Current through Register Vol. 46, No. 19, March 20, 2024
Prescription drugs maintained by a service program shall be
owned by an Iowa-licensed pharmacy or the service program's medical
director.
(1)
Pharmacy-based
service programs. The pharmacist in charge, the medical director, and
the service director shall jointly develop, consistent with the service
program's protocol, a list of drugs to be maintained for administration by the
service program. The pharmacy shall maintain a current list of all prescription
drugs including controlled substances that the pharmacy maintains at the
primary program site and at any program substation.
a.
Replenishment. The
responsible individual, the service director, or designee may request that
replenishment supplies of drugs be maintained at the primary program site
provided that the pharmacy has been supplied with administration records
justifying the order. Records of the administration of Schedule III, IV, and V
controlled substances and noncontrolled prescription drugs provided to and
maintained at the pharmacy shall include, at a minimum: the patient's name; the
name, strength, dosage form, and quantity of the drug administered; and the
date of administration. Records of the administration of Schedule II controlled
substances provided to and maintained at the pharmacy shall consist of a
written prescription including all of the prescription information required
pursuant to Iowa Code section
155A.27
or the patient care report if the patient care report includes the required
prescription information, including an original signature of the authorizing
prescriber. A pharmacist shall verify the accuracy of every drug to be
disbursed to the primary program site. Documentation of this verification shall
be maintained within the pharmacy records.
b.
Replenishment using automated
medication distribution system (AMDS). A pharmacy utilizing an
automated medication distribution system (AMDS) may authorize replenishment of
the service program's drug supplies from the AMDS provided that a pharmacist
verifies the drugs stocked in the AMDS component before the drugs are removed
from the pharmacy. Service program personnel authorized to remove drugs from
the AMDS for restocking the service program's supplies shall be assigned a
unique identification and access code for the purpose of accessing the AMDS.
Access by authorized service program personnel shall be restricted to specific
drug products authorized for use by the service program. A pharmacist shall,
within 72 hours, review the access of and removal of drugs from the AMDS by
service program personnel and shall maintain documentation of that review
within the pharmacy records.
c.
Inspections. The pharmacist in charge shall ensure the
completion of a monthly inspection of all prescription drugs maintained by the
pharmacy at the primary program site and any program substation. Inspection
shall include the removal of outdated or adulterated drugs. All drugs removed
from service program stock shall be returned to the pharmacy. Records of
inspection shall be maintained for two years from the date of the inspection at
the pharmacy. The pharmacist in charge may delegate the completion of the
monthly inspection to another pharmacist, a pharmacist-intern, a certified
pharmacy technician, or another designee of the pharmacist in charge.
(2)
Medical director-based
service programs. The medical director and the service director shall
jointly develop, consistent with the service program's protocol, a list of
drugs to be maintained for administration by the service program. The medical
director shall maintain a current list of all prescription drugs including
controlled substances that the medical director maintains at the primary
program site and at any program substation.
a.
Replenishment. All drugs procured for administration in a
medical director-based service program shall be obtained from an Iowa-licensed
wholesaler, pharmacy, or authorized prescriber.
b.
Inspections. The medical
director shall ensure the completion of a monthly inspection of all
prescription drugs maintained by the medical director at the primary program
site and any program substation. Inspection shall include the removal of
outdated or adulterated drugs. Records of inspection shall be maintained for
two years from the date of the inspection at the primary program site or the
program substation. The medical director may delegate the completion of the
required inspections to the service director or other designee.
