justicedao/ipfs_state_laws huggingface dataset:
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & 689.605 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & 689.605 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & 689.505 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & 689.508 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 475.165 & 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 475.165 & 689.155 History: 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 475.165 & 689.155 History: BP 3-2010, f. 4-29-10, cert. ef. 4-30-10