Bill Text: OR HB3466 | 2013 | Regular Session | Introduced
Bill Title: Relating to the practice of pharmacy.
Spectrum: Slight Partisan Bill (Democrat 2-1)
Status: (Failed) 2013-07-08 - In committee upon adjournment. [HB3466 Detail]
Download: Oregon-2013-HB3466-Introduced.html
77th OREGON LEGISLATIVE ASSEMBLY--2013 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 3810
House Bill 3466
Sponsored by Representative THOMPSON; Representatives KENY-GUYER,
KOMP
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure as
introduced.
Authorizes pharmacist to initiate or modify drug therapy in
accordance with guidelines and protocols established by physician
licensed to practice medicine. Specifies guidelines and protocols
that must be followed. Prohibits pharmacist from initiating or
modifying drug therapy for drugs that are controlled substances
classified in Schedules I through IV of federal Controlled
Substances Act.
Authorizes pharmacist to substitute, under certain conditions,
prescribed drug with therapeutically equivalent drug in
accordance with rules adopted by State Board of Pharmacy.
Clarifies provision authorizing prescriptive authority with
respect to Schedule II controlled substances.
A BILL FOR AN ACT
Relating to the practice of pharmacy; creating new provisions;
and amending ORS 475.185, 475.188, 689.005 and 689.515.
Be It Enacted by the People of the State of Oregon:
SECTION 1. ORS 689.005 is amended to read:
689.005. As used in this chapter:
(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 or research subject by:
(a) A practitioner or the practitioner's authorized agent; or
(b) The patient or research subject at the direction of the
practitioner.
(2) 'Approved continuing pharmacy education program' means
those seminars, classes, meetings, workshops and other
educational programs on the subject of pharmacy approved by the
board.
(3) 'Board of pharmacy' or 'board' means the State Board of
Pharmacy.
(4) 'Continuing pharmacy education' means:
(a) Professional, pharmaceutical post-graduate education in the
general areas of socio-economic and legal aspects of health care;
(b) The properties and actions of drugs and dosage forms; and
(c) The etiology, characteristics and therapeutics of the
disease state.
(5) 'Continuing pharmacy education unit' means the unit of
measurement of credits for approved continuing education courses
and programs.
(6) 'Deliver' or 'delivery' means the actual, constructive or
attempted transfer of a drug or device other than by
administration from one person to another, whether or not for a
consideration.
(7) 'Device' means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent or other similar
or related article, including any component part or accessory,
which is required under federal or state law to be prescribed by
a practitioner and dispensed by a pharmacist.
(8) '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.
(9) 'Distribute' means the delivery of a drug other than by
administering or dispensing.
(10) 'Drug' means:
(a) Articles recognized as drugs in the official United States
Pharmacopoeia, official National Formulary, official Homeopathic
Pharmacopoeia, other drug compendium or any supplement to any of
them;
(b) Articles intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in a human or
other animal;
(c) Articles, other than food, intended to affect the structure
or any function of the body of humans or other animals; and
(d) Articles intended for use as a component of any articles
specified in paragraph (a), (b) or (c) of this subsection.
(11) 'Drug order' means a written order, in a hospital or other
inpatient care facility, for an ultimate user of any drug or
device issued and signed by a practitioner, or an order
transmitted by other means of communication from a practitioner,
that is immediately reduced to writing by a pharmacist, licensed
nurse or other practitioner.
(12) 'Drug outlet' means any pharmacy, nursing home, shelter
home, convalescent home, extended care facility, drug abuse
treatment center, penal institution, hospital, family planning
clinic, student health center, retail store, wholesaler,
manufacturer, mail-order vendor or other establishment with
facilities located within or out of this state that is engaged in
dispensing, delivery or distribution of drugs within this state.
(13) 'Drug room' means a secure and lockable location within an
inpatient care facility that does not have a licensed pharmacy.
