44:80:07:01.  Policies and procedures. Each facility shall establish and practice methods and procedures for medication control that include the following:

 

          (1)  A requirement that each resident's Medicare certified hospice agency provide instructions for the administration of medication, the recording of medication administration by facility staff, medications or drugs kept on the person or in the room of the resident; and release of medications;

 

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

 

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

               (b)  A medication prescribed for one resident not to be administered to any other resident;

 

          (3)  The facility shall have policies and procedures for the self-administration of medications. Self-administration to be accomplished with the supervision of a designated employee and approval of the resident's Medicare certified hospice agency;

 

          (4)  The return of medicines to the residents Medicare certified hospice agency that are discontinued because of the discharge or death of the resident, because the drug is outdated, or because the prescription is no longer appropriate to the care of the resident.

 

          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.

 

          The facility shall use records to ensure the receipt and disposition for all controlled drugs in sufficient detail to enable an accurate reconciliation. The facility, with the assistance of the Medicare certified hospice agency, shall ensure the drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. The facility shall have policies and procedure for the periodic reconciliation of all controlled substances. The policies and procedure shall 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 shall notify the Medicare certified hospice agency to evaluate the residents potentially affected. If the systems have not been effective in preventing the loss or diversion of controlled substances, the facility shall review and revise related controls and procedures as necessary.

 

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

          General Authority: SDCL 34-12-13.

          Law Implemented: SDCL 34-12-13.

 

          44:80:07:02.  Orders for medication required. All orders for medications or drugs administered to residents shall be the responsibility of resident's Medicare certified hospice agency.

 

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

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

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

 

          44:80:07:03.  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 residents 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 (two and eight degrees centigrade). Poisons and medications prescribed for external use shall be stored separately from internal medications, locked and made inaccessible to residents.

 

          The medications or drugs of each resident for whom medications are administered shall be stored in the containers in which they were originally received and may not be transferred to another container unless otherwise allowed by this section. A nurse may move mediations into a medication reminder box or similar device. Special modification of this requirement may be made if single dose packaging is used. The facility that administers and stores medications shall ensure each prescription drug container, including manufacturer's complimentary samples, shall be labeled with the resident’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.

 

          A facility may not procure or stock, including in bulk form any legend or nonlegend medications.

 

          Any container with a worn, illegible, or missing label shall be destroyed. 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).

 

          44:80:07:04.  Control and accountability of medications and drugs. Medications brought from home may be used once approved by the Medicare certified hospice agency and ordered by the residents attending physician and, if prior to administration, is identified as the prescribed drug. Medications prescribed for one resident may not be administered to another. Residents may not keep medications on their person or in their room without approval from the resident's Medicare certified hospice agency allowing self-administration. Written authorization by the resident's physician shall be secured for the release of any medication to a resident upon discharge, transfer, or temporary leave from the facility. The release of medication shall be documented in the resident's medical or care record provided by the Medicare certified hospice agency, indicating quantity, drug name, and strength. The facility shall maintain records provided by the Medicare certified hospice agency that account for all medications and drugs from their receipt through administration or destruction.

 

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

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

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

 

          44:80:07:05.  Documentation of drug disposal. Legend drugs not controlled under SDCL chapter 34-20B shall be destroyed or disposed of by the Medicare certified hospice agency 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 resident upon discharge after authorization by the resident's prescribing practitioner.

 

          Medications controlled under SDCL chapter 34-20B shall not be returned to the dispensing pharmacy or to an authorized reverse distributor company. Documentation of destruction or disposal of medications shall be included in the resident's record. The documentation shall include the method of disposition; the medication name, strength, prescription number, 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 re-dispensing.

 

          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).

 

          44:80:07:06.  Medication administration.    Each medication administered by facility staff shall be recorded in the resident's medical record and signed by the person responsible. Medication errors and drug reactions shall be reported to the resident's Medicare certified hospice provider and an entry made in the resident’s medical record. Abbreviations and chemical symbols may be carried out only if the facility has a standard list of abbreviations and symbols provided by the Medicare certified hospice agency. All medications shall be administered to residents by personnel acting under delegation of a licensed nurse, or individual 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 §§ 44:80:08:02 to 44:80:08:05, 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. A 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 residents receiving administered medications. A registered nurse shall provide medication administration training annually pursuant to § 20:48:04:01 to any unlicensed assistive personnel employed by the facility who will be administering medications.

 

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

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

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

 

          44:80:07:07.  Medication records. Medication administration records provided by the Medicare certified hospice agency shall be used and regularly checked by the Medicare certified hospice agency.

 

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

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

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