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The Pain of Pleasure: Heroin and Other Opioids‐The Implications for Healthcare PractitionersCHS Pharmacy Education Series

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2017 Pharmacy Education Series

September 20, 2017The Pain of Pleasure: Heroin and Other Opioids‐The Implications for Healthcare Practitioners

Featured Speakers:

Merrill Norton Pharm.D.,D.Ph.,ICCDP‐D Tracie Chambers, RPhClinical Associate Professor Regional Director of PharmacyUniversity of Georgia College of Pharmacy CHSPSC, LLCAthens, Georgia Franklin, Tennessee

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It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Norton does not have any relevant commercial and/or financial relationships to disclose. Ms. Chambers does not have any relevant commercial and/or financial relationships to disclose.

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September 20, 2017The Pain of Pleasure: Heroin and Other Opioids‐The Implications for Healthcare Practitioners

Featured Speakers:

Merrill Norton Pharm.D.,D.Ph.,ICCDP‐D Tracie Chambers, RPhClinical Associate Professor Regional Director of PharmacyUniversity of Georgia College of Pharmacy CHSPSC, LLCAthens, Georgia Franklin, Tennessee

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Pharmacy Technician CE)

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Funding:This activity is self‐funded through CHSPSC.



The Pain of Pleasure: Heroin and Other Opioids-The Implications for Healthcare Practitioners

Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP-DClinical Associate Professor

University of GeorgiaCollege of Pharmacy

[email protected]

Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP‐D7

Disclosures

Merrill Norton, PharmD, DPh, ICCDP-D, declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.




Objectives

Pharmacists:

At the conclusion of this presentation, participants will be able to:

1. List the risk factors contributing to substance use disorders.

2. Describe effective prevention strategies for prevention of opioid use and overdose.

3. Discuss current treatment strategies for opioid use disorders.

4. Explain the current neurobiology of substance use disorders.


ObjectivesPharmacy Technicians :

At the conclusion of this presentation, participants will be able to:

1. List the risk factors contributing to substance use disorders.

2. Describe effective prevention strategies for prevention of opioid use and overdose for patient care.

3. Discuss current treatment strategies for opioid use disorders for patient care.

4. Discuss the current neurobiology of substance use disorders.




Case Study- Why I Am Here

LD is a 26 year-old, Caucasian female who is a third year pharmacy student. She has been married to her husband for 4 years and has 1 child

LD came to our treatment center for an opiate addiction. LD stated “I've hit my bottom; I don't want to live this way anymore.” She reports consuming 100 mg of oxycodone per day by taking four Percocet 5 mg tablets 5 times a day. She would also take Lortab and Tramadol to supplement her Percocet abuse. When she drank she would drink about 10 drinks per day on the weekends. LD denies any other prescription drug abuse or illicit drug use


Case Study The first time LD used Lortab was in 2006 when she broke up with her boyfriend

at the time; she knew her mother had Lortab in the cabinet and took them to escape the emotional pain. LD’s oxycodone use began in 2010 after the birth of her first child. She reports that she began drinking alcohol at age 17 and had developed a regular pattern of weekend drinking by 19

LD had jaw surgery in early 2012 and was prescribed Percocet and Lortab; this marked the beginning of her abuse of opiates. During this time she was prescribed opiates chronically; switching between Lortab and Percocet prescriptions. She reports only using the prescribed dose for the first 4 to 5 months until she built up a tolerance. At that point LD began to increase her use of Percocet beyond the prescribed doses. She stated, “I just liked the feeling of not feeling”. She also described herself as “numb, I could handle stress and anxiety a lot easier. I didn’t know how to manage my emotions when I wasn’t on something.” She tried discontinuing her narcotic use in early 2013, but ultimately returned to the drug when her husband had to go out of town for a business trip. This period of sobriety lasted about 1 month. LD eventually realized that she would be unable to stop on her own and sought treatment




Case Study This is LD’s first admission for a substance use disorder. She will need

both medical and psychological therapy to reach and continue sobriety. LD has shown good motivation while in treatment. She strives to learn about this disease, is a willing participant in therapy sessions, and has the support of her family. She knows that recovery will be challenging, and has already faced one challenge in the form of marital distress.

