Proove Opioid Risk Profile Predictive of Opioid Use Disorder Interview with:

Maneesh Sharma, M.D</strong> Director of Pain Medicine MedStar Good Samaritan Hospital Medical Director of the Interventional Pain Institute Baltimore, Maryland

Dr. Maneesh Sharma

Maneesh Sharma, M.D
Director of Pain Medicine
MedStar Good Samaritan Hospital
Medical Director of the Interventional Pain Institute
Baltimore, Maryland What is the background for this study?

Response: Opioid abuse in chronic pain patients is a major public health issue, with rapidly increasing addiction rates and deaths from unintentional overdose more than quadrupling since 1999. Just in the last year alone according to the CDC, synthetic opioid deaths have increased 72%. As a practicing interventional pain specialist, I am confronted with the challenge of assessing patient risk for opioids as I evaluate multi-modal approaches to effective pain management. Existing tools are inadequate, as they either rely on a urine toxicology test to evaluate a patient’s current potential substance abuse as a predictor of future abuse, or on a patient’s honesty to fill out a questionnaire. We know that many patients who are not currently abusing illicit drugs or misusing prescription medications can develop prescription opioid tolerance, dependence, or abuse—especially with prolonged opioid therapy. Furthermore, we know that patients who are looking to abuse medications or divert those prescriptions will obviously lie on questionnaires. What are the main findings?

Response: As such, this study was designed to evaluate a combination of genetic, lifestyle and behavioral factors in a predictive algorithm to identify patient risk for opioid use disorder.

The main findings of the study were that the Proove Opioid Risk profile was an accurate predictor of opioid use disorder. The mean Proove Opioid Risk score for controls versus those diagnosed with opioid use disorder was substantially and significantly different. The study also showed that this precision medicine profile could stratify risk, as a moderate risk rating was associated with being over 4 times more likely to be an opioid abuser, and a high risk rating was associated with being over 16 times more likely. The sensitivity and specificity also gave some insights. The high sensitivity of moderate risk scores and high specificity at high risk scores validate the profile’s ability to capture, with good sensitivity, patients that should be monitored more closely, but not label patients inappropriately as high risk. This addresses a clinical challenge faced by clinicians, as some guidelines restrict opioids for all patients. As a practicing clinician, every patient has unique needs, and these results support the necessity to understand the individual patient and tailor a treatment plan to the patient’s individual needs. What should readers take away from your report?

Response: Readers should understand that precision medicine can help us address the prescription opioid abuse epidemic. An algorithm that reliably predicts patients most at risk of opioid addiction is a valuable tool in a clinician’s arsenal. By stratifying risk, physicians can appropriately identify those patients at higher risk for opioid abuse and then more safely prescribe opioids in most of the population, which is low risk. This knowledge, as displayed by the Proove Opioid Risk algorithm, should lead to more rationale decision-making by allowing patients access to necessary medication management and avoid exposure to those at elevated risk. The Proove Opioid Risk profile gives physicians the information they need about their most susceptible patients, which not only protects the patient, but also protects the physician’s practice as governmental and law enforcement agencies elevate scrutiny on opioid-prescribing and the physician. What recommendations do you have for future research as a result of this study?

Response: Obviously, it is critical to continue the research effort. Proove is committed to further investments in research. It would be interesting to validate these results in other patient cohorts, as well across various medical specialties, such as addiction medicine and primary care. Also, it will be important to conduct prospective studies to further evaluate the algorithms predictability. Is there anything else you would like to add?

Response: Over the past several years, I have served on the Medical Advisory Board of Proove Biosciences, as well as a researcher or consultant for other companies. I am Chief Medical Officer of the Interventional Pain Institute and have ongoing research at Johns Hopkins University. Thank you for your contribution to the community.


An Observational Study to Calculate Additive Risk to Opioids: A Validation Study of a Predictive Algorithm to Evaluate Opioid Use Disorder (O.S.C.A.R.)
Journal Pharmacogenomics and Personalized Medicine

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Last Updated on April 24, 2017 by Marie Benz MD FAAD