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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???