Or. Admin. Code § 855-041-4120 - Remote Dispensing Machine (RDM) - Drug Delivery and Control
(1) Each RDM must
be registered with the Board, under the control of and connected via computer
with a Responsible Pharmacy, but not located in a pharmacy. RDMs must be used
only in settings with an established program of pharmaceutical care that
ensures prescription orders are reviewed by a pharmacist before release to the
patient. The Responsible Pharmacy must establish the policies and procedures
necessary to fulfill the requirements of all applicable state and federal laws
and regulations.
(2) The following
must be conspicuously displayed at the site of the RDM:
(a) RDM license;
(b) DEA registration if required;
(c) A certified copy of the Responsible
Pharmacy license; and
(d) A
certified copy of the Pharmacist-In-Charge license.
(3) Documentation as to type of equipment,
serial numbers, content, policies and procedures, and location shall be
maintained in the pharmacy for review by the board. Such documentation must
include, but is not limited to:
(a) Location
of RDM(s);
(b) Manufacturer's name
and model for each RDM;
(c)
Description of how the RDM is used;
(d) Quality assurance procedures to determine
continued appropriate use of the automated device; and
(e) Policies and procedures for training of
appropriate personnel, system operation, safety, security, accuracy, patient
confidentiality, oral counseling by a pharmacist or pharmacist-intern, access,
and malfunction.
(4)
Policies and procedures addressing the operation of the RDM must be maintained
in the pharmacy responsible for the APS and at the location at which the RDM
has been installed.
(5) All events
involving the contents of the RDM must be recorded electronically. Records must
be maintained by the pharmacy for a minimum of three years and must be readily
available to the Board. Such records shall include:
(a) Identity of RDM accessed;
(b) Identification of the individual
accessing the RDM;
(c) Type of
transaction;
(d) Date and time of
transaction;
(e) Name, strength,
dosage form, and quantity of the drug accessed;
(f) Name of the patient for whom the drug was
ordered;
(g) Name of the
prescribing practitioner
(h) Such
additional information as the pharmacist-in-charge may deem necessary;
and
(6) Only an Oregon
Licensed Pharmacist or Technician may have access to the RDM, except that a
Registered Nurse, upon approval by the Board, may have access to the
RDM.
(7) Only an Oregon licensed
Pharmacist or Technician may stock medications in the RDM, except that a
Registered Nurse, upon approval by the Board, may stock medications in the
RDM.
(8) All containers of
medications stored in the RDM shall be packaged and labeled in accordance with
state and federal laws and regulations, including OAR
855-041-1130.
(9) All aspects of handling controlled
substances shall meet the requirements of all state and federal laws and
regulations.
(10) Oral counseling,
as required by OAR 855-115-0145, shall be provided
by the pharmacist at the time of dispensing by a two-way audio and video hookup
with the Responsible Pharmacy.
(11)
The Automated Pharmacy Systems shall provide a mechanism for securing and
accounting for wasted, discarded or unused medications in accordance with
existing state and federal laws and regulations.
(12) The RDM must be clearly marked with the
name, address, and phone number of the Responsible Pharmacy and
Pharmacist-In-Charge.
(13) A
Responsible Pharmacy located outside of Oregon that operates a RDM in Oregon
must be currently licensed and in good standing in Oregon. The
Pharmacist-In-Charge must also be currently licensed and in good-standing both
in Oregon and in the state in which the Responsible Pharmacy is
located.
(14) A Responsible
Pharmacy may apply for the use of an RDM in a licensed residential facility
that it provides services to, but only when the facility provides 24 hour
nursing care.
Notes
Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.205
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