(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.
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