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Illinois State Opioid Antagonist Training Program March 11, 2016 Version 1.0 1 State Agencies Approval PA99-0480

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Page 1: State Agencies Approval PA99-0480 slides... · Illinois State Opioid Antagonist Training Program March 11, 2016 Version 1.0 7 Heroin Abuse Risk Factors • Male gender, aged 18–25

Illinois State Opioid Antagonist Training Program

March 11, 2016

Version 1.0 1

State Agencies ApprovalPA99-0480

Page 2: State Agencies Approval PA99-0480 slides... · Illinois State Opioid Antagonist Training Program March 11, 2016 Version 1.0 7 Heroin Abuse Risk Factors • Male gender, aged 18–25

Illinois State Opioid Antagonist Training Program

March 11, 2016

Version 1.0 2

ACPE InformationThe Illinois Pharmacists Association is accredited by the Accreditation Council for Pharmacy

Education as a provider of continuing pharmacy education. The online training is approved for 1.75

hours (0.175 CEUs) of continuing pharmacy education credit.

UAN: 0135-0000-16-002-H04-PContact Hours: 1.75 HoursInitial Release Date: March 11, 2016Planned Expiration Date: March 11, 2019Target Audience: Pharmacists in all practice settings

Continuing Pharmacy Education RequirementsThis activity is structured to meet knowledge-based educational needs and acquire factual knowledge. Information in knowledge-type activities is based on evidence as accepted in the literature by the health careprofessions. Continuing pharmacy education (CPE) credit will be earned based on participation in the activity. Participation is required before obtaining CPE credit. Participants must complete an activityevaluation and posttest (if applicable) with a passing score of 70 percent or greater. This activity is accredited through ACPE for pharmacist continuing pharmacy education credit. If all requirements are met,participants will receive continuing pharmacy education credit in the following manner. Partial credit will not be awarded. Please allow 60 days for processing.

PharmacistsCPE Monitor, a national, collaborative effort by ACPE and the National Association of Boards of Pharmacy (NABP) to provide an electronic system for pharmacists and technicians to track their completed CPEcredits, went into effect on January 1, 2013. IPhA, as an ACPE-accredited provider, is required to report pharmacist CPE credit using this tracking system. Pharmacist participants must provide their NABP e-Profile Identification Number and date of birth (in MMDD format) when they register for a CPE activity or complete activity evaluations. It will be the responsibility of the pharmacist to provide the correctinformation (e-Profile Identification Number and Date of birth in MMDD Format). If this information is not provided, NABP and ACPE prohibit IPhA from issuing CPE Credit. Online access to their inventory ofcompleted credits will allow pharmacists to easily monitor their compliance with CPE requirements and print statements of credit. Therefore, IPhA will not provide individual printed statements of credit topharmacists. For additional information on CPE Monitor, including e-Profile set-up and its impact on pharmacists and pharmacy technicians, go to www.nabp.net.

Program Faculty

Kelly Gable, PharmD, BCPPAssociate Professor, Department of  Pharmacy Practice 

Southern Illinois University [email protected]

Chris Herndon, PharmD, BCPSAssociate Professor, Department of Pharmacy Practice

Southern Illinois University [email protected]

Jessica Kerr, PharmD, CDEAssistant Chair and Associate Professor, Department of Pharmacy Practice

Southern Illinois University [email protected]

Garth Reynolds, BSPharm, RPhExecutive Director

Illinois Pharmacists [email protected]

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Illinois State Opioid Antagonist Training Program

March 11, 2016

Version 1.0 3

Disclosures/Conflicts of Interest

• The Speakers of this continuing education program, do not have financial relationships or conflicts of interests.

• The content of this webinar may include information regarding the use of products that may be inconsistent with, or outside the approved labeling for, these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult the prescribing information for these products

Learning Objectives1. Describe the opioid abuse and overdose epidemic on a state and national level.

2. Review unique pharmacological properties of commonly prescribed opioids and heroin.

3. Discuss the neurobiology of addiction and opioid use disorder.

4. Understand risk factors, signs of an opioid overdose, and the role of opioid antagonist

therapy.

5. Describe the role of pharmacy personnel in opioid overdose management.

6. Evaluate key elements of patient and caregiver education on opioid overdose

management.

7. Discuss standardized procedures, naloxone standing order sets, and clinical

documentation.

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Illinois State Opioid Antagonist Training Program

March 11, 2016

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Opioid Abuse and the Overdose Epidemic

Kelly Gable, PharmD, BCPP

Associate Professor, Department of  Pharmacy Practice 

Southern Illinois University Edwardsville

Alarming Statistics - An Epidemic• The CDC has officially declared prescription drug abuse in the US an epidemic

• 1 in 20 people report using prescription opioids for non-medical reasons

• In 2010, enough opioid pain relievers were sold to medicate every adult in the US with 5

mg of hydrocodone every 4 hours for 1 month

• In 2014, ~1.9 million people had an opioid use disorder related to prescription pain

relievers and ~586,000 had an opioid use disorder related to heroin use

• Only 16% of Americans believe that the US is making progress in its efforts to reduce

prescription drug abuse

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Illinois State Opioid Antagonist Training Program

March 11, 2016

Version 1.0 5

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March 11, 2016

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Overdose Deaths• Each day, ~46 people in the United States die from overdose of prescription pain

medications

• >47,000 Americans died of a drug overdose in 2014, an increase of 7% from 2013

• >50% were related to pharmaceuticals (~70% involved opioid analgesics and 30% involved

benzodiazepines)

• The increase was driven largely by deaths from heroin + prescription opioids

• Women who lost their lives opioid overdoses rose 415% between 1999 and 2010

Heroin Use Rising

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March 11, 2016

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Heroin Abuse Risk Factors• Male gender, aged 18–25 years

• Non-Hispanic white race/ethnicity

• Residence in a large urban area

• <$20,000 annual household income with no health insurance or Medicaid

• Past-year abuse or dependence on alcohol, marijuana, cocaine, or opioid pain relievers

National Survey on Drug Use and Health (NSDUH), 2002-2013.CDC Vital Signs, July 2015.

