73rd OREGON LEGISLATIVE ASSEMBLY--2005 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 3000
 
                         House Bill 2786
 
Sponsored by Representative BUTLER (at the request of Darrell St.
  John)
 
 
                             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.
 
  Requires purchaser and practitioner prescribing medications to
authorize substitution of generic drugs. Specifies instructions
required to authorized pharmacist to make substitution.
 
                        A BILL FOR AN ACT
Relating to substitution of generic drug for brand name drug;
  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 - }
 { + with + } 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 - }   { + If specifically authorized by + } 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 - }   { + must + } specify in
writing, by a telephonic communication or by electronic
transmission that   { - there shall be no - }   { + a + }
substitution for the specified brand name drug in any
prescription { +  may be made by the pharmacist if authorized by
the purchaser + }. The phrase   { -  ' no substitution' or the
notation ' N.S.' - }   { +  ' substitution permitted' or
'substitution authorized' or words of similar intent + } must be
in the practitioner's handwriting or, if the
 { - prohibition - }   { + authorization + } was communicated by
telephonic communication or electronic transmission, 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) A pharmacist   { - shall - }   { + may + } substitute a
drug product under this section only when  { + authorized to do
so by the purchaser and the practitioner issuing the prescription
and 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 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) A prescription dispensed by a pharmacist shall 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 licensed pharmacist or
the pharmacist's employer pursuant to this section does not
constitute the practice of medicine.
  (10) 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)   { - Failure of - }   { + Authorization by + } a
practitioner   { - to specify that no - }   { + allowing a + }
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.
                         ----------