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Opioid Use and Misuse:Past, Present, and Future

Jennifer Lawlor, MD

The devil is in the details….

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The Opioid Crisis: in summary

• Pain is Real

• Opioids are not addictive

• Opioids are the answer: more pain? Give more meds

• A few people are dying? We need to develop and sell tamper resistant drugs. Drugs are still the answer

• More people are dying? We need to educate the doctors, weed out the pill mills and “bad doctors”

• Still dying? Urine screens, med agreements, PDMP, ORT to weed out the “bad patients”

• 2016. Get everyone off all opioids. No opioid Rx.

Oregon by the numbers…

• Since 1999, Oregon’s death rate from opiates has more than tripled, and since 2010, fatal drug overdoses have exceeded statewide deaths from auto accidents.

• Oregon has one of the highest rates of recreational use of painkillers in the nation. The number of pills in circulation in the state was estimated at 100 million in 2012.

• Just 20 percent of the doctors, nurses and dentists in Oregon prescribe 78 percent of the opioid painkillers

• An average of three Oregonians die every week from prescription opioid overdose

• Enough opioids are prescribed every year for every Oregonian to have a bottle

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Opioids in the USA by the numbers…

• Deaths from opioid overdose have quadrupled since 1999

• Opioid deaths now exceed MVA

• Opioid deaths = 9/11 every two weeks

• >60,000 people in the died from opioid overdose in 2016

• 91 people die per day due to opioid Rx overdose

• Every 18 minutes someone dies of an opioid Rx overdose

• Drug overdoses are now the leading cause of death among Americans under 50

When did it all begin?

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Pain “Advocacy” Groups

• American Pain Foundation

• American Academy of Pain

• American Pain Society

• Center for Practical Bioethics

• Wisconsin Pain and Policy Studies Group

• Federation of State Medical Boards

• The Joint Commission (Accrediting Body)

Washington Post, 1977

• Dr. Hershel Jick noted less than 1% of patients studied died from a reaction to the drugs

• “I think very serious adverse reactions are about as infrequent as one could possibly expect given the enormous amount of exposure to drugs.”

• Opioids are safe, opioids are the answer

New England Journal of Medicine

• January, 1980: 11-line letter penned by Jane Porter and Dr. Hershel Jick mentioned their analysis of 11,882 patients who were treated with narcotics. They wrote that "the development of addiction is rare in medical patients with no history of addiction."

• Patients with terminal illnesses started being treated more with prescription opioids, and doctors and researchers wanted to look at treating patients with chronic pain

• Opioids are safe, opioids are the answer

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Dr. Portenoy

• Chronicled 38 patients with non-cancer pain

• All treated with opioids, only two developed “addiction”

• Concluded “Opioid maintenance therapy can be safe, salutary, and more humane alternative” to surgery or not treating the patient’s pain

• Opioids are safe, opioids are the answer

Pain, 1986

• Narcotics “can be safely and effectively prescribed to selected patients with relatively little risk of producing the maladaptive behaviors which define opioid abuse.”

• The authors advised caution, and said that the drugs should be used as an “alternative therapy.”

• They also called for longer-term studies of patients on narcotics; we’re still waiting for those to be performed.

• Opioids are safe, opioids are the answer

Pain Relief Promotion Act 1999

• Promotes pain management and palliative care through use of controlled substances, even if such use unintentionally hastens death

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September 4, 1999

New York Times

Oregon Board Disciplines Doctor for Not Treating

Patients' Pain

Oxycontin is born

The Family That Build an Empire of Pain

• The New Yorker, October 30, 2017

• Purdue Pharma:• Medical Advertising Hall of Fame, 1997

• 1990 “MS Contin could face serious generic competition”

• 1995 FDA approved package insert noting Oxycontin was “safer”

• 1997 FDA examiner who approved Oxycontin joined Purdue

• 2003 Dr. Haddox, celery analogy, blame the users

• 2006 635 million fines “intent to defraud or mislead”

• 2006 – 2015 Purdue and others spent 900 million on lobbying

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The New York Radio Hour with David Remnick 10/27/2017

Not just Purdue…

• Endo Pharmaceutical

• Purdue Pharma

• Johnson & Johnson

• Cephalon

• Abbott Laboratories

• Alpharma

• King Pharmaceutical

• Ortho McNeil

Annual Rx for pain medication

Early 1990’s

• 2,000,000 to 3,000,000

1995 - 96

•11,000,000

2012

259,000,000

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1997 Case of Patient X

• Woman in her 30’s

• s/p MVA, cervical strain

• Treatment plan therapy, Tylenol, NSAIDS, heat / ice

• Patient requested stronger pain meds “Percocet”

• Declined to Rx

1999 Case of Patient Z

• 40 something injured worker

• Left upper extremity strain

• Swelling, discoloration, hypersensitivity

• Presentation suggestive of RSD / CRPS

• Vicodin insufficient pain relief, switched to oxycodone, once requiring qid dosing, add bid or tid Oxycontin with prn meds for breakthrough

• Likely told “If you have high blood pressure, we treat it. Similarly, if you have pain, we treat it”

Joint Commission, 2001

• Improve pain management

• Fifth vital sign

• Physician education requirements

• Joint Commission printed a book in 2000 for purchase by doctors as part of required continuing education seminars

• "there is no evidence that addiction is a significant issue when persons are given opioids for pain control."

