Monitoring Patients on Opioids Is Opportunity for Clinical Labs

Indiana health system finds lab test results are useful data for patient compliance

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CEO SUMMARY: When developing a program to identify and treat patients who misused opioids or needed chronic opioid therapy, Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests were one of the few sources of objective data about patient compliance. When CHN developed its Chronic Opioid Therapy (COT) program, protocols were included that called for physicians to regularly use toxicology tests. Use of these tests reduced inconsistent toxicology results and the number of patients misusing opioids.

First of Two Parts

ONE BIG OPPORTUNITY FOR CLINICAL laboratories seeking to improve patient care is to assume a larger role in helping physicians manage some of the 24-million Americans who are on chronic opioid therapy (COT) for pain.

Clinicians, health insurers, and government health officials are perplexed about how to deal with the immense problem behind the large numbers of Americans addicted to opioids and illicit drugs and who have died of drug overdoses and related causes. The National Institute on Drug Abuse (NIDA) estimates that drug overdose deaths doubled in the past decade and that overdoses of illicit drugs and prescription opioids killed more than 70,200 Americans in 2017. The total number of overdose deaths involving all drugs from 1999 to 2017 in the United States rose from 16,849 in 1999 to 70,237 in 2017, NIDA reported.

In many ways, the opioid crisis is a perfect healthcare storm. Health plans, physicians, and policymakers are seeking a solution that can improve patient outcomes while reducing the cost of care for these patients.

Experts in the management of patients who need chronic opioid therapy have begun to recognize the significant role that clinical laboratories can play in helping to manage the opioid-abuse crisis. One of those experts is Gina M. Cooper, a registered nurse and the Pain Management Coordinator for Community Health Network (CHN) in Indianapolis.

As a specialist in the management of pain for adults over 18 who have been prescribed chronic opioid therapy, Cooper explained that clinical laboratory testing is one of the most important and yet overlooked keys to keeping these patients compliant and safe with opioid treatment.

“To identify aberrant drug-related behaviors—meaning the patient’s use of the opioid went against how it was prescribed or against the agreed-upon treatment plan—CHN developed a monitoring plan for managing the care of these patients,” Cooper said during a presentation at the Executive War College in New Orleans in May.“That plan includes regular toxicology testing as part of a comprehensive patient monitoring program.”

CHN’s patient monitoring program evolved overtime. The first step was to develop and implement standardized patient monitoring protocols that included the use of toxicology testing for all patients prescribed chronic opioid therapy, she said.

“Our protocols started with national guidelines, such as those from the federal Centers for Disease Control and Prevention (CDC) and state regulations,” she added. “Next, we applied additional rules to cover best practice recommendtions and to guide clinical decision-making.” The CDC’s guidelines are found online as “CDC Guideline for Prescribing Opioids for Chronic Pain.”

After implementing these protocols, CHN saw a significant decrease in inconsistent toxicology results. “It is important to point out that the primary way we measured success was through confirmatory toxicology testing,” Copper commented.

“The early phase of the program produced a clear and simple conclusion: Better patient monitoring led to better patient behavior,” she added.

CHN’s program succeeds, in part, because it relies on clinical laboratory test data to help physicians treating these patients to manage their care after being prescribed opioid therapy for pain—especially those being treated with chronic opioid therapy—meaning the therapy continues for longer than three months.

Toxicology Test Results

“When treating these patients, our physicians have limited access to objective data on patients’ behavior,” she explained. “That makes the toxicology test results particularly useful as a way to monitor these patients.”

Most data that physicians have on these patients comes from what the patients themselves report. A problem with patients’ self-reports is that the data can be unreliable because the patients could be struggling with dependency, addiction to opioids or other substances, or may fear uncontrolled pain.

CDC data show that among the 24-million Americans on COT, almost half (11.5 million) have misused opioids, and an estimated 1.7 million suffer from opioid use disorder.

During her presentation, Cooper explained the details of a case study on how CHN relied on clinical laboratory test data to help physicians manage the care of these patients. An innovator in pain management and stewardship of controlled substances, CHN has five acute care hospitals and more than 200 primary care physicians working in 60 primary care centers throughout Indiana, Cooper said.

Indiana State Guidelines

“CHN developed its pain-management program after the Indiana legislature passed guidelines in 2013 that physicians and other providers must follow when prescribing opioids to patients on a chronic basis,” she explained.

“Within that legislation were several requirements that providers follow during each patient encounter, including patient monitoring,” Cooper explained. The legislation established Indian’s Prescription Drug Monitoring Program (PDMP) under the Indiana Scheduled Prescription Electronic Collection and Tracking (INSPECT) program.

“Once the legislation became effective, Community Health Network developed and implemented standardized patient monitoring protocols for all patients prescribed chronic opioid therapy,” explained Cooper.

