Surgical leadership is required to reverse the opioid crisis

Physicians reviewing the most commonly prescribed medications at Kaiser Permanente Southern California made an alarming discovery in 2009: the most commonly prescribed drugs were not for hypertension or diabetes but for pain. OxyContin, even as a nonformulary drug, was near the top of the list. A task force was convened to investigate and revise the opioid prescribing practices in the organization. In an article published in The Atlantic earlier this year, “The California doctors who found a way to quit overprescribing opioids,” Sam Quinones relates how the Kaiser group made meaningful progress toward reducing opioid prescriptions through system changes.¹ By implementing reforms and educating prescribers, the routine postoperative analgesic prescription dropped from 60 tablets of a brand name opioid to just 18 generic opioid pills.

The Kaiser example emphasizes the leadership role that physicians and surgeons can play in reversing the opioid crisis through identification of problems, education of colleagues, and enactment of practice-changing guidelines. There is an urgent need for leadership today as opioid-related adverse events have reached epidemic levels.² Outpatient opioid prescriptions have increased dramatically in the U.S. from 76 million in 1991 to 219 million in 2011, and the number of opioid prescriptions sometimes eclipses a state’s population.^3,4 More opioids are consumed per capita in the U.S. than in any other country.⁵ As surgeons, we manage acute postoperative pain with opioids in both opioid-naive and opioid-dependent populations. Consequently, surgeons can be considered the gatekeepers of the opioid epidemic and thus have a duty to develop responsible prescribing practices and strategies.⁶

This article summarizes the scope of the opioid crisis and describes the recent changes to federal and state regulations governing opioid prescribing practices. It also offers several brief profiles that illustrate how individual surgeons are mitigating the effects of the opioid crisis through research and advocacy.

Scope of the problem

The Centers for Disease Control and Prevention (CDC) organizes opioids into the following four categories:²

• Natural opioid analgesics/semi-synthetic opioid analgesics, including morphine, codeine, oxycodone, hydrocodone, hydromorphone, and oxymorphone
• Methadone
• Synthetic opioid analgesics, such as tramadol and fentanyl
• Heroin

From 2014 to 2015, overdose deaths from synthetic opioid analgesics in the U.S. increased 72 percent, and heroin overdose deaths increased 21 percent.² Overall, opioids accounted for 33,091 deaths in the U.S. in 2015—the equivalent of 91 people per day dying from opioid-related causes, or quadruple the number of people who were dying from opioid-related causes in 1999.^2,7,8 The rise in the number of opioid-related deaths coincides with a fourfold increase in the number of prescription opioids sold in the U.S.⁷ As of 2011, drug poisonings and overdoses have surpassed motor vehicle crashes as the leading cause of unintentional injury deaths in the U.S.⁹ In 2014, 5.9 deaths per 100,000 Americans were due to opioid analgesic overdoses, while 10.8 deaths per 100,000 were from motor vehicle-related injuries and 10.3 per 100,000 were firearm-related.⁹ To combat the growing death toll of the opioid epidemic, it is necessary to understand not only the scope, but also the origins of the crisis.

Chronic opioid use often begins with acute pain. The American Pain Society publicized the idea of measuring pain as a vital sign in the 1990s. The U.S. Department of Veterans Affairs (VA) and other health care systems, networks, and institutions quickly adopted this recommendation.^10,11 In 2001, the Joint Commission on Accreditation of Healthcare Organizations (now The Joint Commission) included the concept of pain as the “fifth vital sign” in an example of how to implement Standard RI.1.2.8 in The Comprehensive Accreditation Manual for Hospitals, which states that “patients have the right to appropriate assessment and management of pain.”¹² The societal shift toward treating pain more vigorously was noticed by pharmaceutical companies, which then aggressively marketed pain-relieving opioids to both physicians and patients.¹³ Sadly, the heightened focus on pain management coincided with a rise in both opioid prescriptions and overdoses.⁴ As opioid deaths rose, states implemented prescription drug monitoring programs (PDMPs) and regulated pain management clinics to curb abnormal prescribing practices and to shut down so-called pill mills.¹⁴

Despite efforts to reduce prescription opioid misuse, many Americans continue to take them for nonmedical reasons. Unable to obtain opioids from physicians, patients turn to what are referred to as diverted prescription opioids or illicitly produced opioids. According to 2008–2011 data from the U.S. National Survey on Drug Use and Health, diverted opioids are often freely given to users from friends or family (54 percent), stolen or purchased from friends or family (16 percent), purchased from a drug dealer (4 percent), or they are provided to users in some other way (6 percent), with the rest of the population misusing opioids prescribed by their physician (20 percent).¹⁵ Deaths related to synthetic opioid overdoses rose by 72 percent from 5,544 in 2014 to 9,580 in 2015, and deaths from natural and semi-synthetic opioids rose 2.6 percent to 12,727 in 2015.² Heroin overdoses also have risen by 21 percent during the same time, reaching 12,989 deaths in 2015.² Analyzing 2002–2011 data from the U.S. National Survey on Drug Use and Health, up to four out of five heroin users in the U.S. have misused prescription opioids before using heroin, underscoring the importance of preventing initial prescription opioid misuse.¹⁶

