CHAPTER 44:73:08

MEDICATION CONTROL

Section

44:73:08:01        Repealed.

44:73:08:01.01    Policies and procedures.

44:73:08:02        Written orders for medication required.

44:73:08:03        Medication therapy reviewed monthly.

44:73:08:04        Storage and labeling of medications.

44:73:08:05        Control and accountability of medications.

44:73:08:06        Documentation of medication disposal.

44:73:08:07        Medication administration.

44:73:08:08        Medication records.

44:73:08:09        Administration of facility pharmacy.

44:73:08:10        Stock of legend drugs prohibited -- Exception.

44:73:08:11        Controlled drugs kept for emergency use.

44:73:08:12        Self administration of drugs.

    44:73:08:01.01.  Policies and procedures. Each facility shall establish and implement the following policies and procedures for medication control:

    (1)  A requirement that each resident's prescribing physician, physician assistant, or nurse practitioner provide to the facility electronic or written signed orders for:

        (a)  Any medications taken by the resident;

        (b)  Authorization for medications kept on the resident or in the room of the resident; and

        (c)  Release of medications;

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

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

        (b)  Each resident'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 resident that is not to be administered to any other resident;

    (3)  The self-administration of medications must be accomplished with the supervision of a designated employee of the facility. The requirement must contain:

        (a)  A description of the responsibility of the resident, the resident's family members and the facility personnel; and

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

    (4)  Provision for proper disposition of medications due to:

        (a)  Resident discharge or death;

        (b)  Outdated medication; or

        (c)  The prescription is being discontinued by the physician, physician assistant, or nurse practitioner.

    The facility shall 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.

    The facility and the facility's pharmacist shall establish a system of records of receipt and disposition for all controlled drugs in sufficient detail to enable an accurate reconciliation. The facility and pharmacist shall ensure the drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. The facility and pharmacist shall have policies and procedures for the periodic reconciliation of all controlled substances. The policies and procedures must minimize the time between the actual loss or diversion and the time of detection and follow-up to determine the extent of the loss.

    If a loss or diversion of controlled substances is identified, the facility and pharmacist shall evaluate the residents potentially affected, consistent with the resident's comprehensive assessment and plan of care. If policies and procedures have not been effective in preventing the loss or diversion of controlled substances, the facility and pharmacist must review and revise related controls and procedures as necessary.

    Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; 28 SDR 83, effective December 16, 2001; 29 SDR 81, effective December 11, 2002; transferred from § 44:04:08:02, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:02.  Written orders for medication required. All medications administered to a resident must be ordered electronically or in writing and signed by the prescriber. Verbal orders for medications 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. The prescriber shall sign or initial any verbal orders for residents on the prescriber's next visit to the facility.

    Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; 26 SDR 96, effective January 23, 2000; 30 SDR 84, effective December 4, 2003; transferred from § 44:04:08:03, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:03.  Medication therapy reviewed monthly. The pharmacist shall review a resident's medication regimen at least monthly. The pharmacist shall review the resident's diagnosis, medication regimen, and any pertinent laboratory findings and dietary considerations. The pharmacist shall report potential medication therapy irregularities and make recommendations for improving the medication therapy of the resident to the attending physician, physician assistant, or nurse practitioner, and the administrator. The pharmacist shall document the review by preparing a monthly report of the potential irregularities and recommendations. The administrator shall retain the report in the facility for one year. A copy of the medication review must be in the resident's medical record.

    The pharmaceutical service must be under the supervision of a licensed pharmacist who provides consultation and oversees all aspects of the pharmaceutical service.

    Source: 15 SDR 155, effective April 20, 1989; 22 SDR 70, effective November 19, 1995; 26 SDR 96, effective January 23, 2000; 28 SDR 83, effective December 16, 2001; 38 SDR 115, effective January 9, 2012; transferred from § 44:04:08:03.01, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:04.  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, accessible to those with authority to administer medications, and inaccessible to residents 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 residents and visitors.

    Any resident medication that is facility-administered must be stored in the container in which it was originally received and may not be transferred to another container. Single dose medication received by a resident from a physician, physician assistant, or nurse practitioner must be identified as single dose. Each prescription medication container, including manufacturer's complimentary samples, must be labeled with the resident's name; the name of the resident's physician, physician assistant, or nurse practitioner; the medication name and strength; the directions for use; and the 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 medication name and strength, expiration date, and a control number must be on the unit dose packet.

    A facility may procure and stock, including in bulk form, nonlegend medications and administer them in accordance with written policies and procedures that provide for oversight by qualified personnel.

    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 a label on a medication container.

