On February 10, 2021, the Indiana Department of Health (IDH) published a Proposed Rule (LSA Document #20-603) to reduce the amount of time unused portions of medications must be rendered non-retrievable from seven (7) to three (3) days.
The Proposed Rule is effective 30 days from its publication and applies to both comprehensive care facilities (nursing facilities) and residential care facilities (licensed assisted living communities). We encourage nursing facilities and licensed assisted living communities to communicate with their pharmacy partner as soon as possible to ensure compliance with this rule.
More specifically, the Proposed Rule amends 410 IAC 16.2-3.1-25 and 410 IAC 16.2-5-6 to state that when unused portions of medications are not released with the resident or are returned for credit, the unused portions must be rendered non-retrievable within three (3) days by the consultant pharmacy or a licensed nurse and a witness. Further details of the Proposed Rule are as follows:
- Rendered Non-Retrievable: The Proposed Rule defines “rendered non-retrievable” as “chemically unusable, to such an extent that the medication cannot be recovered or used in the chemically transformed form.” The medication must then be “disposed of pursuant to federal, state, or local law, or it must be stored in a locked, authorized storage container within the facility.”
- Authorized Storage Container: The Proposed Rule specifies that an “authorized storage container” must contain a locked, hard outer layer securely attached to a permanent structure of the building and a removable inner liner. The container shall also adhere to the following:
- An inner liner shall meet the following requirements:
- The inner liner shall be waterproof, tamper evident, and tear-resistant.
- The inner liner shall be removable and sealable immediately upon removal without emptying or touching the contents.
- The contents of the inner liner shall not be viewable from the outside when sealed.
- The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon).
- The inner liner shall bear a permanent, unique identification number that enables the inner liner to be tracked.
- Access to the inner liner shall be restricted to the consultant pharmacist or a licensed nurse of the facility.
- The inner liner shall be sealed by the consultant pharmacist or a licensed nurse, and a witness, immediately upon removal from the permanent outer container, and the sealed inner liner shall not be opened, x-rayed, analyzed, or otherwise penetrated.
- At the time of removal, the contents of the inner liner must be destroyed in the sealed inner liner, returned via a mail-back program, or returned to the original distributor’s registered location by common or contract carrier pick-up.
The Proposed Rule also amends 410 IAC 16.2-5-6 to require residential care facilities to record any released, returned, or destroyed medication in the resident’s clinical record. This requirement is already a part of the administrative code for comprehensive care facilities. The record shall include the following information:
- The name of the resident.
- The name and strength of the drug.
- The prescription number.
- The reason for disposal.
- The amount disposed of.
- The method of disposition.
- The date of disposal.
- The signatures of the persons conducting the disposal of the drug.