After completing treatment and starting aftercare- LD was found by her husband- dead from drug overdose- she was 27 years old. She was only six months away from graduating with her Pharm.D.


The Epidemic




Global Market Study on Opioids

By product, the global opioid market is segmented into morphine, codeine, fentanyl, meperidine and methadone.

The morphine and codeine segments collectively accounted for around 62% of the overall market in 2014.

By application, the global opioids market is segmented into analgesia, cough suppression and diarrhea suppression.

The analgesia segment was valued at US $22,776.3 million

in 2014 and is anticipated to reach US $28,436.8 million by

2021. US has 65% of the global opioid market.

Global Market Study on Opioids: Widespread Usage in Treatment of Cancer to Drive the Growth of Opioids Market During the Forecast Period PR Newswire


Chronic Pain and Prescription Opioids

11% of Americans experience daily (chronic) pain

Opioids frequently prescribed for chronic pain

Primary care providers commonly treat chronic, non‐cancer pain

• account for ~50% of opioid pain medications dispensed

• report concern about opioids and insufficient training

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1.

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SHARP INCREASE IN OPIOID PRESCRIPTIONS INCREASE IN DEATHS

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Role of Prescribing Opioids and Overdose Deaths

*Death rate, 2013, National Vital Statistics System. Opioid pain reliever sales rate, 2013, DEA’s Automation of Reports and Consolidated Orders System

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Challenges

While there were 16,235 deaths involving prescription opioids in 2013, an increase of 1% from 2012, the number of deaths involving heroin increased dramatically. There were 8,257 heroin-related deaths in 2013, up 39% from 2012. Total drug overdose deaths in 2013 hit 43,982, up 6% from 2012.

In 2016, over 59,000 overdose deaths were reported- more deaths than occurred during the Vietnam War.


Opioids: Double-edged Sword

Cornerstone of pain

management Mood altering properties




Opiates (Natural Alkaloids)

Semi-syntheticsNatural

alkaloids

morphine heroin

codeineoxycodone

hydrocodone

thebaine buprenorphine

naloxone

Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP‐D 23

Morphine, Heroin or Codeine:

It does not make any difference

Morphine can arise in the blood and urine through the administration of morphine itself or through the

metabolism of heroin or codeine

Morphine

Morphine CodeineHeroin

6-MAM

Brennan,MJ, Heit,HAChronic Pain: Overcoming Treatment Barriers for Effective Outcomes, Medscape Pharmacists CE, 12/8/2004




Opiates/Opioids Pure

agonists

FULL

• Morphine• Heroin• oxycodone• Fentanyl

PARTIAL

butorphanol

pentazocine

AntagonistsPURE

naloxone

naltrexone

Mixed agonists/

antagonists

buprenorphine

nalbuphine

others

tramadol


Opioid Use ( Addiction) Changes the

following:

Opioid Receptors (mu, kappa, delta)-euphoria

The Endogenous Opioid Peptide System (Endorphins /Dynorphins)

Cellular Membrane Action- down regulation of GTP to GDP (conversion of release of arrestin)

Dopamine Pathways- decreased production, storage, and transport




Opioid Receptors (Euphoria Receptors)

μ (mu): Activated by morphine: Analgesia

Primary action site of all opioids

Distribution: primarily in CNS and also GI

Linked to substance use disorders

δ (delta): for endogenous peptides (endorphins)- Nerve Conduction-slows pain signal between the peripheral nervous system and the central nervous system(brain, hypothalamus, spinal cord)

κ (kappa): analgesia, endocrine changes and dysphoria (brain-amygdala, spinal cord) [dynorphins] Stress Reduction, relationships**

��


Opioid Receptors

Five classes of opioid receptoro Mu(), Delta(), Kappa() Nociceptin Subtypes (, receptors

Subtype of , , receptor

Structural characteristics** ( The more characteristics, the higher addiction liability)

o Typical G-protein-coupled receptor Seven hydrophobic region Three intracellular loops Three extracellular loops Intracellular carboxy-terminal tail Extracellular amino-terminal tail




Opioid Receptors ( II )

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Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP-D 29

