Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.9 - General Requirements for Managing Pharmacy

Current through Register Vol. 47, No. 3, July 24, 2024
(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.