The United States is in the midst of an opioid epidemic that has been responsible for a 200% increase in deaths due to overdose of heroin or an opioid pain reliever since 2000. Guidelines provide clinicians with ways to identify patients at risk of opioid use disorder and best practices of prescribing opioids.
The United States is in the midst of an opioid epidemic that has been responsible for a 200% increase in deaths due to overdose of heroin or an opioid pain reliever since 2000. Between 2013 and 2014, rates of opioid deaths increased from 7.9 to 9.0 per 100,000 people.1 A particular area of concern for the healthcare industry is the increase in overdose deaths involving prescription opioid pain relievers, which claimed 18,893 lives in 2014—the most for any year on record, and more than 4 times the number of such overdoses in 1999.2 The total societal cost burden of prescription opioid overdose and abuse, including healthcare costs, was estimated to be $78.5 billion in 2013.3
Background on the Opioid Epidemic
The spike in prescription opioid deaths is attributed to increased prescribing by practitioners; prescription opioid sales quadrupled from 1999 to 2010.1 Rates of opioid prescriptions varied from state to state so greatly, the highest-prescribing state (Alabama) prescribed opioids at 2.7 times the rate of the lowest-prescribing state (Hawaii).4 Part of the increase in prescribing is attributed to pressure from patients who may give lower satisfaction survey ratings if denied opioids. In particular, question 14 of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey was criticized for asking patients, "How often did the hospital or provider do everything in their power to control your pain?" Because HCAHPS scores are tied to Medicare payments, some doctors feared that not prescribing opioids when a patient asked could have a negative effect on reimbursement.5 In response, CMS announced in July 2016 that it was proposing the removal of the HCAHPS pain management questions from the calculation of hospital scoring and payments.6
Other factors cited as contributing to the prescription opioid epidemic were a lack of consensus on a definition of pain and inadequate physician education on pain management. Beginning in 2001 with the Joint Commission’s release of Pain Management Standards, which required every patient to be assessed for pain, the idea of pain as the “fifth vital sign” was widely adopted by healthcare systems. However, studies have suggested that the accuracy of the commonly used 0 to 10 numeric rating scale for pain is only moderate, and is “much lower in practice than under ideal research circumstances.”7 The quality of pain education in medical schools can also contribute to this variability in assessing pain and prescribing opioids. A 2011 study of American and Canadian medical schools found that “pain education for North American medical students is limited, variable, and often fragmentary.”8
In response to this epidemic of prescription opioid abuse and the lack of consistent direction for providers, the CDC issued a report in March 2016 detailing guidelines for primary care physicians prescribing opioids for chronic pain. The report estimated that 20% of patients who presented to physician offices with pain symptoms or disorders received an opioid prescription, and cited the 7.3% per-capita increase in opioid prescriptions from 2007 to 2012. “In 2012, healthcare providers wrote 259 million prescriptions for opioid pain medication, enough for every adult in the United States to have a bottle of pills,” according to the report.9 The guideline addresses initiation and continuation of opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessing risk and addressing the harms of opioid use.
Patient Selection and Risk Assessment for Opioids
One of the key questions that the CDC prescribing guidelines addresses is the accuracy of risk-assessment tools to determine a patient’s likelihood of opioid overdose, addiction, abuse, or misuse, as well as these tools’ effect on outcomes and the effectiveness of risk-mitigation strategies to reduce the chance of negative outcomes. The CDC rated the body of evidence for risk-assessment tools’ predictive power as Type 3 (observational studies or randomized clinical trials with notable limitations), and the effects of risk-prediction or risk-mitigation tools on outcomes were rated as insufficient.9 The evidence cited for the assessment tools’ effectiveness in predicting risk came primarily from the 2014 Agency for Healthcare Research and Quality (AHRQ) evidence report, “The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain.”10 This report found that a low-strength grade of evidence supported the diagnostic accuracy of the Screening and Opioid Assessment for Patients with Pain (SOAPP)—a 14-question instrument that asks patients to report various risk factors on a scale of 0 to 5—citing 2 studies on the sensitivity of this tool. Additionally, evidence was determined to be insufficient for the remaining measures in the risk category (diagnostic accuracy of the Opioid Risk Tool, which assigns an item score that differs by gender for each applicable risk factor out of the 10 listed; and abuse outcomes for risk prediction instruments and risk-mitigation strategies). The AHRQ report found 3 poor-quality studies that contained “very inconsistent estimates of diagnostic accuracy” for the Opioid Risk Tool. There were no studies found that evaluated the effectiveness of either risk-prediction instruments or risk-mitigation strategies for reducing abuse or overdose outcomes.