The “Dynamite” of Opioids

Aspirin

(1 stick)

Codeine

(1 stick)

Hydrocodone

(3 sticks)

Morphine

(4 sticks)

Fentanyl

(21 sticks)

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Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP-D 30



Who is At Risk for Developing An Addiction? Young developing brains- 12-26years

Aging declining brains 50+ years

Pain brains-acute or chronic

Trauma brains-physical or emotional

Stress brains- competition, grades, relationships, $$

Genetic brains- family history of addiction, mental illness, trauma, suicide

High use brains- low dose long time or high dose short time

Mentally disordered brains-ADHD, MDD, GAD, BP I or II, psychosis


Dynorphin, Dysphoria, and Dependence: the

Stress of Addiction

The hypothesis that the dynorphin-kappa opioid receptor system may be a key component of the neuroplasticity associated with stress-

induced mood disorders and the ‘dark side’ of addiction (withdrawal-negative affect stage) continues to gain preclinical and clinical

experimental support. The endogenous kappa opioid peptides derived from prodynorphin encode the dysphoric, anxiogenic, and cognitive

disrupting responses to behavioral stress exposure (Bruchas et al, 2010; Carroll and Carlezon, 2013)

Neuropsychopharmacology 41, 373-374 (January 2016) | doi:10.1038/npp.2015.258.

Charles Chavkin and George F Koob




Diacetlymorphine

In 1874, English chemist C.R. Wright ventured out into making a non-addictive form of codeine and morphine. In doing so he combined anhydrous morphine alkoid and acetic andhydride (Hodgson). This produced what is known as diacetylmorhpine (Hodgson). In short diacetylmorphine is an acetylated version of morphine.

AcetylationMorphine

Diacetlymorphine


The reason for the that addicts can not stop using is once the dopaminergic system is deactivated (depleted) due to multiple neurobiological reasons- the reinforcing effects of the drug becomes more powerful than a mother’s love for her children. In 2016, the potencies of most street drugs (marijuana/heroin) have increased. This increased potency creates the increased reinforcing effects of dopamine thus increasing the addiction liability of the drug on the brain.

Opioid Addiction is Greater Than a Mother’s Love (Dynorphin)




The “Why” Heroin is So Deadly Heroin and its metabolite 6-monoacetylmorphine [6-MAM] crosses

the blood-brain barrier one-hundred times faster than morphine. This rapid diffusion is due to heroin being highly soluble in lipids.

Heroin’s short-term effects will last over a period of three to six hours.

Pinpoint pupils. Nausea and vomiting. Constipation or explosive diarrhea. Urinary retention due to activity on GIT sphincter muscle systems (plus anticholinergic activity-dry mouth, blurred vision)

Depression of medulla oblongata creates bradycardia( heart rate below 60 BPM ) and abnormal low respirations( less than 8 per minute)

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Then Add A Little Fentanyl

The death rate from accidental drug overdose has risen 19% for 2016 with as estimated 59,000 overdose deaths being reported;

STAT, a national healthcare publication, states that if strong preventive measures are not put into place, the death toll could reach 650,000 in the next decade;

Fentanyl is a synthetic opioid, 50-100 times more potent than morphine, depending on which fentanyl analog;

Added to low potency heroin to increase the “Kick” of the heroin; A new street drug, Gray Death, a mix of several synthetic fentanyl

derivatives can and does cause an “instant overdose”….and death

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Dopamine

Primary chemical in the brain responsible for activating the reward pathway

During the preoccupation phase of addiction, dopamine is being released stimulating desire for a drug

During the intoxication phase, all the dopamine in the brain is released giving the user a euphoric feeling

During the withdrawal phase, the brain has run out of dopamine and can not function properly until more is made

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Fig.8

1.)Behaviors-Pleasure2.)Euphoria-Addiction3.)Movement-Parkinson’s Disease-EPS

4.)Perception-Psychosis

Dopamine Neural Pathways

1

2

3

4




MESOLIMBIC DOPAMINE SYSTEM

Circuit #1 Mu Use- DopamineRelief/Like/Pleasure

Pleasure/Pain circuitMeso-accumbens

Circuit #2 Delta Abuse-Endorphins

Repeat/Want/ReinforcementDesire and urge circuitBasolateral n. of amygdala

Circuit #3 Kappa Addiction-Dynorphin A/B

Need/Craving/AddictionPathologic desire & demand circuitPeriaqueducal gray of brain stemStimulation of the periaqueductal gray

matter of the midbrain activates enkephalin-releasing neurons that project to the raphe nuclei in the brainstem.

