Iowa Admin. Code r. 657-13.9 - General requirements for managing pharmacy
(1)
Distance to telepharmacy
site. The managing pharmacy shall be located in Iowa and within a
200-mile radius of a telepharmacy site to ensure that the telepharmacy site is
sufficiently supported by the managing pharmacy and that necessary personnel or
supplies may be delivered to the telepharmacy site within a reasonable period
of time of an identified need.
(2)
Emergency preparedness plan. A managing pharmacy shall develop
and include in both the managing pharmacy 's and the telepharmacy site's
policies and procedures a plan for continuation of pharmaceutical services
provided by the telepharmacy site in case of an emergency interruption of the
telepharmacy site's services. The plan shall address the timely arrival at the
telepharmacy site of necessary personnel or the delivery to the telepharmacy
site of necessary supplies within a reasonable period of time following the
identification of an emergency need. The plan may provide for alternate methods
of continuation of the services of the telepharmacy site including, but not
limited to, personal delivery of patient prescription medications from an
alternate pharmacy location or on-site pharmacist staffing at the telepharmacy
site.
(3)
Pharmacist in
charge. The pharmacist in charge of the managing pharmacy shall
designate a pharmacist in charge of the telepharmacy site, who will be
identified on the license of the telepharmacy site. The pharmacist in charge of
the telepharmacy site shall be employed by the managing pharmacy . Nothing in
this subrule shall prohibit the pharmacist in charge of the managing pharmacy
from simultaneously serving as the pharmacist in charge of the telepharmacy
site.
(4)
Adequate
audiovisual connection. The pharmacist in charge of the managing
pharmacy shall ensure adequate audiovisual connection with the telepharmacy
site during all periods when the telepharmacy site is open for business
including ensuring confidentiality of communications in compliance with state
and federal confidentiality laws.
(5)
Monthly inspection. The
pharmacist in charge of the telepharmacy site or delegate pharmacist shall be
responsible for performing a monthly inspection of the telepharmacy site.
Inspection reports shall be signed by the individual pharmacist who performed
the inspection. Inspection records and reports shall be maintained at the
telepharmacy site for two years following the date of the inspection. A copy of
the inspection report shall be provided to and maintained at the managing
pharmacy . The monthly inspection shall include, but may not be limited to, the
following:
a. Audit and reconciliation of
controlled substances perpetual and physical inventories.
b. Audit of electronic entry system and
records.
c. Verification that the
video recording system is functioning properly and that the recordings are
maintained and available for at least 60 days past the date of the
recording.
d. Compilation of a
record of the number of prescriptions filled, the number of on-site pharmacist
hours, and the number of hours the pharmacy site was open for business during
the preceding month.
e. Review of
written policies and procedures and verification of compliance with those
policies and procedures.
f. Ensuring
compliance with and review of records in the continuous quality improvement
program, following up with responsible personnel to address issues identified
by incident reports to prevent future incidents.
g. Review of records of the receipt and
disbursement of prescription drugs, including controlled substances, to ensure
compliance with record-keeping requirements.
h. Inspection of drug supplies and storage
areas to ensure removal and quarantine of outdated drugs.
i. Inspection of stock drug supplies and
storage areas to ensure drugs are maintained in a manner to prevent diversion
and maintain the integrity of the drugs, verifying that the temperatures of
storage areas are appropriate for the stored drugs and equipment.
j. Inspection of pharmacy and storage areas
and shelves to ensure areas and shelves are clean and free of pests and other
contaminants.
(6)
On-site pharmacist staffing. In an effort to promote public
health, the telepharmacy site shall be staffed by a pharmacist for at least 16
hours per month. While on site, the pharmacist shall make available to the
community general health care services, which may include, but not necessarily
be limited to, immunizations, medication therapy management, or health
screenings, as deemed necessary and appropriate by the pharmacist in charge and
as provided by policies and procedures.
a. If
a pharmacist will be available at the telepharmacy site to provide in-person
patient services, a consistent schedule of the pharmacist's availability shall
be established and published.
b.
Signage identifying the days and times when a pharmacist is on site and
available to patients shall be conspicuously posted at the telepharmacy site
and may be published by other means, as deemed appropriate.
c. Notice that the pharmacist will not be
present at the telepharmacy site during any routinely scheduled and posted
on-site availability shall be provided to the public in advance of the absence
except as provided in the emergency preparedness plan.
d. If the average number of prescriptions
dispensed per day by the telepharmacy site exceeds 150 prescriptions, the
telepharmacy site shall provide on-site pharmacist staffing 100 percent of the
time the pharmacy is open for business and shall, within ten business days,
apply to the board for licensure as a general pharmacy. The average number of
prescriptions dispensed per day shall be determined by averaging the number of
prescriptions dispensed per day over the previous 90-day period.
Notes
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