Despite this lack of evidence for tools to assess or mitigate the risk of abuse, the CDC guidelines identified several risk factors for opioid harm that warrant special caution from clinicians.9 These include being 65 years or older, and patients with sleep-disordered breathing, pregnancy, renal or hepatic insufficiency, mental health conditions, a history of substance use disorder, or a previous nonfatal overdose. The report recommends that if opioids must be prescribed for these at-risk patients, the clinician should discuss the risks with the patient and carefully monitor the dosage. For patients with a substance use disorder or a previous overdose, clinicians should consider offering a prescription for naloxone to lessen the risk of overdose death, even though the evidence review did not find any studies on the effectiveness of naloxone provision for preventing overdoses among patients taking opioids. The CDC guidelines also recommend performing urine drug tests on patients before prescribing opioids for chronic pain in order to screen for any other opioid medications, benzodiazepines, or heroin.
Monitoring Patients on Opioids
Patients who are on chronic opioid therapy should be assessed periodically and monitored for pain intensity and level of functioning. The CDC recommends evaluating the benefits and harms within 1 to 4 weeks of initiating opioid therapy or escalating a dose.10 The first few days of initiating opioid treatment are critical, and the risk for overdose with prescriptions for extended-release/long-acting opioids (eg, methadone, transdermal fentanyl, oxycodone) is particularly high during the first 2 weeks of treatment.9 Follow-up within as little as 3 days might be appropriate when methadone is prescribed or the dosage of methadone is increased.
During these follow-ups, clinicians should inquire about progress toward functional goals, pain control, and [increased] quality of life, as well as [monitoring for] adverse effects or warning signs for overdose, such as sedation or slurred speech, or opioid use disorder, such as wanting to take opioids more frequently than prescribed or difficulty controlling use.9 During the follow-up, clinicians can assess the patient’s willingness to continue on opioid therapy. There are common adverse events that clinicians should be able to identify and treat:
Continuing the use of opioid therapy for 3 months can increase the risk of opioid use disorder; therefore, clinicians should continue to evaluate the benefits and harms of therapy at least every 3 months.9 Regular monitoring is important because “therapeutic risks and benefits do not remain static and can be affected by changes in the underlying pain condition, presence of coexisting disease, or changes in psychological or social circumstances,” the American Pain Society and American Academy of Pain Medicine wrote in its 2009 opioid treatment guidelines.11 Per CDC recommendations, for the highest chance of preventing the development of an opioid use disorder, follow-up earlier than 3 months may be necessary in cases of continued opioid therapy.9
“Monitoring of compliance is a critical aspect of chronic opioid prescribing, using such tools as random urine drug screening, pill counts, and where available, review of prescription monitoring data base reports,” the American Academy of Pain Medicine released in a statement in 2013.12
Prescribing Opioids in the Emergency Department
The intended audience of these CDC guidelines is primary care clinicians who are treating patients with chronic pain, and although “some of the recommendations might be relevant for acute care settings or other specialists, such as emergency physicians,” those settings are not the focus of the report.9 Acute care practitioners are instead advised to consult resources like the emergency department (ED) prescribing guidelines from the American College of Emergency Physicians (ACEP).
The below guidelines are compiled from the following sources: Washington State Opioid Prescribing Guidelines, as summarized by the Emergency Medicine Patient Safety Foundation (EMPSF) Prescribing and Dispensing Opioids in the Emergency Department13; New York City Emergency Department Opioid Prescribing Guidelines14; Maryland Emergency Department Opioid Prescribing Guidelines15; ACEP’s Clinical Policy: Critical Issues in the Prescribing of Opioids for Adult Patients in the Emergency Department16; and American Academy of Emergency Medicine (AAEM) Emergency Department Opioid Prescribing Guidelines for the Treatment of Non-Cancer Related Pain.17
1. Consider short-acting opioids only if the severity of the pain is reasonably assumed to warrant their use, or if the pain is refractory to other analgesics.14,16 Opioids should always be a second-line treatment to other analgesics unless there is a clear indication for the use of opioids (eg, a patient with acute abdomen pain or a long bone fracture).17 Emergency physicians may also prescribe short-acting opioids for relief of acute musculoskeletal pain while considering the benefits and risks for the individual patient.16
2. Refrain from providing replacement prescriptions for lost, stolen, or destroyed medications.13,15,17 Alternatively, confirm with the treating physician the validity of lost, stolen, or destroyed prescriptions, and if considered appropriate, replace the prescription with only a 1- to 2-day supply.14
3. Generally, ED clinicians should not provide replacement doses of methadone for patients in a methadone treatment program.13 If the patient’s ED treatment has prevented them from obtaining a scheduled dose of methadone or buprenorphine, it may be acceptable to provide the dose after verifying with the treatment program.15
4. Low back pain and exacerbations of chronic pain should first be addressed with non-opioid analgesics, nonpharmacologic therapies, and/or referral to a pain specialist for follow-up.14,16,17 Avoid routinely prescribing opioids for acute exacerbation of chronic pain seen in the ED.16
1. The administration of intravenous and intramuscular opioids in the ED is discouraged.13
