Running head: OPIOID USE

Opioid Use in Chronic Noncancer Pain

Literature Review

Angela Solleder

Samuel Merritt University

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Opioid Use in Chronic Noncancer Pain Literature Review

Although there appears to be relatively little evidence which supports the long-term use

of opioid medications for chronic noncancer pain (CNCP), their use has increased substantially

in recent years. The number of prescriptions for opioids (like hydrocodone and oxycodone

products) have escalated from around 76 million in 1991 to nearly 207 million in 2013, with the

United States their biggest consumer globally, accounting for almost 100 percent of the world

total for hydrocodone (e.g., Vicodin) and 81 percent for oxycodone (e.g., Percocet) (National

Institute on Drug Abuse, 2015). These drugs are not without risk, however, and should be used

judiciously in the primary care setting. Future nurse practitioners will be tasked with caring for

CNCP patients and therefore should have a solid understanding of risks and benefits of opioid

prescribing as well as adjunctive therapies in managing chronic pain. This paper is a review of

the literature investigating the trends in opioid use, best practices for management, and

conjunctive therapies for a multimodal approach to a common, yet complex, clinical problem.

Significance of the Problem

Opioid medications such as morphine, fentanyl, hydrocodone, and oxycodone, just to

name a few, have been increasingly prescribed for chronic pain. By definition, pain is

considered to be chronic pain if the duration is longer than 3 months, is intractable, and thus not

responsive to conventional treatment. Pain diagnoses that fall under this umbrella include:

musculoskeletal pain, including back pain; neuropathic pain, fibromyalgia, sickle cell disease,

inflammatory pain, and headache disorders. In their 2014 review, the AHRQ quoted a recent

Institute of Medicine report noting that up to one-third of U. S. adults, or approximately 100

million Americans, report chronic pain (AHRQ, 2014). In 2010 an estimated 20% of patients

presenting to physician offices in the United States with pain symptoms or diagnoses were

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prescribed opioids (CDC, 2015). Along with this increase in usage has come an upsurge in

adverse outcomes such as overdose (fatal and nonfatal), misuse and diversion, addiction, and

accidents involving injuries (such as falls and motor vehicle accidents) (AHRQ, 2014). Most

pressing from a public health perspective is the increase in deaths from opioid overdose. In 2011

alone, there were 16,917 fatal overdoses involving prescription opioids (AHRQ, 2014), which

have more than tripled in the past 20 years. Opioid misuse and abuse resulted in nearly 660,000

emergency department visits in 2010, over twice as many as in 2004 (AHRQ, 2014).

Additionally, substance abuse treatment admissions for opiates other than heroin increased more

than six-fold from 1999 to 2009 (AHRQ, 2014).

In addition to the health consequences of opioid misuse and abuse, there are economic

ramifications to this issue. In the CDC’s Primary Care and Public Health Initiative, they note

estimations that opioid abuse costs insurers $72.5 billion dollars every year and that people who

abuse opioids generated over 8 times the annual direct health care costs compared with people

who do not abuse these drugs (CDC, 2011). Furthermore, the lost wages and lost productive

time figures are staggering. Lost productive time from common painful conditions was

estimated to be $61.2 billion per year, while 76.6% of lost productive time was explained by

reduced work performance, not absenteeism (AAPM, 2015).

And finally, opioid analgesics are not without side effects. Some of the most common are

nausea, chronic constipation and serious fecal impaction, chronic dry mouth which can lead to

tooth decay, sedation and respiratory depression, hypogonadism and other endocrine effects,

sleep-disordered breathing, and increased pain sensitivity or hyperalgesia (Kolodny, et al,

Physicians for Responsible Opioid Prescribing, 2015). However, many patients presenting to

primary care providers will either be on these medications already, or possibly be evaluated for

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initiation of therapy. Therefore, it behooves clinicians to be well-versed on the latest information

and recommendations in order to prescribe safely and effectively.

Purpose

The purpose of this paper is to review current literature on opioid management and best

practices, as well as to consider the patient’s perspective in this endeavor. Treatments aside from

prescription opioids will also be reviewed briefly as part of a biopsychosocial approach.

As the CDC advises, improving the way opioids are prescribed through clinical practice

guidelines can ensure patients have access to safe, effective treatment while reducing the number

of people who misuse, abuse, or overdose from these powerful drugs (CDC, 2015).

Search Criteria

The criteria for this literature search included peer-reviewed, primary research studies

published within the last 5 years. Literature review articles were not included in the literature

table as part of this review, but are referenced throughout this paper and included in the

Reference section. The PubMed database was the initial search tool used, with search terms

“opioid use”, “nurse practitioner”, and “opioid noncancer pain.” Secondarily, the CINAHL

database was used searching with the same terms, and returned more nurse practitioner-specific

articles, though some were past the 5-year cutoff and/or consisted of review articles and a white

paper.

Critique of the Literature and Identification of Gaps

While the literature search returned many articles on opioid management, particularly

review articles, there were very few expressly directed to nurse practitioners. The few that were

culled were either older than 5 years or were a review article or white paper. In regards to the

efficacy of opioids for the long-term treatment of chronic pain, a dearth of research exists as

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noted by the recent AHRQ review in 2014. Of the 4209 studies pulled up in their search, only 39

were included in their review, and they note that most were low-quality (due to imprecision and

methodological shortcomings) and that evidence on long-term opioid therapy for chronic pain is

very limited, but suggested an increased risk of serious harms that appears to be dose-dependent

(AHRQ, 2014). I chose to review some of these studies related to opioid dose and risk, as this

was a recurring theme relevant to poorer outcomes. Additionally, studies discussing risk

evaluation and mitigation strategies were included as part of an investigation on best practices.