• doctors' concerns about addiction side effects "inaccurate and exaggerated.“

• The book was sponsored by Purdue Pharma.

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Wisconsin Pain and Policy Studies Group

• Highlights of the 2008 Grades

• “more needs to be done to effectively address the national health crisis of undertreated pain”

• “opioid pain medications are often the best treatment for managing serious, persistent pain”

• Seven states (Georgia, Maine, Minnesota, Oregon, Rhode Island, Utah and Washington) had policy change sufficient to improve their grade.

• Oregon received an A, joining Kansas, Michigan, Virginia, and Wisconsin with the highest grades. Georgia showed the largest grade improvement, increasing from a D+ to a B

By 2010: USA 5% of world’s population, consuming:

• 99 % of the hydrocodone

• 88% of the oxycodone

• 65% of the hydromorphone

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2000 – 2010: Drugs are still the answer, we just need a better drug

• Tamper resistant Oxycontin

• Opana ER

• Kadian

• Avinza

• Actiq

• Fentanyl

• Exalgo

• Nucynta ER

• Methadone

• Butrans

• Suboxone

• Embeda

• Pallidone

Washington State Health Care Authority

• 1995-2004, opioid-related poisoning hospitalizations doubled in Washington State

• 2005: Early recognition-Gary Franklin, MD

• 2007: First to create high dose ceiling 120 MED

• People are dying

Washington state

• 2007: AMDG “Educational” guidelines: 120 mg MED (dose) threshold for consultation

• 2009: CDC recommends: 120 mg/day MED

• 2010: AMDG updated “Recommended” guidelines

• 2011: WA State Prescription Monitoring Program

• 2011: “2876” WA State Legislation

• 2015: Updated AMDG Guidelines

• 2016: CDC Guidelines: 50- ≤90 mg/day MED

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Oregon Medical Board

• Pain Management Requirements

• By 2009 or within the first year of licensure, licensees must complete continuing medical education on pain management. The requirements and exemptions are detailed in OAR 847-008-0075. A one-hour course provided by the Oregon Pain Management Commission is required plus at least six more hours in the subjects of pain management or the treatment of terminally ill and dying patients.

• People are dying, we need to educate the doctors

Kate Dunn, et al Annals of Internal Medicine, 2010

• Individuals (n=9940) who received 3+ opioid prescriptions within 90-days for CNCP between 1997 and 2005.

• Fifty-one opioid-related overdoses were identified, including six deaths.

• Patients receiving 50-99 mg had a 3.7 fold increase in overdose risk compared to those receiving 0 – 20 mg per day

• Patients receiving 100mg or more per day had an 8.9 fold increase in overdose risk (95% C.I. 4.0, 19.7) and a 1.8% annual overdose rate.

• More people are dying, we need to do something

Medication Agreements, Urine screens

• Ameritox (actually founded in 1996)

• Fake urine

• Frequency of visits

• Still dying? Urine screens, med agreements, PDMP, ORT to weed out the “bad patients

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Morphine Equivalent Dose

• Morphine Equivalent Dose (MED) is used to translate the dose and route of each of the opioids the patient has received over the last 24 hours to a parenteral morphine equivalent using a standard conversion table.

• Multiple conversion charts

• Roughly• norco = morphine

• oxycodone = 1.5 X morphine

• fentanyl = 2.5 X morphine

• Methadone = 4X morphine

Drugs to “fix” the drug problem?

•Naloxone

•Suboxone

•Vivitrol

Vivitrol

• Alkemers (and Elan)

• Long acting injectable form of naltrexone, q monthly injection

• Originally for alcohol addiction

• 2006 FDA approved for opioid addiction

• Used 7+ days after opioid detox

• Prison population

• Cost $1100 per dose

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Prescription Drug Monitoring Program

• Prior to PDMP

• Oregon PDMP, 2011

• PDMP in all 50 states as of July 2017 (Missouri the last to join)

• OR: opioid overdose declined 38% between 2006 and 2013 and methadone poisoning decreased 58% in the same time period

• HB 4124 allows the integration of the PDMP with health IT systems

• Pitfalls

Purdue never gives up….

