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https://www.hsph.harvard.edu/news/features/what-led-to-the-opioid-crisis-and-how-to-fix-it/

https://youtube.com/playlist?list=PL32kWTQ47RSO373OqQv9Vr-cB0HL7Vpbq

https://stacks.cdc.gov/view/cdc/112340

https://www.sciencedirect.com/science/article/abs/pii/S0376871620305159

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w

https://www.livestories.com/statistics/kentucky/pike-county-opioids-deaths-mortality

https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf

https://www.cdc.gov/opioids/basics/prescribed.html

https://www.dol.gov/agencies/owcp/opioids/riskfactors

https://www.cbo.gov/system/files/2022-09/58221-opioid-crisis.pdf

https://beyer.house.gov/news/documentsingle.aspx?DocumentID=5684#:~:text=Adapting%20a%20methodology%20used%20by,likely%20to%20continue%20to%20increase.

https://www.recoveryanswers.org/research-post/societal-burden-opioid-crisis-estimated-1-trillion-2017/#:~:text=Most%20of%20the%20costs%20are,opioid%20overdose%20(%24481%20billion).

https://journals.lww.com/orthopaedicnursing/fulltext/2019/03000/a_population_health_approach_to_america_s_opioid.4.aspx#:~:text=As%20shown%20in%20Figure%201,%E2%80%9354%20(34.5)%20years.&text=Seventy%2Dnine%20percent%20of%20individuals,Kaiser%20Family%20Foundation%2C%202018

https://www.ohiohospitalforpsychiatry.com/about/columbus-community-resources/opioid-overdose-state-takes-action/#:~:text=As%20Southwestern%20Ohio%20County%20Tops,capital%20of%20the%20United%20States

https://www.ajmc.com/view/preventing-the-next-crisis-six-critical-questions-opioid-epidemic-need-answers

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February 9, 2022 - Without urgent intervention, 1.2 million people in the U.S. and Canada will die from overdoses by the end of the decade, in addition to the more than 600,000 who have died since 1999, according to a February 2 from the Stanford-Lancet Commission on the North American Opioid Crisis. In this Big 3 Q&A, , professor of the practice of public health leadership and a member of the Commission, discusses factors contributing to the crisis and recommendations on how to curb it.
Q: What was the impetus behind this new report on the opioid crisis, and why was it important for this commission to issue the report at this time?
A: The current opioid crisis ranks as one of the most devastating public health catastrophes of our time. It started in the mid-1990s when the powerful agent OxyContin, promoted by Purdue Pharma and approved by the Food and Drug Administration (FDA), triggered the first wave of deaths linked to use of legal prescription opioids. Then came a second wave of deaths from a heroin market that expanded to attract already addicted people. More recently, a third wave of deaths has arisen from illegal synthetic opioids like fentanyl. In addition to the crushing public health burden of preventable deaths, millions more are affected by related problems involving homelessness, joblessness, truancy, and family disruption, for example.

The pandemic has both masked and amplified this crisis. Rising death trends are linked to drivers such as the anxiety and isolation of COVID-19 as well as continued lack of access to quality care and prevention. The crisis seems unchecked. It demands an urgent, unified, and comprehensive response.
Q: What were the main drivers of the opioid crisis, and what are the report's main takeaways on how to minimize the damage?
A: One major conclusion is that the crisis represents a multi-system failure of regulation. OxyContin approval is one example-Purdue Pharma was later shown to have presented a fraudulent description of the drug as less addictive than other opioids. The profit motive of the pharmaceutical industry remains ever present.

And that's just the tip of the iceberg. Post-approval, it's usually left up to industry-not regulators-to educate and advise prescribers on how to evaluate and mitigate risk. Donations from opioid manufacturers to politicians continue to influence policy decisions. In addition, a revolving door of officials leaving government regulatory agencies such as the Drug Enforcement Agency regularly join the pharmaceutical industry with little to no "cooling off" periods. The report details these and other glaring examples.

The report recommends ways to curb pharmaceutical industry influence while also upholding quality care that balances benefits and risks for people with chronic pain. We must continue progress in promoting opioid stewardship-safer prescribing initiatives led by physicians.