Studies looking at the psychosocial components and mental health of chronic pain patients were

also included.

In terms of gaps found while undergoing this research, two areas at least are in need of

more data. One would be studies directed to nurse practitioner practice specifically, and the

unique role that NPs have in chronic pain management. Additionally, as many before have

discovered, studies are lacking that definitively show that opioids are effective and good choices

for long-term pain management for patients with chronic noncancer pain.

Studies on Opioid Dosage and Risk

A recurring finding within current literature is that the dose of opioids prescribed appears

to play in role in risk of harm in patients with chronic noncancer pain (AHRQ, 2014). In A 2011

Canadian study, researchers sought to characterize the relationship between opioid dose and

opioid-related mortality by performing two large (n=607,156), population-based, nested case

control studies (Gomes, Mamdani, Dhalla, Paterson, & Juurlink, 2011). The researchers

reviewed prescription drug data from the Ontario Public Drug Benefit Program database over a

9-year period (1997-2006), and the sample included residents of Ontario, Canada, aged 15-64,

who were eligible for publicly-funded prescription drug coverage and had received an opioid

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prescription for nonmalignant pain. The outcome of interest was opioid-related death, as

determined by the investigating coroner, which was compared among patients treated with

various daily doses of opioids. From the cohort of 607,156 individuals studied, 1463 had an

opioid related death (59% accidental, 16.8% suicide, 24% undetermined) and the average age at

death was 42.7 years (Gomes, et al, 2011). They found that a significant relationship existed

between the average daily opioid dose and death; compared with patients receiving less than 20

mg/day, those prescribed opioids at daily doses of 200 mg or more of morphine (or equivalent)

had a much higher risk of opioid-related mortality (Gomes, et al, 2011). What is really important

to note here is that opioids are widely being prescribed at this 200 mg threshold and higher, and

that providers must be aware of the increased risk these kinds of doses pose. The authors note

that most of these opioid-related deaths occurred in relatively young people, and yet, are

avoidable (Gomes, et al, 2011).

Another study by researchers in Washington State, conducted over an 8-year period

(1997-2005), aimed to estimate the overall overdose rates (fatal and non-fatal) among patients

receiving long-term opioid therapy for CNCP as well as study whether risk for overdose differs

by dose (Dunn, Saunders, Rutter, Banta-Green, Merrill, Sullivan, , . . . Psaty, 2010). They found

similar results in their sample (n=9940), but at an even lower maximum dosage threshold, 100

mg morphine equivalent. Compared with patients receiving 1-20mg/day of opioids (0.2% annual

overdose rate), patients receiving 50-99mg/day had a 3.7-fold increase in OD risk and 0.7%

annual OD rate Patients receiving 100mg/day or more had 8.9-fold increase in overdose risk and

a 1.8% annual OD rate. During the study time frame, there were 51 opioid-related overdoses,

including 6 deaths. While the overall overdose incidents may seem pretty small for an 8-year

period of time, it still speaks to the fact that higher doses put patients at risk and therefore those

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patients must be closely monitored. The authors do acknowledge the small number of overdoses

in this study cohort and highlight that their study cannot establish whether the OD risk

differences are directly related to the dose or patient characteristics (Dunn, et al, 2010). They

also point out that prior studies indicate that the increase in opioid-related overdoses parallels the

increased prescribing of opioids for CNCP but that some evidence suggests that overdose occurs

predominantly by diversion, or by persons obtaining opioids from nonmedical sources (Dunn, et

al, 2010).

Similarly, a 2013 study in the Clinical Journal of Pain called for caution in doses > 120

mg morphine equivalents/day and that duration of opioid therapy was more important than daily

dose in determining opioid disorder (OUD) risk (Edlund, Martin, Russo, Devries, Braden, &

Sullivan, 2013).. The researchers concluded that among individuals with a new CNCP episode,

prescription opioid exposure was a strong risk factor for incident OUDs (6.1% OUD rate) and

that men, and those of younger age (18-30), and who had a history of mental health issues and/or

substance abuse had higher rates of an OUD (Edlund, et al, 2013).

Franklin, Mai, Turner, Sullivan, Wickizer, & Fulton-Kehoe (2011) wanted to assess

changes in opioid dosing patterns and opioid-related mortality in their workers’ compensation

system following a 2007 implementation of a specific Washington State opioid dosing guideline

which was created in response to the escalating number of deaths related to prescription opioids

in that state (Franklin, et al, 2011). The hallmark of this guideline was highlighting a “yellow

flag” of 120 mg/day morphine-equivalent dose (MED). It required that providers must consult

with a pain specialist for CNCP patients receiving over this dose before they could continue to

prescribe at this dosage. What Franklin and the other researchers found was that compared to

prior to 2007, there has been a substantial decline in both MED/day of long-acting schedule II

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opioids (by 27%), the percentage of workers on doses >120 mg/MED /day declined by 35%, and

that there was a 50% decrease from 2009-2010 in the number of deaths (Franklin, et al, 2011).

They concluded that the introduction of these opioid dosing guidelines appeared to be associated

temporally in these findings. They cite other studies, too, which consistently found that in

workers’ compensation populations, use of only a modest amount of opioid soon after injury is

associated with at least double the odds of long-term disability, even after adjusting for other risk

factors (Franklin, et al, 2011). Also mentioned briefly are other studies which concluded that

increasing doses of opioids over time, both in workers’ compensation patients with back

injury/pain, as well as veterans with CNCP, did not improve pain and function in clinically

meaningful ways (Franklin, et al, 2011).