Opioid Abuse - Illinois• 12th lowest drug overdose mortality rate in the US, with 10 per 100,000

drug overdose fatalities

• Drug overdose deaths increased by 49% since 1999

• ~8 people die from prescription drug overdoses/week in Illinois (81%

involve opioid pain relievers)

• Hydrocodone was the most available opioid to nonprescribed users

for nonmedical use in 2013

• In 2012, there were 15,350 primary heroin treatment admissions in

Chicago

• Heroin purity at the street level remains between 10 and 20%- cut

with quetiapine, diphenhydramine, fentanyl

Illinois Department of Human Services. Prescription Drug Abuse: Strategies to Stop the Epidemic.

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Top Abused Prescription Drugs in America

Clinical Pharmacology of Opioids

Chris Herndon, PharmD, BCPS

Associate Professor, Department of  Pharmacy Practice 

Southern Illinois University Edwardsville

Morphine

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Opioid Receptors• μ – mu (MOR)

• κ – kappa (KOR)

• δ – delta (DOR)

• N/OFQ (Noceptin)

Commercially Available OpioidsPure MOR (mu) agonists

morphine, methadone, codeine, hydrocodone, fentanyl, oxycodone, oxymorphone,

levorphanol, hydromorphone, heroin, dihydrocodeine, sufentanil, alfentanil, remifentanyl

Partial MOR (mu) agonist

buprenorphine

Mixed agonist-antagonists

nalbuphine, butorphanol, pentazocine

Centrally acting MOR agonists

tramadol, tapentadol

Nonselective antagonists

naloxone, naltrexone

Peripherally acting MOR opioid antagonists

alvimopan, methylnaltrexone, naloxegol

MOR = mu-opioid receptor

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What is “High Dose” for Opioids?Canadian Guidelines

200mg/day OME

American Pain Society Guideline

200mg/day OME

Washington State Work Comp

120mg/day OME

OME = Oral Morphine Equivalent

Prescription Opioids and Illicit Heroin• Quantitative questionnaire using street outreach, venue-recruitment, and needle-exchange

advertisement (n = 123)

• Median age 29 yrs (75% male, 53% white, 28% hispanic, 19% black or other)

• 39.8% reported problematic prescription opioid use prior to first heroin use

• Heroin rapidly metabolized to morphine in CNS

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Drug IV (mg) Oral (mg)

Morphine 10 30Buprenorphine 0.3 0.4 (SL)

Codeine 100 200Fentanyl 0.1 —

Hydrocodone — 30Hydromorphone 1.5 7.5

Meperidine 100 300Oxycodone 10 20

Oxymorphone 1 10

Relative Equianalgesia

IV = intravenous; mg = milligram; SL = sublingual

Let’s Get Some Practice….CH is a 42 year old male who is currently using opioid and non-opioid analgesics for severe low back pain (failed back surgery syndrome). His current regimenincludes:

• CR morphine 60mg by mouth every 8 hours• IR oxycodone 15mg by mouth every 4 to 6 hours as needed• Pregabalin 50mg by mouth every 12 hours

What is CH’s total daily Oral Morphine Equivalent (OME)?

CR = controlled-release; IR = immediate-release

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Calculate 24 hour Oral Morphine Equivalent (OME)

• CR morphine 60mg Q8h = 180mg OME

• IR oxycodone 15mg Q4-6h

(actually take Q4h) = 90mg of oxycodone

• Ratio is 2:3 (90mg/2)(3) = 135mg OME

• Total OME is 315mg daily

Drug IV (mg) Oral (mg)

Morphine 10 30

Buprenorphine 0.3 0.4 (SL)

Codeine 100 200

Fentanyl 0.1 —

Hydrocodone — 30

Hydromorphone 1.5 7.5

Meperidine 100 300

Oxycodone 10 20

Oxymorphone 1 10

CR = controlled-release; IR = immediate-release; SL = sublingual

Distinct Opioid ConcernsFentanyl

Incredibly potent and lipophilic

Abusers may “cheek” cut patches and accidentally swallow

Continued delivery may prolong exposure and require repeated dosing of reversal

Buprenorphine

Significantly higher MOR binding affinity

More difficult to “antagonize” with reversal agent requiring higher doses for longer

Methadone

Highly variable terminal half-life

May require repeated doses of reversal antagonist

Heroin

Patients recently abstaining cannot tolerate previously high doses used

Often “cut” with acetyl fentanyl increasing potency and respiratory depressant risk

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The Neurobiology of Addiction

Kelly Gable, PharmD, BCPP

Associate Professor, Department of  Pharmacy Practice 

Southern Illinois University Edwardsville

Why Do People Use Substances?

