Addiction Medicine

Chronic pain significantly affects 100 million Americans.^1,2 Pain accounts for $560 to $635 billion in annual financial costs to society, including health care costs and loss of productivity (ie, days missed from work, hours of work lost, and lower wages).^2,3 Although pain prevalence exceeds other chronic diseases, such as diabetes mellitus, cancer, and heart disease, it lacks a sufficient body of evidence-based research and guidelines on the underlying mechanisms, valid methods of assessment, and comparative effectiveness of treatments to effectively implement into clinical practice.^2,4 Prevention and treatment of pain are often delayed, inaccessible, or inadequate.² Primary care providers (PCPs) are most often sought for pain management and treat about 52% of chronic pain patients.^2,3,5 Veterans are especially vulnerable to chronic pain and are at risk for inadequate treatment.²

Background

There is an epidemic of drug abuse and mortality from opioid prescription medication.⁶ In the US, rates of overdose deaths from prescription opioids were 6.1 per 100,000 for men and 4.2 per 100,000 for women in 2017. Opioids were involved in 47,600 overdose deaths in 2017, accounting for 67.8% of all drug overdose deaths.⁷

A large number of patients on long-term opioids have preexisting substance use disorders and/or psychiatric disease, further complicating chronic pain management.^8-10 Prescription opioid use has been the precursor for about 80% of people who are now heroin addicts.¹¹ Iatrogenic addiction from prescription medications isn’t easily captured by standard addiction criteria. Consequently, in patients who are on opioid therapy for prolonged periods, separating complex opioid dependence from addiction is difficult.¹² Improved addiction screening and risk mitigation strategies are needed along with aggressive treatment monitoring to curb the opioid epidemic.

Opioid Management in Primary Care

The majority of opioid medications are prescribed by PCPs, which is magnified in the US Department of Veterans Affairs (VA) health care system due to the high prevalence of service-related injuries.^3,13 The VA is at the forefront of addressing the complexities of opioid addiction through several initiatives.¹⁴ The ability to offer the frequent visits needed to safely manage patients prescribed opioids and the integration of mental health and addiction treatment are often lacking in non-VA primary care clinics. Therefore, a key to solving the opioid crisis is developing these capabilities so they can be delivered within the primary care setting. There is substantial evidence in support of nonopioid alternatives to chronic pain management, including other pharmacologic approaches, exercise, physical therapy, acupuncture, weight loss, smoking cessation, chiropractic care, cognitive behavioral therapy (CBT), and other integrative health modalities.

A 2009 VA directive mandated the development of a comprehensive, integrated, systemwide approach to pain management.¹⁵ The VA Stepped-Care Biopsychosocial Model for Pain Management is dependent on timely access to secondary consultation from pain medicine, behavioral health, physical medicine, and other specialty consultation.¹⁵

History of VHA SCAN-ECHO Model

The Specialty Care Access Network–Extension for Community Health Outcomes (SCAN-ECHO) is a Veterans Health Administration (VHA) adaptation of a program that originated at the University of Mexico.^16,17 The SCAN-ECHO model uses a multisite videoconferencing network to provide specialty care consultations to PCPs and patient aligned care teams (PACTs). During the 60- to 90-minute weekly sessions, case presentations are analyzed in real time so that over time, the PCPs gain knowledge, competency, and confidence in learning how to handle complex chronic conditions.

Since its implementation, the SCAN-ECHO program has been adopted across the VHA in a variety of specialties. One program, the SCAN-ECHO for Pain Management (SCAN-ECHO-PM) was implemented in 7 VHA networks in 31 states, spanning 47 medical centers and 148 community-based outpatient clinics (CBOCs).¹⁸ The SCAN-ECHO-PM program successfully conducted 257 multidisciplinary pain consultations between 2011 and 2013, resulting in increased initiation of nonopioid medications.¹⁸

The aim of this article is to describe the implementation of a multicomponent primary care-based pain clinic with a fully integrated mental health service and addiction service at the North Florida/South Georgia Veterans Health System (NF/SGVHS). A practiced-based intervention of the biopsychosocial model with robust patient engagement has guided the development of the NF/SGVHS pain clinic (Figure 1).^4,19

Pain CLinic

NF/SGVHS comprises the Malcom Randall and Lake City VA medical centers (VAMCs) hospitals, 3 satellite outpatient clinics, and 8 CBOCs. Spanning 33 counties in North Florida and 19 counties in South Georgia, the NF/SGVHS serves more than 140,000 patients. In 2010, the Malcom Randall VAMC established a multidisciplinary primary care pain clinic to manage veterans at high-risk for noncancer chronic pain and addiction. The noncancer pain policy was revised after garnering support from stakeholders who treat chronic pain, including the chiefs of psychiatry, rehabilitation medicine, neurosurgery, psychology, interventional pain, pharmacy, nursing, addiction medicine, and primary care. The clinic is staffed by primary care physicians trained in internal medicine and family medicine and is structured with 1-hour first visits, and 30-minute follow-up visits to allow enough time for comprehensive evaluation while meeting the needs for close follow-up support.