Studies on Risk Evaluation and Mitigation Strategies

When one considers that an estimated 100 million Americans, or up to 1/3 of the U. S.

adult population (AHRQ, 2014), suffers from chronic noncancer pain, it is imperative that

clinicians are educated on, and utilize, best practices in managing their patients on opioids. In a

retrospective cohort study (Starrels, Becker, Weiner, Heo, & Turner, 2011) of University of

Pennsylvania primary care patients on long-term opioid therapy for CNCP, researchers

discovered that monitoring of patients with CNCP on long-term opioids was quite limited.

Although recommendations for urine drug testing, regular office visits, and restricted early refills

have been the backbone of risk reduction strategies to identify aberrant behaviors and misuse,

they clearly are not being consistently implemented. Only 8% of the study patients had had at

least one urine drug test; 49.8% had attended regular office visits, and 23% received more than

one early opioid refill (Starrels, et al, 2011). These researchers recommended more standardized

approaches to opioid risk reduction be implemented by primary care physicians which could

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involve screening tools to identify patients more at risk for misuse, treatment agreements that

stipulate the necessity for regular office visits, restricted early refills, and urine drug screens as

well as team-based care to help facilitate this process (Starrels, et al, 2011).

In a small but relevant study to identify the skills and competencies considered most

critical for primary care physicians to effectively manage opioid risk in patients treated for

chronic pain, Chiauzzi and colleagues found that those rated highest were: how to monitor

opioids, and how to assess for risk factors (Chiauzzi, Trudeau, Zacharoff, & Bond, 2011).

Additionally, managing pain patients with comorbid conditions was rated highly as a needed

skill.

Highlighting the importance of using urine drug testing (UDT) as part of a

comprehensive management approach to opioid-prescribing, a 2012 study published in Pain

Physician (Owen, Burton, & Schade, 2012) unequivocally concluded that UDT must be done

routinely as part of an overall best practice program in order to prescribe chronic opioid therapy

(COT). They emphasize that UDTs are one of the few objective tools that can assist providers in

evaluating appropriate and inappropriate drug use and that psychological evaluations and risk

assessment tools alone are not enough (Owen, et al, 2012).

This study also gave a brief history of how opioid prescribing began to increase after the

1990’s when efforts were underway to treat pain more aggressively. One may recall the

appearance of required pain questionnaires in health care settings as well as pain being referred

to as “the fifth vital sign.” Congress proclaimed 2000-2010 the Decade of Pain Control and

Research, and shortly afterwards controlled opioid therapy (COT) for pain was endorsed by the

American Pain Society (APS) and the American Academy of Pain Management (AAPM), and

subsequently, the prescribing of opioids increased substantially (Owen, et al, 2012). They note

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that this increased availability of opioids has led to both an increase in nontherapeutic use as well

as rising rates of opioid overdose, and we now find ourselves in a situation of what they term

“opioidphobia”, where providers are reluctant to prescribe opioid medications (Owen, et al,

2012).

Another group of researchers at the University of Pennsylvania implemented a

standardized, EMR-based protocol for opioid prescribing to evaluate whether it could improve

care for CNCP patients and improve provider satisfaction and knowledge in providing this care

(Canada, DiRocco, & Day, 2014). Expressing their concern for better training of primary care

providers with respect to opioid management, they emphasized that primary care providers are at

the center of this opioid controversy, as they do 40% of the prescribing—yet training and

knowledge on how to best manage these patients is inadequate. Although participants were paid

for their adherence to the protocol, the results were positive. Urine drug screen ordering

increased by 145% across all 3 practices and documentation of a chronic pain diagnosis in the

EMR problem list increased by 424% (Canada, DiRocco, & Day, 2014). They also note that

provider knowledge of proper management improved significantly as did providers’ role

adequacy, role support, job satisfaction and role related self-esteem when working with patients

taking opioids. Another significant finding was that at all practices, the number of patients

receiving opioids decreased after the intervention.

Studies on Psychosocial Aspects of Chronic Pain

The complex clinical problem of chronic noncancer pain is a challenge not only for

providers, but for patients and their families. The impact on quality of life, ability to function,

enjoyment of activities, ability to concentrate, energy level, ability to sleep, not to mention lost

productive time at work are all factors that cannot be ignored and have a detrimental effect on

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the individual’s overall well-being. A 2015 study in the Journal of Behavioral Medicine sought

to further study the nature of the relationships among chronic pain, PTSD, and depression and

found that PTSD is strongly associated with multiple domains of pain, psychological status,

quality of life, and disability and that these associations remain robust even after controlling for

major depression (Outcalt, Kroenke, Krebs, Chumbler, Wu, Yu & Bair, 2015). They stressed the

importance of screening for PTSD and depression among patients with chronic pain using simple

measures (such as BPI, PC-PTSD, PTSD checklist, PHQ-9, SF-36, GAD-7) and that when the

screen is positive, PCPs should ensure that behavioral health care is incorporated into the overall

plan of care.

Pain Management Nursing published a two-part phenomenological study in 2009 in

which the aim was to investigate the lived experience of adults receiving opioid therapy for

chronic nonmalignant pain (Vallerand & Nowak, 2009, 2010). In the first part of the study

looking at life before and after initiation of opioid therapy, patients described life before

treatment with opioids as characterized by desperation and the inability to function. Life after

opioid therapy was characterized by balancing, living a secret life, fear of losing the pain

management regimen, and thankfulness for a life regained (Vallerand & Nowak, 2009, 2010). In

the second part of this study which focused on barriers to care, participants spoke of being

stigmatized as “addicted and/or morally weak” and felt “disdain and negativity from family”, and

expressed fear of losing their job (Vallerand & Nowak, 2009, 2010). Patients also describe

feeling stigmatized by pharmacies as well as physicians, and being treated as though they were

having acute pain, not chronic pain, in terms of prescribing (Vallerand & Nowak, 2009, 2010).

