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Opioid EpidemicDo not be a contributor!

Optometry’s Responsibility

Rebecca H. Wartman OD

Illinois Optometric Association

September 2019

Disclaimers for Presentation

1. All information was current at time it was prepared

2. Drawn from national policies, with links included in the presentation for your use

3. Prepared as a tool to assist doctors and staff and is not intended to grant rights or impose obligations

4. Prepared and presented carefully to ensure the information is accurate, current and relevant

5. No conflicts of interest exist for the presenter- financial or otherwise. Rebecca writes for Optometric Journals and is a consultant for Eye Care Centers, PA and is the NCOS Third Party Liaison

Disclaimers for Presentation

6. Of course the ultimate responsibility for the correct submission of claims and compliance with provider contracts lies with the provider of services

7. AOA, IOA, its presenters, agents, and staff make no representation, warranty, or guarantee that this presentation and/or its contents are error-free and will bear no responsibility or liability for the results or consequences of the information contained herein

8. Special thank you for Dr. Harvey Richman

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Outline• Definition of terms• Origin of opioid epidemic• Opium History and Production• Early and more Recent Laws• Opioid Pharmacology• Modern Pain Control approaches

• Pre 2018 and Post 2018

• The Opioid Epidemic – Scope of the Problem• Pain Management for Optometry• Rules of the road• Watch out for drug seekers• Tropicamide???? Really???

READY??

Definition of terms• Aberrant drug-related behavior

• Behavior outside agreed-upon treatment plan

• Abuse• Any drug use/intentional self-administration for nonmedical purpose

• pleasure-seeking, consciousness altering

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Definition of terms

• Addiction• Chronic, neurobiological disease (genetic, psychosocial, and environmental factors)

• Behaviors including:1. Craving2. Impaired drug use control3. Compulsive use4. Continuation of use despite harm

• Diversion• Intentional transfer of controlled substance from legitimate

distribution/dispensing channels

Definition of terms• Misuse

• Use of medication other than as directed/indicated –whether willful or unintentional whether harmful results or not

• Physical Dependence• Physical tolerance manifested by specific withdrawal syndrome

produced by:1. Abrupt cessation2. Rapid dose reduction3. Decreasing blood level of the drug4. Administration of an antagonistPhysical dependence not same as addiction

• Tolerance• State of adaptation when drug induced changes result in decrease of drug’s

effects over time

Opium in Ancient times

• Early history and still today

• Opium Poppies are grown by impoverished farmers

small plots in remote regions of the world

• Poppies like dry, warm climates

• Majority of opium poppies are grown in narrow, 4,500-mile stretch of mountains ➔ Asia: Turkey through Pakistan and Burma

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Opium Poppy Growth areas of world

Opium in Ancient times

• Seeds found from 5000 BCE (Neolithic)

• Papaver somniferum: ancient finds been reported throughout

Switzerland, Germany, and Spain

• Numbers of poppy seed capsules at Spanish burial site dated to 4200 BCE

• Opium first mention in 3400 BC - lower Mesopotamia (SE Asia)

• Sumerians called opium Hul Gil, the "joy plant."

• Cultivation spread along Silk Road: Mediterranean through Asia to China

Opium in Ancient timesAncient Greek and Romans

• Inhalation of vapors, suppositories, medical poultices

Ancient physicians used opium as:

1. Powerful pain reliever

2. Sleep inducers

3. Relief to bowels

4. Protect from being poisoned

5. Pleasurable effects

6. Suicide/executions (mixed with Hemlock)

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Opium in Ancient times• Hypnos (God of Sleep) and His mother Nyx (Goddess of Night)

• Hypnos married Pasithea (Deity of hallucinations/relaxation)• Sons

• Morpheus (Winged God of Dreams)

• Phobetor (Creator of Scary Dreams)

• Phantasus (Creator of Fake/Illusional Dreams)

• Ikelos (Creator of True Dreams)

• Hypnos and Thanatos (God of Death) often wreathed in poppies or holding them

• Poppies often adorned statues of Apollo, Asklepios, Pluto, Demeter, Aphrodite, Kybele, and Isis to symbolize nocturnal oblivion

https://www.pbs.org/wgbh/pages/frontline/shows/heroin/maps/

Rank CountryLand Area Devoted To Cultivating Illicit Opium Poppies

1 Afghanistan 225,000 hectares

2 Myanmar 58,000 hectares

3 Mexico15,000 hectares

4 India 12,250 hectares

5 Laos 6,200 hectares

6 Pakistan 2,300 hectares

7 Colombia 298 hectares

8 Iran 100 hectares

Top Opium Poppy Producing Countries

900 Square Miles

https://www.worldatlas.com/articles/top-opium-poppy-producing-countries.html

Afghanistan

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Making of raw opium

Making of raw opiumNushtar or Nishtar

Making of Raw Opium

Home-brew technique to extract morphine from unwashed poppy seeds creates lethal doses

(Sam Houston State University)

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Opium Chemical makeup• Opium Poppy (papaver sonmiferum) makes Poppy Tears = dried latex

• 12 % = analgesic alkaloid morphine ➔ heroin and other synthetic opioids

• Opium production reduces latex by 88% then converted to heroin Heroin is 2-4x more potent

• Plant breeding has made latex with higher concentrations of drug

Opium Chemical makeup• Opium Latex related to codeine and thebaine and non-analgesic alkaloids

Papaverine (vasodilator)

Noscapine (antitussive)

• Thebaine - raw material for the synthesis for oxycodone, hydrocodone, hydromorphone, and other semisynthetic opiates from extracting Papaver orientale (oriental poppies) or Papaver bracteatum (Persian Poppy or Iranian Poppy)

Opium Oriental Persian

Morphine

Papaverine

Thebaine

Opium from India

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History of Drugs in America• America has most always had some trend toward abstinence back to colonial

time –Drugs to alcohol to tobacco

• 18th century pamphlet against use of any drink "which is liable to steal away a man's senses and render him foolish, irascible, uncontrollable and dangerous."

