Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.95-003 - Reg. 34 & Reg. 9(A)

Current through Register Vol. 49, No. 6, June, 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