October 20 th , 2016 Integrated Care Conference Disclosure I do - - PowerPoint PPT Presentation

Maggie Mendes, Pharm.D VA Academic Detailing Service October 20th, 2016 Integrated Care Conference



Disclosure

I do not have relevant financial relationships with commercial interests.

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Objectives

 Clarify the purpose and importance of OEND programs  Identify the role naloxone has in opioid overdose prevention  Discuss the Recommendations For Use of Naloxone Rescue Kits from National PBM  Review different formulations of naloxone kits  Demonstrate patient education on overdose response

3

 Examples of Prescription Opioids

NIDA www.drugabuse.gov

 Statistics

6% of the US population is on chronic opioids 5% of the entire population of the World is in the US AND 80% of

• pioids are

consumed in the US

5

 Statistics

6



Alarming Statistics

 Opioid death rates have quadrupled since 1999  CDC declared an epidemic  Veterans are twice as likely to die from accidental

• verdose compared to non-

Veterans  Veterans at highest risk:  MH diagnosis/PTSD  ≥ 100mg MEDD + SUD

4,030 deaths 16.917 deaths

Opioid Analgesic Poisoning Death Rates: United States, 1999- 2011

• Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999–2011. Page last updated Sept 16, 2014.
• Bohnert AS, et al. Med Care 2011;49: 393–396.
• VA PBM Naloxone Kits RFU, Sept 2014



http://teens.drugabuse.gov/blog/post/drug-overdoses-kill-more-cars-guns-and-falling-update

 Why Do People Overdose?

75% 17% 8% Accident Suicide Unknown 75% of overdoses are ACCIDENTAL

JAMA 2013;309(7):657.

Accidental opioid overdose can affect anyone including celebrities

Prince

Musician Died June 2016, at age 57 from an accidental overdose of fentanyl

“We need to see the Prince in all of us. We need to see the

• vulnerability. We are

all vulnerable here. It’s a wake-up call for how we view these drugs.”

• Dr. Kessler, former commissioner of

the FDA

Photo by Vince Bucci/Getty Images

 Timeline

1996 Purdue releases Oxycontin 1998 VA and JCAHO adopt pain as the 5th vital sign 2007 Purdue plead guilty to false branding of Oxycontin 2008 Drug

• verdoses

surpass MVA 2013 heroin addiction has incresed 286%

Heroin Addiction and Overdose

Heroin addiction can result from RX opioid pain killers



New Threat: Fentanyl and Carfentanil

https://www.drugabuse.gov/drugs-abuse/emerging-trends-alerts



Where do opioids come from?

15

Opioid Dose and Overdose Risk

16

2 4 6 8 10 12 14 1

• 19

mg/d 20

• 49

mg/d 50

• 99

mg/d ≥ 100 mg/d

Hazard Ratio

Morphine MG Equivalent Dose

Chronic Pain Acute Pain SUD Cancer

Bohnert et al. JAMA. 2011;305(13):1315-1321.

Other consequences

Cost of US Prescription Opioid Epidemic

Curtis S. Florence, Chao Zhou, Feijun Luo, Likang Xu. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Medical Care, 2016; 54 (10): 901 DOI: 10.1097/MLR.0000000000000625

 Pain Management Is Important

 It is important to manage pain safely and effectively  Chronic pain is the most common cause of work disability6  Chronic pain is a serious and highly prevalent condition among OIF/OEF service members6  60% of OIF/OEF veterans returning home list chronic pain as a problem  However…  Chronic opioid use is associated with higher rates of disability, medical cost and surgeries7-10  A population based cohort study found that the odds

• f recovery from chronic

pain were almost 4 times higher among individuals not using opioids compared with individuals using opioids10

19

OIF=Operation Iraqi Freedom, OED=Operating Enduring Freedom

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Patient and Family Strategies to Prevent Overdose

1) Encourage persons at high risk and family members to learn how to prevent and manage opioid overdose 2) Ensure safe medication handling and disposal 3) Know what you are taking 4) Encourage the public to call 911 5) Have an overdose plan 6) Remove stigma of addiction

http://projectlazarus.org http://store.samhsa.gov/product/Opioid-Overdose-Prevention- Toolkit/SMA13-4742

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Prescriber Strategies to Improve Opioid Safety

 Obtaining informed consent  Re-examining high dose opioids  Annual urine drug screening for all patients on chronic opioid therapy  Participation in Prescription Drug Monitoring Program  Reassessing opioid + benzodiazepine combinations  Next steps....O.E.N.D

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What is OEND?