These nurse researchers recommend that awareness of the life-enhancing benefits of opioid

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therapy will enable clinicians to intervene appropriately and to act as advocates for patients

receiving opioid therapy (Vallerand & Nowak, 2009, 2010). Additionally, they note that

pain is the most common symptom for which individuals currently seek assistance from the

health care system and thus health care providers should gain a better understanding of the

barriers and stigma these patients experience so that they can individualize as well as optimize

therapy (Vallerand & Nowak, 2009, 2010).

Finding adjunctive treatments to opioid therapy is a valuable goal in the management of

chronic pain. One nurse practitioner-driven study sought to do just this by implementing a 6-

week group cognitive behavioral therapy (CBT) program for their CNCP patients being treated

with opioids to assess if CBT could enhance outcomes for this cohort (Whitten & Stanik-Hutt,

2012). CBT is a form of talk therapy that says that individuals -- not outside situations and

events -- create their own experiences, pain included. And by changing their negative thoughts

and behaviors, people can change their awareness of pain and develop better coping skills, even

if the actual level of pain stays the same (WebMD, 2015). The results of this study were

promising for both patients and their providers. Mood (including negative attitude, performance

difficulty, and physical complaints), depressive symptoms, and patient impression of the benefit

of treatment improved significantly after CBT; there was no significant improvement in physical

function, however (Whitten & Stanik-Hutt, 2012).

PCPs were both pleased with the program and felt it was of benefit to their patients (Whitten &

Stanik-Hutt, 2012). Three out of the 22 participants actually tapered completely off of their

opioids during the course of the program, an unanticipated but welcome finding (Whitten &

Stanik-Hutt, 2012).

Conclusion

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Chronic noncancer pain is a condition experienced by millions of Americans, and one

which is best treated with a biopsychosocial, multimodal approach. At this time, long-term

opioid therapy is still the mainstay of treatment despite limited evidence that its benefit

outweighs its risks. However, many patients find opioids to be life-changing in that they reduce

chronic pain, although they do not eliminate it. Nonpharmaceutical interventions such as CBT

show promise in this patient population as well. Primary care providers, including nurse

practitioners, are in an especially critical position, as these patients present to them frequently

and deserve thoughtful and compassionate care. Practitioners must carefully balance the use of

an opioid with the risks, and when prescribing opioids need to do so with a consistent

management approach that includes risk assessment screening, urine drug testing, and

monitoring for aberrant behaviors such as early medication refills. Additionally, providers must

pay careful attention to the daily opioid dose, as this literature review consistently showed an

increased risk of overdose with higher doses prescribed, whether it was 100 mg, 120 mg, or 200

mg of morphine equivalent per day.

Chronic pain management is a not a simple subject to tackle in one paper, and one could

easily extrapolate on any of the topics touched on in this writing. As care providers, it is our

obligation to be educated on opioid use and management in order to provide comprehensive,

patient-centered care, and to help reduce the public health epidemic of opioid misuse and abuse

that all too often results in preventable mortality.

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11(2), 126-131. doi:10.1016/j.pmn.2009.03.006

Ware, J. E., PhD. (n.d.). The SF Community - SF-36® Health Survey Update. Retrieved July 15,

2015, from http://www.sf-36.org/tools/sf36.shtml#LIT

Whitten, S. K., & Stanik-Hutt, J. (2012). Group cognitive behavioral therapy to improve the

quality of care to opioid-treated patients with chronic noncancer pain: A practice

improvement project. Journal of the American Association of Nurse Practitioners, 25(7),

368-376. doi:10.1111/j.1745-7599.2012.00800.x

Running head: OPIOID USE

Literature Review Table: Research Question: What is the role of the family nurse practitioner in working with patients who use opioids to manage chronic noncancer pain (CNCP)?

Author(s)

Title

Year/Source Purpose Sample

n=

Study Design Variables/Instruments

Results Implications Framework Other/Comments

OPIOID USE 20

Banta-Green, Merrill, Doyle, Boudreau & Calsyn

Opioid use behaviors, mental health and pain—Development of a typology of chronic pain patient

2009

Drug Alcohol Dependence

To describe the roles of pain, addiction, and mental health in a chronic pain population using opioids to improve understanding of these patients & devise ways to identify different types of patients

Pain patients ages 21-79 with chronic opioid prescriptions

Enrolled continuously in a large integrated group practice in Washington state

n=704

*Excluded patients with cancer

Retrospective cohort study (epidemiological study/quantitative study)

Structured phone interview

Subjects received $2 pre-incentive in the initial mailing and then $10 for completing interview

A. summary factor score used for the 7 factors (variables) of interest, derived from factor analyses. Used for the development of patient types.

Opioid Use Behaviors: 1.Addictive Behaviors, 2.Addiction Concerns, 3.Pain Treatment problems, 4.Opioid abuse/dependence

Common MH sxs measured using: 5.PHQ (anxiety) and 6. the PHQ-2 (depression)

Pain intensity and interference measured using:

7. GCPS (Graded Chronic Pain Scale)

B. Automated data based variables: current smoker, any inpatient stay prior year, any ER/UC visit prior year

C. ASSIST tool used (Alcohol Smoking and Substance Involvement Screening Test); also looked at race, employment and marital status

All analyses conducted with the 704 (of the original 778 who were ineligible): Majority of subjects were non-Hispanic (89%), white females (62%), average age of 55; unemployed (40%), unable to work (25%), not in paid work force (30%)-most retired.

Average total days’ supply of opioids in past year was 349 days; average daily dose 50 mg morphine equivalent dose/day.

