Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.97-002 - Regulation 33 & 34 - Regulating the use of electronic data processing in lieu of present record keeping systems in Pharmacies holding Pharmacy permits and Hospital Pharmacies holding Hospital Pharmacy permits, respectively

Current through Register Vol. 49, No. 6, June, 2024
33.
		  REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD
		  KEEPING SYSTEMS IN PHARMACIES HOLDING PHARMACY PERMITS
A. These regulations shall be construed, if
		  possible, so as not to be violative of or in conflict with any federal
		  regulation or requirement and 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
		  and to this end, the provisions of these regulations are declared severable. In
		  any event D.E.A. permission to use Electronic Data Processing record keeping
		  systems must be obtained.
B. The
		  Arkansas State Board of Pharmacy must approve system prior to
		  implementation.
C. Input of drug
		  information into system may be performed only by a pharmacist or pharmacy
		  technician under the supervision of a pharmacist. 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. Any judgmental decision concerning patient utilization of drugs must be
		  performed by a pharmacist.
D. The
		  original prescription order must be numbered, dated, initialed or signed by
		  dispensing pharmacist at the time of the first filling of the prescription
		  order and filed according to regulation.
E. Any electronic data processing system must
		  be capable of the following:
1. Must provide
		  on-line retrieval (CRT or hard copy) of original prescription order
		  information. This shall include, but not be limited to, the following:
a. Original prescription order number, date
		  filled; full name and address of patient; name, address and DEA number (if
		  applicable) of practitioner.
b.
		  Trade name (or generic name and manufacturer's name), strength, dosage form and
		  quantity of drug dispensed.
c.
		  Number of authorized refills or, if not refillable, it must be so
		  indicated.
2. Must
		  provide on-line retrieval (CRT or hard copy) of refill history of each
		  prescription order to include in addition to information in parts a and b,
		  subsection
		  1
		  above, but not limited to the following:
a.
		  Initials or code designation of dispensing pharmacist for each
		  refill.
b. Date refilled.
c. Number of authorized refills
		  remaining.
3.
A. Must provide daily hard copy printout of
		  each day's prescription order activity to include but not limited to the
		  following:
a. Date of record.
b. Prescription order number, patient's name,
		  name of drug, quantity dispensed and dosage form of drug, practitioner's name
		  and DEA number (if applicable), and dispensing pharmacist's designation or
		  initials on each prescription.
c.
		  Above record shall be verified and signed by each pharmacist each day who has
		  filled or refilled one or more prescriptions.
The signature should appear at the end of the printout and it
			 signifies that the pharmacist has reviewed the printout and accepts the
			 responsibility for any prescription with his or her designation or initials on
			 it.
d. Daily log may be
		  replaced by monthly log containing same information. This information must be
		  maintained at pharmacy for a period of two years.
e. Any pharmacy employing a computerized
		  system must have above printout in its possession in 48 hours.
f. Any electronic data processing system must
		  also assure strict confidentiality of patient records.
g. All required information must be entered
		  on the records of all prescription orders filled at the pharmacy including
		  nonrefillable prescriptions.
h.
		  Must be capable of producing a patient profile (CRT or hard copy) indicating
		  all drugs being taken and dates of refills for the patient.
i. A pharmacy shall make arrangements with
		  supplier of data processing services or materials to assure continuing adequate
		  and complete prescription orders and dispensing records. If for any reason the
		  relationship with said supplier terminates, the pharmacy shall assure the
		  continuity of records.
j.
		  Registrants holding a Hospital Pharmaceutical Services Permit shall comply with
		  Regulation No. 34 "Regulating the use of electronic data processing in lieu of
		  present record keeping systems in Hospital Pharmacies holding Hospital Pharmacy
		  Permits."
B. In lieu of
		  signing a daily hard copy printout, the pharmacist in charge of the pharmacy
		  may maintain a bound log book in which an individual pharmacist involved in
		  such dispensing may sign a statement each day, attesting to the fact that the
		  prescription information entered into the computer that clay has been reviewed
		  by him and is correct as shown- The log should identify the time of day at
		  which the pharmacist started filling prescriptions and the time of day at which
		  the pharmacist stopped filling prescriptions. Said log book shall he
		  maintained, by the pharmacist in charge or his successor, in the pharmacy
		  employing such a system for a period of two years after the date of dispensing
		  the appropriately authorized prescription. The pharmacy must still provide a
		  daily hard copy printout of each day's prescription order activity as described
		  in 33. E. 3.
(A) above.
4. Must be capable of providing a
		  refill-by-re fill audit trail for any specific strength and dosage form of any
		  drug in the system to contain but not limited to the following:
a. Practitioner's name.
b. Name and address of patient.
c. Name of drug (must include manufacturer's
		  name if generic name used).
d.
		  Quantity dispensed on original and each refill.
e. Prescription order number.
f. Initials or code designation of dispensing
		  pharmacist on original and each refill.
g. Date of original and each
		  refill.
h. Above printout must be
		  made available within 48 hours after authorized request.
5. If the pharmacy closes, the pharmacist in
		  charge, at the date of closing, shall store said records and within 14 days of
		  closing shall notify the Board of Pharmacy where said records are located. A
		  hard copy printout of any daily log(s) shall be produced and made available to
		  the Board on its request and to any other person authorized by law to examine
		  or receive copies of prescription records.
6. In event of computer breakdown (down
		  time), the pharmacy must have an approved auxiliary record keeping system. This
		  system must contain all necessary information to insure prompt data entry into
		  system as soon as computer is available. 10/09/80