75th OREGON LEGISLATIVE ASSEMBLY--2009 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 1740
 
                           A-Engrossed
 
                         Senate Bill 355
                 Ordered by the Senate April 16
           Including Senate Amendments dated April 16
 
Sponsored by Senators MORRISETTE, KRUSE, BATES
 
 
                             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.
 
  Requires State Board of Pharmacy to establish electronic
prescription monitoring program for information reported by  { +
certain + } pharmacies regarding dispensing of certain
prescription drugs. Restricts access to and limits use of
reported information.  Provides certain immunities from civil
liability relating to reporting or use of information.
   { +  Authorizes board to impose on individual violator of
program and related provisions maximum penalty of $250 and on
drug outlet violator maximum penalty of $1,000.
  Requires licensees of certain boards to pay $25 annual fee for
prescribing and dispensing controlled substances. Establishes
Electronic Prescription Monitoring Fund consisting of portion of
fees. Appropriates moneys in fund to State Board of Pharmacy for
purpose of administering program. + }
  Creates Prescription Monitoring Program Advisory Commission.
  Declares emergency, effective on passage.
 
                        A BILL FOR AN ACT
Relating to an electronic prescription monitoring program;
  appropriating money; and declaring an emergency.
  Whereas the ability to identify and inhibit the diversion of
prescription drugs must be improved; and
  Whereas the appropriate use of prescription drugs for
legitimate medical purposes must be protected; and
  Whereas the goal of this 2009 Act is to improve the ability to
identify and inhibit the diversion of prescription drugs, while
promoting appropriate utilization of prescription drugs for
legitimate medical purposes; and
  Whereas the creation and operation of an electronic system to
track prescriptions of controlled substances would improve the
ability to identify and inhibit the diversion of prescription
drugs but would not adversely effect prescriptions issued for
legitimate medical purposes; and
  Whereas the purpose of this 2009 Act is to authorize the
development, implementation, operation and evaluation of an
electronic system for the monitoring of prescription drugs to
accomplish the goal of this 2009 Act; now, therefore,
Be It Enacted by the People of the State of Oregon:
  SECTION 1.  { + Sections 2 to 10 of this 2009 Act are added to
and made a part of ORS chapter 689. + }
  SECTION 2.  { + As used in sections 2 to 10 of this 2009 Act:
  (1) 'Health professional regulatory board' has the meaning
given that term in ORS 676.160.
  (2) 'Prescription' has the meaning given that term in ORS
475.005. + }
  SECTION 3.  { + (1)(a) The State Board of Pharmacy, in
consultation with the Prescription Monitoring Program Advisory
Commission, shall establish and maintain a prescription
monitoring program for monitoring and reporting prescription
drugs dispensed by pharmacies in Oregon that are classified in
schedules II through IV under the federal Controlled Substances
Act, 21 U.S.C.  811 and 812, as modified under ORS 475.035.
  (b)(A) To fulfill the requirements of this subsection, the
board shall establish, maintain and operate an electronic system
to monitor and report drugs described in paragraph (a) of this
subsection that are dispensed by prescription.
  (B) The system must operate and be accessible by practitioners
and pharmacies 24 hours a day, seven days a week.
  (C) The board may contract with a state agency or private
entity to ensure the effective operation of the electronic
system.
  (2) In consultation with the commission, the board shall adopt
rules for the operation of the electronic prescription monitoring
program established under subsection (1) of this section,
including but not limited to standards for:
  (a) Reporting data;
  (b) Providing maintenance, security and disclosure of data;
  (c) Ensuring accuracy and completeness of data;
  (d) Complying with the federal Health Insurance Portability and
Accountability Act of 1996 (P.L. 104-191) and regulations adopted
under it, including 45 C.F.R. parts 160 and 164, federal alcohol
and drug treatment confidentiality laws and regulations adopted
under those laws, including 42 C.F.R. part 2, and state health
and mental health confidentiality laws, including ORS 179.505,
192.517 and 192.518 to 192.529;
  (e) Ensuring accurate identification of persons or entities
requesting information from the database;
  (f) Assessing civil penalties for failing to report or for