• Nineteenth century linked “delirium tremens, perverted sexuality, impotency, insanity and cancer to the smoking and chewing of tobacco”

http://www.druglibrary.org/schaffer/history/casey1.htm

Other early drug use in america• Cannabis sativa(hemp) – dates back to 2nd millenium B.C. China

• 1850 – 1942: Marijuana considered legitimate medication under "Extractum Cannabis"

• 1851: Hemp recommended for neuralgia, gout, rheumatism, tetanus, hydrophobia, epidemic cholera, convulsions, chorea, hemorrhage

• 1869: Hashish (cannabis indica) known only for intoxicating properties

History of drugs in America• Cannabis sativa (hemp) first appeared in Chile in 1545

• Cannabis sativa was staple crop for colonial farmers – grown for fiber

• Pre-revolution, tobacco and hemp were the major export crops

• Into the 1800’s: Large hemp plantations in Mississippi, Georgia, California, South Carolina, and Nebraska

http://www.druglibrary.org/schaffer/history/casey1.htm

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Other early drug use in america

Post Civil War: Hashish candy available in sweet shops

1870: Peyote used by Native Americans1959: Ritual use of peyote permitted in Native American Church

Until 1960’s: Dried mescal buttons still legally available by mail order

History of drugs in America• Reported that, while growing cannabis for fiber, George Washington

wanted “increase the medicinal or intoxicating potency of his marihuana plants” (Grown at Mount Vernon 1765-1767)

• ….fast forward to today….CDB and marijuana shops

Origins of Opioid use epidemic

Early to mid 1800’s :•Opium was the first “exotic” drug used•Opium dens of West Coast• Brought by Chinese, use was open,

readily available and uncontrolled

Thomas DeQuincey's Confessions of an English Opium Eater... I do not readily believe that any man, having once tasted the divine luxuries of opium, will afterwards descend to the gross and mortal enjoyments of alcohol. I take it for granted "That those eat now who never ate before, and those who always ate now eat the more."...

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Origins of Opioid use epidemic• John Jacob Astor!?!

• “There are few men whose biography would prove more instructive or more acceptable for the present age than the life of John Jacob Astor…”

• Astor was America’s first millionaire – dies in 1848

• Began selling furs…then importing Chinese tea and silk…then smuggling opium

• Thought to have sold hundreds of thousands of pounds of opium between 1816 and 1825 and openly sold and advertised opium in New York

• Astor was not the only one history remembers who dealt in the opium trade

FDR’s father also made millions : calling opium sales “fair, honorable and legitimate” trade

America’s first opium crisis• In mid 1800’s:

“glassy eyes in Fifth Avenue drawing-rooms and opera-stalls” and “permanently stupefied” babies—all people who took or were given opium in prescription or over-the-counter form. (Harper’s magazine 1859)

It wasn’t until the late 19th century that American doctors began to control their prescriptions of opium and derivatives to patients

• https://www.history.com/news/john-jacob-astor-opium-fortune-millionaire

Origins of Opioid use epidemic• Patent medicines with opium

• Advertised to cure most anything - “nerves” to marital problems

VERY common, daily use in high society and by the “gentler sex”

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Origins of Opioid use epidemic• Morphine derived from opium – “non-addicting”

• 1850s: Thought that addiction occurs in stomach

• Morphine injected thus would avoid “addiction” from ingestion

• Frequent use in Civil War – Soldier’s Disease = morphine addiction

Origins of Opioid use epidemic

• Late 1800’s to 1930• Began to use morphine to combat alcohol addiction/abuse

• Morphine for women:

1. Menstrual/menopausal disorders

2. Keep women from drinking in public

“…convenient, gentile drug for a dependent lady who would never be seen drinking in public”

Origins of Opioid use epidemic

Cocaine• 1844: First refined from coca leaves• 1883: Use in Germany for soldiers to endure fatigue during battle• 1884: Freud used cocaine to treat morphine addition

• Even sent to fiancé so she was more lively

• 1890s: Sears and Roebuck catalogue sold a syringe and small amount of cocaine for $1.50

• Even in late 1970’s: many still thought cocaine was only psychologically addicting and not physically addicting

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Origins of Opioid use epidemic• John Styth Pemberton - Atlanta, Georgia

Patent medicines like Triplex Liver Pills and Globe of Flower Cough Syrup

• 1885: "French Wine Coca--Ideal Nerve and Tonic Stumulant" contained extract of coca leaves

• 1886: Syrup introduced = "Coca-Cola“

• 1906: Changed from unadulterated coca leaves to decocainized leaves

Origins of Opioid use epidemic

•Heroin• 1889 Bayer Company first to refine

• 10 times more potent than morphine and non-addicting

• Could cure opium and morphine addictions

• 1925 opium importation for heroin production banned

Early American Drug Laws

• 1875 - San Francisco Opium Den Ordinance banned dens for public smoking of opium

Law fueled by anti-Chinese sentiment and opinion that whites were starting to frequent the dens

• 1891 - California law: misdemeanor to maintain a place where opium was sold, given away, or smoked – aimed at commercial opium dens

• California: first state to establish separate bureau to enforce narcotic laws

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Early American Drug Laws

• 1874-Connecticut: first state law declaring "narcotic addict" incompetent & to be committed to a state insane asylum until cured

• 1877-Nevada first state to prohibit opium smoking

• 1887-Territory of Oregon: first comprehensive anti-substance law directing licenses be issued to physicians and pharmacists for sale of narcotics and making it illegal for any person to sell, give away, or possess opium, "smoking opium," morphine, cocaine, or chloral hydrate without a prescription

Federal Laws• 1906-Pure Food and Drug Act

• Required labelling of opiate contents

• 1914- Harrison Narcotic Act:

• Criminalization of recreational use of Opium, Morphine, Cocaine• Drugs still legally available requiring registration, documentation, taxation

