1.This Act may be cited as
the Prescription Drug Abuse Prevention
and Treatment Act of 2011
.
2.Congress makes the following
findings:
(1)Nonmedical use of
prescription pain relievers is a matter of increasing public health concern.
According to the Substance Abuse and Mental Health Services Administration, the
proportion of all substance abuse treatment admissions aged 12 or older that
reported any pain reliever abuse increased more than 400 percent between 1998
and 2008, from 2.2 to 9.8 percent.
(2)In 2008, among
the population of the United States aged 12 or older, nonmedical use of
prescription pain relievers was the second most prevalent type of illicit drug
use, after marijuana use.
(3)When used
properly under medical supervision, prescription opiates enable individuals
with chronic pain to lead productive lives. However, when taken without a
physician’s oversight and direction, opiates can cause serious adverse health
effects, resulting in dependence, abuse, and death.
(4)As with any
controlled substance, there is a risk of abuse of methadone and other
opiates.
(5)Methadone is an
extensively tested, federally approved, and widely accepted method of treating
addiction to prescription pain relievers or opiates.
(6)For more than 30
years, this synthetic prescription drug has been used for pain management and
treatment for addiction to heroin, morphine, and other opioid drugs.
(7)The efficacy and
lower cost of methadone has resulted in its being prescribed for pain
management.
(8)Prescriptions for
methadone have increased by nearly 700 percent from 1998 through 2006.
(9)According to the
Centers for Disease Control and Prevention, the number of poisoning deaths
involving methadone increased nearly 7-fold from almost 790 in 1999 to almost
5,420 in 2006, which is the most rapid increase among opioid analgesics and
other narcotics involved in poisoning deaths.
(10)The age-specific
rates of methadone death are higher for persons age 35 to 44 and 45 to 54 than
for other age groups. However, the rate of methadone deaths in younger
individuals (age 15 to 24) increased 11-fold from 1999 through 2005.
(11)Deaths from
methadone and other opiates may actually be underreported. There is no
comprehensive database of drug-related deaths in the United States.
(12)The lack of
standardized reporting by Medical Examiners precludes a uniform definition of
cause of death
on death certificates.
(13)The Controlled
Substances Act (21 U.S.C. 801 et seq.) requires that every person who dispenses
or who proposes to dispense controlled narcotics, including methadone, whether
for pain management or opioid treatment obtain a registration from Drug
Enforcement Administration. Unfortunately there is no requirement as a
condition of receiving the registration that these practitioners receive any
education on the use of these controlled narcotics, including methadone.
(14)Current Federal
oversight of methadone and other opioids is inadequate to address the growing
number of opioid-related overdoses and deaths.
(15)Federal
legislation is needed to avert opioid abuse, misuse, and death, without
reducing patient access to needed care.
3.Consumer
education campaignPart A of
title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended
by adding at the end the following:
506C.Consumer
education campaign
(a)The Administrator shall award grants to States and
nonprofit entities for the purpose of conducting culturally sensitive consumer
education about opioid abuse, including methadone abuse. Such education shall
include information on the dangers of opioid abuse, how to prevent opioid abuse
including through safe disposal of prescription medications and other safety
precautions, and detection of early warning signs of addiction.
(b)To
be eligible to receive a grant under subsection (a), an entity shall—
(1)be a State or
nonprofit entity; and
(2)submit to the
Administrator an application at such time, in such manner, and containing such
information as the Administrator may require.
(c)In
awarding grants under this section, the Administrator shall give priority to
applicants that are States or communities with a high incidence of abuse of
methadone and other opioids, and opioid-related deaths.
(d)The
Administrator shall develop a process to evaluate the effectiveness of
activities carried out by grantees under this section at reducing abuse of
methadone and other opioids.
(e)Authorization
of appropriationsThere is authorized to be appropriated to carry
out this section $15,000,000 for each of fiscal years 2012 through
2016.
.
4.
(a)
(1)Registration
considerationSection 303(f) of the Controlled Substances Act (21
U.S.C. 823(f)) is amended by inserting after paragraph (5) the
following:
(6)The applicant's
compliance with the training requirements described in subsection (g)(3) during
any previous period in which the applicant has been subject to such training
requirements.
.
(2)Section 303(g) of the Controlled Substances Act (21
U.S.C. 823(g)) is amended by adding at the end the following:
(3)(A)To be registered to
prescribe or otherwise dispense methadone or other opioids, a practitioner
described in paragraph (1) shall comply with the 16-hour training requirement
of subparagraph (B) at least once during each 3-year period.
