I 112th CONGRESS 2d Session H. R. 6311 IN THE HOUSE OF REPRESENTATIVES August 2, 2012 Ms. Edwards (for herself, Mrs. Bono Mack, Ms. Norton, Ms. Lee of California, Mr. Grijalva, Ms. Schakowsky, Mrs. Napolitano, Mr. Lynch, Ms. Brown of Florida, Mr. Blumenauer, Mr. Buchanan, Mr. Carnahan, Mr. Carson of Indiana, Mr. Towns, Mr. Moran, Mr. Keating, Ms. Richardson, Ms. Wilson of Florida, Mr. Olver, Mr. Hinchey, Mr. Conyers, Ms. Wasserman Schultz, Mr. Davis of Illinois, Mr. Tierney, Mr. Lewis of Georgia, Mrs. Capito, Ms. Bass of California, and Mr. Rush) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To prevent deaths occurring from drug overdoses.

1.

Short title

This Act may be cited as the Stop Overdose Stat Act or the S.O.S Act.

2.

Findings

The Congress finds the following: (1)According to the Centers for Disease Control and Prevention, a drug overdose fatality occurs in the United States every 14 minutes. More people now die from drug-related deaths than traffic fatalities in the United States. (2)The Centers for Disease Control and Prevention reports that nearly 36,500 people in the United States died from a drug overdose in 2008 alone. More than 75 percent of these deaths were due to unintentional drug overdoses, and many could have been prevented. (3)Deaths resulting from unintentional drug overdoses increased more than 400 percent between 1980 and 1999, and more than doubled between 1999 and 2008. (4)Ninety-one percent of all unintentional poisoning deaths are due to drugs. Poisoning deaths cost society $93,464,000 in direct medical costs and $28,142,598,000 in lost productivity costs in the year 2005 alone. (5)Both fatal and nonfatal overdoses place a heavy burden on public health and public safety resources, yet no Federal agency has been tasked with stemming this crisis. (6)Opioid pain medications such as oxycodone and hydrocodone are involved in more than 40 percent of all drug poisoning deaths. Six times as many people died of an overdose from methadone prescribed to treat pain in 2009 than a decade before. Rural and suburban regions are disproportionately affected by opioid prescription overdoses. (7)Naloxone is a medication that rapidly reverses overdose from heroin and opioid pain medications. (8)In April 2012, the Food and Drug Administration (FDA) held a public workshop in collaboration with the National Institute on Drug Abuse (NIDA) and the Centers for Disease Control and Prevention (CDC), and with participation from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of National Drug Control Policy (ONDCP), to discuss making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. (9)Health practitioners often do not adequately inform patients and caregivers on how to recognize overdose symptoms and effectively respond by seeking emergency assistance and providing naloxone and other first aid in order to save a life. (10)The American Medical Association (AMA), the Nation’s largest physician organization, supports further implementation of community-based programs that offer naloxone and other opioid overdose prevention services. (11)Community-based overdose prevention programs have successfully prevented deaths from opioid overdoses by making rescue trainings and naloxone available to first responders, parents, and other bystanders who may encounter an overdose. A CDC report credits overdose prevention programs with saving more than 10,000 lives since 1996. (12)At least 188 local overdose prevention programs are operating in the United States, including in major cities such as Baltimore, Chicago, Los Angeles, New York City, Boston, San Francisco, and Philadelphia, and statewide in New Mexico, Massachusetts, and New York. In New Mexico, which has one of the highest drug overdose death rates in the country, health officials estimate the statewide naloxone distribution program that began in 2001 has reversed 3,000 overdoses. Another program in Wilkes County, North Carolina, reduced overdose deaths 69 percent between 2009 and 2011. (13)Overdose prevention programs are needed in correctional facilities, addiction treatment programs, and other places where people are at higher risk of overdosing after a period of abstinence. (14)A real-time overdose surveillance and reporting database is needed to monitor fatal and nonfatal drug overdoses, identify areas of the country in need of programmatic support, monitor the outcomes of overdose occurrences, and enhance evaluation of community programs and interventions.

3.

Overdose prevention grant program

(a)

Program authorized

The Director of the Centers for Disease Control and Prevention shall award grants or cooperative agreements to eligible entities to enable the eligible entities to reduce deaths occurring from overdoses of drugs. (b)

Application

(1)

In general

An eligible entity desiring a grant or cooperative agreement under this section shall submit to the Director an application at such time, in such manner, and containing such information as the Director may require. (2)

Contents

An application under paragraph (1) shall include— (A)a description of the activities to be funded through the grant or cooperative agreement; and (B)a demonstration that the eligible entity has the capacity to carry out such activities. (c)

Priority

In awarding grants and cooperative agreements under subsection (a), the Director shall give priority to eligible entities that— (1)are a public health agency or community-based organization; and (2)have expertise in preventing deaths occurring from overdoses of drugs in populations at high risk of such deaths. (d)

Eligible activities

As a condition on receipt of a grant or cooperative agreement under this section, an eligible entity shall agree to use the grant or cooperative agreement to carry out one or more of the following activities: (1)Purchasing and distributing the drug naloxone. (2)Educating physicians and pharmacists about overdose prevention and naloxone prescription. (3)Training first responders, other individuals in a position to respond to an overdose, and law enforcement and corrections officials on the effective response to individuals who have overdosed on drugs. (4)Implementing and enhancing programs to provide overdose prevention, recognition, treatment, and response to individuals in need of such services. (5)Expanding a program described in paragraph (1), (2), or (3). (e)

Report

As a condition on receipt of a grant or cooperative agreement under this section, an eligible entity shall agree to prepare and submit, not later than 90 days after the end of the grant or cooperative agreement period, a report to the Director describing the results of the activities supported through the grant or cooperative agreement. (f)

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section for each of the fiscal years 2013 through 2017.