 Opioid Overdose Education and Naloxone Distribution  A harm reduction and risk mitigation initiative that aims to decrease opioid-related overdose deaths  Key Components

 Education and training regarding opioid overdose prevention  Recognition of opioid overdose  Opioid overdose rescue response  Issuing naloxone kits

VA PBM Naloxone Kits RFU, Sept 2014

 Opioid receptors

Mu:  Analgesia  Sedation  Euphoria  Respiratory depression  Constipation  Physical Dependence Kappa:  Mild analgesia  Less respiratory depression Delta:  Mild analgesia

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What is Naloxone?

 Competitive opioid antagonist  Bystander administered like epinephrine or glucagon  Routes: IV, IM, SC, IN  Onset: 2-3 min  DOA: 30-90 min  Bioavailability: 4% IN, 36% IM  Metabolism: hepatic  Antagonist at mu, kappa, and delta receptors  Shows little to no pharmacological effect in patients who have not received opioids

Opioid receptor Naloxone Opioids

• Dowling J, et al. Ther Drug Monit. 2008;30(4):490-6.
• Naloxone package insert
• VA PBM Naloxone Kits RFU, Sept 2014

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Naloxone Safety and Tolerability

• Can induce acute withdrawal

⁻ Agitation/aggression ⁻ NV ⁻ Tremor ⁻ Sweating ⁻ Confusion

• Rare Adverse Effects:
• Seizures
• Pulmonary edema
• Arrhythmias
• Naloxone package insert
• Mariana PJ. Am J Emerg Med. 1989:7:127-29VA PBM
• Naloxone Kits RFU, Sept 2014

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Highest Risk for Overdose

 After a period of abstinence (hospital, residential, detox., or jail /prison)  When using multiple drugs or multiple opioids, especially respiratory depressants (downers, benzodiazepines, barbiturates, alcohol, other opioids, cocaine)  When illness is present (liver/cirrhosis, heart, lung)  When using long-acting opioids or potent / strong opioids (fentanyl)  When using high doses of opioids  When using alone and distressed  Previous overdose

UNODC Opiate Overdose SAMHSA Opiate Overdose Toolkit Harm Reduction Coalition: Opiates

Who Seems to Benefit from OEND?

Direct Association with Benefit Risk criteria used in community health OEND programs associated with reduction in opioid overdose deaths*  Heroin or other injection drug use  Substance use  Opioid or drug use disorder diagnosis  High likelihood of opioid

• verdose or witnessing

an opioid overdose.

VA PBM Recommendations for OEND 2016

Who May Potentially Benefit from OEND?

Indirect Association with Potential Benefit Factors associated with an increased risk for fatal or nonfatal opioid overdose or any drug overdose death in U.S. Veterans. Some of these criteria have been used by an established OEND program without outcome data.

Identified Patient Risk Factors

• SUD diagnosis
• PTSD or other MH diagnosis
• Suspected or confirmed history of heroin or nonmedical
• pioid use
• Male Veterans 30–59 years old
• Any opioid prescription and known or suspected

smoking, COPD, emphysema, asthma, sleep apnea,

• ther respiratory system disease; renal or hepatic

disease; alcohol use Identified Prescription Risk Factors

• High-dose opioid prescription (50 to 100 mg or more

MEDD)

• Long-acting non-tramadol opioid
• Methadone initiation in opioid-naïve patients
• Opioid prescription with concomitant benzodiazepine

use or concurrent antidepressant prescription Situational Risk Factors or Criteria

• Loss of opioid tolerance and likely to restart opioids

(e.g., recent release from jail or prison / post- incarceration re-entry programs)

• Remoteness from or difficulty accessing [emergency]

medical care

• Voluntary patient request

VA PBM Recommendations for OEND 2016

Who May Potentially Benefit from OEND?

