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BOARD OF PHARMACY
DIVISION 41
OPERATION
OF PHARMACIES (AMBULATORY AND RESIDENTIAL DRUG OUTLETS)
855-041-0005
[Renumbered to 855-041-1080]
855-041-0010
[Renumbered to 855-041-1085]
855-041-0015
[Renumbered to 855-041-1090]
855-041-0016
[Renumbered to 855-041-1170]
855-041-0017
[Renumbered to 855-041-1095]
855-041-0020
[Renumbered to 855-041-1010]
855-041-0025
[Renumbered to 855-041-1015]
855-041-0026
[Renumbered to 855-041-1020]
855-041-0035
[Renumbered to 855-041-2100]
855-041-0036
[Renumbered to 855-041-1025]
855-041-0037
[Renumbered to 855-041-1030]
855-041-0040
[Renumbered to 855-041-1035]
855-041-0055
[Renumbered to 855-041-1145]
855-041-0056
[Renumbered to 855-041-1135]
855-041-0057
[Renumbered to 855-041-1140]
855-041-0060
[Renumbered to 855-041-1040]
855-041-0061
[Renumbered to 855-041-1110]
855-041-0065
[Renumbered to 855-041-1105, 855-041-1120, 855-041-1125, 855-041-1130]
855-041-0075
[Renumbered to 855-041-2115]
855-041-0080
[Renumbered to 855-041-1045]
855-041-0086
[Renumbered to 855-041-1115]
855-041-0095
[Renumbered to 855-041-1050]
855-041-0103
[Renumbered to 855-041-1055]
855-041-0105
[Renumbered to 855-041-5005]
855-041-0115
[Renumbered to 855-041-5015]
855-041-0135
[Renumbered to 855-041-6800]
855-041-0140
[Renumbered to 855-041-6840]
855-041-0145
[Renumbered to 855-041-7050]
855-041-0160
[Renumbered to 855-041-7060]
855-041-0162
[Renumbered to 855-041-7070]
855-041-0164
[Renumbered to 855-041-7070]
855-041-0165
[Renumbered to 855-041-8050]
855-041-0170
[Renumbered to 855-043-0600]
855-041-0173
[Renumbered to 855-043-0610]
855-041-0175
[Renumbered to 855-043-0620]
855-041-0177
[Renumbered to 855-043-0630]
855-041-0300
[Renumbered to 855-041-1060]
855-041-0350
[Renumbered to 855-041-4025]
855-041-0355
[Renumbered to 855-041-4035]
855-041-0360
[Renumbered to 855-041-4045]
855-041-0365
[Renumbered to 855-041-4055]
855-041-0600
[Renumbered to 855-041-4100]
855-041-0610
[Renumbered to 855-041-4110]
855-041-0620
[Renumbered to 855-041-4120]
855-041-0645
[Renumbered to 855-041-4200]
General
855-041-1001
Definitions
(1) “Biological product” means,
with respect to the prevention, treatment or cure of a disease or condition of human
beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component,
blood derivative, allergenic product, protein other than a chemically synthesized
polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic
compound.
(2) “Biosimilar product”
means a biological product licensed by the United States Food and Drug Administration
pursuant to 42 U.S.C. 262(k)(3)(A)(i).
(3) “Interchangeable”
means, in reference to a biological product, that the United States Food and Drug
Administration has determined that a biosimilar product meets the safety standards
set forth in 42 U.S.C. 262(k)(4).
(4) “Reference biological
product” means the biological product licensed pursuant to 42 U.S.C. 262(a)
against which a biological product is evaluated in an application submitted to the
United States Food and Drug Administration for licensure of a biological product
as a biosimilar product or for determination that a biosimilar product is interchangeable.
Stat. Auth.: ORS 689.205 & 2013
OL Ch 342
Stats. Implemented: ORS 689.155
& 2013 OL Ch 342
Hist.: BP 2-2014, f. &
cert. ef. 1-24-14
855-041-1010
Personnel
(Both Retail and Institutional Drug Outlets)
(1) Each pharmacy
must have one pharmacist-in-charge employed on a regular basis at that location
who shall be responsible for the daily operation of the pharmacy. The pharmacist-in-charge
shall be indicated on the application for a new or relocated pharmacy and for pharmacy
renewal registration.
(2) The pharmacy
must ensure that it is in compliance with all state and federal laws and rules governing
the practice of pharmacy and that all controlled substance records and inventories
are maintained in conformance with the keeping and inventory requirements of federal
law and board rules.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.151, 689.155, 689.305
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1986,
f. & ef. 12-8-86; PB 10-1987, f. & ef. 12-8-87; PB 9-1989, f. & cert.
ef. 7-20-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef.
2-2-94; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96;
BP 1-2001, f. & cert. ef. 3-5-01; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered
from 855-041-0020, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1015
Operation
of Pharmacy (Both Retail and Institutional Drug Outlets)
(1) Supervision.
A pharmacy may only be operated when a pharmacist licensed to practice in this state
is present. This means that the pharmacist must be physically present in the pharmacy
or institutional facility.
(2) Sanitation:
(a) Pharmacies
shall be kept clean.
(b) Persons
working in a pharmacy shall practice appropriate infection control.
Stat. Auth.: ORS
689.305
Stats. Implemented:
ORS 689.305
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989,
f. & cert. ef. 8-11-89; PB 1-1997, f. & cert. ef. 9-22-97; Renumbered from
855-041-0025, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1020
Security
of Prescription Area
(1) The area in
a registered pharmacy where legend and/or controlled substances are stored, possessed,
prepared, manufactured, compounded, or repackaged shall be restricted in access,
in such a manner as to ensure the security of those drugs.
(2) The pharmacist-in-charge
and each pharmacist while on duty shall be responsible for the security of the prescription
area including provisions for adequate safeguards against theft or diversion of
prescription drugs, and records for such drugs.
(3) When
there is no pharmacist present, the pharmacy shall be secured to prevent entry.
All entrances to the pharmacy shall be securely locked and any keys to the pharmacy
shall remain in the possession of the pharmacist-in-charge and other employee pharmacists
as authorized by the pharmacist-in-charge. When there is no pharmacist present,
and it is necessary for non-pharmacist employees or owners to have access to the
pharmacy, the prescription area shall be secured from entry as described in OAR
855-041- 2100.
(4) Prescription
drugs and devices and non-prescription Schedule V controlled substances shall be
stored within the prescription area or a secured storage area.
(5) Any security
system deviating from the requirements of this section, except as provided in OAR
855-041- 6310, shall be approved by the Board prior to implementation. Requests
for such approval shall be in writing and provide a detailed description of the
proposed system. A written description of such security system, as approved by the
Board, shall be maintained in the pharmacy.
Stat. Auth.: ORS
475.035 & 689.205
Stats. Implemented:
ORS 689.205
Hist.: 1PB
5-1982, f. & ef. 8-6-82; PB 1-1987, f. & ef. 2-3-87; Renumbered from 855-041-0026,
BP 7-2012, f. & cert. ef. 12-17-12
855-041-1025
Disposal
of Drugs
Drugs that are outdated,
damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically
separated from other drugs until they are destroyed or returned to their supplier.
Stat. Auth.: ORS
475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
Hist.: 1PB
2-1984, f. & ef. 3-7-84; PB 1-1990, f. & cert. ef. 1-23-90; PB 1-1992, f.
& cert. ef. 1-31-92 (and corrected 2-7-92); Renumbered from 855-041-0036, BP
7-2012, f. & cert. ef. 12-17-12
855-041-1030
Reporting Drug Loss
(1) Disasters, accidents and emergencies
which may affect the strength, purity, or labeling of drugs or devices shall immediately
be reported to the Board.
(2) The outlet shall notify
the Board in the event of a significant drug loss or violation related to drug theft
within one (1) business day.
(3) At the time a Report of
Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement
Administration, a copy shall be sent to the Board.
Stat. Auth.: ORS 475.035, 689.155, 689.205,
689.305 & 689.315
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1981, f. &
ef. 8-20-81; 1PB 1-1986, f. & ef. 6-5-86; PB 1-1992, f. & cert. ef. 1-31-92
(and corrected 2-7-92); Renumbered from 855-041-0037, BP 7-2012, f. & cert.
ef. 12-17-12; BP 2-2014, f. & cert. ef. 1-24-14
855-041-1035
Minimum Equipment
Requirements (Both Retail and Institutional Drug Outlets)
The minimum equipment
requirement to open and operate a retail drug outlet and institutional drug outlet
in the state of Oregon shall consist of not less than the following:
(1) The most
current issue of at least one pharmaceutical reference with current, properly filed
supplements and updates appropriate to and based on the standards of practice for
the setting.
(2) Current
and properly filed Oregon Revised Statutes, Chapters 689, and 475; current and properly
filed Oregon Administrative Rules, chapter 855; and a minimum of three years of
the Board of Pharmacy quarterly newsletters maintained in house or other readily
retrievable means.
(3) Official
Poison and Exempt Narcotic Register if poisons and exempt narcotics are sold or
distributed.
(4) Suitable
refrigeration.
(5) A sink
with running hot and cold water.
(6) Equipment
and supplies appropriate to and based on the standards of practice for the setting
as determined by the Pharmacy and Pharmacist-in-Charge.
(7) Failure
to have and use equipment necessary to your practice setting constitutes unprofessional
conduct for purposes of ORS 689.405(1)(a).
(8) If an
outlet files original prescriptions electronically, then the outlet must have a
computer and software capable of storing and accessing electronically filed original
prescriptions. Exceptions to the above list may be approved by the Board of Pharmacy.
Stat. Auth.:ORS
689.205 & 689.508
Stats. Implemented:
ORS 689.205 & 689.508
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp),
f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; 1PB 4-1986, f. & ef.
12-8-86; PB 8-1987, f. & ef. 9-30-87; PB 12-1989, f. & cert. ef. 8-11-89;
PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and
corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert.
ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05); Renumbered from 855-041-0040,
BP 7-2012, f. & cert. ef. 12-17-12
855-041-1036
Proper Storage of Drugs
(1) A pharmacy must maintain proper storage
of all drugs. This includes, but is not limited to the following:
(a) All drugs must be stored
according to manufacturer’s published or USP guidelines.
(b) All drugs must be stored
in appropriate conditions of temperature, light, humidity, sanitation, ventilation,
and space.
(c) Appropriate storage conditions
must be provided for, including during transfers between facilities and to patients.
(d) A pharmacy must quarantine
drugs which are outdated, adulterated, misbranded or suspect.
Cold Storage and Monitoring:
(2) A pharmacy must store all
drugs at the proper temperature according to manufacturer’s published guidelines
(pursuant to FDA package insert or USP guidelines).
(a) All drug refrigeration systems
must:
(A) Maintain refrigerated products
between 2 to 8 °C (35 to 46 °F); frozen products between -25 to -10 °C
(-13 to 14 °F); or as specified by the manufacturer.
(B) Utilize a centrally placed,
accurate, and calibrated thermometer;
(C) Be dedicated to pharmaceuticals
only; and
(D) Be measured continuously
and documented either manually twice daily to include minimum, maximum and current
temperatures; or with an automated system capable of creating a producible history
of temperature readings.
(b) A pharmacy must adhere to
a monitoring plan, which includes, but is not limited to:
(A) Documentation of training
of all personnel;
(B) Maintenance of manufacturer
recommended calibration of thermometers;
(C) Maintenance of records of
temperature logs for a minimum of three years;
(D) Documentation of excursion
detail, including, but not limited to, event date and name of persons(s) involved
in excursion responses;
(E) Documentation of action(s)
taken, including decision to quarantine product for destruction, or determination
that it is safe for continued use. This documentation must include details of the
information source;
(F) A written emergency action
plan; and
(G) Routine preventative maintenance
and evaluation of refrigeration equipment and monitoring equipment.
(3) Vaccine Drug Storage:
(a) A pharmacy that stores vaccines
must comply with section two of this rule and the following:
(A) Vaccines must be stored
in the temperature stable sections of the refrigerator;
(B) A centrally placed and accurate
buffered probe thermometer, such as glycol or glass beads, calibrated within a plus
or minus 0.5 °C variance must be utilized;
(C) Each freezer and refrigerator
compartment must have its own exterior door and independent thermostat control;
(D) A system of continuous temperature
monitoring with automated data logging and physical confirmation must be utilized.
Documentation of the temperature of each active storage unit must be logged at least
twice daily, data must be downloaded weekly, and system validations must be conducted
quarterly; and
(E) Must adhere to a written
quality assurance process to avoid temperature excursions.
Stat. Auth.: ORS 689.205, 689.325
Stats. Implemented: ORS 689.155
Hist.: BP 3-2015, f. 7-1-15,
cert. ef. 1-1-16
855-041-1040
Drug Outlet
Procedures
Each drug outlet
is accountable for establishing, maintaining, and enforcing their written procedures
for:
(1) Securing
their legend drugs and the area in which they are prepared, compounded, stored or
repackaged;
(2) Performing
mandatory prospective drug utilization reviews; on all prescriptions both new and
refilled;
(3) Verifying
the accuracy of all completed prescriptions and medical orders before they leave
the pharmacy's secured legend area;
(4) Documenting
the identification of the pharmacist responsible for the verification of each dispensed
medication;
(5) Ensuring
the delivery of each completed prescription to the correct party;
(6) Providing
appropriate confidential professional advice concerning medications to patients
or their agents;
(7) Ensuring
that all who work in the pharmacy are appropriately licensed and adequately trained
to perform their duties and;
(8) Establishing
and maintaining a Continuous Quality Assurance Program.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.151, 689.155, 689.508
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994,
f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f.
& cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1045
Returned
Drugs and Devices
(1) Pharmacists,
pharmacies, pharmacy technicians, and certified pharmacy technicians may only accept
the return of controlled substances upon receiving a waiver from the Board of Pharmacy.
(2) Pharmacists,
pharmacies, pharmacy technicians, and certified pharmacy technicians may accept
the return of drugs or devices as defined by ORS 689.005 once the drugs or devices
have been removed from the pharmacy only if;
(a) The drugs
or devices are accepted for destruction or disposal and;
(b) The drugs
or devices were dispensed in error, were defective, adulterated, misbranded, dispensed
beyond their expiration date, were unable to be delivered to the patient, or are
subject of a drug or device recall; or
(c) After
consultation, a pharmacist determines that, in the pharmacist’s professional
judgment, harm could result to the public or a patient if the drugs or devices were
not accepted for return.
(3) Not withstanding
section 2 of this rule, drugs or devices previously dispensed or distributed may
be returned and redispensed or redistributed provided all the following conditions
are met:
(a) The drug
is in an unopened, tamper-evident unit;
(b) The drugs
or devices have remained at all times in control of a person trained and knowledgeable
in the storage and administration of drugs in long term care facilities or supervised
living groups using the services of a consultant pharmacist;
(c) The drug
or device has not been adulterated or misbranded and has been stored under conditions
meeting United States Pharmacopeia standards.
(4) Upon
written request, the Board may waive any of the requirements of this rule if a waiver
will further public heath or safety or the health and safety of a patient. A waiver
granted under this section shall only be effective when it is issued by the Board
in writing.
Stat. Auth.: ORS
475 & 689
Stats. Implemented:
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp),
f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; PB 5-1989, f. & cert.
ef. 1-30-89; PB 8-1990, f. & cert. ef. 12-5-90; BP 2-2006, f. & cert. ef.
6-9-06); Renumbered from 855-041-0080, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1050
Pharmacy
Depots
(1) Except when
delivering directly to a patient, licensed pharmacists may not participate in the
transfer of completed prescription medication containers to or from any location
that is not a licensed pharmacy, unless the transfer occurs to:
(a) The office
of the patient’s health care practitioner; or
(b) The location
of the patient; or
(A) Patient’s
primary residence; or
(B) Alternate
residence designated by the patient; or
(C) Patient’s
workplace; or
(c) The hospital
or medical care facility in which a patient is receiving care.
(2) Upon
written request, the Board may waive any of the requirements of this rule if a waiver
will further public health or safety or the health and safety of a patient. A waiver
granted under this section shall only be effective when it is issued by the Board
in writing.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 9-2011,
f. 12-30-11, cert. ef. 1-1-12; BP 1-2012, f. 4-26-12, cert. ef. 5-1-12; Renumbered
from 855-041-0095, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1055
Confidentiality
(1) No licensee
or registrant of the Board who obtains any patient information shall disclose that
information to a third party without the consent of the patient.
(2) Section
(1) of this rule does not apply to:
(a) Any disclosure
made to the Board;
(b) Any disclosure
made to a practitioner or to another pharmacist when the pharmacist reasonably believes
that disclosing such information is necessary to protect the patient’s health
or well being; or
(c) To a
third party when disclosure is otherwise authorized or required by law.
Stat. Auth.: ORS
689.155 & 689.205
Stats. Implemented:
Hist.: PB
5-1992, f. & cert. ef. 10-23-92; Renumbered from 855-041-0103, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-1060
Non-Resident Pharmacies
(1) For the purpose of these rules, a non-resident
pharmacy includes, but is not limited to: Retail, Institutional, Remote Processing,
Central Fill, and Drugless/Consulting Drug Outlets.
(2) Every non-resident pharmacy
that provides drugs, devices or services to a resident in this state shall be registered
with the Oregon Board of Pharmacy.
(3) To qualify for registration
under these rules, every non-resident pharmacy shall be registered and in good standing
with the Board of Pharmacy in the pharmacy's state of residence.
(4) Every out-of-state non-resident
pharmacy shall designate an Oregon licensed Pharmacist-in-Charge (PIC), who shall
be responsible for all pharmacy services provided to residents in Oregon, and to
provide supervision and control in the pharmacy. To qualify for this designation,
the person must:
(a) Hold a license to practice
pharmacy in the resident state;
(b) Be normally present in the
pharmacy for a minimum of 20 hours per week;
(c) Complete the annual non-resident
PIC self-inspection report prior to February 1 each year; and
(d) Provide the PIC self-inspection
report as requested by the Board.
(5) Every non-resident pharmacy
will have a pharmacist-in-charge (PIC) who is licensed in Oregon within four months
of initial licensure of the pharmacy.
(6) When a change of Pharmacist-in-Charge
(PIC) occurs, the non-resident pharmacy will notify the Board within ten business
days and identify a contact person. The pharmacy will have an Oregon licensed PIC
employed within 90 days. The contact person must be a licensed pharmacist in the
pharmacy’s state of residence and is responsible for the following:
(a) Supervision of pharmacy
staff and ensuring compliance with laws and rules; and
(b) Responding to Board correspondence
and inquiries.
(7) A new Pharmacist-in-Charge
must be appointed, and communication made to the Board within 90 days, or the non-resident
pharmacy will cease drug distribution and provision of pharmacy services in Oregon.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151,
689.155 & 689.225
Hist.: PB 1-1994, f. &
cert. ef. 2-2-94; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0300,
BP 7-2012, f. & cert. ef. 12-17-12; BP 4-2015, f. & cert. ef. 7-1-15
Licensure
855-041-1080
Pharmacy
Registration (Both Retail and Institutional Drug Outlets)
(1) Pharmacies shall
be registered as either retail drug outlets or institutional drug outlets or both.
