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  1. Article ; Online: Urinary Buprenorphine, Norbuprenorphine and Naloxone Concentrations and Ratios: Review and Potential Clinical Implications.

    Warrington, Jill S / Warrington, Gregory S / Francis-Fath, Samuel / Brooklyn, John

    Journal of addiction medicine

    2020  Volume 14, Issue 6, Page(s) e344–e349

    Abstract: Objectives: Treatment with medications for opioid use disorder such as buprenorphine improves patient morbidity and mortality as well as treatment adherence, an important component of patient care. Buprenorphine is combined with naloxone to reduce ... ...

    Abstract Objectives: Treatment with medications for opioid use disorder such as buprenorphine improves patient morbidity and mortality as well as treatment adherence, an important component of patient care. Buprenorphine is combined with naloxone to reduce misuse; and, when taken sublingually, naloxone is poorly absorbed. Urine testing for buprenorphine is a common way to monitor adherence. Some patients who want to appear adherent may directly tamper with their urine by adding buprenorphine to their urine to allow for the detection without ingestion. Practitioners may rely upon the concentration of buprenorphine and the metabolite, norbuprenorphine, and utilize the ratio of metabolite to parent compound (norbuprenorphine:buprenorphine - N:B ratio) to discern possible evidence of tampering; however, there remains debate as to what specific ratio may signify this practice. Testing for naloxone may also help determine if urine tampering occurred as only low naloxone concentrations are found in the urine when taken by a sublingual route.
    Methods: To determine a reliable N:B ratio that may be used to identify possible urine tampering by adding parent drug directly to urine, we examined 136,605 urine samples for quantitative concentrations of buprenorphine and norbuprenorphine by LC-MS/MS performed at a commercial laboratory. After identifying abnormal ratios (<0.02), we then compared them with naloxone concentrations and specimen validity testing, other markers that may coincide with specimen tampering of this type.
    Results: Correlating urinary buprenorphine and norbuprenorphine concentrations, we found 2 distinct patient populations, which could be distinguished by N:B ratios ranging from 0.01 to 0.2. In addition, while the distribution of urine naloxone concentrations itself did not demonstrate distinct populations, naloxone was able to further flag potential tampered specimens when combined with N:B ratios. Abnormal specimen validity testing was additionally found more commonly in cases with N:B ratios <0.02.
    Conclusions: This comprehensive study compared N:B ratios with naloxone concentrations and specimen validity testing. This study suggests that a N:B ratio of <0.02 in concert with high naloxone concentrations (>1000 ng/ml) can help to identify potential cases of tampered urine samples.
    MeSH term(s) Buprenorphine/analogs & derivatives ; Chromatography, Liquid ; Humans ; Naloxone ; Tandem Mass Spectrometry
    Chemical Substances Naloxone (36B82AMQ7N) ; Buprenorphine (40D3SCR4GZ) ; norbuprenorphine (7E53B4O073)
    Keywords covid19
    Language English
    Publishing date 2020-06-12
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ISSN 1935-3227
    ISSN (online) 1935-3227
    DOI 10.1097/ADM.0000000000000676
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Use of urinary naloxone levels in a single provider practice: a case study.

    Warrington, Jill S / Booth, Kaitlyn / Warrington, Gregory S / Francis-Fath, Samuel

    Addiction science & clinical practice

    2020  Volume 15, Issue 1, Page(s) 3

    Abstract: Background: Urine drug monitoring for medications for opioid use disorder (MOUD) such as buprenorphine can help to support treatment adherence. The practice of introducing unconsumed medication directly into urine (known as "spiking" samples) has been ... ...