Included in the legislation—which Cooper said was among the most comprehensive prescribing guidelines in the country—are five rules for physicians and other providers to follow when monitoring for signs of medication misuse:

  1. Risk assessments: Physicians and other providers assess each patient for the risk of misuse, stratify patients according to their levels of risk, and monitor accordingly.
  2. Opioid agreements: Under these agreements, patients and providers agree on the expectations for each patient, and the agreements address medication safety. The agreements are documented in each patient’s medical record and are reviewed as needed.
  3. PDMP checks: Physicians and other prescribers must consult Indiana’s PDMP-INSPECT before prescribing or refilling a prescription for controlled substances.
  4. Urine drug testing: Over the course of treatment, physicians and other providers order randomized urine drug tests according to the risk-stratified protocol.
  5. Pill counts: During patient visits, physicians and other providers compare the pills on hand with the number the patient should have based on the dosing instructions.

CHN’s protocols include each of these five steps, along with other requirements that CHN added. “While developing our compliance monitoring plan, we began with what the state law requires as well as national guidelines,” said Cooper. “From there we also added additional layers to our monitoring to include best practices. Among those best practices were requirements for consistent urine-drug testing and regular monitoring of toxicology test results.”

Lab Testing Frequency

After implementing its monitoring protocols—including confirmatory testing—CHN added steps that defined the frequency of toxicology lab testing according to each patient’s risk classification.

“Our requirements include adjustments in risk levels based on each patient’s behavior and risk,” Cooper said. “CHN added clinical-level staffing support for physicians and other providers, and added a step to allow for continuous review, analysis, and reporting on patients’ results.

How Providers Can Watch for Opioid Abuse, What Laboratories Can Do to Help Physicians

WHEN DESCRIBING THE CURRENT SITUATION WITH THE OPIOD EPIDEMIC during his session at the Executive War College last May, R. Scott LaNeve, Senior Vice President, High Value Care at of Indianapolis, provided the following lists of information to help clinical laboratory leaders understand the major issues associated with opioid abuse.


MANAGING PATIENTS WHO ARE IN A CHRONIC OPIOD THERAPY (COT) PROGRAM can be complex for physicians and other caregivers. However, clinical laboratories have the expertise and the capabilities to help physicians in other ways besides simply providing accurate, timely toxicology test results. LaNeve identified the following steps clinical labs can take to help physicians:

  • Be aware of what your providers have to do to manage these patients.
  • Know the “five activities” and their value in managing patients.
  • Help with clinical interpretation and convenience.
  • Use the patient med list to provide interpretive results for the provider.
  • Provide patient trend reports or historical results.
  • List common drug brand names as well as compounds on your lab test reports.
  • Identify compounds which are expected metabolites of parent drugs.
  • Make the Prescription Drug Monitoring Program (PDMP) data easier to access for your providers, integrate PDMP into the EMR (through Appriss Health).
  • Pull the PDMP data and compare the results to your lab report for your providers (’s Opioid Advisor).

Assessing Patients’ Risk

“The first requirement for providers is to do a patient risk assessment by evaluating the patient’s mental health status and risk for medication misuse, commented Cooper. “In addition, we do a focused pain assessment.

“The second step involves establishing expectations for patient behavior with what are called ‘controlled-substance agreements,’” she said. “These agreements establish expectations between the patient and the provider.

“Providers also do a PDMP check by reviewing patients’ records in the INSPECT database,” she added. “In addition, they order confirmatory toxicology testing and do pill counts.” Pill counts help to keep patients accountable for the controlled medications dispensed to them. Any patient who has an inconsistent pill count may be misusing the medication and may need education on how to take the medication accurately or need education on the safe storage of medication.”

After Community Health Network introduced the monitoring program for chronic opioid treatment within its network, administrators convened a multidisciplinary group of physicians and other providers to consider additional best practice recommendations.

“Our multidisciplinary team aimed to determine if there were any gaps in following the federal guidelines and Indiana’s requirements under the law,” Cooper explained. “If possible, we wanted to improve on the requirements that were in place. Also, we wanted any additions to our protocol to be in line with best practices.

Implementing Best Practices

“These extra layers included defining our laboratory testing frequency by risk classification,” she commented. “Instead of having a one-size-fits-all approach to patient monitoring, we wanted to individualize patient care wherever possible.

“That meant if we classified a patient as low risk, we would require toxicology test monitoring for that patient less frequently than if we classified a patient as high risk,” noted Cooper.

“Next, we did classification adjustments based on behavior and risk factors,” she said. “As we all know, risk assessment tools can be flawed because patients have different ways to manipulate their test results by answering the questions inaccurately. One of these tools is the ‘Screener and Opioid Assessment for Patients with Pain,’ a 24-question assessment patients are instructed to answer.

“While such tools are flawed and can be manipulated easily, we can gain historical information about the patient by using them,” Cooper explained. “This helps us to establish a risk classification baseline. Then, we can make adjustments as needed based on behavior and toxicology test results.

Test Results Show Variance

“For example, if a patient’s risk assessment score showed that a patient was a low risk, but their toxicology results indicated a variance, that told us that the patient in question was not truly a low-risk patient,” she explained. “In those cases, we would increase that patient’s risk level and monitor the patient accordingly.”

After CHN implemented these steps, the staff recognized that more clinical lab testing could reveal additional patient concerns that were unknown previously. More concerns meant physicians would need more resources during each patient visit.

