Opioid-related Public Health Emergency Declarations

James G. Hodge, Jr., JD, LLMProfessor of Public Health Law and Ethics

Director, Western Region Office, Network for Public Health Law

Sandra Day O’Connor College of LawArizona State Universityjames.hodge.1@asu.edu

Leila Barraza, JD, MPHAssistant Professor of Community,

Environment, and PolicyMel and Enid Zuckerman College of

Public HealthUniversity of Arizona

Consultant, Western Region Office,Network for Public Health Law

lbarraza@email.arizona.edu

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Brief Contents

• Opioid Crisis Timeline• Escalating Opioid Crisis• National Emergency

Declarations/Proposals• State/Tribal Level Emergencies • Specific Issues of Law and

Policy

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Commission recommends

national emergency declaration

Opioid Crisis Timeline

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Dec 30 2016

Mar 292017

Aug 10 2017

President Trump states intention

to declare emergency

July 312017

Mar 18 2016

CDC publishes Opioid Prescribing

Guidelines

First state public health

emergency declaration

(MA)

Mar 27 2014

CDC reports annual opioid overdose

deaths hit record-high of >33,000

President Trump issues Executive Order

establishing White House Commission on Combating

Drug Addiction and the Opioid Crisis

President Trump proclaims Sept. 17-23

Prescription Opioid and Heroin Epidemic

Awareness Week

Sept 182017

The Escalating Crisis• As many as 25% of persons receiving opioids for long-

term non-cancer pain become addicted• About 4 of 5 new heroin users start by misusing

prescription opioids• From 2014-2015, death rates from synthetic opioids

(other than methadone) increased 72% and overdose deaths for teens (15-19 years) increased about 20%

• More than 12.5 million people misused prescription opioids in 2015

• On average 142 Americans die every day from opioid-related overdoses; > 160,000 more deaths by 2020

• Rural overdose death rate exceeds urban rates by 45% • Economic impacts (healthcare, emergency care,

related costs) exceed $92 billion in 20164

5 Source: https://www.nytimes.com/interactive/2016/01/07/us/drug-overdose-deaths-in-the-us.html

Overdose Deaths 2003-2014

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Prescription Opioid Sales and Overdose Deaths

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Heroin and Synthetic Opioid Overdose

8http://jamanetwork.com/journals/jama/fullarticle/2652445

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Declaration of National Emergency

• On July 31, 2017, the White House Commission recommended that President Trump declare a national state of emergency in response to the opioid epidemic in part to:

• reimburse state Medicaid programs to to cover treatment facilities;• require doctors prescribing opiates to receive instruction in pain treatment; • expand access to medication-assisted treatment;• provide law enforcement officials and residents with naloxone;• authorize doctors to prescribe naloxone along with opioids; and• change health information privacy laws to ensure data regarding opioid abuse

disorders are available to HCWs treating and prescribing medication to patients.• On August 8, 2017, President Trump and HHS Sec’y Price declined to issue any federal

emergency declaration.• On August 10, 2017, President Trump reversed course, suggesting a national emergency

will be declared.• To date, no formal emergency declaration has been issued at the federal level.

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Arizona declares emergency

Florida declares

emergency

Maryland declares

emergency

State-based Emergency Declarations Timeline

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Feb 142017

Alaska declares emergency

June 52017

Mar 12017

Mar 27 2014

Massachusetts declares

emergency

Virginia declares emergency

Nov 162016

Mar 132017

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State and Tribal Opioid EmergencyDeclarations

CA

OR

WA

ID

MT

TX

SDWY

NV

OK

KS

NE

CO

NMAZ

UT

ND

SC

MNWI

IA

MO

AR

LA

VA

NC

GA

FL

ALMS

ILWV

KY

TN

NY

PA

IN OH

MI

DENJ

CTRI

MA

ME

DCMD

NHVT

AK – AlaskaHI - HawaiiPR - (Puerto Rico)VI - (U.S. Virgin Islands)

Opioid emergency declarations

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White Earth NationRed Lake Nation

Mashpee Wampanoag

Tribe

Leech Lake, Band of Chippewa

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Former Governor Deval Patrick

• Public Health Emergency declared on March 27, 2014

• Empowers Massachusetts’ public health commissioner to use emergency powers to expand access to naloxone

• Requires physicians and pharmacists to check Prescription Drug Monitoring Programs (PDMPs) in some situations

• Prohibits prescribing and dispensing of hydrocodone-only medication

Massachusetts State of Public Health Emergency

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Governor Terry McAuliffe

• On November 21, 2016, Marissa Levine, MD, Commissioner of Health, declared a public health emergency to address the opioid crisis, which is supported by Governor Terry McAuliffe*

• Allows the public to obtain naloxone in emergency situations

• Lowers stigma toward those suffering from addiction

Virginia State of Emergency

*The Commissioner comments on the declaration, noting it has no force of law and is not a Governor’s emergency declaration

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Governor Bill Walker

• Alaska issued a Declaration of Disaster Emergencyon February 14, 2017

• Authorizes the Commissioner and State Medical Officer of the Department of Health and Social Services to coordinate a statewide Overdose Response Program (ORP)

• Authorizes the issuance of a state-wide medical standing order allowing healthcare officials, first responders, and the public to dispense and administer naloxone

Alaska State of Emergency

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Governor Larry Hogan

• State of Maryland issued Executive Order 01.01.2017.02 regarding the Heroin, Opioid, and Fentanyl Overdoes Crisis Declaration of Emergency on March 1, 2017

• Committed $50 million in new spending over 5 years coordinated by state emergency management authority with local jurisdictions to ensure community involvement

• Expands and coordinates resources to combat the opioid epidemic

Maryland State of Emergency

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• Executive Order Number 17-146 was issued on May 3, 2017• Department of Children and Families, Department of Health, and Department of Law

Enforcement can suspend any statute, rule, ordinance, or order to procure necessary supplies, services, and temporary premises

• Governor is empowered to spend money immediately without legislative approval to expedite public health responses

Governor Rick Scott

Florida State of Emergency

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Arizona State of Emergency

• Declaration of Emergency and Notification of Enhanced Surveillance Advisory declared on June 5, 2017 (and renewed for 60 more days on August 11).

