(Reprinted with amendments adopted on April 21, 2003)

 

Senate Bill No. 387–Senator Titus

 

March 17, 2003

____________

 

Referred to Committee on Commerce and Labor

 

SUMMARY—Revises provisions relating to drugs and prescriptions. (BDR 54‑656)

 

FISCAL NOTE:  Effect on Local Government: No.

                           Effect on the State: No.

 

~

 

EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted.

 

AN ACT relating to drugs; requiring the Board of Medical Examiners and the State Board of Pharmacy to post on the Internet certain information relating to manufacturers of drugs; revising provisions relating to the substitution of generic drugs for drugs prescribed by brand name; and providing other matters properly relating thereto.

 

THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN

SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

 

1-1  Section 1. Chapter 630 of NRS is hereby amended by adding

1-2  thereto a new section to read as follows:

1-3  The Board shall post on a website or other Internet site that is

1-4  operated or administered by or on behalf of the Board:

1-5  1.  A general description of the basic elements of the

1-6  Compliance Program Guidance for Pharmaceutical

1-7  Manufacturers that is published by the Office of Inspector

1-8  General of the United States Department of Health and Human

1-9  Services, or links to websites or other Internet sites that are

1-10  operated or administered by or on behalf of the Office of Inspector

1-11  General where such information may be obtained;

1-12      2.  A general description of the process for reporting unlawful

1-13  or unethical conduct by pharmaceutical manufacturers to the

1-14  Office of Inspector General, or links to websites or other Internet

1-15  sites that are operated or administered by or on behalf of the

2-1  Office of Inspector General where such information may be

2-2  obtained; and

2-3  3.  A current telephone number for the Office of Inspector

2-4  General.

2-5  Sec. 2.  Chapter 639 of NRS is hereby amended by adding

2-6  thereto a new section to read as follows:

2-7  The Board shall post on a website or other Internet site that is

2-8  operated or administered by or on behalf of the Board:

2-9  1.  A general description of the basic elements of the

2-10  Compliance Program Guidance for Pharmaceutical

2-11  Manufacturers that is published by the Office of Inspector

2-12  General of the United States Department of Health and Human

2-13  Services, or links to websites or other Internet sites that are

2-14  operated or administered by or on behalf of the Office of Inspector

2-15  General where such information may be obtained;

2-16      2.  A general description of the process for reporting unlawful

2-17  or unethical conduct by pharmaceutical manufacturers to the

2-18  Office of Inspector General, or links to websites or other Internet

2-19  sites that are operated or administered by or on behalf of the

2-20  Office of Inspector General where such information may be

2-21  obtained; and

2-22      3.  A current telephone number for the Office of Inspector

2-23  General.

2-24      Sec. 3.  NRS 639.2583 is hereby amended to read as follows:

2-25      639.2583  [If]

2-26      1.  Except as otherwise provided in this section, if a

2-27  practitioner has prescribed a drug by brand name and the

2-28  practitioner has not indicated , by a method set forth in subsection

2-29  5, that a substitution is prohibited, [a pharmacist:

2-30      1.  Shall, in a case where he is being paid for the drug by a

2-31  governmental agency; and

2-32      2.  May, in any other case, fill] the pharmacist who fills or

2-33  refills the prescription [with] shall dispense, in substitution, another

2-34  drug which is available to him[, is] if the other drug:

2-35      (a) Is less expensive than the drug prescribed[, is] by brand

2-36  name;

2-37      (b) Is biologically equivalent[, has] to the drug prescribed by

2-38  brand name;

2-39      (c) Has the same active ingredient or ingredients of the same

2-40  strength, quantity and form of dosage as the drug prescribed by

2-41  brand name; and [is]

2-42      (d) Is of the same generic type as the drug prescribed[. The

2-43  pharmacist may also make such a substitution if the prescription was

2-44  written] by brand name.

3-1  2.  If the pharmacist has available to him more than one drug

3-2  that may be substituted for the drug prescribed by brand name, the

3-3  pharmacist shall dispense, in substitution, the least expensive of

3-4  the drugs that are available to him for substitution.

3-5  3.  Before a pharmacist dispenses a drug in substitution for a

3-6  drug prescribed by brand name, the pharmacist shall:

3-7  (a) Advise the person who presents the prescription that the

3-8  pharmacist intends to dispense a drug in substitution; and

3-9  (b) Advise the person that he may refuse to accept the drug

3-10  that the pharmacist intends to dispense in substitution, unless the

3-11  pharmacist is being paid for the drug by a governmental agency.

3-12      4.  If a person refuses to accept the drug that the pharmacist

3-13  intends to dispense in substitution, the pharmacist shall dispense

3-14  the drug prescribed by brand name, unless the pharmacist is being

3-15  paid for the drug by a governmental agency, in which case the

3-16  pharmacist shall dispense the drug in substitution.