    Abstract Background: Urine drug monitoring for medications for opioid use disorder (MOUD) such as buprenorphine can help to support treatment adherence. The practice of introducing unconsumed medication directly into urine (known as "spiking" samples) has been increasingly recognized as a potential means to simulate treatment adherence. In the laboratory, examination of the ratios of buprenorphine and its metabolite, norbuprenorphine, has been identified as a mechanism to identify "spiked" samples. Urine levels of naloxone may also be a novel marker in cases where the combination buprenorphine-naloxone product has been administered. This case study, which encompasses one provider's practice spanning two sites, represents a preliminary report on the utility of using urinary naloxone as an indicator of "spiked" urine toxicology samples. Though only a case study, this represents the largest published evaluation of patients' naloxone levels to date.
    Case presentation: Over a 3-month period across two practice sites, we identified 1,223 patient samples with recorded naloxone levels, spanning a range of 0 to 12,161 ng/ml. The average naloxone level was 633.65 ng/ml with the majority (54%) of samples < 300 ng/ml. 8.0% of samples demonstrated extreme values of naloxone (> 2000 ng/ml). One practice site, which had increased evidence of specimen tampering at collections, had a greater percent of extreme naloxone levels (>  2000 ng/ml) at 9.3% and higher average naloxone level (686.8 ng/ml), in contrast to a second site (570.9 ng/ml; 6.4% at > 2000 ng/ml) that did not have known reports of specimen tampering.
    Conclusions: We postulate that naloxone may serve as an additional flag to identify patient "spiking" of urine samples with use of the combination product of buprenorphine-naloxone.
    MeSH term(s) Buprenorphine/analogs & derivatives ; Buprenorphine/urine ; Buprenorphine, Naloxone Drug Combination/therapeutic use ; Buprenorphine, Naloxone Drug Combination/urine ; Humans ; Narcotic Antagonists/therapeutic use ; Narcotic Antagonists/urine ; Opioid-Related Disorders/drug therapy ; Substance Abuse Detection/standards
    Chemical Substances Buprenorphine, Naloxone Drug Combination ; Narcotic Antagonists ; Buprenorphine (40D3SCR4GZ) ; norbuprenorphine (7E53B4O073)
    Language English
    Publishing date 2020-01-15
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2492632-2
    ISSN 1940-0640 ; 1940-0640
    ISSN (online) 1940-0640
    ISSN 1940-0640
    DOI 10.1186/s13722-020-0178-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Keeping Up with Fentanyl: Failure to Do So Is Not an Option.

    Warrington, Jill S / Walsh, Andrew / Baker, Ed / Lozier, Deidre / Belec, Andrea

    The journal of applied laboratory medicine

    2021  Volume 3, Issue 1, Page(s) 148–151

    Language English
    Publishing date 2021-02-25
    Publishing country England
    Document type Journal Article
    ISSN 2576-9456
    ISSN 2576-9456
    DOI 10.1373/jalm.2017.025510
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Patient-Centered Telehealth Solution for Observed Urine Collections in Substance Use Disorder Care Delivery During COVID-19 and Beyond.

    Brett, Alexa / Foster, Heather / Joseph, Michael / Warrington, Jill S

    Journal of patient experience

    2021  Volume 8, Page(s) 23743735211033128

    Abstract: Patients with substance use disorder (SUD) rely upon urine drug testing to support treatment adherence and to mitigate relapse. Before the onset of coronavirus 2019 (COVID-19), the logistical challenges of randomized observed collections for urine drug ... ...

    Abstract Patients with substance use disorder (SUD) rely upon urine drug testing to support treatment adherence and to mitigate relapse. Before the onset of coronavirus 2019 (COVID-19), the logistical challenges of randomized observed collections for urine drug testing for the patient were significant. During COVID-19, these barriers were often insurmountable. Since SUD patients represent a population at a higher risk for complications from COVID-19, an alternative strategy to support COVID-19 testing was urgently needed. We designed and deployed a telehealth-based solution in which patients could use mobile devices to connect with trained collection professionals to perform observed urine collections, often referred to a UA (urinalysis). The solution was designed with patient-centered best practices for telehealth, stigma prevention, trauma-informed, empathy and compassion, and to remove barriers to access to care. This approach demonstrated high patient satisfaction scores thereby proving that it is possible to provide urine collection services in the patient's home via a telehealth technology, while still upholding SUD testing integrity best practices. This study lays the path for a more patient-centered way to support this population.
    Language English
    Publishing date 2021-07-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2857285-3
    ISSN 2374-3743 ; 2374-3735
    ISSN (online) 2374-3743
    ISSN 2374-3735
    DOI 10.1177/23743735211033128
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: A Descriptive analysis of urine drug screen results in patients with opioid use disorder managed in a primary care setting.

    Sobel, Halle G / Warrington, Jill S / Francis-Fath, Samuel / Crocker, Abigail M / Berger, Claudia A

    Addiction science & clinical practice

    2021  Volume 16, Issue 1, Page(s) 59

    Abstract: Background: Urine drug screening (UDS) is commonly used as part of treatment for opioid use disorder (OUD), including treatment with buprenorphine-naloxone for OUD in a primary care setting. Very little is known about the value of UDS, the optimum ... ...