Labeled the 3 patient classes as:

Typical: 82%

And 2 atypical groups:

Addictive Behaviors: 12%

Pain Dysfunction: 6%

Authors describe 3 distinct types of patient classes related to opioid use behaviors, as well as data elements, that can help providers identify and better understand the two atypical types

Overlapping issues of pain, addiction and mental health in a chronic pain population using opioids

Complex clinical picture that is common for chronic pain patients prescribed opioids

Typical Group: Moderate levels of pain and MH symptoms but very low levels of addictive behavior or concerns

Addictive Behaviors Group: elevated MH sxs and opioid problems, notably addictive behaviors but pain similar to Typical pain patients

Pain Dysfunction Group: significantly higher pain as well as elevated MH and opioid indicators

Authors note their categorization scheme as “novel in that it directly incorporates common, co-morbidities and it divides patients with potentially problematic opioid use into Pain Dysfunction and the Addictive Behaviors groups

OPIOID USE 21

Chiauzzi, Trudeau, Zacharoff, & Bond

Identifying primary care skills and competencies in opioid risk management

2011

Journal of Continuing Education in the Health Professionals

To identify which skills and competencies are most critical for PCPs in order to effectively manage opioid risk in patients treated for chronic pain

AND

To determine IF these key skills can be distilled through a rigorous, statistically based technique called concept mapping

Nationally known experts in Primary care and Pain Management/Addiction

n=16

8: PCPs

8:

specialists

Qualitative study;

One-hour telephone interviews, recruited through APS (American Pain Society)

Received $150 for completing interview and $150 for completing the online concept mapping tasks

Interview questions covered 5 content areas, including:

1. Integration of risk screening into treatment 2. Treatment of patients at increased risk of addiction 3. Patient adherence to medication regimens and pain treatment 4. Addiction treatment referral 5. Treatment dilemmas faced by PCPs who treat pain patients

Participants sent a link/instructions to the online Concept Mapping program

Organized into 10 clusters representing the most critical categories of skills; the cluster that received highest rating was “How to manage pain patients with comorbid conditions”

Specialists rated this cluster, and 5 others, significantly higher than PCPs, suggests that specialists perceive these competencies as more important in opioid risk management

Specific PCP skills rated most important: How to monitor opioid use/tox screens, how to assess for risk factors, and interpersonal skills. Other important skills are: setting goals with patients, using a standardized assessment with all patients, and assessing for comorbid conditions.

Most common comorbid conditions were: psychiatric conditions, substance abuse disorders, and diseases such as DM or HI

According to this study, most important skills for PCPs managing opioid risk in chronic pain patients are: (1) how to monitor opioids, and (2) how to assess for risk factors

Skill category considered most important was managing chronic pain in patients with comorbid conditions

Provider education in chronic pain management

Novel to use “concept mapping” with HCPs

Interestingly, study found that specialists (physiatrists, psychiatrists) rated the importance of general pain treatment skills in primary care much higher than did the PCP experts

OPIOID USE 22

Edlund, Martin, Russo, DeVries, Sullivan,

The role of opioid prescription in incident opioid abuse and dependence

2013

Clinical Journal of Pain

To investigate the association between exposure to prescription opioids and incident Opioid Use Disorders (OUDs) among individuals with a new episode of CNCP

All individuals aged 18 and >, with a new episode of CNCP (no diagnosis in the prior 6 months), and no opioid us or OUD in prior 6 mos.

2000-2005

n=568,640

SES-diverse sample, West, Mid-West, and South East regions

Retrospective, quantitative study

Reviewed claims for 5 commercial health plans from 2000-2005 representing the West, Mid-West, and South East regions

Single, multinomial variable describing prescription opioid days’ supply (none, acute, chronic, and average daily dose (none, low, med, high); examined the association between this variable and incident OUD diagnosis

Outcome of interest was any diagnosis of an OUD within the 18-month period after the index date.

Independent Variables: opioid characteristics, sociodemographic factors, mental health disorders, substance use disorders, physical health, and pain diagnosis

Found that patients with new onset of CNCP who were prescribed opioids had significantly higher rates of OUDs compared to those not prescribed opioids

Risk of an OUD varied widely according to duration and dose. Duration of opioid therapy was more important than daily dose in determining OUD risk. Risk especially high for chronic, high-dose use.

Concluded that among individuals with a new CNCP episode, prescription opioid exposure was a strong risk factor for incident OUDs=6.1% OUD rate

Men, younger, history of MH/SA had higher rates OUD

help clinicians balance the potential benefits of opioid therapy with risks of addiction in CNCP patients for whom they are contemplating initiating opioid therapy

Public health concern over increasing rates of OUDs (opioid use disorders=opioid abuse and dependence) among patients prescribed opioids

Study highlights that opioid regimen is as important as well-established risk factors (such as history of sub abuse, male, etc.). for predicting OUDs

Call for caution in doses > 120 mg morphine equivalents/day;

I think it’s important to remember with this one, that the majority 65.3% had no opioid use in the 12 months after the index date; the remaining % low dose/acute dose was 15.9% and medium dose/acute was 14.7%; high dose/chronic was the least common at 0.1%

OPIOID USE 23

Gomes, Mamdani, Dhalla, Paterson, Juurlink

Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain

2011

Archives of Internal Medicine

To characterize the relationship between opioid dose and opioid-related mortality

Residents of Ontario, Canada Aged 15-64, eligible for publicly-funded Rx coverage, and had received an opioid from August 1997-Dec. 31, 2006 for nonmalignant pain;

n=607,156

2 large, population-based, nested case control studies

Quantitative

1997-2006

Researchers reviewed prescription drug data from the Ontario Public Drug Benefit Program database over a 9-year period (1997-2006)

Outcome of interest was opioid-related death, as determined by investigating coroner