    Source: SL 1975, ch 16, § 1; 4 SDR 14, effective September 14, 1977; 5 SDR 29, effective October 22, 1978; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 15 SDR 155, effective April 20, 1989; 22 SDR 70, effective November 19, 1995; 26 SDR 96, effective January 23, 2000; 27 SDR 59, effective December 17, 2000; 28 SDR 83, effective December 16, 2001; 38 SDR 115, effective January 9, 2012; transferred from § 44:04:08:04, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:05.  Control and accountability of medications. A medication brought from a resident's home may be used if ordered by the resident's physician, physician assistant, or nurse practitioner and, if prior to administration, is identified as the prescribed medication. No resident may keep medications on the resident's person or in the resident's room without an order from a physician, physician assistant, or nurse practitioner allowing self-administration. The facility must receive written authorization from the resident's physician, physician assistant, or nurse practitioner before releasing any medication to a resident upon discharge, transfer, or temporary leave from the facility. The release of medication must be documented in the resident'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: 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; 26 SDR 96, effective January 23, 2000; 28 SDR 83, effective December 16, 2001; transferred from § 44:04:08:04.01, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:06.  Documentation of medication disposal. A facility shall ensure that a legend medication not controlled under SDCL chapter 34-20B is destroyed or disposed of by a nurse and another witness. Destruction or disposal of medication 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. The following are authorized methods of destruction or disposal:

    (1)  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 resident upon discharge after authorization by the resident's prescribing practitioner.

    The facility shall document destruction or disposal of medications in the resident's record. The documentation 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 accessible to nursing and pharmacy personnel only. The facility shall establish a system to reconcile, audit, and monitor medication held for disposal to prevent diversion.

    Source: 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; transferred from § 44:04:08:04.02, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:07.  Medication administration. The facility personnel administering medication to a resident shall record the administration in the resident's medical record. Medication errors and drug reactions must be reported to the resident's physician, physician assistant, or nurse practitioner and an entry must be made in the resident'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 all nursing personnel. All medications must be administered to residents by personnel acting under the delegation of a licensed nurse, or personnel licensed to administer medications.

    No personnel may administer a medication prepared by another person unless the medication was prepared by a pharmacist.

    Medication administration must comply with §§ 44:73:08:02 to 44:73:08:05, 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 any unlicensed assistive personnel who will administer medications. The orientation must be specific to the facility and relevant to the residents receiving administered medications.

    Source: SL 1975, ch 16, § 1; 4 SDR 14, effective September 14, 1977; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; 28 SDR 83, effective December 16, 2001; 31 SDR 62, effective November 7, 2004; 38 SDR 115, effective January 9, 2012; transferred from § 44:04:08:05, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:08.  Medication records. A facility shall use medication administration records and regularly check the record against the physician, physician assistant, or nurse practitioner's orders. Each medication administered must be recorded in the resident's medical record and signed by the individual administering the medication.

    Source: 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:09.  Administration of facility pharmacy. A facility with a full or part-time pharmacy shall have its pharmaceutical service directed by a licensed pharmacist accountable to the administration of the facility.

    Only prepackaged or single-dose-unit medications may be removed from the pharmacy when the pharmacist is not available. A medication 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 medication.

    Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; 24 SDR 90, effective January 4, 1998; transferred from § 44:04:08:06, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:10.  Stock of legend drugs prohibited -- Exception. A facility with a full-time or part-time pharmacist may stock medications in bulk form. The pharmacist shall supervise the procurement, storage, and dispensing of medications within the facility. A facility without a pharmacy must use an emergency drug box or a separate locked cabinet kept on the premises pursuant to § 44:73:08:11.

    Source: SL 1975, ch 16, § 1; 6 SDR 93, effective July 1, 1980; 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; transferred from § 44:04:08:07, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:11.  Controlled drugs kept for emergency use. A facility may keep controlled drugs for emergency use under the following circumstances:

    (1)  The pharmacist supplying the controlled drugs maintains ownership and responsibility for the drugs, including a monthly physical inventory;

    (2)  The controlled drugs are stored in a manner that allows only those individuals authorized to administer the drugs access to them;

    (3)  The controlled drugs are stored in a sealed emergency box or in a separate locked cabinet, with a complete and accurate record kept of the drugs in the box or cabinet and of their disposition;

    (4)  The facility notifies the pharmacist within thirty-six hours after the withdrawal of a Schedule II drug and within seventy-two hours after the withdrawal of a Schedule III or IV drug and the pharmacist replaces the drugs within seventy-two hours after notification; and

    (5)  No more than five different controlled drugs are stored in the emergency box or separate locked cabinet. The emergency box or separate locked cabinet may contain no more than six doses of any Schedule II controlled drug, no more than six doses of any Schedule III or IV injectable controlled drug, and no more than twelve doses of any oral Schedule III or IV controlled drug.

    Source: 14 SDR 81, effective December 10, 1987; 22 SDR 70, effective November 19, 1995; transferred from § 44:04:08:07.01, 42 SDR 51, effective October 13, 2015; 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.

    44:73:08:12.  Self-administration of drugs. A resident with the cognitive ability to perform self-administration may self-administer drugs. At least every three months, a registered nurse, or the resident's physician, physician assistant, or nurse practitioner shall determine and record the continued appropriateness of the resident's ability to self-administer medications. The determination must state whether the resident or healthcare personnel is responsible for storage of the medication and contain documentation of its administration in accordance with this chapter.

    Any resident who stores a medication in the resident's room or self-administers a medication must have an order from a physician, physician assistant, or nurse practitioner allowing self-administration.

    If a resident is permitted to self-administer medications, the facility's policies and procedures must be in accordance with this chapter. The facility shall provide written educational material explaining the resident's rights and responsibilities associated with self-administration to the resident and the resident's representative.

    Source: 51 SDR 53, effective November 11, 2024.

    General Authority: SDCL 34-12-13.

    Law Implemented: SDCL 34-12-13.