• 1920s-State laws prohibiting marijuana use

• 1946-Enacted laws to control synthetic drug

• 1956-Narcotic Control Act: Enhanced existing laws including marijuana/opiates

Federal Laws

• 1968-DOJ Bureau of Narcotics and Dangerous Drugs created to enforce federal laws to suppress illicit drug traffic - replaced Federal Bureau of Narcotics and Bureau of Drug Abuse Control

• 1970-Federal Comprehensive Drug Abuse Prevention and Control Act - Controlled Substance Act (CSA)• Provided rehabilitation services for substance use disorder

• Regulation/distribution of controlled substances

• Regulation of Import-Export of controlled substances

• CSA administered by Drug Enforcement Agency (DEA)

Throughout history – Enacting laws did not curb illicit use of drugs Evolving new drugs and abuse

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DEA Drug Schedules• Schedule I Drugs: High potential for abuse/addition with no medical use

(heroin, LSD, methamphetamine, marijauna)

• Schedule II Drugs: High potential for abuse/addition

(opiods, stimulants)

• Schedule III Drugs: Less potential for abuse/addiction

(buprenorphine, products >90 mg of codeine, ketamine)

• Schedule IV Drugs: Low potential for abuse/addiction

(alprazolam, clonazepam, diazepam, lorazepam, phenobarbital)

• Schedule V Drugs: Even lower potential for abuse/addiction

(antitussives, antidiarrheals, and analgesics)

Recent DEA ChangesDrug Enforcement Agency (DEA) three recent rule changes

1. Hydrocodone Combination Products now classified as Schedule II drugs

2. Increase access to drug disposal solutions (discussed later)

3. CBD with THC below 0.1% are classified as Schedule 5 drugs

(IF been approved by FDA )

FDA approved Epidiolex September 2018

Epidiolex: nonsynthetic, cannabis-derived CBD medicine for rare types of epilepsy

DEA Drug SchedulesSome drugs fall into more than one category:

1. Cannabis• Schedule I: Raw Cannabis

• Schedule III: Products with one or more active ingredients in cannabis (i.e., tetrahydrocannabinol - THC)

• Schedule V: Products with one or more active ingredient CBD with >.1% THC

2. Gamma-hydroxybutyric acid (GHB) -sedative• Schedule I: GHB - street drug (date rape drug)

• Schedule III: GHB - clinical use for treating conditions like narcolepsy

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DEA Drug Schedules

Five classes of drugs:

1. Opioids: not as effective for neuropathic pain

2. Sedative-Hypnotics: lower arousal levels - reduce nervous system excitability

3. Stimulants: enhancing activity of central and peripheral nervous systems

4. Hallucinogens

5. Anabolic steroids

Common opioids• Natural Alkaloids: extract of P. somniferum (plant-derived amines)

• Semi-synthetic opioids derived from alkaloids –

• Synthetic compounds : four chemical groupings:

Naturally occurring compounds Semi-synthetic compounds Synthetic compounds

Morphine Diamorphine (heroin) Pethidine

Codeine Dihydromorphone Fentanyl

Thebaine Buprenorphine Methadone

Papaverine Oxycodone Alfentanil

Remifentanil

Tapentadol

.

Opioid Pharmacology3 Opioid Receptors

1. DOP (OP1) (δ: delta): vas deferens where first isolated)2. KOP (OP2) (ƙ: kappa): ketocyclazocine- first molecule to act at this receptor3. MOP (OP3) (μ: mu): morphine - most common recognized exogenous

molecule

Widely distributed receptors in central nervous system and periphery

(vas deferens, knee joint, gastrointestinal tract, heart, immune system, and others)

Naturally occurring endogenous moldecules, as well, which can act as agonist to receptors

4th ReceptorNOP: (nocieptin receptor - endogenous opioid-like and different endogenous molecules)

Do not react to typical opioid antagonists like the 3 classic receptors react

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DOP Opioid Receptor

Receptor Types: δ1,δ2

Found in:

Brain

Pontine nuclei

Amygdala

Olfactory bulbsDeep cortex

Peripheral sensory neurons

• Action:

• Pain sensitivity (algesia)

• Antidepressant effects

• Convulsant effects• Physical dependence

• May modulate μ-opioid receptor-mediated respiratory depression

KOP Opioid ReceptorsReceptor Types: κ1, κ2, κ3

Found in:

• Brain Hypothalamus Periaqueductal gray Claustrum

• Spinal cord Substantia gelatinosa

• Peripheral sensory neurons

• Action:• Analgesia

• Anticonvulsant effects

• Depression

• Dissociative/hallucinogenic effects

• Diuresis

• Miosis

• Neuroprotection

• Sedation

• Stress

MOP Opioid Receptors• Receptor Types: μ1, μ2, μ3

Found in:• Brain

• Cortex (laminae III and IV)• Thalamus• Striosomes• Periaqueductal gray• Rostral ventromedial medulla

• Spinal cord • Substantia gelatinosa

• Peripheral sensory neurons

• Intestinal tract

Actions:μ1

• Analgesia

• Physical dependence

μ2

• Respiratory depression

• Miosis

• Euphoria

• Reduced GI motility

• Physical dependence

μ3:

• Possible vasodilation

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NOP ReceptorsFound In:

• Brain Cortex

Amygdala

Hippocampus

Septal nuclei

Habenula

Hypothalamus

• Spinal cord

Actions:

• Anxiety

• Depression

• Appetite

• Development of tolerance to μ-opioid agonists

Opioid Pharmacology

Morphine

• Morphine acts on MOP receptors = superior analgesic effect

• 150 minute half life

• Low lipid solubility ➔ slow to enter blood brain barrierslow to see maximum impact

• Oral morphine less impact since 40-60% is metabolized in liver/gut on first pass

Opioid Pharmacology

Fentanyl

• Also act primarily on MOP receptors

• Highly lipid soluble so act very quickly

• Long term use – sequestration in fat deposit of body• Fentanyl = 80 to 100 times stronger than morphine