(2) An application
for registration of a new pharmacy shall be accompanied by a floor plan drawn to
scale and shall be approved by the Board prior to opening.
(3) The application
shall specify the location of the pharmacy and shall indicate the owner, trustee,
receiver, or other person applying for the registration. When an applicant is not
the owner of the pharmacy, the application shall indicate the owner and the applicant's
affiliation with the owner:
(a) If the
owner is a partnership or other multiple owner, the names of the partners or persons
holding the five largest interests shall be indicated on the application;
(b) If the
owner is a corporation, the name filed shall be the same as filed with the Corporation
Commissioner. The name of the corporation, the names of the corporation officers
and the names of the stockholders who own the five largest interests shall be indicated
on the application.
(4) Upon
request by the Board, the applicant shall furnish such information as required by
the Board regarding the partners, stockholders, or other persons not named in the
application.
(5) The application
shall also identify any person who has incidents of ownership in the pharmacy who
also has financial interest in any long-term care facility as defined in ORS 442.015.
(6) A certificate
of registration will be issued upon Board approval of the application.
(7) All registration
renewal applications shall be accompanied by the annual fee and shall contain the
same information required in sections (3) and (4) of this rule.
(8) The initial
and annual registration fee for pharmacies is set out in division 110 of this chapter.
(9) Pharmacy
registration expires March 31, annually. If the annual registration fee referred
to in Division 110 of this Chapter is not paid by March 31 of the current year,
a delinquent fee as set out in Division 110 of this Chapter shall be included with
the application for registration renewal.
(10) The
registration is not transferable and the registration fee cannot be prorated.
(11) A change
of ownership requires the approval of the Board and new certificate of registration.
Application shall be on a form supplied by the Board.
(12) A change
of ownership includes any change in the legal form of the business including additions
or deletions of partners.
(13) Applicants
for change in ownership shall provide the Board with the information required in
sections (3), (4), and (5) of this rule.
(14) A change
of ownership shall be reported to the Board within 15 days of the occurrence.
(15) No pharmacy
shall be operated until a certificate of registration has been issued to the pharmacy
by the Board.
Stat. Auth.: ORS
475.035 & 689.205
Stats. Implemented:
ORS 689.155
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 5-1990,
f. & cert. ef. 4-12-90; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f.
& cert. ef. 2-2-94; Renumbered from 855-041-0005, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1085
Change of
Location of a Pharmacy (Both Retail and Institutional Drug Outlets)
(1) A change of
location of a pharmacy requires the approval of the Board and a new certificate
of registration.
(2) Application
for approval to relocate shall be on a form provided by the Board and shall be accompanied
by fees and a floor plan drawn to scale.
(3) A certificate
of registration will be issued upon Board approval of the application.
(4) Following
Board approval, a change of location, shall be reported to the Board within 15 days
of the occurrence.
(5) No pharmacy
shall be operated until a certificate of registration has been issued to the pharmacy
by the Board.
Stat. Auth.: ORS
475.035 & 689.205
Stats. Implemented:
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 5-1990,
f. & cert. ef. 4-12-90; PB 1-1994, f. & cert. ef. 2-2-94; Renumbered to
855-041-0010, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1090
Change of
Business Name, Closure (Both Retail and Institutional Drug Outlets)
(1) Any change of
business name of a pharmacy must be reported to the Board within 15 days by filing
a new application for which no fee is required.
(2) Any closure
of a pharmacy shall be reported to the Board within 15 days and include notification
of the disposition of controlled substances, dangerous, legend, and restricted drugs.
Stat. Auth.: ORS
475.035 & 689.205
Stats. Implemented:
ORS 689.205
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994,
f. & cert. ef. 2-2-94; Renumbered from 855-041-0015, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1095
Pharmacy
Advertising
No person shall
advertise or otherwise purport to operate as a pharmacy or to advertise or purport
to provide pharmacy services unless the person is registered with the Board pursuant
to ORS 689.305.
Stat. Auth.: ORS
475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
Hist.: PB
1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); Renumbered from 855-041-0017,
BP 7-2012, f. & cert. ef. 12-17-12
Prescriptions
855-041-1105
Requirements for Prescriptions
(1) Prescriptions, prescription refills,
and drug orders must be correctly dispensed in accordance with the prescribing practitioner's
authorization. When a prescription is transmitted orally, both the receiving pharmacist's
name or initials and the name of the person transmitting must be noted on the prescription.
(2) Each pharmacy must document
the following information:
(a) The name of the patient
for whom or the owner of the animal and the species of the animal for which the
drug is dispensed;
(b) The full name and, in the
case of controlled substances, the address and the Drug Enforcement Administration
registration number of the practitioner or other number as authorized under rules
adopted by reference under rule OAR 855-080-0085;
(c) The name, strength, dosage
forms of the substance, quantity prescribed and, if different from the quantity
prescribed, the quantity dispensed;
(d) The directions for use,
if given by the practitioner; and
(e) The date of filling, and
the total number of refills authorized by the prescribing practitioner.
(3) In accordance with ORS 689.515(3),
a practitioner may specify in writing, by a telephonic communication or by electronic
transmission that there may be no substitution for the specified brand name drug
in a prescription.
(a) For a hard copy prescription
issued in writing or a prescription orally communicated over the telephone, instruction
may use any one of the following phrases or notations:
(A) No substitution;
(B) N.S.;
(C) Brand medically necessary;
(D) Brand necessary;
(E) Medically necessary;
(F) D.A.W. (Dispense As Written);
or
(G) Words with similar meaning.
(b) For an electronically transmitted
prescription, the prescriber or prescriber’s agent shall clearly indicate
substitution instructions by way of the text (without quotes) “brand medically
necessary” or words with similar meaning, in the electronic prescription drug
order, as well as all relevant electronic indicators sent as part of the electronic
prescription transmission.
(c) Such instructions shall
not be default values on the prescription.
(4) A pharmacy or pharmacist
filling a prescription or order for a biological product may not substitute a biosimilar
product for the prescribed biological product unless:
(a) The biosimilar product has
been determined by the United States Food and Drug Administration to be interchangeable
with the prescribed biological product;
(b) The prescribing practitioner
has not designated on the prescription that substitution is prohibited;
(c) The patient for whom the
biological product is prescribed is informed of the substitution prior to dispensing
the biosimilar product;
(d) The pharmacy or pharmacist
provides written, electronic or telephonic notification of the substitution to the
prescribing practitioner or the prescribing practitioner’s staff within three
(3) business days of dispensing the biosimilar product; and
(e) The pharmacy or pharmacist
retains a record of the substitution for a period of not less than three (3) years.
(5) Upon written request and
for good cause, the Board may waive any of the requirements of this rule. A waiver
granted under this section shall only be effective when it is issued by the Board
in writing.
Stat. Auth.: ORS 689.205 & 2013
OL Ch. 342
Stats. Implemented: ORS 689.505,
689.515 & 2013 OL Ch. 342
Hist.: 1PB 2-1979(Temp),
f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef.
4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989,
f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f.
& cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92);
PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB
1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97;
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert.
ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000,
f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f.
& cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. &
cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from
855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12; BP 2-2014, f. & cert.
ef. 1-24-14
855-041-1110
Tamper-resistant
Prescription
When the use of
a tamper-resistant prescription is required by any federal or state law or rule,
the term “tamper-resistant” shall have the meaning as defined in OAR
855-006-0015.
Stat. Auth.: 689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08; BP 1-2008, f. & cert.
ef. 2-5-08); Renumbered from 855-041-0061, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1115
Verification
of Prescription Authenticity
Alteration of a
written prescription, other than by a pharmacist's or practitioner's authorization,
in any manner constitutes an invalid order unless verified with the prescriber.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.151, 689.155, 689.508
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 2-2008,
f. & cert. ef. 2-20-08; Renumbered from 855-041-0086, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1120
Prescription
Refills
(1) Where refill authority is given other
than by the original prescription, documentation that such refill authorization
was given, the date of authorization, and name of the authorizing prescriber or
the prescriber's agent must be recorded. This documentation must be readily retrievable.
Prescriptions for controlled substances in Schedules III and IV are limited to five
refills or six months from date of issue, whichever comes first.
(2) If the practitioner is not
available and in the professional judgment of the pharmacist an emergency need for
the refill of a prescription drug has been demonstrated, the pharmacist may dispense
a sufficient quantity of the drug consistent with the dosage regimen, provided it
is not a controlled substance, to last until a practitioner can be contacted for
authorization, but not to exceed a 72-hour supply. The practitioner shall be promptly
notified of the emergency refill.
(3) Each refilling of a prescription
must be accurately documented, readily retrievable, and uniformly maintained for
three years. This record must include.;
(a) The identity of the responsible
pharmacist;
(b) Name of the patient;
(c) Name of the medication;
(d) Date of refill; and
(e) Quantity dispensed.
(4) Refill quantities may be
combined into a single filling if the prescription is not for a controlled substance
or psychotherapeutic drug and the prescriber is notified of the change.
(5) A retail pharmacy may only
dispense a prescription refill upon request of the patient or patient’s agent.
A request specific to each medication is required.
(6) Auto-Refill Programs. A
retail pharmacy may only use a program that automatically refills non-controlled
prescriptions that have existing refills available and are consistent with the patient’s
current medication therapy when the following conditions are met:
(a) Authorization for each prescription
refill by a patient or patient’s agent is received before the pharmacy begins
the filling process;
(b) The prescription is not
a controlled substance; and
(c) The pharmacy must discontinue
auto-refill program enrollment at the request of the patient or patient’s
agent.
(7) An automated reminder cannot
be used to generate a prescription refill unless the patient or patient’s
agent provides authorization for each individual prescription refill. The content
of each reminder must include:
(a) Drug name and strength;
and
(b) Date of last fill.
(8) Pick-up notification to
a patient or patient’s agent may only be generated upon full completion of
the prescription refill.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.505
& 689.515
Hist.: 1PB 2-1979(Temp),
f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef.
4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989,
f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f.
& cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92);
PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB
1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97;
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert.
ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000,
f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f.
& cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. &
cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from 855-041-0065,
BP 7-2012, f. & cert. ef. 12-17-12; BP 12-2014, f. 12-30-14, cert. ef. 1-1-16
855-041-1125
Prescription
Expiration
This section of
rule addresses the expiration date of the prescription and not the expiration date
of the drug.
(1) After
one year from date of issue, a prescription for a non-controlled substance becomes
invalid and must be re-authorized by the prescriber.
(2) When
used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled
substance means that the medication can be refilled in proper context for a period
of one year.
(a) When
this abbreviation is used alone as a means to authorize refills for a controlled
substance, the medication can be refilled in proper context for a period of six
months or five refills, whichever comes first.
(b) When
this abbreviation is used in conjunction with a definite time period, or a specific
number of refills, the non-controlled medication can be refilled in proper context
for a period not to exceed one year.
(3) The prescription
shall not be refilled out of context with the approximate dosage schedule unless
specifically authorized by the prescriber.
(4) A "non-controlled
substance" means those drugs defined as "legend" pursuant to ORS 689.005(29) but
does not include those drugs or substances controlled under the jurisdiction of
the United States Department of Justice Drug Enforcement Administration.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.505 & 689.515
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984,
f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87;
PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB
4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected
2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95;
PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97;
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert.
ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000,
f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f.
& cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. &
cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from
855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
Labeling
855-041-1130
Prescription
Labeling
(1) Prescriptions
must be labeled with the following information:
(a) Name,
address and telephone number of the pharmacy;
(b) Date;
(c) Identifying
number;
(d) Name
of patient;
(e) Name
of drug, strength, and quantity dispensed; when a generic name is used, the label
must also contain the identifier of the manufacturer or distributor;
(f) Directions
for use by the patient;
(g) Name
of practitioner;
(h) Required
precautionary information regarding controlled substances;
(i) Such
other and further accessory cautionary information as required for patient safety;
(j) An expiration
date after which the patient should not use the drug or medicine. Expiration dates
on prescriptions must be the same as that on the original container unless, in the
pharmacist's professional judgment, a shorter expiration date is warranted. Any
drug bearing an expiration date shall not be dispensed beyond the said expiration
date of the drug; and
(k) Any dispensed
prescription medication, other than those in unit dose or unit of use packaging,
shall be labeled with its physical description, including any identification code
that may appear on tablets and capsules.
(l) Upon
written request and for good cause, the Board may waive any of the requirements
of this rule. A waiver granted under this section shall only be effective when it
is issued by the Board in writing.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.505 & 689.515
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984,
f. & ef. 4-16-84; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87;
PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB
4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected
2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95;
PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97;
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert.
ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000,
f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f.
& cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. &
cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10; Renumbered from
855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
855-041-1135
Defines Labeling
and Container Requirements for Repackage Drugs
(1) Drugs prepackaged
by a pharmacy for later own use dispensing on prescription shall be in a container
meeting USP standards and labeled to identify at a minimum:
(a) Brand
name, or generic name and manufacturer;
(b) Strength;
(c) Lot number;
(d) Manufacturer’s
expiration date, or any earlier date which, in the pharmacist’s professional
judgment, is preferable.
(2) An internal
control number which references manufacturer and lot number may be utilized.
Stat. Auth.: ORS
689
Stats. Implemented:
Hist.: PB
6-1987, f. & ef. 5-1-87); Renumbered from 855-041-0056, BP 7-2012, f. &
cert. ef. 12-17-12
855-041-1140
Customized
Patient Medication Packages
In lieu of dispensing two or more prescribed
drug products in separate containers, a pharmacist may, with the consent of the
patient, the patient’s caregiver, or a prescriber, provide a customized patient
medication package (patient med pak). A patient med pak is a package prepared by
a pharmacist for a specific patient comprising a series of containers and containing
two or more prescribed solid oral dosage forms. The patient med pak is so designed
for each container is so labeled as to indicate the day and time, or period of time,
that the contents within each container are to be taken:
(1) Label:
(a) The patient med pak shall
bear a label stating:
(A) The name of the patient;
(B) A serial number for each
patient med pak itself and a separate identifying serial number for each of the
prescription orders for each of the drug products contained therein;
(C) The name, strength, physical
description or identification, and total quantity of each drug product contained
therein;
(D) The directions for use
and cautionary statements, if any, contained in the prescription order for each
drug product therein;
(E) Any storage instructions
or cautionary statements required by the official compedia;
(F) The name of the prescriber
of each drug product;
(G) The date of preparation
of the patient med pak and the beyond-use date assigned to the patient med pak (such
beyond-use date shall be no later than 60 days from the date of preparation);
(H) The name, address, and
telephone number of the dispenser and the dispenser’s registration number
where necessary; and
(I) Any other information,
statements, or warnings required for any of the drug products contained therein.
(b) If the patient med pak
allows for the removal or separation of the intact containers therefrom, each individual
container shall bear a label identifying each of the drug products contained therein.
(2) Labeling: The patient
med pak shall be accompanied by a patient package insert, in the event that any
medication therein is required to be dispensed with such insert as accompanying
labeling. Alternatively, such required information may be incorporated into a single,
overall educational insert provided by the pharmacist for the total patient med
pak.
(3) Packaging:
(a) In the absence of more
stringent packaging requirements for any of the drug products contained therein,
each container of the patient med pak shall comply with the moisture permeation
requirements for a Class B single-unit or unit-dose container. Each container shall
be either not reclosable or so designed as to show evidence of having been opened;
(b) There is no special exemption
for patient med paks from the requirements of the Poison Prevention Packaging Act.
Thus the patient med pak, if it does not meet child-resistant standards shall be
placed in an outer package that does comply, or the necessary consent of the purchaser
or physician, to dispense in a container not intended to be child-resistant, shall
be obtained.
(4) Guidelines: It is the
responsibility of the dispenser, when preparing a patient med pak, to take into
account any applicable compendia requirements or guidelines and the physical and
chemical compatibility of the dosage forms placed within each container, as well
as any therapeutic incompatibilities that may attend the simultaneous administration
of the medications. In this regard, pharmacists are encouraged to report to USP
headquarters any observed or report incompatibilities.
(5) Recordkeeping: In addition
to any individual prescription filing requirements, a record of each patient med
pak shall be made and filed. Each record shall contain, as a minimum:
(a) The name and address
of the patient;
(b) The serial number of
the prescription order for each drug product contained therein;
(c) The name of the manufacturer
or labeler and lot number for each drug product contained therein;
(d) Information identifying
or describing the design, characteristics, or specifications of the patient med
pak sufficient to allow subsequent preparation of an identical patient med pak for
the patient;
(e) The date of preparation
of the patient med pak and the beyond-use date that was assigned;
(f) Any special labeling
instructions; and
(g) The name or initials
of the pharmacist who prepared the patient med pak.
(4) Upon written request,
the Board may waive any of the requirements of this rule if a waiver will further
public health or safety or the health and safety of a patient. A waiver granted
under this section shall only be effective when it is issued by the Board in writing.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: PB 1-1989, f. &
cert. ef. 1-3-89; Renumbered from 855-041-0057, BP 7-2012, f. & cert. ef. 12-17-12;
BP 8-2013, f. & cert. ef. 9-25-13
Dispensing
855-041-1145
New Containers
In filling the original
prescriptions, nothing but new containers may be used. A patient’s original
container may be refilled if clean and the label is legible and up-to-date. The
container shall comply with the current provisions of the Federal Consumer Packaging
Act (Public Law 91-601, 91st Congress, S. 2162) and rules or regulations adopted
thereunder. It must also conform with the current United States Pharmacopoeia/National
Formulary monographs for preservation, packaging, storage and labeling.
[Publications: Publications
referenced are available from the agency.]
Stat. Auth.:
ORS 689
Stats. Implemented:
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80); Renumbered
from 855-041-0055, BP 7-2012, f. & cert. ef. 12-17-12
Records
855-041-1160
Prescription
Records and Retention
(1) Definitions.
The following definitions apply to this rule:
(a) An "original
prescription" is a prescription maintained in the same physical manner in which
a pharmacy first receives the prescription. For example, for a prescription received
by the pharmacy in writing on a prescription form, the original prescription consists
of the original writing on the prescription form. For a prescription received by
the pharmacy orally over the telephone, the original consists of the writing or
electronic record that reflects receipt of the oral prescription.
(b) "Filing"
and "file" mean the storage of the original prescription in such a manner that the
original prescription is safeguarded and readily retrievable.
(2) Every
pharmacy and pharmacist-in-charge of a pharmacy must ensure that original prescriptions
are properly filed in compliance with this rule.
(3) All original
prescriptions shall be filed for a minimum of three years from the date of first
dispensing and shall at all times be open for inspection by the prescriber, and
the Board of Pharmacy or its duly authorized agent.