Clinical Judgment of Potential Benefit Common factors found in drug overdose deaths in nonveterans; factors associated with increased risk for nonfatal overdose or for respiratory depression from

• pioid therapy, and other

clinical factors suggested by experts

Identified Patient Risk Factors

• Previous suicide attempt or on high-risk suicide

list

• Outpatient opioid prescription with the

following:

• Unstable renal or hepatic disease
• Cardiac illness
• HIV/AIDS
• Age 65 years or older, cognitive impairment or

debilitated condition

• Voluntary caregiver request

Identified Prescription Risk Factors

• Home-based continuous intraspinal opioid

infusion

• Home-based patient-controlled opioid infusion
• Opioid rotation to methadone
• Opioid induction, upward titration or rotation

(for SUD or pain) Situational Risk Factors

• Fear of police arrest (reluctance to call 911)
• Aberrant opioid use / misuse (e.g., early fills;

extra doses; overlapping, multi-site fills). VA PBM Recommendations for OEND 2016

 Indications for Naloxone

Taking or using

• pioids (or likely to)?

THINK/OFFER NALXONE!

Many factors can influence risks of fatal

• pioid overdose

We can’t predict who will overdose and when a will need a kit

 CDC Guidelines

• If ≥ 50 MME /day total (≥ 50 mg

hydrocodone; ≥ 33 mg oxycodone),increase frequency of follow-up; consider

• ffering naloxone



Opportunity of Intervention to Prevent Fatal Opioid Overdoses

 Many overdoses occur in the presence of others  Typically take 1-2 hours to result in death  Responding is not medically complicated

 Rescue breathing + Naloxone

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Assessing the Signs

INTOXICATION OVERDOSE Will respond to stimulation like yelling, sternum rub, pinching, etc. Heavy nod, will not respond to stimulation Nodding out Breathing is very slow, irregular, or has stopped/faint pulse Muscles become relaxed Deep snoring or gurgling (death rattle) or wheezing; less than 1 breath every 6-8 seconds Speech is slowed/slurred Blue or grayish skin- usually lips and fingertips begin to darken first Sleepy looking Sweaty, clammy skin

VAPAHCS OEND Trainer’s Manual

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Opioid Overdose Response with Naloxone

911-NARC-RECOVERY

• 1. Call 911
• 2. Give Naloxone
• 3. Airway Open

− Rescue Breathing − Chest Compressions

• 4. Recovery Position

VA Opioid Overdose Response with Naloxone Intranasal Kit Brochure



Call 911

 Check for a response

 Give person a light shake, say person’s name, firmly rub person’s sternum with knuckles, hand in a fist  If person does not respond (i.e., wake up and stay awake) – CALL 911  Give the address and say the person is not breathing

VAPAHCS OEND Trainer’s Manual



Legal

 911 Good Samaritan Law effective January 1, 2013

 Protect caller and overdose victim from arrest and/or prosecution for simple drug possession, possession of paraphernalia, and/or being under the influence  Does not provide immunity against:

 sales or distribution  forcibly administering a drug against a person’s will  DUI or drugged driving

 California Civil Code 1714.22 effective January 1, 2014

 Removes civil/criminal liability for prescribers  Removes civil/criminal liability for lay administration  No criminal liability for possession without a prescription

http://www.drugpolicy.org/911-good-samaritan-fatal-overdose-prevention-law

 Administer Naloxone

 If there is no response to stimulation and initial breaths, administer naloxone  Naloxone should take effect in 3-5 minutes (may need second dose)  Naloxone wears off in 30-90 minutes

 Patient can go back in to overdose, particularly if they used LA opioids  Dependent patients may experience withdrawal symptoms and may want to use again to alleviate discomfort



Intramuscular Naloxone Kit

 2 naloxone 0.4 mg/ml (1 ml) vials  2 syringes 3 ml, 25g, 1-inch needle  2 alcohol pads  1 face shield  1 pair nitrile gloves  1 opioid safety brochure  1 IM naloxone kit brochure  1 black zippered pouch

VA PBM Naloxone Kits RFU, Sept 2014

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Give Naloxone (IM)

VA Opioid Overdose Response with Naloxone Intramuscular Kit Brochure

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Intranasal Naloxone Kit

 2 naloxone 1 mg/ml (2ml) prefilled needleless syringes  2 mucosal atomizer devices  1 face shield  1 pair nitrile gloves  1 opioid safety brochure  1 IN naloxone kit brochure  1 blue zippered pouch

VA PBM Naloxone Kits RFU, Sept 2014

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Give Naloxone (IN)

VA Opioid Overdose Response with Naloxone Intranasal Kit Brochure

 Naloxone Auto Injector (Evzio)

 Http://evzio.com/hcp/



Give Naloxone Auto Injector (Evzio)

VA Academic Detailing Patient Guide

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FDA Approved Nasal Spray (Narcan)



Give Naloxone Nasal Spray (Narcan)

VA Academic Detailing Patient Guide

Route of Administration Comparison

Intramuscular (IM) Naloxone Intranasal (IN) Naloxone Advantages

• Formulation manufactured for this route
• ↓risk of needlestick injury
• Similar responder rate vs. IV
• ↓ risk of blood-borne virus transmission
• Fewer assembly steps
• Easy access to nares

Disadvantages

• Risk of blood-borne virus transmission
• May have ↓ bioavailability
• Risk of needlestick injuries
• Similar/slightly ↓ responder rate
• Risk of injury from improper injection

technique

• Nasal abnormalities and prior IN drug

use may ↓ effectiveness

• Requires competence in techniques for

extraction of drug from vial and injection

• Not manufactured in a formulation for

this route (injectable form is aerosolized)

• Requires adequate muscle mass
• Involves more steps to assemble

VA PBM Naloxone Kits RFU, Sept 2014

Airway Open

 Rescue Breathing

If overdose is witnessed i.e., you see the person stop breathing  Place face shield (optional)  Tilt head back, lift chin, pinch nose  Give 2 slow breaths  Chest should rise  Give 1 breath every 5 seconds

 Chest Compressions

If overdose is UNwitnessed; i.e., you find someone not breathing  Place heel of one hand over center of person’s chest (between nipples)  Place other hand on top of first hand, keeping elbows straight with shoulders directly above hands  Use body weight to push straight down, at least 2 inches, at rate of 100 compressions per minute  Place face shield (optional)  Give 2 breaths for every 30 compressions

VA Opioid Overdose Response with Naloxone Intranasal Kit Brochure

Recovery Position

 If the person is breathing but unresponsive, put the person on his/her side to prevent choking if person vomits  Because naloxone wears off in 30-90 minutes and the person may stop breathing again

 Stay with person until emergency medical staff arrive  If person’s breathing stops, give 2nd dose of naloxone

VAPAHCS OEND Trainer’s Manual

What Naloxone Administration Does NOT Look Like

Pulp Fiction 1994

 Common Concerns

 “Will I hit a bone? He is too skinny. I’ll hurt her.”  “Is it like that scene in Pulp Fiction?”  Difficulty- drawing up fluid in syringe  Re-capping  “If they are not breathing, how will the naloxone work?”  “What if they have a cold?”

 Naloxone might not work if

 The overdose was misdiagnosed  The overdose involved other drugs  The overdose happened too long ago  There are other complicating medical conditions / events (seizure, heart attack)  The victim has an allergy to naloxone (rare) Critical to have timely medical support in the case the naloxone does not work!



Managing someone reversed with naloxone

 Victim will not know they overdosed  Might experience withdrawal symptoms  Responder should explain

 Naloxone was used to reverse overdose  Naloxone wears off in 30-90 minutes; opioid is still in the body and overdose could return  Using more opioids will not alleviate the withdrawal symptoms and may worsen the overdose

 Is this cost effective?

Coffin PO, Sullivan SD. Ann intern Med. 2013;158(1):1-9



Potential Behavioral Impact

http://www.fda.gov/downloads/Drugs/NewsEVents/UCM304621.pdf Patient and Provider Interview: San Francisco Department of Public Health. July 2014



 Pharmacist Training: A pharmacist must successfully complete a training program with a minimum of one hour

• f approved continuing education on the use of naloxone

prior to furnishing  Patient Education: The pharmacist must provide education, including opioid overdose education (prevention, recognition, and response), administration of naloxone, potential side effects or adverse effects, and the requirement to seek emergency medical care for the

• patient. The pharmacist must ensure that the information

is understood and all questions are answered before the naloxone kit is provided

California Pharmacist Protocol for Furnishing Naloxone (AB 1535)