(B)The training requirement of this
subparagraph is that the practitioner has completed not less than 16 hours of
training (through classroom situations, seminars at professional society
meetings, electronic communications, or otherwise) with respect to—
(i)the treatment and management of
opioid-dependent patients;
(ii)pain management treatment guidelines;
and
(iii)early detection of opioid addiction,
including through such methods as Screening, Brief Intervention, and Referral
to Treatment (SBIRT),
that is provided by the American Society of Addiction
Medicine, the American Academy of Addiction Psychiatry, the American Medical
Association, the American Osteopathic Association, the American Psychiatric
Association, the American Academy of Pain Management, the American Pain
Society, the American Academy of Pain Medicine, the American Board of Pain
Medicine, the American Society of Interventional Pain Physicians, or any other
organization that the Secretary determines is appropriate for purposes of this
subparagraph..
(b)Requirements
for participation in opioid treatment programsEffective July 1,
2012, a physician practicing in an opioid treatment program shall comply with
the requirements of section 303(g)(3) of the Controlled Substances Act (as
added by subsection (a)) with respect to required minimum training at least
once during each 3-year period.
(c)In
this section, the term opioid treatment program has the meaning
given such term in section 8.2 of title 42, Code of Federal Regulations (or any
successor regulation).
(d)The
Drug Enforcement Administration shall fund the enforcement of the requirements
specified in section 303(g)(3) of the Controlled Substances Act (as added by
subsection (a)) through the use of a portion of the licensing fees paid by
controlled substance prescribers under the Controlled Substances Act (21 U.S.C.
801 et seq.).
5.Moratorium on
methadone hydrochloride tablets
(a)Notwithstanding any other provision of law, during the
period beginning on the date of enactment of this Act and ending on the date
described in subsection (b), no individual or entity may prescribe or otherwise
dispense a 40-mg diskette of methadone unless such prescription or dispensation
is consistent with the methadone 40-mg diskette policy of the Drug Enforcement
Administration as in effect on the date of enactment of this Act, except that
such prohibition shall extend to hospitals unless such hospitals provide for
direct patient supervision with respect to such methadone.
(b)Ending date of
moratoriumThe moratorium under subsection (a) shall cease to
have force and effect—
(1)on the date that
the Controlled Substances Clinical Standards Commission publishes in the
Federal Register dosing guidelines for all forms of methadone, in accordance
with section 506D(b)(1)(A) of the Public Health Service Act (as added by
section 7); and
(2)if, as part of
such dosing guidelines, such Commission finds that 40-mg diskettes of methadone
are safe and clinically appropriate.
6.Operation of
opioid treatment programsSection 303 of the Controlled Substances Act
(21 U.S.C. 823) is amended by adding at the end the following:
(i)(1)An opioid treatment
program that is registered under this section, and that closes for business on
any weekday or weekend day, including a Federal or State holiday, shall comply
with the requirements of this subsection.
(2)The program shall make acceptable
arrangements for each patient who is restricted, by Federal regulation or
guideline or by the determination of the program medical director, from having
a take home dose of a controlled substance related to the treatment involved,
to receive a dose of that substance under appropriate supervision during the
closure.
(3)The Administrator of the Substance
Abuse and Mental Health Services Administration shall issue a notice that
references regulations on acceptable arrangements under this subsection, or
shall promulgate regulations on such acceptable
arrangements.
.
7.Establishment of
the Controlled Substances Clinical Standards CommissionPart A of title V of the Public Health
Service Act (42 U.S.C. 290aa et seq.), as amended by section 3, is further
amended by adding at the end the following:
506D.Establishment
of the Controlled Substances Clinical Standards Commission
(a)The Secretary shall establish a Controlled Substances
Clinical Standards Commission (referred to in this section as the
Commission), to be composed of representatives from the
Administration, the Centers for Disease Control and Prevention, the Food and
Drug Administration, the Pain Management Consortia of the National Institutes
of Health, and other agencies that the Secretary may deem necessary, to
develop—
(1)appropriate and
safe dosing guidelines for all forms of methadone, including recommendations
for maximum daily doses of all forms as provided for in subsection
(b)(1);
(2)benchmark
guidelines for the reduction of methadone abuse, as provided for in subsection
(b)(2);
(3)appropriate
conversion factors for use by health care providers in transitioning patients
from one opioid to another;
(4)specific
guidelines for initiating pain management with methadone that prescribing
practitioners shall comply with in order to meet certification requirements set
forth in part C of the Controlled Substances Act (21 U.S.C. 821 et seq.);
and
(5)patient and
practitioner education guidelines for both methadone maintenance therapy and
pain management that apply to safe and effective use and include
detoxification.