(4) After
120 days, the paper prescription may be destroyed and filed in an electronic form
if:
(a) The electronic
form shows the exact and legible image of the original prescription;
(b) Notes
of clarifications of and changes to the prescription are directly associated with
the electronic form of the prescriptions; and
(c) The prescription
is not for a controlled substance.
(5) This
rule is not intended to alter or supersede the recordkeeping requirements of any
other federal or Oregon statute or rule, including but not limited to ORS 689.508,
OAR 855-041-1120, and rules related to records for prescriptions for controlled
substances.
(6) Unless
specified otherwise, all records and documentation required by OAR 855 Division
041 must be retained for three years and made available to the Board for inspection
upon request. Records must be stored onsite for at least one year and may be stored
in a secured off-site location if retrievable within three business days. Records
and documentation may be written, electronic or a combination of the two.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.151, 689.155, 689.508
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994,
f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f.
& cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1165
Patient Medical
Record
(1) A patient record
system shall be maintained by pharmacies for all patients for whom prescription
drug orders are dispensed, except for those patients who the pharmacist has good
reason to believe will not return to that pharmacy to obtain drugs. The patient
record system shall provide for readily retrievable information necessary for the
dispensing pharmacist to identify previously dispensed drugs at the time a prescription
drug order is presented for dispensing. The pharmacist shall make a reasonable effort
to obtain, record, and maintain the following information:
(a) Full
name of the patient for whom the drug is intended;
(b) Address
and telephone number of the patient;
(c) Patient's
age or date of birth;
(d) Patient's
gender;
(e) Chronic
medical conditions;
(f) A list
of all prescription drug orders obtained by the patient at the pharmacy maintaining
the patient record showing the name of the drug or device, prescription number,
name and strength of the drug, the quantity and date received, and the name of the
prescriber;
(g) Known
allergies, drug reactions, and drug idiosyncrasies; and
(h) If deemed
relevant in the pharmacist's professional judgment:
(A) Pharmacist
comments relevant to the individual's drug therapy, including any other information
peculiar to the specific patient or drug; and
(B) Additional
information such as chronic conditions or disease states of the patient, the patient's
current weight, and the identity of any other drugs, including over-the-counter
drugs, or devices currently being used by the patient which may relate to prospective
drug review.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.151, 689.155, 689.508
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994,
f. & cert. ef. 2-2-94; BP 3-2005, f. & cert. ef. 4-14-05; BP 2-2008, f.
& cert. ef. 2-20-08; Renumbered from 855-041-0060, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-1170
Grounds for
Discipline
The State Board
of Pharmacy may impose one or more of the following penalties which includes: suspend,
revoke, or restrict the license of an outlet or may impose a civil penalty upon
the outlet upon the following grounds:
(1) Unprofessional
conduct as defined in OAR 855-006-0005;
(2) Advertising
or soliciting that may jeopardize the health, safety, or welfare of the patient
including, but not be limited to, advertising or soliciting that:
(a) Is false,
fraudulent, deceptive, or misleading; or
(b) Makes
any claim regarding a professional service or product or the cost or price thereof
which cannot be substantiated by the licensee.
(3) Failure
to provide a working environment that protects the health, safety and welfare of
a patient which includes but is not limited to:
(a) Sufficient
personnel to prevent fatigue, distraction or other conditions that interfere with
a pharmacist’s ability to practice with reasonable competency and safety.
(b) Appropriate
opportunities for uninterrupted rest periods and meal breaks.
(c) Adequate
time for a pharmacist to complete professional duties and responsibilities including,
but not limited to:
(A) Drug
Utilization Review;
(B) Immunization;
(C) Counseling;
(D) Verification
of the accuracy of a prescription; and
(E) All other
duties and responsibilities of a pharmacist as specified in Division 19 of this
chapter of rules.
(4) Introducing
external factors such as productivity or production quotas or other programs to
the extent that they interfere with the ability to provide appropriate professional
services to the public.
(5) Incenting
or inducing the transfer of a prescription absent professional rationale.
Stat. Auth: ORS
689.151, 689.155(2), 689.205, 689.225(4)
Stats. Implemented:
ORS 689.155
Hist.: BP
2-2012, f. & cert. ef 6-12-12; Renumbered from 855-041-0016, BP 7-2012, f. &
cert. ef. 12-17-12
General Community
Pharmacy
855-041-2100
Operation
of a Double Set-Up Pharmacy in a Retail Drug Outlet
A double set-up
is an establishment having both a retail drug outlet registration and a nonprescription
drug outlet registration. In a double set-up:
(1) The retail
drug outlet (pharmacy) must be a separate operation, completely contained by an
enclosure which assures safe storage. This enclosure must be from floor to ceiling
or be at least ten feet from the floor. This area is to be easily distinguished
by the public. When the retail drug outlet (pharmacy department) is closed, then
as a nonprescription drug outlet the establishment is subject to the provisions
of OAR 855-035-0005 and 855-035-0020.
(2) When
a pharmacist is not in attendance, a closed sign shall be posted at the entrances
stating the hours of the pharmacy's operation. All entrances to the retail drug
outlet shall be closed off and securely locked. Any keys to the retail drug outlet
(pharmacy) shall remain in the possession of the pharmacist-in-charge and other
employee pharmacists as authorized by the pharmacist-in-charge if the retail drug
outlet (pharmacy) is closed while the nonprescription outlet (shopkeeper) remains
open.
(3) Any system
deviating from the requirement of this section, except as provided in OAR 855-041-
6310, shall be approved by the Board prior to implementation. Requests for such
approval shall be in writing and provide a detailed description of the proposed
system. A written description of such system, as approved by the Board, shall be
maintained in the pharmacy.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.205
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1989,
f. & cert. ef. 1-3-89; Administrative correction 9-8-97; Renumbered from 855-041-0035,
BP 7-2012, f. & cert. ef. 12-17-12
855-041-2115
Transfer
of Prescription Information Between Pharmacies
(1) Prescriptions
may be transferred between pharmacies for the purpose of refill dispensing provided
that:
(a) The prescription
is invalidated at the sending pharmacy; and
(b) The receiving
pharmacy obtains all the information constituting the prescription and its relevant
refill history in a manner that ensures accuracy and accountability.
(2) Prescriptions
for controlled substances can only be transferred one time.
(3) Pharmacies
using the same electronic prescription database are not required to transfer prescriptions
for dispensing purposes.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: 1PB
2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1982,
f. & ef. 3-8-82; 1PB 1-1986, f. & ef. 6-5-86; PB 2-1990, f. & cert.
ef. 2-9-90; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); BP 2-1998,
f. & cert. ef. 3-23-98; BP 6-2000, f. & cert. ef. 6-29-00; Renumbered from
855-041-0075, BP 7-2012, f. & cert. ef. 12-17-12
Distribution of Emergency Medication
855-041-2300
Purpose and Scope
The purpose of OAR 855-041-2300 through
855-041-2330 is to define the procedures for distributing emergency medication to
certain authorized individuals for the use in emergency health circumstances. The
authorized person is someone who has been trained under the guidelines set forth
in 333-055-0110.
Stat. Auth: ORS 689.205& 2013 OL
Ch. 340
Stats. Implemented: ORS 689.155
& 2013 OL Ch. 34
Hist.: BP 6-2013(Temp), f.
9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14
855-041-2310
Definitions
The following words and terms, when used
in OAR 855-041-2300 through 855-041-2330 shall have the following meanings, unless
the context clearly indicates otherwise.
(1) “Allergic reaction”
means a medical condition caused by exposure to an allergen, with physical symptoms
that may be life threatening, ranging from localized itching to severe anaphylactic
shock and death.
(2) “Authorization to
Obtain Epinephrine” means a certificate that contains the name, signature,
and license number of the supervising professional authorizing the dispensing of
epinephrine to the individual whose name appears on the certificate. Additionally,
the certificate contains a record of the number of epinephrine orders filled to
date.
(3) “Authorization to
Obtain Naloxone” means a certificate that contains the name, signature, and
license number of the supervising professional authorizing the dispensing of naloxone
to the individual whose name appears on the certificate. Additionally, the certificate
contains a record of the number of naloxone orders filled to date.
(4) “Opiate” means
a narcotic drug that contains: opium, any chemical derivative of opium, or any synthetic
or semi-synthetic drug with opium-like effects.
(5) “Opiate overdose”
means a medical condition that causes depressed consciousness and mental functioning,
decreased movement, depressed respiratory function, and the impairment of vital
functions as a result of ingesting opiates in any amount larger than can be physically
tolerated.
(6) “Statement of Completion”
means a certificate that states the specific type of emergency the trainee was trained
to respond to, the trainee’s name and address, the name of the authorized
trainer and the date that the training was completed.
(7) “Supervising Professional”
means a physician or nurse practitioner licensed to practice in this state who has
prescription writing authority.
(8) “Trainee” means
an individual who has attended and successfully completed the formal training pursuant
to the protocols and criteria established by the Oregon Health Authority, Public
Health Division.
(9) “Trainer” means
an individual conducting the formal training as directed by the supervising professional
and in accordance with the protocols and criteria established by the Oregon Health
Authority, Public Health Division.
Stat. Auth: ORS 689.205 & 2013 OL
Ch. 340
Stats. Implemented: ORS 689.155
& 2013 OL Ch. 340
Hist.: BP 6-2013(Temp), f.
9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14
855-041-2320
Epinephrine
(1) A pharmacist may fill an order for
epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must
be 18 years of age or older and must have responsibility for or contact with at
least one (1) other person as a result of the trainee’s occupation or volunteer
status, such as, but not limited to, a camp counselor, scout leader, forest ranger,
school employee, tour guide or chaperone.
(2) Individuals must successfully
complete a training program approved by the Oregon Health Authority, Public Health
Division. Upon successful completion, the trainee will receive the following certificates:
(a) Statement of Completion;
and
(b) Authorization to Obtain
Epinephrine.
(3)(a) Distribution of epinephrine
from a pharmacy to be used for the treatment of allergic emergencies may occur in
the following manner:
(b) A trainee may obtain epinephrine
upon presentation of the Statement of Completion and Authorization to Obtain Epinephrine
certificate to a pharmacy which:
(A) A pharmacist may generate
a prescription for, and dispense an emergency supply of epinephrine for not more
than one (1) child and one (1) adult in an automatic injection device, as specified
by the supervising professional whose name, signature, and license number appear
on the Authorization to Obtain Epinephrine certificate.
(B) The pharmacist who generates
the hardcopy prescription for epinephrine in this manner shall reduce the prescription
to writing, and file the prescription in a manner appropriate for a non-controlled
substance.
(C) Once the pharmacist generates
the epinephrine prescription, the pharmacist shall write in the appropriate space
provided on the Authorization to Obtain Epinephrine certificate, the date and the
number of doses dispensed, and return the certificate to the trainee.
(4) The Statement of Completion
and the Authorization to Obtain Epinephrine certificate may be used to obtain epinephrine
up to four (4) times within three (3) years from the date of the initial training.
(a) Both the Statement of Completion
and the Authorization to Obtain Epinephrine certificate expire three (3) years from
the date of the trainee’s last Oregon Health Authority approved allergy response
training.
(b) Upon completion of the training,
the trainee will receive a new Statement of Completion and Authorization to Obtain
Epinephrine certificate, with a valid duration of three (3) years.
Stat. Auth: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 6-2013(Temp), f.
9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14
855-041-2330
Naloxone
(1) A Pharmacy may fill orders for unit-of-use
naloxone to be used by trainees for opiate overdose emergencies. Individuals must
successfully complete a training program approved by the Oregon Health Authority,
Public Health Division. Upon successful completion, the trainee will receive the
following certificates:
(a) Statement of Completion;
and
(b) Authorization to Obtain
Naloxone.
(2) Distribution of naloxone
from a pharmacy to be used for opiate overdose emergencies may occur in the following
ways:
(a) A supervising professional
may obtain a supply of naloxone for a program pursuant to a request by the supervising
professional and a pharmacy sale by invoice. The pharmacy shall keep the invoice
on record for three (3) years.
(b) A trainee may obtain naloxone
upon presentation of the Statement of Completion and Authorization to Obtain Naloxone
certificate to a pharmacy which:
(A) A pharmacist may generate
a prescription for, and dispense up to two (2) unit-of-use doses of naloxone as
specified by the supervising professional whose name, signature, and license number
appear on the Authorization to Obtain Naloxone certificate.
(B) The pharmacist who generates
the hardcopy prescription for naloxone in this manner shall reduce the prescription
to writing and file the prescription in a manner appropriate for a non-controlled
substance.
(C) Once the pharmacist generates
the naloxone prescription, the pharmacist shall write in the appropriate space provided
on the Authorization to Obtain Naloxone certificate the date and the number of doses
dispensed, and return the certificate to the trainee.
(3) The Statement of Completion
and Authorization to Obtain Naloxone certificate may be used to obtain naloxone
up to six (6) times within three (3) years from the date of the initial training.
(a) Both the Statement of Completion
and the Authorization to Obtain Naloxone certificate expire three (3) years from
the date of the trainee’s last Oregon Health Authority, Public Health Division
approved naloxone training.
(b) Upon completion of the training,
the trainee will receive a new Statement of Completion and Authorization to Obtain
Naloxone, with a valid duration of three (3) years.
(4) The naloxone container must
be labeled with the following information:
(a) A statement that the naloxone
is intended for use in the Oregon Opiate Overdose Treatment program;
(b) Trainees name; and
(c) Trainer; or
(d) Supervising Professional.
Stat. Auth: ORS 689.205 & 2013 OL
Ch. 340
Stats. Implemented: ORS 689.155
& 2013 OL Ch. 340
Hist.: BP 6-2013(Temp), f.
9-23-13, cert. ef. 9-24-13 thru 3-23-14; BP 2-2014, f. & cert. ef. 1-24-14
Central Fill Drug Outlets, Remote
Processing Drug Outlets and Consulting or Drugless Pharmacies
855-041-3000
Purpose and Scope
(1) The purpose of OAR 855-041-3005 through
855-041-3045 is to provide minimum requirements of operation for centralized prescription
drug filling by a pharmacy.
(2) The purpose of OAR 855-041-3100
through 855-041-3130 is to provide minimum requirements of operation for remote
prescription processing by a pharmacy.
(3) Prior to initiating one
of the above drug outlet models, a description of how the model will be utilized
must be submitted to the Board.
(4) The purpose of OAR 855-041-3300
through 855-041-3340 is to establish a secure environment where a consulting pharmacist
can provide pharmaceutical care and store health protected information in a consulting
or drugless pharmacy. Prior to initiating this model, a description of how the model
will be utilized to improve patient safety must be submitted to the Board.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
Central Fill Drug Outlets
855-041-3005
Purpose and Scope
The purpose of OAR 855-041-3005 through
855-041-3045 is to provide minimum requirements of operation for centralized prescription
drug filling by a pharmacy. Any facility established for the purpose of filling
drug orders on behalf of an Oregon pharmacy shall be licensed as a retail or institutional
drug outlet. An applicant must submit its policies and procedures to the Board of
Pharmacy. An applicant must submit to the Board for approval policies and procedures
and a description of how using central fill will improve patient safety and redirect
a pharmacist at a primary pharmacy from a distributive task to a cognitive task.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3010
Definitions
The following words and terms, when used
in OAR 855-041-3005 through 855-041-3045 shall have the following meanings, unless
the context clearly indicates otherwise. Any term not defined in this section shall
have the definition set out in the OAR chapter 855, division 006.
(1) “Central Fill Pharmacy”
means an Oregon licensed pharmacy that provides centralized prescription filling
for both initial or prescription refills on behalf of a primary pharmacy.
(2) “Primary Pharmacy”
means a pharmacy located and licensed in Oregon that receives a patient’s
or a prescribing practitioner’s request to fill a prescription, dispenses
the prescription directly to the patient or patient’s agent, or the pharmacy
delivers the drug to the patient’s agent for administration. The primary pharmacy
maintains ownership of the prescription.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3015
General Requirements
An Oregon licensed pharmacy may outsource
prescription drug filling to a central fill pharmacy provided that both pharmacies:
(1) Have the same owner; or
(2) Have a written shared pharmacy
services contract or agreement that specifies:
(a) The services to be provided
by each pharmacy;
(b) The responsibilities of
each pharmacy; and
(c) The accountabilities of
each pharmacy.
(3) Maintain a separate Oregon
pharmacy license for each location involved in providing prescription drugs and
services to Oregon patients;
(4) Share a common electronic
file or have appropriate technology or interface to allow access to information
required to fill a prescription drug order;
(5) Establish, maintain and
enforce a policy and procedures manual as required by OAR 855-041-3020;
(6) Ensure that each prescription
has been properly processed and filled and that counseling has been provided to
the patient;
(7) Designate a pharmacist-in-charge.
To qualify for this designation, the person must hold a license to practice pharmacy
in the state of Oregon and in the state in which the pharmacy is located if the
pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with
both licensing boards;
(8) Conduct an annual review
of the written policies and procedures and document such review;
(9) Comply with all applicable
federal and state laws and rules;
(10) Direct all patient communication
to the primary pharmacy.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3020
Policies and Procedures
(1) In addition to the requirements of
OAR 855-041-1040, the central fill pharmacy and the primary pharmacy is each accountable
for establishing, maintaining, and enforcing its written policies and procedures
manual. The policies and procedures manual must include, but need not be limited
to the following:
(a) The responsibilities of
each pharmacy;
(b) The policies and procedures
that protect confidentiality and ensure integrity of patient information;
(c) Compliance with all applicable
federal and state laws and rules;
(d) Cancelation of a filled
prescription after the prescription is filled by the primary pharmacy;
(e) Records sufficient to identify
by name, initials or unique identification code, the identify and specific activities
of each pharmacist or technician who performed any centralized filling function,
and the pharmacy where each activity was performed;
(f) The mechanism for tracking
the prescription drug order during each step in the filling and dispensing process;
(g) Pharmacist completion of
a Drug Utilization Review (DUR) on each prescription;
(h) A continuous quality improvement
program for pharmacy services designed to objectively and systematically monitor
and evaluate the quality and appropriateness of patient care, to pursue opportunities,
to improve patient care, and to resolve identified problems;
(i) Documentation of any errors
or irregularities identified by the quality improvement program;
(2) This manual shall be maintained
at both the central fill and primary pharmacy and must be made available to the
Board upon request.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3025
Labeling
(1) The label affixed to the prescription
container filled by a central fill pharmacy on behalf of the primary pharmacy shall:
(a) Include all information
required by OAR 855-041-1130 and OAR 855-041-1140;
(b) Comply with all labeling
requirements identifying only the primary pharmacy.
(2) If the Central Pharmacy
dispenses the completed prescription to the patient, the label must also comply
with retail labeling requirements in OAR 855-041-1130 through 855-041-1140.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3030
Records
(1) The recordkeeping requirements in OAR
855-041-3005 through 855-041-3045 are in addition to the requirements of other recordkeeping
rules of the Board.
(2) Each recordkeeping system
must include quality improvement program documentation.