All physicians in the clinic have buprenorphine prescribing credentials to aid in the management of opioid addiction, as some patients feel more comfortable receiving addiction treatment in a primary care setting. The multimodal care model consists of several services that include addiction psychiatrists, interventional pain specialists, pain psychologists, and pain pharmacologists who coordinate the care to the veterans. The addiction psychiatrists offer a full range of services with inpatient residential and outpatient programs. Through recurring meetings with primary care pain clinic staff, the addiction psychiatrists are available to discuss use of buprenorphine and arrange follow-up for patients with complex pain addiction. There is ongoing collaboration to develop the best care plan that meets the patient’s needs for chronic pain, addiction, and/or mental health issues. The interventional pain service has 3 fellowship-trained pain care providers who deliver comprehensive evaluation, pharmacologic recommendations, and a full range of interventional and complementary therapies with an emphasis on objective functional improvement. Pain care providers offer alternatives to patients who are being weaned from opioids and support the multidisciplinary patient engagement model.

The pain psychology program, established in 2011, delivers CBT to 5 onsite locations and 5 telehealth locations. The service includes an advanced CBT program and a couples CBT program. The pharmacy pain fellowship program provides staff for an outpatient e-consult pain management service and an inpatient pharmacy consult service. Harnessing pain specialty pharmacists, the pharmacy service addresses pharmacokinetic issues, urine drug screen (UDS) results, opioid tapering and discharge planning for pain, addiction and mental health needs. The NF/SGVHS Primary Care Pain Clinic was established to support PCPs who did not feel comfortable managing chronic pain patients. These patients were typically on high-dose opioid therapy (> 100-mg morphine equivalent daily doses [MEDDs]); patients with a history of opioid addiction; patients with an addiction to opioids combined with benzodiazepines; and patients with comorbid medical issues (eg, sleep apnea), which complicated their management. The process of addressing opioid safety in these complex pain patients can be labor intensive and generally cannot be accomplished in a brief visit in a primary care setting where many other medical problems often need to be addressed.

Most patients on high-dose opioids are fearful of any changes in their medications. The difficult conversation regarding opioid safety is a lengthy one and frequently will occur over multiple visits. In addition, safely tapering opioids requires frequent follow-up to provide psychological support and to address withdrawal and mental health issues that may arise. As opioids are tapered, the clinic reinforces improved pain care through a multimodal biopsychosocial model. All veterans receiving pain care outside the VA are monitored annually to assure they are receiving evidence-based pain care as defined by the biopsychosocial model.

Education

Since 2011, the NF/SGVHS SCAN-ECHO pain and addiction educational forum has created > 50 hours of approved annual continuing medical education (CME) on pain management and addiction for PCPs. Initially, the 1-hour weekly educational audioconferences presented a pain management case along with related topics and involved specialists from interventional pain, physical therapy, psychiatry, nursing, neurology, and psychology departments. In 2013, in conjunction with the VA SCAN-ECHO program of Hunter Holmes McGuire VAMC in Richmond, Virginia, and Walter Reed National Military Medical Center in Bethesda, Maryland, the audioconference was expanded to 2 days each week with additional topics on addiction management. Residency and fellowship rotations were developed that specifically targeted fellows from psychiatry, pharmacology, and interventional pain departments.

Currently, an 8-session pain school is delivered onsite and at 7 telehealth locations. The school is a collaborative effort involving interventional pain, psychology, pharmacy, nutrition, and the primary care pain clinic staff. As the cornerstone of the program, the pain school stresses the biopsychosocial patient engagement model.

Program Evaluation

The VA is equipped with multiple telehealth service networks that allow for the delivery of programs, such as the pain school, a pain psychology program, and a yoga program, onsite or offsite. The VA Computerized Patient Record System (CPRS) manages electronic health records, allowing for rapid chart review and e-consults. The NF/SGVHS Pain Management Program provides about 1500 e-consults yearly. The CPRS includes templates with pain metrics to help PCPs deliver pain care more efficiently and evaluate performance measures. This system also allows for the capture of data to track improvements in the care of the veterans served.

From 2012 to 2017, more than 5000 NF/SGVHS patients were weaned from opioids. Overall, there was an 87% reduction in patients receiving opioids ( ≥ 100-mg MEDDs) within the NF/SGVHS, which is significantly more than the 49% seen nationally across the VHA (Figure 2). Percent reduction was calculated by taking the difference in number of patients receiving opioids in 2012 and 2017, dividing by the number of patients receiving opioids in 2012 and multiplying by 100. The largest proportion of opioid dose reductions for NF/SGVHS and VHA patients, respectively, were seen in 300-mg to 399-mg MEDDs (95% vs 67%, respectively); followed by ≥ 400-mg MEDDs (94% vs 71%, respectively); 200-mg to 299-mg MEDDs (91% vs 58%, respectively); and 100-mg to 199-mg MEDDs (84% vs 40%, respectively). When examining NF/SGVHS trends over time, there has been a consistent decline in patients prescribed opioids (18 223 in 2012 compared with 12 877 in 2017) with similar trends in benzodiazepine-opioid combination therapy (2694 in 2012 compared with 833 in 2017) (Figure 3).

Similar declines are seen when patients are stratified by the MEDD (Figure 4). From 2012 to 2017, 92% of the patients were successfully tapered off doses ≥ 400-mg MEDD (2012, n = 72; 2017, n = 6), and tapered off 300-mg to 399-mg MEDD (2012, n = 107; 2017, n = 5); 95% were tapered off 200-mg to 299-mg MEDD (2012, n = 262; 2017, n = 22); and 86% were tapered off 100-mg to 199-mg MEDD (2012, n = 876; 2017; n = 127).

