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Hooked

Responding to the Prescription Opioid Abuse Epidemic

By Kathleen T. Brady, M.D., PHD; Kelly S. Barth, DO; and Kimberly McGhee
Illustration by Timothy Banks

On completion of the article, readers should be able to:

  • Summarize the definition of opiate use disorder from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and use the DSM-V criteria to Identify patients with the disorder
  • Recognize that good pharmacological and nonpharmacological treatments for addiction are available and refer patients appropriately to addiction centers for such treatment with proper follow-up
  • Recognize the importance of regular urine drug testing in patients prescribed opioids and of consulting the South Carolina Reporting & Identification Prescription Tracking System (SCRIPTS) to monitor for aberrant drug-seeking behavior and possible diversion

Patients with a prescription opioid use disorder do not fit the stereotype of an addict. Most began taking opioids seeking not a cheap high but relief from legitimate pain and obtained opioids not from a shadowy dealer on the street but through a legal prescription from a trusted physician.1 And yet they became “hooked” on the euphoria the drugs offered, and, once the euphoria faded, were driven by their addiction to seek out the drugs they then needed merely to feel normal.

The kneejerk response is to blame either the victims, assuming some moral failing or deficit made them susceptible to addiction, or the physicians, caricaturing them as eager to make a buck by overprescribing opioids. In reality, the explosion in prescription opioid abuse in recent years had less to do with a moral decline on the part of patients or callous profiteering on the part of physicians and more to do with an unfortunate convergence of trends that has unleashed a flood of prescription opioids, leading to increased addiction among patients and higher rates of diversion for nonmedical purposes.

The Pendulum Swings

In the late 1990s, a paradigm shift occurred in pain management. “For a long time, there was such fear of overuse of prescription opioids that physicians were reluctant to use them at all, even in cancer patients. Then there came a movement that began to talk about pain as the fifth vital sign and the need to assess pain aggressively in all patients and treat it, and I think with that there was liberalization around the use of opioids. I think that the pendulum swung from undertreatment to now overtreatment in some cases,” remarks Kathleen T. Brady, M.D., PhD, a noted addiction researcher and Associate Provost for Clinical and Translational Science at the Medical University of South Carolina.

In 2000, the Joint Commission on Accreditation of Health Organizations (JCAHO) implemented pain management standards making pain control a patients’ rights issue, encouraging increased usage of quantitative (10-point) assessments of pain, and calling for better education and training in pain management.2 Indeed, the lack of training provided during residency about pain management and opioid administration was identified as one of the main contributors to physicians’ reluctance to provide adequate pain relief for their patients. Critics raised concerns that these new standards could lead to physicians overprescribing opioids when pressured by patients (for whom pain control was now considered a right),3 but proponents of the changes saw little threat of abuse.2

Fast forward to today. The Centers for Disease Control and Prevention have declared abuse of prescription drugs, particularly prescription opioids, a national epidemic. Although the US population represents only 4.6% of the global population, Americans consume 80% of the global opioid supply and 99% of the hydrocodone supply.4 More people die in the US as a result of prescription opioid overdose than from heroin and cocaine overdose combined.5 More than three times as many people died of prescription painkiller overdoses in 2008 (15,000) than in 1999 (4,000).6 For young adults, prescription painkillers have now become the drugs of choice for illicit use, second only to marijuana.6,7 Prescription drug abuse and misuse also places a heavy burden on the health care system, accounting for almost a half million visits to emergency departments in 20094 and costing health insurers $72.5 billion annually in direct health care costs.8

A Quick Fix Gone Wrong

Why did such catastrophic consequences follow such a well-intentioned effort to better attend to patients’ pain?

In an ideal world, the calls for pain assessment and management would have been met by multidisciplinary teams who received appropriate training in pain and who evaluated the patient; presented a full spectrum of treatment choices that included psychological interventions (eg, cognitive behavioral therapy to control pain) and nonopioid as well as opioid painkillers; and, when using opioids, started with low doses and provided close follow-up. In the real world, busy primary care physicians, who (as JCAHO noted) had little training during residency in pain management and opioid prescribing, treated most cases of chronic pain. The time constraints of a typical primary care appointment did not permit extended discussion of cognitive behavioral therapy as an effective nonpharmacological therapy for pain, albeit one that might take longer to work than an opioid. Patients wanted immediate relief for their pain, and, in the setting of the more liberalized attitude toward using medications for pain management, some physicians opted for the “quick fix” of prescribing opioids. “In a system where there is so much time pressure, medications can be the easiest way to provide a solution with immediate relief for the patient,” notes Dr. Brady.