Care, treatment, and prevention are all absolutely critical. Currently, addiction care, for example, is not only often separate from mainstream medicine but also unequal. It is also often clouded by stigma, uneven quality, and inaccessibility. Addiction remains a constant long-term threat to human health and won't respond to only short-term fixes or short-term funding. We have to fully integrate addiction care into mainstream health care, provide enduring and sustained funding, and assure that both public and private insurance cover the full range of addiction services. Parity laws require that most private health plans cover substance use disorder services and not limit them more stringently than services associated with other medical conditions. But such laws are not always followed and that must change.

Addiction training should be an essential part of all health professional education. The public health community can also work with the criminal justice system to move more affected people away from incarceration and towards treatment.

And prevention, starting with kids, is absolutely key. We have to support stronger and more resilient children and families to address threats from opioids, tobacco, alcohol, and other substances that rob so many people of well-being.
Q: When you look at the current state of this crisis, does anything give you hope?
We can see progress in some vital areas. For example, more health professionals are using the term "substance use disorder" instead of "substance abuse" to recognize the condition as a medical and health issue and not a moral failing. And instead of references to people being "clean" or "dirty," people are increasingly using the medical terms "recovery" and "relapse." It's gratifying to see this change in the language of addiction.

The Affordable Care Act has also helped in major ways, starting by requiring that private insurance plans cover substance use disorder services as part of essential health benefits. It also has facilitated expansion of Medicaid, the single largest payer of opioid use disorder services. The report notes that states that have expanded Medicaid eligibility have shown evidence of decreased overdose deaths and increased receipt of treatment.

It is inspiring to celebrate the estimated 25 million people who are in recovery. People in recovery are heroes for me. So many have been able to rebuild relationships with people they care for, contribute again to society, and regain a sense of purpose and meaning in their lives. It may seem to be a hopeless situation but it's not. In the midst of this terrible crisis, that's what gives me the greatest hope for the future.

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What led to the opioid crisis-and how to fix it

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Howard Koh, professor of the practice of public health leadership, discusses factors contributing to the opioid crisis and recommendations on how to curb it.

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To combat the opioid crisis, there have been efforts to increase access to addiction treatment

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Create a new document and edit with others at the same time -- from your computer, phone or tablet. Get stuff done with or without an internet connection. Use Docs to edit Word files. Free from Google.

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it's an increase in opioid-related overdose deaths and addiction in recent years

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HAs the federal government failed states by inadequately performing its fiduciary responsibility?

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HAs the federal government failed states by inadequately performing its fiduciary responsibility?

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For example, rather than having 50 states independently regulate the safety and efficacy of pharmaceuticals, which would be quite costly, individual commonwealths, instead, defer to the FDA. In the case of the opioid epidemic, criticism has been directed at the FDA for the initial decision to approve prescription opioids; there was additional criticism for delaying to act after the addictive properties of these compounds became clear. The FDA has also been disparaged for failing to take action against drug manufacturers for the allegedly unethical and deceptive advertising that was used to market drugs.38 In response to this, a 2017 Consensus Report released by the National Academies to address prescription opioid misuse recommended that the FDA adopt stricter policies regarding how opioids are advertised to the public and to prescribers.39

part of the scientific process for drug approval, historically, the FDA has focused on efficacy and safety

If the FDA becomes aware of drug advertising that is inconsistent with FDA-approved product labeling, it issues the drug manufacturer a written notice requesting that the material be withdrawn.

the FDA has been criticized for being “captured” by the very industry it is supposed to regulate—the pharmaceutical industry&mdash;based on how the FDA receives its financial resources from industry and the perceived favors associated with relationships between FDA regulators and industry.

example, news stories have documented how FDA employees who worked on opioid regulation accepted high-paying jobs with Purdue—the company at the epicenter of current lawsuits.44 This raises the question of whether appropriate procedures and firewalls are in place to prevent the ethical compromises that can occur when the regulator is “captured” by industry. Since states rely on the federal government to perform these critical roles, it is important to assess whether that will prevent the next epidemic.

Because all prescription opioid pain medications are subject to Automation of Reports and Consolidated Orders System reporting by distributors, the Drug Enforcement Administration (DEA) has rich data on the flow of opioids to pharmacies across the country. As reports have shown, these medications were flowing to pharmacies that were facilitating their illegal use or flooding certain communities with significantly higher volumes of pain medications than could be justified based on the health needs of the patient populations in these communities.