Surgeon prescribing practices are germane to any discussion of the opioid epidemic, as more than one-third of the average surgeon’s prescriptions are for opioids.¹⁷ Surgeons prescribed opioids to approximately 80 percent of patients who underwent an elective, low-risk operation such as a knee arthroscopy, with increases in prescriptions and dosages from 2004 to 2012.¹⁸ Furthermore, studies examining patients who underwent low-risk procedures revealed that opioid prescriptions were associated with a greater likelihood of long-term use.^19,20 A study of 1.3 million opioid-naive noncancer patients with acute pain indicated that patients with an opioid prescription for at least one day had a 6 percent chance of continued opioid use after one year and a 3 percent likelihood after three years.²¹ In a study of 39,000 patients who underwent a major operation such as coronary artery bypass graft surgery via sternotomy, 3 percent of opioid-naive patients continued to use opioids more than 90 days after their operation.²² Because of the risk of chronic dependence, the opioid prescribing patterns of surgeons are now the subject of close examination, and state regulations are being implemented with or without surgeon involvement.

Policies that have affected opioid prescribing patterns, such as mandatory use of a PDMP, have shown notable success for chronic opioid use at the state level.²³ Another policy that affects opioid prescribing patterns is the development of guidelines that instruct physicians in appropriate use of prescription opioids for chronic pain.²⁴ However, guidelines for the management of acute postoperative pain require further delineation.

Regulatory policy

Regulations pertaining to prescription opioid medications have been enacted at both the federal and state levels.

Federal regulation

The U.S. Drug Enforcement Administration (DEA) has implemented several important opioid-related policy changes. In October 2014, the DEA rescheduled hydrocodone from Schedule III to a more restrictive Schedule II substance under the Controlled Substances Act. Prescriptions for hydrocodone decreased by 22 percent in the first year after the change.²⁵ Then, in October 2016, the DEA reduced the amount of Schedule II opioid medications that can be manufactured by 25 percent or more, thereby decreasing the total supply of these medications available for distribution.²⁶

In response to a July 2012 petition from the Physicians for Responsible Opioid Prescribing, the U.S. Food and Drug Administration (FDA) changed the mandatory labeling for extended-release or long-acting opioids, removing the previously accepted treatment indication for moderate pain.²⁷ As of May 2014, the new indication for these medications is for pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.”²⁷ Additionally, the FDA has called for further post-marketing surveillance studies on these agents by the manufacturers, as well as mandatory provider education programs.²⁸ Other federal interventions were included in the Affordable Care Act, calling for states to develop PDMPs and increase funding for substance abuse treatment programs.²⁹

On July 22, 2016, President Obama signed the Comprehensive Addiction and Recovery Act, which calls for implementing incremental steps to combat the opioid epidemic. If fully funded, this law would expand access to evidence-based therapies to treat patients who have disorders related to certain opioids, including methadone, buprenorphine, and naltrexone.³⁰

State regulation

Several states have enacted regulations to reduce opioid-related adverse events. For example, as of April, 49 states and the District of Columbia have enacted PDMP regulations (although some are not fully operational at press time), each with specific requirements regarding opioid access and use. The only state without a PDMP is Missouri, though the Missouri General Assembly considered PDMP legislation in the 2017 legislative session.³¹ After mandating use of PDMPs, New York and Tennessee showed a reduction in patients seeking prescriptions from multiple providers by 75 percent and 36 percent, respectively.²³

A total of 17 states now require licensed physicians to undergo supplemental opioid prescribing or addiction education for licensure (see Figure 1).³² Several other states require that health care professionals undergo this training if they are responsible for pain management or addiction treatment. Unfortunately, physicians in training are often overlooked as controlled substance prescribers and, therefore, miss out on additional educational opportunities. The reason that residents and fellows are excluded from many studies examining physician prescribing habits is that they often use their training facility’s DEA registration rather than using DEA registration under their own name.