• Fentanyl = 30 to 50 times more potent than heroin

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Opioid Pharmacology

Codeine

• Has to metabolized to morphine for any effect

• 5%- 10% of lack ability to convert to morphine so receive very limited or no pain relief

Opioid Pharmacology

Oxycodone

• Thebaine derivative acts on MOP and KOP receptors

• High oral bioavailability and can be in time-released formula

• Analgesia at lower plasma concentrations via MOP receptors

• Anti-analgesic effects at high doses via KOP and NOP receptors

• Lower potential for respiratory depression and overdose

Opioid PharmacologyMethadone

• Long duration of action

• Limited first-pass metabolism but high bioavailability

• More limited potential to induce euphoria

• Postulated antagonistic activity at N-methyl-d-aspartate receptor could aid in effect on neuropathic pain

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Opioid Pharmacology• Naloxone and naltrexone

• Used at high doses to act as antagonists at all three classical opioid receptors

• Do not bind to nor modulate agonist effects at NOP receptors

• Basic opioid pharmacology: an update. Pathan and Williams. Br J Pain. 2012 Feb; 6(1): 11–16

Abuse deterrent opioid formulations

• Properties of pills that resist manipulation and create barrier to unintended administration routes: chewing, nasal snorting, smoking, intravenous injection – physical or chemical barriers

• Majority of opioid abuse is by swallowing so ?? impact of abuse deterrent formulations

• Not abuse proof - not tamper proof - but ABUSE DETERRENT

• Abuse deterrence must be based on evidence-based science

Understanding Abuse Deterrent Opioids - FDA

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Abuse Deterrent Formulas - FDAFDA-Approved Labeling Describing Abuse-Deterrent Properties

• OxyContin

• Embeda

• Hysingla ER

• MorphaBond ER

• Xtampza ER

• Arymo ER

• RoxyBond

Pain - Defined“An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage” (International Association for the Study of Pain, 1986)

• Pain is a function of neuronal activity

• BUT the clinically significant pain experience:1. Subjective

2. Not always in conjunction with known tissue damage

• Acute pain = lasting <3months

• Chronic pain = lasting >3 months1. Associated terminal illness

2. Not associated with terminal illness

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Pain Facts

• Pain: more common than the following COMBINED:1. diabetes

2. heart disease

3. cancer combined

• Pain: most common reason Americans access health care system

• Pain: major contributor to health care costs

• Chronic pain: most common cause of long-term disability

Pain Facts• 1/4 of Americans (76.2 million) have pain for more than 24 hours

(2006: National Center for Health Statistics)

• Pain can be chronic disease, in and of itself

• Pain can be a barrier to cancer treatment

• Pain can occur with many diseases/conditions (depression, PTSD, TBI)

Pain Facts

• Gender differences in pain perceptions and responses to treatment

(kappa-opioids provide good relief from acute pain in women, but increase pain in men)

• Gene variant of an enzyme discovered that reduces sensitivity to acute pain and decreases risk of chronic pain – possible therapy???

• Behavioral interventions for pain can provide relief either in conjunction with or in lieu of drug interventions

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History of Pain Management• Early Greeks and Romans: believed brain played role in perception of pain

• 19th century physician-scientists discovered opiates could relieve pain

• Felix Hoffmann developed aspirin from willow bark and aspirin still commonly used pain reliever

•

History of Pain Management• 1931: Dr. Albert Schweitzer said “Pain is a more terrible lord of mankind

than even death itself.”

push for pain management

• 1960s: Pain management became field of medicine

• 1970s: Pain (research journal) and Internal Association for the Study of Pain

A short history of pain management.Collier .CMAJ. 2018 Jan 8; 190(1): E26–E27

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push for pain management

• 1980s: Prominent pain specialists push “low incidence of addictive behavior” associated with opioids

Pushed for increased use of drugs to treat long-term, non-cancer pain

• 1994: International Association for the Study of Pain (IASP) defined pain

• Thus started the …”20-year campaign, backed by the pharmaceutical industry, that convinced many physicians they could prescribe opioids more freely, and with a clean conscience…”

A short history of pain management.Collier .CMAJ. 2018 Jan 8; 190(1): E26–E27

Pre-2018 Pain ManagementJohn J. Bonica (anesthesiologist): Father of Modern Pain Management

Multidisciplinary Approach in Dedicated Pain Clinics using patient self-management

1. 2 physicians, pain psychologist, physical therapist, other health care providers necessary to served clinic population (e.g., occupational therapist) - all with common philosophy of pain rehabilitation

2. Located in same office with regular staff meetings for care planning

3. Comprehensive assessment and treatment options a) physical exam

b) medication management

c) biopsychosocial evaluation/cognitive behavioral treatment for chronic pain

d) physical therapy, occupational therapy

e) ability to refer to specialists not offered by the team

Pre-2018 Pain Management

Multidisciplinary Pain Clinics led to:1. Improvement in overall patient functioning

2. Reductions in health care costs

3. Increase in rate of patient returned to employment

4. Sparing use of opioid therapy

Meta-analyses: multidisciplinary pain clinics compared single discipline treatment approached or no treatment showed gains for up to 13 years

But, alas, our modern system of medical economics, insurance company policies, and managed care meant this successful approach was not economical feasible

Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma. Tompkins , et al. Drug and Alcohol Dependence 173 (2017) S11–S21

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Pain Management in 1990s

• 1986: World Health Organization cancer pain treatment guidelines included opioids for first time recognizing treatment of pain as universal right

• 2001: Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) mandated pain assessment/ treatment of all patients in accredited healthcare settings to receive federal health care dollars

• 2001: Drug Enforcement Agency (DEA) had “balanced policy” in examining prescribing practices: encourage use of opioids to relieve pain and reduce oversight of physicians with high opioid prescribing rate

Patient satisfaction (including pain relief) became a more valued health care outcome -facilities with highest patient satisfaction scores reported larger expenditures on prescription drugs

Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma. Tompkins , et al. Drug and Alcohol Dependence 173 (2017) S11–S21

Pain Management in 1990sOpioid addiction fears reduced among physicians due to two small (but heavily cited) retrospective studies suggested when opioids were used for pain treatment, patients rarely develop opioid use disorder

1. Letter suggested 0.03% addiction rates in hospitalized patients given opioids for acute, non-recurrent pain (Porter and Lick, 1980)

2. Report on 38 patients from one practice prescribed opioids for chronic non-malignant pain showed 5.3% had opioid use issues -2 patients, both with substance abuse histories, had diversion or use acceleration (Portenoy and Foley, 1986)

Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma. Tompkins , et al. Drug and Alcohol Dependence 173 (2017) S11–S21

Pain Management in 1990sRole of Big Parma: Aggressive marketing claiming low addiction ratesExample:1996: Purdue Pharmaceuticals released Oxycontin®(oxycodone extended release)

FDA-approved labeling claiming addiction was “very rare” and “delayed absorption” of OxyContin was believed to reduce the abuse potential

Result: exponential increase Oxycontin prescriptions from 670,000 (1997) to 6.2 million in (2002)

Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma. Tompkins , et al. Drug and Alcohol Dependence 173 (2017) S11–S21

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Joint Commission Standards2001 Joint Commission on Accreditation of Healthcare Organizations (now The Joint Commission), issued pain management standards

76 million Rx in 1991219 million Rx in 2011

Pain: 5th Vital Sign

status of Opioid epidemic: 2017

• 2006: steady increase in the overall national opioid prescribing rate

• 2012: Peak of >255 million = Rx rate of 81.3 Rx/100 people

• 2017: 191 million Opioid Rx = 58.7 Rx/100 people

• 2017: 16% U.S. counties➔1 opioid Rx/person dispensed

• 2017: Some US counties rates that were 7x higher

US Opioid Prescribing Rates 2017

Alabama Highest

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Cost to System

• 130 people in US die from opioid overdosing DAILY

“The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.”

From NIH National Institute on Drug Abuse: Opioid Abuse Crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

Cost to System• Big Pharma role:

• 1990s: pharmaceutical companies tell medical community prescription opioid pain relievers are not addicting when prescribed for pain

Cost to System• 2017: > 47,000 Americans died from opioid overdose

• (prescription opioids, heroin, and illicitly manufactured fentanyl)

• 2017: 1.7 million people in US suffered from prescription opioid substance use (OSU) disorders

• 2017: 652,000 suffered from heroin use disorder

(Pockets of high abuse in US as map shows)

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US Overdose Mortality by State- 2015

Shifting problem

1999: New Mexico

15/100,000

2014: West Virginia

35.5/100,000

Pain Associations today

• January 2019: Academy of Integrative Pain Management (AIPM) closed its doors

• Three-decade legacy of bringing together clinicians, policy experts, mental health professionals, social workers, acupuncturists, massage therapists, and other healers to address acute and chronic pain

• Primary group promoting non-opioid approaches to pain management

• June 28, 2019 American Pain Society declared bankruptcy

• Professional group for scientists who study, and clinicians who treat, chronic pain

Just the Facts

• 21 - 29 % of patients prescribed opioids for chronic pain misuse them

• 8 -12 % develop an opioid use disorder

• 4 - 6 % who misuse prescription opioids transition to heroin

• 80 % who use heroin first misused prescription opioids

From NIH National Institute on Drug Abuse: Opioid Abuse Crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

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CDC.com

Just the Facts• 30% increase in opioid overdoses: 7/16 to 9/17 for 52 areas in 45 states

• 70% increase in opioid overdoses-Midwestern region: 7/16 to 9/17

• 54% increase of opioid overdoses in large in 16 states

From NIH National Institute on Drug Abuse: Opioid Abuse Crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

Just the Facts

• US life expectancy went down 3 months 2000-2015 from opioid overdoses (Contribution of Opioid-Involved Poisoning to the Change in Life Expectancy in the United States, 2000-2015 Dowell, et al. JAMA. 2017;318(11):1065-1067. doi:10.1001/jama.2017.9308)

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Opioid deaths higher than Car Crashes

Drug Overdose deaths: Illinois

•2013-2016:

48.8% increase in all drug overdose deaths

76.2% increase in Rx opioid overdose deaths

2013 2016All Overdose Deaths 1579 2331Rx Opioids Deaths 344 1233Heroin Deaths 583 1002

Other Impacts

• Rising incidence of neonatal abstinence syndrome • Neonates born addicted

• Increase in injection drug use increased rate of infectious diseases• HIV

• Hepatitis C

• Life expectancy in US went down by about 3 months from 2000-2015 due to opioid overdoses

(Contribution of Opioid-Involved Poisoning to the Change in Life Expectancy in the United States, 2000-2015 Dowell, et al. JAMA. 2017;318(11):1065-1067. doi:10.1001/jama.2017.9308)

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Neonatal Abstinence Syndrome (NAS)Drug withdrawal syndrome: opioid-exposed infants shortly after birth1. Poor fetal growth and preterm birth2. Symptoms

a) Seizuresb) Excessive irritabilityc) Poor feedingd) Dehydration

3. Complications at birtha) Low birth weightb) Respiratory problemsc) Jaundiced) Sepsise) Seizures

http://www.dph.illinois.gov/topics-services/prevention-wellness/prescription-opioids-and-heroin/neonatal-abstinence-syndrome

Neonatal Abstinence Syndrome - Illinois• Infants with NAS have longer hospital stays and higher hospital charges

• 2016: median stay of 11 days longer

• 2016: median charges $29,300 more ($33,700 compared to $4,400)

• 2016: total hospital care charges almost $18 million higher due to NAShttp://www.dph.illinois.gov/topics-services/prevention-wellness/prescription-opioids-and-heroin/neonatal-abstinence-syndrome

Neonatal Abstinence Syndrome - Illinois

• 2016: NAS 2.7/1000 live births NAS cases per 1,000 live births (391 infants)

• 2016: NAS highest for:1. Non-Hispanic White infants

2. Infants covered by public insurance (Medicaid) or who are uninsured

3. Infants residing in urban counties outside Chicago metropolitan areahttp://www.dph.illinois.gov/topics-services/prevention-wellness/prescription-opioids-and-heroin/neonatal-abstinence-syndrome

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Neonatal Abstinence Syndrome - Illinois2011-2016 NAS rates

27% Collar counties

137% in urban counties outside Chicago area223% in rural counties9% in Chicago 2% in suburban Cook County

http://www.dph.illinois.gov/topics-services/prevention-wellness/prescription-opioids-and-heroin/neonatal-abstinence-syndrome

There was a 52% increase in the Illinois NAS rate between 2011 and 2016.