Enkephalin (endogenous opioid neurotransmitter), binds to mu opioid receptors.

Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP-D39

The Changing of the Brain’s Communication Highway

1.) Alcohol, Marijuana, Rx medications alter the receptors and neurotransmitters with any use; it happens like this:

2.) The person experiences euphoria from the release of dopamine (excessive amounts) when they drink or use a drug;

3.) The brain records this pleasurable experience in short term memory-”this was a good time”;

4.) If the person begins to repeat the pleasurable experience, the dopamine becomes depleted, the brain attempts to stabilize the chemistry by using another set of chemicals, the endorphins, to reset the brain back to normal; but this attempt just creates a need for more of the drug-tolerance and withdrawal;

5.) If the persons continues to use (thinking that they can get back to normal), the brain activates a third set of chemicals, the dynorphins, to keep the brain’s communication highway open.

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The Changing of the Brain’s Communication Highway

6.) The dynorphins are responsible for many things in the brain, one of the most important is stress reduction created by intimate relationships (family, friends, church,etc.) A long term memory system is activated.

7. As the person continues to use the drug, the dynorphins are depleted over time, making normal relationships less important.

8. As the depletion of the dynorphins continues, the brain will begin to substitute the drug of abuse for the brain’s natural dynorphin.

9.) The brain becomes “hijacked” using the drug of abuse as the primary relationship of importance, instead of the normal relationships in the person’s life. This is addiction.

10.) Once the hijacking occurs-it is irreversible-addiction is a chronic disease process.

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Overdosing- #1 Issue

Drug overdose is now one of the top causes of death in US claiming over 59,000 deaths in 2016.

The CDC reports that for every overdose death in the U.S., a person taking opioids on average will overdose nine times. While overdose deaths can occur anytime, the most high-risk individuals are those using escalating doses of drugs and those using a combination of drugs such as opioids and benzodiazepines.




Naloxone

Antidote; Opioid Antagonist

Significant adverse reactions:

Related to reversing dependency and precipitating withdrawal

Withdrawal symptoms are the result of sympathetic excess


How does naloxone work?

Naloxone has a strongeraffinity to the opioidreceptors than the opioid, soit knocks the heroin off thereceptors for a short timeand lets the person breatheagain.

Opioid receptor

Naloxone

Opioid




Naloxone Safety

Naloxone requires a prescription

Opioid antagonist - no potential for abuse

Little to no effect on person unless they are experiencing an opioid overdose

Accidental administration poses no threat or danger

Including to children or pregnant women


Naloxone Safety WHO’s List of Essential Medicines

>50,000 people in US trained to administer naloxone

>10,000 opioid overdoses have been reversed with naloxone from 1996 to 2010

Studies suggest laypersons trained in administration can do so as effectively as EMS personnel




Recognizing an Overdose

Unresponsiveness to yelling or stimulation, like rubbing your knuckles on breast bone

Effectively draws the line between overdosing and being really high but not overdosing

Slow, shallow, or no breathing

Turning pale, blue or gray (especially lips and fingernails)

Choking sounds


Risk Factors

Overdose is most common when:

History of prior overdose

Tolerance is down due to not using – like after being in jail, detox or drug-free treatment

Drugs are mixed, especially with alcohol or benzodiazepines

Person uses alone




What NOT to do During an Overdose

DO NOT put the individual in a bath They could drown.

DO NOT induce vomiting or give the individual something to eat or drink They could choke.

DO NOT give over-the-counter drugs or vitamins

(eg, No-Doz or niacin) They don’t help and the patient could choke.


Responding to a Suspected Opioid

Overdose




Step 1 - Rub to wake

Rub your knuckles on the bony part of the chest (sternum) to try to get them to wake up and breathe.