3-17      5.  A pharmacist shall not dispense a drug in substitution for a

3-18  drug prescribed by brand name if the practitioner has indicated

3-19  that a substitution is prohibited using one or more of the following

3-20  methods:

3-21      (a) By oral communication to the pharmacist at any time

3-22  before the drug is dispensed.

3-23      (b) By handwriting the words “Dispense as Written” on the

3-24  form used for the prescription, including, without limitation, any

3-25  form used for transmitting the prescription from a facsimile

3-26  machine to another facsimile machine. The pharmacist shall

3-27  disregard the words “Dispense as Written” if they have been

3-28  placed on the form used for the prescription by preprinting or

3-29  other mechanical process or by any method other than

3-30  handwriting.

3-31      (c) By including the words “Dispense as Written” in any

3-32  prescription that is given to the pharmacist by electronic

3-33  transmission pursuant to the regulations of the Board, including,

3-34  without limitation, an electronic transmission from a computer

3-35  equipped with a facsimile modem to a facsimile machine or from a

3-36  computer to another computer pursuant to the regulations of the

3-37  Board.

3-38      6.  The provisions of this section also apply to a prescription

3-39  issued to a person by a practitioner from outside this state [and

3-40  indicates] if the practitioner has not indicated, by a method set

3-41  forth in subsection 5, that a substitution [may be made.] is

3-42  prohibited.

3-43      7.  The provisions of this section do not apply to:

4-1  (a) A prescription drug that is dispensed to any inpatient of a

4-2  hospital by an inpatient pharmacy which is associated with that

4-3  hospital;

4-4  (b) A prescription drug that is dispensed to any person by mail

4-5  order or other common carrier by an Internet pharmacy which is

4-6  certified by the Board pursuant to NRS 639.23288 and authorized

4-7  to provide service by mail order or other common carrier pursuant

4-8  to the provisions of this chapter; or

4-9  (c) A prescription drug that is dispensed to any person by a

4-10  pharmacist if the substitution:

4-11          (1) Would violate the terms of a health care plan that

4-12  maintains a mandatory, exclusive or closed formulary for its

4-13  coverage for prescription drugs; or

4-14          (2) Would otherwise make the transaction ineligible for

4-15  reimbursement by a third party.

4-16      Sec. 4.  NRS 639.2589 is hereby amended to read as follows:

4-17      639.2589  1.  The form used for any prescription which is

4-18  issued or intended to be filled in this state must contain a line for the

4-19  signature of the [prescriber, the printed words “dispense only as

4-20  written” and a box near that statement for the purpose of indicating

4-21  that a substitution may not be made.] practitioner.

4-22      2.  Substitutions may be made in filling prescriptions contained

4-23  in the orders of a physician, or of an advanced practitioner of

4-24  nursing who is a practitioner, in a facility for skilled nursing or

4-25  facility for intermediate care. [Each page of the document which

4-26  contains the order must be printed with the words: “The biological

4-27  equivalent of drugs ordered may be dispensed unless initialed by the

4-28  prescriber here” and a box must be provided near that statement for

4-29  the purpose of indicating that a substitution may not be made.]

4-30      3.  Substitutions may be made in filling prescriptions ordered

4-31  on a patient’s chart in a hospital if the hospital’s medical staff has

4-32  approved a formulary for specific generic substitutions.

4-33      Sec. 5.  NRS 639.259 is hereby amended to read as follows:

4-34      639.259  No employer of a pharmacist may require the

4-35  pharmacist to dispense any specific generic drug in substitution for

4-36  another drug if[:] the:

4-37      1.  Substitution is not permitted by the prescription as signed by

4-38  a practitioner; [or]

4-39      2.  Substitution would be against the professional judgment of

4-40  the pharmacist[.] ; or

4-41      3.  Substitution would violate any provision of NRS 639.2583

4-42  to 639.2599, inclusive.

4-43      Sec. 6.  NRS 639.2585 is hereby repealed.

 

5-1  TEXT OF REPEALED SECTION

 

5-2  639.2585  Pharmacist to advise person presenting

5-3   prescription; exception; substitution prohibited if cost of

5-4   generic drug is higher.

5-5  1.  Except where a substitution is required by subsection 1 of

5-6   NRS 639.2583:

5-7  (a) Before he makes a substitution, a pharmacist shall advise the

5-8   person who presents the prescription of:

5-9       (1) The generic drug which he proposes to substitute; and

5-10          (2) The price difference between the drug under the brand

5-11   name prescribed and the drug which he proposes to substitute.

5-12      (b) The person presenting the prescription may refuse to accept

5-13   the proposed substitution.

5-14      2.  A pharmacist shall not make any substitution of drugs if the

5-15   drug to be substituted is higher in cost than the drug prescribed by

5-16   brand name.

 

5-17  H