52% increase NAS rate between 2011 and 2016

Health care providers attitudes

• “Seeker” outlook: exhibiting mistrust of self-reported pain

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2018 Joint Commission StandardsNew standards for pain assessment in effect in 20181. Identify psychosocial risk factors affecting self-reported pain

2. Involve patients in developing treatment plan, measureable goal setting and realistic expectations

3. Focus reassessment on pain impairment of physical function

4. Monitor opioid prescribing patterns

5. Promote non-pharmacologic pain treatment approaches

Joint Commission’s Pain Standards: Origins and Evolution. David Baker. May 27,2017

HEAL

• NIH HEAL (Helping to End Addiction Long-termSM) Initiative

• Aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis

• The NIH HEAL Initiative℠ will bolster research across NIH to improve treatments for opioid misuse and addiction and enhance pain management.

https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative

FDA Opioid analgesic Risk Evaluation and Mitigation strategy (REMS)

• Opioid Analgesic REMS approved September 18, 2018• Mission:

1. Education about risks of opioids and use of other therapies intended to reduce adverse outcomes of addiction, unintentional overdose, and death from inappropriate prescribing, abuse, and misuse

2. Training based on FDA Blueprint to educate prescribers and other healthcare providers - pharmacists and nurses - about recommended pain management practices and appropriate use of opioids

3. Inform patients about their responsibilities regarding their pain treatment plan -risks , use and storage of opioid outlined in Medication Guides and Patient Counseling Guide for opioids

https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17

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Pain Definitions• Acute Pain: Typically sudden

with known cause -injury, surgery, infection

• Chronic Pain: Lasting longer than 3 months typically from underlying condition, such as arthritis

• Neuropathic vs Non-Neuropathic

Approaches to Reasonable acute Pain Control

• American Pain Society and American Academy of Pain Medicine task force clarified the classification of acute pain, the role of psychosocial factors, multimodal pain management, new non-opioid therapy, and the effect of the “opioid epidemic” in their joint report.

• Suggested that opioid treatment as short as 10 days can lead to opioid dependency and up to 15% of surgical patients may become dependent following the perioperative use of opioids

Recent advances in acute pain management: understanding the mechanisms of acute pain, the prescription of opioids, and the role of

multimodal pain therapy. Wardhan et al. F1000Res. 2017; 6: 2065.

Approaches to Reasonable acute Pain Control

• Psychosocial factors: anxiety or tendency to magnify/dread pain and feel helpless in context of pain (pain catastrophizing) play major role in development of chronic pain

• SCOPE trial (Stepped Care to Optimize Pain care Effectiveness) studied the independent effects of depression, anxiety, and pain catastrophizing on pain outcomes

• Concurrent use of primarily non-opioid analgesics for the additive, if not synergistic, effects of superior analgesia thus decreasing opioid use and opioid-related side effects

• Recent advances in acute pain management: understanding the mechanisms of acute pain, the prescription of opioids, and the role of multimodal pain therapy. Wardhan et al. F1000Res. 2017; 6: 2065.

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Acute Pain Management-Steps to consider

1. Non-drug pain management

Hot-cold compresses, artificial tears, bandage CL, etc

2. NSAIDs

Decrease opioid consumption by 25–30% (Topical NSAIDS, oral NSAIDS)

3. Acetaminophen

Be highly selective with additive, but not necessarily synergistic, effect when combined with NSAIDs

4. Tramadol

Weak opioid agonist (binds to μ-opioid receptor-inhibiting serotonin/ norepinephrine reuptake)

Recent advances in acute pain management: understanding the mechanisms of acute pain, the prescription of opioids, and the role of multimodal pain therapy. Wardhan et al. F1000Res. 2017; 6: 2065.

Acute Pain Management-Steps to consider5. Ketamine

NMDA-blocking ability and has emerged as front-runner in for perioperative pain (Use in eyecare??)

6. Gabapentin and pregabalin

Anticonvulsants but are also neuromodulators (reduce neuronal excitability)

7. Opioid-Acetaminophen combinations

Postoperative pain management, work synergistically, reducing pill burden

Recent advances in acute pain management: understanding the mechanisms of acute pain, the prescription of opioids, and the role of multimodal pain therapy. Wardhan et al. F1000Res. 2017; 6: 2065

CDC Acute Pain Control guidelines

Strongly urges providers to consider alternative pain

management options

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CDC Acute pain Opioid use patient Information

Educate your patients about expected side effects

1. Tolerance: might need to take more of medication for same pain relief

2. Constipation

3. Nausea and vomiting

4. Dry mouth

5. Sleepiness and dizziness

6. Physical dependence: can have withdrawal symptoms after only few days use

7. Confusion

8. Depression

9. Itching

Provider Documentation Rules - prescribingFebruary 2019

• 15 states acute pain opioid prescribing limit - 7-day supply(Alaska, Hawaii, Colorado, Utah, Oklahoma, Louisiana, Missouri, Indiana, West Virginia, South Carolina, Pennsylvania, New York, Maine, Connecticut, Massachusetts)

