Bill Text: OR HB3541 | 2011 | Regular Session | Introduced

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Bill Title: Relating to therapeutic substitution.

Sponsorship: Moderate Partisan Bill (Republican 32-7-1)

Status: (Failed) 2011-06-30 - In committee upon adjournment. [HB3541 Detail]

Download: Oregon-2011-HB3541-Introduced.html

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     76th OREGON LEGISLATIVE ASSEMBLY--2011 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 2211

                         House Bill 3541

Sponsored by Representative THOMPSON; Representatives BENTZ,
  BREWER, CAMERON, CLEM, CONGER, ESQUIVEL, FREEMAN, GARRARD,
  GARRETT, GILLIAM, HUFFMAN, JENSON, JOHNSON, KENNEMER, KRIEGER,
  MATTHEWS, MCLANE, OLSON, READ, SCHAUFLER, SHEEHAN, SPRENGER,
  THATCHER, WAND, WEIDNER, WHISNANT, WINGARD, Senators BEYER,
  BOQUIST, DEVLIN, GEORGE, GIROD, KRUSE, MORSE, NELSON, TELFER,
  THOMSEN, WHITSETT, WINTERS

                             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.

  Prohibits pharmacist from dispensing drug that is not
therapeutically equivalent to drug ordered or prescribed unless
prescriber and patient have consented in writing.

                        A BILL FOR AN ACT
Relating to therapeutic substitution; amending ORS 689.515.
Be It Enacted by the People of the State of Oregon:
  SECTION 1. 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.
  (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) A pharmacist may not dispense a drug product that is
not therapeutically equivalent to the drug product originally
ordered or prescribed by a prescriber unless the prescriber and
the patient have consented to the substitution in writing. + }
    { - (6) - }   { + (7) + } 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) - }   { + (8) + } Except as provided in subsection
 { - (8) - }   { + (9) + } 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) - }   { + (9) + } 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) - }   { + (10) + } 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) - }   { + (11) + } 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) - }   { + (12) + } 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.
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