(3) Unless otherwise specified,
all records and documentation required by OAR 855-041-3005 through 855-041-3045
must be retained for three years and made available to the Board for inspection
upon request. Records must be stored onsite for at least one year and may be stored,
after one year, in a secured off-site location if retrievable within three business
days. Records and documentation may be kept in hard copy, electronic copy, or a
combination of the two.
(4) Each pharmacy must be able
to produce an audit trail which identifies each prescription process in their pharmacy.
(5) The primary pharmacy shall
maintain the original prescription for a period of three years from the date the
prescription was filled.
(6) The primary pharmacy must
maintain records that:
(a) Identify by prescription
or drug order, the name or unique identification code of the pharmacist who performed
the drug utilization review. Identify by prescription drug order the pharmacist
or technician that transmitted the prescription drug order to the central fill pharmacy.
These records may be maintained separately by each pharmacy and pharmacist or technician
or in a common electronic file, as long as the data processing system is capable
of producing a printout that lists each function performed by each pharmacy and
pharmacist or technician, and identifies the pharmacist or technician who performed
each function;
(b) Document the date the filled
prescription was received from the central fill pharmacy and the name of the person
accepting delivery.
(7) The central fill pharmacy
must maintain records that:
(a) List the name, address,
telephone numbers, and all license and registration numbers of the pharmacies involved
in centralized prescription filling; and
(A) Document verification of
each license and registration; and
(B) Document the name of the
individual responsible for verification of licensure and registration status.
(b) Track the prescription drug
order during each step in the filling process and identify the name, initials, or
unique identification code and specific activity of each pharmacist or pharmacy
technician who performed any portion of the process including transmission, filling,
dispensing and delivery of information.
(A) The date the prescription
was received by the central fill pharmacy;
(B) The name and address where
the filled prescription was shipped;
(C) The method of delivery (e.g.,
private, common, or contract carrier).
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3035
Delivery of Medications
(1) A central fill pharmacy may deliver
or mail medications to the primary pharmacy or patient in compliance with OAR 855-041-1050.
(2) A central fill pharmacy
must comply with all federal and state requirements when using private, common or
contract carriers to transport filled prescriptions for delivery. When a central
fill pharmacy contracts with private, common or contract carriers to transport filled
prescriptions the central fill pharmacy is responsible for reporting any in-transit
loss upon detection by use of DEA Form 106.
(3) A central fill pharmacy
must maintain and use adequate storage or shipment containers and shipping processes
to ensure drug stability and potency. Such shipping processes shall include the
use of packaging material and devices to ensure that the drug is maintained at the
temperature range required to maintain the integrity of the medication throughout
the delivery process.
(4) Filled prescriptions must
be shipped in containers that are sealed in a manner that shows evidence of opening
or tampering.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3040
Filled Prescriptions
(1) Any filled prescription that has not
been picked up, may be put into the primary pharmacy’s inventory. Each pharmacy
is responsible for documenting any such transfer of a drug.
(2) A prescription for a controlled
substance may be filled by a central fill pharmacy when permitted by law, consistent
with federal requirements set forth at 21 C.F.R. § 1300 et seq;
(3) The pharmacy that fills
the prescription and the pharmacy to which the filled prescription is provided for
dispensing to the patient shall each be responsible for ensuring the prescription
has been properly filled.
(4) A primary pharmacy will
notify the patient of the possible use of a central fill pharmacy.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3045
Prohibited Practices
(1) A primary pharmacy may not use the
services of a central fill pharmacy that is not registered with the Board.
(2) A central fill pharmacy
may not fill a prescription on behalf of a primary pharmacy that is not registered
with the Board if the laws and rules of Oregon require the primary pharmacy to be
registered with the Board.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
Remote Processing Drug Outlets
855-041-3100
Purpose and Scope
The purpose of OAR 855-041-3100 through
855-041-3130 is to provide minimum requirements of operation for remote prescription
drug processing by a pharmacy. Any facility that processes drug orders on behalf
of an Oregon pharmacy shall be licensed in Oregon as a retail or institutional drug
outlet. An applicant must submit its policies and procedures to the Board of Pharmacy.
An applicant must submit to the Board for approval policies and procedures and a
description of how using remote processing will improve patient safety.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3105
Definitions
The following words and terms, when used
in OAR 855-041-3100 through 855-041-3130, shall have the following meanings, unless
the context clearly indicates otherwise. Any term not defined in this section shall
have the definition set out in OAR chapter 855, division 006.
(1) “Remote Processing
Pharmacy” means an Oregon licensed pharmacy operated under the direction of
a pharmacist-in-charge that processes information related to the practice of pharmacy
and engages in remote prescription processing, including central processing.
(2) “Remote Processing
Functions” may include, but are not limited to, data entry, prospective drug
utilization reviews, refill authorizations and interventions. This does not include
the filling process.
(3) “Primary Pharmacy”
means an instate Oregon licensed pharmacy that receives a patient’s or a prescribing
practitioner’s request to fill a prescription or drug order and delivers the
drug or device directly to the patient or patient’s agent, and maintains ownership
of the prescription or drug order.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3110
General Requirements
An Oregon licensed pharmacy may outsource
prescription drug processing to a remote processing pharmacy provided both pharmacies:
(1) Have the same owner; or
(2) Have a written shared pharmacy
services contract or agreement that specifies:
(a) The services to be provided
by each pharmacy;
(b) The responsibilities of
each pharmacy; and
(c) The accountabilities of
each pharmacy.
(3) Maintain a separate Oregon
pharmacy license for each location involved in providing services;
(4) Share a common electronic
file or have appropriate technology or interface to allow access to information
required to process and fill a prescription drug order;
(5) Establish, maintain and
enforce a policy and procedures manual as required by OAR 855-041-3115;
(6) Ensure that each prescription
has been properly processed, filled and counseling has been provided to the patient;
(7) Designate a pharmacist-in-charge.
To qualify for this designation, the person must hold a license to practice pharmacy
in the state of Oregon and in the pharmacy’s resident state if the pharmacy
is out-of-state. The pharmacist-in-charge must be in good standing with both licensing
Boards;
(8) Allow prospective drug utilization
reviews, refill authorizations, interventions, and patient counseling for an Oregon
patient must be performed only by a licensed pharmacist in Oregon or in the state
in which the pharmacy is located;
(9) Ensure that each technician
processing an order for an Oregon patient is a Certified Oregon Pharmacy Technician
and is supervised by a licensed pharmacist or is a licensed technician in the state
in which the pharmacy is located and is supervised by a licensed pharmacist in the
state in which the pharmacy is located;
(10) Comply with all applicable
federal and state laws and rules;
(11) Conduct an annual review
of the written policies and procedures and document such review.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3115
Policies and Procedures
(1) In addition to the requirements of
OAR 855-041-1040, the primary and the remote processing pharmacy is each accountable
for establishing, maintaining, and enforcing its own written policies and procedures
manual. The policies and procedures manual must include, but need not be limited
to the following:
(a) The responsibilities of
each pharmacy;
(b) The policies and procedures
that protect confidentiality and ensure the integrity of patient information;
(c) Compliance with all applicable
federal and state laws and rules;
(d) Records sufficient to identify
by name, initials, or unique identification code, the identity and the specific
activities of each pharmacist or technician who performed any processing function,
and the location where each activity was performed;
(e) A continuous quality improvement
program for pharmacy services designed to objectively and systematically monitor
and evaluate the quality and appropriateness of patient care, to pursue opportunities
to improve patient care, and to resolve identified problems; and
(f) Documentation of any errors
or irregularities identified by the quality improvement program.
(2) The written policies and
procedures manual shall be maintained at all pharmacies involved in remote processing
and must be available to the Board upon request.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3120
Records
(1) The recordkeeping requirements OAR
855-041-3100 through 855-041-3130 are in addition to the requirements of other recordkeeping
rules of the Board.
(2) The remote processing pharmacy
must maintain all required records unless these records are maintained in the primary
pharmacy.
(3) Both recordkeeping systems
must:
(a) List the name, address,
telephone number, and all license and registration numbers of each pharmacy involved
in remote prescription processing;
(A) Document verification of
each license and registration;
(B) Document the name of the
individual responsible for verification of licensure and registration status.
(b) Identify by name, initials,
or unique identification code the identity and the specific activities of each pharmacist
or technician who performed any part of the prescription process;
(c) Include quality improvement
program documentation;
(d) Be able to produce an audit
trail showing each prescription process.
(4) Unless otherwise specified,
all records and documentation required by these rules, must be retained for three
years and made available to the Board for inspection upon request. Records must
be stored onsite for at least one year and may be stored, after one year, in a secured
off-site location if retrievable within three business days. Records and documentation
may be written, electronic or a combination of the two;
(5) The primary pharmacy shall
maintain records that:
(a) Indicate the date the request
for processing was transmitted to the remote processing pharmacy; and
(b) Indicate the date the prescription
information was received by the primary pharmacy.
(6) The remote processing pharmacy
shall maintain records that:
(a) Track the prescription drug
order during each step in the order entry process;
(b) Identify the name, initials,
or unique identification code and the specific activity of each pharmacist or pharmacy
technician who performed any activity related to processing the prescription including
receipt, transmission or delivery of information.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3125
Prescription or Drug Order Processing
A prescription or drug order for a controlled
substance may be processed by a remote processing pharmacy when permitted by law
and consistent with federal rules.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3130
Prohibited Practices
A remote processing pharmacy may not process
a prescription on behalf of a primary pharmacy that is not registered with the Board,
if required by the laws and rules of Oregon to be registered.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
Consulting or Drugless Pharmacies
855-041-3300
Purpose and Scope
The purpose of OAR 855-041-3300 through
855-041-3340 is to establish a secure environment where a consulting pharmacist
can provide pharmaceutical care and store health protected information in a single
physical location. This location may be an office located in a home or other secure
location. Registration is not required if records used or generated by a consulting
pharmacist are stored in a location registered by the Board as a retail or institutional
drug outlet or if the location is under the control of a practitioner who uses the
services of the consulting pharmacist. The consulting pharmacist must be able to
provide the Board with documentation of their pharmaceutical care activities. These
rules are intended to ensure that a location where a pharmacist is engaged in Independent
Pharmacy Practice may safely store records and protected health information. An
applicant must submit to the Board for approval policies and procedures and a description
of how their consulting or drugless pharmacy will be utilized to improve patient
safety.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3305
Definitions
The following words and terms, when used
OAR 855-041-3300 through 855-041-3340 shall have the following meanings, unless
the context clearly indicates otherwise. Any term not defined in this section shall
have the definition set out in the OAR chapter 855, division 6.
(1) “Consulting or Drugless
Pharmacy” means any single physical location where pharmaceutical care services
are performed or protected health information may be stored without the storage,
possession, or ownership of any drug.
(2) “Consulting Pharmacist”
means any pharmacist as defined by OAR chapter 855, division 6 and is described
by chapter 855, division 19.
(3) “Independent Pharmacy
Practice” means the provision of pharmaceutical services not related to physically
handling or dispensing pharmaceuticals drugs or devices. This practice is characterized
by the practice of an Oregon licensed pharmacist acting as an independent contractor
whether or not directly employed or affiliated with an entity that is licensed by
the Board. This service also does not include the provision of pharmaceutical care
that is conducted within the physical confines or location of a licensed pharmacy
registered with the Board.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3310
Registration
(1) The Consulting Pharmacy shall be registered
as a retail or institutional drug outlet and comply with all the requirements of
licensure as defined in OAR 855-041-1080 through 855-041-1100.
(2) The location must be available
for inspection by the Board.
(3) A consulting pharmacist
for an Oregon licensed healthcare facility must perform all duties and functions
required by the healthcare facility's licensure, as well as any applicable federal
and state laws and rules.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3315
Personnel
(1) Each pharmacy must have a pharmacist-in-charge.
To qualify for this designation, the person must hold a license to practice pharmacy
in the state of Oregon and in the state in which the pharmacy is located if the
pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with
both licensing Boards;
(2) The pharmacy must comply
with all applicable state and federal laws and rules governing the practice of pharmacy
and maintain records in compliance with requirements of federal law and Board rules;
(3) A consulting pharmacist
who provides services to any person or facility located in Oregon, must be an Oregon
licensed pharmacist except that a pharmacist working in an out-of-state pharmacy,
who only performs the professional tasks of interpretation, evaluation, DUR, counseling
and verification associated with their dispensing of a drug to a patient in Oregon;
and
(4) Prospective drug utilization
reviews, refill authorizations, interventions and patient counseling not associated
with the dispensing of a drug for an Oregon patient must be performed by an Oregon
licensed pharmacist.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3320
Confidentiality
(1) Each consulting pharmacy must comply
with all applicable federal and state laws and rules regarding confidentiality,
integrity and privacy of patient information.
(2) Each consulting pharmacy
must ensure that electronic data systems are secure and comply with applicable federal
and state laws and rules.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3325
General Provisions and Minimum Standards
(1) A consulting pharmacy shall:
(a) Maintain appropriate reference
materials for drug information according to the scope of consulting services.
(b) Be located in a secure room
with a door and suitable lock, and accessible only to persons authorized by the
pharmacist-in-charge.
(c) Provide storage sufficient
to secure confidential documents and any hardware necessary to access information.
(d) Be constructed in a manner
of materials that make the space separate and distinct from the rest of the home
or office building, and that protects the records from unauthorized access.
(2) A consulting pharmacy located
in a residence must be approved by the Board.
(3) The consulting pharmacist
must be able to provide the Board, upon request, with documentation of their pharmaceutical
care activities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3330
Security Requirements
(1) All consulting services must occur
in a secure environment that includes but is not limited to:
(a) A closed system or other
electronic storage device that is password protected;
(b) A secure room or safe that
is locked to store records when the pharmacist is not directly monitoring them;
(c) Sufficient encryption for
securing confidential documents and any hardware used in accessing authorized patient
health information by electronic connection; and
(d) A data processing system
that complies with all federal and state laws and rules to ensure compliant security
software.
(2) Records stored at a practitioner’s
office must be kept secure either with other records at the facility or independently
in a locked room where only the pharmacist, and physician and their agents have
access;
(3) All records must be stored
at the approved consulting or drugless pharmacy; and
(4) Any breach in the security
of the system or breach of confidentiality must be documented and reported to the
Board within seven days.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3335
Policies and Procedures
The consulting pharmacy must maintain a
current policy and procedures manual that includes at a minimum:
(1) A policy on protecting confidentiality
and integrity of patient information;
(2) An outline of responsibilities
and scope of services;
(3) A policy on compliance with
federal and state laws and rules;
(4) An operational Quality Assurance
Program;
(5) A policy that describes
use of computer systems.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
855-041-3340
Records
(1) The recordkeeping and storage requirements
in OAR 855-041-3300 through 855-041-3340 are in addition to the requirements of
other recordkeeping and storage rules of the Board. Records and documentation may
be written, electronic or a combination of the two.
(2) Each recordkeeping system
must include quality improvement program documentation;
(3) The PIC must ensure maintenance
of written or electronic records and reports as necessary to ensure patient health,
safety, and welfare. Records must include but need not be limited to:
(a) Patient profiles and records;
(b) A list of current employees
and their license numbers;
(A) Verification of each license
and registration;
(B) The name of the individual
responsible for verification of licensure and registration status.
(c) Copies of all contracts
for consulting services and collaborative therapy agreements;
(d) Copies of all consultation
reports submitted to practitioners and facilities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 10-2013, f. &
cert. ef. 11-6-13
Expedited Partner
Therapy
855-041-4000
Purpose
(1) There is substantial
evidence that rates of re-infection with certain sexually transmitted diseases can
be reduced by treating all sexual partners for the disease, even when the treating
clinician has not examined those partners. This practice is known as Expedited Partner
Therapy.
(2) Because
of the important public health implications, the 2009 Oregon Legislature passed
HB 3022 authorizing this practice. This law permits health professional regulatory
boards to adopt rules permitting practitioners to practice Expedited Partner Therapy.
(3) The law
specifies that a prescription issued in the practice of Expedited Partner Therapy
is valid, even if the name of the patient the prescription is intended for is not
on the prescription.
Stat. Auth.: ORS
689.205
Stats. Implemented:
2009 OL Ch 522
Hist.: BP
1-2010, f. & cert. ef. 2-8-10
855-041-4005
Procedures
(1) Expedited Partner
Therapy (EPT) means the practice of prescribing or dispensing an antibiotic drug
for the treatment of a sexually transmitted disease to the partner of a patient
without first examining that partner.
(2) Notwithstanding
any other rules in this division that mandate requirements for a valid prescription
and for labeling, when a prescription is marked EPT or a similar notation by the
prescribing practitioner, this rule shall govern.
(3) An EPT
prescription may only be dispensed for a drug that has been determined by the Department
of Human Services (DHS) to be appropriately used for EPT.
Prescription
(4) An EPT
treatment protocol must conform to the following:
(a) It must
include a prescription for each named or unnamed partner of the patient;
(b) It must
contain a hand written or electronic signature of the prescribing practitioner;
(c) The practitioner
must identify the prescription in the following manner:
(A) Write
“for EPT,” or a similar notation, on the face of the prescription;
(B) For a
verbal order, the practitioner must identify the prescription as an “EPT Prescription,”
or similar identification;
(C) The practitioner
must identify the prescription for each partner either by including the name of
the patient, such as “John Doe – Partner 1” or by labeling the
prescription as “EPT Partner”
(d) An EPT
Prescription expires 30 days after the date written;
(e) An EPT
Prescription may not be refilled;
(f) If any
component of the prescription is missing, the pharmacist must contact the prescriber
or the prescriber’s agent and must record the additional information on the
prescription.
(5) A patient
may give the prescription to each unnamed partner for that person to fill at a pharmacy
of their choice; or the patient may give all prescriptions to one pharmacy and then
give the dispensed drugs to each unnamed partner.
Labeling
(6) The pharmacist
must label the drug for the named patient in accordance with normal procedures as
specified in the other rules of this division, however when either the patient or
partner is unnamed, the pharmacy may create a unique identifier and use that instead
of a name for both labeling and record keeping purposes.
(7) The pharmacist
must assign a separate and unique identifier to each prescription and clearly identity
this number on each corresponding prescription label.
Counseling
(8) The pharmacist
is not required to obtain an EPT patient’s or partner’s name, address,
or demographics; however, the pharmacist must:
(a) Provide
counseling in the form of written patient information to accompany each prescription
for each partner and ask the patient about any known allergies or other drugs being
taken by each partner. The pharmacist should advise the patient to encourage each
partner to call the pharmacist before taking the drug if they have experienced any
adverse effect from a drug in the past or if they are taking other drugs;
(b) Document
counseling.
Records
(9) All documentation
required by this rule must be attached to the prescription and must be referenced
to each partner’s prescription. Such documentation must be retained in accordance
with the other rules in this division and must be made available to the Board upon
request.
