Pain Treatment andPrescription Drug Abuse

Cathy Carlson, PhD, APN, FNP-BC

Aaron Gilson, MS, MSSW, PhD

Conflict of Interest Disclosure

• Authors Conflicts of Interest;

– C. Carlson, No Conflict of Interest

– A. Gilson, No Conflict of Interest

True Disclosure:

WE ARE ONLY RESPONSIBLE FOR WHAT WE SAY…….

NOT WHAT THE GOVERNMENT DOES!!!

Opioid Rx per 100 People per Year by State

CDC. (2012). Opioid painkiller prescribing infographic. Retrieved from http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html

MI = 107

The Problem…. Deaths involving prescription opioid

analgesics now outnumber deaths from heroin and cocaine combined

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 20130

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

Overdose Deaths Involving Opioid Anal-gesics, Cocaine, & Heroin: U. S. 1999-2013

Opioid Analgesics** Cocaine Heroin

Center for Disease Control & Prevention. (2014). Release of 2013 multiple cause of death data file. Retrieved from http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf

The Problem…… Death involving prescription drug

abuse is one of the most prevalent public health epidemics, outpacing deaths from traffic fatalities

Center for Disease Control & Prevention. (2014). Release of 2013 multiple cause of death data file. Retrieved from http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf

2013: Statistics on Death in the U.S.

Death Determinations Numbers of Deaths

Drug Overdoses 43,982

Prescription Drug Overdoses 22,767

Overdoses involving Opioids 16,235 (71.3%)

Overdoses involving Benzodiazapines

6,973 (30.6%)

MVA 33,804

Past Month Nonmedical Use of Psychotherapeutic Drugs

Aged 12 or Older, 2002-2014

U.S. Department of Health and Human Services. (2014). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. Retrieved from http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.htm#idtextanchor001

Perc

ent U

sing

in th

e Pa

st M

onth

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 20140

0.5

1

1.5

2

2.5

1.92

1.81.9

2.1 2.1

1.9

2.12

1.7

1.9

1.71.6

0.8 0.80.7 0.7 0.7 0.7 0.7

0.80.9

0.70.8

0.60.7

0.6 0.60.5 0.5

0.6

0.4 0.40.5

0.4 0.40.5 0.5

0.6

0.20.1 0.1 0.1

0.20.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

Pain Relievers TranquilizersStimulants Sedatives

Non-Medical Use ofRx Opioids

What is “non-medical use” of prescription

opioids?

Considering the Spectrum ofNon-Medical Use of Rx Opioids

Misuse(unintentional)

e.g.,- sharing with others- unknowingly taking

larger amountsthan directed

- inadvertent poisoning

OpioidDependence(“Addiction”)Abuse

Misuse(intentional)

e.g.,- recreational use for

psychic effects- decide to increase dose

for pain control- suicidal gesture

or attempt

Use involvingaberrant behaviors

e.g.,- forging/altering prescriptions

- going to multiple doctors- stealing drugs

Concurrent useof illicit drugs

orUndisclosed

Rx medication use

“Substance UseDisorder”

The Problem… Nonmedical users of pain relievers most

often get the drug from family and friends

How Different Nonmedical Users of Pain Relievers Get Their Drugs

Law Enforcement Definition of Drug Diversion

“Diversion” is the transfer of a drug from a licit to an illicit channel of distribution or use.

Manufacturers andDistributors

1. DRUG CONTROL SYSTEM (lawful distribution)

•Pharmacies•Hospitals/Clinics•Internet w/Rx•PractitionersPrescribersDispensers•Nursing homes•Hospices

Patients(Lawful medical use)

(“Prescribed”)

(Common Carriers)

2. PRIMARY DIVERSION (unlawful; supplies some abusers

and re-distribution)

Theft from manufacturers and distributors*

Theft in transit *

•Theft from hospitals*Pharmacies/robbery*Employee/customer Pilferage *

•Script docs/pill mills•Inappropriate prescribing•Doctor shopping

Internet sales without Rx

Theft of Rx/forgery

•Patient sells or gives•Theft from home•Theft from patient•Improper disposal

PPSG, 2007

* = Amounts reported by law on DEA Form 106

WHOLESALE

WHOLESALE

RETAIL

RETAIL

ULTIMATE

USER

ULTIMATE

USER

International smuggling

Non-medical use●MisuseUnintentional(sharing with others)Intentional(suicide attempt)

●Aberrant behaviors(forging/altering Rx)

●“Substance Use Disorders”(abuse & addiction)

Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

Medical Use

“Prescription medication”

Prescribed medication≠

Essential to determine whethervalid prescription was involved

Association Between Overdose/ Deaths and

“Prescribing”Factors to Consider Diversion (i.e., no prescription found) Doctor-shopping (i.e., diversion) Motivations?? Non-medical routes of administration Co-morbidities (e.g., substance use history) Poly-pharmacy Previous overdose episodes Little clinical information Not a linear effect Not causal Methadone

Hall et al. (2008)Dunn et al. (2010)Gomes et al. (2011a)Gomes et al. (2011b)Bonhert et al. (2011)Paulozzi et al. (2012)

Legitimate Patients?

Controlled Substances Act (CSA)

First enacted in 1970 to regulate the manufacture, importation, possession, use, and distribution of certain substances

DEA is responsible for interpreting and enforcing the CSA, although DHHS has a number of supporting responsibilities

Federal Drug Control Responsibility(CSA)

Balance“Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people…the illegal importation, manufacture, distribution, and possession and improper use of controlled substances have substantial and detrimental effect on the health and general welfare of the American people…the United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.”

21 USC § 801

Principle of Policy ChangeBalance

Opioids can be effective, are indispensable Must be available to relieve pain and suffering

Opioids have a potential for abuse Must be controlled

“Controlled substance” label does not change medical value of medications

Efforts to prevent abuse must not interfere with medical practice and patient care

PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014.

Imperative to Achieve BalanceU.S. Sources

Department of Health and Human Services (DHHS) Food and Drug Administration (FDA) National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA) Center for Disease Control & Prevention (CDC) National Cancer Institute (NCI) Substance Abuse and Mental Health Services

Administration (SAMHSA) Drug Enforcement Administration (DEA) Office of National Drug Control Policy (ONDCP)

Institute of Medicine (IOM) American Medical Association (AMA) American Cancer Society (ACS) Federation of State Medical Boards (FSMB) National Association of Attorneys General (NAAG)

“…the prevention of drug abuse is an important societal goal that can and should be pursued without hindering proper patient care…”

Law Enforcementon the Principle of Balance

U.S. Drug Enforcement Administration2001 Joint Policy

Statement

Still Awake???

Update: What is Happening at the Federal Level….

1. Legislative and Regulatory Mandates

2. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) Requests/Rulings

3. Office of National Drug Control Policy (ONDCP) - White House Initiatives

Legislative and Regulatory Mandates

Food and Drug Administration Safety and Innovation Act (FDASIA) Signed into law on July 9, 2012, expanded the

FDA’s authorities and strengthens the agency's ability to safeguard and advance public health.

An amendment to the Act:

Section 1139 “Scheduling of Hydrocodone”

• Required FDA to hold a public meeting • Solicit advice and recommendations to assist in

conducting a scientific and medical evaluation and scheduling recommendation to DEA regarding drug products containing hydrocodone, combined with other analgesics, or as an antitussive

FDA. (2014). Food and Drug Administration Safety and Innovation Act (FDASIA). Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/

Hydrocodone Rescheduling: Yesterday’s Solutions for

Today’s Problem(Barber, L. (2013, Nov 19). DEA Chronicles

• Hydrocodone combination products were officially rescheduled, 8.22.2014• Effective 10.6.2014

New Rule Effect• Need a new written prescription for

each 30 day supply• May write up to 90 day supply (multiple

prescriptions – with instructions indicating earliest date when pharmacy may fill each)

• May fax prescription, but patient must have written prescription to obtain Rx from pharmacy

• May call in for an emergency – Only for amount needed to cover

emergency– Need written prescription within 7 days

Wide Availability Leads to Leftovers

• Utah post-op patients reported: – Most received

hydrocodone (63%)– 67% had leftover

medication– 92% received no disposal

instructions – 91% kept the extra

medication at home

• Will rescheduling change this data? (Bates et al, 2011; Webster, 2013)

Beware of Unintended Consequences

“supply reduction … in the absence of demand reduction and

harm reduction could paradoxically increase

overdoses.”