    Abstract Background: Urine drug screening (UDS) is commonly used as part of treatment for opioid use disorder (OUD), including treatment with buprenorphine-naloxone for OUD in a primary care setting. Very little is known about the value of UDS, the optimum screening frequency in general, or its specific use for buprenorphine treatment in primary care. To address this question, we thought that in a stable population receiving buprenorphine-naloxone in the primary care setting it would be useful to know how often UDS yielded expected and unexpected results.
    Methods: We present a descriptive analysis of UDS results in patients treated with buprenorphine-naloxone for OUD in a primary care setting over a two-year period. An unexpected test result is: 1. A negative test for buprenorphine and/or 2. A positive test for opioids, methadone, cocaine and/or heroin.
    Results: A total of 161 patients received care during the study period and a total of 2588 test results were analyzed from this population. We found that 64.4% of the patient population (n = 104 patients) demonstrated both treatment adherence (as measured by buprenorphine positive test results) and no apparent unexpected test findings, as defined by negative tests for opioids, methadone, cocaine and heroin. Of the 161 patients, 20 results were positive for opioids, 5 for methadone, 39 for heroin and 2 for cocaine. Analysis at the UDS level demonstrated that, of the 2588 test results, 38 (1.5%) results did not have buprenorphine. Of the 2588, 28 (1.1%) test results were positive for opioids, 8 (0.3%) were positive for methadone, 39 (1.5%) for cocaine and 2 (0.1%) for heroin.
    Conclusion: Given that the majority of patients in our study had expected urine results, it may be reasonable for less frequent urine testing in certain patients.
    MeSH term(s) Analgesics, Opioid/therapeutic use ; Buprenorphine/therapeutic use ; Buprenorphine, Naloxone Drug Combination/therapeutic use ; Humans ; Methadone/therapeutic use ; Narcotic Antagonists/therapeutic use ; Opiate Substitution Treatment ; Opioid-Related Disorders/diagnosis ; Opioid-Related Disorders/drug therapy ; Primary Health Care
    Chemical Substances Analgesics, Opioid ; Buprenorphine, Naloxone Drug Combination ; Narcotic Antagonists ; Buprenorphine (40D3SCR4GZ) ; Methadone (UC6VBE7V1Z)
    Language English
    Publishing date 2021-09-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 2492632-2
    ISSN 1940-0640 ; 1940-0640
    ISSN (online) 1940-0640
    ISSN 1940-0640
    DOI 10.1186/s13722-021-00264-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Urinary Buprenorphine, Norbuprenorphine and Naloxone Concentrations and Ratios: Review and Potential Clinical Implications

    Warrington, Jill S / Warrington, Gregory S / Francis-Fath, Samuel / Brooklyn, John

    Abstract: OBJECTIVES: Treatment with medications for opioid use disorder such as buprenorphine improves patient morbidity and mortality as well as treatment adherence, an important component of patient care. Buprenorphine is combined with naloxone to reduce misuse; ...

    Abstract OBJECTIVES: Treatment with medications for opioid use disorder such as buprenorphine improves patient morbidity and mortality as well as treatment adherence, an important component of patient care. Buprenorphine is combined with naloxone to reduce misuse; and, when taken sublingually, naloxone is poorly absorbed. Urine testing for buprenorphine is a common way to monitor adherence. Some patients who want to appear adherent may directly tamper with their urine by adding buprenorphine to their urine to allow for the detection without ingestion. Practitioners may rely upon the concentration of buprenorphine and the metabolite, norbuprenorphine, and utilize the ratio of metabolite to parent compound (norbuprenorphine:buprenorphine - N:B ratio) to discern possible evidence of tampering; however, there remains debate as to what specific ratio may signify this practice. Testing for naloxone may also help determine if urine tampering occurred as only low naloxone concentrations are found in the urine when taken by a sublingual route. METHODS: To determine a reliable N:B ratio that may be used to identify possible urine tampering by adding parent drug directly to urine, we examined 136,605 urine samples for quantitative concentrations of buprenorphine and norbuprenorphine by LC-MS/MS performed at a commercial laboratory. After identifying abnormal ratios (<0.02), we then compared them with naloxone concentrations and specimen validity testing, other markers that may coincide with specimen tampering of this type. RESULTS: Correlating urinary buprenorphine and norbuprenorphine concentrations, we found 2 distinct patient populations, which could be distinguished by N:B ratios ranging from 0.01 to 0.2. In addition, while the distribution of urine naloxone concentrations itself did not demonstrate distinct populations, naloxone was able to further flag potential tampered specimens when combined with N:B ratios. Abnormal specimen validity testing was additionally found more commonly in cases with N:B ratios <0.02. CONCLUSIONS: This comprehensive study compared N:B ratios with naloxone concentrations and specimen validity testing. This study suggests that a N:B ratio of <0.02 in concert with high naloxone concentrations (>1000 ng/ml) can help to identify potential cases of tampered urine samples.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32530884
    Database COVID19

