Ala. Admin. Code r. 680-X-2-.15
Current through Register Vol. 43, No. 1, October 31, 2024
Section 680-X-2-.15 - Use Of Computers For Recordkeeping In Pharmacies In Alabama(1) Title 34, Chapter 23, Code of Ala. 1975, specifies the power and duty of the Board to adopt rules concerning the records and reports to be kept and made by a pharmacy. (a) The computerized system shall provide for the storage and retrieval of original prescription orders as follows: 1. The original prescription number.2. The prescribing practitioner's name.3. Full name and address of the patient.4. Date the original prescription was issued and the date it was dispensed, if different from the date of issue.5. Name, strength, dosage form, and quantity of drug dispensed.6. Total number of refills authorized by the prescriber.8. In the case of controlled substance, the DEA registration number and the Alabama controlled substances number of the prescribing practitioner.9. Identification of the dispensing pharmacist.(b) The computerized system shall provide for the retrieval of the refill history of all prescriptions entered into the computer. This refill history shall include: 3. Quantity dispensed originally and on each refill.4. Identification of the dispensing pharmacists originally and for each refill.5. The total number of refills dispensed to date for that prescription order.(c) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct must be provided by the individual pharmacist who makes use of such a system in either of two ways.1. If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed. The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a legal document. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed; or in lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement each day in the same manner as he or she would sign a legal document, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown.(d) Any such computerized system shall have the capability producing a printout of any refill data which the user pharmacy is responsible for maintaining under the Alabama Controlled Substances Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand, generic name, or both). Such a printout must include the name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing on each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order.(e) In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of sending the printout to the pharmacy within two business days; and if an inspector of the Alabama State Board of Pharmacy or DEA special agent or compliance investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the inspectors of the Alabama State Board of Pharmacy, the agent or investigator, verify the printout transmittal capability of its system by documentation (e.g., postmark).(f) In the event that a pharmacy which employs such a computerized system experiences system downtime, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedules III, IV, and V controlled substance prescription orders. This auxiliary procedure must ensure that refills are authorized by original prescription order; that the maximum number of refills have not been exceeded; and that all of the appropriate data is retained for on-line entry as soon as the computer system is available for use again.(g) Each pharmacy shall maintain its own series of consecutive numbered prescriptions. A series of numbers cannot be shared with another pharmacy, even if they are using the same computer.(h) In addition to the controlled substances printout referred to in paragraph (c), a printout shall be obtained at least weekly of all new and refill prescription activity of the pharmacy for this period.(i) All documentation required under this rule shall be kept in a separate binder and retained for two years.(2) Computer systems for the storage and retrieval of prescribes' orders for legend drugs prescribed for in-patients does not replace the requirement that the practitioners' orders be written and retained as a permanent record of the institution. Institution shall provide sufficient alternate records to maintain adequate controls and accountability. Author: Jerry Moore
Ala. Admin. Code r. 680-X-2-.15
Filed June 1, 1982. Amended: Filed February 13, 1997; effective March 20, 1997.Statutory Authority:Code of Ala. 1975, § 34-23-92.