Conclusion

Successful integration of primary care with mental health and addiction services is paramount to aggressively taper patients with chronic pain from opioids. There is evidence that drug dependence and chronic pain should be treated like other chronic illness.²⁰ Both chronic pain and addiction can be treated with a multidimensional self-management approach. In view of the high incidence of mental health and addiction associated with opioid use, it makes sense that an integrated, 1-stop pain and addiction clinic that understands and addresses both issues is more likely to improve patient outcomes.

Acknowledgments

This material is the result of work supported by the resources and facilities at the North Florida/South Georgia Veterans Health System, Geriatric Research Education Clinical Center in Gainesville, Florida.

Chronic pain significantly affects 100 million Americans.^1,2 Pain accounts for $560 to $635 billion in annual financial costs to society, including health care costs and loss of productivity (ie, days missed from work, hours of work lost, and lower wages).^2,3 Although pain prevalence exceeds other chronic diseases, such as diabetes mellitus, cancer, and heart disease, it lacks a sufficient body of evidence-based research and guidelines on the underlying mechanisms, valid methods of assessment, and comparative effectiveness of treatments to effectively implement into clinical practice.^2,4 Prevention and treatment of pain are often delayed, inaccessible, or inadequate.² Primary care providers (PCPs) are most often sought for pain management and treat about 52% of chronic pain patients.^2,3,5 Veterans are especially vulnerable to chronic pain and are at risk for inadequate treatment.²

Background

There is an epidemic of drug abuse and mortality from opioid prescription medication.⁶ In the US, rates of overdose deaths from prescription opioids were 6.1 per 100,000 for men and 4.2 per 100,000 for women in 2017. Opioids were involved in 47,600 overdose deaths in 2017, accounting for 67.8% of all drug overdose deaths.⁷

A large number of patients on long-term opioids have preexisting substance use disorders and/or psychiatric disease, further complicating chronic pain management.^8-10 Prescription opioid use has been the precursor for about 80% of people who are now heroin addicts.¹¹ Iatrogenic addiction from prescription medications isn’t easily captured by standard addiction criteria. Consequently, in patients who are on opioid therapy for prolonged periods, separating complex opioid dependence from addiction is difficult.¹² Improved addiction screening and risk mitigation strategies are needed along with aggressive treatment monitoring to curb the opioid epidemic.

Opioid Management in Primary Care

The majority of opioid medications are prescribed by PCPs, which is magnified in the US Department of Veterans Affairs (VA) health care system due to the high prevalence of service-related injuries.^3,13 The VA is at the forefront of addressing the complexities of opioid addiction through several initiatives.¹⁴ The ability to offer the frequent visits needed to safely manage patients prescribed opioids and the integration of mental health and addiction treatment are often lacking in non-VA primary care clinics. Therefore, a key to solving the opioid crisis is developing these capabilities so they can be delivered within the primary care setting. There is substantial evidence in support of nonopioid alternatives to chronic pain management, including other pharmacologic approaches, exercise, physical therapy, acupuncture, weight loss, smoking cessation, chiropractic care, cognitive behavioral therapy (CBT), and other integrative health modalities.

A 2009 VA directive mandated the development of a comprehensive, integrated, systemwide approach to pain management.¹⁵ The VA Stepped-Care Biopsychosocial Model for Pain Management is dependent on timely access to secondary consultation from pain medicine, behavioral health, physical medicine, and other specialty consultation.¹⁵

History of VHA SCAN-ECHO Model

The Specialty Care Access Network–Extension for Community Health Outcomes (SCAN-ECHO) is a Veterans Health Administration (VHA) adaptation of a program that originated at the University of Mexico.^16,17 The SCAN-ECHO model uses a multisite videoconferencing network to provide specialty care consultations to PCPs and patient aligned care teams (PACTs). During the 60- to 90-minute weekly sessions, case presentations are analyzed in real time so that over time, the PCPs gain knowledge, competency, and confidence in learning how to handle complex chronic conditions.

Since its implementation, the SCAN-ECHO program has been adopted across the VHA in a variety of specialties. One program, the SCAN-ECHO for Pain Management (SCAN-ECHO-PM) was implemented in 7 VHA networks in 31 states, spanning 47 medical centers and 148 community-based outpatient clinics (CBOCs).¹⁸ The SCAN-ECHO-PM program successfully conducted 257 multidisciplinary pain consultations between 2011 and 2013, resulting in increased initiation of nonopioid medications.¹⁸

The aim of this article is to describe the implementation of a multicomponent primary care-based pain clinic with a fully integrated mental health service and addiction service at the North Florida/South Georgia Veterans Health System (NF/SGVHS). A practiced-based intervention of the biopsychosocial model with robust patient engagement has guided the development of the NF/SGVHS pain clinic (Figure 1).^4,19

Pain CLinic

NF/SGVHS comprises the Malcom Randall and Lake City VA medical centers (VAMCs) hospitals, 3 satellite outpatient clinics, and 8 CBOCs. Spanning 33 counties in North Florida and 19 counties in South Georgia, the NF/SGVHS serves more than 140,000 patients. In 2010, the Malcom Randall VAMC established a multidisciplinary primary care pain clinic to manage veterans at high-risk for noncancer chronic pain and addiction. The noncancer pain policy was revised after garnering support from stakeholders who treat chronic pain, including the chiefs of psychiatry, rehabilitation medicine, neurosurgery, psychology, interventional pain, pharmacy, nursing, addiction medicine, and primary care. The clinic is staffed by primary care physicians trained in internal medicine and family medicine and is structured with 1-hour first visits, and 30-minute follow-up visits to allow enough time for comprehensive evaluation while meeting the needs for close follow-up support.