• 3 states acute pain opioid prescribing limit - 5-day supply ( Arizona, North Carolina, New Jersey)

• 1 state limit opioid prescribing initial limit to 14 days (Nevada)

Provider Documentation Rules - prescribing

• Minnesota 4 day limit for acute dental or ophthalmic pain

• 3-4 day limit on initial opioid prescribing (Tennessee, Kentucky, Florida)

• Post surgical procedures

• Arizona, Nevada - 14 day supply

• North Carolina 7-day supply

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Illinois has no limits currentlyRecommendation to abide by CDC

Guidelines and Clinical Practice Guidelines

Illinois Rules of the Road• Illinois Controlled Substances Act mirrors federal act

• Prescribers may issue three sequential 30-day prescriptions for same Schedule II drug

Up to 90-day supply

Before authorizing 90-day prescription of Schedule II drugs

1. Each separate prescription must be issued for legitimate medical purpose by an individual physician acting in the usual course of professional practice

2. Must also provide written instructions on each prescription indicating earliest date pharmacy may fill Rx

3. Must document attempt to check the Illinois Drug Monitoring site for all Schedule II Rxs

Patient Contracts suggestions if prescribingContracts designed to promote good communication, clear expectations, and trust between provider and patients

1. Inform of addiction possibilities

2. No more Rx if patient breaks agreement

3. Discuss need to taper off if on for longer time to avoid withdraw symptoms

4. Use no illegal substances while using Rx Opioids

5. Will not misuse prescription medication

6. Will not share medication

7. Will refill only as due and not early

8. Add pharmacy information and not pharmacy hop

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CDC Guidance for prescribers

• Prescribe lowest effective dose of immediate-release opioids

• Prescribe treatment for 3 days or less (enough for most acute conditions)

• Follow up with patients to ensure pain resolved as expected

• Check your state’s prescription drug monitoring program – Required in Illinois

• Conduct urine drug testing during opioid treatment if suspect issues

• Instruct on tapering opioids to minimize withdrawal symptoms, if necessary

Prescription Drug Monitoring programs (PMDP)

PDMPs Best practices: 1.Universally used prior to prescribing2.Real time updates for accurate data and information3.Actively managed to be accurate4.Easy access and Use

Prescription Drug Monitoring programs (PMDP)PDMP resulted in changes in prescribing behaviors, reduced use of multiple providers by patients, and decreased substance abuse treatment admissions in states with good programs

Currently Missouri is only state without a PDMP

49 states, District of Columbia and Guam have legislation authorizing the creation and operation of a PDMP

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Illinois Prescription Monitoring Program (ILPMP)

• ILPMP collects information on Schedule II, III, IV and V controlled substance prescriptions

• All retail pharmacies required to daily report dispensing prescription

• ALL Illinois prescribers must document attempt to check with IPMP for all initial Schedule II narcotics {Public Act 100-0564 (2017)}

• ILPMP data aids in 1. Assess prescribing practices

2. Inform efforts to reduce high-risk opioid prescribing

3. Help prevent misuse of controlled substances and medical error

• Illinois Prescription Monitoring Program (ILPMP)

Drug Disposal Guidance• Recent federal rule change

• Secure and Responsible Drug Disposal Act of 2010

• Expand options for disposal of prescription drugs by patientsa) Expand disposal options: include dedicated take-back sites (retail

pharmacies, other registered locations)

b) Promote “mail-back” options

CDC/FDA/DEA Safe drug disposal guidance• CDC – Use drug disposal sites & Do not flush medications or throw in trash

• DEA- National Take Back Drug day & DO not flush to keep our water clean

• FDA- Use drug disposal sites BUT if not available:• Can flush some drugs

• Can throw some drugs in trash

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FDA Position on flushing/ throwing away drugs

• FDA published paper entitled "Risks Associated with the Environmental Release of Pharmaceuticals on the U.S. Food and Drug Administration ‘Flush List’“

• Purpose: evaluates environmental and human health risks associated with flushing of 15 active medication ingredients

• Conclusion: flushing medicines present negligible risk to environment• BUT also stated additional data would help to confirm

• FDA believes “known risk of harm to humans from accidental, and sometimes fatal, exposure to medicines on the flush list far outweighs any potential risk to human health and the environment from flushing these leftover or unneeded medicines only when a take-back option is not readily available

• FDA Resources for drug take back location

Illinois Safe Unused Drug Disposal• Often abusers obtain opioids from friends or family• Often from unused or expired medication • All unused prescription medications especially prescription opioids (& other

controlled substances) should be disposed of properly • Proper disposal avoids misuse/diversion and medication confusion

• Flushing or throwing away unused prescription medications in the trash are not recommended Use safe, or secure disposal methods

• Best disposal➔ drug take-back programs and locations• Some pharmacies offer “opioid disposal solutions” to mixed with opioids,

thus unusable

http://www.dph.illinois.gov/opioids/prevention#Disposal

For Safe Drug Disposal• DuPage County RxBox Disposal Program

• Walgreens Safe Medication Disposal Kiosk Locator

• DEA Controlled Substance Collection Locator

• Lake County Prescription Drug Disposal Box Program

• DisposeMyMeds Medication Disposal Locator

• Walmart Opioid Disposal Solution

• Illinois EPA Medication Disposal FAQ

http://www.dph.illinois.gov/opioids/prevention#Disposal

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drug disposal sites

• https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1

• Illinois Environmental Protection Agency

• National Association of Boards of Pharmacy

• National Community Pharmacists Association

Spotting drug seeking Patients

Do not be fooled• Signed to watch for potential abuse

• Communications with colleagues when indicated

• Must be seen right away and toward end of day

• Calls or comes in after regular hours

• Traveling through town, visiting friends or relatives , does not live in your town

• Feigns physical problems possibly inconsistent with findings to obtain narcotics

• States specific non-narcotics do not work or allergic

• States that prescription has been lost or stolen so wants replaced

Spotting drug seeking colleagues: Dos -DontsDO:• Perform appropriate, thorough examination and document results and questions