Step 2 - Call 911

Tell them

The address and where to find the person

A person is not breathing

When medics come tell them what drugs the person took if you know

Tell them if you gave Naloxone




Step 3 - If the person stops breathing, give breaths

mouth to mouth or use a disposable breathing mask

Put them on their back

Pull the chin forward to keep the airway open put one hand on the chin, tilt the head back, and pinch the nose closed

Make a seal over their mouth with yours and breathe in two breaths. The Chest, not the stomach, should rise

Give one breath every 5 seconds


Step 4 - Give naloxone

Injectable:

Give naloxone (discard any opened naloxone within 6 hours of using) Injectable naloxone: inject into the arm or upper outer top of thigh muscle 1cc at a time always start from a new vial

Intranasal:

Squirt half the vial into each nostril, pushing the applicator fast to make a fine mist.




Injectable Naloxone


Intranasal Naloxone




Step 5 - Stay with the person and keep them breathing

Continue giving mouth to mouth breathing if the person is not breathing on their own after that administration of naloxone

Give second dose of naloxone after 2-5 minutes if they do not wake up and breath more than 10-12 breaths a minute

Naloxone can spoil their high and they may want to use again, make sure they are aware that overdosing is still possible when naloxone wears off


Step 6 - Place the person on their side

People can breathe in their own vomit and die.

If a person is breathing put them on their side to prevent this.

Naloxone can induce vomiting, this position will help protect them from inhaling that vomit.




Step 7 - Convince the person to

follow the paramedics advice

If paramedics advise to proceed to an emergency room then health care staff can

Relieve symptoms of withdrawal

Prevent a second overdose

Observe and administer naloxone as needed

Assess risk of the person for other overdoses brought on by drugs other than opioids


Contents Of Narcotic Overdose Kit




Withdrawal # 2 Issue

The onset of withdrawal symptoms vary among users. Typically those who use heroin once a day experience peak withdrawal effects within 36-48 hours of there last administered dose. Symptoms such as pain, restlessness and vomiting go away within in 7-10 days.

Medication assisted treatments (MAT) is recommended by SAMHSA for withdrawal.


Why is it needed?




Clinical Opiate Withdrawal Scale


Source: NSW Department of Health (2007) NSW Drug and Alcohol Withdrawal Clinical Practice Guidelines




Heroin Withdrawal

0 1 2 3 4 5 6 7 8 9 10

Day

Withdra

wal

sev

erity

Unmedicated

Lofexidine / clonidine

Methadone (7 day)

Buprenorphine (7 day)

Rapid detox' (naltrexone)

Lintzeris, N (2008) unpublished data. Reprinted with permission.


Think About This- Opioids Act

As Hormones

Fibromyalgia, Autism, and Opioid Addiction as Natural and Induced Disorders of the Endogenous Opioid Hormonal System

Autism is a hyperopioidergic response and opioid maintained individuals relate autistically

Post Withdrawal of Opioid Addiction is fibromyalia

Hypothesis 1 — The Endogenous Opioid System is a Hormonal System that Regulates Both Pain and Relatedness

Hypothesis 2 — Neuropsychoanalytic Therapy Including LDN Enhances Outcomes of Opioid Addiction Treatment by Addressing Key Aspects of the Disease Including Persistent Low Opioid Tone

http://www.discoverymedicine.com/Brian-Johnson-2/files/2014

/10/discovery_medicine_no_99_brian_johnson_figure_1.jpg




Think About This- Opioids

Act As Hormones

Hypothesis 3 — Fibromyalgia Is an Autoimmune Disease of the Endogenous Opioid System

Hypothesis 4 — Autism May Be Treatable with High Dose Naltrexone

Hypothesis 5 — The Increasing Prevalence of Autism Is Caused by the Increasing Administration of Opioids During Childbirth

http://www.discoverymedicine.com/Brian-Johnson-2/files/2014/10/discovery_medicine_no_99_brian_johnson_figure_1.jpg





Figure 1. The hypothesized ʹinverse Uʹ relationship of pleasure and opioid tone in central nervous system subcortical pathways. The left side of the x-axis corresponds with low opioid tone, associated with post acute withdrawal syndrome and opioid induced hyperalgesia (OIH) after opioid withdrawal and with fibromyalgia. The right side of the x-axis corresponds with high opioid tone, associated with patients maintained on opioid drugs and with autism. Pleasure is at its peak when regulated by human interactions in the band labeled ʹhealthy functioning.ʹ


What Is MAT?