Albert et al., 2011, Project Lazarus: Community-based overdose

prevention in rural North Carolina, Pain Medicine, 12, p. S83

Unintended Consequences• There was a large increase in the number of the

opioid prescriptions from 2002-2010 • Followed by a slight decrease in the number of

opioid prescriptions during 2011-2013 • The rates of opioid diversion and abuse and

opioid related deaths followed a similar pattern of a large increase during the years of 2002-2010 followed by a slight decrease during 2011-2013

• Findings suggest that the U.S. may be making progress in controlling the diversion and abuse of prescription opioids and decreasing opioid related deaths

• Abuse of heroin and the number of deaths from heroin has tripled during the years of 2011-2013

Dart, R. C., Surratt, H. L., Cicero, T. J., Parrino, M. W., Severtson, S. G., Bucher-Bartelson, B., & Green, J. L. (2015). Trends in opioid analgesic abuse and mortality in the United States. New England Journal of Medicine, 372(3), 241-248

FDA Requests/Rulings Oxycodone extended-release capsules with abuse

deterrent properties (Xtampza ER) close to being approved by FDA (approved by advisory committees 9.11.2015)

Hydrocodone bitartrate extended-release capsules (Zohydro ER) approved 10.25.2013

Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” issued 4.1.2015

Hydrocodone bitartrate with abuse deterrent properties (Hysingla ER) approved 11.20.2014

Combination products with greater than 325 mg of acetaminophen per unit were voluntarily withdrawn by the manufacturers at FDA’s request• Effective 01.01.2014

Naloxone hydrochloride auto-injection (Evzio) approved 04.03.2014

Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER) approved 07.23.2013

Office of National Drug Control Policy (ONDCP)

National Drug Control Strategy 20141. Emphasizing prevention over

incarceration

2. Training health care professionals to intervene early before addiction develops

3. Expanding access to treatment

4. Taking a "smart on crime" approach to drug enforcement

5. Giving a voice to Americans in recovery

Office of National Drug Control Policy (ONDCP)

Epidemic: Responding to America’s Prescription Drug Abuse Crisis 2011

1. Education – parents, youth, patients, & HCP

2. Tracking & Monitoring

3. Proper medication disposal

4. Enforcement

Prescription Drug Monitoring Programs (PDMPs)

All states but 4 (3 of the 4 have legislation)

Most states established PDMPs to address the prescription drug abuse problem beginning in 2005

To reduce prescription drug abuse and diversion

Statewide electronic databases• Collect, monitor, and reports

electronically transmitted dispensing data on controlled substances

Authorized healthcare professionals• Physicians (known as prescribers)• Pharmacists (known as dispensers)• Other authorized HCPs

Where

When

Why

What

Who

PDMP Value

PDMPs contain useful information• Identify patients who are potentially

abusing or diverting prescription drugs• Inform clinical decisions regarding

controlled substancesThe issue is how to make this

information more available to three key groups of clinical decision-makers:• HCP practices• Emergency departments• Pharmacies

PDMP Usage

PDMPs are not used as much as desired because of issues with awareness and system registration

Members of the care team supporting prescribers and dispensers often are not permitted access to PDMP systems

The use of standalone Web portals and unsolicited reports do not adequately support clinical practices and workflows

There is a lack of system-level access and standards among PDMPs, EHRs, and pharmacy systems.

The business and health IT landscape increasingly contains third‐party intermediaries which currently lack optimized business agreements to adequately protect information

Prescription Drug Overdose: Prevention for States

CDC plans to give 16 states annual awards between $750,000 and $1 million to advance prevention in four key areas:• Enhancing and Maximizing State Prescription

Drug Monitoring Programs (PDMPs)• Implementing Community or Insurer/Health

Systems Interventions• Conducting Policy Evaluations• Developing and Implementing Rapid Response

Projects

Arizona, California, Illinois, Kentucky, Nebraska, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Utah, Vermont, and Wisconsin

State Successes

CDC. (2014). Opioid painkiller prescribing infographic. Retrieved from http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html

National All Schedules Prescription Electronic Reporting

Reauthorization Act of 2015

• S. 480 – 2014– Assigned to a congressional

committee on 2.12.2015 • 1% chance of being enacted.

• H.R. 1725 – Passed the House – To the Senate– 44% chance of being enacted

We Cannot Bury Our Heads in the Sand and Not Act

– Require comprehensive prescriber education on opioid pharmacology and management--including risks, benefits, and alternatives

– Advocate for increased access and funding for mental health treatment services, including substance use disorder treatment

– Advocate for increased research funding for pain management and substance use disorder treatment

– Develop safe, convenient and environmentally friendly medication disposal programs

– Expand Prescription Drug Monitoring Program features

• Support expanded access for all health professionals to PDMP websites

• Support interstate/national sharing of information• Simplify and standardize state requirements for account

registration

Promote Government and Society Actions

Institutes of Medicine. (2011). Relieving pain in America: A blueprint for transforming prevention, care, education, and research. Retrieved from http://www.nap.edu/catalog.php?record_id=13172