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Substance Use DisordersComplex biological health conditions involving the brain

Encompass many different drug classes:

CaffeineAlcohol

CannabisHallucinogens

InhalantsSedative-hypnotics / anxiolytics

StimulantsNicotineOpioids

Neurochemical Imbalance: AddictionReceptor DOPAMINE OPIOID SEROTONIN

Roles MoodAttentionPsychosisRewardPleasure

AnalgesiaEuphoriaSedationDysphoria

Respiratory depression

AppetiteMoodSleep

Drug Effects • Opioids, Nicotine, Alcohol, Stimulants increase dopamine release

Reinforcing effects of endogenous opiates

Stimulants inhibit removal of serotonin synapses Alcohol depletes

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Drugs of AbuseTargeting of the Brain’s Pleasure Center

Risk / Protective Factors for AddictionRisk Factors Protective Factors

Aggressive behavior in childhood Good impulse-control

Poor parental supervision Parental support

Poor social skills Positive relationships

Drug experimentation Academic competence

Availability of drugs at school School anti-drug policies

Community poverty Neighborhood pride

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Substance Use Disorders

Substance Use Disorders:Relapse and Recover

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Substance Use Disorders:Barriers to Treatment

• Only 1 in 10 Americans with a substance use disorder actively receive treatment.

• Stigmas that prevent treatment:

“Treatment doesn’t work”

“They have an addictive personality”

People with addiction are “bad, crazy, can’t be helped, don’t want to be helped”

• Treatment outcomes are improved if the substance use disorder / psychiatric disorder are

addressed collaboratively with other medical conditions.

Substance Use DisordersRecovery Options

1. Traditional 12 step programs

2. Inpatient / outpatient programs

3. Harm reduction and behavioral therapy

4. Pharmacotherapy: treatment of withdrawal syndromes, anti-craving medication (naltrexone),

buprenorphine, methadone maintenance

5. Screening, Brief Intervention, and Referral to Treatment (SBIRT): evidenced-based practice

used to identify, reduce, and prevent problematic use, abuse, and dependence on alcohol

and drugs

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Opioid Use Disorders: Risk Factors for Abuse and Overdose

Kelly Gable, PharmD, BCPP

Associate Professor, Department of  Pharmacy Practice 

Southern Illinois University Edwardsville

Warning Signs of AbuseJason is a 25 year-old patient who you see routinely

at the pharmacy. He is receiving treatment for

chronic low back pain and panic disorder. He is

prescribed the following regimen from his psychiatrist:

• Alprazolam (Xanax) 0.5 mg twice daily

• Oxycodone 10mg every 6 hours prn pain

• Paroxetine (Paxil) 10 mg daily

Jason shows up 2 weeks early for his refills reporting

that he “lost the rest of his medication and really

needs his Xanax.”

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Warning Signs of Abuse1. Frequently running out of medication

2. Reporting lost or stolen prescriptions

3. Presenting with prescriptions from multiple prescribers

4. Filling prescriptions at multiple pharmacies

5. Urine drug screen negative

6. Reports allergies to all other drugs but ….

7. Frequently demonstrating signs and symptoms of intoxication

Opioid-Related Disorders• Opioid Use Disorder

• Opioid Intoxication 

• Opioid Withdrawal 

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Opioid Use Disorder, Withdrawal, or Intoxication• Stacy is a 34 year-old female presenting to the

emergency department for treatment of an infected

abscess on her arm.

• She experiences chronic back pain from a car accident 2

years ago.

• In an effort to gain better control of her pain, she started

using heroin 3 months ago, on top of her routine

treatment with oxycodone, cyclobenzaprine, and

alprazolam.

• After testing positive for heroin use, she was released

from treatment by her PCP. She now uses heroin daily.

Opioid Use DisorderProblematic pattern of opioid use leading to clinically significant impairment within a 1 year

period, consisting of ≥ 2 of the following:

1. Taken in larger amounts over longer period then intended

2. Unsuccessful efforts to stop or decrease use

3. Excessive time spent obtaining opioid, using, or recovering from use

4. Craving to use

5. Use results in failure to fulfill work, school, home obligations

6. Use continues despite negative consequences

7. Opioid use becomes more important than social, work, or recreational activities

8. Continued use despite risky situations

9. Persistent use despite knowledge of physical or psychological problems

10.Tolerance has developed (need more opioid to achieve desired effects)

11.Withdrawal occurs when opioid is stopped

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Prescription Opioid Abuse Almost all prescription drugs involved in

overdoses come from prescriptions

originally (not pharmacy theft)

• Frequently diverted to people using

them without prescriptions

Most prescriptions come from primary

care physicians, internal medicine

physicians, and dentists; not specialists

• Roughly 20% of prescribers prescribe

80% of all prescription opioids

Prescription Opioid Abuse Risk FactorsThose who abuse prescription opioids (vs heroin):

1. Are more likely to have complaints of pain

2. Are more likely to be in psychiatric treatment

3. Have greater social stability

4. Are less likely to use other illicit substances

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Opioid Use Disorder, Withdrawal, Intoxication?• Shane is a 53 year-old male diagnosed with

prostate cancer with bone metastasis.

• On top of his chemotherapy treatment, he

receives treatment for bone pain with oxycodone

controlled-release (OxyContin) 80 mg daily and

oxycodone 10 mg q 4 hours for break-through

pain.

• Last month his wife phoned 911 because she

found Shane unresponsive on the couch.