Former senior administrators within the DEA argue that the agency had gathered thorough evidence documenting that certain opioid distributors were not in compliance with the Federal Controlled Substances Act,46 allegedly turning a blind eye to knowledge that the drugs they were distributing were being used for illegal purposes, thus catalyzing opioid addiction across the United States.47-49

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How has an opioid crisis change over time?

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How has an opioid crisis change over time?

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it began with increased prescription of opioids in the 1990s, increasing since 1999
second wave was in 2010, most of deaths were involving heroin

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When looking at statistics, what year counts as current?

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When looking at statistics, what year counts as current?

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2015-2023, best if the most recent date was included

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who's job is it to keep track of opioid crisis?

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who's job is it to keep track of opioid crisis?

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prescription drug monitoring program (PDMP)
- electronic database that tracks controlled substance prescriptions.
PDMPs can help identify patients who may be at risk for overdose. PDMP data also can be helpful when patient medication history is unavailable and when care transitions to a new clinician.

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What was one of the influential factors leading up to the opioid crisis?

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What was one of the influential factors leading up to the opioid crisis?

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OxyContin (mid 1990s) promoted by Purdue Pharma, approved by FDA
it triggered the first wave of deaths linked to use of legal prescription opioids.

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What states had the highest addiction rates within vulnerable populations?

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What states had the highest addiction rates within vulnerable populations?

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Can professionals be trusted to do the right thing?

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Can professionals be trusted to do the right thing?

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New York State survey conducted by Siena College Research Institute in February 2018 demonstrated that most New Yorkers blame physicians for exacerbating the opioid epidemic by overprescribing opioid medications.Many physicians face a difficult decision when weighing the necessity of treating a patient’s pain symptoms with the possibility of addiction if the patient is prescribed an opioid. Many still believe, however, that physician organizations at both the community and the national levels have not done enough to slow down or stop the epidemic.

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Why haven’t states invested in better data and surveillance to facilitate a more rapid response to emerging epidemics?

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Why haven’t states invested in better data and surveillance to facilitate a more rapid response to emerging epidemics?

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One federal entity that has been commended for its work on the opioid epidemic is the CDC. The CDC is credited with tracking and monitoring data regarding mortality due to opioid overdose, thus allowing the magnitude of the problem to be acknowledged and reported.

The CDC monitors infectious disease outbreaks, working with state and local public health departments to monitor the same issues regionally. In this capacity, the CDC reports on and cautions about problems as they arise in communities, which could spread across the country. For example, the CDC’s Wide-ranging Online Data for Epidemiologic Research (WONDER) database has been used to track cause of death in communities and associate it with drug overdose and opioid overdose

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Why is substance misuse so Common? What are the underlying factors?

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Why is substance misuse so Common? What are the underlying factors?

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This is a complex topic that involves expertise across many disciplines, including neurology, substance misuse and addiction, and social distress and economic inequalities. As highlighted in the recent work by Case and Deaton,61 which discusses the rise in the rate of “deaths of despair” in the United States, particularly among middle-aged white men—a group previously thought to be relatively privileged&mdash;

including social justice concerns, economic equality, and the current social stigmas associated with mental illness. Substance misuse and addiction existed long before the current opioid epidemic, but the destruction they wreak has never been as damaging and as costly as now.

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What are the real opportunity costs of the opioid epidemic?

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What are the real opportunity costs of the opioid epidemic?

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Opportunity cost - using resources for one purpose reduces or eliminates the ability to use thoe resources for a different purpose

In short, much of the press coverage and public discourse about the opioid epidemic has been focused disproportionately on assigning blame and highlighting the direct costs, such as the most recent death count or the latest attempt to make naloxone treatment available to the public without a prescription. Much less attention has been placed on the fact that because of the opportunity costs, every American has borne the brunt and will continue to withstand the harmful effects of resources being diverted to the epidemic—funds that could have been made available for a more productive societal use if the opioid epidemic had been avoided. These damages are currently being considered in the pending multidistrict legislation in the Cleveland District,31 as well as in the myriad other lawsuits and settlements, such as in Oklahoma, where the state government is trying to recover expenditures from those alleged to have created the epidemic—primarily drug manufacturers and distributors&mdash;in efforts that are reminiscent of the tobacco settlement of 1998.32-37 Regardless of the outcome of these lawsuits, it seems certain that any damages that are awarded will not come close to covering the opportunity costs of the epidemic. In this sense, it is critical that constituents, community leaders, and politicians learn from this disaster and do everything in their power to ensure that the next similar preventable epidemic does not occur and further divert public resources that should otherwise be used to advance society.