HCP Actions to Decrease Risks Associated with Opioid RX

• Conduct a thorough history and physical exam including the patient’s medical, psychiatric, and social history that also ascertains any substance use disorder

• Obtain records from other providers treating the patient with pain

• Facilitate interdisciplinary management (including specialist referrals) of comorbid conditions, including psychiatric and substance use disorders/conditions that may affect risk with opioid use (i.e., OSA, obesity, depression, PTSD, anxiety)

• Utilize multimodal pharmacologic treatment, combining non-opioids with opioids

• Initiate opioid therapy as a trial with the understanding if it decreases pain and increases function it may be maintained

CDC.(2013). Common Elements in Guidelines for prescribing opioids for chronic pain. Retrieved from http://www.cdc.gov/homeandrecreationalsafety/pdf/Common_Elements_in_Guidelines_for_Prescribing_Opioids-a.pdf

HCP Actions Cont…• Start opioid therapy on lowest effective dose. Recommend

pain specialist referral with higher doses of opioids (Some guidelines cite 90-100 mg morphine sulfate equivalents [Nuckols, Anderson, Popescu, Diamant, Doyle, Di Capua, & Chou, 2014])

• Use Pain Management Universal Precautions regularly to monitor and manage potential risks with chronic opioid use (Gourlay, Heit, & Almahrezi, 2005):

– Employ regular risk evaluations for all patients on opioids– Implement written Pain/Opioid treatment agreements– Determine opioid adjustments on outcomes of the 5 ‘A’s:

Analgesia, activity, adverse effects, aberrant behavior, and affect

– Employ intermittent adherence monitoring measures as indicated, including:

• Urine drug testing • Pill counts • State prescription monitoring program (PMP) websites

– Plan for safe opioid tapering when discontinuing therapy Nuckols, T. K., Anderson, L. Popescu, I. Diamant, A. L., Doyle, B., Di Capua, P., & Chou, R. (2014). Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Annals of Internal Medicine, 160(1), 38-47.Gourlay, D. L., Heit, H. A., & Almahrezi, A. (2005). Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain. Pain Medicine, 6(2), 107-112.

Let’s Change fromFederal to State

Authorize healthcare practice, medical use of drugs

Define unprofessional conduct, and prohibit unauthorized distribution of controlled substances

Restrict prescriptive practices

Why State Policies are Important

Recognize value of controlled substances and pain management

Encourage pain management Address barriers (e.g., concern about

regulatory scrutiny)

Policies can also…

Recognizing Types of State Policy

Legislation(Statutes)

Regulatory Policy(Regulations or Guidelines/Policy Statements)

Legislature(members of

legislative committees)

Boards

Executive Director(with Nursing, focus on license-specific

division)

EntityGoverningControlled

Substances

Past sponsors ofrelated bills

Practice Acts Healthcare Regulations

ControlledSubstances

Act

Policy Change/Adoption

Add language that promotes safe and effective pain relief and palliative care

Repeal or avoid potential barriers Severe restrictions Archaic terminology Ambiguous requirements

Content and clarity of policy is essential Unintended consequences Example – Prescription Monitoring

Programs

PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014.

www.painpolicy.wisc.edu/sites/

www.painpolicy.wisc.edu/files/evalguide2013.pdf

(+) Criteria: Policy LanguageEnhance Pain Management

1. Controlled substances necessary for public health2. Pain management is general healthcare practice3. Medical use of opioids is legitimate professional

practice4. Pain management is encouraged5. Addresses practitioners’ concerns about

regulatory scrutiny6. Prescription amount is insufficient to determine

legitimacy7. Addiction not confused with physical

dependence/tolerance8. Other positive language

Category A: Issues related to healthcare professionalsCategory B: Issues related to patientsCategory C: Regulatory or policy issues

9. Opioids are relegated as last resort10. Opioids are outside legitimate practice11. Addiction is confused with physical

dependence/tolerance12. Medical decisions are unduly restricted13. Prescription validity is restricted14. Additional undue prescription requirements15. Other restrictive language16. Ambiguous language

Category A: Arbitrary standards for legitimate prescribingCategory B: Unclear intent contributing to misinterpretationCategory C: Conflicting or inconsistent policies or provisions

(-) Criteria: Policy LanguageImpede Pain Management

www.painpolicy.wisc.edu/sites/

www.painpolicy.wisc.edu/files/prc2013.pdf

Why a Progress Report Card?

