August 1, 2016

The death in April of the musician Prince from an accidental overdose of fentanyl is only one of the more highly publicized instances of a public health problem in the United States that has reached epidemic scale. According to the Department of Health and Human Services (HHS), 44 people die every day in the U.S. from an overdose of prescription painkillers.

A recent analysis of more than 800,000 prescriptions written in 2013 showed that pain specialists and anesthesiologists wrote the most opioid prescriptions of any group of healthcare professionals—an average per physician of 900 - 1,100 and 500 prescriptions, respectively. Combine that with the fact that regular use of opioid painkillers—even as prescribed by a physician—can lead to dependence, and it is clear why the opioid crisis is an issue that should be on every anesthesia provider’s front burner.

The Numbers

One need not look far for additional data demonstrating the extent of opioid use and abuse in this country.

A study published by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) in the Journal of Clinical Psychiatry in June found that nonmedical use by adults of prescription opioids, including OxyContin and Vicodin, more than doubled between 2001-2002 and 2012-2013. Almost 10 million Americans—4.1 percent of the adult population in the past year compared with 1.8 percent in 2001-2002—used opioid painkillers without a prescription or in greater amounts, more often, or longer than prescribed, the study reports.

According to the 2014 National Survey on Drug Use and Health (NSDUH) of the Substance Abuse and Mental Health Services Administration (SAMHSA), 1.4 million people used prescription painkillers nonmedically for the first time in the past year, while 4.3 million Americans used prescription painkillers nonmedically in the previous month.

Although many patients benefit from prescription opioids to help manage their pain, these medications often find their way into the hands of other individuals who use them for nonmedical purposes. The 2014 NSDUH found that 50.5 percent of people who misused prescription painkillers were given them by a friend or relative, and that 22.1 percent got them from a physician.

In addition, according to SAMHSA, as patients develop opioid tolerance and the medications become less effective with frequent use, many individuals seek opioids through illegal means or begin using riskier alternatives, such as heroin. Many people who use heroin report having misused prescription opioids before turning to the drug.

Soaring Prescriptions

Further evidence of the opioid overuse and abuse problem comes from a new report from the Office of the Inspector General. Approximately 12 million Medicare beneficiaries—one in three—received at least one opioid painkiller prescription in 2015 at a drug cost to Medicare of $4.1 billion. From 2006 to 2015, spending on these drugs increased by 165 percent.

In 2012, healthcare providers wrote 259 million prescriptions for opioids, enough prescriptions for every adult in the U.S. to have a bottle of opioid medication.

Despite the lack of an overall increase in reported pain, sales of prescription opioids rose four-fold between 1999 and 2014. An estimated 20 percent of patients with non-cancer pain or pain-related diagnoses receive an opioid prescription. About half of these prescriptions come from primary care physicians. However, from 2007 – 2012, the rate of opioid prescribing rose steadily among specialists who treat pain, including pain medicine specialists (49 percent) , surgeons (37 percent), and physical medicine/rehabilitation specialists (36 percent).

What Happened?

Only a few decades ago, physicians hesitated to prescribe opioids even for cancer patients due to fears that they would become addicted. In 2001, however, attitudes and prescribing patterns began to move in the other direction when Congress launched the Decade of Pain Control and Research. Close to this time, The Joint Commission (TJC) also introduced its Standards for Pain Management.

Pain soon came to be referred to by many within health care as the “fifth vital sign.” An increase in opioid-related overdoses and deaths followed the large increase in prescriptions for opioid painkillers that took place during this period.

Taking Action

Government agencies and healthcare organizations are now working to curtail the problem of opioid overuse and abuse. At the same time, researchers are seeking effective alternatives to opioid therapy and clinicians are developing new approaches to the management of pain. (A recent article in the New York Times describes efforts by one emergency department to reduce the use of opioids in treating pain.)

As noted in our March 7th eAlert, the American Pain Society has released a Clinical Practice Guideline on the Management of Postoperative Pain, including 32 recommendations developed by a 23-member panel of anesthesiologists and other specialists. Among other things, the Guideline calls for greater use of multimodal pain management strategies to lower doses of opioids and potentially reduce adverse effects by affecting pain through different pathways and mechanisms of action.

Arguing that “pain is a symptom, not a vital sign,” the advocacy group Physicians for Responsible Opioid Prescribing (PROP), recently sent a letter to TJC asking it to re-evaluate its pain management standards. PROP contends the standards have contributed to a pattern of opioid overprescribing among physicians. An article published on the physician blog KevinMD argues that TJC, in its 2001 monograph, “Pain: Current Understanding of Assessment, Management, and Treatments,” set the tone for clinicians that patients are always to be trusted to report their pain accurately. This, along with other attitudes about pain put forth in the monograph, contributed to the current opioid overuse crisis. (TJC has issued a Statement on Pain Management that attempts to clarify what it says are misconceptions regarding the standards.)

