71st OREGON LEGISLATIVE ASSEMBLY--2001 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 2975
 
                         Senate Bill 568
 
Sponsored by Senator FISHER (at the request of Oregon State
  Pharmacist Association)
 
 
                             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.
 
  Eliminates requirement that pharmacy post sign advising patrons
that less expensive equivalent drug may be available for
substitution to fill prescription. Requires prescription to be
labeled with name of medication or as instructed by prescriber.
 
                        A BILL FOR AN ACT
Relating to information provided by pharmacy about prescription
  medications; 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) - }
 { +  (4) + } of this section, unless the purchaser instructs
otherwise, the 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 or by a telephonic
communication that there shall be no substitution for the
specified brand name drug in any prescription. The phrase 'no
substitution' or the notation 'N.S.' must be in the
practitioner's handwriting or, if the prohibition was
communicated by telephonic communication, in the pharmacist's
handwriting and shall not be preprinted or stamped or initialed
on the prescription form.
    { - (4) Every 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 shall 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) - }   { + (4) + } A pharmacist shall substitute a
drug product under this section only when there will be a savings
in or no increase in cost to the purchaser.
    { - (6) - }   { + (5) + } 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) - }   { + (6) + } Except as provided in subsection
 { - (8) - }   { + (7) + } of this section, when a pharmacist
dispenses a substituted drug as authorized by subsection (2) of
this section, the pharmacist must label the prescription
container with the name of the dispensed drug. If the dispensed
drug does not have a brand name, the prescription label shall
indicate the generic name of the drug dispensed along with the
name of the drug manufacturer.
    { - (8) - }   { + (7) + } A prescription dispensed by a
pharmacist shall bear upon the label the name of the medication
in the container   { - except if the prescriber writes 'do not
label,' or words of similar import, on the prescription or so
designates in an oral transmission of the prescription - }  { +
or shall be labeled as intended by the prescriber + }.
    { - (9) - }   { + (8) + } The substitution of any drug by a
licensed pharmacist or the pharmacist's employer pursuant to this
section does not constitute the practice of medicine.
    { - (10) - }   { + (9) + } No 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 shall 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) - }   { + (10) + } 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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