Current through Register Vol. 49, No. 9, September, 2024
34.
REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD
KEEPING SYSTEMS IN HOSPITAL PHARMACIES HOLDING HOSPITAL PHARMACY PERMITS.
In accordance with the Drug Enforcement Administration's final
ruling June 30, 1977, which allows a pharmacy to use a data processing system
as an additional manner of storing and retrieving prescription refill
information for Schedule III and IV controlled substances, the following
proposed regulation is submitted to regulate the use of Electric Data
Processing (EDP) systems for holders of Hospital Pharmaceutical Services
Permits in the State of Arkansas.
A.
These regulations shall be construed, if possible, so as not to be violative of
or in conflict with any federal regulation or requirement. If any part hereof
is held invalid because of such conflict, such invalidity shall not affect
other provisions or applications of these regulations which can be given effect
without the invalid provisions of these regulations are declared
severable.
B. The Arkansas State
Board of Pharmacy must approve system prior to implementation.
C. Input of drug information into system may
be performed by a pharmacist or supportive personnel. The final verification of
prescription information, into the computer shall be made by the supervising
pharmacist who is then totally responsible for all aspects of the data and data
entry.
D. Any Electronic Data
Processing System must be capable of furnishing the following information:
1. Patient Medication Profile (accessible
electronically on line or by hard copy.) INTERPRETATION: The Patient Medication
Profile is the basic document used by the Hospital Pharmacist to monitor a
patient's medication regimen, drug compliance, drug interactions, allergies and
drug usage.
a. The Patient Medication Profile
must contain as a minimum the following: Patient name, patient identification
number, practitioner's name, drug name, drug strength and dosage form, number
of doses issued, initials, name or identification number of pharmacist
approving original order into the system, and date original order was entered
into the system.
b. The Final
Patient Medication Profile must be maintained by the pharmacy for a period of
two years in hard copy or- on electronic media.
E.
1.
Patient Daily Medication Printout (hard copy printed daily is required).
INTERPRETATION: The Patient Daily Medication Printout is a
supporting document to the Patient Medication Profile. It is printed on a daily
basis and may be used to fill patient medication orders for transport to the
patient care area and may serve as a daily log of all medication issued on any
given day.
a. The Patient Daily
Medication Printout (daily hard copy) must contain as a minimum the following:
date of record, patient name, patient identification number, drug name, drug
strength and dosage form and number of doses issued on that day.
b. The following additional information must
appear on the Patient Daily Medication Printout if it is not shown on the
Patient Medication Profile described in D.1 above; initials of the Pharmacist
who checked and verified the doses issued on the Patient Daily Medication
Printout.
INTERPRETATION: Since the Patient Medication Printout is a
supporting document to the Patient Medication Profile, some information such as
practitioner's name, initials, name or identification number of pharmacist
entering the original order into the system and the date of the original order
may or may not be duplicated because the information is readily retrievable
from the base document.
c.
The Patient Daily Medication Printout or daily log must be signed by all
pharmacists filling orders, and may be replaced by a monthly log containing
same information. This information must be maintained at the Pharmacy for a
period of two years. INTERPRETATION: The Patient Daily Medication Printout
provides a daily refill-by-refill audit trail on all drugs issued and
supplements the base document, the Patient Medication Profile.
2. Assure strict confidentiality
of all patient records.
3. Must be
capable of receiving a hard copy printout of all the above mentioned reports
within 48 hours.
F.
Hospital pharmacies who make arrangements with outside suppliers of data
processing services or materials must assure themselves of continuing adequate
and complete drug information data and issuing records. If for any reason the
relationship with said supplier terminates, the pharmacy shall assure the
continuity of records.
G. In the
event of computer breakdown (down time), the pharmacy must have an auxiliary
record keeping system. The backup system must contain all necessary information
to insure prompt data entry into the system as soon as computer is again
available.
H. Registrants holding a
Hospital Pharmaceutical Service Unit Permit who fill outpatient prescriptions
and who wish to utilize Electric Data Processing Equipment as a record keeping
system must then comply with all the requirements of the Arkansas State Board
of Pharmacy Regulation Number 33.
I. The electronic data processing systems
described in this regulation are acceptable as the disposition records for all
drugs, except that the actual signed disposition (proof of use) records for
Schedule II Controlled Substances must be retained separate from other records
for a period of two years. 10/09/80
