75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
 
HA to HB 3103
 
LC 2888/HB 3103-1
 
                       HOUSE AMENDMENTS TO
                         HOUSE BILL 3103
 
                   By COMMITTEE ON HEALTH CARE
 
                            April 27
 
  On page 5 of the printed bill, delete lines 22 through 45.
  On page 6, delete lines 1 through 38 and insert:
  '  { +  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,   { - the - }
 { + 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
 { - shall - }   { + may + } be no substitution for the specified
brand name drug in   { - any - }   { + a + } 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 or electronic
transmission, in the pharmacist's handwriting and shall not be
preprinted or stamped or initialed on the prescription form. - }
  ' (4)   { - Every - }   { + 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
 { - shall - }   { + 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   { - shall - }   { + 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   { - must - }
 { + shall + } 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
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   { - shall - }
 { + 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   { - licensed - }
pharmacist or the pharmacist's employer pursuant to this section
does not constitute the practice of medicine.
  ' (10)   { - No - }   { + 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
  { - shall - }   { + 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.'.
                         ----------