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