intentional wrongful disclosure of data; and
  (g) Accepting printed or nonelectronic reports from pharmacies
that do not have the capability to provide electronic reports.
  (3) The board shall submit an annual report to the commission
regarding the prescription monitoring program established under
this section. + }
  SECTION 4.  { + (1) Not later than one week after dispensing a
prescription drug subject to the prescription monitoring program
established under section 3 of this 2009 Act, a pharmacy shall
electronically report to the State Board of Pharmacy the:
  (a) Name, address and date of birth of the patient;
  (b) Identification of the pharmacy dispensing the prescription
drug;
  (c) Identification of the practitioner who prescribed the drug;
  (d) Identification of the prescription drug by a national drug
code number;
  (e) Date of origin of the prescription;
  (f) Date the drug was dispensed;
  (g) Quantity of drug dispensed; and
  (h) Other relevant information as required by rules adopted by
the board.
  (2) Notwithstanding subsection (1) of this section, the board
may not:
  (a) Require the reporting of prescription drugs administered
directly to a patient or dispensed pursuant to ORS 127.800 to
127.897; or
  (b) Collect or use Social Security numbers in the prescription
monitoring program.
  (3) Upon receipt of the data reported pursuant to subsection
(1) of this section, the board shall record the data in the
electronic system operated pursuant to the prescription
monitoring program.
  (4)(a) The board may grant a pharmacy a waiver of the
electronic submission requirement of subsection (1) of this
section for good cause as determined by the board. The waiver
shall state the format, method and frequency of the alternate
nonelectronic submissions from the pharmacy and the duration of
the waiver.
  (b) As used in this subsection, 'good cause' includes financial
hardship.
  (5) This section does not apply to pharmacies in institutions
as defined in ORS 179.010. + }
  SECTION 5.  { + (1)(a) Except as provided under subsection (2)
of this section, prescription monitoring information submitted
under section 4 of this 2009 Act to the prescription monitoring
program established in section 3 of this 2009 Act:
  (A) Is protected health information under ORS 192.518 to
192.529.
  (B) Is not subject to disclosure pursuant to ORS 192.410 to
192.505.
  (b) Except as provided under subsection (2)(a)(D) of this
section, prescription monitoring information submitted under
section 4 of this 2009 Act to the prescription monitoring program
may not be used to evaluate a practitioner's professional
practice.
  (2)(a) If prescription monitoring information disclosures
comply with the federal Health Insurance Portability and
Accountability Act of 1996 (P.L. 104-191) and regulations adopted
under it, including 45 C.F.R. parts 160 and 164, federal alcohol
and drug treatment confidentiality laws and regulations adopted
under those laws, including 42 C.F.R. part 2, and state health
and mental health confidentiality laws, including ORS 179.505,
192.517 and 192.518 to 192.529, the State Board of Pharmacy shall
disclose the information:
  (A) To a practitioner or pharmacist who certifies that the
requested information is for the purpose of evaluating the need
for or providing medical or pharmaceutical treatment for a
patient to whom the practitioner or pharmacist anticipates
providing, is providing or has provided care.
  (B) To designated representatives of the board or any vendor or
contractor with whom the board has contracted to establish or
maintain the electronic system of the prescription monitoring
program.
  (C) Pursuant to a valid court order based on probable cause and
issued at the request of a federal, state or local law
enforcement agency engaged in an authorized drug-related
investigation involving a person to whom the requested
information pertains.
  (D) To a health professional regulatory board that certifies in
writing that the requested information is necessary for an
investigation related to licensure, renewal or disciplinary
action involving the applicant, licensee or registrant to whom
the requested information pertains.
  (E) To a prescription monitoring program of another state if
the confidentiality, security and privacy standards of the
requesting state are determined by the State Board of Pharmacy to
be equivalent to those of the board.
  (b) The board may disclose information from the prescription
monitoring program that does not identify a patient, practitioner
or drug outlet:
  (A) For educational, research or public health purposes; and
 