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drug overdose deaths increased during 1999-2014, they tripled, among 47055 overdoses, 61% involved an opioid

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have prescriptions of opioids increased or decreased?

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have prescriptions of opioids increased or decreased?

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declined from 2012-2020, fallen to the lowest in 15 years - 43.3 prescriptions per 100 persons
(142 mil prescriptions)

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Professor Emeritus of Family Medicine
he's an expert in addiction substance abuse, opioids
contact: goldbaum@buffalo.edu / 716 645 4605

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she's Clinical Assistant professor of family medicine
she's an expert in addiction medicine, substance use treatment, opioid epidemic, methadone
contact: 716 829 6775
drsitler@buffalo.edu

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internal medicine physician Board Certified in Addiction Medicine
he conducts research on the transfer of treatments for opioids use disorder + alcohol use disorder from specialized settings to office - based, primary care
he has American Society of Addiction Medicine awards ad other - Association for Medical Education + Research in substance abuse
contact: david.fiellin@yale.edu / 203 737 3347

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professo of Emergency Medicine
she's Inaugural Chair of the Departament of Emergency Medicine at yale school of medicine
She's known for her work in alcohol + other substance use disorder
she has many science awards (including Hazelden Betty Ford Foundation
contact: gail.donofrio@yale.edu / 203 785 7059

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a synthetic opioid that is 50-100 times more potent than morphine and has been responsible for a significant increase in overdose deaths.

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a medication used to reverse the effects of opioid overdose, saving lives.

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Use of opioids, leading to physical dependence, withdrawal symptoms, and negative consequences in an individual's life

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increase in opioid-related overdose deaths and addiction in recent years.

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Addressing the opioid crisis by prescribing guidelines, improving access to treatment and recovery services, and promoting the safe disposal of unused medications.

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The use of FDA-approved medication, in combination with counseling and behavioral therapies, for the treatment of opioid use disorder

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approach to reducing the negative consequences associated with opioid use disorder: preventing overdose and reducing the transmission of infectious diseases among drug users.

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Prescribing naloxone alongside opioids in order to prevent an overdose in case the patient has an unexpected reaction to the opioid.

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Gradually reducing the dose of opioids over time to minimize withdrawal symptoms and dependence on the drugs.

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Long-term pain that lasts for more than three months. Opioids are often prescribed to treat chronic pain, but long-term use can lead to opioid use disorder and other negative consequences.

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Legal actions taken against pharmaceutical companies, manufacturers, distributors, and other entities that have been accused of contributing to the opioid crisis through deceptive marketing practices, failure to report suspicious orders, and other actions.

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Criminal activity that is directly or indirectly related to the opioid crisis, such as drug trafficking, prescription fraud, and theft to support a drug habit.

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The number of deaths caused by opioid overdose, which has been increasing in recent years, and is considered a major public health crisis.

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Opioid-involved overdose deaths rose from 21,089 in 2010 to 47,600 in 2017 and remained steady through 2019. This was followed by a significant increase in 2020 with 68,630 reported deaths and again in 2021 with 80,411 reported overdose deaths

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2 factors that triggered opioid epidemic 

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2 factors that triggered opioid epidemic 

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introduction and supply of new opioid drugs, whether through prescription painkillers in the 2000s or illicit opioids such as fentanyl in the 2010s, were major drivers of the opioid epidemic

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Oxycodone is widely available in tablet, capsule, and oral solution formulations. Immediate-release tablets are available in 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, while capsules are 5 mg strength.

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expand access to overdose-reversal medications like naloxone

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and strengthening regulations around prescription opioids. However, there is still much work to be done to address this complex and multifaceted issue.

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The easy access to opioids has created a crisis within vulnerable populations, leading to addiction, overdose, and other unfortunate health outcomes. To address this crisis, it is crucial to implement policies that improve access to addiction treatment, increase access to non-opioid pain management options, and reduce the availability of opioids.

