D.C. Mun. Regs. tit. 22, r. 22-B1914

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1914 - COMPUTERIZED RECORDKEEPING

1914.1

A pharmacy may use an automated data processing system to meet the recordkeeping requirements under § 1913 of this Title if the system meets the requirements of this section.

1914.2

The automated data processing system shall have:

(a) Adequate security and systems safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. A pharmacy shall document any alterations in the prescription drug order, occurring after the prescription has been dispensed, and identify the pharmacist responsible for the alteration;

(b) The capability of producing:

(1) Readable required documentation and information on all original and refilled prescriptions through on-line retrieval, or, from the cathode ray tube (CRT), microfiche, microfilm, printout, or other method acceptable to the Board of Pharmacy; and

(2) A refill-by-refill audit trail for any specified strength and dosage form of any drug. The audit trail shall be by printout, and include the name of the prescribing practitioner, name and location of the patient, quantity dispensed on each refill, dispensing date of each refill, name or identification code of the pharmacist performing the final verification, and unique identifier of the prescription drug order.

(c) The capability to print all information entered into the system on paper within three (3) business days; and

(d) Adequate safeguards to ensure security and confidentiality of patient records pursuant to the applicable federal and District of Columbia laws and regulations.

1914.3

A pharmacist shall be responsible for the completeness and accuracy of the information he or she enters into the automated data processing system.

1914.4

All entries made into the automated data processing system shall include the initials or identification code of the dispensing pharmacist responsible for the transaction giving rise to the entry.

1914.5

The pharmacist-in-charge shall maintain a record keeping system in which each pharmacist involved in dispensing shall sign a statement each day attesting to the fact that the prescription information entered into the computer that day has been reviewed and is correct as shown. The log book or file shall be maintained at the pharmacy for a period of five (5) years from the date of dispensing. Records which are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request.

1914.6

Any facility maintaining centralized prescription records shall be capable of sending a requested printout to the Pharmacy within seventy-two (72) hours.

1914.7

The pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist, as applicable, shall develop and implement a policy and procedure manual for the operational aspects of the automated data processing system which shall:

(a) Identify the required output documentation stored and provided by the system;

(b) Identify the procedures for when the system is not operational;

(c) Outline the regular and routine backup file and file maintenance procedures;

(d) Outline the audit procedures;

(e) Identify personnel responsibilities; and

(f) Provide a quality assurance mechanism for data entry validation.

1914.8

A pharmacy shall maintain sufficient patient data and prescription drug order data, in hard copy format, to permit reconstruction of the data and proper dispensing of prescription orders, within two (2) hours of an unscheduled system interruption or malfunction of the automated data processing system.

1914.9

A pharmacy shall have an auxiliary system or procedures in place to ensure that all refills are authorized and that the maximum number of refills is not exceeded, if the automated data processing system is inoperative for any reason. In the event the actual number of remaining authorized refills cannot be determined and the pharmacist is unable to contact the prescribing provider for a new prescription, the pharmacist may use his or her professional judgment to dispense not more than a seven (7) day supply to cover or prevent a medical emergency.

1914.10

The auxiliary system set forth in § 1914.9 shall be capable of meeting the requirements of this chapter and functioning in the place of the automated data processing system until the automated data processing system is again operational.

1914.11

All prescription drug order information shall be entered into the automated data processing system not more than ninety-six (96) hours after the automated data processing system is again operational.

1914.12

A pharmacy shall implement routine backup file and file maintenance procedures to prevent loss of patient data.

1914.13

A pharmacy shall notify the Board of Pharmacy of a permanent loss of prescription drug order information or patient information due to a system failure, not more than twenty-four hours (24) after the discovery.

1914.14

A pharmacy shall be responsible for continuity in the maintenance of prescription records if the relationship with its data processing services supplier terminates.

1914.15

A pharmacy using an automated data processing system shall comply with all applicable federal and District of Columbia laws and regulations.

D.C. Mun. Regs. tit. 22, r. 22-B1914

Final Rulemaking published at 38 DCR 6734, 6746 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008)