4729-17-05. Controlled substance recordkeeping

(A) All controlled substances dispensed to inpatients in an institutional facility in quantities exceeding a seventy-two-hour supply shall be dispensed and maintained according to the following requirements:

(1) All controlled substances dispensed in quantities exceeding a seventy-two-hour supply shall be packaged in tamper-evident, unit-of-use containers except multidose liquids and injectables where unit-of-use packaging is not available;

(2) The drugs shall be stored in a secure location with access limited to authorized individuals;

(3) A proof-of-use sheet or other board-approved recordkeeping system shall be maintained for each drug and shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity obtained,

(d) The positive identification of the person doing the administration, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(4) At every change of shift, a reconciliation must be conducted by both the leaving and arriving licensed health care professional responsible for the security of these drugs in the area in which they are stored and must include at least the following:

(a) A physical count and reconciliation of the controlled substances and proof-of-use sheets, if applicable, to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified.

(B) All controlled substances maintained as stock in areas outside of the pharmacy pursuant to paragraph (B) of rule 4729-17-03 of the Administrative Code shall meet the following requirements, unless they are stored in a secure, automated storage system that meets the requirements of paragraph (C) of this rule:

(1) The drugs shall be stored in a secure location with access limited to authorized individuals;

(2) A proof-of-use sheet or other board approved recordkeeping system shall be maintained for each drug and shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity obtained,

(d) The positive identification of the person doing the administration, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(3) At every change of shift, a reconciliation must be conducted by both the leaving and arriving licensed health care professional responsible for the security of these drugs in the area in which they are stored and must include at least the following:

(a) A physical count and reconciliation of the controlled substances and proof-of-use sheets, if applicable, to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified;

(4) All controlled substances shall be packaged in tamper-evident containers except multidose liquids and injectables where unit-of-use packaging is not available.

(C) All controlled substances maintained as stock in areas outside of the pharmacy pursuant to paragraph (B) of rule 4729-17-03 of the Administrative Code that are stored in a secure, automated storage system shall be handled as in paragraph (B) of this rule unless the automated storage system meets all of the following requirements:

(1) The drugs shall be stored in a secure location with access limited to authorized individuals;

(2) The system shall document the positive identification of every person accessing the system and shall record the date and time of access;

(3) A recordkeeping system shall be maintained that shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity removed,

(d) The positive identification of the person removing the drug, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(4) Periodically, the responsible person shall cause a reconciliation of the automated storage system to be conducted which must include at least the following:

(a) A physical count and reconciliation of the controlled substances to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified;

(5) Access to all controlled substances stored in the automated storage system shall be limited to one drug and strength at a time;

(6) All controlled substances stored in the automated storage system shall be packaged in tamper-evident containers, unless the system only allows access to one dose at a time.

Five Year Review (FYR) Dates: 01/21/2016 and 12/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.07, 4729.37, 4729.55
Prior Effective Dates: 2/1/98, 3/1/99, 1/1/11

Prior History: (Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.07, 4729.37, 4729.55
Prior Effective Dates: 2/1/98, 3/1/99 )