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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.

Data current as of December 13, 2017.
*Prescription pain medications, heroin, and illicitly manufactured fentanyl.
† 52 Jurisdictions in 45 States.

Adapted from Vivolo-Kantor. MMWR Morbidity and Mortality Weekly Report. 2018;67(9):279-285.

According to these data from the National Syndromic Surveillance Program (NSSP), from July 2016 to September 2017, a total of 142,557 of about 91 million ED visits were suspected opioid overdoses.1 Opioid overdose ED visits in NSSP increased 29.7% during this period, and all five U.S. regions experienced prevalence increases. The largest increase was seen in the Midwest (69.7%), followed by the West (40.3%), Northeast (21.3%), Southwest (20.2%), and Southeast (14.0%). Substantial increases occurred among all demographic groups during the same period, including males (30.2%), females (24.0%), and persons aged 25 to 34 years (30.7%), 35 to 54 years (36.3%), and ≥55 years (31.9%).

  1. Vivolo-Kantor AM, Seth P, Gladden RM, et al. Vital signs: trends in emergency department visits for suspected opioid overdoses - United States, July 2016-September 2017. MMWR Morb Mortal Wkly Rep. 2018;67(9):279-285. PMID: 29518069

Weiss AJ (Truven Health Analytic), Elixhauser A (AHRQ), Barrett ML (M.L. Barrett, Inc.), Steiner CA (AHRQ), Bailey MK (Truven Health Analytics), O'Malley L (Truven Health Analytics). Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009-2014. HCUP Statistical Brief #219. December 2016.
Agency for Healthcare Research and Quality, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf.

The rate of opioid-related inpatient hospital stays increased 64.1% between 2005 and 2014, from 136.8 per 100,000 population in 2005 to 224.6 in 2014.1 This represented a 5.7% average annual growth rate. During this same period, the rate of opioid-related ED visits increased 99.4%, from 89.1 per 100,000 population in 2005 to 177.7 in 2014. This represented an 8% average annual growth rate.

Reference

  1. Weiss AJ, Elixhauser A, Barrett ML, et al. Opioid-related inpatient stays and emergency department visits by state, 2009 -2014: statistical brief #219. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006-2016 Dec [updated 2017 Jan 01].

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.