Section 410 IAC 16.2-5-6 - Pharmaceutical servicesAuthority: IC 16-28-1-7
Affected: IC 16-28-5-1; IC 25-26-13
Sec. 6.
(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.(b) The facility shall maintain clear written policies and procedures on medication assistance. The facility shall provide for ongoing training to ensure competence of medication staff.(c) If the facility controls, handles, and administers medications for a resident, 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 Indiana.(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 (expired);(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 the administrator's 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.(3) The medication review, recommendations, and notification of the physician, if necessary, shall be documented in accordance with the facility's policy.(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 date.(5) Labeling of prescription drugs shall include the following:(A) Resident's full name.(D) Name and strength of the drug.(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.
(6) Over-the-counter medications must be identified with the following: (d) If a facility operates its own duly licensed pharmacy, it shall comply with IC 25-26-13.(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.(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 regimens.(g) Unused portions of medications not released with the resident or returned for credit shall be rendered nonretrievable within three (3) days by the consultant pharmacist or licensed nurse, and a witness.(h) To be rendered nonretrievable, a medication must be rendered chemically unusable, to such an extent that the medication cannot be recovered or used in the chemically transformed form, and disposed of pursuant to federal, state, or local law, or it must be stored in a locked, authorized storage container within the facility.(i) 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 and shall include the following requirements: (1) An inner liner shall meet the following requirements:(A) The inner liner shall be waterproof, tamper evident, and tear-resistant.(B) The inner liner shall be removable and sealable immediately upon removal without emptying or touching the contents.(C) The contents of the inner liner shall not be viewable from the outside when sealed.(D) The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon).(E) The inner liner shall bear a permanent, unique identification number that enables the inner liner to be tracked.(2) Access to the inner liner shall be restricted to the consultant pharmacist or a licensed nurse of the facility.(3) 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.(4) 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.(j) Disposition of any released, returned, or destroyed medication shall be written 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 disposal.(8) The signatures of the persons conducting the disposal of the drug.(k) For purposes of IC 16-28-5-1, a breach of:(1) subsection (c)(2), (c)(4), (c)(5), (c)(6), (d), or (e) is a deficiency; and(2) subsection (a), (b), (c)(1), (c)(3), (f), or (g) is a noncompliance.Indiana State Department of Health; 410 IAC 16.2-5-6; filed May 2, 1984, 2:50 p.m.: 7 IR 1498; filed Jan 10, 1997, 4:00 p.m.: 20 IR 1579, eff Apr 1, 1997; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; filed Jan 21, 2003, 8:34 a.m.: 26 IR 1932, eff Mar 1, 2003; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFAReadopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFAFiled 4/19/2021, 10:25 a.m.: 20210512-IR-410200603FRA