PROP also has called on the Centers for Medicare and Medicaid Services to eliminate the questions related to pain management from Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) questionnaires, asserting that tying reimbursements to patient satisfaction with pain management might also fuel a tendency to overprescribe. Bipartisan legislation was introduced in April to remove this provision of the Affordable Care Act.

In 2016, the CDC issued a Guideline for Prescribing Opioids for Chronic Pain to encourage the more judicious use of opioids by primary care physicians. The Guideline contains 12 recommendations grouped into three areas: 1) determining when to initiate or continue opioids for chronic pain; 2) opioid selection, dosage, duration, follow-up, and discontinuation; and 3) assessing risk and addressing harms of opioid use.

Recommendations include:

• Using nonpharmacologic and nonopioid therapy for chronic pain and opioid therapy only if the expected benefits outweigh the risks establishing realistic treatment goals with patients before initiating opioid therapy
• Prescribing the lowest effective dose of immediate-release opioids when opioids are used for acute pain
• Evaluating risk factors for opioid-related harms before and periodically during opioid therapy
• Reviewing the patient’s history of controlled substance abuse prescriptions using state prescription drug monitoring program (PDMP) data.

In a July 21th editorial in Anesthesiology News, Lynne R. Webster, M.D., a past president of the American Academy of Pain Medicine, argues that the CDC Guideline fails to challenge payers for their lack of coverage for other treatment modalities, “choosing instead to push for opioid supply reduction measures that include dosing limits without regard for the necessity of individualized therapy and with very little consideration of the needs of people in pain.”

He proposes the following:

1. Apply the “Eight Principles for Safer Opioid Prescribing” endorsed by the AAPM (Pain Med 2013;14:959-961).
2. Use abuse-deterrent formulations when an extended-release opioid is indicated.
3. Remove the cap on the number of opioid-addicted people who can be treated for addiction with medications such as buprenorphine.
4. Allow nurse practitioners to prescribe medication agonist therapy for opioid addiction.
5. Recommend affordable, perhaps free, access to buprenorphine and methadone therapy in line with public policy that recognizes addiction as a disease.
6. Push U.S. and state legislatures to issue mandates to payers demanding a minimum level of benefits for patients in pain to increase coverage for evidence-based alternatives to opioids.
7. Remove methadone as a preferred opioid for pain from state formularies.
8. Ask that payers require prescribers to demonstrate methadone-specific knowledge before being allowed to prescribe methadone for chronic pain.
9. Encourage the U.S. Congress to increase funding to find safer and more-effective alternatives to opioids for the treatment of acute and chronic pain.
10. Recommend legislation for partial prescription filling for Schedule II controlled substances to reduce the quantity of unused prescription drugs.
11. Implement the National Pain Strategy as a top priority.
12. Consider prescribing naloxone with all extended-release opioid prescriptions.

The National Pain Strategy for population health-level pain prevention, management, and research was released by the Interagency Pain Research Coordinating Committee of the NIH in response to a 2011 Institute of Medicine report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.

Although opioids “are considered medically appropriate and safe for acute and for intractable pain that is not adequately managed with other methods, when used as prescribed. . . Access to care for people suffering from pain remains a priority that needs to be balanced in parallel with efforts to minimize the harms from opioids,” the document states.

The American Society of Anesthesiologists (ASA) has also focused on reducing opioid overuse and abuse through several initiatives, including:

• Providing formal recommendations to the CDC for the Guideline.
• Forming an Ad Hoc Committee on Prescription Opioid Abuse to promote access to a wide range of therapies for chronic pain, encourage discussions between patients and physicians about the safe use of opioids, and support access to naloxone among first responders, family members, and caregivers of individuals at risk of opioid overdose. “While expanding access to naloxone does not address the underlying causes of the opioid abuse epidemic, it is an important step in preventing opioid overdose fatalities,” states Committee Co-chair James Rathmell, M.D.
• Partnering with the AMA and other medical organizations on the Task Force to Reduce Prescription Opioid Abuse. The task force is working to enhance physician education on effective prescribing practices, reduce the stigma of pain and substance use disorder, and expand access to naloxone in the community and through co-prescribing.
• Working as a member of the Pain Coalition along with the American Academy of Pain Medicine and the American Pain Society to support policies that promote responsible pain care. The PCC advocated for passage of the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, which provides funding for PDMPs. According to the PCC, PDMPs help physicians prevent abuse and diversion and ensure that they prescribe opioids only to patients who will use them responsibly for legitimate medical reasons.
• Developing a consensus document in collaboration with medical and pharmacy organizations to spread awareness among physicians and pharmacists of the red flag warning signs of controlled substance diversion, misuse, and abuse
• Developing and distributing an illustrated Opioid Overdose Resuscitation Card for caregivers and friends of patients that lists symptoms of an opioid overdose and provides easy-to-follow lifesaving techniques. The card was developed in collaboration with the White House Office of National Drug Control Policy.
• Supporting the Comprehensive Addiction and Recovery Act (CARA), signed into law by President Obama on July 21. The legislation includes provisions to expand access to naloxone, allow patients to partially fill prescriptions for controlled substances, provide additional funding for NASPER, and promote interoperability among state PDMPs.