Opioid Intoxication vs. WithdrawalOpioid Intoxication Opioid Withdrawal*

EuphoriaDysphoriaApathyMotor RetardationSedationSlurred speechAttention impairmentPinpoint pupilsRespiratory depression

LacrimationRhinorrhea

Dilated pupilsGoosebumps

Sweating, feverDiarrheaYawningInsomnia

Muscle aching

*Duration of withdrawal = 7 to 14 days

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Opioid OverdoseReduced sensitivity to changes in O2 and CO2 outside of normal ranges

Decreased tidal volume and respiratory frequency

Respiratory failure and death due to hypoventilation

Signs and symptoms:

1. Pinpoint pupils

2. Not arousable with sternal rub

3. Breathing less then 8 per minute

4. Choking, gurgling, snoring sounds

5. Blue/gray lips and fingertips

Who is at Risk for Overdose?1. Taking multiple controlled substance prescriptions from multiple providers “doctor shopping”

2. Taking high daily dosages of prescription opioids and/or misuse multiple abuse-prone prescription drugs

3. People with chronic medical conditions (HIV, cardiovascular disease, respiratory diseases, mental illnesses)

4. Changes in opioid purity

5. Previous history of overdose

6. Lower socioeconomic status and those living in rural areas

7. Recent discharge from incarceration or substance use facility

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Risky Situations• Pam is a 50 year-old female patient diagnosed with Crohn’s

Disease, fibromyalgia, generalized anxiety disorder, PTSD, chronic back pain, and sleep apnea

• She receives treatment from her primary care physician, rheumatologist, and psychiatrist.

• She struggles with ongoing pain and frequently over takes her pain medication.

• She is prescribed: Olanzapine (Zyprexa), lorazepam (Ativan), amitriptyline (Elavil), oxycodone (OxyContin), trazodone (Desyrel), zolpidem (Ambien), tramadol (Ultram), duloxetine (Cymbalta), quetiapine (Seroquel), diazepam (Valium), hydrocodone / acetaminophen (Vicoden), prednisone

PTSD = Post Traumatic Stress Disorder

Dangerous CombinationsMultiple CNS Depressants:

• Opioids

• Benzodiazepines- alprazolam, diazepam, clonazepam,

chlordiazepoxide

• Barbiturates

• Z-hypnotics- zolpidem, zaleplon, eszopiclone

• Muscle relaxants- cyclobenzaprine, nabumetone,

carisoprodol

• Alcohol

• Sedating antipsychotics: quetiapine

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Opioid Overdose and Naloxone Rescue Therapy

Kelly Gable, PharmD, BCPP

Associate Professor, Department of  Pharmacy Practice 

Southern Illinois University Edwardsville

Image taken from hpubchem.ncbi.nlm.nih.gov. Accessed Feb 14, 2016

Naloxone Rescue TherapyNaloxone (Narcan): a competitive antagonist at all opioid receptor sites

Reverses analgesic, dysphoric, and other pharmacologic effects of opioids

1 mg can reverse the effect of ~25mg heroin

Naloxone is NOT naltrexone (a long-acting opioid antagonist)

Naloxone is NOT effective in reversing an overdose with benzodiazepines, barbiturates, or

stimulants

Is it safe to use?

FDA-approved and used by EMS to reverse opioid overdose for > 40 years

Has minimal interaction in the body without the presence of opioids

Rapid opioid reversal causes: hypertension, tachycardia, sweating, recurring pain, agitation,

other withdrawal symptoms

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Programs that WorkRhode Island

• All Walgreens and CVS pharmacies supply and dispense IM and IN naloxone through a

collaborative practice agreement

Project Lazarus

• A public health model based on the premises that drug overdose deaths are preventable and

that all communities are ultimately responsible for their own health.

• Facilitated overdose prevention in Wilkes in collaboration with Health Department, law

enforcement, schools, clinicians, hospitals, and faith community.

• Over 3 years: overdose deaths ↓ 42%; drug-related hospital visits ↓ 15%; the number of

prescriptions for controlled substances stabilized

IM = intramuscular; IN = intranasal

Why at the Pharmacy?1. Many patients at risk for an overdose do not visit routine

providers.2. There is a shortage of physicians/providers prescribing

naloxone.3. Patients may not report opioid misuse due to fear of loss of

access to pain management.4. It ensures easier access to a life saving treatment.5. An opioid overdose can happen within minutes to hours.6. Naloxone is rapid-acting, safe, and effective at reversing

opioid overdose.7. Bystanders are easily trainable to recognize and respond

to an overdose.8. Risk of liability is no higher than with other prescription

medications.

*The practice of harm reduction follows a patient-centered philosophy of care with the primary goal focusing on a reduction of harm, rather than complete cessation of opioid use. When a patient is offered naloxone rescue therapy, it allows the healthcare provider to further discuss opioid use, safety concerns, and overdose risk.