“After identifying all the steps we wanted our providers to follow, our next goal was to support our physicians and other providers in completing these steps,” Cooper commented.

“In the network, some providers had large panels of patients on opioids,” she added. “We knew these providers would require additional time just to initiate the first steps needed to follow the protocols for each of their 200 or so patients on opioids.

How Appropriate Utilization of Toxicology Testing Improves Compliance of Patients on Opioid Therapy

ONE WAY TO MEASURE THE EFFECTIVENESS OF INCLUDING TOXICOLOGY TESTING as part of managing patients on chronic opioid therapy (COT), is to look at the percentage of patients whose toxicology lab test results show they are out of compliance.

In her session at the Executive War College last May, Gina Cooper, RN, Pain Management Coordinator for Community Health Network (CHN) of Indianapolis, presented the chart below. It shows the percent of patients not in compliance with the COT program at Community Health Network. Between February 2015 and October 2018, the percent of patients with inconsistent toxicology results fell from a range of 50% to 60% to just above 20%. That’s an impressive improvement and is based on 17,231 patient toxicology results during that 45-month period.

Need for Intervention

“Before being tested regularly, these patients were getting routine care,” Cooper commented. “But once we got the urine-drug test results, we expected to find that some patients might need more complex care or an intervention of some sort.

“It would be unrealistic to ask physicians to follow these protocols and then ask how they were doing after a few weeks or a few months,” she said. “That wasn’t going to work. Plus, we didn’t want our providers to stop prescribing opioids out of frustration because many of their patients benefit from opioids. Maybe some of their patients had failed other treatment modalities, which could mean that opioids were the best way to manage those patients.

“We certainly did not want our providers to step away from a care plan that was working for those patients,” Cooper added. “Therefore, we needed a way to support physicians who treat patients whose toxicology tests showed a requirement for additional care.

“We wanted to add clinical and medical resources for physicians and other providers, so when they discuss difficult cases peer-to-peer, they could develop the best treatment plan for each patient moving forward,” she commented.

Using Results to Track Trends

CHN also added a reporting process that included analyzing data to monitor results physicians and other providers could use to improve patient management. “We added this reporting step because we wanted to use the results to recognize trends,” she said.

To implement this step, Community Health Network used urine-drug test results. “For the patients we tracked in our monitoring program, we plotted inconsistent toxicology test results over time,” she commented.

CHN compared the results it collected in its drug-monitoring program to national averages that Quest Diagnostics published in the report, “Drug Misuse in America 2018: Diagnostic Insights into the Changing Opioid Epidemic.”

“Once we recognized trends, then we could implement new educational initiatives for our providers,” Cooper explained. “We knew that if we tailored patient education based on the trends we identified, then they could target education to each individual patient, which ultimately is what brings about the behavior change.

High-risk Patients

“In our data set, we had more than 3,400 enrolled patients, and from that data we saw that 54% of patients were low risk and 17% were high risk. The remainder fell into the moderate risk category,” she said.

Then CHN compared the results shown in the PDMP data with the results CHN collected from all patients’ urine-drug test results. The results in the PDMP database showed inconsistent results in only 1% of patients, and areas of concern for only 1% of patients, both of which were much lower than the corresponding rates that CHN showed from the data gathered from monitoring patients over time, Cooper said. The remaining 98% of patients in the PDMP data showed no inconsistent results.

“In our results from the third quarter of 2018, we saw that the toxicology pie graph shows an errancy rate (meaning inconsistent results) of 19% and consistent toxicology results of 72%,” she explained.

“The rest of the graph shows areas of potential concern, which means that someone on our staff would need to do a deeper dive,” she commented. “Maybe the toxicology results showed something that wasn’t on the patient’s medication list. Maybe it was just something we didn’t expect.”

After comparing the PDMP data against the data they had from regular monitoring of urine-drug test results, Cooper and other clinicians found an area of significant concern. “When we compared the inconsistent results on the PDMP side versus the toxicology side, we saw a large gap where patients can potentially fall through,” she explained.

Comparing CHN’s results against national averages from Quest and other sources, CHN’s numbers were similar to the national average data, Cooper concluded. “In 2015, for example, we can see that our results were pretty well in line with the national average,” she explained. “But then our numbers of patients with inconsistent results started to decrease, and they continued to drop over time.”

The data show the numbers of patients with inconsistent results rising and falling over time. “The ups and downs represent the points in time when we brought in more providers and clinics into the program,” she said. “That’s because we didn’t roll out the whole program across our entire network in one big push.

“Instead, we did a slow and controlled roll out so that we could provide appropriate resources for providers as we added more physicians and more clinics,” she said. “Still it’s possible to see that over time, we had a significant decrease in the proportion of inconsistent results by the end of 2018.

Managing Patients’ Pain

“For us, these results are important because all the data we have in healthcare represents the people we treat—meaning the patients we care for,” she concluded. “The data show that we are producing better patient outcomes in our chronic opioid treatment program.”

Contact Gina Cooper at 317-443-8987 or


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