MAT is any treatment for opioid addiction that includes a medication (e.g., methadone, buprenorphine, naltrexone, naloxone) approved by the U.S. Food and Drug Administration (FDA) for opioid addiction detoxification or maintenance treatment. MAT may be provided in an OTP or an OTP medication unit (e.g., pharmacy, physician’s office) or, for buprenorphine, a physician’s office or other health care setting. Comprehensive maintenance, medical maintenance, interim maintenance, detoxification, and medically supervised withdrawal are types of MAT.

TIP 43 U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment. HHS PublicationSMA12-4214. First Print 2005, Reprinted 2006, 2010, 2011,2012, 2014.




Outcome Challenge: The Treatment

Gap: DATA 2000 Waiver

Waiver Authority for Physicians Who Dispense or Prescribe Certain Narcotic Drugs for maintenance or detoxification treatments:o # of Physicians in the U.S. = 916,264o # of DATA Certified Physicians = 33,806

This comes out to only 3.7% of physicians being DATA Certified, left to treat 1.9 million opioid addicted patients in the US.

One physician for 55,800 opioid addicted patientsUnderstanding the Epidemic. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/drugoverdose/epidemic/index.htmlPhysician and Program Data. Substance Abuse and Mental Health Services Administration Web site. http://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/physician-program-data


Cravings # 3 Issue

Craving: memory of rewarding aspects of drug use superimposed on a negative emotional state

o Compels drug-seeking in dependent individuals

3 Types of Cravingso Withdrawal inducedo Cue-inducedo Drug-induced




Methadone Stabilization

Reprinted from The Lancet. Haber, PS et al (2009) “Management of injecting drug users admitted to hospital” Lancet, 374(9697):1284-93. © 2009 with permission from Elsevier.


Options of Pharmacological Treatment

1. Methadone • Full μ agonists

• Once/day dosed

• 40-60 mg/d: sufficient to block withdrawal sx.

2. Buprenorphine and Buprenorphine/Naloxone• μ Receptor partial agonist

• Kappa receptor partial antagonist

• 12-16 mg/d

• Combination ↓ risk of diversion

3. Naltrexone • Opioid antagonist

• Oral or injectable

• This extended-release injectable medication is the most recent drug, approved in October of 2010, for the treatment of opioid addiction.

4. Naloxone- Overdose Prevention




Components of Comprehensive Drug Addiction Treatment

www.drugabuse.gov75

BuprenorphineDetoxification

Buprenorphine and Medically Supervised Withdrawal

BUP can be used to cease opiate use or to transition out of agonist (methadone) treatment. Cease opiate use

Withdrawal symptoms present

1-2 initial doses on first day

Build up dose over next couple days

Make sure consumer is compliant and stable

Reduction of dose over next few days

Some consumers may need to take longer in reduction phase or enter maintenance treatment




Other MedicationsMedication

Managing Symptoms

Clonidine, nausea & diarrhea meds, hypertension meds, etc.

Full Agonist

Methadone

Partial Agonist

Buprenorphine

Partial Agonist w/ Antagonist

Buprenorphine-Naloxone

Full Antagonist

Naltrexone (Revia, Depade, Vivitrol)


CDC Guidelines for Prescribing Opioids

for Chronic Pain




Purpose, Use, and Primary Audience

Primary Care Providers• Family medicine, Internal medicine• Physicians, nurse practitioners, physician assistants

Treating patients >18 years with chronic pain• Pain longer than 3 months or past time of normal tissue healing

Outpatient settings

Does not include active cancer treatment, palliative care, and end‐of‐life care

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Determine when to initiate or continue opioids for chronic painRecommendations 1-2




Opioid selection, dosage, duration, follow-up, and discontinuationRecommendations 3-6


Assessing Risk and Addressing Harms of

Opioid Use Recommendations

6-12




• FDA REMS for opioid medications.• Good medical practice requires Screening & monitoring all patients for signs of abuse and addiction;