Simplifies complex evaluationSingle index of quality to compare

statesPositive context for critical

evaluationSimplifies measurement of progressSupports goal-setting Increases visibility of the need to

improve pain policy

Distribution of Grades2006, 2012, & 2013

F D D+ C C+ B B+ A0

5

10

15

20

25

2006 2012 2013

Number of States

PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014.

2008 Policy:

Report of Disciplinary Resources Committee(September, 2008, pp. 114-324)

National Council ofState Boards of Nursing

MS

ID

MT ND

NE

MN

IL INOH

MOCO

NV

CA

NM

KY

MA

GAAL

NC

MD

NJ

NY

CT

NH

ME

DE

LA

IA

MI

AK

KS

AZ

HI

OK

OR

PA

RI

SC

SD

TN

TX

UT

VT

VA

WA

WV

WI

WY

AR

DC

FL

Pain Management Policies(n=49)

MS

ID

MT ND

NE

MN

IL INOH

MOCO

NV

CA

NM

KY

MA

GAAL

NC

MD

NJ

NY

CT

NH

ME

DE

LA

IA

MI

AK

KS

AZ

HI

OK

OR

PA

RI

SC

SD

TN

TX

UT

VT

VA

WA

WV

WI

WY

AR

DC

FL

Nursing Regulatory Pain Policy(n=27)

APN Prescribing Authority2010, 2012, & 2013

0

5

10

15

20

25

No Rxauthority

MDinvolvement

+ limits

MDinvolvement

IndependentRx authority

201020122013

Number of States

PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014.

Independent Prescribing Authority(23 states)

Alaska Arizona Colorado Connecticut DC Hawaii Idaho Iowa Maine Maryland Minnesota Mississippi

Montana Nevada New Hampshire New Mexico North Dakota Oregon Rhode Island Vermont Virginia Washington Wyoming

Prescribing Requires Formal Physician Involvement

(12 states)

California Delaware Indiana Kansas Massachusetts Nebraska

New Jersey New York Tennessee Texas Utah Wisconsin

Prescribing Requires Formal Physician Involvement/Other

Limits (8 states)

Illinois Kentucky Louisiana Michigan

North Carolina Ohio Pennsylvania South Dakota

PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014.

No Prescribing Authority(8 states)

Alabama Arkansas* Florida Georgia*

Missouri* Oklahoma* South Carolina* West Virginia*

* No prescribing authority for Schedule II medications only

PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014.

Potential Policy Barriers to Nursing Pain Practice

Prescribing authority is prohibitedFormal physician involvement (??)Additional requirements/limitations

Supply limits (e.g., 24 hours, 72 hours, 7 days, 30 days)

Not for chronic pain (including cancer pain)

Ambiguous languageRecent, not widespread, regulatory

guidancePPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014.

Ways to Improve Practice Related to Pain Management

“Multidisciplinary” (team approach)ReimbursementResearch to inform practiceIntegrating PDMP with EMRHarmonizing both professional and

regulatory guidanceIncreasing use of risk identification

and mitigation strategies

2

MS

ID

MT ND

NE

MN

IL INOH

MOCO

NV

CA

NM

KY

MA

GAAL

NC

MD

NJ

NY

CT

NH

ME

DE

LA

IA

MI

AK

KS

AZ

HI

OK

OR

PA

RI

SC

SD

TN

TX

UT

VT

VA

WA

WV

WI

WY

AR

DC

FL

States with “Pill Mill” Activity(n=46)

Assessed via Internet search, September 14, 2015

Engage with existing initiative

Established network with policy-makers• Supportive of pain management issues• Sponsors• “Cue-givers” (Matthews & Stimson, 1975)

MultidisciplinaryAnticipate other policy implicationsRelevant initiatives becoming more

prevalent

What We Can Do to Engage at the State Level

Gilson, Joranson, & Maurer. Improving state pain policies: Recent progress and continuing opportunities. CA: A Cancer Journal for Clinicians. 2007;57:341-353.

State Pain Policy Advocacy Network (SPPAN)• State Legislation and Regulations

Tracking• http://sppan.aapainmanage.org

ACS Cancer Action Network• Quality of Life/Access to Care Initiatives• http://www.acscan.org

U.S. Pain Foundation• Pain Advocacy Efforts (e.g., PDMPs,

Federal)• http://uspainfoundation.org/uspain-advocacy-e

fforts.html

What We Can Do to Engage at the State Level

Questions???