Monitoring Patients on Opioids with Toxicology Screens Is Opportunity for Clinical Labs

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

This is an excerpt of a 2,883-word article in the Sept. 23, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.

CEO SUMMARY: In this first industry briefing on such a program, THE DARK REPORT explains that Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests are one of the few sources of objective data about patient compliance, and is using such toxicology screens in its program to identify and treat patients who misuse opioids or need chronic opioid therapy. When CHN developed its Chronic Opioid Therapy (COT) program, protocols were included that called for physicians to regularly use toxicology tests. Use of these tox screens 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 screens 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 screen results. “It is important to point out that the primary way we measured success was through confirmatory toxicology testing,” Cooper 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 for Monitoring

“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-reporting 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 as a Model

“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.

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 is Critical

After implementing its monitoring protocols—including confirmatory testing—CHN added steps that defined the frequency of toxicology screening 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.

What Laboratories Can Do 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).

Could your lab add value to its work for healthcare providers using toxicology screens? Please share your thoughts with us in the comments below.


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