Exacerbating the situation was an aggressive marketing campaign by a large pharmaceutical company to encourage primary care physicians to prescribe OxyContin® for pain because it was less addictive due to its slow-release formula. This claim proved to be false (crushing or snorting it overcame its slow-release safeguards), and officials responsible for the fraudulent marketing campaign were fined, but not before the damage had been done.9

Between 1997 and 2006, retail sales of opioids increased 127% (from 50.7 million grams to 115.3 million grams), with much higher spikes for some opioids (eg, 732% for OxyContin®).4 During that same period, average per-person sales of opioids increased by 347% (from 74 milligrams to 329 milligrams).4 This flood of prescription opioids brought sharp increases in emergency department visits for prescription-controlled drugs,4 accidental deaths due to opioid overdose,10 and opioid abuse.4
As some patients became “hooked,” they engaged in “doctor shopping,” seeking to increase their supply by obtaining prescriptions from numerous physicians. Pill mills sprang up to satisfy this demand—clinics that sought quick profit by prescribing opioids on the slightest of medical pretexts. The appeal of prescription opioids for the illicit drug user is easy to understand: they are easier to obtain, of higher purity, and presumably safer than street drugs because they have been prescribed by a physician. In point of fact, of course, the prescription opioids are just as addictive and dangerous when used without medical supervision.

The Dilemma of the Primary Care Physician

Primary care physicians remain on the front lines of chronic pain management, and the training provided them in pain management and opioid administration during residency remains minimal. Primary care physicians often “inherit” patients who have already been placed on opioid therapy by surgeons or other physicians and are left to manage as best they can. Given the potential for abuse of prescription opioids that has become abundantly clear, many physicians would greatly prefer to refer patients with chronic nonmalignant pain to a pain center where specialists are much more familiar with the dosing and monitoring of these medications, but such centers are not always available and sometimes focus their practice on more lucrative procedures instead of chronic pain management.11

What Can the Primary Care Physician Do to Curb Opioid Abuse?

Recognize the Difference Between Physical Dependence and Addiction
It is expected that many patients on long-term opioid therapy will develop a physical dependence, meaning that they will have increased tolerance and require higher dosages and that they will experience withdrawal if they discontinue the medication. However, being physically dependent does not mean that they have a prescription opioid use disorder, the term being used to replace addiction in the Diagnostics and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Whereas physical dependence need not impede function, prescription opioid use disorder is characterized by an increasing preoccupation with opioids that has a detrimental effect on many areas of a patient’s life. For a patient to be identified as having an opioid use disorder, he or she must meet two of the criteria in Table 1 in the previous 12 months.

TABLE
1

Diagnostic Criteria (DSM-V) for Prescription Opiate Use Disorder

Patients are considered to have an opioid use disorder if they have a problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least two of the following, occurring within a 12-month period:

  • They take more opioids or take them longer than prescribed.

  • They have a persistent desire or a history of unsuccessful efforts to control opioid use.

  • They spend a great deal of time obtaining the opioid, using the opioid, or recovering from its effects.

  • They have a strong craving or urge to use opioids.

  • Their recurrent opioid use prevents them from fulfilling major work, school, and home obligations.

  • They continue to use opioids despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids.

  • They forego or restrict important social, occupational, or recreational activities because of opioid use.

  • They use opioids in physically hazardous situations.

  • They continue to use opioids despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance.

  • Tolerance*

  • Withdrawal*

*Not considered a criterion if the patient is under appropriate medical supervision

DSM-V= Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. For more information on the DSM-V, visit http://www.dsm5.org/Pages/Default.aspx

Screen for Aberrant Medication-Related Behaviors
Screening patients for aberrant drug-related behaviors is the single most important step a physician can take in helping combat the prescription opioid abuse epidemic (Table 2). Physicians should avail themselves of tools that have been developed for evaluating risk for aberrant medication-related behavior both before and during opioid therapy. The Revised Screener and Assessment for Patients with Pain (SOAPP®-R), released in 2008, is a scientifically validated brief paper-and-pencil tool intended to be used before commencement of opioid therapy to predict which patients being considered for long-term opioid therapy are most likely to exhibit aberrant medication-related behaviors in the future. The Current Opioid Misuse Measure (COMM)® is a scientifically validated brief paper-and-pencil tool for use with patients already receiving long-term opioid therapy intended to help clinicians identify whether a patient is exhibiting aberrant drug-related behaviors associated with misuse of opioid medications. Both tools are available for download at PainEDU.org upon free registration (http://www.painedu.org/registration.asp?target=terms). Physicians should also watch carefully for known risk factors for opioid overdose (Table 3).