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The first reason why easy access to opioids has created a crisis within vulnerable populations is that opioids are highly addictive. Opioids, such as fentanyl and oxycodone, are potent pain relievers that create a sense of euphoria when taken in large doses. This euphoria is highly addictive, leading many individuals to continue using opioids even after their pain has stopped. Vulnerable populations such as low-income individuals, minorities, and those with chronic pain are particularly susceptible to opioid addiction due to the lack of access to alternative pain management options.

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https://www.ncbi.nlm.nih.gov/books/NBK458661/

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Trends in Opioid Use, Harms, and Treatment - Pain Management and the Opioid Epidemic - NCBI Bookshelf

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Not since the HIV/AIDS epidemic has the United States faced as devastating and lethal a health problem as the current crisis of opioid misuse and overdose and opioid use disorder (OUD). Current national trends indicate that each year more people die of overdoses—the majority of which involve opioid…

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https://nida.nih.gov/publications/drugfacts/prescription-opioids

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Prescription Opioids DrugFacts | National Institute on Drug Abuse

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A plain language summary of prescription opioids that explains effects on the brain and reported use.

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From 2019 to 2020, the rate of drug overdose deaths increased for all sex, age, and race and Hispanic-origin groups.

Overall, the age-adjusted rate increased 31.0%, from 21.6 per 100,000 in 2019 to 28.3 in 2020. From 2019 to 2020, the rate for males increased from 29.6 to 39.5, and the rate for females increased from 13.7 to 17.1.

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As shown in Figure 1, opioid overdose rates were highest for persons aged 25–34 (34.6 per 100,000), 35–44 (35.0), and 45–54 (34.5) years. Seventy-nine percent of individuals who overdose on opioids are non-Hispanic White, 10% are Black and non-Hispanic, and 8% are Hispanic

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synthetic opioids other than methadone stats

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synthetic opioids other than methadone stats

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The age-adjusted rate of drug overdose deaths involving synthetic opioids other than methadone, which include such drugs as fentanyl, fentanyl analogs, and tramadol, increased from 1999 through 2020, with different rates of change over time (Figure 4). From 2019 to 2020, the rate increased 56%, from 11.4 to 17.8 per 100,000

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In both 2019 and 2020, adults aged 35–44 had the highest age-adjusted rate among people aged 15 and over.

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Continuing Education Activity

Oxycodone is a potent opioid that can be useful when used judiciously for pain. However, it can cause physical dependence and addiction. The immediate-release formulation of oxycodone is FDA approved for the management of acute or chronic moderate to severe pain, for which the use of opioid medication is deemed appropriate and for which other pain management strategies are insufficient. The extended-release formulation is FDA approved for the management of pain severe enough to require continuous long-term opioid treatment and for which there are no alternative options to treat the pain. The oxycodone to morphine dose equivalent ratio is approximately 1 to 1.5 for immediate-release and 1 to 2 for extended-release formulations. This activity reviews the indications, side effects, and contraindications for oxycodone and highlights the role of the interprofessional team in helping patients manage their pain.

Objectives:

Identify the mechanism of action of oxycodone.

Describe the adverse effects of oxycodone.

Review the contraindications to oxycodone.

Summarize the importance of collaboration and communication within the interprofessional team to enhance care coordination and help patients effectively and safely manage their pain.

Access free multiple choice questions on this topic.
Indications

Oxycodone is an opioid agonist prescription medication. The oxycodone immediate-release formulation is FDA-approved for the management of acute or chronic moderate to severe pain, for which other treatments do not suffice, and for which the use of opioid medication is appropriate.[1] The extended-release formulation is FDA-approved for the management of pain severe enough to require continuous (24 hours per day) long-term opioid treatment and for which there are no alternative options to treat the pain.[2] The oxycodone to morphine dose equivalent ratio is approximately 1 to 1.5 for immediate-release and 1 to 2 for extended-release formulations.[3]

Mechanism of Action

Oxycodone is a semisynthetic opioid with agonistic properties on mu, kappa, and delta-type opioid receptors, with the strongest affinity being for mu-type receptors.[4] Upon binding to these G-protein coupled receptors, oxycodone stimulates the exchange of GDP on the G-alpha subunit for GTP, resulting in the inhibition of adenylate cyclase and a decrease in intracellular cAMP. This signal cascade leads to a consequent inhibition of the nociceptive neurotransmitters acetylcholine, dopamine, GABA, noradrenaline, and substance P and the hormones glucagon, insulin, somatostatin, and vasopressin. As with other opioids, oxycodone causes hyperpolarization and reduced excitability of neurons in the central nervous system (CNS). This generalized CNS depression results from the agonistic effect on kappa-type receptors, leading to N-type voltage-gated calcium channel closure. In contrast, stimulation of the mu and delta-type receptors opens calcium-dependent inward-rectifying potassium channels.[5]

Pharmacokinetics

The onset of action is 10 to 30 minutes for the immediate-release formulation and about 1 hour for controlled-release.