Stat. Auth.: ORS
689.205
Stats. Implemented:
2009 OL Ch 522
Hist.: BP
1-2010, f. & cert. ef. 2-8-10
Retail Drug Outlet
for Home Dialysis Supplies
855-041-4025
Purpose and
Scope
A Retail Drug Outlet
for Home Dialysis supplies may provide dialysis solutions under the general supervision
and direction of a pharmacist with special training in renal disease and dialysis
to end stage renal disease (ESRD) patients who have chosen the option of home dialysis
therapy and who have been appropriately trained.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0350, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-4035
Definitions
“Dialysis
solutions” means peritoneal dialysis solutions, dialysate solutions, and legend
devices including hardware, bloodlines and dialysis tubing and connectors.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0355, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-4045
Drug Delivery
and Control
(1) An Oregon licensed
pharmacist must be designated as the pharmacist-in-charge who will provide direction
and supervision of the operation and staff.
(2) Deliveries
of supplies must be made only pursuant to a current prescription order from an authorized
prescriber. The prescription order must be maintained on file at the outlet. Supplies
will be limited to dialysis solutions as defined in OAR 855-041 — 4035. No
other legend medication ordered for the patient may be provided by the outlet.
(3) All patient
records must be maintained in a secure area with a locking door. Access to the patient
records area is allowed only when a pharmacist is present except in the event of
an emergency. In the event of an emergency, any entry by individuals other than
the pharmacist must be documented. In the absence of a pharmacist, the door to the
patient records area must remain locked at all times.
(4) Copies
of all prescriptions must be reviewed by the pharmacist and a complete set of prescription
records for all patients serviced by the outlet must be maintained in the patient
records area for a minimum of three years.
(5) A minimum
of two current reference books that are specific and relevant to dialysis therapy
must be maintained in the outlet to assist in the appropriate delivery of care to
patients. Other reference material and equipment must be maintained to be consistent
with the scope of services provided by the outlet.
(6) A current
copy of Oregon Revised Statutes, Chapter 689, a current copy of Oregon Administrative
Rules, chapter 855, and a minimum of three years of the Oregon Board of Pharmacy
quarterly newsletters must be maintained in a loose leaf binder or other readily
retrievable means.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0360, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-4055
Duties of
the Pharmacist
(1) The pharmacist-in-charge
must review, at least weekly, the drug outlet operation and perform, at least monthly,
quality assurance audits that include the review of prescription orders prior to
delivery for accuracy and completeness, and the review of the assembled order with
the prescription order prior to delivery for accuracy and completeness.
(2) The pharmacist-in-charge
is responsible for the following on an ongoing basis:
(a) Ensure
compliance of dialysis distribution operation to all applicable federal and state
pharmacy laws and rules;
(b) Ensure
valid prescriptions are received for all patient orders by performing periodic assessments
of prescription files;
(c) Perform
periodic assessments of distribution processes and procedures to ensure quality
and compliance;
(d) Provide
pharmaceutical care by reviewing all patient profiles and performing drug therapy
assessments on those identified as abnormal;
(e) Provide
pharmaceutical care by responding on a toll free telephone access to questions received
from any patient or health care provider;
(f) Maintain,
update and train personnel on policies and procedures specific to home dialysis
patient deliveries and pharmacy requirements;
(g) Prepare
educational materials for staff members of dialysis clinics as requested;
(h) Prepare
and maintain on file monthly reports of activities performed;
(i) Ensure
security of the patient record area; and
(j) Maintain
a policy and procedure manual for the Drug Outlet operation that must include written
protocols for the product delivery system, methods for supervising deliveries to
patients, and a quality assurance program with which to monitor the qualifications,
training and performance of personnel.
(3) The pharmacist-in-charge
must perform an annual inspection of the outlet on a form provided by the Board,
and must provide a copy of this inspection to the Board upon request.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
8-2000, f. & cert. ef. 6-29-00; Renumbered from 855-041-0365, BP 7-2012, f.
& cert. ef. 12-17-12
Remote Dispensing
855-041-4100
Definitions
(1) "Automated Pharmacy
System" (APS) means a mechanical system that performs operations or activities,
including but not limited to, those related to the storage, packaging, dispensing,
or distribution of medications, but not including compounding or administration,
and that collects, controls, and maintains all transaction information.
(2) "Remote
Dispensing Facility" (RDF) means a facility where drugs are prepared for administration
and where requisite pharmacist supervision is provided remotely as approved by the
Board.
(3) "Remote
Dispensing Machine" (RDM) means a component of an Automated Pharmacy System that
contains prepackaged drugs for dispensing.
(4) "Responsible
Pharmacy" means the licensed pharmacy that is responsible for the APS, and RDM.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
2-2005, f. 2-14-05, cert. ef. 3-1-05; BP 9-2010(Temp), f. & cert. ef. 7-9-10
thru 12-24-10; Administrative correction 1-25-11; BP 3-2011, f. & cert. ef.
4-18-11; Renumbered from 855-041-0600, BP 7-2012, f. & cert. ef. 12-17-12
855-041-4110
Duties and
Responsibilities of the Pharmacist-in-Charge.
Each RDM must be
under the supervision of the Pharmacist-in-Charge of the Responsible Pharmacy. The
Pharmacist-in-Charge must:
(1) Develop
written policies and procedures prior to installation of the RDM that:
(a) Ensure
safety, accuracy, security, and patient confidentiality;
(b) Define
access to the RDM and to medications contained within or associated with the RDM,
including but not limited to policies that assign, discontinue, or change access
to the RDM and medications.
(c) Ensure
that access to the medications complies with state and federal laws and regulations.
(2) Obtain
written approval by the Board prior to installing any RDM.
(3) Train
all personnel who will access the APS (including the RDM) before being allowed access
to the APS. Training must ensure the competence and ability of all personnel who
operate any component of the APS. Documentation of original training and continuing
education must be kept both in the pharmacy and at the site of the RDM, and readily
available for inspection by the Board.
(4) Ensure
that the RDM is in good working order and accurately dispenses the correct strength,
dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping
and security safeguards.
(5) Implement
an ongoing quality assurance program that monitors performance of the APS, including
the RDM, and the personnel who access it.
(6) Notify
the Board within 15 days of removal or closure of the RDM and the disposition of
drugs contained in the RDM before it was removed or closed.
(7) Ensure
that the RDM is stocked accurately and in accordance with established, written policies
and procedures. A pharmacist must check the accuracy of the product supplied for
stocking the machine.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.205
Hist.: BP
2-2005, f. 2-14-05, cert. ef. 3-1-05; Renumbered from 855-041-0610, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-4120
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 registered technician or an Oregon licensed pharmacist may have access
to the RDM.
(7) Only
an Oregon registered technician or an Oregon licensed pharmacist 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 855-019-0230, 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.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.205
Hist.: BP
2-2005, f. 2-14-05, cert. ef. 3-1-05; Renumbered from 855-041-0620, BP 7-2012, f.
& cert. ef. 12-17-12
Remote Dispensing Facilities
855-041-4200
Remote Dispensing
Facility (RDF)
(1) A pharmacy physically located in Oregon
may make written application to operate an RDF.
(2) At its discretion, the Board
may approve an application for registration as an RDF which includes the following:
(a) An operation plan;
(b) Policies and Procedures;
(c) A training plan;
(d) A quality assurance plan
for ensuring that there is a planned and systematic process for the monitoring and
evaluation of the quality and appropriateness of pharmacy services and for identifying
and resolving problems; and
(e) The fee specified in OAR
855-110-0007(14).
(3) Notwithstanding the definition
of “supervision by a pharmacist” in OAR 855-006-0005, supervision in
an RDF may be accomplished by a pharmacist via an audio-visual technology from the
applying pharmacy.
(4) Notwithstanding rules in
this division and in Division 19, a Certified Pharmacy Technician who works in an
RDF may have access to the facility without the physical presence of a pharmacist,
but may only perform Board approved functions when under the supervision of a pharmacist.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2011, f. &
cert. ef. 4-18-11; Renumbered from 855-041-0645, BP 7-2012, f. & cert. ef. 12-17-12;
BP 1-2014, f. & cert. ef. 1-3-14
Residential Drug
Outlets
855-041-5005
Definitions
For purposes of
these rules, OAR 855-041-5000 through 855-041-9999 the following definitions apply:
(1) "Institutional
Facility" means a hospital or other health care facility which is an inpatient care
facility referred to in ORS 442.015, which includes long-term care facilities and
special inpatient care facilities, and such facility is licensed by the appropriate
state agency. For the purpose of this rule, an Institutional Facility is a Residential
Drug Outlet.
(2) "Institutional
Pharmacy" means a pharmacy where medications are dispensed to other health care
professionals for administration to institutionalized patients served by an institutional
facility, and which is:
(a) Located
within the institutional facility;
(b) Located
outside the facility but provides pharmaceutical services to institutionalized patients;
and
(c) For the
purpose of this rule, an Institutional Pharmacy is a Residential Pharmacy.
(3) "Drug
Room" means a secure and lockable location within an inpatient care facility that
does not have a pharmacy.
(4) "Pharmaceutical
Service" means the control of the utilization of drugs, biologicals and chemicals
including procuring, manufacturing, compounding, dispensing, distribution and storing
of drugs, biologicals and chemicals under the conditions prescribed by this rule.
The provision of drug information to patients and to other health professionals
is included within the meaning of pharmaceutical services.
(5) "Supervision"
means stationed within the same work area, coupled with the ability to control and
be responsible for an action.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: 1PB
2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90; Renumbered from
855-041-0105 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5015
Registration
All residential
drug outlets shall register annually with the Board of Pharmacy. Residential drug
outlets which also provide outpatient pharmacy services shall also register as retail
drug outlets.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: 1PB
2-1980, f. & ef. 4-3-80; Renumbered from 855-041-0115 by BP 1-2012, f. 4-26-12,
cert. ef. 5-1-12
Technician Checking
Validation Program (TCVP)
NOTE: The TCVP is a tool
to allow the re-direction of a pharmacist from a distributive task to a cognitive
task. It is designed to allow a pharmacist to improve patient safety by focusing
on assessing the accuracy and appropriateness of the medications ordered and on
educating staff and patients. The development of individualized training programs
is the responsibility of each pharmacy in order to tailor the program to the patient
population and medication distribution system of the institution. Assessment questions
must be tailored to the site and be changed periodically as appropriate. It is the
responsibility of the pharmacist-in-charge to ensure that all training is completed
and documented prior to a technician performing as a technician checker.
855-041-5100
Definitions
(1) “Error”
in Automated Distribution Cabinet (ADC) is any occurrence of a wrong drug, dose,
quantity, or dosage form or the inclusion of any drug with an expired date in a
line item. All errors in a line item counts as one error.
(2) “Error”
in a unit of use cart is any occurrence of a wrong drug, dose, quantity, or dosage
form or the inclusion of any drug with an expired date. All errors in any single
dose count as one error.
(3) “Line
Item” is a checking unit for ADC restocking (example: one specific drug and
dose, regardless of quantity).
(4) “Technician
Checker” is an Oregon certified technician who has completed the TCVP validation
process and is currently authorized to check another technician’s work.
(5) “Technician
Checking Validation Program (TCVP)” is a program that uses a technician checker
to check functions completed by another technician.
(6) “Unit
Dose” is the physical quantity of a drug product designed to be administered
to a patient specifically labeled to identify the drug name, strength, dosage amount
and volume, if applicable. The unit dosed drug can be obtained from the manufacturer
or repackaged from an external re-packager. A drug may be repackaged on-site through
a batch repackaging process that includes a pharmacist as a check. Unit dose examples
include oral solids individually packaged by a manufacturer or re-packaged, oral
liquids drawn up in a labeled oral syringe, all individually labeled injectable
products, and pre-mixed IV products.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5120
Hospital
and Pharmacist in Charge Requirements
(1) Only a hospital
pharmacy may apply to participate in a TCVP. To participate in the TCVP, the hospital
pharmacy must meet the following requirements:
(a) The hospital
pharmacy must develop policies and procedures for the TCVP to include a list of
high-risk medications that are excluded from the TCVP. The policies and procedures
for the TCVP must be available in the pharmacy for board inspectors.
(b) The hospital
pharmacy must obtain approval from the appropriate committee before the TCVP can
be implemented;
(c) The hospital
pharmacy must have a drug distribution system that is structured to allow for one
additional check of the distributed medications by a licensed nurse or other licensed
health care professional with authority to administer medications after the delivery
of checked medications; and
(d) The Pharmacist-in-Charge
is responsible for the TCVP and will document any error, or irregularity in the
quality assurance documentation records.
(2) A hospital
may not operate a TCVP without prior written approval from the Oregon Board of Pharmacy.
To apply for approval, the hospital must submit the following to the Board:
(a) Copies
of written training material that will be used to train technicians as technician
checkers;
(b) Copies
of quality assurance documentation records and forms that will be used to evaluate
the technician checkers and the proposed TCVP;
(c) Copies
of the policy and procedures for the proposed TCVP; and
(d) A description
of how the proposed TVCP will improve patient safety by focusing on assessing the
accuracy and appropriateness of the medications ordered and on educating staff and
patients.
(e) Other
items as requested by the Board.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5130
Technician
Eligibility and Training
(1) Only Oregon
certified technicians who undergo specific training may work as technician checkers.
The training must include the following:
(a) A minimum
of one year of drug distribution experience;
(b) Didactic
lecture or equivalent training with a self-learning packet;
(c) Practical
sessions that consist of individual training in checking a cart fill or ADC that
is provided by a pharmacist; and
(d) Initial
Validation Process as described in OAR 855-041-5140(1).
(2) The practical
training sessions must include:
(a) The trainee
observing a technician checker or pharmacist performing the checking process that
the trainee is learning;
(b) The trainee
performing the initial check with a pharmacist verifying all doses;
(c) The trainee
completing the validation process with a pharmacist verifying all doses;
(d) The introduction
of artificial errors into a live or simulated environment, to monitor the ability
of the technician to catch errors. Artificial errors introduced into the live environment,
which are not corrected by the technician, must be removed.
(e) The pharmacist
must document and notify a technician checker of any errors found during training.
(3) If at
any time a TCVP technician loses his or her validation the technician must be retrained
and revalidated before acting as a technician checker.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5140
Initial Validation
Process and Quality Assurance Process
(1) Initial Validation
Process: The initial process to validate a trainee’s ability to accurately
check another technician’s work must include:
(a) Unit
of Use: For initial validation of a trainee to check a unit of use cart fill, the
trainee must obtain a 99.8% accuracy rate in 1500 total doses, divided among five
separate training checks. A trainee who makes more than three errors in 1500 doses
fails the validation and may not work as a technician checker until the checking
process is repeated and until successfully completed.
(A) In each
initial validation check, a pharmacist must check the accuracy of all unit of use
medications after the trainee has checked them. The pharmacist must document any
errors in the unit of use cart and discuss them with the trainee.
(B) In each
initial validation check, the pharmacist will introduce at least three errors. The
pharmacist coordinating the training check will keep a record of the introduced
errors and will ensure that all introduced errors are removed before medications
are distributed.
(C) The pharmacist
must document the results of each initial validation check and retain the results
in the quality assurance file.
(b) ADC or
non-emergent trays and kits: For initial validation of a trainee to fill ADC or
non-emergent trays and kits, the trainee must obtain a 99.8% accuracy rate in 500
total line items, divided among five separate training checks. A trainee who makes
more than one error in 500 line items fails the validation and may not work as a
technician checker until the checking process is repeated and until successfully
completed.
(A) In each
initial validation check, a pharmacist must check the accuracy of all ADC or non-emergent
tray or kit medications after the trainee has checked them. The pharmacist must
document any errors and discuss them with the trainee.
(B) In each
initial validation check, the pharmacist will artificially introduce at least three
errors. The pharmacist will keep a record of the introduced errors and will ensure
that all introduced errors are removed before medications are distributed.
(C) The pharmacist
must document the results of each initial validation check and retain the results
in the quality assurance file.
(2) Quality
Assurance Process: The Quality Assurance Process that ensures on-going competency
of technician checkers must include:
(a) Quality
checks conducted in the same manner as the applicable initial validation process
described in section one of this rule, except that the quality check sample must
consist of at least 300 doses for technicians checking unit of use carts and at
least 100 line items for technicians checking ADC or non-emergent trays and kits.
(b) The quality
checks must occur on random and unannounced dates and times.
(c) A technician
checker who makes more than one error fails the quality check and may not work as
a technician checker unless the technician first passes a second quality check within
30 days of the failed quality check. If the technician does not pass the second
quality check within 30 days, the technician must be retrained and revalidated before
working as a technician checker.
(d) The results
of each quality check must be documented, including the total number of doses or
line items checked, a description of each error, the total number of errors, and
the percent error rate. Documentation must be retained in the quality assurance
file.
(3) Timing
and Frequency of Quality Checks: A technician checker must undergo a quality check
at least monthly. A technician checker who has successfully completed three consecutive
monthly quality checks must be checked at least quarterly for at least one year.
A technician checker who has successfully completed four consecutive quarterly quality
checks must be checked at least every six months.
(4) A technician
checker who does not perform TCVP duties for more than six months must undergo initial
validation as described in section one of this rule.
(5) A description
of the quality assurance process must be included in the hospital’s and the
pharmacy’s quality assurance program and error reporting system.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5150
Checking
Procedure
(1) A technician
checker must use the following procedure when checking another technician’s
work:
(a) A pharmacy
technician fills the medication for the cart fill or ADC restocking batch or non-emergent
trays and kits.
(b) A technician
checker must check the accuracy of cart fill batches or ADC or non-emergent trays
and kits. The technician checker shall review the medications for the correct drug,
dose, dosage form, and quantity and must review the expiration dates of medications.
(c) If the
technician checker discovers a filling error the technician checker must record
the error and return the product to the technician who originally filled it, if
available, or to another technician. The filling technician must correct the error
and the technician checker must check the correction. A pharmacist or another technician
checker must check any cart fill batches, ADC or non-emergent tray or kit, or medication
corrections filled by a technician checker
(d) If a
technician checker is not available, then all doses must be checked by a pharmacist.
(2) This
checking process continues until all doses have been checked and determined to be
correct.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5160
Eligible
Specialized Functions
(1) The following
specialized functions are eligible for participation in the TCVP:
(a) Cart
fill;
(b) ADC batch
replacement; and
(c) Non-Emergent
kits and trays.
(2) Upon
written request, the Board may permit additional specialized functions if to do
so will further public health or safety. A waiver granted under this section shall
be effective only when issued in writing and approved by the Board.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
855-041-5170
Records
(1) Unless specified
otherwise, all records and documentation required by these rules must be retained
for three years and made available to the Board for inspection upon request. Records
must be stored onsite for at least one year and may be stored in a secured off-site
location if retrievable within three business days. Records and documentation may
be written, electronic or a combination of the two.
(2) The PIC
must ensure maintenance of written or electronic records and reports as necessary
to ensure patient health, safety and welfare. Records must include:
(a) Technician
checker training documents;
(b) List
of high risk medications;
(c) Documentation
of any errors, irregularities and results of each initial validation check.