All physicians in the clinic have buprenorphine prescribing credentials to aid in the management of opioid addiction, as some patients feel more comfortable receiving addiction treatment in a primary care setting. The multimodal care model consists of several services that include addiction psychiatrists, interventional pain specialists, pain psychologists, and pain pharmacologists who coordinate the care to the veterans. The addiction psychiatrists offer a full range of services with inpatient residential and outpatient programs. Through recurring meetings with primary care pain clinic staff, the addiction psychiatrists are available to discuss use of buprenorphine and arrange follow-up for patients with complex pain addiction. There is ongoing collaboration to develop the best care plan that meets the patient’s needs for chronic pain, addiction, and/or mental health issues. The interventional pain service has 3 fellowship-trained pain care providers who deliver comprehensive evaluation, pharmacologic recommendations, and a full range of interventional and complementary therapies with an emphasis on objective functional improvement. Pain care providers offer alternatives to patients who are being weaned from opioids and support the multidisciplinary patient engagement model.

The pain psychology program, established in 2011, delivers CBT to 5 onsite locations and 5 telehealth locations. The service includes an advanced CBT program and a couples CBT program. The pharmacy pain fellowship program provides staff for an outpatient e-consult pain management service and an inpatient pharmacy consult service. Harnessing pain specialty pharmacists, the pharmacy service addresses pharmacokinetic issues, urine drug screen (UDS) results, opioid tapering and discharge planning for pain, addiction and mental health needs. The NF/SGVHS Primary Care Pain Clinic was established to support PCPs who did not feel comfortable managing chronic pain patients. These patients were typically on high-dose opioid therapy (> 100-mg morphine equivalent daily doses [MEDDs]); patients with a history of opioid addiction; patients with an addiction to opioids combined with benzodiazepines; and patients with comorbid medical issues (eg, sleep apnea), which complicated their management. The process of addressing opioid safety in these complex pain patients can be labor intensive and generally cannot be accomplished in a brief visit in a primary care setting where many other medical problems often need to be addressed.

Most patients on high-dose opioids are fearful of any changes in their medications. The difficult conversation regarding opioid safety is a lengthy one and frequently will occur over multiple visits. In addition, safely tapering opioids requires frequent follow-up to provide psychological support and to address withdrawal and mental health issues that may arise. As opioids are tapered, the clinic reinforces improved pain care through a multimodal biopsychosocial model. All veterans receiving pain care outside the VA are monitored annually to assure they are receiving evidence-based pain care as defined by the biopsychosocial model.

Education

Since 2011, the NF/SGVHS SCAN-ECHO pain and addiction educational forum has created > 50 hours of approved annual continuing medical education (CME) on pain management and addiction for PCPs. Initially, the 1-hour weekly educational audioconferences presented a pain management case along with related topics and involved specialists from interventional pain, physical therapy, psychiatry, nursing, neurology, and psychology departments. In 2013, in conjunction with the VA SCAN-ECHO program of Hunter Holmes McGuire VAMC in Richmond, Virginia, and Walter Reed National Military Medical Center in Bethesda, Maryland, the audioconference was expanded to 2 days each week with additional topics on addiction management. Residency and fellowship rotations were developed that specifically targeted fellows from psychiatry, pharmacology, and interventional pain departments.

Currently, an 8-session pain school is delivered onsite and at 7 telehealth locations. The school is a collaborative effort involving interventional pain, psychology, pharmacy, nutrition, and the primary care pain clinic staff. As the cornerstone of the program, the pain school stresses the biopsychosocial patient engagement model.

Program Evaluation

The VA is equipped with multiple telehealth service networks that allow for the delivery of programs, such as the pain school, a pain psychology program, and a yoga program, onsite or offsite. The VA Computerized Patient Record System (CPRS) manages electronic health records, allowing for rapid chart review and e-consults. The NF/SGVHS Pain Management Program provides about 1500 e-consults yearly. The CPRS includes templates with pain metrics to help PCPs deliver pain care more efficiently and evaluate performance measures. This system also allows for the capture of data to track improvements in the care of the veterans served.

From 2012 to 2017, more than 5000 NF/SGVHS patients were weaned from opioids. Overall, there was an 87% reduction in patients receiving opioids ( ≥ 100-mg MEDDs) within the NF/SGVHS, which is significantly more than the 49% seen nationally across the VHA (Figure 2). Percent reduction was calculated by taking the difference in number of patients receiving opioids in 2012 and 2017, dividing by the number of patients receiving opioids in 2012 and multiplying by 100. The largest proportion of opioid dose reductions for NF/SGVHS and VHA patients, respectively, were seen in 300-mg to 399-mg MEDDs (95% vs 67%, respectively); followed by ≥ 400-mg MEDDs (94% vs 71%, respectively); 200-mg to 299-mg MEDDs (91% vs 58%, respectively); and 100-mg to 199-mg MEDDs (84% vs 40%, respectively). When examining NF/SGVHS trends over time, there has been a consistent decline in patients prescribed opioids (18 223 in 2012 compared with 12 877 in 2017) with similar trends in benzodiazepine-opioid combination therapy (2694 in 2012 compared with 833 in 2017) (Figure 3).

