reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-4055 - Home Dialysis - Duties of the Pharmacist

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-4100 - Definitions - Automated Pharmacy System

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 drugs for dispensing.
(4)
			 "Responsible Pharmacy" means the licensed pharmacy that is responsible for the
			 APS, and RDM.
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-4110 - Remote Dispensing Machine (RDM) - Duties and Responsibilities of the Pharmacist-in-Charge

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-4120 - Remote Dispensing Machine (RDM) - Drug Delivery and Control

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-5005 - Definitions - Institutional and Residential Pharmacy Drug Outlets

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-5015 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-5050 - Remote Distribution Facility (RDF) - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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 Distribution Facility"
			 (RDF) means an in-state/resident facility where drugs are prepared for
			 administration and where requisite pharmacist supervision is provided remotely
			 as approved by the Board.
(3)
			 "Responsible Pharmacy" means the licensed resident pharmacy that is responsible
			 for the RDF.
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-5055 - Remote Distribution Facility (RDF)

Current through Register Vol. 63, No. 7, July 1, 2024
The purpose of these rules is to provide for the use of a
				Certified Oregon Pharmacy Technician functioning outside of a pharmacy to
				prepare drugs only for administration to a patient by another healthcare
				provider, and where requisite pharmacist supervision and verification is
				provided remotely by an Oregon licensed pharmacist via an audiovisual
				communication system.
(1) A pharmacy
			 physically located in Oregon may make written application to operate a
			 RDF.
(2) The board may approve an
			 application for registration as a 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 Division
			 110.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6050 - Definitions - Automated Distribution Cabinet (ADC)

Current through Register Vol. 63, No. 7, July 1, 2024
In these rules, OAR 855-041-6000 through 855-041-6999, the
				terms below have these meanings:
(1)
			 "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;
(2) "Drug" means a drug, a prescription
			 device, a biological medication, a chemical or any combination of these
			 terms;
(3) "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;
(4)
			 "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;
(5) "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;
(6) "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;
(7) "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;
(8) "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;
(9) "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;
(10) "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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6100 - Registration

Current through Register Vol. 63, No. 7, July 1, 2024
(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 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. A
			 waiver is not valid for more than five years.
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155 & ORS
				  689.305
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6150 - General Pharmacy Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 855-041-1035, 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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6200 - Chief Pharmacy Officer and Pharmacist in Charge

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 855-115-0210.
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6220 - Records

Current through Register Vol. 63, No. 7, July 1, 2024
(1) All records and
			 documents required by ORS 475, ORS 689, and OAR 855:
(a) Must be stored on-site for 12 months and
			 must be provided to the board immediately upon request.
(b) May be stored in a secured off-site
			 location after 12 months of on-site storage and must be provided to the board
			 upon request within three business days; and
(c) May be written or electronic
			 format.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6240 - Drug Administration

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6250 - Patient's Own Drugs and Other Drugs from Outside Sources

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6260 - Investigational Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6270 - Institutional Drug Outlet Pharmacy Prescription Labeling

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each pharmacy
			 record keeping system must identify all pharmacy personnel involved in the
			 repackaging including the pharmacist who verified the repackaged
			 drug.
(2) Each repackaged drug,
			 prepared by the pharmacy and intended for use within the facility must be in an
			 appropriate container with a label that meets the requirements of OAR
			 855-041-1135 and includes:
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6300 - Absence of the Pharmacist

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Statutory/Other Authority: ORS
				  689.205
Statutes/Other Implemented: ORS
				  689.155 & ORS
				  689.605
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6305 - Night Cabinet

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6310 - After Hours Access to Pharmacy

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6400 - Emergency Dispensing by a Nurse

Current through Register Vol. 63, No. 7, July 1, 2024
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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6410 - Emergency Department Distribution

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 must 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 must 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;
(d) Except as described in SB 450 (2023), 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)
			 Except as described in SB 450 (2023), 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.
(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 must
			 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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6420 - Emergency Kit and Code Cart

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6500 - Practitioner's Drug Order

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6510 - In-patient Drug Profile

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6520 - Cart-Fill

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6530 - Robotic Distribution Systems

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6540 - Automated Distribution Cabinets

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6550 - Secondary and Remote Storage

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6560 - Floor-Stock

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6570 - Trays and Kits

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6600 - Controlled Drug Accountability

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6610 - Schedule II Drugs

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6620 - Electronic Safe Systems

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-6800 - Supervision of Consulting Pharmacist

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-7060 - Long Term Care Pharmacy - Drug Distribution and Control

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-7070 - Long Term Care Pharmacy - Labeling and Distribution

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-7080 - Pharmaceutical Care in Community Based Care Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 41 - OPERATION OF PHARMACIES › Section 855-041-8050 - Emergency Drug Supply in Home Health Care Agencies

Current through Register Vol. 63, No. 7, July 1, 2024
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.