Use opioid agreement;

Keep detailed prescribing records;

Educate patients/caregivers:

Take medication only as prescribed,

Protect against accidental use, theft, and misuse

Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP‐D

Principles of BalanceOpioid Therapy

83

Elements to Assure Safe Use (ETASU)

May require any of the following:

Training or certification of prescribers

Training or certification of pharmacists and pharmacies

Restriction on where drug is dispensed (e.g., infusion settings, hospital)

Evidence of patient safe use conditions such as lab results

Patient monitoring

Enrollment of patients in a registry




Screening Instruments

Overview

Looking for HIDDEN substance abuse

Subjective (self-report) vs. objective

Active vs. latent

Testing vs. application

Access resources in clinical practice

PainEDU.org

www.appalachianaware.org



CURRENT Substance Abuse

Subjective

Interview history

CAGE and Trauma Test

Drug Abuse Screening Test (DAST)

Reassessment: Current Opioid Misuse Measure (COMM)

Objective

Addiction Behaviors Checklist





LATENT Substance Abuse

Screener and Opioid Assessment for Patients in Pain (SOAPP®)

Long (24 questions) and short (5) versions

Opioid Risk Tool (ORT®)


Pain Management of the Cancer Patient




The Statistics

• In 2016, an estimated 1,685,210 new cases of cancer will be diagnosed in the United States and 595,690 people will die from the disease.

• The number of people living beyond a cancer diagnosis reached nearly 14.5 million in 2014 and is expected to rise to almost 19 million by 2024.

• Approximately 39.6% of men and women will be diagnosed with cancer at some point during their lifetimes (based on 2010-2012 data).

• In 2014, an estimated 15,780 children and adolescents ages 0 to 19 were diagnosed with cancer and 1,960 died of the disease.

• As the overall cancer death rate has declined, the number of cancer survivors has increased.


AmericanSocietyofClinicalOncology(ASCO)

Statementonthe OpioidEpidemic

Regulations designed to curb opioid abuse and addiction should "largely exempt cancer patients," according to a policy statement from the American Society of Clinical Oncology (ASCO)

Characterizing cancer patients as a "special population,”ASCO said a broad exemption from regulations that limit access to or doses of prescription opioids is justified because of the "unique nature of their disease, its treatment, and potentially life-long adverse health effects from having had cancer.”

ASCO Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain 2016




ASCO Recommendations for Cancer Patients

Healthcare provider access to a choice of materials on prescribing education that is "evidence based and tailored by specialty”; No prescription limits that would "artificially impede access to medically necessary treatment for patients with cancer";

Patient education emphasizing safe use, storage, and disposal of prescription pain medication;

Allowances in prescription drug monitoring programs for providers who treat cancer related pain and "may prescribe relatively large numbers of opioids or provide multiple controlled drugs at relatively high doses";

Appropriate patient screening and assessment before and during opioid treatment, although use of compliance tools should not be mandated for all patients who receive opioids;


ASCO Recommendations for Cancer Patients

Use of abuse-deterrent -- or non-abuse deterrent -- formulations of prescription pain medication, as determined by clinical and patient-specific circumstances;

Rapid patient access to assessment, diagnosis, and treatment for opioid misuse, abuse, or addiction;

Increased access to naloxone, "a life-saving medication in cases of opioid overdose"; and

Prescription "take-back" programs to decrease availability of unused or unwanted opioids, including readily available authorized collection sites for patients.

ASCO Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain 2016




Tools and Materials

Provider and patient materials

• Checklist for prescribing opioids for chronic pain

• Fact sheets

• Posters

• Web banners and badges

• Social media web buttons and infographics

CDC Opioid Overdose Websitewww.cdc.gov/drugoverdose/index.html

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References

CDC. Wide‐ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016. Available at http://wonder.cdc.gov.

Centers for Disease Control and Prevention. CDC Health Advisory: Increases in Fentanyl Drug Confiscations and Fentanyl‐related Overdose Fatalities. HAN Health Advisory. October 26, 2015. http://emergency.cdc.gov/han/han00384.asp

Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid‐Involved Overdose Deaths —United States, 2010–2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016. DOI: http://dx.doi.org/10.15585/mmwr.mm6550e1

National Institute on Drug Abuse. (2015). Drugs of Abuse: Opioids. Bethesda, MD: National Institute on Drug Abuse. Available at http://www.drugabuse.gov/drugs‐abuse/opioids.