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  7. Article ; Online: Use of urinary naloxone levels in a single provider practice

    Jill S. Warrington / Kaitlyn Booth / Gregory S. Warrington / Samuel Francis-Fath

    Addiction Science & Clinical Practice, Vol 15, Iss 1, Pp 1-

    a case study

    2020  Volume 4

    Abstract: ... administered. This case study, which encompasses one provider’s practice spanning two sites, represents ...

    Abstract Abstract Background Urine drug monitoring for medications for opioid use disorder (MOUD) such as buprenorphine can help to support treatment adherence. The practice of introducing unconsumed medication directly into urine (known as “spiking” samples) has been increasingly recognized as a potential means to simulate treatment adherence. In the laboratory, examination of the ratios of buprenorphine and its metabolite, norbuprenorphine, has been identified as a mechanism to identify “spiked” samples. Urine levels of naloxone may also be a novel marker in cases where the combination buprenorphine–naloxone product has been administered. This case study, which encompasses one provider’s practice spanning two sites, represents a preliminary report on the utility of using urinary naloxone as an indicator of “spiked” urine toxicology samples. Though only a case study, this represents the largest published evaluation of patients’ naloxone levels to date. Case presentation Over a 3-month period across two practice sites, we identified 1,223 patient samples with recorded naloxone levels, spanning a range of 0 to 12,161 ng/ml. The average naloxone level was 633.65 ng/ml with the majority (54%) of samples < 300 ng/ml. 8.0% of samples demonstrated extreme values of naloxone (> 2000 ng/ml). One practice site, which had increased evidence of specimen tampering at collections, had a greater percent of extreme naloxone levels (> 2000 ng/ml) at 9.3% and higher average naloxone level (686.8 ng/ml), in contrast to a second site (570.9 ng/ml; 6.4% at > 2000 ng/ml) that did not have known reports of specimen tampering. Conclusions We postulate that naloxone may serve as an additional flag to identify patient “spiking” of urine samples with use of the combination product of buprenorphine–naloxone.
    Keywords Naloxone ; Urine drug testing ; Spiking ; Buprenorphine ; Medicine (General) ; R5-920 ; Social pathology. Social and public welfare. Criminology ; HV1-9960
    Subject code 360
    Language English
    Publishing date 2020-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article: All Hands-On Deck and All Decks on Hand: Surmounting Supply Chain Limitations During the COVID-19 Pandemic.

    Warrington, Jill S / Crothers, Jessica W / Goodwin, Andrew / Coulombe, Linda / Hong, Tania / Bryan, Lynn / Wojewoda, Christina / Fung, Mark / Warrington, Gregory / Clark, Vanessa / Risley, Lauren / Lewis, Michael

    Academic pathology

    2021  Volume 8, Page(s) 23742895211011928

    Abstract: Testing during the COVID-19 pandemic has been crucial to public health surveillance and clinical care. Supply chain constraints-spanning limitations in testing kits, reagents, pipet tips, and swabs availability-have challenged the ability to scale COVID- ... ...