Risk of opioid-related death compared among patients treated with various daily doses of opioids

From the cohort of 607,156 individuals studied, 1463 had an opioid related death:

59% accidental, 16.8% suicide, 24% undetermined

Avg age at death was 42.7 years

Significant relationship between the average daily opioid dose and death; compared with patients receiving less than 20 mg/day, those prescribed opioids at daily doses of 200 mg or more of morphine (or equivalent) had a much higher risk of opioid-related mortality

Opioid doses over 200 mg/morphine equivalent are high-risk; providers need to consider seriously, as many patients are already on doses that exceed this threshold

Opioids are widely prescribed for CNCP, often at doses exceeding those recommended in clinical practice guidelines—however the risk: benefit ratio not well defined

Most opioid-related deaths are avoidable and occurred in young people

Starrels, Becker, Weiner, Li, Heo & Turner

Low use of opioid risk reduction strategies in primary care even for high risk patients with chronic pain

2011

Journal of General Internal Medicine

To evaluate the frequency of monitoring (urine drug testing, regular office visits, and restricted early refills) for potential opioid misuse by PCPs

Primary care patients from the University of Pennsylvania Health System (urban and suburban), 2004-2008

Aged 18 and > who:

1). Had 3 or more completed visits to a study primary care practice, 2). On long-term opioid treatment defined by 3 or more opioid Rxs written at least 21 days apart within 6 months, and 3).

Retrospective cohort study (quantitative study) using electronic medical records review

Reviewed data from Jan 2004-April 2008

Outcome variables: 1.) Urine drug test completed at least once at any point during opioid treatment; 2.) At least one PCP visit within each 6 mos. on opioid tx AND within 30 days before or after each dose increase or change in opioid medications; and 3). Restricted early refill-defined as being written at least 7 days before the previous Rx for the same medication should

Discovered that monitoring of patients with CNCP on long-term opioids was quite limited in this primary care setting.

Only 8% of study patients had had at least one urine drug test, 49.8% had regular office visits, and 23% received more than one early opioid refill.

Primary care is the dominant setting in which opioids are prescribed for CNCP, yet monitoring for misuse and abuse is lax—even for patients at increased risk for misuse

Widespread use of opioids in primary care has significant health consequences---and should be accompanied by monitoring of patients for misuse and abuse

Researchers recommend more standardized approaches to opioid risk reduction be implemented by primary care physicians—

Could involve screening tools to identify patients more at risk for misuse, treatment agreements that stipulate necessity for regular OVs, restricted early refills, and UDS’ as well as team-based care to track this

OPIOID USE 24

and to examine the association of patient risk factors for opioid misuse with receipt of each of the 3 monitoring strategies.

Authors hypothesized that use of these strategies would be low, but would increase among patients with risk factors or misuse

An inpatient or outpatient dx for musculoskeletal or neuropathic pain; excluded cancer patients except non-melanoma skin or remote prostate Ca;

studied only African American and White patients due to low prevalence and heterogeneity of other races

Most were female and African American

n=1612

have been finished. They did permit up to one early refill, as has been done in previous studies

Independent Variables: 5 risk factors for opioid misuse:

1. Age <45 at time of first opioid prescription 2. Current or past drug use disorder 3. Current or past ETOH use disorder 4. Current or past tobacco use 5. Current or past mental health disorder

OPIOID USE 25

Canada, DiRocco, & Day

A better approach to opioid prescribing in primary care

2014

The Journal of Family Practice-Online Exclusive

To evaluate whether a clinical protocol for opioid prescribing could improve care for CNCP patients and improve provider satisfaction & knowledge in providing this care

26 Attending Providers (MDs and NPs) and 33 select staff (RNs, LPNs, MAs, Pt Svc Reps) at 3 Internal Medicine clinical practices at U Penn in Philadelphia

Protocol intervention:

1. EMR-based protocol to standardize documentation and management of pts taking opioids

2. instruction on the protocol

3. data collection

4. $$ incentive for MDs to adhere to protocol ($1500)—Protocol required standardized documentation of pain history and tx plan, use of UDS and a CMA (controlled med agreement)

Measured impact of intervention by assessing physician compliance with 2 measures of the protocol: UDS and chronic pain diagnosis;

*also looked at number of office visits but decided not to include in the analysis, as >90% of their patients were seen at least every 6 months before the intervention

Provider satisfaction, and knowledge evaluated via a survey which included and attitude component and a knowledge component for provider;, similar components for staff survey

UDSs ordered Increased by 145% across all 3 practices

Documentation of chronic pain diagnosis in EMR problem list increased by 424%

Statistically significant improvement in providers’ role adequacy, role support, job satisfaction/role related self-esteem when working with patients taking opioids

Provider knowledge of proper management improved significantly

89% attained the $ incentive

At ALL practices, the number of patients receiving opioids decreased after the intervention

Authors predict that by increasing adherence to a straightforward protocol based on best practice standards will lead to improved management of CNCP patients, as well as improved provider knowledge and attitudes when taking care of patients on opioids

Need for better regulation of opioid prescribing given the “national epidemic” of nonmedical use of prescription opioids and subsequent overdose deaths

Consistent approach to patient management

Primary care providers are at the center of the opioid controversy, as they do 40% of the prescribing—yet training and knowledge on how to best manage these patients is inadequate

Since 2003, more OD deaths have involved opioid analgesics than heroin and cocaine combined

Washington State now mandates the use of a CMA, provider education for those who prescribe high-dose and/or long-acting meds, and extensive patient evaluation and documentation

OPIOID USE 26

Literature Review Table: Research Question: What is the role of the family nurse practitioner in working with patients who use opioids to manage chronic noncancer pain (CNCP)?