TABLE
2

Aberrant Drug-Related Behaviors

Addictive Behaviors

Possible Addictive Behavior

Selling

doses ↑

Forging

Hoarding Drugs

Stealing/borrowing

Asking for a specific prescription

Injecting

Engaging in "doctor shopping"

Obtaining from nonmedical sources

1-2 dose ↑

Multiple dose ↑

Requesting prescription for another symptom

Losting prescription repeatedly

Exhibiting psychic effects

Adapted from Passik SD, Portenoy RK, Ricketts PL. Substance abuse issues in cancer patients. Part 1: prevalence and diagnosis. Oncology 1998;12(4):517-521,524.

Communicate Empathically But Honestly With Patients About Their Opioid Use Disorder
Physicians should be honest with patients whom they suspect of having an opioid use disorder, while at the same time reassuring them that effective, life-saving treatments are available at addiction centers. They should not evict these patients from their practice; a recent study showed that only 17% of those who were referred for addiction treatment actually pursued it without follow-up by their primary care physician.12

Refer Patients With an Opioid Use Disorder to Addiction Treatment
Physicians in South Carolina can search for addiction centers on the website of the Department of Alcohol and Other Drug Abuse Services (http://www.daodas.state.sc.us/LocalResources.asp). This includes MUSC’s Center for Drug and Alcohol Programs (CDAP). The South Carolina Department of Health and Environmental Control also maintains a list of licensed facilities offering inpatient or outpatient treatment for patients with psychoactive substance use problems at https://www.scdhec.gov/health/licen/hrtypfac.htm. Physicians can also search for authorized Suboxone® providers by zip code at http://www.suboxone.com/treatment-plan/find-a-doctor.


TABLE
3

Risk Factors for Opioid Overdose

  • Higher doses of opioids

  • 100 mg morphine equivalent or higher

  • Opioid use with sedatives (eg, benzodiazepines) or alcohol

  • Comorbid mental health or medical issues

  • Recent abstinence (and thus reduced tolerance)

  • Substance abuse

  • Aberrant behavior (multiple pharmacies)

  • Opioid use while alone or in a remote area

Data from Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose. JAMA. 2011;305(13):1315-1321.

Explain to Patients That Life-Saving Treatments Are Available
Although nonpharmacological treatments (cognitive behavioral therapy, 12-step facilitation, motivational enhancement interviewing) are invaluable for successful treatment of opioid use disorder, some patients will require medications for successful treatment. The popular misconception that this is merely replacing one drug with another is unjustified. While pharmacological treatments for opioid use disorder may lead to a physical dependence, they spare patients the most life-disrupting effects of addiction, such as extreme cravings and compulsive drug-seeking behavior, enabling them to regain function and lead normal lives, maintaining relationships and holding down jobs. All of these pharmacological interventions are much more likely to be successful if patients are also receiving psychological support and counseling.

Pharmacological therapies either block the opioid receptors (naltrexone) or use a substitute to bind them (ie, methadone, Suboxone® [buprenorphine and naloxone]).13 Naltrexone, an opioid blocker, binds much (100-fold) more strongly to opiate receptors than opioids themselves, meaning that it prevents the opioids from triggering the reward circuitry of the brain (or from controlling pain) by monopolizing the receptors. Its primary advantage is that it poses no risk of addiction. Methadone has been the “workhorse” therapy for opioid use disorder since the 1960s and remains a viable option for some patients. Unlike most opioids of abuse, which are fast-acting, methadone, a full opioid, remains in the body for days and has a steadier influence on opiate receptors. As a result, it is less likely to lead to compulsive drug-seeking behavior.13 However, methadone must be dispensed in specialized clinics, potentially presenting barriers to care for some patients (eg, stigma, inaccessibility). Buprenorphine is a partial opioid agonist that partially activates the opiate receptor while simultaneously blocking it from other opioid drugs (eg, oxycodone, morphine, and heroin). Suboxone® combines buprenorphine with the opioid blocker naloxone as a deterrent against diversion and nonmedical use. When Suboxone® is taken as directed (sublingually), the naloxone is inactive, but if injected for nonmedical purposes, the naloxone can precipitate severe withdrawal, minimizing its appeal for illicit use. A key advantage of Suboxone® is that, unlike methadone, it can be prescribed in general office-based practices, making it more convenient and accessible to patients and minimizing any stigma. For more details on the advantages and disadvantages of each of these therapies, see Table 4.