(d) Documentation
of quality assurance and forms used to evaluate the technician checker including:
(A) Total
number of doses or line item checks;
(B) Description
of errors;
(C) Total
number of errors; and
(D) Percent
error rate.
(e) Documentation
of the initial validation check.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
1-2012, f. 4-26-12, cert. ef. 5-1-12
Hospitals with
Pharmacies
855-041-6050
Definitions
(1) In these rules,
OAR 855-041-6000 through 855-041-6999, the terms below have these meanings:
(a) “Automated
Distribution Cabinet” (ADC) means a computerized drug storage device or cabinet
that allows a drug to be stored and dispensed near the point-of-care, while controlling
and tracking drug distribution;
(b) “Drug”
means a drug, a prescription device, a biological medication, a chemical or any
combination of these terms;
(c) “Central
pharmacy” means a pharmacy within a licensed hospital with a single location
and inventory, which prepares and distributes drugs to secondary storage areas in
the facility, and remote locations;
(d) “Chief
Pharmacy Officer” (CPO) means an Oregon licensed pharmacist who supervises
the pharmacy operations in a hospital. The CPO may hold the title of Pharmacy Manager,
Pharmacy Director, Director of Pharmacy, Pharmacy Administrator or other pharmacy
supervisory management title within the organization. The PIC may also be the CPO
if there is only one pharmacy in the hospital;
(e) “Drug
profile” means a complete and comprehensive summary of a patient’s current
drugs and details of each drug including information such as active ingredient,
strength and form, dose and directions for use, and other supplementary information;
(f) “Licensed
Independent Practitioner” (LIP) means an individual permitted by law and by
the organization to provide care and services, without direction or supervision,
within the scope of the individual's license;
(g) “Out-patient”
means a person who is not residing in the facility but who is registered with the
facility and is using the facility for treatment or diagnostic services;
(h) “Remote
storage area” means a patient care area which is part of the hospital that
is under the supervision and control of the hospital’s central pharmacy but
is not located in the same building as the central pharmacy;
(i) “Secondary
drug storage area” means an area in a hospital or licensed residential facility,
which is supplied by a central pharmacy and may include facilities such as a drug
room, a distribution cabinet or a hospital department;
(j) “Unit-dose”
means a quantity of a drug designed to be administered to a patient, such as:
(A) An oral
solid individually packaged or re-packaged;
(B) An oral
liquid drawn up in a labeled oral syringe;
(C) An injectable
product; or
(D) A pre-mixed
IV product.
(2) Not withstanding
855-006-0005 and 855-019-0200(2) and (3), for the purpose of these rules, OAR 855-041-6000
through 855-041-6999, verification or final verification means the confirmation
by a pharmacist of the correctness, exactness and accuracy of the act, tasks, or
function as specified elsewhere in this Division of rules.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6100
Registration
(1) Each central
pharmacy must be registered with the Board. In a hospital with multiple central
pharmacies, each pharmacy location must be registered with the Board.
(2) A secondary
drug storage area within the hospital or in a structure physically attached to the
hospital does not require a separate registration.
(3) A registered
pharmacy in a hospital may use additional locations within the hospital, supervised
by a pharmacist, without acquiring separate registrations for each additional location.
(4) A secondary
drug storage area in a separate location must be registered as a drug room and must
follow all rules that apply to secondary storage areas in the hospital.
(5) A residential
healthcare facility that is licensed by DHS and that has a central pharmacy must
register the pharmacy with the Board.
(6) Upon
written request, the Board may waive any of the requirements of this rule if a waiver
will further public heath or safety or the health and safety of a patient. A waiver
granted under this section shall only be effective when it is issued by the Board
in writing. A waiver is not valid for more than five years.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.305
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6150
General Pharmacy
Requirements
(1) Each hospital
pharmacy must have an Oregon licensed pharmacist designated as Pharmacist-in-Charge
(PIC).
(2) A hospital
that has more than one pharmacy must designate an Oregon licensed pharmacist as
CPO or an equivalent position who has responsibility for directing pharmacy services
in the hospital. The CPO may also be the PIC of one of the pharmacies.
(3) A hospital
pharmacy may only be operated when under the direct supervision of an Oregon licensed
pharmacist. The pharmacist shall be responsible for all areas of the hospital where
drugs are stored, including remote storage areas
(4) The pharmacy
must be operated at least part-time, five days a week.
(5) The hospital
pharmacy must have adequate space so that drugs can be prepared in sanitary, well-lit,
enclosed places. Space and equipment must be adequate for the pharmaceutical services
provided including compounding, distributing, and storage of drugs and parenteral
preparations.
(6) As a
minimum, the pharmacy must have the following:
(a) Equipment
listed in OAR 855-041-0040, except that a pharmacy that is only registered as an
institutional drug outlet does not need to have an Official Poison and Exempt Narcotic
Register;
(b) A drug
formulary approved by the appropriate hospital committee;
(c) Pharmacy
policy and procedures.
(7) All areas
occupied by a hospital pharmacy must be secured to prevent access by unauthorized
personnel.
(a) Whenever
any area of a hospital pharmacy is not under direct supervision of a pharmacist,
the area must be secured;
(b) The CPO
shall designate in writing, by title and specific area, those persons who may have
access to specific areas within the pharmacy;
(c) Unless
otherwise permitted by these rules, a non-pharmacist may not have access to the
pharmacy unless a pharmacist is on duty and present in the hospital.
(8) A residential
healthcare facility that has a central pharmacy must comply with these rules.
(9) Upon
written request, the Board may waive any of the requirements of this rule if a waiver
will further public health or safety or the health and safety of a patient. A waiver
granted under this section shall only be effective when it is in writing. A waiver
is not valid for more than five years.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Drug Distribution
and Control
855-041-6200
Chief Pharmacy
Officer and Pharmacist in Charge
(1) The CPO must
specify the respective responsibilities of the CPO and the PIC if separate individuals
hold these positions.
(2) In addition
to the duties listed in this rule, the PIC has the responsibilities listed in OAR
855-019-0300.
(3) The CPO
must establish policies and procedures that include:
(a) Procedures
for general distribution of drugs throughout the hospital;
(b) A procedure
for review and revision of the policies and procedures not less than every three
years;
(c) Procedures
for the supervision of pharmacy services including storage, distribution, control
and accountability for drugs including controlled drugs;
(d) Procedures
to ensure that all areas of the hospital where drugs are stored are inspected not
less than every two months to verify proper drug storage, documentation of distribution
and administration of controlled substances, absence of outdated drugs, and the
integrity of the emergency drug supplies;
(e) Policies
and procedures that govern the preparation, verification and sterilization of parenteral
drugs compounded within the hospital. Procedures must comply with OARs 855-045-0200
through 855-045-0270 and these rules;
(f) Procedures
for administration of drugs, including self-administration;
(g) Procedures
for labeling drugs;
(h) Policies
and procedures that govern the filling and labeling of containers from which drugs
are to be administered;
(i) Procedures
for a Quality Assurance program to ensure that there is a planned, ongoing and systematic
process for the monitoring and evaluation of the quality and appropriateness of
pharmacy services, and for identifying and resolving problems. Such monitoring and
evaluation must be accomplished through ongoing collection of information and periodic
assessment of the collected information;
(j) Emergency
drug distribution;
(k) Procedures
for procurement of all drugs subject to approval of the appropriate committee of
the hospital;
(l) Procedures
to ensure that discontinued, outdated, adulterated or misbranded drugs are returned
to the pharmacy for proper disposition, or that the PIC makes proper disposition
or disposal of such drugs at the storage site;
(m) A recall
procedure that can be quickly activated to assure the CPO and pharmacy staff, and
the medical staff that all drugs included in the recall have been returned to the
pharmacy for proper disposition;
(n) Policies
and procedures for the use of investigational drugs;
(o) Procedures
to be followed in the absence of the pharmacist.
(4) The CPO
must:
(a) Participate
in the development and revisions of a hospital formulary;
(b) Maintain
an emergency and disaster plan for pharmacy services, and participate in the facility’s
emergency and disaster plan;
(c) Ensure
that records of all transactions of the hospital pharmacy that are required by state
and federal laws and regulations are maintained, and maintain accurate control and
accountability for all pharmaceutical materials;
(d) Participate
in the hospital’s Quality Assurance program related to drugs;
(e) Comply
with all inspection and other requirements of the pharmacy in accordance with all
applicable state and federal laws and regulations.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6220
Records
(1) Unless specified
otherwise, all records and documentation required by these rules, OAR 855-041-6000
through 855-041-6999 must be retained for three years and made available to the
Board for inspection upon request. Records must be stored onsite for at least one
year and may be stored in a secured off-site location if retrievable within three
business days. Records and documentation may be written, electronic or a combination
of the two.
(2) The PIC
must ensure maintenance of written or electronic records and reports as necessary
to ensure patient health, safety and welfare. Records must include:
(a) Patient
profiles and drug administration records;
(b) Reports
of suspected adverse drug reactions;
(c) Inspections
of drug storage areas;
(d) Annual
controlled substance inventories;
(e) Controlled
drug accountability reports;
(f) Collaborative
Drug Therapy agreements;
(g) Current
hospital drug formulary;
(h) Any other
records and reports required by state and federal laws and regulations.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.508
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6240
Drug Administration
(1) In a hospital,
a drug may only be administered upon an order initiated by:
(a) A member
of the medical staff who has been granted clinical privileges;
(b) An authorized
member of the house staff; or
(c) An authorized
licensed practitioner.
(2) Each
administration of a drug must be in accordance with policies and procedures approved
by the appropriate committee of the hospital, must comply with all applicable laws,
rules and regulations, and must follow usual and customary standards of good medical
practice.
(3) Self-administration.
A patient may only be permitted to self-administer a drug when specifically authorized
by the treating or ordering practitioner, and when the patient has been educated
and trained in the proper self-administration of the drug.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6250
Patient’s
Own Drugs and Other Drugs from Outside Sources
When a patient or
a patient’s agent brings a drug into the hospital, the drug may only be administered
to the patient if:
(1) The practitioner
or pharmacist has identified it and it is in a pharmacy labeled container; and
(2) Any administration
is pursuant to a practitioner’s order; or
(3) In the
pharmacist’s professional judgment, withholding the drug would be detrimental
to the patient’s health. In such a case, the pharmacist may authorize administration
of the drug pursuant to a practitioner’s order.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6260
Investigational
Drugs
(1) All in-patient
investigational drugs must be stored in the pharmacy and may only be distributed
from the pharmacy when properly labeled.
(2) Information
concerning the dosage form, route of administration, strength, actions, uses, side
effects, adverse effects, interactions and symptoms of toxicity of such drugs must
be available in the pharmacy.
(3) Investigational
drugs may only be ordered by a designated physician-investigator or their authorized
clinician, subject to the prior approval of the appropriate hospital committee.
(4) Each
order must include the appropriate protocol number.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6270
Labeling
(1) Each pharmacy
record keeping system must identify and document the pharmacist who verifies the
drug.
(2) Each
pre-packed drug, including a unit-dosed drug, prepared by the pharmacy and intended
for use within the facility shall be in an appropriate container with a label that
contains:
(a) The brand
or generic name and expiration date;
(b) The manufacturer
and lot number, or an internal pharmacy code that references manufacturer and lot
number;
(c) The strength
of the drug.
(3) In-patient:
Each drug dispensed to an in-patient other than in a unit-dose or manufacturer’s
unit-of-use packaging must be labeled with the following information:
(a) Name
and location of patient;
(b) Name
and strength of drug;
(c) Route
of administration, when necessary for clarification;
(d) Manufacturer
and lot number, or internal pharmacy code;
(e) Auxiliary
labels as needed, and
(f) Expiration
date.
(4) A drug
that is to be sent with the patient upon discharge must be labeled in accordance
with ORS 689.505(5) and other rules in this Division. Drug counseling information
must be provided to the patient or patient’s agent.
(5) A label
for an outpatient prescription must comply with ORS 689.505(5) and other rules in
this Division.
(6) New bar
coding or electronic label: When a new barcode or electronic label is used to identify
a drug the pharmacist must verify and document the accuracy of the identification
with all electronic verification systems prior to distribution.
(7) Whenever
a drug is added to a parenteral solution under the direct supervision of a pharmacist,
the admixture must be labeled with a distinctive supplementary label that contains
(a) The name,
quantity and concentration of the drug added and the primary solution;
(b) The date
and time of addition;
(c) The expiration
date;
(d) The scheduled
time for administration;
(e) The infusion
rate, when applicable;
(f) The name
or initials of person performing admixture;
(g) The identification
of the pharmacy where the admixture was performed; and
(h) The name
or initials of the verifying pharmacist.
(8) The label
applied at a secondary storage or remote storage area by a nurse or physician must
include: the patient name or patient identifier, quantity and concentration of the
drug added and the primary IV solution; the date and time of addition and the initials
of the nurse or physician adding the drug.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.505
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Absence of a Pharmacist
855-041-6300
Untitled
The CPO must make
appropriate arrangements for provision of drugs to the medical staff and other authorized
personnel by use of a night cabinet or by access to the pharmacy, or both, for situations
when hospital pharmacy services are not available.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.605
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6305
Night Cabinet
(1) If a night cabinet
is used, the following procedures must be followed:
(a) The cabinet
or other enclosure located outside the pharmacy must be secure from unauthorized
access;
(b) Only
one authorized registered nurse on a shift may have access to the night cabinet
and may remove drugs. Such nurse must be designated in writing by the appropriate
committee of the hospital and prior to being given access to the night cabinet,
must receive appropriate training in the proper procedures for access, removal of
drugs, and recordkeeping;
(c) The PIC
or designee must give this training, and must require, at a minimum, the following
procedures:
(A) A drug
may only be removed from the night cabinet on a practitioner's written order or
a verbal order that has been reduced to writing;
(B) A copy
of the practitioner's order must be left in the night cabinet for the pharmacist
to verify for accuracy. Both the nurse supervisor and the verifying pharmacist must
initial the order.
(2) In conjunction
with the appropriate hospital committee, the CPO must develop an inventory of those
drugs to be included in each cabinet and establish procedures to ensure that:
(a) Drugs
are available and labeled as required by these rules;
(b) Only
prepackaged drugs are placed in the cabinet;
(c) Quantities
do not exceed those reasonable for immediate therapeutic requirements;
(d) Whenever
a cabinet has been accessed, a written record is kept of the drug order and certification
of the drug use;
(e) Controlled
substances are kept securely and are accounted for using a reconciled perpetual
inventory;
(f) An audit
of controlled substances in the cabinet is conducted at least once per month. If
a tamper-evident seal system is not used, a quality assurance program must be in
place to identify any diversion.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.605
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6310
After Hours
Access to Pharmacy
When a drug required
to treat the immediate needs of a patient is not available from floor-stock or a
night cabinet, it may be obtained from the pharmacy in accordance with the following
procedures:
(1) Only
one registered nurse supervisor on a shift may have access to the pharmacy and may
remove drugs. The nurse supervisor must be designated in writing by the appropriate
hospital committee and prior to being permitted to obtain access to the pharmacy,
must receive appropriate training in the proper procedures for access, removal of
drugs, and recordkeeping;
(2) The PIC
or designee must give such education and training, and must require, at a minimum,
the following procedures:
(a) A drug
may only be removed from the pharmacy on a practitioner's order that has been posted
to the patient’s medical record;
(b) A copy
of the practitioner's order must be left either with the container from which the
drug was removed or with an identical unit-dose, and must be placed conspicuously
for a pharmacist to verify for accuracy;
(c) A record
of each drug removed from the pharmacy by the nurse supervisor must include:
(A) Name
and hospital location of the patient;
(B) Name
and strength of drug distributed;
(C) Units
used;
(D) Date
and time of distribution;
(E) Initials
of the nurse supervisor distributing the drug;
(F) Date
and initials of the pharmacist who confirmed the accuracy of the transaction.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.605
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Outpatient Drug
Distribution
855-041-6400
Emergency
Dispensing by a Nurse
A hospital may provide
for the emergency dispensing of a drug to an outpatient who is under the care of
a practitioner who is a member of the hospital medical staff, when there is a legitimate
medical need as described in hospital policies and procedures.
(1) A designated
registered nurse may dispense a drug to an outpatient subject to the following:
(a) There
is a prescription from a practitioner authorized to prescribe the drug or a verbal
order that the nurse has reduced to writing. A practitioner who issues a verbal
order or prescription must send a written prescription to the hospital pharmacy
within seven days;
(b) The drug
is in a manufacturer’s bulk unit-of-use, such as an inhaler, or hospital pre-pack
that has been labeled by the pharmacy with;
(A) Name
of drug, strength, and number of units. When a generic name is used, the label must
also contain the name of the manufacturer or distributor;
(B) Accessory
cautionary information as required for patient safety;
(C) Product
identification label if the drug is not in unit-of-use packaging;
(D) An expiration
date after which the patient should not use the drug;
(E) Name,
address and phone number of the hospital pharmacy.
(c) The following
information must be added to the drug container by the nurse before dispensing to
the patient:
(A) Name
of patient;
(B) Directions
for use by the patient;
(C) Date
of issue;
(D) Unique
identifying number;
(E) Name
of prescribing practitioner;
(F) Initials
of the dispensing nurse or practitioner.
(d) The patient
must be given instructions on the use and precautions for taking the drug;
(e) A prescription
must be completed by the practitioner or nurse. This prescription must contain:
(A) Name
of patient;
(B) Date
of issuance;
(C) Name
and strength of drug distributed;
(D) Units
issued;
(E) Name
of practitioner and initials of dispensing nurse;
(F) Instructions
given to the patient.
(f) Any additional
information required by state and federal laws and regulations for the distribution
of a drug to an outpatient.
(2) The patient
may not be given more than an emergency supply, as that is defined in the hospital
policy and procedures.
(3) The pharmacist
must verify, document and date the original prescription.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.505
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6410
Emergency
Department Distribution
(1) A practitioner
or associate practitioner with prescriptive authority in Oregon who is a member
of the hospital's medical staff may dispense an emergency supply of drugs to a patient
examined by them or by an associate practitioner subject to the following requirements:
(a) The prescriber
shall offer the patient the option of being provided a prescription that may be
filled at the pharmacy of the patient’s choice.
(b) During
consultation with the patient or the patient’s caregiver, the prescriber shall
clearly explain the appropriate use of the drug supplied and the need to have a
prescription for any additional supply of the drug filled at a pharmacy of the patient’s
choice.
(c) The patient
must be given instructions on the use and precautions for taking the drug;
Labeling
(d) The drug is
in a manufacturer’s unit-of-use container, such as an inhaler, or hospital
pre-pack that has been labeled by the pharmacy with:
(A) Name
of drug, strength, and number of units. When a generic name is used, the label must
also contain the identifier of the manufacturer or distributor;
(B) Accessory
cautionary information as required for patient safety;
(C) Product
identification label if the drug is not in unit-of-use packaging;
(D) An expiration
date after which the patient should not use the drug; and
(E) Name,
address and phone number of the hospital pharmacy.