Duration range is from 3 to 6 hours for immediate-release or 12 hours in controlled-release formulations.

The plasma half-life is 3 to 5 hours, and stable plasma levels are reached within 24 to 36 hours.

Oxycodone is metabolized by the hepatic enzymes CYP3A4 and CYP2D6, producing the metabolites noroxycodone and oxymorphone, respectively. These metabolites get excreted from the body via the kidneys.[6]

Administration

Oxycodone is widely available in tablet, capsule, and oral solution formulations.

Immediate-release tablets are available in 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, while capsules are 5 mg strength. Oral solution is available in 5 mg / 5 ml strength, and oral concentrate is available in 100 mg/5 mL strength. Manufacturers discontinued the 160 mg dose in May 2001 due to the high misuse potential.

Extended release tabelts are available in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths. Tablets are intended to be taken whole and must not be broken, chewed, crushed, or dissolved in liquid.

Abuse-Deterrent tablets are available in 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg strengths.

Oxycodone is available in combination with other analgesics, including acetaminophen, aspirin, or ibuprofen.

In some countries, oxycodone may be available in intramuscular and/or intravenous forms.

Adult Dosing

Acute pain: Initial recommended doses of oxycodone are in the 5 to 15 mg range, every 4 to 6 hours as needed for adequate analgesia of acute pain. Further dosing should titrate upwards for pain control, with attention and monitoring for potential side effects.

Chronic pain: It is recommended to titrate dosage slowly upwards, starting at the lowest possible dose for analgesia (2.5 to 10 mg every 4 to 6 hours) for patients with chronic pain. However, the medication should be taken at regularly scheduled intervals for chronic pain management to prevent the reoccurrence of pain instead of treating the pain after it has started.

Pediatric Dosing

Acute pain: Initial recommended doses of oxycodone are 0.05 to 0.15 mg/kg, every 4 to 6 hours as needed for adequate analgesia of acute pain. Further dosing should titrate upwards for pain control, with attention and monitoring for potential side effects.

Chronic pain: It is recommended to titrate dosage slowly upwards, starting at the lowest possible dose for analgesia for patients with chronic pain. However, the medication should be taken at regularly scheduled intervals for chronic pain management to prevent the reoccurrence of pain instead of treating the pain after it has started.

Specific Patient Population

Patients with Liver Impairment: Dose reduction may be necessary for patients with hepatic failure. Initiating a starting dose at one-third to one-half the usual doses and close monitoring is recommended. Titration upwards should proceed at a careful rate.

Patients with Renal Impairment: If CrCl is more than 60 ml/minute, no dose adjustment is necessary. If CrCl <30 mL/minute, 75% to 50% of the usual dose is recommended.[7]

Geriatric Patients: Dose reduction may be necessary for the elderly; initiating a starting dose at one-third to one-half the usual doses and close monitoring is recommended. Titration upwards should proceed at a careful rate.

Pregnancy Considerations: Maternal oxycodone use during pregnancy may result in serious and sometimes fatal events, as opioids can cross the placental barrier. These events may include preterm delivery, congenital abnormalities, and reduced fetal growth. In addition, with prolonged exposure, babies born to opioid-dependent mothers may suffer from potentially life-threatening neonatal opioid withdrawal syndrome. Therefore, clinicians should discuss the neonatal risks of oxycodone therapy in pregnant women or consider alternative treatments.