(b)
(1)Publication of
dosing guidelines
(A)Not later than 2 years after the date of enactment of
this section, the Commission established under subsection (a) shall publish in
the Federal Register—
(i)safe and
clinically appropriate dosing guidelines for all forms of methadone used for
both pain management and opioid treatment programs, including recommendations
for maximum daily doses of all forms, including recommendations for the
induction process for patients who are newly prescribed methadone;
(ii)requirements for
individual patient care plans, including initial and follow-up patient physical
examination guidelines, and recommendations for screening patients for chronic
or acute medical conditions that may cause an immediate and adverse reaction to
methadone;
(iii)appropriate
conversion factors for use by health care providers in transitioning patients
from one opioid to another;
(iv)specific
guidelines for initiating pain management with methadone, that prescribing
physicians or other clinicians shall comply with in order to meet Drug
Enforcement Administration certification and re-certification requirements;
and
(v)consensus
guidelines for pain management with prescription opioid drugs.
(B)Not later than 3 years after the publication of
guidelines under subparagraph (A), and at least every 3 years thereafter, the
Commission shall update such guidelines.
(2)Publication of
benchmark guidelines
(A)Not later than 3 years after the date of enactment of
this section, the Commission established under subsection (a) shall publish in
the Federal Register—
(i)the initial
benchmark guidelines for the reduction of methadone abuse to be used—
(I)by opioid
treatment programs in providing methadone therapy; and
(II)by entities in
the initial accreditation or certification, and the re-accreditation and
re-certification, of such opioid treatment programs;
(ii)a model policy
for dispensing methadone to be used by pharmacists that dispense methadone,
which should include education and training guidelines for such
pharmacists;
(iii)the continuing
education guidelines that all prescribers shall comply with in order to meet
Drug Enforcement Administration certification and re-certification
requirements, as set forth in section 303(g)(3) of the Controlled Substances
Act (21 U.S.C. 823(g)(3)), which should include a minimum of 16 training hours
at least every 3 years that include the integration of both addiction and pain
management curricula; and
(iv)patient
education guidelines for both opioid treatment programs and pain management,
including recommendations for patient counseling prior to and during opioid
addiction treatment or treatment for pain.
(B)Not later than 1 year after the publication of
guidelines under subparagraph (A), and at least annually thereafter, the
Commission shall update the guidelines published under clauses (iii) and (iv)
of such subparagraph.
(3)In
developing and publishing the guidelines under this section, the Commission
shall consult with relevant professional organizations with expertise in the
area of addiction, relevant professional organizations with expertise in the
area of pain management, physician groups, pharmacy groups (including the
National Association of Boards of Pharmacy), patient representatives, and any
other organization that the Secretary determines is appropriate for purposes of
this section.
(c)Not
later than 180 days after the date of enactment of this section, the Commission
shall establish and operate a Commission website.
(d)Not later than 1 year after the date of enactment of this
section, the Commission shall establish, and distribute to practitioners that
are registered to prescribe or otherwise dispense methadone, a methadone
toolkit. The Commission shall make the components of the toolkit that are
available in electronic form available on the Commission website.
(e)Practitioner
education programThe Commission shall develop a practitioner
education program that shall be used for the practitioner education described
in section 303(g)(3) of the Controlled Substances Act, and shall make such
program available to providers of such practitioner education.
(f)Authorization
of appropriationsThere is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2012
through
2016.
.
8.Prescription
monitoring programSection
399O of the Public Health Service Act (42 U.S.C. 280g–3) is amended—
(1)in subsection
(d)(1), by inserting (including prescribers of methadone)
after
dispensers
;
(2)in subsection
(e), by adding at the end the following:
(5)Subject to the
requirements of section 543, the State shall, at the request of a Federal,
State, or local officer whose duties include enforcing laws relating to drugs,
provide to such officer information from the database relating to an individual
who is the subject of an active drug-related investigation conducted by the
officer's employing government entity.
