DIVISION 43
PRACTITIONER DISPENSING
855-043-0001
Practitioner Labeling
All drugs dispensed by a practitioner shall be labeled with the following information:
(1) Name, address and telephone number of the practitioner;
(2) Date;
(3) Name of the patient or the owner of the animal for which the drug is dispensed. If the prescription is for an animal, the species of the animal for which the drug is dispensed;
(4) Name of drug, strength, the quantity dispensed. When a generic name is used, the label shall also contain the name of the manufacturer or distributor;
(5) Direction for use;
(6) Required precautionary information regarding controlled substances;
(7) Such other and further accessory cautionary information as required for patient safety; and
(8) An expiration date after which the patient should not use the drug or medicine. Expiration dates on drugs dispensed must be the same as that on the original container unless, in the practitioners professional judgement, a shorter expiration date is warranted. Any drug bearing an expiration date shall not be dispensed beyond the said expiration date of the drug.
Stat. Auth.: ORS 689.155 & ORS 689.205
Stats. Implemented:
Hist.: PB 4-1992, f. & cert. ef. 8-25-92
County Health Clinics
855-043-0110
Purpose and Scope
(1) A registered nurse who is an employee of a local health department established under the authority of a county or district board of health and registered by the board under ORS 689.305 may dispense a drug or device to a client of the health department for purposes of caries prevention, birth control, or prevention or treatment of a communicable disease.
(2) Such dispensing shall be pursuant to the order of a person authorized to prescribe a drug or device, and shall be subject to rules jointly adopted by the Board and the Health Division.
Stat. Auth.: ORS 689.155, ORS 689.205, ORS 689.305 & ORS
689.315
Stats. Implemented:
Hist.: PB 2-1992, f. & cert. ef. 3-26-92
855-043-0120
Definitions
(1) "Administer" means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient by:
(a) A practitioner of the authorized agent thereof;
(b) The patient at the direction of the practitioner.
(2) "Dispense" or "Dispensing" means the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.
(3) "Formulary" means a list of drugs approved by the Board and the Health Division for dispensing by registered nurse employees of county health clinics. The formulary shall not include controlled substances.
(4) "Health Officer" means a physician licensed by the Board of Medical Examiners for the State of Oregon and employed by or under contract with a county or district health department or the State Health Division.
Stat. Auth.: ORS 689.155, ORS 689.205, ORS 689.305 & ORS
689.315
Stats. Implemented:
Hist.: PB 2-1992, f. & cert. ef. 3-26-92; PB 4-1992, f. &
cert. ef. 8-25-92
855-043-0130
Drug Delivery and Control
(1) Policies and Procedures. The health officer shall be held responsible for the following:
(a) Written policies and procedures for drug dispensing, storage, security, and accountability;
(b) Maintenance of all drug records required by federal and state law;
(c) Procedures for procurement of drugs.
(2) Dispensing:
(a) Drugs shall be personally dispensed either by the health officer or by a registered nurse;
(b) Drugs shall be dispensed in containers complying with the federal Poison Prevention Packaging Act unless the patient requests a non-complying container;
(c) Registered nurses shall only dispense drugs listed in the formulary;
(d) The health officer or a registered nurse shall label prescription drugs with the following information:
(A) Name of patient;
(B) Name of prescriber;
(C) Name, address, and phone number of the clinic;
(D) Date of dispensing;
(E) Name and strength of the drug. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;
(F) Directions for use;
(G) Initials of the person dispensing;
(H) Cautionary statements, if any, as required by law;
(I) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug.
(e) A drug information fact sheet, as approved by the Board, shall accompany all drugs dispensed from a county health clinic.
(3) Repackaged Drugs. Drugs repackaged for dispensing 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 a earlier date if preferable. An internal control number which references manufacturer and lot number may be utilized.
(4) Drug Security, Storage, and Disposal:
(a) In the absence of the health officer or of a registered nurse, drugs shall be kept in a locked drug cabinet or drug room which is sufficiently secure to deny access to unauthorized persons. Only the health officer and registered nurses shall have a key to the drug cabinet or drug room. In their absence, the drug cabinet or drug room shall remain locked;
(b) All drugs shall be stored in areas which will assure proper sanitation, temperature, light, ventilation and moisture control as required in official compendium (such as the United States Pharmacopeia and National Formulary);
(c) Drugs which 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.
(5) Drug Records;
(a) A dispensing records shall be maintained separately from the patient chart and kept for a minimum of three years. The record shall show, at a minimum, the following:
(A) Name of patient;
(B) Brand name of drug, or generic name and name of manufacturer or distributor;
(C) Date;
(D) Initials of person dispensing the prescription.
(b) All records of receipt and dispersal of drugs shall be kept for a minimum of three years;
(c) All records required by these rules or by federal and state law shall be readily retrievable and available for inspection by the Board.
[Publications: The publication(s) referred to or incorporated by reference in this rule are available from the agency.]