2. Long-acting, controlled-release, or extended-release opioids should not be prescribed in the ED.13-16
3. The administration of Demerol (meperidine) in the ED is discouraged, as it lowers the seizure threshold.13
4. Opioids should not be prescribed [in the ED] for patients taking benzodiazepines, sedative-hypnotic medications, and/or concurrent opioids.14,17
1. Use a validated screening tool to assess the patient’s history of substance abuse and risk for opioid misuse, abuse, or diversion.13-16
2. Use a prescription drug monitoring program for information on recent controlled substance prescriptions, which can help identify patients who are “doctor shopping” or at high risk for prescription opioid diversion.15-17
3. Maintain a list of local chemical dependency treatment resources so that any patient suspected of opioid abuse can be referred to treatment.14
4. Maintain a list of primary care clinics that patients with chronic pain should consult in the future instead of visiting the ED.14
1. When prescribing opioids for acute pain or injury, prescribe only for a short course (eg, less than 3 days or 1 week)14-17 and minimal quantity (no more than 30 pills).13,15
2. When prescribing opioids for exacerbations of chronic pain, contact the patient’s primary opioid prescriber and prescribe only enough pills to last until that patient’s prescriber opens.13
3. Start with the lowest possible effective dose of opioid medication.14,16,17
1. Provide patients with information about the risks of opioid dependence, addiction, and overdose, as well as guidelines for safe storage and disposal. In particular, caution patients not to share their prescription with anyone and to avoid sedatives while taking opioid medication.14,15,17
2. Following ED treatment with opioids (particularly the parenteral form), consider an appropriate period of observation and monitoring before discharge.15
3. When writing a prescription for opioids in the ED, state that the patient is required to show government-issued photo ID to the pharmacy filling the prescription.13
4. EDs are encouraged to photograph and keep a record of patients who present for pain-related complaints but do not have a photo ID.13
Determining Appropriateness of Situations for Prescribing OpioidsDo Not Prescribe Before PrescribingPrescribing GuidelinesPatient Interaction After Prescribing
1. Patients with chronic pain should have a single medical provider that prescribes all opioids.13 Refer patients seeking a refill of their chronic opioid prescription to their original treating clinician.15 ED providers prescribing opioids for acute exacerbation of a chronic condition should attempt to notify the patient’s primary medical provider of the visit and prescription.15
2. Share the patient’s ED visit history with other physicians via a health information exchange, if possible.13,15
3. Physicians should make pain treatment contracts with their patients and send them to local EDs.12 ED prescribers should honor these agreements whenever possible.16
4. EDs should use an ED care coordination program to consistently coordinate the care of patients who frequently visit the ED. This could be done by including an ED care plan in the patient’s electronic health record.13
1. The Emergency Medical Treatment and Labor Act requires by law that every ED patient must be evaluated. However, it does not require the use of opioids for pain, so providers should use their clinical judgment when prescribing such treatment in the ED.13,17
Sharing Information with Other Medical ProvidersGeneral
Recognizing Opioid Use Disorder and Discontinuing Opioid Use
The risk of opioid use disorder varies depending on the dosage; it is described as existing across a continuum from mild to severe, which can help determine [an appropriate] type of treatment or if treatment is needed at all.18 If the medication is taken appropriately, then the criteria for opioid use disorder are related to maladaptive behavior patterns, which include:
For a moderate to severe opioid use disorder, clinicians are recommended to treat the patient with methadone or buprenorphine maintenance along with behavioral therapies.18 In addition, naloxone can be prescribed to patients as a preventive rescue medication, and family members can be counseled on how to assist the patient in the case of an opioid-related overdose.18
There are a few reasons why clinicians might consider discontinuing opioid therapy, including that the patient may have experienced no clinically meaningful improvement, the patient experienced a severe adverse outcome or overdose event, or the patient has requested an opioid taper.18 Discontinuation can be complicated by the addition of physical withdrawal symptoms or behavioral issues, which can possibly be prevented by the clinician setting expectations at the beginning of treatment.18 Importantly, once a taper is initiated, it should not be reversed, according to recommendations from the Washington State Agency Medical Directors’ Group: “Do not reverse the taper; it must be unidirectional. The rate may be slowed or paused while monitoring for and managing withdrawal symptoms.”18
The CDC noted in its guidelines that when tapering, it is recommended to reduce the weekly dosage by 10% to 50% of the original dosage, but a more rapid taper is recommended when there is a severe adverse event.10 Clinicians should avoid very rapid tapers with anesthesia, such as naloxone.10,18
Non-Opioid Options for Pain Management
Medical therapies should not be the only treatment considered—physical activation and behavioral health interventions should also be used during pain management.18 The Washington State Agency Medical Directors’ Group worked with an expert advisory panel that included practicing providers, public stakeholders, and senior state officials to highlight nonpharmacological interventions for pain management:
Staying active and engaged in an individual’s usual activity can often result in better pain [management] and functional outcomes.18 The use of an activity diary can help with monitoring the progress being made,18 as well as ensuring patient adherence to home exercise programs, which can also help to manage pain.