The American Hospital Association (AHA) has joined forces with the CDC to educate the public about opioid abuse. With the help of various healthcare experts, the organizations created a document entitled, Prescription Opioids: What You Need to Know, detailing the risks and side effects of opioids.

Other Government Action

In addition to educating the public about risks and side effects, developing guidelines for physicians, and passing legislation, the federal government has promised more funding to combat opioid use and abuse. On June 7, the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee approved $161.9 billion in base discretionary funding for the departments of Labor, Health and Human Services, Education and Related Agencies in fiscal year 2017. This includes a $126M increase to CDC and SAMHSA programs for the treatment and prevention of opioid abuse.

Specifically, the bill provides a $28 million increase for CDC Prescription Drug Overdose program, a $49 million increase to SAMHSA for treatment, prevention, and overdose reversal, and $50 million for Community Health Center treatment and prevention. Further, the bill continues to provide $1.9 billion for the Substance Abuse Prevention and Treatment Block Grant, $94 million in mandatory funds to Community Health Centers, and an additional $52.5 million to the National Institute on Drug Abuse at the NIH. The bill was approved by the Senate Committee on Appropriations on June 9 and cleared for Senate consideration.

Hospital-Based Efforts

The Society of Hospital Medicine (SHM) has developed a guide, Improving Pain Management for Hospitalized Medical Patients, offering suggestions and best practices. The focus of the Guide is toward implementing and sustaining a pain management quality improvement program and how facilities can improve their policies and procedures to assist providers in combatting opioid addiction and abuse.

According to the Guide, the program should begin with an interdisciplinary Core Project Team charged with defining the team’s scope and aims, obtaining support from institutional leaders, and conducting a formal assessment of the current state of pain management at the facility. Once the assessment has been conducted, SHM recommends the team identify the resources available to it, hold stakeholder meetings to understand stakeholder concerns, and assess internal structures and processes related to pain management in the facility. SHM recommends asking the following questions:

• What hospital policies guide the assessment and treatment of pain?
• What pain scales are used in your hospital and unit? How frequently is pain assessed? Do protocols guide the reassessment of pain after an intervention?
• Do protocols specify how/when to monitor for opioid dose effectiveness (decrease in pain) and side effects using sedation scales?
• Are there specific protocols for patient-controlled analgesia (PCA)?
• Do audits, e.g., Joint Commission or other hospital audits, assess how well your protocols for pain management and monitoring are being followed?
• What order sets include medications or other interventions for pain management? For example, do the admission order sets include as-needed pain medications? Are there other specific order sets, such as for acute pain or PCA? Are these order sets utilized properly?
• Are there methods for flagging and monitoring or adjusting doses for patients who may be at risk for adverse events related to opioids, e.g., patients with obstructive sleep apnea or renal disease?
• Are there hospital guidelines that regulate the use of, or who can prescribe, high-risk medications such as methadone or fentanyl patches?
• Are pharmacy, pain management and/or palliative care automatically consulted for certain patients, e.g., patients with sickle cell disease or post-operative patients?
• Are there reports or audits to track the use of high-risk medications such as methadone or fentanyl patches?
• Are there reports or audits to track opioid adverse events such as respiratory depression, or is naloxone use tracked?

Clinical staff should also be educated about how to discuss pain goals with a patient using the following key principles: expressing commitment to care for pain; explaining the decision to use multiple therapies besides opioids and to use the minimal medication necessary; and expressing empathy while setting clear limits in a non-judgmental fashion. Instead of asking “What is your goal for pain on a 0 to 10 scale?” staff can ask statements that could be considered more likely to yield specific information. Examples include asking what the patient would like to be able to do while living with the pain and what kind of level of pain does the patient consider tolerable.

On an operational level, hospitals should review the following to improve opioid use in their facilities: ensuring the safe initiation and titration of opioids, monitoring and minimizing the side effects of opioid use, evaluating non-pharmacological interventions, and closely monitoring patients with one or more of the following risk factors: concurrent use of other central nervous system depressants such as benzodiazepines, sleep apnea and cardiovascular diseases.

Conclusion

As the data clearly show, opioid overuse and abuse has become a serious problem in the United States. Although payment policies will change slowly, if they change at all, anesthesiologists and practice managers should stay abreast of the issue and begin to update their own practices as appropriate.

With best wishes,

Tony Mira
President and CEO