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Who Should Get Naloxone?1. Prescribed long-term opioid therapy; doses > 50 mg of morphine equivalent/day

2. Prescribed rotating opioid medication regimens

3. Prescribed methadone

4. Taking an opioid plus other CNS depressants (benzodiazepines, alcohol)

5. Prescribed or taking an opioid with co-occurring renal/hepatic dysfunction, cardiovascular

disease, respiratory disorders (sleep apnea), mental illness, or HIV/AIDS

6. Using heroin

7. Recently discharged from a substance abuse treatment facility or from an acute medical

center following opioid intoxication or poisoning

8. Recently released from jail and history of opioid abuse

Naloxone Dispensing StepsPatient requests overdose prevention product

• Perform real-time claim submissions to determine coverage; patients can pay cash if

uninsured

• Initiate education with caregiver present

Filling an opioid prescription

• Check prescription monitoring program database and review current medications

prescribed

• Discuss any potential overdose risk with current medications

• Educate on opioid overdose and naloxone rescue therapy

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Prescription Monitoring Programs

Teaching Patients, Friends, Family, Caregivers

Education specific to prescription opioid use:

1. Use prescription opioids only as directed by a health care provider

2. Ensure that all prescribers and pharmacists know of all medications you are taking

3. Don’t mix opioids with alcohol or other sedating drugs

4. Store your medication in a safe and secure place and dispose of unused medication

5. Know that not taking your opioids for a period of time and change your tolerance and you

may need a lower dose when you restart

6. Ensure that your friends and family know how to respond to an overdose and administer

naloxone

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Teaching Patients, Friends, Family, Caregivers

Requirements during naloxone training session:

1. Review the signs of opioid intoxication, overdose, and withdrawal

2. Ensure understanding of naloxone purpose

3. Review insurance coverage and personal preference for IM or IN delivery system

4. Discuss the contents of the naloxone kit

5. Demonstrate naloxone administration (IM or IN) and verify understanding of method

6. Re-enforce importance of calling 911

7. Provide informational brochure

8. Document/record required patient information

Throughout your session, try to avoid stigmatizing terminology- addict, user, abuse

Teaching Patients, Friends, Family, Caregivers

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Identify the Overdose• STEP 1: Identify if someone is experiencing an

overdose-- No response upon yelling their name or

vigorously rubbing chest with knuckles -- Blue lips or fingertips-- Slow breathing (< 8 breaths/minute)-- Limp body or choking/gurgling/snoring noise

• STEP 2: Call 911 for help• STEP 3: If breathing is shallow or non-existent,

perform mouth-to-mouth rescue breathing

Perform Rescue Breathing• Place the person on their back.

• Tilt their chin up to open the airway.

• Check to see if there is anything obstructing the airway.

• Place your mouth over the person’s mouth to make a seal.

• Give 2 slow breaths. The person’s chest should rise.

• Breathe again. Give one breath every 5 second.

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Administer Naloxone andStay Until Help Arrives!

1. Administer naloxone via IM or IN delivery system

2. Place the person in the recovery position.A. On their side with their top leg and arm crossed over their body

3. Stay with the person- do not leave someone alone after giving

naloxone A. The effect of naloxone wears off in 30 to 90 minutes and patients can go back

into overdose if a long-acting opioid was taken (methadone, oxycodone)

B. Patients may want to take more opioids upon reversal due to feeling opioid

withdrawal symptoms

C. Some patients may become agitated or combative during withdrawal

IM = intramuscular; IN = intranasal

Naloxone Product Information

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Administration of Naloxone IM1. Single Dose or Multi-dose vials of naloxone are available

2. Use a 1-1.5 inch 25 gauge needle and 3mL syringe

• Do not draw up naloxone into syringe until ready to administer

• Remove cap from naloxone vial and uncover needle

• Insert needle through rubber plug with vial upside down; pull back on plunger and draw up

1 mL

• Inject 1mL at 90 degree angle into muscle, can be deltoid or outer thigh

• IM injection may be administered through clothing if needed

3. Prompt reversal of opioid agonist should occur within 3 to 5 minutes (hypotension and

sedative effects)

4. A second dose may be administered if there is no response in 3 to 5 minutes

IM = intramuscular

Administration of Naloxone IM Auto-Injector1. Pull auto-injector out of case from white end

2. Follow automated voice prompts

3. Remove red cap

4. Place black end against patients outer thigh, hold firmly for 5 seconds

IM = intramuscular

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Administration of Naloxone Intrasal (IN)1. Remove yellow caps at both ends of syringe and red cap from naloxone

2. Attach to Luer lock syringe and twist naloxone into barrel of syringe

3. Place nasal applicator into one nostril of patient, administer half of medication with a short,

vigorous push

4. Repeat for other nostril

Contraindications to IN deliverynasal septal abnormalities

nasal traumaepistaxis

cocaine induced septal damagerecent use of topical decongestants

IN = intranasal

Resources for Further Education• Overdose prevention education and naloxone rescue therapy:

• Prescribe to Prevent: www.prescribetoprevent.org• SAMHSA Opioid Overdose Prevention Toolkit • Project Lazarus: http://www.projectlazarus.org/• Centers for Disease Control and Prevention (CDC):

http://www.cdc.gov/Features/VitalSigns/PainkillerOverdoses• Harm Reduction Coalition: http://www.harmreduction.org/• College of Psychiatric and Neurologic Pharmacists (CPNP):

http://cpnp.org/guideline/naloxone

• Opioid prescribing education: • SAMHSA and NIDA: http://www.opioidprescribing.com

• Substance use treatment locator: • http://findtreatment.samhsa.gov or call 1-800-662-HELP

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Rationale and Method for Implementation

Jessica L. Kerr, PharmD, CDE

Associate Professor

Assistant Chair – Department of Pharmacy Practice

Southern Illinois University Edwardsville School of Pharmacy

Garth Reynolds, RPh

Executive Director – Illinois Pharmacists Association

Springfield, Illinois

Overview• Key elements of Public Act 99-0480.

• The approved Naloxone Standardized Procedures

• Clinical documentation and record keeping

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Illinois Naloxone Standardized Procedures

• PA-99-0480 amended the Illinois Pharmacy Practice Act by adding Section 19.1(b)

• Section 19.1(b) – Dispensing naloxone antidote

• Notwithstanding any general or special law to thecontrary, a licensed pharmacist may dispense and opioidantagonist in accordance with written, standardizedprocedures or protocols developed by the Department withthe Department of Public Health and the Department ofHuman Services if procedures or protocols are filed at thepharmacy before implementation and are available to theDepartment upon request.

‘the Department’ = Illinois Department of Financial and Professional Regulations

Illinois Naloxone Standardized Procedures

• Definitions per Public Act 099-0480

• “Opioid antagonist” means a drug that binds toopioid receptors and blocks or inhibits theeffect of opioids acting on those receptors,including, but not limited to naloxonehydrochloride or any other similarly acting andequally safe drug approved by the U.S. Food andDrug Administration for the treatment of drugoverdose.

‘the Department’ = Illinois Department of Financial and Professional Regulations

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Illinois Naloxone Standardized Procedures

• Definitions per Public Act 099-0480

• Changes in the Alcoholism and other Drug Abuse and Dependency Act

• “Health Care Professional” means a physician licensed to practicemedicine in all its branches, a physician assistant who has beendelegated prescriptive authority by his or her supervising physician,an advanced practice registered nurse who has written collaborativeagreement with a collaborating physician that authorizes prescriptiveauthority, or an advanced practice nurse or physician assistant whopractices in a hospital, hospital affiliate, or ambulatory surgicaltreatment center and possesses appropriate clinical privileges inaccordance with the Nurse Practice Act or a pharmacist licensed topractice pharmacy under the Pharmacy Practice Act.

Illinois Naloxone Standardized Procedures

• Definitions per Public Act 099-0480

• Changes in the Alcoholism and other Drug Abuse and Dependency Act

• “Patient information” included information provided to the

patient on drug overdose prevention and recognition; how

to perform rescue breathing and resuscitation; opioid

antagonist dosage and administration; the importance of

calling 911; care for the overdose victim after

administration of the overdose antagonist; an other issues

as necessary.

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Illinois Naloxone Standardized Procedures

• A health care professional who, acting in good faith, directly or by standing order, prescribes or dispenses an opioid antagonist to:

• a patient who, in the judgment of the health care professional, is capable of administering the drug in an emergency

• A person who is NOT at risk of opioid overdose but who, in the judgement of the health care professional, may be in a position to assist another individual during an opioid-related drug overdose

• AND – who has received basic instruction on how to administer an opioid antagonist

Illinois Naloxone Standardized Procedures

• A health care professional SHALL NOT , as a result of his or her

acts or omissions, be subject to:

• Any disciplinary or other adverse action under the Illinois

Pharmacy Practice Act

• Any criminal liability, except for willful and wanton misconduct.

• Any civil liability, except for willful and wanton misconduct.

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Illinois Naloxone Standardized Procedure

• Several amendments in other Acts • Alcoholism and Other Drug Abuse and Dependency Act

• Illinois Criminal Justice Information Act

• Illinois Police Training Act

• Illinois Fire Protection Training Act

• School Code

• Emergency Medical Services (EMS) Systems Act

• Hospital Licensing Act

• Safe Pharmaceutical Disposal Act

• Environmental Protection Act

• Illinois Controlled Substance Act

• Others

Other Changes of PA-099-0480• Provides guidance for drug overdose response policy

• Law Enforcement Officers, Fireman and EMS

• On-hand opioid antagonist

• Training

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Other Changes of PA-099-0480• School Code amendment

• Administration of opioid antagonist

• School personnel or nurse on-hand carry

• May allow for school to obtain opioid antagonist through the standing order of Standardized Procedures.

• School must immediately active the EMS system and notify guardian and emergency contact and within 24 hours notify the health care professional who provided the prescription

• Within 3 days after administration the school must report to the Board

• Annual Training and proof of CPR and AE certification is required

Other Changes of PA-099-0480• Safe Pharmaceutical Disposal Act amended to include:

• Coverage for opioid antagonist

• Includes medication product, administration devices and pharmacy

administration frees

• Refills must be included for expired or utilized medication

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Other Changes of PA-099-0480• Director of the Division of Alcoholism and Substance Abuse shall publish annual reports on drug overdose trends

statewide that reviews State death rates

• Report shall also provide:

• Trends in drug overdose death rates

• Trends in emergency room utilization

• Trends in utilization of prehospital and emergency services and the cost impact of emergency services utilization

• Suggested improvements in data collection

• Descriptions of efforts undertaken to educate the public about unused medications

• Description of other interventions to achieve outcome

Naloxone Standardized Procedures• The Naloxone Standardized Procedures are divided into the following sections:

• Background

• Continuing Education

• Standardized Procedures

• Pharmacist Standardized Procedure to Dispense Naloxone

• Standardized Procedures for Naloxone Distribution for Overdose Prevention (December 2015)

• Counseling Protocol for Naloxone Standardized Procedures

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Background• Review that PA99-0480 was passed in September 2015 expanding access to opioid antagonists (including Naloxone).

• Establishes the Standardized Procedures and required training for pharmacists.

• Naloxone to the following patient (or patient’s agent) group that would benefit:

• Individual at risk of overdose

• Family member, friend, or other person in a position to assist a person at risk of overdose

• Trained First Responder

• Trained School Nurse

• PA99-480 establishes that Department of Financial and Professional Regulation in accordance with the Department of Human Services and the Department of Public Health may approve the standardized procedures for pharmacists.

Continuing Pharmacy Education• Eligible pharmacists must have completed:

• A Certificate Training Program in Opioid Overdose

Prevention;

• Be CPR certified, in accordance with 68 IAC

1330.50 (a) (4)

The pharmacist shall maintain a current Basic

Life Support Certification for Healthcare

Providers issued by the American Heart

Association, the American Red Cross, the

American Safety and Health Institute, or an

equivalent as determined by the Division.

• Training Program shall consist:

Opioid overdose prevention;

Reducing the risk of prescription opioid abuse;

Safe use of opioids for the management of chronic

pain;

Use of screening tools to detect opioid abuse or

dependency and management of difficult patients;

Preventing diversion of prescribed opioid

medications;

Naloxone administration techniques;

Knowledge of Protocol for Naloxone Standing

Order for Opioid Antagonist Initiative.

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Standardized Procedures• Once pharmacists have completed the certified Naloxone Antagonist Training (such as this course)

and wish to participate in the Illinois Naloxone Antagonist Overdose Prevention Program:

• The pharmacy may request a copy of the Standardized Procedures for Naloxone Opioid Overdose by contacting the Illinois Prescription Monitoring Program (ILPMP) at their website –ilpmp.org.

• The Standardized Procedures covers dispensing and possession of Naloxone Kits.

• Kits include: Naloxone HCl, IM syringe, injection supplies, nasal atomizers, or commercial Naloxone auto-injectors.

• The Standardized Procedures authorizes the pharmacist to maintain supplies for Naloxone Kits to dispense according to the Protocol for the identified individuals.

IM = intramuscular

Pharmacist Standardized Procedure to Dispense Naloxone

• The Protocol allows the Pharmacist to dispense one Naloxone Kit to an identified individual.

• Individual is approved to receive Naloxone by meeting the criteria outlined in the standardized procedures.

• 1. Individual is a person at risk of experiencing an opiate-related overdose or a family member, friend, or other person in a position to assist a person at risk of experiencing an opiate-related overdose.

• 2. Individual has received counseling by a pharmacist trained in the use of Naloxone regarding the recognizing and responding to suspected opioid overdose.

• Family member, friend, or other person in a position to assist a person at risk of overdose

• Trained First Responder

• Trained School Nurse

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Auto-injector Kits Containing the following:• Naloxone HCL 0.4 mg/ml

pre-packaged kits (Evzio, NDC 60842-030-01)

• Containing 2 auto-injectors with audio instructions and 1 training device and step by step instructions for administration of Naloxone by auto-injector.

Pharmacist Standardized Procedure to Dispense Naloxone

Intramuscular Naloxone Kits contain the following,

at a minimum:• Two (2) single-use 1 ml

vials Naloxone Hydrochloride (0.4mg/ml)

• Two (2) intramuscular needle syringes

• Overdose prevention information pamphlet with step by step instructions for use.

Intranasal Naloxone Kits containing, at a minimum:• Two 2 ml Luer-Jet Luer-

lock syringes prefilled with Naloxone Hydrochloride (2mg/2ml)

• Two mucosal atomization devices

• Overdose prevention information pamphlet with step by step instructions for use.

Counseling is required to cover the proper use of the dosage forms listed below:

Standardized Procedures for Naloxone Distribution for Overdose Prevention - December 2015

The Pharmacist shall review the “Directions for Use”:

1. Evaluate the individual for signs and symptoms of potential Opioid or Heroin Overdose.

2. If individual is not breathing, start rescue breathing using a disposable rescue breathing device.

3. Administer Naloxone as follows (of the select dispensed dosage form).

4. Call 911 as soon as possible for a person suspected of an opioid overdose with respiratory depression or unresponsiveness.

5. Continue rescue breathing and monitor respiration and responsiveness of the Naloxone recipient until emergency help arrives.

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Standardized Procedures for Naloxone Distribution for Overdose Prevention - December 2015

Auto-injector Naloxone:

• Pull auto-injector from outer case pull off red safety guard.

• Place the black end of the auto-injector against the outer thigh, through clothing if needed, press firmly and hold in place for 5 seconds.

• Repeat if there is no response after three minutes.

Intramuscular Naloxone:

• Uncap the Naloxone vial and uncap the muscle needle-syringe.

• Insert the muscle needle through the rubber membrane on the Naloxone vial, turn the vial upside down, draw up 1 ml of Naloxone liquid, and withdraw the needle.

• Insert the needle into the muscle of the upper arm or thigh of the victim, through clothing if needed, and push on the plunger to inject the Naloxone.

• Repeat the injection if there is no response after three minutes.

Intranasal Naloxone:

• Pop off two colored caps from the delivery syringe and one from the Naloxone vial.

• Screw the Naloxone vial gently into the delivery syringe.

• Screw the mucosal atomizer device onto the top of the syringe.

• Spray half (1 ml) of Naloxone in one nostril and the other half (1 ml) in the other.

• Repeat if there is no response after three minutes.

The Pharmacist shall cover how to administer Naloxone as follows (of the select dispensed dosage form):

Counseling Protocol for Naloxone Standardized Procedures

The Pharmacist shall cover the following areas in counseling the individual on the use of Naloxone.

Indications and Usage;

Assessment;

Provider Actions;

Follow Up Requirements;

Contraindications;

Precautions;

Adverse Reactions.

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Counseling Protocol for Naloxone Standardized Procedures

Indications and Usage:

• Naloxone is indicated for the complete or partial reversal of opioid

overdose induced by natural or synthetic opioids and exhibited by

respiratory depression or unresponsiveness.

Counseling Protocol for Naloxone Standardized Procedures

Assessment:

• Subjective Findings

• Individual is at risk of experiencing an opiate-related overdose or is in a position to assist a family member, friend, or other person at risk of experiencing an opiate-related overdose.

• Individual reports no known sensitivity or allergy of the intended recipient to Naloxone Hydrochloride.

• Objective Findings

• In the pharmacist’s judgement, the client is oriented to person, place, and time and able to understand and learn the essential components of overdose response and Naloxone administration.

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Counseling Protocol for Naloxone Standardized Procedures

Provider Actions:

• Screen individual for contraindications / precautions to dispensing Naloxone.

• If a contraindication / precaution exists, refer individual to medical provider for evaluation.

• Provide Opioid overdose training information which covers at least the following:

1. Risk factors for opioid overdose and possible prevention actions;

2. Recognition of opioid overdose;

3. Calling 911;

4. Rescue breathing, using a disposable rescue breathing device.

5. Administration of Naloxone as described within the Standardized Procedures.

• Upon the successful counseling session, the pharmacist will dispense the Naloxone kit and explain contents to individual.

• The pharmacy is to report dispensed kits to the ILPMP with daily reporting of dispensed controlled substances.

• As part of the mandatory counseling function, the pharmacist shall provide information and /or referral for substance abuse or behavioral health treatment options.

Counseling Protocol for Naloxone Standardized Procedures

Follow Up Requirements:

• The pharmacist shall instruct individual/parent/guardian to call medical provider if questions, concerns, or problems arise.

• The pharmacist shall, instruct individual/parent/guardian to return for refill as needed, subject to use and expiration of Naloxone (approx. 18 months).

• The pharmacist shall encourage opioid user or other concerned individual to communicate with primary care provider regarding overdose, use of Naloxone, and availability of behavioral health services.

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Counseling Protocol for Naloxone Standardized Procedures

Contraindications:

• Patient is known to be hypersensitive to Naloxone Hydrochloride.

Counseling Protocol for Naloxone Standardized Procedures

Precautions:

• Pre-existing cardiac disease or seizure disorder

• Person is suspected to be physically dependent on opioids including newborns of mothers with narcotic dependence. (Reversal of narcotic effect will precipitate acute abstinence syndrome).

• Use in Pregnancy:

1. Teratogenic Effects: Pregnancy category C, no adequate or well-controlled studies in pregnant women.

2. Non-teratogenic Effects: Pregnant women known or suspected to have opioid dependence often have associated fetal dependence. Naloxone crosses the placenta and may precipitate fetal withdrawal symptoms as well.

• Nursing Mothers: Caution should be exercised when administering to nursing women due to transmission in human milk. Risk and benefits must be evaluated.

• Geriatric Use: Choose lower range dose taking precautions for potential decreased hepatic, renal and cardiac function, as well as, concomitant disease and other pharmacotherapies.

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Counseling Protocol for Naloxone Standardized Procedures

Adverse Reactions:

• Adverse reactions are related to reversing dependency and precipitating withdrawal and includes fever, hypertension, tachycardia, agitation, restlessness, diarrhea, nausea/vomiting, myalgia, diaphoresis, abdominal cramping, yawning, sneezing.

1. These symptoms may appear within minutes of Naloxone administration and subside in approximately 2 hours.

2. The severity and duration of the withdrawal syndrome is related to the dose of Naloxone and the degree of opioid dependence.

• Adverse effects beyond opioid withdrawal are rare.

Clinical Documentation and Recordkeeping

• All records shall be kept for at least five (5) years as according to the Pharmacy Practice Act - 225 ILCS 85. This shall include:

• Prescription Records (including from a pharmacy workflow management system);

• Any corresponding clinical and/or patient documentation completed.

• Naloxone dispensing records shall be transmitted to the Illinois Prescription Monitoring Program within one (1) business day as required according to the authority given the ILPMP – 720 ILCS 570/316, 570/318.

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Claiming of CPE Credits• The participant must complete the following:

• All components of the Illinois State Opioid Antagonist Training Program;

• Successfully complete the post-test examination (70% passing score required);

• Complete the Training Program evaluation.

• The participant’s information and CPE credit will be electronically submitted to the NABP CPE monitor by the Illinois Pharmacists Association.

• The participant’s record of completion of the Illinois State Opioid Antagonist Training Program will be electronically submitted to the Illinois Prescription Monitoring Program by the Illinois Pharmacists Association.

• Any questions:

• Concerning the completion of the Training Program, please contact the Illinois Pharmacists Association at 217/522-7300 or via email at [email protected].

• Concerning your record of completion or access to the Standardized Procedures, please contact the Illinois Prescription Monitoring Program at 217/524-1311, 217/785-9013, or 217/524-2158 or via email at ilpmp.org contact page.

Recourses to Further Education• Public Act 099-0480

http://www.ilga.gov/legislation/publicacts/99/PDF/099-0480.pdf

http://www.ilga.gov/legislation/publicacts/fulltext.asp?Name=099-0480

• Illinois Controlled Substance Act

http://www.ilga.gov/legislation/ilcs/ilcs5.asp?ActID=1941

• Illinois Prescription Monitoring Program (ILPMP)

https://www.ilpmp.org/

• Opioid Treatment Program Directory - SAMHSA

http://dpt2.samhsa.gov/treatment/

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