Executive Summary
Pressure from the media and the populace is mounting for legislators, local leaders, the military and the civilian health care community to take decisive action to stem the opioid epidemic. Ameritox and Valor Healthcare have been working in partnership toward that end.
For patients being treated for chronic pain or a severe mental illness, clinic physicians may perform a basic urine drug screening to monitor patient adherence to their prescription regimen. Common methods for drug screening have limitations in that they detect the presence or absence of opioids, but do not distinguish between individual types of drugs, nor do they detect quantities to a meaningful degree. This may cause difficulty for physicians to determine if a patient has duplicate opiate prescriptions or is consuming dangerous levels of a drug or combination of drugs.
Ameritox tackled this deficit in adherence monitoring in two parts: First, with confirmation testing (i.e., LC/MSMS) performed in an industry-leading lab that boasts a .02 percent error rate, compared with .05 percent error rate typical of other testing labs. This testing is sensitive enough to detect minute quantities of natural, synthetic, and semisynthetic opiates, including hydrocodone, naloxone, and buprenorphine, respectively. Second, Ameritox offered added knowledge with RxGuardian, a reference database of samples from patients who have been clinically assessed as adherent to their prescription medication regimens. RxGuardian can improve upon existing urine screens by offering clinicians a baseline of medication adherence to compare their patients’ urine test results against.
In 2015, Ameritox joined with Valor Healthcare, launching an initiative to provide VA clinic physicians with this tool to help them evaluate patients’ medication adherence and establish safer opioid prescribing practices. This paper describes the use of LC/MSMS confirmatory testing and RxGuardian data analysis by VA clinicians in Valor Healthcare veteran treatment facilities. LC/MSMS confirmation results combined with RxGuardian data analysis generated results that differed from the conclusions of the existing monitoring system 12% of the time.
Based on the successes of the initiative, Ameritox and Valor Healthcare are poised to offer urine drug testing and RxGuardian to the other 31 CBOCs as well as civilian laboratories and clinics.
Background
The Scale of the Epidemic
We don’t need to look far down the newspaper page or beyond our circle of acquaintances to know that opioid abuse is epidemic in America today. Opioid dependency is devastating to users and their families, and strains our national resources to the tune of $78.5 billion a year.1
The consequences of opioid misuse are significant. In 2015, drug overdose in the U.S. accounted for 52,404 deaths, with 33,091 (63.1%) of these involving an opioid.2 More deaths resulted from all drug overdoses than from either car accidents or gun-related violence.3 Prescription opioids, not illicit drugs, are the most common gateway to opioid dependence. A full 75% of people entering treatment for heroin use between 2000 and 2010 were introduced to opioids through a prescription to relieve pain.4 The National Academy of Medicine estimates that in 2011 about 1 in 3 Americans were affected by chronic pain.5
Our strongest are also our most vulnerable
Where just under a third of all Americans suffer from some chronic pain, 44% of veterans report suffering from chronic pain.6 Between 1999 and 2010 veteran opioid prescriptions shot up by a precipitous 287%,7 while the overall sales of opioid medications quadrupled between 1999 and 2014.8
In 2012, over 50,000 veterans were treated by the VA for serious problems associated with opioid abuse, nearly double the number from the previous decade.7 This number has increased to 68,000 veterans in 2016.9 Additionally, the fatal overdose rate among veterans was nearly double the national average in 2013.10
It is daunting to try and unravel the many factors that contribute to chronic pain among civilians. However, there is greater visibility into what initiates the cycle of pain and pain medication for our veterans, even though questions of what is a physical versus emotional wound still confound treatment plans. Prolonged deployments, guerilla assault tactics and chemical exposure, all with their attendant long-term pain risks, have raised the need for stronger medicines for chronic pain. Formulations with fewer overt or short-term side effects were there to meet the demand, making for unintended consequences.
Challenges With Current Adherence Monitoring Under COT
One of the biggest challenges with current COT adherence monitoring is the inherent shortcomings of enzyme immunoassay EIA screenings themselves. These widely used basic urine screens detect the presence of an opioid, but lack the sensitivity to distinguish between substances of the same drug class, and are unable to accurately discern the level of drug present within a patient’s system. This lack of information obviously muddies the water for VA Primary Care Providers (PCPs) trying to make informed decisions about patients receiving COT.
The RxGuardian Difference
In 2011, using a quantitative medication monitoring confirmation technology, Ameritox introduced a data analysis system to help address these limitations. The resulting product, RxGuardian, provides physicians with enhanced data on likely prescription adherence. The RxGuardian data analysis provides a normalized and transformed database of likely adherent patients which can be used to assess the probable adherence of any given patient test result. Thus clinicians can feel confident not only in the identity of the drug in question, but in the consistency of that test result with the RxGuardian database population.
Unlike other urine screening systems, LC/MSMS confirmation can differentiate between drugs of the same drug class, and analyze drug levels as low as parts per billion (ng/mL, or PPB). Confirmation testing is able to distinguish between a prescribed opioid on a patient’s regimen and an illicit opioid like heroin, for example, or between OxyContin and Vicodin. With this segregation, physicians can have much more specific information to help them assess if the patient is adherent to their prescribed medication(s) or using illicit or other non-prescribed substances within the same drug class.
Confirmation LC/MSMS technology is quantitative versus the qualitative results determined with EIA. A quantitative confirmation technology provides highly accurate readings of the levels of substances and medications in the urine sample. In contrast, CBOCs employ qualitative EIA screening, which only indicates if a drug class — opioids in this case — is present. It neither differentiates between substances within the same drug type, nor provides accurate data about drug levels. Within the Valor Healthcare veteran treatment facilities, LC/MSMS confirmation results combined with RxGuardian data analysis generated results that differed from the conclusions of the existing monitoring system 12% of the time.
The increased visibility into patients’ medication levels enables earlier intervention, before addiction or patterns of abuse develop, and provides providers with confidence in writing appropriate future prescriptions.
