other patient;
(3) Self-administration of medications to be accomplished with the supervision of a licensed nurse to include:
(a) A description of the responsibilities of the patient, the patient's family members, and the facility personnel; 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 medications due to:
(a) Patient discharge or death of the patient;
(b) Outdated medication; or
(c) The prescription being discontinued by the physician, physician assistant, or nurse practitioner.
The facility shall also establish written policies and procedures for 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.
For the purpose of subdivision (3), the phrase, self-administration of medications, means the removal of the correct dosage from the pharmaceutical container and self-injecting, self-ingesting, or self-applying the medication with no assistance or with assistance from qualified personnel of the facility for the correct dosage or frequency.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:02. Written orders for medication required. All medications administered to patients must be ordered electronically or in writing and dated, timed, 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 hospitals. The prescriber shall date, time, and authenticate the orders for hospital patients on the next visit to the facility. A facility shall establish a policy on stop orders for antibiotics, anticoagulants, and controlled drugs based on recommendations of the medical staff.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:03. Medication therapy review. Repealed.
Source: 42 SDR 51, effective October 13, 2015; 42 SDR 173, effective June 21, 2016.
44:75:08:04. Storage and labeling of medications. A facility shall store all medications in a well illuminated, locked storage area that is well-ventilated, maintained at a temperature appropriate for medication storage, and inaccessible to patients and visitors at all times. Medications suitable for storage at room temperature must be maintained between fifty-nine and eighty-six degrees Fahrenheit or fifteen and thirty degrees centigrade. Medications that require refrigeration must be maintained between thirty-six and forty-six degrees Fahrenheit or two and eight degrees centigrade. Poisons and medications prescribed for external use must be stored separately from medications prescribed for internal use, locked, and made inaccessible to patients and visitors.
Locked storage does not apply to drugs and medications needed for emergency use in intensive care, emergency room, neonatal intensive care, pediatric intensive care, or coronary care units. Medications utilized in these care units must be in a storage area that is readily available to the professional staff but inaccessible to patients or visitors.
The medication of each patient for whom medications are facility-administered must be stored in the containers in which the medication was originally received. Special modification of this requirement may be made if single dose packaging is used. Each prescription drug container, including manufacturer's complimentary samples, must be labeled with the patient's name; physician, physician assistant, or nurse practitioner’s name; medication name and strength; directions for use; and prescription date.
A container with a medication that will not be used within thirty days of issue or with contents that expire in less than thirty days of issue must bear an expiration date. If a single dose system is used, the drug name and strength, expiration date, and a control number must be on the unit dose packet.
A co-located hospital and assisted living center may procure and stock, including in bulk form, non-legend medications and administer them in accordance with written policies and procedures that provide for oversight by qualified personnel.
If a stock bottle system is used in a facility with a licensed pharmacy, the container must be labeled with the drug name and strength, expiration date, and a control number. Any container with a worn, illegible, or missing label must be destroyed pursuant to § 44:73:08:06. A licensed pharmacist is responsible for the labeling, relabeling, or altering of labels on medication containers.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:05. Control and accountability of medications. A medication brought from a patient's home may be used if ordered by the attending physician, physician assistant, or nurse practitioner, and, if prior to administration, it is identified as the prescribed medication. Medications prescribed for one patient may not be administered to another. Patients may not keep medications on their person or in their room without a physician's, physician assistant's, or nurse practitioner's order allowing self-administration. The patient's physician, physician assistant, or nurse practitioner must authorize the release of any medication to a patient upon discharge, transfer, or temporary leave from the facility. The release of medication must be documented in the patient's record, indicating quantity, medication name, and strength. The facility shall maintain records that account for all medications from their receipt through administration, destruction, or return.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:06. Documentation of medication disposal. A facility shall ensure that a legend drug not controlled under SDCL chapter 34-20B is destroyed or disposed of by a nurse and another witness. Destruction or disposal of medications controlled under SDCL chapter 34-20B must be witnessed by two persons, both of whom must be 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 must 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 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.
The facility shall document destruction or disposal of medications in the patient's record and must include the method of disposition; the medication name and strength; prescription number; quantity; date of disposition; and the name of any person who witnessed the destruction or disposal.
A facility may return medication, excluding those controlled under SDCL chapter 34-20B, contained in unit dose packaging meeting the requirements of § 20:51:13:02.01 to the dispensing pharmacy for credit and redispensing.
Any medication held for disposal must be physically separated from the medications being used in the facility and locked in an area with limited access. The facility shall establish a system to reconcile, audit, and monitor medication held for disposal to prevent diversion.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:07. Medication administration. The healthcare personnel administering medication to a patient shall record the administration in the patient's medical record. Medication errors and drug reactions must 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. The facility shall make the list available to its nursing personnel. All medications must be administered to patients by personnel acting under delegation of a licensed nurse, or licensed to administer medications.
A person may not administer medications prepared by another person unless the medication was prepared by a pharmacist.
Medication administration must comply with §§ 44:75:08:02 to 44:75:08:05, 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 must be specific to the facility and relevant to the patients receiving administered medications.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:08. Medication records. A facility must use medication administration records and regularly check the record against the practitioner's orders. Each medication administered must be recorded in the patient's medical record and signed by the individual administering the medication.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
44:75:08:09. Administration of facility pharmacy. A facility with a licensed full or part-time pharmacy must have its pharmaceutical service directed by a licensed pharmacist accountable to the administration of the facility.
Only prepackaged or a single dose drugs may be removed from the pharmacy when the pharmacist is not available. A drug may be removed by a designated registered nurse or physician, physician assistant, or nurse practitioner in amounts sufficient only for immediate therapeutic needs. A record of the removal must be made by the designated nurse or the physician, physician assistant, or nurse practitioner removing the drug.
Source: 42 SDR 51, effective October 13, 2015; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13.