Author(s)Title

Year/Source

Purpose Samplen=

Study Design Variables/Instruments Results Implications Framework Other/Comments

Whitten, S.K., and Stanik-Hutt, J.Group cognitive behavioral therapy to improve the quality of care to opioid-treated patients with chronic noncancer pain: A practice improvement project

2012

Journal of the American Association of Nurse Practitioners

To enhance outcomes of patients with chronic noncancer pain (CNCP) treated with opioids in a primary care setting by implementing a 6-week CBT program

Opioid-treated patients with CNCP at a VA clinic in rural Vermont 21 men, 1 woman

n=22

The researchers compared pre- and post-CBT intervention outcomes Collected data from participants at beginning of week 1 and repeated at the end of week 6 of the CBT program; also collected data from the patients’ PCPs to evaluate the project

Independent variable: the 6-week CBT program implementationDependent variables: Impact on mood (BDI and SF-36 MH component), functional status (BPI and SF-36), and perception of treatment benefit (PGIC); 1)Beck Depression Inventory II (BDI-II): measures the presence and severity of depressive symptoms2)Short Form-36 (SF-36): general quality of life (QOL) health survey, both mental and physical3)Brief Pain Inventory (BPI): measures pain intensity and effect on physical functioning4)Patient Global Impression of Change (PGIC): single-item, visual analogue scale used to determine, from the patient perspective, change in condition following a treatment intervention

Mood (including negative attitude, performance difficulty, and physical complaints),depressive symptoms, and patient impression of treatment benefit improved significantly after CBT; was no significant improvement in physical function; PCPs were both pleased with the program and felt it was of benefit to their patients.

The addition of a CBT program improved outcomes in this self-selected sample of patients with CNCP treated with opioids

Chronic noncancer pain is a challenge not only for patients for but for their PCPsAfter observing ineffective pain management in the opioid-treated patients, researchers decided to implement this CBT program as a PI project

Unanticipated effects: 3:22 successfully tapered off of their opioids over the course of the program (under PCP supervision)A 4th patient self-discontinued opioids w/o PCP knowledge

Vallerand, A., & Nowak, L.Chronic opioid therapy for nonmalignant pain: The patient's perspective.

2009

Pain Management Nursing

Authors note that very little data exists regarding patient’s perspectives of chronic nonmalignant painAim was to

n = 22age 29-8416 women6 menChronic pain patients from two pain practices in the Eastern

Phenomenological studyPart I focused on life before/after opioid treatment

Tape-recorded serial interviews

Life before treatment with opioids characterized by desperation and the inability to functionLife after characterized by balancing, living a secret life, fear of losing the pain

“awareness of the life-enhancing benefits of opioid therapy will enable clinicians to intervene appropriately and to act as advocates for patients receiving opioid therapy”

Most studies to date that measure QOL issues with CNCP are quantitative—this study was unique in that it looked at the lived experience through the patient interviews/narrativeImportant for clinicians to hear the patient’s story=rich information

Authors note that although opioids have been “shown to decrease pain intensity, restore levels of function, and improve QOL for adults with CNCP, they are rarely used as a long term option…”

Emotional incapacitation

OPIOID USE 27

Part I—Life before and after opioid therapy

investigate the lived experience of adults receiving opioid therapy for chronic nonmalignant pain—a highly debated treatment modality

U.S. on opioids from 1-4 years

mgmt. regimen, and thankfulness for a life regained

and inability to function in normative roles are as significant as the physical limitations

Vallerand, A., & Nowak, LChronic opioid therapy for nonmalignant pain: The patient's perspective. Part II: Barriers to chronic opioid therapy

2010

Pain Management Nursing

Authors note that very little data exists regarding patient’s perspectives of chronic nonmalignant painAim was to investigate the lived experience of adults receiving opioid therapy for chronic nonmalignant pain-- a highly debated treatment modality

n = 22age 29-8416 women6 menChronic pain patients from two pain practices in the Eastern U.S. on opioids from 1-4 years

Phenomenological study

Part II focused on the barriers to receiving opioid therapy

Tape-recorded serial interviews

Barriers from family, socially, in the workplace as well as from physicians, pharmacies and the health care system at largeSpoke of being stigmatized as “addicted and/or morally weak”; “disdain and negativity from family, fear of losing job, being treated as though having acute pain, not chronic pain, in terms of prescribing

Pain is the most common symptom for which individuals currently seek assistance from the health care system (Simpson, 2004)—thus health care providers should gain a better understanding of the barriers and stigma these patients experience so can individualize AND optimize therapy

Pain is unique, complex and multidimensional—thus the value of the phenomenological study

Addresses the stigma associated with opioid use and pain patients

Outcalt, S. D., Kroenke, K., Krebs, E. E., Chumbler, N. R., Wu, J., Yu, Z., & Bair, M. J. Chronic pain and comorbid mental health conditions: Independent associations of posttraumatic stress

2015Journal of Behavioral Medicine

To further study the nature of the relationships among chronic pain, PTSD, and depression.

n = 250age 28-65207 men 43 womenVA Midwestern primary care patients from 5 clinics

43 met PTSD criteria60 for depressionMusculoskeletal pain, including regional

Randomized controlled pain treatment trial comparing a collaborative care intervention vs. usual care in reducing pain severity and disability

Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a

“this is a secondary analysis of the SCOPE study (Stepped Care to Optimize Pain care Effectiveness”--Independent variables: PTSD and DepressionMeasures assessed:1. Pain measures: BPI2. Psychological measures: PC-PTSD, PTSD checklist, PHQ-9, SF-36, GAD-7, Perceived stress scale, sense of coherence scale3. Health-related quality of life and disability measures: SF-36, SF-12, PHQ, and disability

PTSD strongly associated with multiple domains of pain, psychological status, quality of life, and disability---AND these associations remain robust even after controlling for major depressionThe magnitude of association with pain, psychological, and disability domains is similar for PTSD and depression\

Both PTSD and

Importance of assessing PTSD and depression among patients with chronic painWhen screen is positive, PCPs should ensure that behavioral health care is incorporated into overall plan

Consensus lacking as to the nature of relationships between PTSD, depression, and chronic painWant to understand the impact of PTSD on the chronic pain experienceRecognize common comorbidity of PTSD and depressionLearn how these two mental health conditions may each contribute to chronic pain

Simple measures to screen for both PTSD and depression are available and should be used to identify those at risk of worsening pain and greater disability and impairment

OPIOID USE 28

disorder and depression with pain, disability, and quality of life.