(14) 'Electronically transmitted' or 'electronic transmission'
means a communication sent or received through technological
apparatuses, including computer terminals or other equipment or
mechanisms linked by telephone or microwave relays, or any
similar apparatus having electrical, digital, magnetic, wireless,
optical, electromagnetic or similar capabilities.
(15) 'Institutional drug outlet' means hospitals and inpatient
care facilities where medications are dispensed to another health
care professional for administration to patients served by the
hospitals or facilities.
(16) 'Intern' means a person who is enrolled in or has
completed a course of study at a school or college of pharmacy
approved by the board and who is licensed with the board as an
intern.
(17) 'Internship' means a professional experiential program
approved by the board under the supervision of a licensed
pharmacist registered with the board as a preceptor.
(18) 'Itinerant vendor' means a person who sells or distributes
nonprescription drugs by passing from house to house, or by
haranguing the people on the public streets or in public places,
or who uses the customary devices for attracting crowds,
recommending their wares and offering them for sale.
(19) 'Labeling' means the process of preparing and affixing of
a label to any drug container exclusive, however, of the labeling
by a manufacturer, packer or distributor of a nonprescription
drug or commercially packaged legend drug or device.
(20) 'Manufacture' means the production, preparation,
propagation, compounding, conversion or processing of a device or
a drug, either directly or indirectly by extraction from
substances of natural origin or independently by means of
chemical synthesis or by a combination of extraction and chemical
synthesis and includes any packaging or repackaging of the
substances or labeling or relabeling of its container, except
that this term does not include the preparation or compounding of
a drug by an individual for their own use or the preparation,
compounding, packaging or labeling of a drug:
(a) By a practitioner as an incident to administering or
dispensing of a drug in the course of professional practice; or
(b) By a practitioner or by the practitioner's authorization
under supervision of the practitioner for the purpose of or as an
incident to research, teaching or chemical analysis and not for
sale.
(21) 'Manufacturer' means a person engaged in the manufacture
of drugs.
(22) 'Nonprescription drug outlet' means shopkeepers and
itinerant vendors registered under ORS 689.305.
(23) 'Nonprescription drugs' means drugs which may be sold
without a prescription and which are prepackaged for use by the
consumer and labeled in accordance with the requirements of the
statutes and regulations of this state and the federal
government.
(24) 'Person' means an individual, corporation, partnership,
association or any other legal entity.
(25) 'Pharmacist' means an individual licensed by this state to
engage in the practice of pharmacy.
(26) 'Pharmacy' means a place that meets the requirements of
rules of the board, is licensed and approved by the board where
the practice of pharmacy may lawfully occur and includes
apothecaries, drug stores, dispensaries, hospital outpatient
pharmacies, pharmacy departments and prescription laboratories
but does not include a place used by a manufacturer or
wholesaler.
(27) 'Pharmacy technician' means a person licensed by the State
Board of Pharmacy who assists the pharmacist in the practice of
pharmacy pursuant to rules of the board.
(28) 'Practice of pharmacy' means:
(a) The interpretation and evaluation of prescription orders;
(b) The compounding, dispensing and labeling of drugs and
devices, except labeling by a manufacturer, packer or distributor
of nonprescription drugs and commercially packaged legend drugs
and devices;
(c) The prescribing and administering of vaccines and
immunizations pursuant to ORS 689.645;
(d) The administering of drugs and devices to the extent
permitted under ORS 689.655;
(e) The participation in drug selection and drug utilization
reviews;
(f) The proper and safe storage of drugs and devices and the
maintenance of proper records therefor;
(g) The responsibility for advising, where necessary or where
regulated, of therapeutic values, content, hazards and use of
drugs and devices;
(h) The monitoring of therapeutic response or adverse effect to
drug therapy; { - and - }
{ + (i) The initiation or modification of drug therapy as
described in section 3 of this 2013 Act; and + }
{ - (i) - } { + (j) + } The offering or performing of those
acts, services, operations or transactions necessary in the
conduct, operation, management and control of pharmacy.
