All drug records shall be maintained for a period of three years pursuant to section 4729.37 of the Revised Code. All drug records must be readily retrievable within three working days, excluding holidays and weekends, of all drug transactions within the previous three years. Electronic drug record keeping systems, computerized record keeping systems, or subsequent storage of such records, must be readily retrievable via digital display, hard copy printout, or other mutually agreeable transfer medium. If an electronic drug record keeping system is being utilized as defined in paragraph (H) of rule 4729-17-01 of the Administrative Code the method(s) of achieving positive identification must be approved by the state board of pharmacy prior to implementation pursuant to paragraph (I) of rule 4729-17-01 of the Administrative Code. The responsible person shall be responsible for maintaining the following records:
(A) A record of all drugs purchased, the quantity received, and the name, address, and wholesale distributor registration number of the person from whom the drugs were purchased.
(B) All drug orders and records relating to the practice of pharmacy.
(1) Records of drugs dispensed shall include, but are not limited to:
(a) The name, strength, and quantity of drugs dispensed;
(b) The date of dispensing;
(c) The name of the inpatient to whom, or for whose use, the drug was dispensed; and
(d) Positive identification of all pharmacists involved in the dispensing.
(2) All other records relating to the practice of pharmacy other than dispensing shall include, but are not limited to:
(a) The name of the inpatient to whom, or for whose benefit, the activity was performed;
(b) The practice of pharmacy activity performed;
(c) The results of the activity, if applicable; and
(d) Positive identification of all pharmacists involved in the activity, identifying the function performed by each pharmacist.
(C) A record of all drugs compounded or repackaged for use only within the institution, which shall include at least the following:
(1) Name of drug, strength, quantity, and dosage form;
(2) Manufacturer's or distributor's control number;
(3) Manufacturer's or distributor's name, if a generic drug is used;
(4) Pharmacy control number;
(5) Manufacturer's or distributor's expiration date;
(6) The pharmacy's expiration date or beyond-use date;
(7) Positive identification of the pharmacist responsible for the compounding or repackaging of the drug.
(D) A record of the distribution of dangerous drugs to other areas of the institution for administration or use as described in paragraph (B) of rule 4729-17-03 of the Administrative Code, which shall include at least the following:
(1) The name, strength, dosage form, and amount of drug distributed;
(2) The area receiving the drug;
(3) The date distributed;
(4) Positive identification of the individual receiving the drug if it is a controlled substance;
(5) The area of the institution receiving the dangerous drug shall make a record of all such drugs administered to patients. Such records shall include at least the following:
(a) Name of the patient;
(b) Name, dosage form, and strength when applicable of the drug;
(c) Date and time the drug was administered;
(d) Quantity administered;
(e) Positive identification of the personnel administering the drug.
(E) A log that must be maintained of all changes made to a drug record in an electronic drug record keeping system or a computerized record keeping system after a drug transaction has been made. Such log may be accessible for review, but shall be protected from being altered in any way. The log must contain at least, but is not limited, to the following:
(1) Date and time of change;
(2) Changes made;
(3) Person making the change.
Five Year Review (FYR) Dates: 01/21/2016 and 09/01/2021
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.09, 4729.28, 4729.51
Prior Effective Dates: 9/1/85, 7/1/91, 1/10/96, 2/1/98, 3/1/99, 1/1/06, 1/1/09