(joints, limbs, back, neck) and more generalized (fibromyalgia or chronic widespread pain; at least mod to severe on the BPI; and >3 months persistent despite trying at least one analgesic medication before trial

Excluded: pending pain-related disability claim, dementia, bipolar disorder, schizophrenia, illicit drug use, active suicidality or life expectancy <12 months

telephone-based, nurse care manager/physician pain specialist team to treat pain.

measurements, work effectiveness

SCOPE STUDY:All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices.

major depression are strongly associated with disability—higher number of disability days by over 50%

OPIOID USE 29

Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al

Opioid prescriptions for chronic pain and overdose: A cohort study

“to estimate overall overdose rates (fatal and nonfatal) among patients receiving medically prescribed, long-term opioid therapy for CNCP AndTo study whether risk for overdose differs by dose

2010

Annals of Internal Medicine

n = 9940

9940 persons who received 3 or more opioid prescriptions for CNCP1997-2005

HMO setting, Washington stateMean age=54 years59% female

Pharmacy data and medical records review

Cox proportional hazard models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose

Reported findings from the CONSORT study(Consortium to study Opioid Risks and Trends)

51 opioid-related overdoses, included 6 deathsCompared with patients receiving 1-20mg/day of opioids (0.2% annual overdose rate), patients receiving 50-99mg/day had 3.7-fold increase in OD risk and 0.7% annual OD rate.Patients receiving 100mg/day or more had 8.9-fold increase in overdose risk and a 1.8% annual OD rate

Patients receiving higher doses of prescribed opioids are at increased risk for overdose, so need to be closely supervised by providers

Scant information exists about overdose in patients prescribed long-term opioid therapy

Authors acknowledge the small number of overdoses in this study cohortAlso—can’t establish whether the OD risk differences are directly related to the dose or patient characteristics

Points out that prior studies indicate that the increase in opioid-related overdoses parallels the increased prescribing of opioids for CNCP BUT…some evidence suggests that overdose occurs predominantly by diversion, or persons obtaining opioids from nonmedical sources

Although based on this study it seems like the overdose rate is really small, we’ve seen an increase in hospitalizations for opioid overdose

Owen, G. T., Burton, A. W., & Schade, C. M.

Urine drug testing: Current recommendations and best practices.

To clarify the importance of routine UDT (urine drug testing) in the U. S. as part of opioid prescribing and identify best practices/standard of care

2012

Pain Physician

n = 102 Survey mailed to Texas Pain Society members (chronic pain experts)

36% response rate

20-item questionnaire To determine practice patterns, attitudes and practical matters regarding UDT

UDT must be done routinely as part of an overall best practice program in order to prescribe chronic opioid therapy (COT). This program may include risk stratification, baseline and periodic UDT; behavioral monitoring; and prescription monitoring programs

UDT one of the few objective tools that can assist providers in evaluating appropriate and inappropriate drug use;Psych eval and risk assessment tools alone are not enough

Increased availability of opioids has led to unanticipated problems including an increase in nontherapeutic useIncrease in prescribing came after the 1990’s when efforts underway to treat pain more aggressively—2000-2010 Congress proclaimed the Decade of Pain Control and Research; COT endorsed by APS and AAPM---Now we have reluctance to prescribe, term “opioidphobia” coined

Limited sample size, one geographic location

“The U. S. contains 5% of the world’s population but consumes 99% of the world’s hydrocodone”

Franklin, G. M., Mai, J., Turner, J., Sullivan, M., Wickizer, T.,

To determine whether dissemination of the

2011

American Journal of Industrial

Examined total # of prescriptions in the workers’

Retrospective data review

Reviewed detailed

Variables:Overall prevalence of opioid prescriptionsAverage morphine-equivalent (MED)

Compared to before 2007, has been substantial decline in both MED/day of long-acting schedule

Dosing guidance to prevent harms associated with opioid prescribing

Study conducted as a response to emerging epidemic of deaths from prescription opioids in WA state and nationallyHallmark was the “yellow flag” of

Yellow flag: 120mg/day of morphine equivalent dose (MED)

OPIOID USE 30

& Fulton-Kehoe, D.

Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline

WA Guideline on opioid dosing in 2007 might have been associated with temporally with changes in trends in opioid dosing and overdose mortality in WA workers’ compensation

Medicine comp system in WA state

computerized billing data from WA workers’ comp

2003-2010

dose/dayProportion of workers on disability receiving opioids and high-dose opioids (>120 mg/day MED) over the past decadeTrend of unintentional opioid deaths during same time frame

II opioids (by 27%) % or workers on doses >120 mg/MED /day declined by 35%50% decrease from 2009-2010 in number of deaths

Conclude that the introduction of opioid dosing guidelines appears to be associated temporally in the above

120 mg/day MED---required providers must consult with a pain physician for CNCP patients receiving over this dose before they could continue to prescribe

Running head: OPIOID USE