Table 4

FDA-Approved Treatments for Opioid Addiction

Naltrexone (Vivitrol®, ReVia®)
Buprenorphine/
Naloxone (Suboxone®)


Methadone

Mechanism
Opioid antagonistOpioid partial agonist/partial antagonistOpioid agonist
Availability
Extended-release injection, tablet

Sublingual

Tablets; syrup
Prescribing Conditions
None

Must be authorized Suboxone® provider

Patients must obtain from a methadone clinic
InitiationMust wait to initiate until patient has been free of opioids for 7–10 days
Must wait to initiate until after withdrawal symptoms have started to appear

May initiate immediately to avoid withdrawal
Abuse Potential
No abuse potential

Less likely than methadone; only a partial agonist; dissolution and injection may induce withdrawal

Low compared with other opiates
Very low within methadone clinic
Patient Population/OtherConcomitant alcohol dependence
Highly motivated patients
Patients with mandated use (eg, medical boards)

Variable insurance coverage, some may only cover for 60 days
Usually requires pre-authorization

Not covered by insurance (~$20/day)

Take Universal Precautions When Prescribing Opioids
When prescribing opioids, physicians are advised to adopt universal precautions, requiring patients to sign opioid contracts and submit to urine drug tests, and checking for any aberrant drug-seeking behavior through statewide prescription-monitoring programs, such as the South Carolina Reporting & Identification Prescription Tracking System (SCRIPTS).

Opioid contracts should spell out treatment plans that include nonpharmacological as well as pharmacological approaches; provide measurable goals to gauge progress and mark the termination of opioid therapy; stipulate any medication-related conditions, such as regular urine drug tests or the need to provide a police report in the event of lost medications; and explicitly state the penalties for failing to meet these conditions or engaging in aberrant drug-related behavior. These contracts can provide useful negotiating tools for physicians who are “inheriting” patients who have already been prescribed opioids with high abuse potential and are trying to transition them to treatment with pain medications that have less addictive potential.

South Carolina physicians should consult SCRIPTS, which chronicles all sales of controlled substances statewide, before accepting patients receiving opioid therapy into their practice. All patients prescribed opiates should be monitored regularly for aberrant behavior. Regular urine drug testing verifies that patients are taking the opioids they have been prescribed (rather than diverting them) and that they are not taking other prescription medications or illicit drugs without their physician’s knowledge. Physicians and pharmacists can apply for access to the SCRIPTS database at http://www.scdhec.gov/administration/drugcontrol/pmp-practitioner-pharmacist.htm.

Educate Patients About Safe Storage and Disposal
To minimize opportunities for diversion, physicians should teach patients about how to safely store and dispose of their prescription opioids. It is recommended that opioids be kept in a locked box to discourage theft by other members of the household, in particular adolescents. Although the recommendation for disposal of most medications involves making them unpalatable by mixing them with coffee grounds or used kitty litter, the US Food and Drug Administration recommends that most opioids be flushed to remove any possibility that another member of the family could accidentally ingest them.

A New Model

Clearly, the current model for using opioids to address pain is not working.

Some states have taken matters into their own hands to ensure that opioids are prescribed in a safe and effective manner. In 2007, Washington established its own evidence-based opioid-dosing guidelines. Early results have been promising, with drug-related deaths reduced by half from 2009 to 2010.14 Combining such evidence-based prescribing guidelines with new models of care like the patient-centered medical home could help turn the tide of prescription opioid addiction.14
The patient-centered medical home is a team-based model of care in which primary care physicians, specialists (in this case pain or addiction specialists), a nurse coordinator, and other health care professionals work collaboratively to offer patients coordinated and accountable care. The patient is empowered to participate actively in his or her pain management. Treatment plans are “stepped,” beginning with standard first-line interventions and assessing the outcomes of those interventions thoroughly before moving to more aggressive treatment.14

If the prescription opioid abuse epidemic was, in part, an unintended consequence of the paradigm shift from cautious to aggressive treatment of pain, another paradigm shift, this time in care models, may be required to ensure good pain control while minimizing abuse potential.