• Request picture I.D., or other I.D. and Social Security number and photocopy documents

• Call previous provider or pharmacy to confirm story

• Confirm telephone number provided by patient

• Confirm current address at each visit

• Write prescriptions for limited quantities IF you prescribe

DON'T:

• DO NOT "take their word for it" if suspicious

• DO NOT dispense drugs just to get rid of drug-seeking patients

• DO NOT prescribe controlled substances outside the scope of practice or in absence of formal practitioner-patient relationship

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Securing your prescription pads against theft

DEA Guidance for Safeguards for Prescribers• Keep prescription pads in safe place where cannot be stolen; minimize # in use

• Write out actual amount prescribed + number to discourage alterations

• Do NOT use prescription pads for notes

• Never sign prescription blanks in advance

• Assist pharmacist if called to verify information to ensure accuracy of prescription

• Contact nearest DEA field office to discuss suspicious prescription activities

• Use tamper-resistant prescription pads

Erx versus Written Prescriptions• E-prescribing for Controlled Substances is permitted in all states and

many states require E-prescribing – check with your specific state

• When combining Erx with comprehensive medication history reduces prescriber and pharmacy hopping, enables better prescription tracking, and reduces fraud

Providing educational materials for patients•Waiting room information on opioid abuse and

resources for help if addicted- non intrusive

•Opioid discussions with patients

•Patient Use Contracts if prescribing

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are Opioids necessity in eye care

• How often are Opioids REALLY necessary in eye care

• Always try non-drug and non-opioid approaches first

• Case for opioids: When alternatives just do not help• Patient with thorn penetration into eye, question of toxin reaction,

acute severe pain without relief from NSAIDS/acetomenophin or tramadol- prescribed opioid for 48 hours provided relief

When Opioids are necessary1. Educate your patients about safe use of prescription opioids2. Remind your patients that medications should be stored out

of reach of children – and in a safe place3. Talk to your patients about the most appropriate way to

dispose of expired, unwanted and unused medications

Recent Illinois Law-Opioid Alternative

• Opioid deaths in Illinois increase 13% between 2016 and 2017

• Alternative to Opioids Act of 2018 - Effective January 1, 2019• Stated long term goal ➔Reduce opioid deaths

• Changed Compassionate Use of Medical Cannabis Pilot Program Act• Created Opioid Alternative Pilot Program (OAPP)• Allows access to medical cannabis as alternative to opioid prescription

(If certified by Illinois prescriber)• Allows individuals alternative pain • The long-term goal of this program is to reduce opioid deaths

http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis/opioid-alternative-pilot-program

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Recent Illinois Law-Opioid alternativeTo Qualify-• Must be 21 or older and an Illinois resident• Licensed prescriber must certify a medical condition where opioid would

be used (Clinical Care Guidelines)• Must be registered with the program ($10 fee/90days)• THEN - patients can purchase 2.5 ounces medical cannabis every 14 days• Certifications for use valid for 90 days period - can be renewed for

continued access to medical cannabis

http://www.dph.illinois.gov/topics-services/prevention-wellness/medical-cannabis/opioid-alternative-pilot-programMonthly Opioid Alternative Pilot Program data can be found on the statewide Medical Cannabis Pilot Program website

Spot drug-seeking patients/practice visitors

• Be wary of practice visitors who are not patients

• Be wary of visitors asking to use the bathroom• Drugs can be wrapped in plastic - placed underneath or in toilet tanks

for later pick up

• Vents and cold air return ducts present nooks where users can put their drugs

• Behind light switches covers and outlet plates

• In dropdown grid ceiling panels

• Be careful to control where visitors to practice can go within practice

What does Tropicamide have to do with it?

• Reports of dilation drops being stolen from practices…WHY?

• Reported the use of tropicamide as injectable by intravenous drug

• help with the symptoms of opiate withdrawal

• reported hallucinogenic and euphorigenic effects

• Earliest report was United Kingdom in August 2011

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Dilating drugs and their role in drug abuse

• Known as 'seven-monther' — the amount of time it takes to kill

• Reports including Internet blog reports by drug users —…indicated the effect to be "enjoyable" and "fun," but also "horrific," "scary" and "dangerous.“

• Least you think this is isolated…several reports in Optometry Office in Asheville, NC of person stealing dilation drops from practices

Naxolone

Naxolone access• 41 states have legalized its sale without a prescription

• Many states have Health Department standing orders to allow pharmacist to dispense

• Other locations: many needle exchange programs and community organizations that work with drug abuse

Naxolone Use• Binds to brain opioid receptors in place of opioid drugs preventing opioids from binding

• Can temporarily reverse an overdose

• Naloxone begin within 2-5 minutes after the medication is administered

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Illinois and Naloxone Use

2010: Drug Overdose Prevention Law

• Legal in Illinois for non-medical persons atp give naloxone to another individual to prevent fatal opioid overdose

• Allowed the Illinois Department of Human Services/Division of Alcoholism and Substance Abuse (IDHS/DASA) to create Drug Overdose Prevention Program (DOPP)

• Authorized/established community naloxone distribution programs in Illinois

Illinois and Naloxone Use

• 2015 Heroin Crisis ActAmended almost 25 state laws:

• Facilitate coordinated activity to improve statewide capacity to prevent/manage opioid overdoses

• Expands access to naloxone statewide

• Supports education/training initiatives for naloxone use

(law enforcement, schools, emergency responders, and others )

• Strengthens Illinois Prescription Monitoring Program (ILPMP)• Provides more access to all FDA-approved medication-assisted treatment

for Illinois Medicaid-eligible patients

Summary

1.Seriously consider if opioids are necessary

2.Seriously consider alternative pain management: Ibuprofen/ acetaminophen

3.Maximum initial Rx for acute pain – know your state Minimum necessary is good rule of thumb

4.Be very alert to possibility of drug seeking patients

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•Thank you!!