Similar declines are seen when patients are stratified by the MEDD (Figure 4). From 2012 to 2017, 92% of the patients were successfully tapered off doses ≥ 400-mg MEDD (2012, n = 72; 2017, n = 6), and tapered off 300-mg to 399-mg MEDD (2012, n = 107; 2017, n = 5); 95% were tapered off 200-mg to 299-mg MEDD (2012, n = 262; 2017, n = 22); and 86% were tapered off 100-mg to 199-mg MEDD (2012, n = 876; 2017; n = 127).

Conclusion

Successful integration of primary care with mental health and addiction services is paramount to aggressively taper patients with chronic pain from opioids. There is evidence that drug dependence and chronic pain should be treated like other chronic illness.²⁰ Both chronic pain and addiction can be treated with a multidimensional self-management approach. In view of the high incidence of mental health and addiction associated with opioid use, it makes sense that an integrated, 1-stop pain and addiction clinic that understands and addresses both issues is more likely to improve patient outcomes.

Acknowledgments

This material is the result of work supported by the resources and facilities at the North Florida/South Georgia Veterans Health System, Geriatric Research Education Clinical Center in Gainesville, Florida.

Chronic pain significantly affects 100 million Americans.^1,2 Pain accounts for $560 to $635 billion in annual financial costs to society, including health care costs and loss of productivity (ie, days missed from work, hours of work lost, and lower wages).^2,3 Although pain prevalence exceeds other chronic diseases, such as diabetes mellitus, cancer, and heart disease, it lacks a sufficient body of evidence-based research and guidelines on the underlying mechanisms, valid methods of assessment, and comparative effectiveness of treatments to effectively implement into clinical practice.^2,4 Prevention and treatment of pain are often delayed, inaccessible, or inadequate.² Primary care providers (PCPs) are most often sought for pain management and treat about 52% of chronic pain patients.^2,3,5 Veterans are especially vulnerable to chronic pain and are at risk for inadequate treatment.²

Background

There is an epidemic of drug abuse and mortality from opioid prescription medication.⁶ In the US, rates of overdose deaths from prescription opioids were 6.1 per 100,000 for men and 4.2 per 100,000 for women in 2017. Opioids were involved in 47,600 overdose deaths in 2017, accounting for 67.8% of all drug overdose deaths.⁷

A large number of patients on long-term opioids have preexisting substance use disorders and/or psychiatric disease, further complicating chronic pain management.^8-10 Prescription opioid use has been the precursor for about 80% of people who are now heroin addicts.¹¹ Iatrogenic addiction from prescription medications isn’t easily captured by standard addiction criteria. Consequently, in patients who are on opioid therapy for prolonged periods, separating complex opioid dependence from addiction is difficult.¹² Improved addiction screening and risk mitigation strategies are needed along with aggressive treatment monitoring to curb the opioid epidemic.

Opioid Management in Primary Care

The majority of opioid medications are prescribed by PCPs, which is magnified in the US Department of Veterans Affairs (VA) health care system due to the high prevalence of service-related injuries.^3,13 The VA is at the forefront of addressing the complexities of opioid addiction through several initiatives.¹⁴ The ability to offer the frequent visits needed to safely manage patients prescribed opioids and the integration of mental health and addiction treatment are often lacking in non-VA primary care clinics. Therefore, a key to solving the opioid crisis is developing these capabilities so they can be delivered within the primary care setting. There is substantial evidence in support of nonopioid alternatives to chronic pain management, including other pharmacologic approaches, exercise, physical therapy, acupuncture, weight loss, smoking cessation, chiropractic care, cognitive behavioral therapy (CBT), and other integrative health modalities.

A 2009 VA directive mandated the development of a comprehensive, integrated, systemwide approach to pain management.¹⁵ The VA Stepped-Care Biopsychosocial Model for Pain Management is dependent on timely access to secondary consultation from pain medicine, behavioral health, physical medicine, and other specialty consultation.¹⁵

History of VHA SCAN-ECHO Model

The Specialty Care Access Network–Extension for Community Health Outcomes (SCAN-ECHO) is a Veterans Health Administration (VHA) adaptation of a program that originated at the University of Mexico.^16,17 The SCAN-ECHO model uses a multisite videoconferencing network to provide specialty care consultations to PCPs and patient aligned care teams (PACTs). During the 60- to 90-minute weekly sessions, case presentations are analyzed in real time so that over time, the PCPs gain knowledge, competency, and confidence in learning how to handle complex chronic conditions.

