Iowa Admin. Code r. 657-6.7
Current through Register Vol. 47, No. 8, October 30, 2024
While on duty, each pharmacist shall be responsible for the security of the prescription department and of the provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs, including those collected through an authorized collection program, records for such drugs and authorized collection program activities, and patient records as provided in 657-Chapters 10 and 21 and federal regulations for authorized controlled substance collection programs, which can be found at www.deadiversion.usdoj.gov/drug_disposal/.
(1)Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrules 6.7(2) and 6.7(4).(2)Temporary absence of pharmacist. In the temporary absence of the pharmacist, only the pharmacist in charge may designate pharmacy technicians or pharmacy support persons who may be present in the prescription department to perform technical or nontechnical functions, respectively, designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours.a. In the absence of the pharmacist, the pharmacy shall be secured from public access and the pharmacy shall notify the public that the pharmacist is temporarily absent and that no prescriptions will be dispensed until the pharmacist returns. If the pharmacist in charge has authorized the presence in the pharmacy of a pharmacy technician or a pharmacy support person to perform designated functions when the pharmacy is closed, the pharmacy technician or the pharmacy support person may not dispense or deliver any drug, chemical, device, or prepared prescription to a patient or patient's agent.b. A pharmacy technician or a pharmacy support person who is present in the pharmacy when the pharmacy is closed shall prepare and maintain in the pharmacy a log identifying each period of time that the pharmacy technician or pharmacy support person worked in the pharmacy while the pharmacy was closed and identifying each activity performed during that time period. Each entry shall be dated, and each daily record shall be signed by the pharmacy technician or pharmacy support person who prepared the record. The log shall be periodically reviewed by the pharmacist in charge, and documentation of such review shall be maintained for two years from the date of entry.(3)Activities prohibited in absence of pharmacist. Activities which shall not be designated and shall not be performed during the temporary absence of the pharmacist include:a. Dispensing or distributing any prescription drugs or devices to patients or others.b. Providing the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order.c. Conducting prospective drug use review or evaluating a patient's medication record for purposes identified in rule 657-8.21 (155A).d. Providing patient counseling, consultation, or drug information.e. Making decisions that require a pharmacist's professional judgment such as interpreting or applying information.f. Transferring prescriptions to or from other pharmacies.(4)Refill sales during pharmacist break. At the discretion of the on-duty supervising pharmacist and pursuant to established policies and procedures, the pharmacist may delegate to a technician the dispensing of previously verified prescriptions which have been identified to not require pharmacist counseling pursuant to rule 657-6.14 (155A) when the pharmacist is on a break of limited duration and is absent from the pharmacy department.(5)Minimum physical security and monitoring system requirements. Each pharmacy located in Iowa shall develop and implement policies and procedures to ensure appropriate physical security and monitoring of the pharmacy to prevent unauthorized access to prescription drugs, including controlled substances, and pharmacy records. The physical security and monitoring shall include the components identified herein, and the policies and procedures shall establish the utilization of such components commensurate with the pharmacy operation. The policies and procedures shall establish the retention of documentation of activities or recordings retained from the alarm and video surveillance systems, as well as contingencies when the systems are temporarily unavailable. a. No later than July 6, 2023, a basic alarm system.b. No later than July 6, 2023, a video surveillance system, except in areas where drugs are stored in an automated medication dispensing system or an alternative electronic storage unit which uses biometric restricted access or other electronic monitoring mechanism.c. Controlled access to computer records.d. A designated location that can be monitored, away from drug storage and handling areas, where personal items of pharmacy staff may be stored while on site.Iowa Admin. Code r. 657-6.7
ARC 8673B, IAB 4/7/10, effective 6/1/10; ARC 1308C, IAB 2/5/2014, effective 3/12/2014Amended by IAB February 17, 2016/Volume XXXVIII, Number 17, effective 3/23/2016Amended by IAB February 14, 2018/Volume XL, Number 17, effective 3/21/2018Amended by IAB December 19, 2018/Volume XLI, Number 13, effective 1/23/2019Amended by IAB June 1, 2022/Volume XLIV, Number 24, effective 7/6/2022