  (B) To officials of the Department of Human Services who are
conducting special epidemiologic morbidity and mortality studies
in accordance with ORS 432.060 and rules adopted under ORS
431.110.
  (c) The board shall disclose information relating to a patient
to that patient if requested in accordance with procedures
established by the board. The information shall be disclosed to
the patient within 10 business days of the request being received
by the board, and the patient may make a request to the board up
to once every six months. A patient may request the board to
correct any information about the patient that is erroneous.
  (d) In accordance with ORS 192.518 to 192.529 and federal
privacy regulations, any person authorized to prescribe or
dispense a prescription drug and who is entitled to access a
patient's prescription monitoring information may discuss or
release the information to other health care providers involved
with the patient's care, in order to provide safe and appropriate
care coordination.
  (3)(a) The board shall maintain records of the information
disclosed through the prescription monitoring program including,
but not limited to:
  (A) The identification of each person who requests or receives
information from the program and the organization, if any, the
person represents;
  (B) The information released to each person or organization;
and
  (C) The date and time the information was requested and the
date and time the information was provided.
  (b) Records maintained as required by this subsection may be
reviewed by the Prescription Monitoring Program Advisory
Commission.
  (4) Information in the prescription monitoring program that
identifies an individual patient must be removed no later than
three years from the date the information is entered into the
program.
  (5) A pharmacy required to report information to the board, or
a person authorized under this section to obtain or use
information from the prescription monitoring program, is immune
from civil liability arising out of the reporting or release of
the information if the pharmacy or person reports, obtains or
uses the data in good faith.
  (6) The board and the commission are immune from civil
liability arising from the inaccuracy of any information
submitted under section 4 of this 2009 Act to the prescription
monitoring program.
  (7) Nothing in sections 2 to 10 of this 2009 Act requires a
practitioner or pharmacist who prescribes or dispenses a
prescription drug to obtain information about a patient from the
prescription monitoring program. A practitioner or pharmacist who
prescribes or dispenses a prescription drug may not be held
liable for damages in any civil action on the basis that the
practitioner or pharmacist did or did not request or obtain
information from the prescription monitoring program. + }
  SECTION 6.  { + A pharmacist may not refuse to fill a valid
prescription solely because the pharmacist cannot receive patient
information from the prescription monitoring program established
under section 3 of this 2009 Act at the time the patient requests
that the prescription be filled. + }
  SECTION 7.  { + (1) In addition to any other penalty provided
by law, the State Board of Pharmacy may impose a civil penalty
for any violation of sections 4 to 6 of this 2009 Act. A civil
penalty imposed under this section may not exceed $250 for each
violation by an individual and $1,000 for each violation by a
drug outlet.
 
 
  (2) Civil penalties recovered under this section shall be
deposited in the State Board of Pharmacy Account established in
ORS 689.139.
  (3) Civil penalties under this section shall be imposed as
provided in ORS 183.745.
  (4) Notwithstanding ORS 183.745, the person to whom the notice
is addressed has 10 days from the date of service of the notice
to make written application for a hearing before the board. + }
  SECTION 8.  { + (1) As used in this section, 'board' means:
  (a) The Oregon Medical Board;
  (b) The Oregon Board of Dentistry;
  (c) The Board of Naturopathic Examiners;
  (d) The Oregon State Board of Nursing;
  (e) The Oregon Board of Optometry; and
  (f) The State Board of Pharmacy.
  (2) The State Board of Pharmacy may accept grants, donations,
gifts or moneys from any source for expenditures consistent with
the purposes of sections 2 to 10 of this 2009 Act.
  (3)(a) In addition to other licensing fees imposed by a board
on licensees, a board shall adopt rules imposing a fee of $25 per
year on each person licensed by the board who is authorized to
prescribe or dispense controlled substances. A board shall
collect the fee at the same time the board collects other
licensing fees imposed on licensees.
  (b) A board shall retain 10 percent of the fees collected under
paragraph (a) of this subsection to cover the costs of accounting
and collection of the fees.
  (c) On the first day of each calendar quarter, a board shall
transmit 90 percent of the fees collected under paragraph (a) of
this subsection during the preceding calendar quarter to the
Electronic Prescription Monitoring Fund established in section 11
of this 2009 Act. + }
  SECTION 9.  { + (1) The Prescription Monitoring Program
Advisory Commission is created for the purposes of:
  (a) Studying issues related to the prescription monitoring
program established under section 3 of this 2009 Act;
  (b) Reviewing the program's annual report and making
recommendations to the State Board of Pharmacy regarding the
operation of the program; and
  (c) Developing criteria that should be used to evaluate program
data.
  (2) The commission shall consist of 15 members appointed by the
board as follows:
  (a) A person nominated by the Pain Management Commission;
  (b) A person nominated by the Oregon State Pharmacy
Association;
  (c) A person nominated by the Oregon Dental Association;
  (d) A physician nominated by the Oregon Medical Association;
  (e) A doctor of osteopathy nominated by the Osteopathic
Physicians and Surgeons of Oregon;
  (f) A person nominated by the Oregon Nurses Association;
  (g) A person nominated by the Oregon Association of
Naturopathic Physicians;
  (h) A person nominated by the Oregon Board of Dentistry;
  (i) A physician nominated by the Oregon Medical Board;
  (j) A person nominated by the Board of Naturopathic Examiners;
  (k) A person nominated by the Oregon State Board of Nursing;
  (L) A person nominated by the State Board of Pharmacy;
  (m) A member of the public nominated by the State Board of
Pharmacy;
  (n) A person nominated by a health professional licensing board
that regulates addiction counselors; and
  (o) A person nominated by the Department of Human Services from
a division of the department responsible for administering
addiction services. + }
 
