0295 Pharmaceutical Services – Noncompliance
410 IAC 16.2-5-6(a)
(a) Residents who self-medicate may keep and use prescription and nonprescription
medications in their unit as long as they keep them secured from other residents.
0296 PharmaceuticalServices –
Noncompliance 410 IAC 16.2-5-6(b)
(b) The facility shall maintain clear written policies and procedures on medication
assistance. The facility shall provide for ongoing training to ensure competence of
0297 Pharmaceutical Services – Noncompliance
410 IAC 16.2-5-6(c)(1)
(c) If the facility controls, handles, and administers medications for a resident, the
the facility shall do the following for that resident:
(1) Make arrangements to ensure that pharmaceutical services are available to
provide residents with prescribed medications in accordance with applicable laws of
0298 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(c)(2)
(2) A consultant pharmacist shall be employed, or under contract, and shall:
(A) be responsible for the duties as specified in 856 IAC 1-7;
(B) review the drug handling and storage practices in the facility;
(C) provide consultation on methods and procedures of ordering, storing,
administering, and disposing of drugs as well as medication record keeping;
(D) report, in writing, to the administrator or his or her designee any irregularities in
dispensing or administration of drugs; and
(E) review the drug regimen of each resident receiving these services at least once
every sixty (60) days.
0299 Pharmaceutical Services – Noncompliance
410 IAC 16.2-5-6(c)(3)
(3) The medication review, recommendations, and notification of the physician, if
necessary, shall be documented in accordance with the facility ‘ s policy.
0300 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(c)(4)
(4) Over-the-counter medications, prescription drugs, and biologicals used in the
facility must be labeled in accordance with currently accepted professional principles
and include the appropriate accessory and cautionary instructions and the expiration
0301 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(c)(5)
(5) Labeling of prescription drugs shall include the following:
(A) Resident ‘ s full name.
(B) Physician ‘ s name.
(C) Prescription number.
(D) Name and strength of the drug.
(E) Directions for use.
(F) Date of issue and expiration date (when applicable).
(G) Name and address of the pharmacy that filled the prescription.
If medication is packaged in a unit dose, reasonable variations that comply with the
acceptable pharmaceutical procedures are permitted.
0302 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(c)(6)
(6) Over-the-counter medications must be identified with the following:
(A) Resident name.
(B) Physician name.
(C) Expiration date.
(D) Name of drug.
0303 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(d) (
d) If a facility operates its own duly licensed pharmacy, it shall comply with IC
0304 Pharmaceutical Services – Deficiency
410 IAC 16.2-5-6(e)
(e) Medicine or treatment cabinets or rooms shall be appropriately locked at all times
except when authorized personnel are present. All Schedule II drugs administered by
the facility shall be kept in individual containers under double lock and stored in a
substantially constructed box, cabinet, or mobile drug storage unit.
0305 PharmaceuticalServices -Noncompliance
(f) Residents may use the pharmacy of their choice for medications administered by
the facility, as long as the pharmacy:
(1) complies with the facility policy receiving, packaging, and labeling of
pharmaceutical products unless contrary to state and federal laws;
(2) provides prescribed service on a prompt and timely basis; and
(3) refills prescription drugs when needed, in order to prevent interruption of drug
0306 Pharmaceutical Services -Noncompliance
410 IAC 16.2-5-6(g)(1-9)
(g) Medications administered by the facility shall be disposed of in compliance with
appropriate federal, state, and local laws, and disposition of any released, returned, or
destroyed medication shall be documented in the resident’s clinical record and shall
include the following information:
(1) The name of the resident.
(2) The name and strength of the drug.
(3) The prescription number.
(4) The reason for disposal.
(5) The amount disposed of.
(6) The method of disposition.
(7) The date of the disposal.
(8) The signature of the person conducting the disposal of the drug.
(9) The signature of a witness, if any, to the disposal of the drug.