Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-4-5 - Record of Retrieval (Documentation of Activity)5.1. The pharmacy must be able to provide a current history of all authorized prescription activity required to be kept by section 4. In addition, this information must be capable of production on a patient-by-patient basis in the form of patient profiles which allows immediate review of at least the following data about the patient which may be reasonably obtained by the pharmacist:(a) The patient's biographical data;(b) The patient's medications;(c) The patient's disease states and drug allergies;(d) The pharmacist's notes; and(e) Any other data necessary to make rational judgments about pharmacist care.5.2. An ADP system, if used, must provide this information by a suitable computer screen or monitor display and be capable of providing a printout.5.3. An ADP system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, subject to the following conditions: 5.3.1. The ADP system shall provide on-line retrieval (via computer screen or monitor display or printout) of the original prescription order information for those prescription orders which are currently authorized for refilling. Order information includes, but is not limited to: the original prescription number, the date of issuance of the original prescription order by the prescribing practitioner, the full name and the address of the patient, the name, the address, and the DEA registration number of the prescribing practitioner, and the name, the strength, the dosage form and quantity of the controlled substance prescribed and the quantity dispensed if different from the quantity prescribed, and the total number of refills authorized by the prescribing practitioner.5.3.2. The ADP system shall provide on-line retrieval (via computer screen or monitor display or printout) of the current refill history for Schedule III or IV controlled substance prescription order (those authorized for refill during the past six (6) months). This refill history shall include, but not be limited to, the name of the controlled substance, the date of refill, the name of the controlled substance, the date of the refill, the quantity dispensed, the name or initials (or identification code if used) of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.5.3.3. The ADP system shall contain documentation that an individual pharmacist has taken the responsibility for the accuracy of the information entered into the system for original prescriptions and for refills of the original prescription for a Schedule III or IV Controlled Substance. A printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using the ADP system within seventy-two (72) hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. (In lieu of a printout, the pharmacy shall maintain a bound log book, shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown. The book or file must be maintained at the pharmacy employing the system for a period of two (2) years after the date of dispensing the appropriately authorized refill.5.3.4. The ADP system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining under W. Va. Code § 30-5-1 et seq. and its implementing regulations. This includes a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). The printout must include the name of the prescribing practitioner, the name and address of the patient, the quantity dispensed on each refill, the date of dispensing for each refill, the name or identification code of the dispensing pharmacist, and the number of the original prescription order. Any recordkeeping location must be capable of sending the Special Agent or Compliance Investigator a copy of the printout from the user pharmacy if requested to do so by the Agent or Investigator and must verify the printout transmittal capability of its system by documentation, (e.g., postmark).5.3.5. In the event that pharmacy which employs a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.5.3.6. When filing refill information for original prescription orders for Schedule III or IV Controlled Substances, a pharmacy may use the system described in Chapter 11, Drug Enforcement Administration, Department of Justice, as it relates to the Code of Federal Regulations under Section 1306.22, Titled, Refilling of Prescriptions.