• Provides better coordination between state, local, and private-sector partners to distribute naloxone throughout the community

• Enhances surveillance for increased reporting of overdose death from health care entities

• Develops guidelines to educate healthcare providers on responsible prescribing practices

Governor Doug Ducey

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Tribal Emergency Declarations

Red Lake Nation 2011 and 7/11/17Public Health Emergency

Mashpee Wampanoag Tribe7/16/16Public Health Emergency

White Earth Nation2011Public Health Emergency

Leech Lake, Band of Chippewa Indians4/18/11Public Health Emergency

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Topical Legal Issues

Good Samaritan Statutes: At least 40 states and D.C. have implemented immunity from arrest for drug possession when a person dials 911 or seeks medical attention during an instance of opioid overdose.

Medical Professional Liability: Maryland, like many states, provides stronger legal protections from civil and professional liability for medical professionals who prescribe and dispense naloxone.

Product Liability: 8/30/17: Arizona files suit against Insys for deceptive marketing of Subsys, a synthetic opioid spray 50x more potent than heroin, alleging the company and execs bribed doctors to prescribe large quantities to non-cancer patients.

Insurance Coverage: Insurance companies are limiting coverage of less addictive opioid alternatives because they are more costly, thus exposing more patients to an increased risk of opioid misuse or abuse.

Liability

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Topical Legal Issues

Naloxone Expansion: Arizona’s emergency declaration includes naloxone distribution for communities and law enforcement statewide

Statewide Standing Order: On 11/21/16 VA Health Commissioner issued statewide standing order authorizing pharmacists to dispense naloxone.

Naloxone Limitation: In June 2017, Middletown, Ohio city councilmember proposed a ‘three-strikes’ policy for people who repeatedly overdose, limiting access to emergency medical attention and overdose reversal.

Overdose Prevention and

Treatment

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Topical Legal Issues

Prescription Drug Monitoring Program (PDMP): In 2016, Massachusetts passed legislation requiring prescribers to report and query opioid prescribing practices.

Law Enforcement PDMP Access: Proposed New Jersey legislation would allow law enforcement to access PDMP database without a court order to investigate doctor-shopping.

HIPAA and Overdose ‘Notification:’ In June 2017, White House Commission discussed possible requirement to inform family members when a person is revived with nalox-one after an opioid overdose.

Privacy

Opioid-related Public Health Emergency – Focus on Arizona

Leila Barraza, J.D., M.PHAssistant Professor of Community,

Environment, and PolicyMel and Enid Zuckerman College of

Public HealthUniversity of Arizona

Consultant, Western Region Office,Network for Public Health Law

lbarraza@email.arizona.edu

PHE in Arizona: Enhanced Surveillance

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June 13, 2017: Executive Order 2017-05 Enhanced Surveillance Advisory• Healthcare providers, EMS, Medical Examiners,

Pharmacists, other criminal justice and health information entities

• Required to report within 24 hours and share information on:

• Suspected opioid overdose;• Suspected opioid death;• Naloxone doses administered;• Naloxone doses dispensed; and• Cases of neonatal abstinence syndrome

• Requires blood sample collection from suspected overdose

PHE in Arizona

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• Real Time Opioid Data (June 22 – August 31)• 280 suspect opioid

deaths• 2,361 suspect opioid

overdoses• 172 cases of neonatal

abstinence syndrome• 1,807 naloxone doses

dispensed• 1,578 naloxone doses

administeredSource: http://www.azdhs.gov/prevention/womens-childrens-health/injury-prevention/opioid-prevention/index.php

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Controlled Substance Prescription Monitoring Program (CSPMP)

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• In May 2016, Arizona passed legislation targeted at “Doctor Shopping”• Effective 10/16/17, medical practitioners are

required to obtain patient report from PDMP database before prescribing an opioid analgesic

• Patient reports must be tracked at the beginning of treatment and quarterly during treatment

• Liability protection for administration of prescription in good faith

A.R.S. §36-2606

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CSPMP: Exceptions to Obtaining a Report

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• Exceptions to obtaining a report:• Palliative or hospice care,

cancer-related treatment, or dialysis treatment

• Acute pain treatment lasting less than 5-10 days

• Patient is in a nursing, health, or correctional care facility

• If a medical practitioner administers medication

A.R.S. §36-2606

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Naloxone Standing Order

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• Effective June 9, 2017, ADHS Director Dr. Cara Christ issuedstanding order• Authorizes pharmacists to

dispense naloxone to individuals

• Per Enhanced Surveillance E.O., pharmacists are now required to report naloxone doses dispensed to CSPMP

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ADHS Opioid Response Recommendations

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• On 9/6/17, ADHS released its “Opioid Overdose Epidemic Response Report”

• Includes recommendations outlining legislative proposals to reduce illicit acquisition of opioids and promote safer prescribing and dispensing practices

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Key Report Recommendations

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Acknowledgments/More Information

• Special thanks to Sarah Wetter, JD, and Alex Hess at ASU’s Sandra Day O’Connor College of Law for their research & assistance

• Ask the Network concerning questions or comments relating to this information

• James Hodge - jhodge@networkforphl.org• Leila Barraza - lbarraza@networkforphl.org• Sarah Wetter - swetter@networkforphl.org