• 2015 FDA approved marketing of OxyContin to children as young as 11 years old

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Fentanyl, the new character in the story

CDC Guidelines

• 1. Non-pharmacologic therapy and non-opioid preferred

• 2. Establish treatment goals for pain and function

• 3. Discuss risks, realistic benefits, and patient responsibilities

• 4. Prescribe immediate-release opioids not extended-release / LAO

• 5. Prescribe the lowest effective dosage, preferably MED <50, max 9 MED 90

• 6. For acute pain, Rx 3 days or less, 7 days only for major trauma/surgery

• 7. Follow up 1 to 4 weeks after starting opioids, then q <=3 months

CDC Guidelines continued…

• 8. Evaluate and mitigate risk. Consider Rx Naloxone, avoid use with benzodiazepines

• 9. PDMP when starting and q 1 -3 months

• 10. Urine drug testing before starting opioid therapy and consider urine drug testing at least annually

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Legislators take action across the country

• Massachusetts: 2016 • First law limiting to 7-day supply for pain medications

• 7-day limit on every opiate prescription for minors

• Prescribers must check PDMP

• Continuing education requirements

• increased bulk purchasing of Narcan in municipalities by offering Narcan at a discount to our first responders and changed reporting requirements for the Prescription Monitoring Program from 7 days to 24 hours.

Salem gets busy….

Education

Obstruction

Incarceration

Legislation

Rehabilitation

?

HB 2518

• Expands PDMP to include tracking naloxone dispensed

• Facilitates hospital systems monitoring of their opioid prescribing

• Directs educational effort to those healthcare providers who do not follow safe prescribing practices (review team)

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HB 2645

•HB 2645: Sets up a system for disposal of unused prescription painkillers

•HB2355: Seeks to decriminalize first time offenders with small amounts of illicit drugs

HB 3440

• Improves access to Nalaxone

• Eliminating insurance barriers to relief

• Ensuring offenders supervised by drug courts will be able to continue their recovery treatment even if it includes methadone or buprenorphine.

• Requires the Oregon Health Authority to report fatal and non-fatal overdoses by county every quarter

July 2017

• The Oregon legislature passed a bill that reclassifies possession of several drugs from a felony to a misdemeanor, reducing the punishments and expanding access to drug treatment for people without prior felonies or convictions for drug possession.

• Oregon lawmakers hope to encourage drug users to seek help rather than filling up the state’s prisons as an epidemic of abuse spreads.

• Opponents of the bill dubbed it “hug a thug”

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CareMark Comp LAO/SAO Guidelines

• SAO < 90 MED up to 6 weeks or LAO post-op 1 week

• Precertification process:• Opioid Risk Assessment

• Urine Drug Analysis

• Signed Medication Agreement

• Signed Material Risk Notice

• Initiate VAS/Functional Monitoring

• Submit documentation +/- Pain Physician Consultation

Combined cost of Opioid Crisis in 2016?

(Health care + labor + criminal justice costs)

A: 100 million

B: billion

C: 100 billion

We are not alone…

• Tramadol in Africa

• Heroin use in Afghanistan

• Carfentinil manufacturing in China

• Philippine drug use

• Mexican economy

• Central America

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Addiction, Dependence, Tolerance

Addiction: Chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences.

Dependence: Physiological adaptation, development of withdrawal symptoms when opioids are discontinued

Tolerance: Physiological state characterized by a decrease in the effects of a drug (e.g., analgesia, nausea or sedation) with chronic administration

Opioid Use Disorder

*This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision.Severity: Mild: 2-3 symptoms, Moderate: 4-5 symptoms. Severe: 6 or more symptoms.

• DSM-5

• 2 criteria over 12 months

• 10 criteria

• Blending of dependence, tolerance, addiction

Not surprisingly, hospitals are filling up

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Hospitals respond…

Opioid Use Disorder Consult teams

Pain Specialist

Nursing staff training

Pharmacist

Predominately Medicaid followed by Medicare

The Opioid Crisis: in summary

• Pain is Real

• Opioids are not addictive

• Opioids are the answer: more pain? Give more meds

• A few people are dying? We need to develop and sell tamper resistant drugs. Drugs are still the answer

• More people are dying? We need to educate the doctors, weed out the pill mills and “bad doctors”

• Still dying? Urine screens, med agreements, PDMP, ORT to weed out the “bad patients”

• 2016. Get everyone off all opioids. No opioid Rx.

Pain is STILL REAL…

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Case of V.M.

• But as I thought, Dr ________is totally against opiates and thinks no one should be on them, even when it's a cheap alternative to help the quality of life. My quality of life has been so degraded from when I was pain free, or at least pain being addressed and tried to be kept in check, that no one is listening. I've been dealing with this pain for 25 years. Why, would anyone think that the pain I feel would ever go away? The only reason I haven't turned to street drugs is because I don't want to be classified as a "junkie" when they find me dead from some bad dope. This makes me the most upset. That I have to look to the under world to help with my pain, all because no one wants to believe that the pain I feel is real and they want me to live like this …When no one will listen and I have to rely on self medication, it's no wonder patients are dying and they are counted as "accidental over doses." That's crap when it's totally avoidable.

Case of S.K.

• 55 +/- year old with 35+ years of tetraplegia

• Recurrent dysreflexia with SBP 180 – 200, DBP 90 – 115

• Workup negative for common causes

• Likely cause underlying osteoarthritis, spondylosis of spine

• ED and PCP unwilling to Rx any opioids

The end of my talk…

But not the end of the story…