    Abstract Testing during the COVID-19 pandemic has been crucial to public health surveillance and clinical care. Supply chain constraints-spanning limitations in testing kits, reagents, pipet tips, and swabs availability-have challenged the ability to scale COVID-19 testing. During the early months, sample collection kits shortages constrained planned testing expansions. In response, the University of Vermont Medical Center, University of Vermont College of Medicine, Vermont Department of Health Laboratory, Aspenti Health, and providers across Vermont including 16 area hospitals partnered to surmount these barriers. The primary objectives were to increase supply availability and manage utilization. Within the first month of Vermont's stay-at-home order, the University of Vermont Medical Center laboratory partnered with College of Medicine to create in-house collection kits, producing 5000 per week. University of Vermont Medical Center reassigned 4 phlebotomists, laboratory educators, and other laboratory staff, who had reduced workloads, to participate (requiring a total of 5.3-7.6 full-time equivalent (FTE) during the period of study). By August, automation at a local commercial laboratory produced 22,000 vials of media in one week (reducing the required personnel by 1.2 FTE). A multisite, cross-institutional approach was used to manage specimen collection kit utilization across Vermont. Hospital laboratory directors, managers, and providers agreed to order only as needed to avoid supply stockpiles and supported operational constraints through ongoing validations and kit assembly. Throughout this pandemic, Vermont has ranked highly in number of tests per million people, demonstrating the value of local collaboration to surmount obstacles during disease outbreaks and the importance of creative allocation of resources to address statewide needs.
    Language English
    Publishing date 2021-05-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2819382-9
    ISSN 2374-2895
    ISSN 2374-2895
    DOI 10.1177/23742895211011928
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Integrating Social Determinants of Health and Laboratory Data: A Pilot Study To Evaluate Co-Use of Opioids and Benzodiazepines.

    Warrington, Jill S / Lovejoy, Nick / Brandon, Jamie / Lavoie, Keith / Powell, Chris

    Academic pathology

    2019  Volume 6, Page(s) 2374289519884877

    Abstract: As the opioid crisis continues to have devastating consequences for our communities, families, and patients, innovative approaches are necessary to augment clinical care and the management of patients with opioid use disorders. As stewards of health ... ...

    Abstract As the opioid crisis continues to have devastating consequences for our communities, families, and patients, innovative approaches are necessary to augment clinical care and the management of patients with opioid use disorders. As stewards of health analytic data, laboratories are uniquely poised to approach the opioid crisis differently. With this pilot study, we aimed to bridge laboratory data with social determinants of health data, which are known to influence morbidity and mortality of patients with substance use disorders. For the purpose of this pilot study, we focused on the co-use of opioids and benzodiazepines, which can lead to an increased risk of fatal opioid-related overdoses and increased utilization of acute care. Using the laboratory finding of the copresence of benzodiazepines and opioids as the primary outcome measure, we examined social determinants of health attributes that predict co-use. We found that the provider practice that ordered the laboratory result is the primary predictor of co-use. Increasing age was also predictive of co-use. Further, co-use is highly prevalent in specific geographic areas or "hotspots." The prominent geographic distribution of co-use suggests that targeted educational initiatives may benefit the communities in which co-use is prevalent. This study exemplifies the Clinical Lab 2.0 approach by leveraging laboratory data to gain insights into the overall health of the patient.
    Language English
    Publishing date 2019-10-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2819382-9
    ISSN 2374-2895
    ISSN 2374-2895
    DOI 10.1177/2374289519884877
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Patient-Centered Telehealth Solution for Observed Urine Collections in Substance Use Disorder Care Delivery During COVID-19 and Beyond

    Alexa Brett BAS HCML, CPXP, COTA/L / Heather Foster / Michael Joseph BS / Jill S. Warrington MD, PhD

    Journal of Patient Experience, Vol

    2021  Volume 8

    Abstract: ... to provide urine collection services in the patient’s home via a telehealth technology, while still upholding ...

    Abstract Patients with substance use disorder (SUD) rely upon urine drug testing to support treatment adherence and to mitigate relapse. Before the onset of coronavirus 2019 (COVID-19), the logistical challenges of randomized observed collections for urine drug testing for the patient were significant. During COVID-19, these barriers were often insurmountable. Since SUD patients represent a population at a higher risk for complications from COVID-19, an alternative strategy to support COVID-19 testing was urgently needed. We designed and deployed a telehealth-based solution in which patients could use mobile devices to connect with trained collection professionals to perform observed urine collections, often referred to a UA (urinalysis). The solution was designed with patient-centered best practices for telehealth, stigma prevention, trauma-informed, empathy and compassion, and to remove barriers to access to care. This approach demonstrated high patient satisfaction scores thereby proving that it is possible to provide urine collection services in the patient’s home via a telehealth technology, while still upholding SUD testing integrity best practices. This study lays the path for a more patient-centered way to support this population.
    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-07-01T00:00:00Z
    Publisher SAGE Publishing
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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