Opioid Overdose: What the Data Tell Us About Who is at Risk June 12, - - PowerPoint PPT Presentation

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Opioid Overdose: What the Data Tell Us About Who is at Risk June 12, - - PowerPoint PPT Presentation

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Opioid Overdose: What the Data Tell Us About Who is at Risk June 12, 2015 Exploring Naloxone Uptake and Use Public Meeting Christopher M. Jones PharmD, MPH Senior Advisor Office of Public Health Strategy and Analysis Office of the Commissioner Food

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Opioid Overdose: What the Data Tell Us About Who is at Risk

June 12, 2015 Exploring Naloxone Uptake and Use Public Meeting

Christopher M. Jones PharmD, MPH Senior Advisor Office of Public Health Strategy and Analysis Office of the Commissioner Food and Drug Administration

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Overview

  • Background
  • Patients receiving prescription opioids
  • Potential data sources to identify patients

for naloxone co-prescription

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BACKGROUND

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Who Should Receive Naloxone

Patient Characteristics Naloxone Provision People with prior history of overdose People receiving medical care for an opioid overdose People who inject drugs People with opioid use disorder People released from criminal justice system with history of opioid abuse Patients receiving opioids for pain

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PATIENTS RECEIVING PRESCRIPTION OPIOIDS

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Patients Receiving Prescription Opioids

  • Should all patients be offered naloxone?
  • What do the data tell us about who is at

risk for an overdose?

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Percent of patients with opioid poisoning

Prescription History Among People with Opioid Poisoning

60 50 40 30 20 10 1 2-10 >10 1-29 30-89 ≥ 90 1-19 20-49 50-89 90-119 ≥ 120 Number of Opioid Rxs In Year Total Days Supply in Year MED/Day in Week Prior to Event Before Event Before Event

Source: Fulton-Kehoe, Garg, Turner et al. J Ind Med. 2013 7

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Past Year Prescription Behaviors Among

Percent of patients receiving an opioid 50 45 40 35 30 25 20 15 10 5

Opioid Overdose Deaths

n=2,024,551

47.1 44.6 1.6 7.6 2.5 2.8 0.3 1 Rx 2-12 Rxs ≥ 25 Rxs ≥ 4 Prescribers ≥ 4 RPHs > 100 MMEs 3 High-risk factors

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Source: Baumblatt et al.,. JAMA IM. 2014;174:796-801.

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Opioid Overdose Deaths and Relationship with Multiple Prescribers and Pharmacies

Source: Baumblatt et al.,. JAMA IM. 2014;174:796-801.

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Opioid Overdose and Relationship with Opioid Dose

Source: Baumblatt et al.,. JAMA IM. 2014;174:796-801.

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Opioid Overdose and Relationship with Opioid Dose

10 100

1 1.44 3.73 8.87

1-19 20-49 50-99 100+ 9 90 8 80 7 70 6 60 Risk (Odds Ratio) 5 50 4 40 3 30 2 20 1 10 Opioid dosage (MME/d) % Patient Years

Source: Dunn et al, Ann Int Med 2010.

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Percent 100 90 80 70 60 50 40 30 20 10

Opioid Overdose and Relationship with Opioid Dose

Pct of Controls Pct of Deaths Pct of MME

89.8 4.3 2.6 3.5 48.4 11.0 13.8 26.8 32.2 4.4 5.5 57.8 <20 >20-40 >40-100 >100

Average Opioid Dosage over six months (MME/day)

Source: Unpublished data from New Mexico case-control study. Paulozzi et al, Pain Medicine. 2012.

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Overdose death rate per 1,000 person-months

2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0

Opioid Overdose and Relationship with Opioid Dose

Acute Pain Dx CNCP Dx 1 to < 20 20 to < 50 50 to < 100 ≥ 100 Maximum prescribed daily opioid dose, mg/day

Source: Bohnert et al., JAMA 2011. 13

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Opioid Overdose Incidence Rate by Prescription History

30 Incidence rate, per 1,000 person-years 25 20 15 10 5 4.3 18.5 10.7 26.3 No Shopping/No Overlap No Shopping/Overlap Shopping/No Overlap Shopping/Overlap

  • Overlapping prescriptions defined as 2 prescriptions of the same drug type that overlapped by 25% of the days prescribed, with the initial dispensed

prescription having a supply time of 5 days or longer.

  • Pharmacy shopping defined as ≥ 4 pharmacies in a 90 day setting.

Source: Yang, W ilsey, Bohm, et al. J Pain 2015 14

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15 9.7 11.1 25.0 32.4 89.3 25.9 43.6 30.0 63.1 37.5 31.4

Small Percentage of Patients Account for Greatest Risk

Non-users Other users Daily users

1.0

100 Percent of Patients and Percent of Events 90 80 70 60 50 40 30 20 10 Patients Drug abuse diagnoses Drug overdoses Opioid overdoses

Source: Paulozzi, Zhang, Jones, Mack, J Am Board Fam Med. 2014

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Additional Considerations for People Receiving Prescription Opioids

  • Concurrent benzodiazepine or other

sedative/hypnotic prescription

  • History of non-opioid substance use

disorder

  • History of mental health disorder
  • Underlying respiratory conditions
  • Family member/co-habitant at-risk for
  • pioid overdose

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POTENTIAL DATA SOURCES TO IDENTIFY PATIENTS FOR NALOXONE CO-PRESCRIPTION

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Data sources

  • PDMPs
  • Insurer/PBM claims data
  • EHR systems
  • ED data systems

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Conclusions

  • There is not yet consensus on which patients receiving

prescription opioids should be offered naloxone

  • The available data provide a foundation for developing a

risk-based approach to naloxone co-prescription

– Common factors among overdose decedents include:

  • High opioid dose, longer duration of treatment, and large supply;

concomitant benzodiazepine Rx, multiple providers/pharmacies, history of SUD/MH, underlying respiratory conditions

  • Some advocate a strategy of offering naloxone to all

patients receiving prescription opioids

  • Additional research is needed to identify most effective

strategy for naloxone co-prescription

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Questions?

Christopher.M.Jones@fda.hhs.gov The findings in this presentation do not represent the official position of the US Food and Drug Administration, the Department of Health and Human Services, or the U.S. Government

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