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11 Articles in Volume 14, Issue #4
Recognizing and Treating Concussions Related to Sports Injuries
CDC Initiative: Concussion in Sports and Play
Pain Management After ACL Surgery
Risk Assessment in the Digital Age: Developing Meaningful Screening Tools for Opioid Prescribers
Testosterone Replacement: Essential in Pain Management
Why Is There Hydromorphone In My Patient’s Urine?
Benzodiazepines in Pain Practice: Necessary But Troubling
Commentary: Risk Assessment in the Digital Age
Zohydro Debate: Drug Hysteria or True Concern
Benefit of Long-acting Versus Short-acting Opioids?
Epidural Steroid Injections, Coping Skills, Medical Marijuana

Risk Assessment in the Digital Age: Developing Meaningful Screening Tools for Opioid Prescribers

Balancing the needs of patients with that of society is a tightrope that many pain clinicians now face. The authors discuss a new screening tool to perform before prescribing opioids to chronic pain patients.

Pain management physicians have been presented with a conundrum: providing patients with the best care available while preventing the misuse, abuse, and diversion of opioid pain medications. This often places the clinician in opposing roles—health care provider sworn to first do no harm and amateur drug enforcement agent. How can caring physicians walk this ethical tightrope? One way is to carefully screen patients—with an eye on both medical diagnosis and signs of aberrant behaviors that would warn of potential abuse or misuse. To that end, we have developed a sophisticated screening tool that patients can use in the waiting room. Once completed, the clinical team then can use it when they interact with the patient.

The Need to Screen

Over the last two years physicians have had to reconcile two very different messages regarding pain and the use of opioids issued by institutions that guide healthcare in the United States. First, in June 2011, The Institute of Medicine (IOM) issued a “Blueprint for Relieving Pain” in America.1 The IOM rightfully pointed out that chronic pain was underdiagnosed and undertreated and cost the nation up to $635 billion each year in medical treatment and lost productivity. They encouraged “federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments.”1

Following the call to action, in January 2012, the Centers for Disease Control and Prevention (CDC) also rightfully proclaimed “Prescription Drug Overdoses—A US Epidemic.”2 The CDC reported that the increase in unintentional drug overdose death rates in recent years has been driven by increased use of opioid analgesics. Since 2003, more overdose deaths have involved opioid analgesics than heroin and cocaine combined. In addition, for every reported unintentional overdose death related to an opioid analgesic, there were 461 reports of nonmedical uses of opioids, 161 reports of drug abuse or dependence, 35 reported visits to emergency departments, and 9 reported admissions for substance abuse treatment.2

In step with the CDC, the FDA has developed a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids.3 One of the recommendations in the REMS is related to assessment of the risk for abuse, misuse, and diversion. Table 1 lists the tools physicians are encouraged to use when prescribing these classes of opioids.

For example, the Opioid Risk Tool (ORT), developed by Lynn Webster, MD, was designed to predict the risk for opioid misuse, obviously a critical assessment that clinicians must perform prior to prescribing narcotic analgesics (Read Dr. Webster commentary). The assessment consists of 5 questions assigned a total of 26 points (Table 2).4 The tool’s scoring is heavily dependent on a patient’s reporting either a family or personal history of substance abuse.

The ORT, which was studied using data collected in Utah in 2000, fit well for the period in which it was developed. In the year 2000, paper was the main mode of data collection and, thus, the method used for the ORT. This required time and resources to administer and score the results and to capture data for research purposes. Since then, technology has caught up with research needs, and now electronic data capture results in large quantities of information, with minimal resources required to administer and query for research purposes.

Self-reporting patient surveys, which are employed throughout our practice network, collect patient data in a non-threatening way. This clearly is a different methodology from that employed in the face-to-face encounters using the ORT. Based on our patient-reported data that included the ORT (with permission from Lynn Webster, MD), we noticed sensitivity was not meeting expectations, and we felt compelled to test the validity of the ORT in our environment.

Study Methods

Clinical Setting and Patient Selection

The study was conducted at Michigan Pain Consultants (MPC), an interdisciplinary community-based pain medicine practice in Grand Rapids that was established in 1984. The practice has 7 clinical locations covering a service area of 6 counties in Western Michigan. The data was collected using the PRISMTM patient management system (ProCare Systems),5 a digital toolbox containing among other components, the Pain Health Assessment (PHA), a patient reported health outcomes tool. The information is gathered routinely from chronic pain patients in the practice using Institutional Review Board (IRB)-approved language in consent forms.

A detailed analysis of observed behaviors associated with narcotic misuse was constructed and correlated with elements in the PHA and ORT. An independent-samples t-test was run on 13,986 de-identified unique patients. Data was further evaluated using Shapiro-Wilks test and Chi-squared tests.