(e) The following
information must be added to the drug container by the practitioner or nurse before
dispensing to the patient:
(A) Name
of patient;
(B) Directions
for use by the patient;
(C) Date
of issue;
(D) Unique
identifying number as determined by policy and procedure;
(E) Name
of prescribing practitioner; and
(F) Initials
of the dispensing nurse or practitioner.
Distribution
Record
(f) A prescription
or record of the distribution must be completed by the practitioner or nurse. This
record must contain:
(A) Name
of patient;
(B) Date
of issuance;
(C) Drug
name and strength distributed;
(D) Units
issued;
(E) Name
of practitioner;
(F) Initials
of the dispensing nurse or practitioner; and
(G) Instructions
given to the patient as labeled.
(g) Any additional
information required by state and federal laws and regulations for the distribution
of a drug to an outpatient;
(h) The record
must be reviewed and documented by a pharmacist for accuracy and completeness.
The pharmacist shall review the record of dispensing of drugs within 24 hours. However,
if the pharmacy is closed, records shall be reviewed during the first day the pharmacy
is open but not to exceed 72 hours following the dispensing; and
(i) Errors
and discrepancies will be included in hospital and pharmacy QA review process and
available to the Board.
(2) A controlled
substance may only be distributed or dispensed to an outpatient by the examining
practitioner after the patient has been examined by the practitioner and a legitimate
medical purpose for a controlled substance has been determined. Distribution of
a controlled substance must comply with all applicable state and federal laws and
regulations.
(3) The CPO
or PIC and appropriate hospital committee will establish a limited selection and
quantity of drugs to be included in the Emergency Department formulary and the amount
contained in each prepak that may be distributed to meet only the acute care needs
of a patient; for example, an emergency supply of drugs. The amount dispensed may
not exceed a 48 hour supply except for:
(a) A drug
in the manufacturer’s unit-of-use packaging such as an inhalant or a topical
drug;
(b) A full
course of therapy that may be dispensed if in the professional judgment of the pharmacist
or practitioner this would be in the patient’s best interest such as an antibiotic;
(4) Any additional
preparation for use of the medication must be completed prior to discharge; for
example, reconstituting antibiotics;
Automated Dispensing
Machine
(5) For the purpose
of this rule an Automated Dispensing Machine (ADM) is a machine or contrivance which
will prepare a completed and labeled prescription which is ready for dispensing
to the patient or patient’s representative.
(6) An Automated
Dispensing Machine; may only be located within the Emergency Department in a secure
environment that has no direct public access, and when used, must be part of the
discharge procedure;
(7) When
the patient or patient’s representative receives the prescription from an
ADM;
(a) A registered
nurse or practitioner or pharmacist must be present at the time of dispensing; and
(b) A registered
nurse or practitioner or pharmacist will grant access to the ADM for the release
of the drugs to be dispensed using a password protected or biometric security system;
and
(c) The patient
or patient’s representative will obtain the drug using a specific patient
access code.
(8) Only
a pharmacy technician, certified pharmacy technician, intern or pharmacist may access
the drug supply in the ADM.
(9) The CPO
or PIC will establish policies and procedures for use of the ADM including, but
not limited to emergency access and down time procedures for the ADM.
(10) Upon
written request, the Board may waive any of the requirements of this rule if a waiver
will further public health or safety. A waiver granted under this section shall
only be effective when it is issued in writing and will be time limited.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.505
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 8-2012, f. & cert. ef. 12-21-12
In-Patient Drug
Distribution
855-041-6420
Emergency
Kit and Code Cart
An emergency kit
consists of those drugs which may be required to meet the immediate therapeutic
needs of in-patients and which are not available from any other authorized source
in sufficient time to prevent risk of harm to patients.
(1) An emergency
kit may be placed in a code cart or as a stand-alone emergency kit.
(2) A pharmacist
must verify and document the contents of each emergency kit.
(3) The CPO
in cooperation with the appropriate hospital committee shall determine the list
and quantity of drugs to be included in an emergency kit. The CPO must ensure that
this list is reviewed annually.
(4) An emergency
drug kit must use a tamper-evident system and be stored to prevent unauthorized
access.
(5) All drugs
in emergency kits and code carts must be labeled in accordance with OAR 855-041-6270.
(6) An emergency
kit or code cart must be labeled to indicate that it is a drug supply for emergency
use. A label must also contain the name, strength, quantity of all drugs in the
kit or code cart and the expiration date of the kit. The label shall be affixed
to or be available on the exterior of the code cart.
(7) The expiration
date of an emergency kit or code cart must be the same as the earliest expiration
date of any drug in the kit or cart. Prior to the expiration date, the pharmacist
must replace expired drugs.
(8) Only
an authorized person may remove a drug from an emergency kit or code cart. Any removal
must be pursuant to a valid order or approved protocol.
(9) The pharmacy
must be notified when an emergency kit or code cart has been opened or has expired
and the pharmacist must restock or replace the emergency kit within a reasonable
time.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6500
Practitioner’s
Drug Order
(1) An order for
a drug for an in-patient must be transmitted to the pharmacy using a system that
produces a direct or an electronic copy.
(2) A pharmacist
must review the drug order before the initial dose is dispensed, and must document
the review and DUR except:
(a) When
a drug is dispensed under OAR 855-041-6310;
(b) In an
emergency;
(c) When
pharmacy services are not available; or
(d) When
a LIP is present.
(3) An order
for a drug must contain:
(a) The patient’s
name and location;
(b) The drug
name and strength;
(c) Route
of administration;
(d) Directions
for use;
(e) The date
and time; and
(f) The practitioner’s
written or electronic signature, or the signature of the practitioner’s agent.
(4) The hospital
must follow the following procedures for verbal drug orders:
(a) A verbal
drug order should be used infrequently;
(b) A verbal
drug order of an authorized individual may be accepted and transcribed only by a
qualified person who has been identified by title or category in the hospital policies
and procedures;
(c) A verbal
order must be reduced to writing and read back to the prescribing practitioner to
verify accuracy;
(d) A verbal
order must be signed or initialed by the prescribing practitioner as soon as possible.
(5) A drug
administered to a patient must be ordered by an authorized prescribing practitioner
or otherwise allowed by these rules.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6510
In-patient
Drug Profile
(1) Each pharmacist
must ensure that a drug order for a patient requiring continuous drug therapy is
entered into the patient’s drug profile. The profile must contain:
(a) The patient's
name, location and important clinical data such as age, height, weight, sex, chronic
disease states, problem list and allergies;
(b) The drug
name, strength, dosage form, route of administration and directions for administration;
(c) The drug
therapy start and end date as applicable;
(d) The name
or ID of the pharmacist responsible for entry or verification of the drug order.
(2) Prior
to the drug being released for access by the nurse, a pharmacist must enter the
drug order into a drug profile and perform a DUR except when:
(a) The drug
is being dispensed from an after-hours cabinet in the absence of a pharmacist;
(b) The drug
is from an emergency drug kit; or
(c) A system
override is being used by a LIP or nurse to treat the emergency needs of a patient.
Subject to a prescriber’s order, a sufficient quantity to meet the emergency
needs of the patient may be used until a pharmacist is available to review and confirm
the drug order.
(3) The pharmacist
must continue to monitor the appropriateness of the patient’s drug utilization
throughout the patient’s stay in the hospital.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6520
Cart-Fill
(1) A unit-dose
cart-fill system is a pharmacy controlled unit-of-use drug distribution system.
(a) A unit-dose
cart-fill system must provide for separation of drugs by patient name and location,
and must be designed to record in an individual patient’s record:
(A) The drug,
dose strength, and dosing regimen of those drugs dispensed by the pharmacy;
(B) The number
of doses dispensed;
(C) The date
of the original order, and the date the order is discontinued.
(b) The system
must:
(A) Provide
a means for the pharmacist to verify the prescriber's original order;
(B) Provide
a means for the pharmacist to verify the accuracy of the selected drug before the
dose is delivered for administration to the patient; and
(C) Provide
a mechanism to identify controlled substances.
(c) The pharmacist
must verify the prescriber’s original order and the accuracy of the selected
drug.
(2) Controlled
substances may be included in the unit-dose system if the system complies with all
applicable state and federal laws and regulations.
(3) Each
drug must be in unit-dose packaging when dispensed except when this is impracticable.
(4) A drug
not dispensed in unit-dose packaging must be labeled in accordance with other rules
in this Division.
(5) A drug
in a single container multiple-dose package such as an inhaler or a topical drug
must be labeled with the patient’s name and location within the facility.
(6) A pharmacy
technician, certified pharmacy technician, intern or pharmacist may fill daily unit-dose
drug supplies for a hospital in-patient or a nursing home patient.
(7) The pharmacist
must verify the accuracy of a unit-dose package before the dose is delivered for
administration to the patient.
(8) Each
drug must be stored in a locked area or locked cart.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6530
Robotic Distribution
Systems
(1) A robotic drug
distribution system used in a central pharmacy must be in a secure area under the
control of the PIC and must be connected with the system that contains the patient’s
drug profile.
(2) The pharmacy
must maintain the following documentation for each system:
(a) Details
of the equipment including manufacturer's name, model and serial number;
(b) A description
of how the system is used;
(c) Policies
and procedures that include:
(A) Quality
assurance performed at least quarterly including a requirement that a pharmacist
visually verifies the accuracy of the electronic or bar code labeling using an audit
procedure that includes random sampling;
(B) Procedures
for training personnel in safe system operation, security, accuracy, patient confidentiality,
access and downtime procedures.
(3) All distribution
records must be recorded electronically and retained for 3 years or as approved
by the Board. Records must include:
(a) Identity
of robotic drug distribution system accessed;
(b) Type
of transaction;
(c) Date
and time of transaction;
(d) Name,
strength, dosage form, and quantity of the drug accessed;
(e) Identity
of the patient for whom the drug was ordered;
(f) Any other
information the PIC may deem necessary.
(4) Only
a pharmacy technician, certified pharmacy technician, intern, pharmacist or a person
designated by the PIC may have access to the system.
(5) Only
a pharmacy technician, certified pharmacy technician, intern or pharmacist may stock
drugs in the system.
(6) All drugs
in the system must be packaged and labeled in accordance with state and federal
laws and regulations.
(7) Controlled
Substances:
(a) Controlled
substances must be handled in accordance with all applicable state and federal laws
and regulations;
(b) Schedule
III, IV and V drugs may be stocked in a robotic drug distribution system provided
there is adequate security to limit access to those personnel designated by the
PIC;
(c) Schedule
II drugs may not be stocked in any robotic drug distribution system.
(8) Drugs
prepared by a robotic system must be packaged and separated by patient or as approved
by hospital protocol, prior to distribution for administration.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155 & 689.508
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6540
Automated
Distribution Cabinets
(1) Each ADC must
be under the control of the pharmacy. The PIC must establish policies and procedures
to meet the requirements of all applicable state and federal laws and regulations.
(2) Policies
and procedures addressing the operation of the ADC must be maintained in the pharmacy.
They must include:
(a) Training
of personnel granted access to the ADC;
(b) System
operation, safety, security, access, accuracy and patient confidentiality;
(c) Cabinet
replenishment procedures;
(d) Downtime
procedures;
(e) A procedure
for securing and accounting for any wasted, discarded or unused drug in accordance
with existing state and federal laws and regulations.
(3) All events
involving the contents of the ADC must be recorded and must include:
(a) Identity
of ADC accessed;
(b) Identification
of the individual accessing the ADC;
(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 or patient identifier for whom the drug was ordered;
(g) Such
additional information as the PIC may deem necessary.
(4) Only
a pharmacist, pharmacy technician, certified pharmacy technician, intern or other
person designated by the PIC may have access to the ADC.
(5) Stocking
drugs in an ADC:
(a) Only
a pharmacy technician, certified pharmacy technician, intern, pharmacist or other
licensed healthcare personnel designated by the PIC may stock drugs in the ADC;
(b) A pharmacist
must visually or electronically verify the name, strength and accuracy of the drug
to be released from the central pharmacy for restocking;
(c) When
a barcode or other electronic system is used to confirm the accuracy of the replenishment
of the stock in an ADC, the system must receive an initial quality assurance validation;
(d) When
all drug doses for an individual storage unit or bin have been packaged in one container,
a single barcode verification may be used;
(e) The PIC
must monitor the accuracy of the replenishment of drugs with a quality assurance
process that includes:
(A) Reconciling
the ADC fill list with established unit specific drugs using the drug profile, ADC
discrepancy and inventory reports; and
(B) Monitoring
the accuracy of the restocking and withdrawal procedures used by all hospital staff
approved for drug administration.
(f) The PIC
may permit medical supplies and devices to be included in the ADC.
(6) All drugs
stored in the ADC must be packaged and labeled in accordance with state and federal
laws and regulations.
(7) A drug
that has been removed from the ADC for any purpose may not be returned to the system
unless:
(a) A pharmacist
has examined the drug, the packaging, and the labeling and determined that reuse
of the drug is appropriate; or
(b) It is
a drug, such as a multi-dose vial, which has been exempted by the appropriate hospital
committee.
(8) At the
time of loading, unloading, inventorying, removing or accessing any controlled substance
from the ADC, a blind count or confirmation of the correct count must be conducted.
Any discrepancy must be reported immediately to the PIC or pharmacist on duty who
is responsible for reconciliation of the unresolved discrepancy or proper reporting
of the loss.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6550
Secondary
and Remote Storage
(1) All drugs must
be stored in designated areas to ensure proper sanitation, temperature, light, ventilation,
moisture control, and security.
(2) Drugs
may only be stored in nursing units when space is available for the storage, security,
and preparation of drug doses. Such space must include:
(a) A locked
drug cabinet or room that is equipped so that each patient’s drugs are separated
physically or electronically. Drugs may be stored in secured individual patient
storage areas or individually labeled for each patient;
(b) A container
or compartment that is permanently attached to a storage cart or the drug room in
which controlled substances can be secured;
(c) Alcohol
and other flammables must be stored in areas that meet local building code requirements
for the storage of volatiles, and such other laws and regulations that apply.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Floor-stock and
Non–emergency Trays and Kits
855-041-6560
Floor-Stock
(1) A minimal quantity
of drugs may be stocked in patient care areas to meet the immediate therapeutic
needs of a patient where delay would interrupt the continuity of, or compromise
the care of the patient.
(2) A hospital
pharmacy must not use a floor-stock drug distribution system as its primary system
of drug distribution except in departments staffed with a LIP such as the Emergency
Room, Operating Rooms and Radiology.
(3) The CPO,
in consultation with nursing staff, must prepare a list of drugs by identity and
quantity for each area where such supplies are stocked. This list must be kept in
the pharmacy.
(4) Floor-stock
drug supplies must be stored in a secure area only accessible to pharmacy-authorized
personnel.
(5) All drugs
in floor-stock must be labeled in accordance with other rules in this Division.
(6) Drugs
may only be removed from floor-stock by personnel authorized by the appropriate
hospital committee. A drug may only be removed pursuant to a valid prescriber’s
order. Removal from stock must be recorded in accordance with policy and in the
patient's medical record.
(7) The CPO
may permit medical supplies and devices to be included in the floor-stock.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6570
Trays and
Kits
(1) All drug trays
and kits must be prepared by the pharmacy prior to release from the central pharmacy
except that trays and kits may be prepared from floor-stock by an LIP who administers
the drug or by authorized hospital staff in the case of emergency use if:
(a) The pharmacy
and appropriate hospital departments jointly develop guidelines for the proper use,
preparation, and security for the trays or kits; and
(b) The pharmacy
has a quality assurance program for monitoring the proper use, preparation and security
of the kits.
(2) A pharmacist
must verify the accuracy and secure the contents of each tray or kit prepared in
the pharmacy prior to release from the central pharmacy.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Controlled Substances
855-041-6600
Controlled
Drug Accountability
(1) The hospital
must establish procedures and maintain records to account for all controlled substances
and any other drugs designated by the appropriate hospital committee. Records must
include:
(a) Name
of drug;
(b) Dose
ordered, dose dispensed, and dose administered;
(c) Identity
of patient;
(d) Date
and time of administration;
(e) Person
administering the drug;
(f) Verification
and documentation of any wasted drug including partial doses.
(2) The pharmacy
must provide separately locked, securely affixed compartments for storage of controlled
drugs and other drugs subject to abuse, except when the facility uses single-unit
packaged drug distribution systems in which the quantity stored is minimal and a
missing dose can be readily detected.
(3) The pharmacy
must obtain a delivery receipt for all controlled drugs supplied as floor-stock.
This record must include the date, drug name and strength, quantity, hospital unit
receiving drug and the signatures of the distributing pharmacist and the receiving
nurse.
(4) A record
must be kept of each administration of a controlled drug from floor-stock. The record
must be returned to the pharmacy monthly and the PIC or designee must:
(a) Match
returned records with delivery receipts to verify that all records are returned;
(b) Periodically
audit administration records for completeness;
(c) Reconcile
administration records with inventory and verify that sums carried from one record
to the next are correctly recorded;
(d) Periodically
verify that doses documented on administration records are reflected in the medical
record; and
(e) Initial
the returned record and file by date of issue.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 475.165 & 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6610
Schedule
II Drugs
(1) In addition
to the requirements above, Schedule II record keeping must include:
(a) A perpetual
inventory system for all Schedule II drugs received, stored and distributed by the
pharmacy. The perpetual inventory must be reconciled with an actual inventory at
least monthly and the results and any discrepancies must be noted;
(b) Schedule
II drugs stored as floor-stock in patient-care areas must be controlled with a perpetual
inventory system that includes an actual inventory count and reconciliation when
the department or nursing unit is open. The CPO must develop policies and procedure
to ensure a regular audit of the inventory;
(c) Quality
assurance procedures for the random sample of perpetual inventory sheets including
sign-out sheets or other dose-by-dose documentation, must be performed at least
quarterly and must be used to determine the accuracy and effectiveness of Schedule
II floor-stock drug control;
(d) All Schedule
II drugs stored in the pharmacy must be kept in a locked area or secured storage
system that tracks the identity of each person making entry into and out of the
system whenever a pharmacist is not physically present in the department.
(2) Policies
and Procedures must specify the conditions under which Schedule II controlled substances
can be transferred into or removed from an ADC.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 475.165 & 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
855-041-6620
Electronic
Safe Systems
(1) The pharmacy
must maintain policies and procedures that address the operation of any electronic
safe system. These policies must include:
(a) Training
of personnel granted access to the electronic safe system;
(b) System
operation, safety, security, access, accuracy and patient confidentiality;
(c) Downtime
procedures.
(2) All events
involving the contents of the electronic safe system must be recorded electronically.
Such records must include:
(a) Identity
of electronic safe system accessed;
(b) Identification
of the individual accessing the electronic safe system;
(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 when applicable;
(g) Any additional
information that the CPO requires.
(3) Only
a pharmacist, pharmacy technician, certified pharmacy technician or intern may have
access to the electronic safe system.