Figure 1. CDS licensing and registration and medical education training requirements by state, as of June 21, 2017

Other initiatives at the state level aimed at addressing the opioid epidemic include Florida, which enacted regulations curtailing clinics and providers from dispensing painkillers from their offices beginning in 2010, resulting in a 52 percent decrease in overdose deaths from oxycodone.³³ Recently, Connecticut, Maine, Massachusetts, New Jersey, New York, Rhode Island, and Vermont passed laws limiting the length of opioid prescriptions for acute pain, with the most common limit being seven days.³⁴ In all, 22 states, plus Guam, Puerto Rico, and the District of Columbia, require prescribers of controlled substances to obtain a state-issued controlled dangerous substance (CDS) license (see Figure 1).³⁵ This mandate allows the states to monitor a practitioner’s prescribing practices of controlled substances.

Massachusetts deserves special mention for leading opioid prescribing policy changes at the state level by requiring that prescribers complete training in pain management and addiction, among other requirements.³⁶ Physicians must adhere to specific documentation requirements if a patient is prescribed more than a seven-day supply of opioids. Patients may request a partially filled prescription at the pharmacy, and the pharmacist is expected to explain the implications of this prescription to the consumer. For Schedule II opioids, physicians must document that they discussed the risks of opioids with their patients. When prescribing extended-release, long-acting opioids, the prescriber and the patient must enter into a written pain management agreement. Policymakers in Massachusetts also established a benchmarking mechanism for prescribers to monitor and compare their opioid prescribing patterns against similar specialty or practice types. These data allow the Board of Registration in Medicine to investigate and notify physicians who deviate from their peers.³⁶

Surgeon advocates

The previous U.S. Surgeon General, Vivek Murthy, MD, sent an open letter in August 2016 to U.S. physicians asking them to “treat pain safely and effectively” by correctly identifying and appropriately treating patients for opioid use disorder, calling on health care providers to “shape how the rest of the country sees addiction by talking about and treating it as a chronic illness, not a moral failing.”³⁷ As prescribers of pain medications for acute postoperative pain, surgeons have been working to reduce the consequences of the opioid epidemic, both before and after the Surgeon General’s call for action.

An example of a surgeon who is leading the charge in reversing the opioid epidemic is DuPage County Coroner Richard A. Jorgensen, MD, FACS. In 2013, he created the DuPage Narcan Program, the first overdose prevention program of its kind in Illinois.³⁸ The use of naloxone (Narcan) by nonmedical personnel such as police officers is permitted under legislation passed by the Illinois General Assembly in 2010. Funded through private donations, grants, and local revenues, the program resulted in 145 “saves” from opioid overdoses in 2016.³⁹ Individual surgeons, like Dr. Jorgensen, are working tirelessly throughout the U.S. to eradicate the source of diverted drugs by encouraging careful prescribing habits and competently treating the patients most deeply affected by opioid addiction.

Fellows of the American College of Surgeons (ACS) have been instrumental in leading efforts to prevent and treat the epidemic. Atul A. Gawande, MD, MPH, FACS, a general and endocrine surgeon, Brigham and Women’s Hospital, Boston, MA, and a leader in the discussion of surgical quality improvement, recently weighed in on the importance of surgical leadership in controlling the opioid crisis.⁴⁰ For example, although all states allow electronic prescription writing for opioids, less than 10 states require it, and more than 90 percent of physicians’ practices do not use electronic prescriptions for these drugs. Dr. Gawande exhorts surgeons to take the lead in the implementation of electronic opioid prescriptions, even without a government mandate.

Jennifer F. Waljee, MD, MPH, MS, FACS, assistant professor, plastic surgery, and Michael J. Englesbe, MD, FACS, associate professor, transplant surgery, University of Michigan, are using grant funding to explore innovative ways to reduce excess opioid prescriptions and subsequent diversion. Through the Michigan Opioid Prescribing Engagement Network (also known as Michigan-OPEN)⁴¹, Drs. Waljee and Englesbe are promoting preoperative discussions with patients regarding postoperative pain expectations, organizing the collection of excess opioid medications, and educating surgeons to prescribe fewer opioids.⁶ Drs. Waljee and Englesbe also recently published their research showing 6 percent of opioid-naive patients (no opioid prescriptions filled between one to 12 months before an operation) were still taking opioids more than 90 days after a surgical procedure.⁴² By identifying patient-level risk factors for persistent postoperative opioid use, such as tobacco use, anxiety, depression, chronic pain, and others, these surgeons are contributing to a deeper understanding of the opioid epidemic. This research is crucial in advocating for effective policies and regulations with insurance companies and state and federal governments.

ACS efforts

Under the leadership of Executive Director David B. Hoyt, MD, FACS, the ACS is developing a collection of educational materials for patients and surgeons called Opioids and Surgery: Use, Abuse and Alternatives.⁴³ By creating an evidence-based resource that will inform preoperative discussions, aid in the identification of patients at high risk for potential abuse, and highlight nonopioid treatment options, the ACS Division of Education is advocating for improved pain management strategies aimed at preventing Americans from becoming victims of the opioid crisis.