Stat. Auth.: ORS 475.035 & ORS 689.205
Stats. Implemented:
Hist.: PB 2-1992, f. & cert. ef. 3-26-92; PB 4-1992, f. &
cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94
855-043-0210
Purpose and Scope
The Oregon State Board of Nursing may grant to a certified nurse practitioner the privilege of writing prescriptions described in the formulary under ORS 678.385. A certified nurse practitioner may submit an application to the Oregon State Board of Nursing to dispense prescription drugs. An application for the authority to dispense prescription drugs as authorized by ORS 678.385 shall include evidence of completion of a prescription drug dispensing training program jointly developed and adopted by rule by the Oregon State Board of Nursing (851-050-0162) and the State Board of Pharmacy. The training program shall be as follows:
(1) Documented review of content regarding safe dispensing listed below:
(a) Board of Nursing handbook "Nurse Practitioner Prescriptive Authority in Oregon";
(b) The Drug Enforcement Administration Pharmacist's Manual (2001);
(c) OAR 851 division 50;
(d) ORS Chapter 689 and OAR chapter 855;
(e) US Consumer Product Safety Commission publication "Poison Prevention Packaging: A Text for Pharmacist's and Physicians," and;
(f) The Institute for Safe Medication Practices (ISMP) "List of Error-Prone Abbreviations, Symbols, and Dose Designations" (Nov.2003); and
(g) Information on available electronic or hard copy prescription drug references which provide information to professionals authorized to dispense prescription medications
(2) Successful self examination as provided by the Board of Nursing on these materials.
Stat. Auth.: ORS 689.205, 2003 OL, Ch. 617
Stats. Implemented: ORS 689.205
Hist.: BP 3-2003(Temp), f. 12-29-03, cert. ef. 12-31-03 thru 6-28-04;
BP 4-2004, f. 5-21-04 cert. ef. 6-1-04
855-043-0300
Purpose and Scope
(1) A registered nurse, or a nurse practitioner who is an employee of a clinic supported by the Oregon Health Division for purposes of providing public health family planning services, which is licensed by the Board under ORS 689.305 may dispense drugs or devices from the Board's approved formulary to clients for purpose of birth control, the treatment of amenorrhea, hormone deficiencies, urinary tract infections or sexually transmitted diseases.
(2) Such dispensing must be pursuant to the prescription of a person authorized to prescribe a drug or device, and shall be subject to rules jointly adopted by the Board and the Health Division.
Stat. Auth.: ORS
689.205
Stats. Implemented: ORS 689.305
Hist.: BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
855-043-0310
Drug Delivery and Control
(l) Policies and Procedures. The licensed facility shall be held responsible for the following:
(a) Written policies and procedures for drug dispensing, storage, security, and accountability;
(b) Maintenance of all drug records required by federal and state law; and
(c) Procedures for procurement of drugs.
(2) Dispensing:
(a) For the initial dispensing, drugs must be personally dispensed either by a physician, pharmacist, registered nurse, or nurse practitioner. After the initial dispensing if the patient's medication profile has not changed, nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by a physician, nurse, or nurse practitioner prior to being delivered or transferred to the patient.
(b) Drugs must be dispensed in containers complying with the federal Poison Prevention Packaging Act unless the patient requests a non-complying container.
(c) Prescriptions must be labeled with the following information:
(A) Name of patient;
(B) Name of prescriber;
(C) Name, address, and phone number of the clinic;
(D) Date of dispensing;
(E) Name and strength of the drug. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;
(F) Directions for use;
(G) Initials of the person dispensing;
(H) Cautionary statements, if any, as required by law; and
(I) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug.
(d) The prescriber must verbally counsel the patient concerning all new medications and a drug information fact sheet must accompany all drugs dispensed from a family planning clinic.
(3) Repackaged drugs. Drugs repackaged for dispensing must 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; and
(d) Manufacturer's expiration date, or an earlier date if preferable. An internal control number which references manufacturer and lot number may be utilized.
(4) Drug security, storage, and disposal:
(a) In the absence of a physician, pharmacist, registered nurse, or nurse practitioner, all drugs must be kept in a locked drug cabinet or drug room which is sufficiently secure to deny access to unauthorized persons. Only physicians, pharmacists, registered nurses, or nurse practitioners shall have a key to the drug cabinet or drug room. In their absence, the drug cabinet or drug room must remain locked.
(b) All drugs must be stored in areas which will assure proper sanitation, temperature, light, ventilation, and moisture control as required in official compendium (such as the United States Pharmacopeia and National Formulary).
(c) Drugs which are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.
(5) Drug records:
(a) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following:
(A) Name of patient;
(B) Brand name of drug, or generic name and name of manufacturer or distributor;
(C) Date of dispensing; and
(D) Initials of person dispensing the prescription;
(b) All records of receipt and dispersal of drugs must be kept for a minimum of three years.
(c) All records required by these rules or by federal and state law must be readily retrievable and available for inspection by the Board.
(6) A consultant pharmacist must conduct and document an annual inspection of the clinic in accordance with the directions of the Board. The completed report form must be filed in the clinic, and be available to the Board for inspection for three years.
Stat. Auth.: ORS
689.205
Stats. Implemented: ORS 689.305
Hist.: BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
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