References
1 Barth KS, Moran-Santa Maria M, Lawson K, Shaftman S, Brady KT, Back SE. Pain and motives for use among non-treatment seeking Individuals with prescription opioid dependence. Am J Addict 2013;22:486-491.
2 Phillips DM. JCAHO pain management standards are unveiled. Joint Commission on Accreditation of Healthcare Organizations. JAMA 2000 Jul 26;284(4):428-429.
3 Hansen G. Assessment and management of pain. JAMA. 2000;284(18):2317-2318.
4 Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician 2008; 11:S63-S88.
5 Vital Signs: Overdoses of prescription opioid pain relievers — United States, 1999—2008. MMWR. November 4, 2011;60(43);1487-1492.
6 Substance Abuse and Mental Health Services Administration, Office of Applied Studies. (July 15, 2010). The TEDS Report: Substance Abuse Treatment Admissions Involving Abuse of Pain Relievers: 1998 and 2008. Rockville, MD.
7 Substance Abuse and Mental Health Services Administration. Results from the 2009 National Survey on Drug Use and Health: Volume 1: summary of national findings. Rockville, MD: US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies; 2010. Available at http://oas.samhsa.gov/nsduh/2k9nsduh/2k9resultsp.pdf. Accessed October 3, 2011.
8 Coalition Against Insurance Fraud. Prescription for peril: how insurance fraud finances theft and abuse of addictive prescription drugs. Washington, DC: Coalition Against Insurance Fraud; 2007. Available at http://www.insurancefraud.org/downloads/drugDiversion.pdf. Accessed September 26, 2011.
9 Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. American Journal of Public Health February 2009;
99(2):221-225
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10 Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose. JAMA. 2011;305(13):1315-21.
11 Mavromatis JK. How primary care should manage chronic pain patients. KevinMD.com. May 28, 2010.
12 Barth KS, Becker WC, Wiedemer NL, et al. Association between urine drug test results and treatment outcome in high-risk chronic pain patients on opioids. J Addict Med. 2010;4(3):167-73.
13
Kosten TR, Georg TP. The neurobiology of opioid dependence: implications for treatment. Sci Pract Perspect. 2002 Jul;1(1):13-20.
14 Cahana A, Dansie EJ, Theodore BR, et al. Redesigning delivery of opioids to optimize pain management, improve outcomes, and contain costs. Pain Medicine 2013;14:36-42

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March 12, 2014
Date of Expiration:
March 12, 2016
You can complete the steps necessary to receive your AMA PRA Category 1 Credit(s)™ by visiting MUSC Health’s Physician Portal at MUSChealth.com/progressnotescme.

CREDIT DESIGNATION:
Physicians: The Medical University of South Carolina designates this enduring material for a maximum of .50 AMA PRA Category 1 Credits™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

Nursing Credit: Most states accept CMEs that apply to a specific nursing specialty as nursing continuing education. Please check with your respective State Board of Nursing to ascertain the equivalent number of contact hours offered for .50 AMA PRA Category 1 Credits™.

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Accreditation Statement: The Medical University of South Carolina is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Disclosure Statement: In accordance with the ACCME Essentials and Standards, anyone involved in planning or presenting this educational activity is required to disclose any relevant financial relationships with commercial interests in the healthcare industry. Authors who incorporate information about off-label or investigational use of drugs or devices will be asked to disclose that information at the beginning of the article.

Kathleen T. Brady, M.D., PhD, Kelly S. Barth, DO, and Kimberly McGhee have no relevant financial relationships to disclose.
"Prescription Opiates: Improving Safety" - CME Telepresentation

Register for the sister telepresentation “Prescription Opiates: Improving Safety” by Kathleen Brady, M.D., PhD, and Kelly Barth, D.O. on May 8 from 2-3 (EST), by visiting scahec.net/schools. New users will need to create a profile.

The live activity has been approved for AMA PRA Category 1 Credit™.The session will be recorded as enduring material and made available at MUSChealth.com/ProgressnotesCME for those who could not attend the live session.