Since its implementation, the SCAN-ECHO program has been adopted across the VHA in a variety of specialties. One program, the SCAN-ECHO for Pain Management (SCAN-ECHO-PM) was implemented in 7 VHA networks in 31 states, spanning 47 medical centers and 148 community-based outpatient clinics (CBOCs).¹⁸ The SCAN-ECHO-PM program successfully conducted 257 multidisciplinary pain consultations between 2011 and 2013, resulting in increased initiation of nonopioid medications.¹⁸

The aim of this article is to describe the implementation of a multicomponent primary care-based pain clinic with a fully integrated mental health service and addiction service at the North Florida/South Georgia Veterans Health System (NF/SGVHS). A practiced-based intervention of the biopsychosocial model with robust patient engagement has guided the development of the NF/SGVHS pain clinic (Figure 1).^4,19

Pain CLinic

NF/SGVHS comprises the Malcom Randall and Lake City VA medical centers (VAMCs) hospitals, 3 satellite outpatient clinics, and 8 CBOCs. Spanning 33 counties in North Florida and 19 counties in South Georgia, the NF/SGVHS serves more than 140,000 patients. In 2010, the Malcom Randall VAMC established a multidisciplinary primary care pain clinic to manage veterans at high-risk for noncancer chronic pain and addiction. The noncancer pain policy was revised after garnering support from stakeholders who treat chronic pain, including the chiefs of psychiatry, rehabilitation medicine, neurosurgery, psychology, interventional pain, pharmacy, nursing, addiction medicine, and primary care. The clinic is staffed by primary care physicians trained in internal medicine and family medicine and is structured with 1-hour first visits, and 30-minute follow-up visits to allow enough time for comprehensive evaluation while meeting the needs for close follow-up support.

All physicians in the clinic have buprenorphine prescribing credentials to aid in the management of opioid addiction, as some patients feel more comfortable receiving addiction treatment in a primary care setting. The multimodal care model consists of several services that include addiction psychiatrists, interventional pain specialists, pain psychologists, and pain pharmacologists who coordinate the care to the veterans. The addiction psychiatrists offer a full range of services with inpatient residential and outpatient programs. Through recurring meetings with primary care pain clinic staff, the addiction psychiatrists are available to discuss use of buprenorphine and arrange follow-up for patients with complex pain addiction. There is ongoing collaboration to develop the best care plan that meets the patient’s needs for chronic pain, addiction, and/or mental health issues. The interventional pain service has 3 fellowship-trained pain care providers who deliver comprehensive evaluation, pharmacologic recommendations, and a full range of interventional and complementary therapies with an emphasis on objective functional improvement. Pain care providers offer alternatives to patients who are being weaned from opioids and support the multidisciplinary patient engagement model.

The pain psychology program, established in 2011, delivers CBT to 5 onsite locations and 5 telehealth locations. The service includes an advanced CBT program and a couples CBT program. The pharmacy pain fellowship program provides staff for an outpatient e-consult pain management service and an inpatient pharmacy consult service. Harnessing pain specialty pharmacists, the pharmacy service addresses pharmacokinetic issues, urine drug screen (UDS) results, opioid tapering and discharge planning for pain, addiction and mental health needs. The NF/SGVHS Primary Care Pain Clinic was established to support PCPs who did not feel comfortable managing chronic pain patients. These patients were typically on high-dose opioid therapy (> 100-mg morphine equivalent daily doses [MEDDs]); patients with a history of opioid addiction; patients with an addiction to opioids combined with benzodiazepines; and patients with comorbid medical issues (eg, sleep apnea), which complicated their management. The process of addressing opioid safety in these complex pain patients can be labor intensive and generally cannot be accomplished in a brief visit in a primary care setting where many other medical problems often need to be addressed.

Most patients on high-dose opioids are fearful of any changes in their medications. The difficult conversation regarding opioid safety is a lengthy one and frequently will occur over multiple visits. In addition, safely tapering opioids requires frequent follow-up to provide psychological support and to address withdrawal and mental health issues that may arise. As opioids are tapered, the clinic reinforces improved pain care through a multimodal biopsychosocial model. All veterans receiving pain care outside the VA are monitored annually to assure they are receiving evidence-based pain care as defined by the biopsychosocial model.

Education

Since 2011, the NF/SGVHS SCAN-ECHO pain and addiction educational forum has created > 50 hours of approved annual continuing medical education (CME) on pain management and addiction for PCPs. Initially, the 1-hour weekly educational audioconferences presented a pain management case along with related topics and involved specialists from interventional pain, physical therapy, psychiatry, nursing, neurology, and psychology departments. In 2013, in conjunction with the VA SCAN-ECHO program of Hunter Holmes McGuire VAMC in Richmond, Virginia, and Walter Reed National Military Medical Center in Bethesda, Maryland, the audioconference was expanded to 2 days each week with additional topics on addiction management. Residency and fellowship rotations were developed that specifically targeted fellows from psychiatry, pharmacology, and interventional pain departments.

Currently, an 8-session pain school is delivered onsite and at 7 telehealth locations. The school is a collaborative effort involving interventional pain, psychology, pharmacy, nutrition, and the primary care pain clinic staff. As the cornerstone of the program, the pain school stresses the biopsychosocial patient engagement model.

Program Evaluation

The VA is equipped with multiple telehealth service networks that allow for the delivery of programs, such as the pain school, a pain psychology program, and a yoga program, onsite or offsite. The VA Computerized Patient Record System (CPRS) manages electronic health records, allowing for rapid chart review and e-consults. The NF/SGVHS Pain Management Program provides about 1500 e-consults yearly. The CPRS includes templates with pain metrics to help PCPs deliver pain care more efficiently and evaluate performance measures. This system also allows for the capture of data to track improvements in the care of the veterans served.