Breastfeeding Considerations: Oxycodone is excreted in variable concentrations into human milk. There is a lack of study on oxycodone use in lactating women and its effect on milk production. Access the maternal need for oxycodone and perform a risk-benefit analysis of oxycodone use. Monitor for potential adverse reactions (excessive sedation and respiratory depression) in infants with maternal administration of opioids, including oxycodone. Monitor for withdrawal symptoms when breastfeeding is stopped, or oxycodone administration is stopped to mother.[8] While some sources recommend not more than 30 mg of oxycodone to breastfeeding women, others recommend against using it while breastfeeding.[9]

Opioid Overdose Prevention

Discuss the naloxone for the emergency treatment of oxycodone overdose with the patient and/or caregiver and assess the need for access to naloxone, especially when initiating and renewing a treatment with oxycodone. Naloxone is available by prescription from clinicians, as part of a community-based program, or directly from a pharmacist. Clinicians should consider prescribing naloxone based on the patient's medical history, clinical need, and risk for overdoses, such as a history of an opioid use disorder or concomitant use of other CNS depressants. Providers can also prescribe naloxone when the patient has household members (e.g., children) or close contacts at risk for overdose or accidental ingestion.[10]

Adverse Effects

Oxycodone has the potential for addiction, and it is classified as a control substance.[11] The side effect profile of oxycodone is similar to that of other opioid medications. Constipation is the most common overall side effect. The intensity of these side effects tends to decrease over time.[12]

Most Common (more than 5%)

Other Reported Side Effects

Cardiovascular

Dermatologic

Gastrointestinal

Neurologic

Respiratory

Contraindications

Oxycodone therapy is contraindicated in patients with:

While there is limited information involving studies of allergenic cross-reactivity in opioid medications, the possibility of a cross-sensitivity cannot be fully excluded. For patients with an opioid allergy, a clear description of the allergic reaction should be explored and properly documented before considering oxycodone. Patients who are found to have a true allergic reaction to other opioid medications should avoid oxycodone therapy when possible.

US Boxed Warnings

Opioid analgesic risk evaluation and mitigation strategy

Addiction, abuse, and misuse

Risks with concomitant use with benzodiazepines or other CNS depressants and cytochrome P450 3A4 inducers/inhibitors. Monitor patients receiving oxycodone and any of these classes of medicines.[14]

Life-threatening respiratory depression

Pregnancy is not an absolute contraindication to oxycodone therapy; however, the FDA lists Neonatal opioid withdrawal as a US Boxed Warning.

Monitoring

Patients taking oxycodone require monitoring for the presence of constipation, pain relief, other side effects, and appropriate usage. Their blood pressure, heart rate, and respiratory rate should also be monitored, especially for the first 24 to 72 hours after initiating therapy or increasing dosage. If pain continues to increase after stabilizing dosage, the clinician should investigate alternative causes of pain before increasing medication dosage or frequency. If adverse effects develop, consider decreasing the dosage to find an appropriate therapeutic level without unacceptable adverse effects. Patients taking oxycodone should be monitored or cautioned when starting a new medication that is a known CYP450 inhibitor. Inhibition of these enzymes can lead to potentially fatal oxycodone concentrations in the blood.[14] In addition, this medication should not be abruptly discontinued in patients who may be opioid-dependent, as this could precipitate withdrawal symptoms. If oxycodone therapy requires termination, consider decreasing in increments of 10% to 50% of the dose every few days to a few weeks while monitoring for withdrawal symptoms. Newer abuse-deterrent formulations could also be used to prevent the misuse and abuse of oxycodone.[15]

Due to the high misuse potential and possibly fatal results of an oxycodone overdose, prescriptions should be written for the lowest therapeutic dose and only for the period the patient is expected to be in pain. Close follow-up should be arranged. Many hospital systems, states, and government agencies in the United States have published guidelines to help physicians with pain management and opioid prescriptions. The legislation is evolving in the United States, and in some states, state law will require signed informed consent to prescribe opioid medications to a patient. In opioid-naive patients with acute pain, long-acting opioids are not an advisable approach to pain control.[16] For patients who require long-term opioid therapy for pain management, regularly scheduled visits should be conducted to reassess their pain level and monitor possible indications of opioid abuse.[17]

Toxicity

Signs and symptoms of an oxycodone overdose include bradycardia, hypotension, miosis, respiratory depression, somnolence, muscle flaccidity, cold and clammy skin, and death.[17] Its use is also linked with acute hepatic injury, especially when used in higher doses and in combination with high acetaminophen doses.[18] When a person overdoses on oxycodone, an opioid antagonist such as naloxone should be administered. Clinicians should not give opioid antagonists in the absence of clinically significant respiratory or circulatory depression. Repeat dosing may be necessary as the duration of action of these drugs can vary from 30 to 120 minutes.[10]

