(a)

1. (1) All medications stored for residents by the facility must be stored in a locked area or a locked medication cart labeled with the resident’s name.
2. (2) Provided, however, that if the resident administers his or her own medication, the resident shall have access to his or her medication.

(b)

1. (1) Medications may be kept in the residents’ apartments or units.

2. (2) Prior to a resident being permitted to keep medications in his or her apartment or unit, the facility shall:

   1. (A) Assess the resident to determine the resident’s understanding of and ability to follow the instructions on the prescription or label, and the understanding of and ability to follow storage requirements or recommendations on the prescription or label, or as made by the pharmacist or facility employees;
   2. (B)

(i) Document the assessment in the resident’s records.

1. (ii) The assessment shall include at a minimum, the:

(b) (b) Name of person performing assessment; and

1. (c) (c) Information obtained by the assessment that indicated the resident’s ability to understand and follow prescription or label directions and instructions;

   1. (C)

      1. (i) Assess all residents to determine whether any resident may be at risk of taking or introducing into their system medications kept in the room of another resident.
      2. (ii) In the event that any resident is found to be at risk due to medications being kept in an unsecured room, the facility shall take actions to protect the resident, including but not limited to:

(b) (b) Requiring the rooms of residents keeping medication in their rooms be locked; and

1. (D)

   1. (i) Residents who have been assessed and are able to manage their own medications may determine which medications they will keep in their rooms to self-administer and which, if any, they will request the facility to store.

      1. (ii) The assessment shall be documented in the residents' occupancy admission agreement.
      2. (iii) After the initial assessment, facilities shall perform reassessments as needed, including upon changes of conditions of residents, and shall perform the steps outlined in subdivisions (b)(2)(A) – (C) of this section.
      3. (iv)

(b) (b) Resulting harm from a failure to assess or reassess, or to identify residents at risk of harm from medications in unsecured locations or rooms shall constitute a deficient facility practice.

1. (c)
2. (1) Medications must be stored in an environment that is clean, dry, and not exposed to extreme temperature ranges.
3. (2) Medications requiring cold storage shall be refrigerated.

4. (3) A locked container placed below food level in a facility’s refrigerator is acceptable storage.

   1. (d) All drugs on the premises of the facility shall be labeled in accordance with accepted professional principles and practices.

(g)

1. (1) Medications must be individually labeled with the resident’s name and kept in the original container unless the resident or responsible party transfers the medication into individual dosage containers.
2. (2) Under no circumstances may an owner or personnel of the facility repackage medication.

(h)

1. (1) Any medication that is stored by the facility that has been prescribed for but is no longer in use by a resident must be destroyed or disposed of in accordance with state law or may be given to the resident’s family in accordance with this section.
2. (2) Any medication stored by the facility that has been placed on hold status by the resident’s physician or advanced practice nurse may be transferred to a locked medication cabinet in a locked office for future use by the resident.

3. (3) Upon physician notice to resume the medication, all current medication labeling must be in accordance with subsection (e) of this section.

   1. (i)
4. (1) Schedule II, III, IV, and V drugs dispensed by prescription for a resident and no longer needed by the resident must be delivered in person or by registered mail to Drug Control Division of the Department of Health, along with the Department of Health’s Form PHA-DC-1, Report of Drugs Surrendered for Disposition According to Law.
5. (2) When unused portions of controlled drugs go with a resident who leaves the facility, the person who assumes responsibility for the resident and the person in charge of the medications for the facility shall sign the controlled drug record in the facility.
6. (3) This shall be done only on the written order of the physician or advanced practice nurse and at the time that the resident is discharged, transferred, or visits home.

(k) Under no circumstance will one (1) resident’s medication that is under the facility’s control be shared with another resident.

1. (l)

2. (1) For all medication that is stored by the facility, the facility must remove from use:

   1. (A) Outdated or expired medication or drugs;
   2. (B) Drug containers with illegible or missing labels; and
   3. (C) Drugs and biologicals discontinued by the physician or advanced practice nurse.

3. (2) All such medications shall be destroyed or returned in accordance with law and applicable rules.

   1. (m)
4. (1) All controlled drugs or substances stored by the facility shall be stored in a locked, permanently affixed, substantially constructed cabinet within a locked room designed for the storage of drugs.

5. (2)

   1. (A)

      1. (i) When mobile medication carts for unit-dose or multiple day card systems are used, the cart must be in a locked room when the cart is not in use and the unit contains controlled drugs.
      2. (ii) When the cart is in use, the facility shall ensure that the cart remains in the observation of staff utilizing the cart and that residents are not able to access the cart or obtain medications from the cart.

   2. (B)

      1. (i) Controlled substances of less than minimal quantity shall be stored in a separately locked compartment within the cart.
      2. (ii) “Minimal quantity” means a twenty-four-hour or less supply.

(n)

1. (1) In all cases in which the facility destroys drugs, destruction shall be made by a nurse and witnessed by a nonlicensed employee.

2. (2) A record shall be made of the:

   1. (A) Date;
   2. (B) Quantity;
   3. (C) Prescription number and name;
   4. (D) Resident’s name; and
   5. (E) Strength of the medication.
3. (3) Destruction shall comply with state laws and rules governing the destruction of drugs.
4. (4) The record of the destruction shall be recorded in a bound ledger, in ink, with consecutively numbered pages, and retained by the facility as a permanent, retrievable record.