Lawriter - OAC - 4729-17-11 Hospital self-service employee prescription kiosks.

4729-17-11 Hospital self-service employee prescription kiosks.

(A) As used in this rule:

(1) "Business day" means any day that is not a Saturday or a Sunday and not a day on which governmental offices of the state of Ohio or banks in the state of Ohio are required or permitted to be closed.

(2) Hazardous drug means any dangerous drug identified by at least one of the following criteria:

(a) Carcinogenicity, teratogenicity, or developmental toxicity;

(b) Reproductive toxicity in humans;

(c) Organ toxicity at low dose in humans or animals; or

(d) Genotoxicity or new drugs that mimic existing hazardous drugs in structure or toxicity.

(3) "Self-service employee prescription kiosk" or "kiosk" means a self-service kiosk for the pickup of new or refill prescriptions only for hospital employees and their family members.

(B) A self-service employee prescription kiosk shall meet all the security requirements of this rule and be located either:

(1) On the campus of a hospital licensed as a terminal distributor of dangerous drugs and located in the immediate proximity of a pharmacy, unless otherwise approved by an agent of the board; or

(2) At a location that is licensed as a terminal distributor of dangerous drugs that not located on the campus of a hospital but is owned by the hospital.

(C) Only a dangerous drug prescription dispensed by a hospital-owned pharmacy may be provided to the patient or employee representative of the patient via a self-service kiosk. A kiosk shall not provide any of the following:

(1) Any drug that must be refrigerated; or

(2) Any hazardous drug, except for conventionally manufactured hazardous drugs that are tablets or capsules that do not require any further manipulation other than counting or repackaging.

(D) A kiosk located in accordance with paragraph (B)(2) of this rule shall be placed in an area that is restricted to hospital employees and is secured by both a physical barrier with suitable locks and an electronic barrier to detect unauthorized entry.

(E) All kiosks shall be continuously monitored by one or more video cameras that possess the capability of having its picture recorded. The video camera(s) shall provide one hundred per cent video coverage of the kiosk. Camera recordings shall be maintained for at least ninety days and shall made available within three business days of a request by an agent of the state board of pharmacy. The kiosk location must have adequate lighting to produce clear digitally recorded and still picture production.

(F) A kiosk shall only be stocked by a hospital employed pharmacist, pharmacy intern, certified pharmacy technician, registered pharmacy technician or qualified pharmacy technician.

(G) A dispensing pharmacy described in paragraph (C) of this rule shall maintain an appropriate recordkeeping system that will provide accountability for proper receipt of all prescriptions provided to a patient or employee representative of the patient via a self-service kiosk.

(H) A kiosk shall employ a method of two-factor authentication to identify a patient or employee representative of the patient such that a finished prescription is delivered from a kiosk only to its intended recipient.

(I) A kiosk must prominently display notification that patient counseling is available pursuant to agency 4729 of the Administrative Code. Counseling may be provided by a pharmacist reachable at a toll-free telephone number who has access to the patient profile. Instructions on how to contact a pharmacist via toll-free telephone must be displayed by the kiosk and must also be printed on the customer receipt or included with the patient instructions.

(J) A self-service employee prescription kiosk shall meet all of the following:

(1) Is electronically protected against unauthorized access;

(2) Be bolted to the floor or installed in a wall;

(3) Be constructed in such manner as to prevent tampering, break-in and theft of inventory; and

(4) Is able to either:

(a) Sound an alarm if a break-in is attempted; or

(b) Transmit a notification to on-site security if a break-in is attempted.

(K) Prior to the deployment of a kiosk, the responsible person at the location licensed as a terminal distributor of dangerous drugs shall test the kiosk to ensure that it releases drugs properly. The responsible person shall monitor performance of the kiosk on an ongoing basis and test the kiosk for accuracy whenever any change or upgrade is made.

(L) All drugs and devices in a kiosk shall be maintained in a clean and orderly condition. Kiosks shall be maintained at temperatures which will ensure the integrity of the drugs as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(M) Dangerous drugs stored in a kiosk that are not picked up by a patient may be returned to stock shelves in accordance with rule 4729-9-04 of the Administrative Code.

(N) Prior to the operation of a kiosk, the board shall receive a request for approval from the responsible person on the terminal distributor of dangerous drugs license. Upon notification, the board shall conduct an inspection of the area where the kiosk shall be located and review system specifications to determine if it meets the requirements of this rule.

(O) If an inspection does not result in the approval of a kiosk, the responsible person named on the terminal distributor of dangerous drugs license may request an in-person meeting with the board to appeal the denial.

Effective: 6/1/2018
Five Year Review (FYR) Dates: 06/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.54