4.

Sentinel surveillance system

(a)

Data collection

The Director of the Centers for Disease Control and Prevention shall annually compile and publish data on both fatal and nonfatal overdoses of drugs for the preceding year. To the extent possible, the data shall be collected from all county, State, and tribal governments, the Federal Government, and private sources (such as the National Poison Data System), shall be made available in the form of an Internet database that is accessible to the public, and shall include— (1)identification of the underlying drugs that led to fatal overdose; (2)identification of substance level specificity where possible; (3)analysis of trends in polydrug use in overdose victims, as well as identification of emerging overdose patterns; (4)results of toxicology screenings in fatal overdoses routinely conducted by State medical examiners; (5)identification of— (A)drugs that were involved in both fatal and nonfatal unintentional poisonings; and (B)the number and percentage of such poisonings by drug; and (6)identification of the type of place where unintentional drug poisonings occur, as well as the age, race, and gender of victims. (b)

Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2013 through 2017.

5.

Surveillance capacity building

(a)

Program authorized

The Director of the Centers for Disease Control and Prevention shall award grants or cooperative agreements to State, local, or tribal governments, or the National Poison Data System, working in conjunction with the State, local, or tribal governments, to improve fatal and nonfatal drug overdose surveillance and reporting capabilities, including the following: (1)Implementing or enhancing the capacity of a coroner or medical examiner’s office to conduct toxicological screenings where drug overdose is the suspected cause of death. (2)Providing training to improve identification of drug overdose as the cause of death by coroners and medical examiners. (3)Establishing, in cooperation with the National Poison Data System, coroners, and medical examiners, a comprehensive national program for surveillance of, and reporting to an electronic database on, drug overdose deaths in the United States. (4)Establishing, in cooperation with the National Poison Data System, a comprehensive national program for surveillance of, and reporting to an electronic database on, fatal and nonfatal drug overdose occurrences, including epidemiological and toxicologic analysis and trends. (b)

Application

(1)

In general

A State, local, or tribal government or the National Poison Data System desiring a grant or cooperative agreement under this section shall submit to the Director an application at such time, in such manner, and containing such information as the Director may require. (2)

Contents

The application described in paragraph (1) shall include— (A)a description of the activities to be funded through the grant or cooperative agreement; and (B)a demonstration that the State, local, or tribal government or the National Poison Data System has the capacity to carry out such activities. (c)

Report

As a condition on receipt of a grant or cooperative agreement under this section, a State, local, or tribal government or the National Poison Data System shall agree to prepare and submit, not later than 90 days after the end of the grant or cooperative agreement period, a report to the Director describing the results of the activities supported through the grant or cooperative agreement. (d)

Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2013 through 2017.

6.

Reducing overdose deaths

(a)

In general

Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall develop a plan in consultation with a task force comprised of stakeholders to reduce the number of deaths occurring from overdoses of drugs and shall submit the plan to Congress. The plan shall include— (1)an identification of the barriers to obtaining accurate data regarding the number of deaths occurring from overdoses of drugs; (2)an identification of the barriers to implementing more effective overdose prevention strategies and programs; (3)an examination of overdose prevention best practices; (4)a plan for implementation of a public health campaign to educate physicians and the public about overdose prevention and naloxone prescription; (5)recommendations for improving and expanding overdose prevention programming; and (6)recommendations for such legislative or administrative action as the Director considers appropriate. (b)

Definition

In this section, the term stakeholder means any individual directly impacted by drug overdose, any direct service provider who engages individuals at risk of a drug overdose, any drug overdose prevention advocate, the National Institute on Drug Abuse, the Center for Substance Abuse Treatment, the Centers for Disease Control and Prevention, the Food and Drug Administration, the American Association of Poison Control Centers, and any other individual or entity with drug overdose expertise.

7.

Overdose prevention research

(a)

Overdose research

The Director of the National Institute on Drug Abuse shall prioritize and conduct or support research on drug overdose and overdose prevention. The primary aims of this research shall include— (1)examinations of circumstances that contributed to drug overdose and identification of drugs associated with fatal overdose; (2)evaluations of existing overdose prevention program intervention methods; and (3)pilot programs or research trials on new overdose prevention strategies or programs that have not been studied in the United States. (b)

Dosage forms of naloxone

The Director of the National Institute on Drug Abuse shall support research on the development of dosage forms of naloxone specifically intended to be used by lay persons or first responders for the prehospital treatment of unintentional drug overdose. (c)

Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2013 through 2017.

8.

Definitions

In this Act: (1)

Director

Unless otherwise specified, the term Director means the Director of the Centers for Disease Control and Prevention. (2)

Drug

The term drug— (A)means a drug (as that term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)); and (B)includes any controlled substance (as that term is defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)). (3)

Eligible entity

The term eligible entity means an entity that is a State, local, or tribal government, a correctional institution, a law enforcement agency, a community agency, a professional organization in the field of poison control and surveillance, or a private nonprofit organization. (4)

National poison data system

The term National Poison Data System means the system operated by the American Association of Poison Control Centers, in partnership with the Centers for Disease Control and Prevention, for real-time local, State, and national electronic reporting, and the corresponding database network. (5)

State

The term State means any of the several States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and any other territory or possession of the United States. (6)

Training

The term training means any activity that is educational, instructional, or consultative in nature, and may include volunteer trainings, awareness building exercises, outreach to individuals who are at-risk of a drug overdose, and distribution of educational materials.