Iowa Admin. Code r. 657-6.7 - Security
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
(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.
Notes
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