  SECTION 10.  { + (1) The term of office of each member of the
Prescription Monitoring Program Advisory Commission is four
years, but a member serves at the pleasure of the State Board of
Pharmacy. Before the expiration of the term of a member, the
board shall appoint a successor whose term begins on July 1 next
following. A member is eligible for reappointment. If there is a
vacancy for any cause, the board shall make an appointment to
become immediately effective.
  (2) The commission shall elect one of its members to serve as
chairperson.
  (3) The commission shall meet at least once annually at a time
and place specified by the chairperson of the commission. The
commission may meet at other times and places specified by the
call of the chairperson or of a majority of the members of the
commission.
  (4) The commission may adopt rules necessary for the operation
of the commission.
  (5) A majority of the members of the commission constitutes a
quorum for the transaction of business.
  (6) Official action by the commission requires the approval of
a majority of the members of the commission.
  (7) The board shall provide staff support to the commission.
  (8) Members of the commission are not entitled to compensation,
but may be reimbursed for actual and necessary travel and other
expenses incurred by them in the performance of their official
duties in the manner and amounts provided for in ORS 292.495.
Claims for expenses incurred in performing functions of the
commission shall be paid out of funds appropriated to the board
for that purpose.
  (9) All agencies of state government, as defined in ORS
174.111, are directed to assist the commission in the performance
of its duties and, to the extent permitted by laws relating to
confidentiality, to furnish such information and advice as the
members of the commission consider necessary to perform their
duties. + }
  SECTION 11.  { + The Electronic Prescription Monitoring Fund is
established in the State Treasury, separate and distinct from the
General Fund. The Electronic Prescription Monitoring Fund
consists of moneys transmitted to the fund under section 8 of
this 2009 Act. Interest earned by the fund shall be credited to
the fund.  Moneys in the fund are continuously appropriated to
the State Board of Pharmacy for the purpose of carrying out the
provisions of sections 2 to 10 of this 2009 Act. + }
  SECTION 12.  { + Notwithstanding the term of office specified
by section 10 of this 2009 Act, the members first appointed to
the Prescription Monitoring Program Advisory Commission shall
determine by lot at the first meeting of the commission the
initial terms of office for commission members as follows:
  (1) Five shall serve for a term ending July 1, 2010.
  (2) Five shall serve for a term ending on July 1, 2011.
  (3) Five shall serve for a term ending on July 1, 2012. + }
  SECTION 13.  { + (1) Sections 4 to 6 of this 2009 Act become
operative on July 1, 2010.
  (2) The State Board of Pharmacy may take any action before the
operative date in subsection (1) of this section that is
necessary to enable the board to exercise on or after the
operative date in subsection (1) of this section, all of the
duties, functions and powers conferred on the board by sections 4
to 6 of this 2009 Act. + }
  SECTION 14.  { + This 2009 Act being necessary for the
immediate preservation of the public peace, health and safety, an
emergency is declared to exist, and this 2009 Act takes effect on
its passage. + }
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