Pain Health Assessment

The PHA is a multidimensional structured self-report questionnaire that the patient completes on an iPad prior to seeing the physician. It contains core outcomes domains that evaluate the efficacy and effectiveness of treatments that are consistent with the recommendations of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.6 The PHA assesses disease presence, pain characteristics, physical function (self-care, mobility), and psychosocial function (emotional and social health dimensions of depression, anxiety, life control, and social support), as well as patient satisfaction. It was inspired by the Short Form (36) Health Survey (SF-36), and includes the ORT. Responses are coded on an 11-point numeric and descriptive pain intensity scale, with 0 “most positive” and 10 “most negative.”

Study Findings

From our total population of 13,986 patients seen at our clinics between September 2012 and January 2013, we identified nearly 400 patients (3%) who misused their opioid analgesics.7 Controls were defined as those who did not misuse their medications (13,586).

Misuse was defined as:

  • Testing abnormal on urine drug screens
  • The absence of prescribed medications
  • The presence of recreational drugs (marijuana, cocaine, etc.)
  • The presence of non-disclosed prescription narcotics
  • Abnormal MAPS (Michigan Automated Prescription System)
  • The patient received multiple opioid prescriptions from other providers without disclosing them (if patients had an appropriate explanation for additional prescriptions, surgical procedure for example, the MAPS was not counted against them.)
  • Use of several pharmacies was not held against patients
  • Exhibiting behaviors such as calling in early for prescriptions multiple times or being abusive to staff regarding the opioid prescription.

Figure 1 demonstrates the findings of the study and shows that 66% of the patients who misused their medications presented with low-risk ORT scores. While the ORT was statistically significant in differentiating misusers from patients in the control group, it lacked sensitivity. This observation inspired us to begin our quest for a better tool. Our goal was to examine other domains from the PHA that are less likely to be misrepresented by respondents.

Narcotic Risk Manager

At the American Academy of Pain Medicine 2014 annual meeting, held in Phoenix, our group presented a poster describing a new opioid risk assessment called the Narcotic Risk Manager (NRM).8 Between September 2012 and July 2013, 5,940 patients completed a PHA, evaluating prescribed opiates. A total of 408 patients (6.87%) were identified as misusers among the opioid prescribed group. The reason the number of patients shrank in the second study from nearly 14,000 to almost 6,000, was because it was conducted on only those patients prescribed opioids. The patients in the initial analysis included all patients either on opioids or not. Misuse behavior was defined as it was in the first analysis.

As demonstrated in Figure 2 (above), the NRM decreases the number of patients assigned a low-risk score who actually misused their prescriptions by almost 50%. While still not perfect, it is a substantial improvement, nearly doubling the sensitivity of the ORT.

Exploratory analysis identified variables that were significant predictors of opioid misuse, all of which were considered for the final model. Logistic regression was used to model the probability that a patient prescribed opioids would demonstrate misuse behaviors. All 2-way interactions were considered for the final model, which was determined using backward selection with α=0.01. The factors that were initially considered were based on the analysis of data in the PHA, as well as a literature review and other risk tools.

Marital status and a history of preadolescent abuse did not stand up to further analysis, so only the significant 8 variables make up the final prediction model created using logistic regression (Table 3).

Results of Analysis

Looking at the number of patients in this analysis who were on opioids and misused them, the number is very close to 7% (408/5940). We, therefore, define the average risk of misuse as 7%, moderate risk as 14%, high risk as 21%, and very high risk as 28%. The NRM identified that the risk of narcotic misuse is elevated in those who are younger, male, smokers, have a history of substance abuse, have multiple psychological problems, are insured by Medicaid or self pay, and are Caucasian. The overall sensitivity of the new tool was twice that of the ORT.

Clinical Implications of NRM Screening

Clinicians can readily use the NRM online to evaluate their patients with their smart phone, tablet, or computer at www.narcoticrisk.com. Using the NRM, it takes only seconds to fill in the pertinent information on the
8 significant factors. The patient’s risk is reported as both a percent risk and also is characterized as low, moderate or high risk. The NRM provides suggestions on clinical management based on the risk category (Table 4).

Limitation of Screening Tool

Although we have demonstrated a correlation between observed opioid misuse and NRM stratification, the next step is to further validate the tool by evaluating risk groups against the predictors. In addition, continual mining of the data is needed to improve the NRM’s sensitivity. Like any self-reported assessment tool, patients can misrepresent their answers. However, many of the questions are self-evident or not perceived by the patient as an obvious predictor of misuse, such as their age and insurance coverage.

Summary

We believe that the NRM represents an improvement in the tools to estimate the risk for opioid misuse, abuse, or diversion, which is recommended by REMS programs. Although the calculation of the NRM is more complicated than the ORT because of the logistic regression formula, the NRM can be accessed easily online at www.narcoticrisk.com. The advent of technology brings a more sensitive tool for risk assessment to all health care providers prescribing opioids.

Last updated on: May 8, 2014
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