SECTION 558.862. Management of Drugs and Biologicals and Disposal of Controlled Substance Prescription Drugs in an Inpatient Hospice Unit

(a) The requirements stated in §558.861(a)-(g) of this division (relating to Management of Drugs and Biologicals and Disposal of Controlled Substance Prescription Drugs in a Client's Home or Community Setting) also apply to a hospice that provides inpatient care directly in its own inpatient unit.

(b) A hospice that provides inpatient care directly in its own inpatient unit must provide pharmaceutical services under the direction of a qualified licensed pharmacist who is an employee of or under contract with the hospice. The services provided by the pharmacist must include evaluation of a client's response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.

(c) A hospice that provides inpatient care directly in its own inpatient unit must:

(1) have a written policy in place that promotes dispensing accuracy; and

(2) maintain current and accurate records of the receipt and disposition of all controlled drugs.

(d) Clients receiving care in a hospice inpatient unit may only be administered medications by the following persons:

(1) a licensed nurse, physician, or other health care professional in accordance with their scope of practice and State law;

(2) a home health medication aide; or

(3) a client, upon approval by the interdisciplinary team.

(e) A hospice that provides inpatient care directly in its own inpatient unit must comply with the following additional requirements.

(1) All drugs and biologicals must be stored in secure areas. All controlled drugs listed in Schedules II, III, IV, and V, established under 21 United States Code §812, must be stored in locked compartments within such secure storage areas. Only personnel authorized to administer controlled drugs as noted in subsection (i) of this section may have access to the locked compartments.

(2) Discrepancies in the acquisition, storage, dispensing, administration, disposal, or return of controlled drugs must be investigated immediately by the pharmacist and hospice administrator and reported, without limitation, to the United States Department of Justice, Drug Enforcement Administration, Diversion Control Division. A hospice must maintain a written account of its investigation and make it available to State and federal officials if requested.

(f) A hospice that provides inpatient care directly in its own inpatient unit must dispose of controlled drugs in compliance with the hospice's policy and in accordance with State and federal requirements, including Texas Health and Safety Code Chapter 481. The hospice must maintain current and accurate records of the receipt and disposition of all controlled drugs.

Source Note: The provisions of this §558.862 adopted to be effective April 25, 2021, 46 TexReg 2427