In addition, there are non-opioid analgesics that can be equally or more effective in treating pain, plus they carry less risk for harm. Providers should consider acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), or other non-opioid analgesics before initiating opioid therapies. Mild to moderate pain can be initially treated with acetaminophen dosed up to 4 grams.18 NSAIDS can be prescribed for inflammatory pain, but during use, patients should be monitored for renal, gastrointestinal, and cardiac adverse events.18
1. Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in drug and opioid overdose deaths—United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016;64(50-51):1378-1382. doi: 10.15585/mmwr.mm6450a3.
2. National Center for Health Statistics. Number and age-adjusted rates of drug-poisoning deaths involving opioid analgesics and heroin: United States, 1999-2014. CDC website. http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf. Accessed December 5, 2016.
3. 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;54(10):901-906. doi: 10.1097/MLR.0000000000000625.
4. Paulozzi LJ, Mack KA, Hockenberry JM; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Vital signs: variation among states in prescribing of opioid relievers and benzodiazepines—United States, 2012. MMWR Morb Mortal Wkly Rep. 2014;63(26):563-568.
5. Adams J, Bledsoe GH, Armstrong JH. Are pain management questions in patient satisfaction surveys driving the opioid epidemic? Am J Public Health. 2016;106(6):985-986. doi: 10.2105/AJPH.2016.303228.
6. Morse S. To combat opioid epidemic, HHS moves to remove pain management questions from HCAHPS surveys. Healthcare Finance News website. http://www.healthcarefinancenews.com/news/combat-opioid-epidemic-hhs-moves-remove-pain-management-questions-hcahps-surveys. Published July 6, 2016. Accessed December 5, 2016.
7. Lorenz KA, Sherbourne CD, Shugarman LR, et al. How reliable is pain as the fifth vital sign? J Am Board Fam Med. 2009;22(3):291-298. doi: 10.3122/jabfm.2009.03.080162.
8. Mezei L, Murinson BB; Johns Hopkins Pain Curriculum Development Team. Pain education in North American medical schools. J Pain. 2011;12(12):1199-1208. doi: 10.1016/j.jpain.2011.06.006.
9. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain— United States, 2016. MMWR Recomm Rep. 2016;65(1);1-49. doi: 10.15585/mmwr.rr6501e1.
10. The effectiveness and risks of long-term opioid treatment of chronic pain. Agency for Healthcare Research and Quality website. http://www.ahrq.gov/research/findings/evidence-based-reports/opoidstp.html. Published October 2014. Accessed December 5, 2016.
11. Chou R, Fanciullo GJ, Fine PG, et al; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. doi: 10.1016/j.jpain.2008.10.008.
12. Use of opioids for the treatment of chronic pain. The American Academy of Pain Medicine website. http://www.painmed.org/files/use-of-opioids-for-the-treatment-of-chronic-pain.pdf. Published 2013. Accessed December 5, 2016.
13. Pappa A. Prescribing and dispensing opioids in the emergency department. https://dl.dropboxusercontent.com/u/36429995/Patient%20Safety%20Briefings/2013%20PSB/Prescribing%20and%20Dispensing%20Opioids%20in%20the%20ER_Hallam%20Final.pdf. Published January 2013. Accessed December 5, 2016.
14. New York City Department of Health. New York City emergency department discharge opioid prescribing guidelines. City of New York website. http://www1.nyc.gov/assets/doh/downloads/pdf/basas/opioid-prescribing-guidelines.pdf. Accessed December 5, 2016.
15. Maryland emergency department opioid prescribing guidelines. Maryland Hospital Association website. http://www.mhaonline.org/docs/default-source/Resources/Opioid-Resources-for-Hospitals/maryland-emergency-department-opioid-prescribing-guidelines.pdf. Accessed December 5, 2016.
16. Opioid prescribing [adult]. American College of Emergency Physicians website. https://www.acep.org/MobileArticle.aspx?id=88136&coll_id=618&parentid=740. Accessed December 5, 2016.
17. Cheng D, Majlesi N, Heller M, Rosenbaum S, Winters M. Emergency department opioid prescribing guidelines for the treatment of non-cancer related pain. American Academy of Emergency Medicine website. http://www.aaem.org/UserFiles/file/Emergency-Department-Opoid-Prescribing-Guidelines.pdf. Published November 12, 2013. Accessed December 5, 2016.
18. Interagency guideline on prescribing opioids for pain. Agency Medical Directors’ Group website. http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf. Accessed December 5, 2016.