 Primary Care Physician notification. If patient allows consent, the patient’s treating physician should be notified once the naloxone kit is furnished, otherwise refusal should be documented.  Prescription order

Required Documentation

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Summary of Key Points

 OEND aims to reduce opioid-related

• verdose through the provision of

training, education, and naloxone distribution to people at risk for

• pioid overdose

 Community OEND programs have revealed decreased mortality  Naloxone is an opioid antagonist that is safe and effective  Overdose education and naloxone kits complement, and do not replace, safe and responsible opioid use  Kits are easily available through prescriptions, community outreach and through pharmacist protocol.



Resources

 Office of National Drug Control Policy (ONDCP) supports overdose prevention and use of naloxone as part of national prevention and treatment efforts  http://www.whitehouse.gov//sites/default/files/ondcp/preven1on/  SAMHSA Toolkit (http://store.samhsa.gov/products/sma13-4742  Includes information for prescribers on:  Legal and liability concerns  Claims coding and billing  Additional resources  College of Psychiatric and Neurologic Pharmacists  http://cpnp.org/guideline/naloxone  Taking Opioids Responsibly for Your Safety and the Safety of Others  http://www.ethics.va.gov/docs/policy/Taking_Opioids_Responsibly_2013528.pdf  Community-Based Overdose Prevention and Naloxone Distribution Program Locator  Identifies programs outside of the VA that distribute naloxone  http://hopeandrecovery.org/locations/  Prescribe to Prevent  Patient resources and videos demonstrating overdose recognition and response, including naloxone administration  http://prescribetoprevent.org/video

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References

 Albert S, Brason FW 2nd, Sandord CK, et al. Project Lazarus: community-based overdose prevention in rural North Carolina. Pain Med. 2011;12 Suppl 2:S77-85.  Bohnert AS, Ilgen MA, Galea S, et al. Accidental Poisoning Mortality Among Patients in the Department of Veterans Affairs Health System. Med Care 2011;49:393-396.  Centers for Disease Control and Prevention. Prescription Drug Overdose in the United States: Fact Sheet. http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html. Accessed October 28, 2014.  Centers for Disease Control and Prevention. Prescription Painkiller Overdoses in the US. Available at: http://www.cdc.gov/vitalsigns/PainkillerOverdoses/index.html, Accessed Oct 28, 2014.  Centers for Disease Control and Prevention. Prescription Painkiller Overdoses Policy Impact Brief. Available at: http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. Accessed: October 28, 2014.  Centers for Disease Control and Prevention. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999–2011. Available at: http://www.cdc.gov/nchs/data/databriefs/db166.htm. Accessed October 29, 2014.  Dowling J, Isbister GK, Kirkpatrick CM, et al. Population Pharmakokinetics of Intravenous, Intramuscular, and Intranasal Naloxone in Human

• Volunteers. Ther Drug Monit. 2008;30(4):490-6.

 Harrington LW: Acute Pulmonary Edema Following Use of Naloxone: A Case Study. Crit Care Nurse. 1988;8:69-73.  Interim Recommendations for Issuing Naloxone Kits for the VA Overdose Education and Naloxone Distribution (OEND) Program. Washington, DC: Pharmacy Benefits Management Services, Medical Advisory Panel and VISN Pharmacist Executives, Veterans Health Administration, Department of Veterans Affairs; September 2014.  Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws. https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf. Accessed November 3, 2014.  Mariana PJ. Seizure Associated with Low Dose Naloxone (Letter). Am J Emerg Med. 1989:7:127-29  Product Informtion: Naloxone HCl injection. Hospira, Inc, Lake Forest, IL, 2005.  Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. BMJ. 2013;346:f174.  Wheeler E, Davidson PJ, Jones S, et al. Community-based Opioid Overdose Prevention Programs Providing Naloxone. Morbidity and Mortality Weekly

• Report. 2012;61(6):101-105.

 VA Palo Alto Health Care System Opioid Overdose Education and Naloxone Distribution Trainer’s Manual. October 2013.  911 Good Samaritan Fatal Overdose and Prevention Law. http://www.drugpolicy.org/911-good-samaritan-fatal-overdose-prevention-law. Accessed November 3, 2014.