Enhancing Healthcare Team Outcomes

Healthcare workers who prescribe opiates should be familiar with the recent changes in their state laws. Liberal prescribing of these agents is no longer recommended and can lead to legal difficulties with the DEA. Patients with pain should receive pain management with alternative means, and a pain consultant should be involved. Healthcare providers are recommended to follow REMS guidelines to ensure proper prescribing of opioids. Currently, the DEA scans all healthcare workers who frequently write opiate prescriptions, and any mortality in a patient can lead to loss of the DEA certificate and even license to practice medicine.[19]

Nurses, pharmacists, and physicians should educate patients about the dangers of opioids and their misuse. All interprofessional healthcare team members should be familiar and knowledgeable about the signs of opioid misuse and overdose and report any concerns to the prescribing clinician. Pharmacists can report "doctor shopping" when they see it. They can also recommend alternative agents for pain control, as many trials are underway to seek different means to control pain that has historically been treated with opioid drugs. Nursing will also inform the prescriber of any concerns about the misuse, is a source of counsel for the patient, and is often the point of contact for the pharmacist. The entire interprofessional healthcare team needs to function collaboratively to control the patient's pain and prevent potential misuse and dependence on opioid medications like oxycodone. [Level 5]

References

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Oxycodone is a potent opioid that can be useful when used judiciously for pain. However, it can cause physical dependence and addiction. The immediate-release formulation of oxycodone is FDA approved for the management of acute or chronic moderate to severe pain, for which the use of opioid medication is deemed appropriate and for which other pain management strategies are insufficient.

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The opioid epidemic has had a devastating impact on individuals, families, and communities across the United States. In addition to the high death rate, opioid addiction has led to increased healthcare costs, lost productivity, and increased rates of infectious diseases such as HIV and hepatitis C. It has also placed a significant strain on law enforcement and criminal justice systems, as well as social services. According to the Centers for Disease Control and Prevention (CDC), more than 500,000 people died from opioid overdoses in the United States between 1999 and 2019. The states that have been hit hardest by the opioid epidemic are West Virginia, Ohio, Pennsylvania, Kentucky, and New Hampshire. Out of all these states, West Virginia had the highest rate of drug overdose deaths involving opioids in 2019, with a rate of 52.8 deaths per 100,000 population. Ohio had the second-highest rate at 42.6 deaths per 100,000 population, followed by Kentucky at 37.2 deaths per 100,000 population.

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https://www.cdc.gov/opioids/data/index.html

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Data on the drug overdose epidemic since 1999, including interactive US maps and tables.

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Efforts to increase access to opioid addiction treatment have been ongoing for many years, particularly as the opioid epidemic has continued to worsen. Here are two sources that provide information on these efforts:

The Substance Abuse and Mental Health Services Administration (SAMHSA) is a federal agency that works to improve access to treatment for substance use disorders, including opioid addiction. SAMHSA has implemented several initiatives to increase access to opioid addiction treatment, including the following:
The Medication-Assisted Treatment (MAT) program, which provides funding to states and territories to expand access to medication-assisted treatment for opioid addiction.
The Opioid State Targeted Response (STR) program, which provides grants to states to support the expansion of prevention, treatment, and recovery services for opioid use disorders.
The Comprehensive Addiction and Recovery Act (CARA), which was passed in 2016 and includes provisions to increase access to medication-assisted treatment for opioid addiction.
Source: SAMHSA. (2021). Opioid Treatment Programs (OTPs). Retrieved from https://www.samhsa.gov/medication-assisted-treatment/otp-factsheet

The National Institute on Drug Abuse (NIDA) is a research-focused agency that is part of the National Institutes of Health. NIDA supports research on the treatment of opioid addiction and works to translate research findings into clinical practice. Some of the efforts NIDA has undertaken to increase access to opioid addiction treatment include:
Research on the effectiveness of different medication-assisted treatment approaches, such as methadone, buprenorphine, and naltrexone.
The development of treatment guidelines and resources for healthcare providers, including the NIDA Clinical Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use.
Collaboration with other federal agencies and organizations to raise awareness of the importance of treatment for opioid addiction and to promote evidence-based approaches to treatment.
Source: National Institute on Drug Abuse. (2021). Medications to Treat Opioid Use Disorder. Retrieved from https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction.