Senate Bill No. 327–Senators Wiener, Rawson, Washington, Titus, Amodei, Care, Mathews and McGinness

 

March 17, 2003

____________

 

Referred to Committee on Human Resources and Facilities

 

SUMMARY—Provides for reuse of certain prescription drugs. (BDR 39‑66)

 

FISCAL NOTE:  Effect on Local Government: No.

                           Effect on the State: No.

 

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

 

AN ACT relating to drugs; establishing procedures for reusing certain prescription drugs that are dispensed to, but not used by, a patient in a mental health facility, facility for skilled nursing or facility for intermediate care, or an offender incarcerated in an institution or facility operated by the Department of Corrections; 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 433 of NRS is hereby amended by adding

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

1-3  1.  A public or private mental health facility may return a

1-4  prescription drug that is dispensed to a patient of the facility, but

1-5  will not be used by that patient, to the dispensing pharmacy for the

1-6  purpose of reissuing the drug to fill other prescriptions for patients

1-7  in that facility if:

1-8  (a) The drug is not a schedule II drug specified in or pursuant

1-9  to chapter 453 of NRS;

1-10      (b) The drug is dispensed in a unit dose, in individually sealed

1-11  doses or in a bottle that is sealed by the manufacturer of the drug;

1-12      (c) The drug is returned unopened and sealed in the original

1-13  manufacturer’s packaging or bottle;

2-1  (d) The usefulness of the drug has not expired;

2-2  (e) The packaging or bottle contains the expiration date of the

2-3  usefulness of the drug; and

2-4  (f) The name of the patient for whom the drug was originally

2-5  prescribed, the prescription number and any other identifying

2-6  marks are obliterated from the packaging or bottle before the

2-7  return of the drug.

2-8  2.  A dispensing pharmacy to which a drug is returned

2-9  pursuant to this section may reissue the drug to fill other

2-10  prescriptions for patients in the same facility if the registered

2-11  pharmacist of the pharmacy determines that the drug is suitable

2-12  for that purpose in accordance with standards adopted by the State

2-13  Board of Pharmacy pursuant to subsection 5.

2-14      3.  No drug that is returned to a dispensing pharmacy

2-15  pursuant to this section may be used to fill other prescriptions

2-16  more than one time.

2-17      4.  A mental health facility shall adopt written procedures for

2-18  returning drugs to a dispensing pharmacy pursuant to this section.

2-19  The procedures must:

2-20      (a) Provide appropriate safeguards for ensuring that the drugs

2-21  are not compromised or illegally diverted during their return.

2-22      (b) Require the maintenance and retention of such records

2-23  relating to the return of such drugs as are required by the State

2-24  Board of Pharmacy.

2-25      (c) Be approved by the State Board of Pharmacy.

2-26      5.  The State Board of Pharmacy shall adopt such regulations

2-27  as are necessary to carry out the provisions of this section

2-28  including, without limitation, requirements for:

2-29      (a) Returning and reissuing such drugs pursuant to the

2-30  provisions of this section.

2-31      (b) Maintaining records relating to the return and the use of

2-32  such drugs to fill other prescriptions.

2-33      Sec. 2.  Chapter 449 of NRS is hereby amended by adding

2-34  thereto a new section to read as follows:

2-35      1.  A facility for skilled nursing or a facility for intermediate

2-36  care may return a prescription drug that is dispensed to a patient

2-37  of the facility, but will not be used by that patient, to the

2-38  dispensing pharmacy for the purposes set forth in subsection 2 if:

2-39      (a) The drug is not a schedule II drug specified in or pursuant

2-40  to chapter 453 of NRS;

2-41      (b) The drug is dispensed in a unit dose, in individually sealed

2-42  doses or in a bottle sealed by the manufacturer of the drug;

2-43      (c) The drug is returned unopened and sealed in the original

2-44  manufacturer’s packaging or bottle;

2-45      (d) The usefulness of the drug has not expired;

3-1  (e) The packaging or bottle contains the expiration date of the

3-2  usefulness of the drug; and

3-3  (f) The name of the patient for whom the drug was originally

3-4  prescribed, the prescription number and any other identifying

3-5  marks are obliterated from the packaging or bottle before the

3-6  return of the drug.

3-7  2.  A dispensing pharmacy to which a drug is returned

3-8  pursuant to this section may:

3-9  (a) Reissue the drug to fill other prescriptions in the same

3-10  facility if the registered pharmacist of the pharmacy determines

3-11  that the drug is suitable for that purpose in accordance with

3-12  standards adopted by the State Board of Pharmacy pursuant to

3-13  subsection 5; or

3-14      (b) Transfer the drug to a nonprofit pharmacy designated by

3-15  the State Board of Pharmacy for the purpose of reissuing the drug

3-16  to other patients free of charge. Any person, pharmacy or facility

3-17  is immune from civil liability for damages sustained as a result of

3-18  any act or omission in carrying out the provisions of this

3-19  subsection if:

3-20          (1) That person, pharmacy or facility complied with the

3-21  procedures adopted pursuant to subsection 4 and the regulations

3-22  adopted pursuant to subsection 5; and

3-23          (2) The act or omission does not amount to gross

3-24  negligence or willful misconduct.

3-25      3.  No drug that is returned to a dispensing pharmacy

3-26  pursuant to this section may be used to fill other prescriptions

3-27  more than one time.

3-28      4.  A facility for skilled nursing or facility for intermediate

3-29  care shall adopt written procedures for returning drugs to a

3-30  dispensing pharmacy. The procedures must:

3-31      (a) Provide appropriate safeguards for ensuring that the drugs

3-32  are not compromised or illegally diverted during their return.

3-33      (b) Require the maintenance and retention of such records

3-34  relating to the return of drugs to dispensing pharmacies as are

3-35  required by the State Board of Pharmacy.

3-36      (c) Be approved by the State Board of Pharmacy.

3-37      5.  The State Board of Pharmacy shall adopt such regulations

3-38  as are necessary to carry out the provisions of this section

3-39  including, without limitation, requirements for:

3-40      (a) Transferring such drugs from a facility for skilled nursing

3-41  or a facility for intermediate care to a dispensing pharmacy.

3-42      (b) Transferring such drugs from a dispensing pharmacy to a

3-43  nonprofit pharmacy.

3-44      (c) Using drugs that are returned to a dispensing pharmacy

3-45  pursuant to this section to fill other prescriptions.

4-1  (d) Maintaining records relating to the return of such drugs to

4-2  dispensing pharmacies, the transfer of such drugs to nonprofit

4-3  pharmacies and the use of such drugs to fill other prescriptions.

4-4  Sec. 3.  Chapter 639 of NRS is hereby amended by adding

4-5  thereto the provisions set forth as sections 4 and 5 of this act.

4-6  Sec. 4.  1.  The Board shall prepare an annual report

4-7  concerning drugs that are returned or transferred to pharmacies

4-8  pursuant to sections 1, 2 and 5 of this act and are reissued to fill

4-9  other prescriptions. The report must include, without limitation:

4-10      (a) The number of drugs that are returned to dispensing

4-11  pharmacies.

4-12      (b) The number of drugs that are transferred to nonprofit

4-13  pharmacies designated by the Board for the purpose of reissuing

4-14  the drugs to other patients free of charge.

4-15      (c) The number of drugs that are reissued to fill other

4-16  prescriptions.

4-17      (d) An estimate of the amount of money saved by reissuing

4-18  such drugs to fill other prescriptions.

4-19      (e) Any other information that the Board deems necessary.

4-20      2.  The report must be:

4-21      (a) Available for public inspection during regular business

4-22  hours at the office of the Board; and

4-23      (b) Posted on a website or other Internet site that is operated or

4-24  administered by or on behalf of the Board.

4-25      Sec. 5.  1.  A prescription drug that is dispensed by a

4-26  pharmacy to an offender incarcerated in a correctional institution,

4-27  but will not be used by that offender, may be returned to that

4-28  dispensing pharmacy for the purpose of reissuing the drug to fill

4-29  other prescriptions for offenders incarcerated in that correctional

4-30  institution if:

4-31      (a) The drug is not a schedule II drug specified in or pursuant

4-32  to chapter 453 of NRS;

4-33      (b) The drug is dispensed in a unit dose, in individually sealed

4-34  doses or in a bottle that is sealed by the manufacturer of the drug;

4-35      (c) The drug is returned unopened and sealed in the original

4-36  manufacturer’s packaging or bottle;

4-37      (d) The usefulness of the drug has not expired;

4-38      (e) The packaging or bottle contains the expiration date of the

4-39  usefulness of the drug; and

4-40      (f) The name of the patient for whom the drug was originally

4-41  prescribed, the prescription number and any other identifying

4-42  marks are obliterated from the packaging or bottle before the

4-43  return of the drug.

4-44      2.  A pharmacy to which a drug is returned pursuant to this

4-45  section may reissue the drug to fill other prescriptions for

5-1  offenders incarcerated in the same correctional institution if the

5-2  registered pharmacist of the pharmacy determines that the drug is

5-3  suitable for that purpose in accordance with standards adopted by

5-4  the Board pursuant to subsection 5.

5-5  3.  No drug that is returned to a dispensing pharmacy

5-6  pursuant to this section may be used to fill other prescriptions

5-7  more than one time.