(29) 'Practitioner' means a person licensed and operating
within the scope of such license to prescribe, dispense, conduct
research with respect to or administer drugs in the course of
professional practice or research:
(a) In this state; or
(b) In another state or territory of the United States if the
person does not reside in Oregon and is registered under the
federal Controlled Substances Act.
(30) 'Preceptor' means a pharmacist or a person licensed by the
board to supervise the internship training of a licensed intern.
(31) 'Prescription drug' or 'legend drug' means a drug which
is:
(a) Required by federal law, prior to being dispensed or
delivered, to be labeled with either of the following statements:
(A) 'Caution: Federal law prohibits dispensing without
prescription'; or
(B) 'Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian'; or
(b) Required by any applicable federal or state law or
regulation to be dispensed on prescription only or is restricted
to use by practitioners only.
(32) 'Prescription' or 'prescription drug order' means a
written, oral or electronically transmitted direction, given by a
practitioner authorized to prescribe drugs, for the preparation
and use of a drug. When the context requires, 'prescription '
also means the drug prepared under such written, oral or
electronically transmitted direction.
(33) 'Retail drug outlet' means a place used for the conduct of
the retail sale, administering or dispensing or compounding of
drugs or chemicals or for the administering or dispensing of
prescriptions and licensed by the board as a place wherein the
practice of pharmacy may lawfully occur.
(34) 'Shopkeeper' means a business or other establishment, open
to the general public, for the sale or nonprofit distribution of
drugs.
(35) 'Unit dose' means a sealed single-unit container so
designed that the contents are administered to the patient as a
single dose, direct from the container. Each unit dose container
must bear a separate label, be labeled with the name and strength
of the medication, the name of the manufacturer or distributor,
an identifying lot number and, if applicable, the expiration date
of the medication.
(36) 'Wholesale drug outlet' means any person who imports,
stores, distributes or sells for resale any drugs including
legend drugs and nonprescription drugs.
SECTION 2. { + Section 3 of this 2013 Act is added to and made
a part of ORS chapter 689. + }
SECTION 3. { + (1)(a) Except as provided in paragraph (b) of
this subsection, a pharmacist may initiate or modify drug therapy
in accordance with guidelines and protocols established by a
physician licensed to practice medicine under ORS chapter 677 if
the guidelines and protocols are in compliance with the
provisions of this section.
(b) A pharmacist may not initiate or modify drug therapy for a
drug that is a controlled substance classified in Schedules I
through IV under the federal Controlled Substances Act, 21 U.S.C.
811 and 812, as modified under ORS 475.035.
(2) Guidelines and protocols established under this section
must contain, at a minimum:
(a) The identities of the physician and the pharmacist;
(b) The time period, not to exceed two years, during which the
pharmacist may initiate or modify drug therapy;
(c) The scope of the pharmacist's prescriptive authority,
including:
(A) The types of injuries, illnesses or diseases for which the
pharmacist may initiate or modify drug therapy; and
(B) The types of drugs that the pharmacist may prescribe for
those injuries, illnesses or diseases;
(d) The procedures that the pharmacist must follow and the
criteria that the pharmacist must consider when initiating or
modifying drug therapy; and
(e) The procedures that the pharmacist must follow after
initiating or modifying drug therapy, including:
(A) The procedures for documenting the initiation or
modification;
(B) The means of documenting the initiation or modification;
and
(C) The procedures for communicating the initiation or
modification to the physician. + }
SECTION 4. ORS 689.515 is amended to read:
689.515. (1) As used in this section unless the context
requires otherwise:
(a) 'Brand name' means the proprietary or trade name selected
by the manufacturer and placed upon a drug, its container, label
or wrapping at the time of packaging.
(b) 'Dosage form' means the physical formulation or medium in
which the product is intended, manufactured and made available
for use, including but not limited to tablets, capsules, oral
solutions, aerosols, ointments, inhalers and suppositories, and
the particular form of which utilizes a specific technology or
mechanism to control, enhance or direct the release, targeting,
systemic absorption or other delivery of a dosage regimen in the
body.
(c) 'Generic name' means the official title of a drug or drug
ingredients published in the latest edition of the official
Pharmacopoeia, Homeopathic Pharmacopoeia or Formulary.
(d) 'Substitute' means to dispense without the prescriber's
express authorization a different drug product in place of the
drug ordered or prescribed.
(e) 'Therapeutically equivalent' means drugs that are approved
by the United States Food and Drug Administration for interstate
distribution and the Food and Drug Administration has determined
that the drugs will provide essentially the same efficacy and
toxicity when administered to an individual in the same dosage
regimen.
(2) Except as limited by subsections (3) and (5) of this
section, unless the purchaser instructs otherwise, a pharmacist
may substitute as follows:
(a) A drug product with the same generic name in the same
strength, quantity, dose and dosage form as the prescribed drug
which is, in the pharmacist's professional opinion,
therapeutically equivalent.
(b) When the prescriber is not reasonably available for
consultation and the prescribed drug does not utilize a unique
delivery system technology, an oral tablet, capsule or liquid
form of the prescribed drug so long as the form dispensed or
administered has the same strength, dose and dose schedule and is
therapeutically equivalent to the drug prescribed.
{ + (c) A drug that is therapeutically equivalent to the drug
prescribed as established by the State Board of Pharmacy by
rule. + }
(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.
(4) A pharmacy shall post a sign in a location easily seen by
patrons at the counter where prescriptions are dispensed or
administered stating that, 'This pharmacy may be able to
substitute a less expensive drug which is therapeutically
equivalent to the one prescribed by your doctor unless you do not
approve.' The printing on the sign must be in block letters not
less than one inch in height. If the pharmacist has reasonable
cause to believe that the purchaser cannot read the sign or
comprehend its content, the pharmacist shall endeavor to explain
the meaning of the sign.
(5) A pharmacist may substitute a drug product under this
section only when there will be a savings in or no increase in
cost to the purchaser.
(6) If the practitioner prescribes a drug by its generic name,
the pharmacist shall, consistent with reasonable professional
judgment, dispense or administer the lowest retail cost,
effective brand which is in stock.
(7) Except as provided in subsection (8) of this section, when
a pharmacist dispenses a substituted drug as authorized by
subsection (2) of this section, the pharmacist shall label the
prescription container with the name of the dispensed drug. If
the dispensed drug does not have a brand name, the pharmacist
shall label the prescription container with the generic name of
the drug dispensed along with the name of the drug manufacturer.
(8) A prescription dispensed by a pharmacist must bear upon the
label the name of the medication in the container or shall be
labeled as intended by the prescriber.
(9) The substitution of any drug by a pharmacist or the
pharmacist's employer pursuant to this section does not
constitute the practice of medicine.
(10) A substitution of drugs made by a pharmacist or the
pharmacist's employer in accordance with this section and any
rules that the { - State - } board { - of Pharmacy - } may
adopt thereunder does not constitute evidence of negligence if
the substitution was made within reasonable and prudent practice
of pharmacy or if the substituted drug was accepted in a
generally recognized formulary or government list.
(11) Failure of a practitioner to specify that no substitution
is authorized does not constitute evidence of negligence unless
the practitioner knows that the health condition of the patient
for whom the practitioner is prescribing warrants the use of the
brand name drug product and not the substituted drug.
SECTION 5. ORS 475.185 is amended to read:
475.185. { - (1) Except when dispensed directly by a
practitioner to an ultimate user, a controlled substance in
Schedule II may not be dispensed without the written prescription
of a practitioner. - }
{ - (2) - } { + (1) + } In emergency situations, as defined
by rule of the State Board of Pharmacy, Schedule II drugs may be
dispensed upon oral or electronically transmitted prescription of
a practitioner, reduced promptly to writing and filed by the
pharmacy. Prescriptions shall be retained in conformity with the
requirements of ORS 475.165. A prescription for a Schedule II
substance may not be refilled.
{ - (3) - } { + (2) + } Except when dispensed directly by a
practitioner to an ultimate user, a controlled substance included
in Schedule { + II, + } III or IV may not be dispensed without a
written, oral or electronically transmitted prescription of a
practitioner. The prescription { + for a controlled substance in
Schedule II may not be refilled. Additional quantities of a
controlled substance in Schedule II may be authorized by a
practitioner only through issuance of a new prescription. The
prescription for a controlled substance in Schedule III or IV + }
may not be filled or refilled more than six months after the date
on which it was issued and a prescription authorized to be
refilled may not be refilled more than five times. Additional
quantities of the controlled substances listed in Schedule III or
IV may { - only - } be authorized by a practitioner
{ + only + } through issuance of a new prescription.
{ - (4) - } { + (3) + } Except when dispensed directly by a
practitioner to an ultimate user, a controlled substance included
in Schedule V that is a prescription drug may not be dispensed
without a written, oral or electronically transmitted
prescription of a practitioner. The prescription may not be
filled or refilled more than six months after the date on which
it was issued and a prescription authorized to be refilled may
not be refilled more than five times. Additional quantities of
the controlled substances listed in Schedule V may { - only - }
be authorized by a practitioner { + only + } through issuance of
a new prescription.
{ - (5) - } { + (4) + } A controlled substance may not be
delivered or dispensed other than for a medical purpose.
{ - (6) - } { + (5) + } Except in good faith and in the
course of professional practice only, a practitioner or a
pharmacist may not dispense controlled substances.
{ - (7) - } { + (6) + } Any oral or electronically
transmitted prescription authorized by statute or rule must be
stored by electronic means or reduced promptly to writing and
filed by the pharmacy.
{ - (8) - } { + (7) + } Issuance, preparation, labeling,
dispensing, recordkeeping and filing of prescriptions or
medication orders must be in conformance with the requirements of
the federal law and rules of the board.
SECTION 6. ORS 475.188 is amended to read:
475.188. (1) Prescription drug orders may be transmitted by
electronic means from a practitioner authorized to prescribe
drugs directly to the dispensing pharmacist.
(2) All prescription drug orders communicated by way of
electronic transmission shall:
(a) Be transmitted only by an authorized practitioner;
(b) Be transmitted directly to a pharmacist in a pharmacy of
the patient's choice with no intervening person having access to
the prescription drug order;
(c) Specify the prescribing practitioner's telephone number for
verbal confirmation, the time and date of transmission, the
identity of the pharmacy intended to receive the transmission and
all other information required for a prescription by federal or
state law; and
(d) Be traceable to the prescribing practitioner by an
electronic signature or other secure method of validation.
(3) An electronic transmission of a prescription drug order
shall be stored by electronic means or reduced promptly to
writing, filed by the pharmacy and retained in conformity with
the requirements of ORS 475.165.
(4) The dispensing pharmacist shall exercise professional
judgment regarding the accuracy, validity and authenticity of an
electronically transmitted prescription drug order.
(5) All equipment for transmission, storage or receipt of
electronically transmitted prescription drug orders shall be
maintained to protect against unauthorized access.
(6) A pharmacist, pharmacy or pharmacy department shall not
enter into an agreement with a practitioner or health care
facility concerning the provision of any electronic transmission
equipment or apparatus that would adversely affect a patient's
freedom to select the pharmacy or pharmacy department of the
patient's choice.
(7) A pharmacist, pharmacy or pharmacy department shall not
provide any electronic equipment or apparatus to a practitioner
or health care facility for the purpose of providing an incentive
to the practitioner or health care facility to refer patients to
a particular pharmacy or pharmacy department.
(8) There shall be no additional charge to the patient because
the prescription drug order was electronically transmitted.
(9) Nothing in this section shall be construed as authorizing
the electronic transmission of a prescription drug order when a
written prescription is required under ORS 127.815, 137.473,
169.750 { - , - } { + or + } 453.025 { - or 475.185 (1) - }
.
----------