(4) Only
a pharmacist, pharmacy technician, certified pharmacy technician or intern may stock
drugs in the electronic safe system.
(5) All activities
involving the electronic safe system must comply with all applicable state and federal
laws and regulations.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 475.165 & 689.155
Hist.: BP
3-2010, f. 4-29-10, cert. ef. 4-30-10
Hospitals with
Drug Rooms
855-041-6800
Supervision
of Consulting Pharmacist
(1) In a hospital
having a drug room and no pharmacy, the drug room must be supervised by a licensed
pharmacist who provides his or her services with sufficient professionalism, quality
and availability to adequately protect the safety of the patients and to properly
serve the needs of the facility. The arrangements for a consulting pharmacist shall
be in writing, and shall, at a minimum, provide that:
(a) The pharmacist
is to act in the capacity of a part-time director;
(b) The pharmacist
shall provide on-call service at all times;
(c) Adequate
storage facilities for drugs will be provided; and
(d) All drugs
supplies shall be labeled so as to insure that recalls can be effected and that
proper control and supervision of such drugs may be exercised.
(2) One registered
nurse supervisor and only one in any given shift may have access to the drug room
and may remove drugs therefrom, except in an emergency situation. In that case,
such nurse may designate another licensed nurse to obtain the required drug(s).
Any access to the drug room deviating from the requirements of this section must
be approved by the Board prior to implementation. The registered nurse supervisor
shall be designated in writing by the appropriate committee of the hospital and
shall, prior to being permitted to obtain access to the drug room, receive thorough
education and training in the proper methods of access, removal of drugs, and records
and procedures required. Such education and training shall be given by the director
of pharmacy, who shall require, at a minimum, the following records and procedures:
(a) Drugs
can only be removed from the drug room on a practitioner's written order, or verbal
order which has been reduced to writing;
(b) A log
of drugs withdrawn from a drug room shall be maintained and initialed by the registered
nurse;
(c) Drugs
shall be removed for outpatients only in compliance with section (3) of this rule.
(3) The consultant
pharmacist who is the part-time director of pharmaceutical services shall in concert
with the appropriate committee of the hospital medical staff, develop policies and
procedures which shall be implemented to provide emergency pharmaceuticals to outpatients
during the hours when normal community or hospital pharmacy services are not available.
Such policies shall allow the designated registered nurse supervisor to issue medications
pursuant to the pharmacist's standing orders, which shall provide:
(a) A written
order of a practitioner authorized to prescribe a drug is presented;
(b) The medication
is prepackaged by a pharmacist and contains:
(A) Name,
address and telephone number of the hospital;
(B) Name
of drug, strength, and number of units; when a generic name is used, the label shall
also contain the name of the manufacturer or distributor;
(C) Required
precautionary information regarding controlled substances;
(D) Such
other and further accessory cautionary information as required for patient safety;
(E) An expiration
date after which the patient should not use the medication.
(c) No more
than a 24-hour supply is provided to the patient, except when the pharmacist has
informed the nurse supervisor that normal services will not be available within
24 hours;
(d) The container
is labeled by the nurse supervisor before presenting to the patient, and shows the
following:
(A) Name
of patient;
(B) Directions
for use to the patient;
(C) Date;
(D) Identifying
number;
(E) Name
of prescribing practitioner;
(F) Initials
of the supervisor.
(e) The original
written order by the prescriber is retained for verification by the pharmacist after
completion by the nurse supervisor and shall bear:
(A) Name
and address of patient;
(B) Date
of issuance;
(C) Units
issued;
(D) Initials
of supervisor issuing medication.
(f) The original
written order is verified by the pharmacist, initialed, dated, and filed in a separate
location for a period of three years for Board inspection;
(g) The withdrawal
of a single dose for immediate administration to the patient need not follow the
requirements of subsection (d) of this section.
(4) Emergency
Kits:
(a) Emergency
Kit Drugs Defined. Emergency kit drugs are those drugs which may be required to
meet the immediate therapeutic needs of in-patients, and which are not available
from any other authorized source in sufficient time to prevent risk of harm to patients
by delay resulting from obtaining such drugs from such other source;
(b) Supplying
Pharmacist. All emergency kit drugs shall be prepared by a licensed pharmacist;
(c) Drugs
Included. The director of pharmacy and the medical staff of the hospital shall jointly
determine and prepare a list of drugs, by identity and quantity, in amounts sufficient
for immediate therapeutic requirements, to be included in emergency kits. Such list
of drugs shall be reviewed annually by the appropriate medical staff committee;
(d) Storage.
Emergency kits shall be stored in areas to prevent unauthorized access and to insure
a proper environment for preservation of the drugs within them, as required in official
compendia;
(e) Labeling
— Interior. All drugs contained in emergency kits shall be labeled in accordance
with OAR 855-041-6420;
(f) Labeling
— Exterior. The exterior of emergency kits shall be labeled to clearly and
unmistakably indicate that it is an emergency drug kit and it is for use in emergencies
only; such label shall also contain a listing of the name, strength and quantity
of the drugs contained therein and an expiration date;
(g) Expiration
Date. The expiration date of an emergency kit shall be the earliest expiration date
on any drug supplied in the kit. Upon the occurrence of the expiration date, the
supplying pharmacist shall open the kit and replace expired drugs;
(h) Removal
of Drugs. Drugs shall be removed from emergency kits by authorized personnel only
pursuant to a valid order or by the supplying pharmacist;
(i) Notifications.
Whenever an emergency kit is opened or has expired, the supplying pharmacist shall
be notified and the pharmacist shall restock and reseal the kit within a reasonable
time so as to prevent risk of harm to patients.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.205
Hist.: 1PB
3-1979(Temp), f. & ef. 10-31-79; 1PB 2-1980, f. & ef. 4-3-80; PB 12-1989,
f. & cert. ef. 8-11-89; Renumbered from 855-041-0135, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-6840
Drug Distribution
and Control from a Drug Room in a Hospital
(1) General. The
director of pharmacy shall establish and implement written procedures for the safe
and efficient distribution of pharmaceutical products. An annually updated copy
of such procedures shall be available for inspection by the Board.
(2) Availability.
A pharmacist providing pharmaceutical services to a hospital maintaining a drug
room shall be engaged by the hospital and shall schedule on-premises visits on at
least a weekly basis.
(3) Span
of Control. The pharmacist’s span of supervision shall extend to all areas
of the hospital where drugs are stored. No less than every two months inspections
of these areas shall be conducted and substantiated by records so as to verify at
least proper drug storage, documentation of distribution and administration of controlled
substances, absence of outdated drugs, and the integrity of the required emergency
drug supply.
(4) Director’s
Absence. In the absence of the director of the pharmaceutical service, pharmaceutical
services shall be directed by a designated pharmacist.
(5) Responsibility.
The director of pharmacy shall be responsible for procedures for the safe and efficient
distribution of, control of and accountability for drugs. Accordingly, the director
shall be responsible for, at a minimum, the following:
(a) Procedures
for preparation and sterilization of parenteral medications manufactured within
the hospital;
(b) Procedures
for admixture of parenteral products, including education and training of nursing
personnel concerning incompatibility and provision of proper incompatibility information.
When the admixture of parenteral products is not accomplished under the direct supervision
of a pharmacist, such preparation shall be limited to a practitioner or registered
nurse;
(c) Manufacture
and compounding of drugs;
(d) Procedures
for establishment of specifications for procurement of all pharmaceutical materials,
including drugs, chemicals and biologicals, subject to approval of the appropriate
committee of the hospital;
(e) Procedures
for participation in the development and revisions of a hospital formulary system;
(f) Procedures
for filling and labeling all stock containers from which drugs are to be administered;
(g) Maintaining
and making available a sufficient inventory of antidotes and other emergency drugs,
as well as current antidote information, telephone numbers of poison control center(s)
and other emergency assistance organizations, and such other materials and information
as may be deemed necessary by the appropriate committee of the hospital;
(h) Records
of all transactions of the hospital relating to pharmaceutical services as may be
required by state or federal law, and maintenance of accurate control over and accountability
for all pharmaceutical materials. The procedures shall include the keeping of accurate
and complete records of the receipt, withdrawal from stock and use or other disposal
of all legend drugs stored in the drug room and all other locations in the hospital;
(i) Participation
in those aspects of the hospital’s patient care evaluation program which relate
to pharmaceutical material utilization and effectiveness;
(j) Meeting
all inspection and other requirements of the pharmacy and drug laws of this state
and rules thereunder.
Stat. Auth.: ORS
689
Stats. Implemented:
Hist.: 1PB
3-1979(Temp), f. & ef. 10-31-79; 1PB 2-1980, f. & ef. 4-3-80; Renumbered
from 855-041-0140, BP 7-2012, f. & cert. ef. 12-17-12
Pharmacists Serving
Long Term Care Facilities and Community Based Care Facilities
855-041-7050
Definitions
As used in OAR 855-041-
7000 through 855-041- 7080:
(1)(a) "Long
term care facility" means a facility with permanent facilities that include inpatient
beds, providing medical services, including nursing services but excluding surgical
procedures except as may be permitted by the rules of the director, to provide treatment
for two or more unrelated patients. "Long Term Care facility" includes skilled nursing
facilities and intermediate care facilities but may not be construed to include
facilities licensed and operated pursuant to ORS 443.400 to 443.455.
(b) For the
purposes of Schedule II prescriptions in 21 CFR 1306.11-1306.13, the DEA definition
of "long term care facility" as defined in 21 CFR 1300.01(25) includes "community
based care facilities."
(2) "Community
Based Care Facility" means a home, facility or supervised living environment licensed
or certified or otherwise recognized by an agency of the state of Oregon which provides
24-hour care, supervision, and assistance with medication administration. These
include but are not limited to Adult Foster Homes, Residential Care Facilities (RCF),
Assisted Living Facilities (ALF), Group Homes for the Developmentally Disabled and
Mentally Retarded and Inpatient Hospice.
(3) "Pharmaceutical
Care" means the responsible provision of any or all of the following services by
the pharmacist:
(a) Develop
and maintain policies and procedures for pharmaceutical services;
(b) Provide
direction and oversight regarding all aspects of the acquisition, disposition, handling,
storage, and administration of drugs including but not limited to the following:
(A) Receipt
and interpretation of physician's orders;
(B) Ordering
and receiving of medications;
(C) Handling
of emergency drugs and supplies;
(D) Labeling
of all drugs;
(E) Selection
of drug delivery systems;
(F) Development
of systems to provide timely delivery of drugs and supplies;
(G) Monitoring
of drug storage conditions and expiration dates;
(H) Monitoring
accuracy and efficiency of medication administration and compliance with physician's
orders;
(I) Establishing
and monitoring of appropriate record keeping;
(J) Accountability
of controlled substances;
(K) Return,
release, and/or destruction of discontinued or outdated drugs; and
(L) Compliance
with state and federal laws and regulations related to pharmaceutical services and
medication management.
(c) Provide
training and in-service education to facility staff;
(d) Perform
drug regimen review for each resident on a regularly scheduled basis for the purpose
of promoting therapeutic appropriateness and achieving the desired drug therapy
outcomes by identifying issues such as:
(A) Over-utilization
or underutilization;
(B) Therapeutic
duplication;
(C) Drug-disease
contraindications;
(D) Drug-drug
interactions;
(E) Incorrect
drug, drug dosage or duration of drug treatment;
(F) Drug-allergy
interaction;
(G) Clinical
abuse/misuse;
(H) Untreated
indication;
(I) Monitoring
and assessing of drug therapy outcomes;
(e) Communicate
effectively with residents' physicians and facility staff; and
(f) Participate
in resident care planning.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.0305
Hist.: 1PB
2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90; BP 4-2002, f.
6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0145, BP 7-2012, f. & cert.
ef. 12-17-12
855-041-7060
Drug Distribution
and Control
(1) Pharmacies or
pharmacists that supply emergency drug kits to and/or accept returned medications
from long term care facilities or community based care facilities must:
(a) Assist
in the establishment and supervision of:
(A) The policies
and procedures for the safe storage, distribution, administration, and disposition
of drugs;
(B) The maintenance
of controlled drug accountability records; and
(C) The policies
and procedures for professional advice/medication counseling of patients and/or
their care givers.
(b) Have
some pharmacists visit and provide consultant services on a regular basis; and
(c) Supervise
the implementation of the policies and procedures involving the security, storage,
stocking, labeling, and notification of use of emergency drugs kits and supplemental
drug supplies.
(2) Arrangements
can be made in advance by a provider pharmacy with a long term care facility or
a community based care facility to:
(a) Provide
emergency drug kits to those facilities permitted by their license to have them;
and
(b) Allow
only a designated licensed nurse present in the facility access to the emergency
drug kit or the on-site pharmacy pursuant to OAR 855-041-6310.
(3) An emergency
drug kit consists of those drugs that may be required and are authorized by a practitioner
to meet the immediate therapeutic needs of patients, when medication is not readily
available directly from a pharmacy.
(4) The emergency
drug kit inventory is the property of the provider pharmacy, and the provider pharmacy
consultant is responsible for developing the policy and procedures for storing and
stocking the emergency drug kit.
(5) Medication(s)
can only be removed from the emergency drug kit or the on-site pharmacy by a designated
licensed nurse pursuant to a practitioner's order.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: 1PB
2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981,
f. & ef. 8-20-81; PB 1-1990, f. & cert. ef. 1-23-90; PB 8-1990, f. &
cert. ef. 12-5-90; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0160,
BP 7-2012, f. & cert. ef. 12-17-12
855-041-7070
Labeling
and Distribution
(1) Except as provided
in subsection (2) of this section, all drugs dispensed for individual patients must
be labeled as required by OAR 855-041- 1120, or administered by health care professionals
from a unit dose system as defined in OAR 855-041- 6050(j).
(2) Pharmacies
that provide long term care facilities or community based care facilities with pharmaceuticals
can supply, on the order of a practitioner, and consistent with the policy and procedures
of the pharmacy or pharmacist providing consultant services:
(a) Injectables
for immunization and screening;
(b) Irrigation
solutions; and
(c) Bulk
manufacturer's container(s) of topical scabicides and pediculicides.
(3) Institutional
pharmacies that dispense medications to patients in long term care facilities and
community based care facilities must maintain for three years the records required
by
OAR 855-041-1120,
and comply with the patient counseling requirements of OAR 855-19-0230.
Stat. Auth.: ORS
689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0162, BP 7-2012, f.
& cert. ef. 12-17-12
855-041-7080
Pharmaceutical
Care in Community Based Care Facilities
When a pharmacist
provides pharmaceutical care to patients in a Community Based Care facility under
an arrangement with the facility, the pharmacist may provide the following services:
(1) Assist
facilities in establishing the appropriate policies and procedures for distribution,
storage, documentation and disposal of drugs;
(2) Assist
facilities in establishing and maintaining proper record keeping related to medication
administration;
(3) Visit
the facility on a regularly scheduled basis;
(4) Supervise
the distribution and storage of drugs;
(5) Assist
in providing appropriate training, in-service education, and clinical support to
facility staff; and
(6) Communicate
with physicians and other practitioners as needed.
Stat. Auth.:
ORS 689.205
Stats. Implemented:
ORS 689.305
Hist.: BP
4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-041-0164, BP 7-2012, f.
& cert. ef. 12-17-12
Home Health Care Agencies
855-041-8050
Emergency
Drug Supply in Home Health Care Agencies
Pharmacists serving
home health care agencies may provide for an emergency supply of drugs to be made
available to registered nurses to treat immediate therapeutic needs of their patients
or clients during such time as the pharmacy services are not available. Arrangements
shall be made in advance by the provider pharmacist for provision of the emergency
drug supply:
(1) Emergency
drugs defined. Emergency drugs are those non-controlled substances which may be
required to meet the immediate therapeutic needs of patients and which are not available
from any other authorized source in a timely manner;
(2) Portable
Container. Subject to all provisions of this section, a licensed pharmacy may furnish
to a home health agency licensed by the State an emergency drug supply in a portable
container for emergency in home treatment or adjustment of drug therapy by the home
health agency nurse;
(3) Drugs
included. The pharmacist(s) and the practitioner(s) who represent the agency shall
jointly determine and review annually a list of items and quantities to be included
in the emergency supply. Drugs shall only be available therein, in amounts sufficient
for immediate therapeutic requirements. The selected list shall include only drugs
to treat the following specific conditions:
(a) Allergic
reactions;
(b) Diabetic
emergencies;
(c) Severe
nausea and vomiting;
(d) Pulmonary
congestion or congestive heart failure;
(e) Local
or topical anesthetics for catheter and needle placement;
(f) Hydration
due to hypovolemia or shock;
(g) Routine
catheter maintenance; and
(h) Narcotic
analgesic overdose.
(4) Security.
The emergency drug supply shall be stored in a manner to prevent loss of drugs,
and available only to authorized licensed personnel. It may be kept in a room adjacent
to the locked pharmacy, or in a secure area in the Home Health/Home I.V. nursing
office;
(5) Storage.
The emergency drug supply shall be stored in areas suitable to prevent unauthorized
access and to insure a proper environment for preservation of the drugs as required
in official compendia;
(6) Labeling-Exterior.
The exterior of the emergency drug supply shall be labeled to clearly indicate it
as an emergency supply. Labeling shall also include the expiration date of the drug
supply. A complete listing of the contents of the supply shall be readily available;
(7) Labeling-Interior.
All drugs contained in the emergency medication supply shall in the manufacturer's
container or be labeled in accordance with OAR 855-041-1135;
(8) Drugs
added to parenteral solutions. Whenever any drug is added to a parenteral solution,
whether within or outside the direct personal supervision of a pharmacist, such
admixtures shall be labeled with a distinctive supplementary label indicating the
name and amount of the drug added, date and time of addition, expiration date, administration
time and infusion rate when applicable, and name or initials of person so adding.
This excludes any single dose medication prepared and totally administered immediately;
(9) Removal
of drugs. Emergency drugs shall be removed for administration only by authorized
licensed personnel pursuant to a prescriber's order. A copy of this order shall
be forwarded to the provider pharmacist within 72 hours to be reviewed and filed
in the pharmacy. Verification of this review shall be a hand written initial of
the reviewing pharmacist on that copy of the order;
(10) Expiration
Date. The expiration date of the emergency drug supply shall indicate the month
and year, and shall be the earliest expiration date of any drug in the supply. The
provider pharmacist shall examine the supply and replace drugs prior to their expiration.
Stat. Auth.: ORS
475.035 & 689.205
Stats. Implemented:
ORS 689.225
Hist. PB
1-1996, f. & cert. ef. 4-5-96; Renumbered from 855-041-0183; BP 4-2002, f. 6-27-02,
cert. ef. 7-1-02; Renumbered from 855-041-0165, BP 7-2012, f. & cert. ef. 12-17-12
The official copy of an Oregon Administrative Rule is
contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
The Oregon Administrative Rules and the Oregon Bulletin are
copyrighted by the Oregon Secretary of State. Terms
and Conditions of Use