;
and
(3)by striking subsection (n) and inserting
the following:
(n)There
is authorized to be appropriated to carry out this section $25,000,000 for each
of fiscal years 2012 through 2016.
.
9.Part A of title V of
the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section
7, is further amended by adding at the end the following:
506E.
(a)Model Opioid
Treatment Program Mortality Report
(1)Not later than July 1, 2012, the Secretary, acting
through the Administrator, shall require that a Model Opioid Treatment Program
Mortality Report be completed and submitted to the Administrator for each
individual who dies while receiving treatment in an opioid treatment
program.
(2)Requirement of
States that receive funding for the Controlled Substance Monitoring
ProgramAs a condition for receiving funds under section 399O,
each State shall require that any individual who signs a death certificate
where an opioid drug is detected in the body of the deceased, or where such
drug is otherwise associated with the death, report such death to the
Administrator by submitting a Model Opioid Treatment Program Mortality Report
described in paragraph (3). Such report shall be submitted to the Administrator
on or before the later of—
(A)90 days after the
date of signing the death certificate; or
(B)as soon as
practicable after the date on which the necessary postmortem and toxicology
reports become available to such individual, as required by the
Secretary.
(3)The
Administrator, in consultation with State and local medical examiners,
prescribing physicians, hospitals, and any other organization that the
Administrator determines appropriate, shall develop a Model Opioid Treatment
Program Mortality Report to be used under paragraphs (1) and (2).
(b)National Opioid
Death Registry
(1)Not later than July 1, 2012, the Administrator shall
establish and implement, through the National Center for Health Statistics, a
National Opioid Death Registry (referred to in this subsection as the
Registry) to track opioid-related deaths and information related
to such deaths.
(2)In
establishing the uniform reporting criteria for the Registry, the Director of
the Centers for Disease Control and Prevention shall consult with the
Administrator, State and local medical examiners, prescribing physicians,
hospitals, and any other organization that the Director determines is
appropriate for purposes of this subsection.
(3)The
registry shall be designed as a uniform reporting system for opioid-related
deaths and shall require the reporting of information with respect to such
deaths, including—
(A)the particular
drug formulation used at the time of death;
(B)the dosage
level;
(C)a description of
the circumstances surrounding the death in relation to the recommended dosage
involved;
(D)a disclosure of
whether the medication involved can be traced back to a physician’s
prescription;
(E)a disclosure of
whether the individual was in an opioid treatment program at the time of
death;
(F)the age and sex
of the individual; and
(G)other
non-personal information such as that included in filed National Association of
Medical Examiners Pediatric Toxicology Registry case reports as required under
the privacy standard for the de-identification of health information pursuant
to the regulations contained in part 164 of title 45, Code of Federal
Regulations.
(4)There
is authorized to be appropriated $5,000,000 for each of fiscal years 2012
through 2016 to carry out this subsection.
(c)Report on
Registry informationNot later than the January 1 of the first
fiscal year beginning 2 years after the date of enactment of this section, and
each January 1 thereafter, the Director of the Centers for Disease Control and
Prevention shall submit to the Secretary a report, based on information
contained in the Registry described in subsection (b), concerning the number of
methadone-related deaths in the United States for the year for which the report
is
submitted.
.
10.Part A of title V of
the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by section
9, is further amended by adding at the end the following:
506F.
(a)Report on
methadone usage
(1)Not later than January 1 of the first fiscal year
beginning 2 years after the date of enactment of this section, and each January
1 thereafter, the Administrator and the Commissioner of Food and Drugs shall
submit to the Secretary a report containing detailed statistics on methadone
usage for opioid treatment and pain management. Such statistics shall
include—
(A)information on
the distribution of prescribed doses of methadone at federally qualified health
centers, opioid treatment clinics, other health-related clinics, physician
offices, pharmacies, and hospitals; and
(B)information
relating to adverse health events resulting from such methadone usage.
(2)Availability of
informationThe Secretary shall make the reports submitted under
paragraph (1) available to the general public, including through the use of the
Internet website of the Department of Health and Human Services.
(b)Annual report
on effectivenessNot later than September 30, 2012, and annually
thereafter until September 30, 2016, the Secretary shall submit to the
appropriate committees of Congress, a report concerning the effectiveness of
the methadone maintenance therapy program. Such report shall evaluate the
success of efforts to reduce opioid addiction and methadone-related deaths,
including the impact of health care provider and patient education.
(c)Authorization
of appropriationsThere is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2012
through
2016.
.