5-8  4.  The director of a correctional institution shall adopt

5-9  written procedures for returning drugs to a dispensing pharmacy

5-10  pursuant to this section. The procedures must:

5-11      (a) Provide appropriate safeguards for ensuring that the drugs

5-12  are not compromised or illegally diverted during their return.

5-13      (b) Require the maintenance and retention of such records

5-14  relating to the return of such drugs as are required by the Board.

5-15      (c) Be approved by the Board.

5-16      5.  The Board shall adopt such regulations as are necessary to

5-17  carry out the provisions of this section including, without

5-18  limitation, requirements for:

5-19      (a) Returning and reissuing such drugs pursuant to the

5-20  provisions of this section.

5-21      (b) Maintaining records relating to the return and the use of

5-22  such drugs to fill other prescriptions.

5-23      6.  As used in this section, “correctional institution” means an

5-24  institution or facility operated by the Department of Corrections.

5-25      Sec. 6.  NRS 639.267 is hereby amended to read as follows:

5-26      639.267  1.  As used in this section, “unit dose” means that

5-27  quantity of a drug which is packaged as a single dose.

5-28      2.  A pharmacist who provides a regimen of drugs in unit doses

5-29  to a patient in a facility for skilled nursing or facility for

5-30  intermediate care as defined in chapter 449 of NRS may credit the

5-31  person or agency which paid for the drug for any unused doses. The

5-32  pharmacist may return the drugs to the [issuing] dispensing

5-33  pharmacy, which may reissue the drugs to fill other prescriptions[.]

5-34  in accordance with the provisions of section 2 of this act.

5-35      3.  Except schedule II drugs specified in or pursuant to chapter

5-36  453 of NRS[,] and except as otherwise provided in sections 1, 2

5-37  and 5 of this act, unit doses packaged in ampules or vials which do

5-38  not require refrigeration may be returned to the pharmacy which

5-39  dispensed them. The Board shall, by regulation, authorize the return

5-40  of any other type or brand of drug which is packaged in unit doses if

5-41  the Food and Drug Administration has approved the packaging for

5-42  that purpose.

5-43      Sec. 7.  NRS 639.282 is hereby amended to read as follows:

5-44      639.282  1.  Except as otherwise provided in NRS 639.267[,]

5-45  and sections 1, 2 and 5 of this act, it is unlawful for any person to

6-1  have in his possession, or under his control, for the purpose of

6-2  resale, or to sell or offer to sell or dispense or give away, any

6-3  pharmaceutical preparation, drug or chemical which:

6-4  (a) Has been dispensed pursuant to a prescription or chart order

6-5  and has left the control of a registered pharmacist or practitioner;

6-6  (b) Has been damaged or subjected to damage by heat, smoke,

6-7  fire or water, or other cause which might reasonably render it unfit

6-8  for human or animal use;

6-9  (c) Has been obtained through bankruptcy or foreclosure

6-10  proceedings, or other court action, auction or other legal or

6-11  administrative proceedings, except when the pharmaceutical

6-12  preparation, drug or chemical is in the original sealed container;

6-13      (d) Is no longer safe or effective for use, as indicated by the

6-14  expiration date appearing on its label; or

6-15      (e) Has not been properly stored or refrigerated as required by

6-16  its label.

6-17      2.  The provisions of subsection 1 do not apply if the person in

6-18  whose possession the pharmaceutical preparation, drug or chemical

6-19  is found also has in his possession a valid and acceptable

6-20  certification of analysis attesting to the purity and strength of the

6-21  pharmaceutical preparation, drug or chemical and attesting to the

6-22  fact that it can be safely and effectively used by humans or animals.

6-23  The preparation, drug or chemical must not be sold or otherwise

6-24  disposed of until the certification required by this subsection has

6-25  been presented to and approved by the Board.

6-26      3.  In the absence of conclusive proof that the preparation, drug

6-27  or chemical can be used safely and effectively by humans or

6-28  animals, it must be destroyed under the direct supervision of a

6-29  member or an inspector of the Board, or two persons designated as

6-30  agents by the Board who include an inspector of a health care board,

6-31  a licensed practitioner of a health care board or a peace officer of an

6-32  agency that enforces the provisions of chapters 453 and 454 of NRS.

6-33      4.  As used in this section, “health care board” includes the

6-34  State Board of Pharmacy, the State Board of Nursing, the Board of

6-35  Medical Examiners and the Nevada State Board of Veterinary

6-36  Medical Examiners.

6-37      Sec. 8.  This act becomes effective on July 1, 2003, for the

6-38  purpose of adopting policies and regulations necessary to carry out

6-39  the provisions of this act, and on October 1, 2003, for all other

6-40  purposes.

 

6-41  H