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Why Rethink Opioids?: The Problem of Prescription Opioid Abuse

Abuse of Prescription Opioids Is a Serious and Growing Problem

Redoubling Our Efforts to Combat the Problem

Given the magnitude of the problem, addressing the opioid epidemic has become a top priority among federal agencies, state legislatures, payors, pharmaceutical companies, and providers. As such, significant efforts have been undertaken to eliminate misuse, abuse, and diversion of prescription opioids.

Of particular note are the 2016 reforms enacted by Congress, including the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act, both of which authorize additional funding for opioid prevention, treatment, and educational programs.1,2

State-led legislation has included (but has not been limited to) expanding the use and efficacy of prescription drug monitoring programs (PDMPs), updating prescribing guidelines, encouraging (or requiring) pain management education for opioid prescribers, implementing the use of pain treatment agreements, and improving patient access to naloxone and other treatment and recovery services.3

Federal agencies, including the Food and Drug Administration (FDA) and Centers for Disease Control (CDC), have both been focused on combating opioid abuse. In recent years, the FDA has implemented several labeling changes and new boxed warnings that highlight the risks of misuse and abuse with prescription opioid analgesics and the need to consider nonopioid treatments as first-line therapy.3-5

Additionally, the FDA considers the development of abuse-deterrent opioids (ADOs) to be a high public health priority.6 While not abuse-proof, ADOs can serve as an additional step to discourage opioid abuse. Accordingly, the FDA has issued guidance on appropriate evaluation and labeling of ADOs and recommended a path forward for the development of generic ADOs.7 The CDC also released guidelines that address appropriate use of opioids, as well as outline approaches for assessing and mitigating the risk of opioid abuse.8

The problem of prescription opioid misuse, abuse, and diversion will not be solved by any one group of individuals, but clearly, health care providers can play a lead role in helping to encourage the appropriate use of opioids. While opioids are potentially harmful medications, they can be beneficial when used appropriately. Rethink Opioids helps to highlight some of the strategies that clinicians can adopt to help mitigate opioid abuse, including comprehensive patient assessment and screening to identify clinically appropriate patients for opioid therapy and implementation of universal precautions (eg, risk evaluation, use of ADO formulations, and ongoing patient monitoring) when prescribing opioids.

Data from the Centers for Disease Control and Prevention indicate that deaths involving prescription opioid overdose have quintupled in the last 15 years.1,2 Pharmaceuticals, and prescription opioids in particular, have driven this increase. Nearly half of all opioid overdose deaths in the United States involve a prescription opioid.2

References

  1. National Center on Health Statistics, CDC Wonder. National Overdose Deaths from Select Prescription and Illicit Drugs. National Institute on Drug Abuse. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. Accessed November 6, 2017.
  2. Centers for Disease Control and Prevention. Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed November 6, 2017.

According to these data from the Drug Abuse Warning Network (DAWN), emergency department (ED) visits for nonmedically used prescription opioid medications increased approximately 183% from 2004 to 2011.1 In 2011, an estimated 1,000 people per day were treated in emergency departments for prescription opioid misuse.2 ED visits for the adverse consequences of prescription pharmaceuticals totaled 1,244,872 —nearly as many as those for illicit drugs (1,252,500). Prescription opioid medications were responsible for 488,004 of these ED visits.1

  1. Adapted from Substance Abuse and Mental Health Services Administration (SAMHSA). Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: SAMHSA; 2013. HHS Publication No. (SMA) 13-4760, DAWN Series D-39.
  2. Centers for Disease Control and Prevention. Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed November 6, 2017.

National-level data from the Treatment Episode Data Set (TEDS) for 2011, and trend data for 2001 to 2011, show that admissions for treatment of prescription opioid abuse have increased more than 5-fold over this period.1 There were more than 180,000 opioid-related admissions in 2011 alone. These data include patients 12 years and older. Note that TEDS provides information on the demographic and substance abuse characteristics of admissions for the abuse of alcohol and/or drugs to facilities that report to individual state administrative data systems. TEDS is an admission-based system, and each admission does not necessarily represent a unique patient.1

Reference

  1. Adapted from Substance Abuse and Mental Health Services Administration (SAMHSA). Treatment Episode Data Set (TEDS). 2001–2011. National Admissions to Substance Abuse Treatment Services. Rockville, MD: SAMHSA Office of Applied Studies; 2013. BHSIS Series S-65, HHS Publication No. (SMA) 13-4772.

Incidence of fatal prescription opioid overdose from the National Vital Statistics System. Prevalence of abuse and dependence from the National Survey of Drug Use and Health. Fatality data are for US population; nonfatality data are a nationally representative sample of the US civilian noninstitutionalized population ages 12 and older. Cost data are from various sources, including health care claims data from the Truven Health MarketScan Research Databases and cost of fatal cases from the WISQARS (Web-based Injury Statistics Query and Reporting System) cost module. Criminal justice costs were derived from the Justice Expenditure and Employment Extracts published by the Department of Justice. Estimates of lost productivity were based on a previously published study.

In 2013, the total economic burden of prescription opioid dependence, abuse, and overdose was estimated to be $78.5 billion per year in a study that included data from a diverse set of sources, including health care claims data.1 Over one-third of this amount ($28.9 billion) was due to increased health care and substance abuse treatment costs. Additionally, opioid abusers generate an average of $14,810 in excess costs to payers in the 6 months before and after an initial abuse episode.2

References

  1. Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. PMID: 27623005
  2. Kirson NY, Scarpati LM, Enloe CJ, Dincer AP, Birnbaum HG, Mayne TJ. The Economic Burden of Opioid Abuse: Updated Findings. J Manag Care Spec Pharm. 2017;23(4):427-445. PMID: 28345440

References

  1. Congress.Gov. S.524 – Comprehensive Addiction and Recovery Act of 2016. Available at: https://www.congress.gov/bill/114th-congress/senate-bill/524. Accessed November 6, 2017.
  2. Hernandez-Delgado H. CARA, the 21st Century Cures Act: More Tools to Address the Opioid Epidemic. http://www.napsw.org/assets/docs/Advocacy/caracuresact%202.22.17%201.pdf. Accessed November 6, 2017.
  3. Webster LR, Grabois M. Current Regulations Related to Opioid Prescribing. American Academy of Physical Medicine and Rehabilitation. 2015;236-S247. PMID: 26568503.
  4. US Department of Health and Human Services, Food and Drug Administration. Fact Sheet - FDA Opioids Action Plan. Available at: https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm484714.htm. Accessed November 6, 2017.
  5. Califf RM, Woodcock J, Ostroff S. A Proactive Response to Prescription Opioid Abuse. N Engl J Med. 2016;374(15):1480-1485. PMID: 26845291.
  6. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Abuse-deterrent opioids; evaluation and labeling. Available at:
    https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf. Published April 2015. Accessed November 6, 2017.
  7. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products; Guidance for Industry. https://www.fda.gov/downloads/Drugs/.../Guidances/UCM492172.pdf. Published November 2017. Accessed November 27, 2017.
  8. Dowell D, et al. 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.