070.00.95 Ark. Code R. 003

Current through Register Vol. 49, No. 10, October, 2024

Rule 070.00.95-003 - Reg. 34 & Reg. 9(A)

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.

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

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070.00.95 Ark. Code R. 003

7/14/1995