The United Nations Office on Drug and Crime(UNDOC) “2015 World Drug Report”www.undoc.org/wrd2015

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For more information on CDC Guideline on Prescribing Opioids for Chronic Pain please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333

Telephone: 1‐800‐CDC‐INFO (232‐4636)/TTY: 1‐888‐232‐6348

Visit: www.cdc.gov | Contact CDC at: 1‐800‐CDC‐INFO or www.cdc.gov/info

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Centers for Disease Control and Prevention

National Center for Injury Prevention and Control 95

Narcotic Diversion MonitoringThriving in Tough Terrain

Presented by:

Tracie Chambers, RDOP

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Narcotic Diversion Monitoring

A necessary evil…

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• CHS CS policies provide a strong foundation for the necessary monitoring .

– Located on the CHS intranet under my policies

– CS policies begin with RX15‐01‐RX15‐23

• Build upon these policies to provide a solid program that assures safe and appropriate CS usage in your facility.

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Establish a written controlled substance plan– Evaluate CS use in all areas of the hospital

– Include all staff

– Include all CS medications

– System to look at non‐profile machines

– Limit access for staff

– Process to remove employees from ADM that have separated from the system (run report of users that have not accessed the ADM system within last 90 days)

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Narcotic Diversion MonitoringPotential Red Flags

• The same individual’s name on monthly Proactive Diversion Report

• Discrepancies created by the same person repeatedly

• Provider utilizing more medications per case than peers

• Incorrect counts on Tylenol/ASA/Benadryl injection

The basics working for your success• Entering data from daily

reconciliations into a spreadsheet for tracking and trending

• CII safe Compare report/Send to non‐ADM report

• Discrepancy reports

• Last access >90 days

• Proactive Diversion Report

– Nursing

– Anesthesia providers 100




Discrepancy reports– Potential issue with pharmacies/technicians throwing away sleeves of drugs in “empty boxes”

• Implement process that all CS must be removed from packaging before delivery and all packaging must be saved and checked by another person before discarding

– Miscount is chosen for resolution 99.9% of the time

• Verify and validate

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• Compare reports verify all CS removed from the Narcotic vault are delivered to the appropriate Med station‐ this should be run daily prior to the technician leaving.

• How do you verify if medications removed from the Narcotic vault/pharmacy are not delivered to a Med station?

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Review Narcotic vault daily event report?Scanning bar codes on delivery records?

Easiest solution:Reports, review reports, send reports, check date, click Not into ADM

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ED reconciliations and OR reconciliation

– Completed daily

– Make the work useful

– Input data into a spreadsheet

– Look for trends among drugs and users including nurses, prescribers and other staff.

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ED spreadsheet example

Date#

Reviewed Type of errorPatient ID

# Floor Other FindingsNurse

Involved Dr.

Anesthesia spreadsheet example

RPh/Tech Date

# Reviewed Provider

Patient ID #

Waste Verified? Other Findings Action

# of narcotics removed / # of

cases

Average # of

narcs/case

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Narcotic Diversion MonitoringProactive Diversion Search

Step 1 Step 2

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Proactive Diversion Search

Step 3

• Holds data forever

• Never deletes a user

• Can set specific parameters

Note: Similar information can also be obtained from CareFusion Analytics

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Additional tips learned from previous diversions:

– When counting expired control meds, seal the bags and sign across the seal

– Implement process for accountability of prescription blanks that are stored on the floors

– Reconcile all overrides daily and log into spreadsheet for tracking and trending

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Success

• Teamwork is the ability to work together toward a common vision. The ability to direct individual accomplishments toward organizational objectives. It is the fuel that allows common people to attain uncommon results.– Andrew Carnegie

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Jerry H. Reed, MS, RPh, FASCP, FASHP

Senior Director, Pharmacy Services

Community Health Systems

Update on Current Pharmacy Initiatives and Strategies

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