Through its Division of Advocacy and Health Policy (DAHP), the ACS continually tracks opioid-related legislative proposals at both the state and federal levels. The DAHP not only advocates for policy changes that benefit surgical patients and surgeons, it also communicates the relevant details of these laws to the ACS membership through the Bulletin, ACS NewsScope, and other communication platforms. For example, a 2013 Bulletin article summarized state legislative efforts to enhance PDMPs and improve Continuing Medical Education (CME) requirements.⁴⁴ In December 2016, a Bulletin article updated readers on new state laws for PDMPs, CME, and prescribing limitations for opioids.⁴⁵ Furthermore, the efforts of the DAHP to support $1 billion of state grant funding for opioid research and treatment through the 21st Century Cures Act were highlighted in a January 2017 article.⁴⁶

ACS chapters have been active in grassroots advocacy for opioid-related state laws, due in large part to the ACS grant program for state capital lobby days.⁴⁷ Through these state lobby days, the Connecticut, Indiana, Metro Chicago, New York, Ohio, Oregon, Tennessee, and Wisconsin Chapters advocated on behalf of their patients and surgeons for practical opioid-related legislation under consideration in their respective states.⁴⁷ Surgeon participation in state lobby days is crucial for productive change in the opioid crisis, and the surgical community is indebted to the participants for their selfless contribution of time and money.

Most recently, in June the ACS Board of Regents approved a Statement on the Opioid Abuse Epidemic, which supports the following: the use of fully functional and interoperable prescription drug monitoring programs; research and training for safe prescribing practices of opioids and nonopioid analgesics; addressing issues specific to military veterans; detaching the relationship between provider reimbursement and patient pain control; and supporting patient safety legislation. With this statement, the ACS outlines the principles for alleviating the opioid epidemic, and demonstrates that it will represent the surgeon’s voice in the search for solutions.

A common goal

Other surgical and medical organizations have also developed policies and guidelines with the common goal of diminishing the opioid epidemic. The American Academy of Orthopaedic Surgeons (AAOS) and the American Association of Neurological Surgeons (AANS) released statements in 2015 and 2016, supporting and making recommendations regarding the CDC’s guideline for Prescribing Opioids for Chronic Pain.^48,49 In November 2016, the AANS and the AAOS both petitioned the 114th U.S. Congress to provide the maximum funding for the programs designated under the Comprehensive Addiction and Recovery Act.⁵⁰

Through its Task Force to Reduce Opioid Abuse, the American Medical Association has been promoting evidence-based strategies to combat the opioid epidemic.⁵¹ Advocacy efforts have been led by multidisciplinary pain management societies like the Academy of Integrative Pain Management (AIPM), which gathers extensive information on state and federal regulations and advocates for effective pain policies. Through these organizations, surgeons are educating fellow surgeons and advocating for policy changes and funding of legislation to reverse the opioid epidemic.

The future direction of the opioid epidemic depends on the efforts of individual surgeons, in both the treatment of patients and the support of evidence-based state and federal policies. Addressing this nationwide crisis will require sustained efforts by all stakeholders, including surgeons. By advocating for evidence-based legislation that addresses opioid use, surgeon leaders can positively affect the health of our nation by reducing the number of patients addicted to opioid medications.

Conclusion

The opioid crisis began after an earnest effort by physicians to relieve pain and has taken years to evolve into the complex health problem it is today. The physicians in Southern California in 2009 were understandably surprised by the prevalence of opioid prescriptions at Kaiser Permanente. However, no physician or surgeon should be shocked by the magnitude of opioid prescriptions and overdoses in 2017. Opioid-related deaths exceed liver cancer or prostate cancer deaths in the U.S. And while Pandora’s box has been opened with regard to opioid misuse, hope remains that the medical community can remedy the opioid epidemic through education and advocacy efforts.

Federal and state regulation may help guide physicians into making the right choices for patients, but productive legislation requires expert recommendations. Surgeons can become involved with these efforts through their local ACS chapters and through collaboration with the DAHP to advocate for constructive policies. Members of the ACS can continue to work with legislators to support or modify bills in their home states, while appropriately treating individual patients daily who suffer from acute and chronic pain.

Surgeons and surgical organizations have previously led the way in initiatives to reduce mortality and morbidity from surgical, medical, and systems processes. To curb the opioid epidemic, it will take strong individual and organizational leadership, and, fortunately, many dedicated surgeons are willing to take up the mantle. With sustained advocacy research and policy implementation, surgeons can shut the lid on the opioid epidemic.

Acknowledgment

The authors would like to thank Justin Rosen, Congressional Lobbyist, Division of Advocacy and Health Policy, Washington, DC, for his review of the content of this article.

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