From 2012 to 2017, more than 5000 NF/SGVHS patients were weaned from opioids. Overall, there was an 87% reduction in patients receiving opioids ( ≥ 100-mg MEDDs) within the NF/SGVHS, which is significantly more than the 49% seen nationally across the VHA (Figure 2). Percent reduction was calculated by taking the difference in number of patients receiving opioids in 2012 and 2017, dividing by the number of patients receiving opioids in 2012 and multiplying by 100. The largest proportion of opioid dose reductions for NF/SGVHS and VHA patients, respectively, were seen in 300-mg to 399-mg MEDDs (95% vs 67%, respectively); followed by ≥ 400-mg MEDDs (94% vs 71%, respectively); 200-mg to 299-mg MEDDs (91% vs 58%, respectively); and 100-mg to 199-mg MEDDs (84% vs 40%, respectively). When examining NF/SGVHS trends over time, there has been a consistent decline in patients prescribed opioids (18 223 in 2012 compared with 12 877 in 2017) with similar trends in benzodiazepine-opioid combination therapy (2694 in 2012 compared with 833 in 2017) (Figure 3).

Similar declines are seen when patients are stratified by the MEDD (Figure 4). From 2012 to 2017, 92% of the patients were successfully tapered off doses ≥ 400-mg MEDD (2012, n = 72; 2017, n = 6), and tapered off 300-mg to 399-mg MEDD (2012, n = 107; 2017, n = 5); 95% were tapered off 200-mg to 299-mg MEDD (2012, n = 262; 2017, n = 22); and 86% were tapered off 100-mg to 199-mg MEDD (2012, n = 876; 2017; n = 127).

Conclusion

Successful integration of primary care with mental health and addiction services is paramount to aggressively taper patients with chronic pain from opioids. There is evidence that drug dependence and chronic pain should be treated like other chronic illness.²⁰ Both chronic pain and addiction can be treated with a multidimensional self-management approach. In view of the high incidence of mental health and addiction associated with opioid use, it makes sense that an integrated, 1-stop pain and addiction clinic that understands and addresses both issues is more likely to improve patient outcomes.

Acknowledgments

This material is the result of work supported by the resources and facilities at the North Florida/South Georgia Veterans Health System, Geriatric Research Education Clinical Center in Gainesville, Florida.

The “opioid epidemic” has become, perhaps, the most talked-about health crisis of the 21st century. It is a pervasive topic of discussion in the health literature and beyond, written about on the front pages of national newspapers and even mentioned in presidential state-of-the-union addresses.

As practicing physicians, we are all too familiar with the ills of chronic opioid use and have dealt with the implications of the crisis long before the issue attracted the public’s attention. In many ways, we have felt alone in bearing the burdens of caring for patients on chronic controlled substances. Until this point it has been our sacred duty to determine which patients are truly in need of those medications, and which are merely dependent on or – even worse – abusing them.

Health care providers have been largely blamed for the creation of this crisis, but we are not alone. Responsibility must also be shared by the pharmaceutical industry, health insurers, and even the government. Marketing practices, inadequate coverage of pain-relieving procedures and rehabilitation, and poorly-conceived drug policies have created an environment where it has been far too difficult to provide appropriate care for patients with chronic pain. As a result, patients who may have had an alternative to opioids were still started on these medications, and we – their physicians – have been left alone to manage the outcome.

Recently, however, health policy and public awareness have signaled a dramatic shift in the management of long-term pain medication. Suddenly, prevention of opioid use and abuse has become a national priority. Significant legislation has been enacted on national, state, and local levels, and parties who are perceived to be responsible for the crisis are being held to task. For example, in August a landmark legal case was decided in an Oklahoma district court. Johnson & Johnson Pharmaceuticals was found guilty of promoting drug addiction through false and misleading marketing and was thus ordered to pay $572 million to the state to fund drug rehabilitation programs. This is likely a harbinger of many more such decisions to come, and the industry as a whole is bracing for the worst.

Physician prescribing practices are also being carefully scrutinized by the DEA, and a significant number of new “checks and balances” have been put in place to address dependence and addiction concerns. Unfortunately, as with all sweeping reform programs, there are good – and not-so-good – aspects to these changes. In many ways, the new tools at our disposal are a powerful way of mitigating drug dependence and diversion while protecting the sanctity of our “prescription pads.” Yet, as with so many other government mandates, we are burdened with the onus of complying with the new mandates for each and every opioid prescription, while our EHRs provide little help. This means more “clicks” for us, which can feel quite burdensome. It doesn’t need to be this way. Below are two straightforward things that can and should occur in order for providers to feel unburdened and to fully embrace the changes.
 

PDMP integration

One of the major ways of controlling prescription opioid abuse is through effective monitoring. Forty-nine of the 50 U.S. states have developed Prescription Drug Monitoring Programs (PDMPs), with Missouri being the only holdout (due to the politics of individual privacy concerns and conflation with gun control legislation). Most – though not all – of the states with a PDMP also mandate that physicians query a database prior to prescribing controlled substances. While noble and helpful in principle, querying a PDMP can be cumbersome, and the process is rarely integrated into the EHR workflow. Instead, physicians typically need to login to a separate website and manually transpose patient data to search the database. While most states have offered to subsidize PDMP integration with electronic records, EHR vendors have been very slow to develop the capability, leaving most physicians with no choice but to continue the aforementioned workflow. That is, if they comply at all; many well-meaning physicians have told us that they find themselves too harried to use the PDMP consistently. This reduces the value of these databases and places the physicians at significant risk. In some states, failure to query the database can lead to loss of a doctor’s medical license. It is high time that EHR vendors step up and integrate with every state’s prescription drug database.

Electronic prescribing of controlled substances

The other major milestone in prescription opioid management is the electronic prescribing of controlled substances (EPCS). This received national priority when the SUPPORT for Patients and Communities Act was signed into federal law in October of 2018. Included in this act is a requirement that, by January of 2021, all controlled substance prescriptions covered under Medicare Part D be sent electronically. Taking this as inspiration, many states and private companies have adopted more aggressive policies, choosing to implement electronic prescription requirements prior to the 2021 deadline. In Pennsylvania, where we practice, an EPCS requirement goes into effect in October of this year (2019). National pharmacy chains have also taken a more proactive approach. Walmart, for example, has decided that it will require EPCS nationwide in all of its stores beginning in January of 2020.

Essentially physicians have no choice – if they plan to continue to prescribe controlled substances, they will need to begin doing so electronically. Unfortunately, this may not be a straightforward process. While most EHRs offer some sort of EPCS solution, it is typically far from user friendly. Setting up EPCS can be costly and incredibly time consuming, and the procedure of actually submitting controlled prescriptions can be onerous and add many extra clicks. If vendors are serious about assisting in solving the opioid crisis, they need to make streamlining the steps of EPCS a high priority.
 

A prescription for success

As with so many other topics we’ve written about, we face an ever-increasing burden to provide quality patient care while complying with cumbersome and often unfunded external mandates. In the case of the opioid crisis, we believe we can do better. Our prescription for success? Streamlined workflow, smarter EHRs, and fewer clicks. There is no question that physicians and patients will benefit from effective implementation of the new tools at our disposal, but we need EHR vendors to step up and help carry the load.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

The “opioid epidemic” has become, perhaps, the most talked-about health crisis of the 21st century. It is a pervasive topic of discussion in the health literature and beyond, written about on the front pages of national newspapers and even mentioned in presidential state-of-the-union addresses.

As practicing physicians, we are all too familiar with the ills of chronic opioid use and have dealt with the implications of the crisis long before the issue attracted the public’s attention. In many ways, we have felt alone in bearing the burdens of caring for patients on chronic controlled substances. Until this point it has been our sacred duty to determine which patients are truly in need of those medications, and which are merely dependent on or – even worse – abusing them.

Health care providers have been largely blamed for the creation of this crisis, but we are not alone. Responsibility must also be shared by the pharmaceutical industry, health insurers, and even the government. Marketing practices, inadequate coverage of pain-relieving procedures and rehabilitation, and poorly-conceived drug policies have created an environment where it has been far too difficult to provide appropriate care for patients with chronic pain. As a result, patients who may have had an alternative to opioids were still started on these medications, and we – their physicians – have been left alone to manage the outcome.

Recently, however, health policy and public awareness have signaled a dramatic shift in the management of long-term pain medication. Suddenly, prevention of opioid use and abuse has become a national priority. Significant legislation has been enacted on national, state, and local levels, and parties who are perceived to be responsible for the crisis are being held to task. For example, in August a landmark legal case was decided in an Oklahoma district court. Johnson & Johnson Pharmaceuticals was found guilty of promoting drug addiction through false and misleading marketing and was thus ordered to pay $572 million to the state to fund drug rehabilitation programs. This is likely a harbinger of many more such decisions to come, and the industry as a whole is bracing for the worst.

Physician prescribing practices are also being carefully scrutinized by the DEA, and a significant number of new “checks and balances” have been put in place to address dependence and addiction concerns. Unfortunately, as with all sweeping reform programs, there are good – and not-so-good – aspects to these changes. In many ways, the new tools at our disposal are a powerful way of mitigating drug dependence and diversion while protecting the sanctity of our “prescription pads.” Yet, as with so many other government mandates, we are burdened with the onus of complying with the new mandates for each and every opioid prescription, while our EHRs provide little help. This means more “clicks” for us, which can feel quite burdensome. It doesn’t need to be this way. Below are two straightforward things that can and should occur in order for providers to feel unburdened and to fully embrace the changes.
 

PDMP integration

One of the major ways of controlling prescription opioid abuse is through effective monitoring. Forty-nine of the 50 U.S. states have developed Prescription Drug Monitoring Programs (PDMPs), with Missouri being the only holdout (due to the politics of individual privacy concerns and conflation with gun control legislation). Most – though not all – of the states with a PDMP also mandate that physicians query a database prior to prescribing controlled substances. While noble and helpful in principle, querying a PDMP can be cumbersome, and the process is rarely integrated into the EHR workflow. Instead, physicians typically need to login to a separate website and manually transpose patient data to search the database. While most states have offered to subsidize PDMP integration with electronic records, EHR vendors have been very slow to develop the capability, leaving most physicians with no choice but to continue the aforementioned workflow. That is, if they comply at all; many well-meaning physicians have told us that they find themselves too harried to use the PDMP consistently. This reduces the value of these databases and places the physicians at significant risk. In some states, failure to query the database can lead to loss of a doctor’s medical license. It is high time that EHR vendors step up and integrate with every state’s prescription drug database.

Electronic prescribing of controlled substances

The other major milestone in prescription opioid management is the electronic prescribing of controlled substances (EPCS). This received national priority when the SUPPORT for Patients and Communities Act was signed into federal law in October of 2018. Included in this act is a requirement that, by January of 2021, all controlled substance prescriptions covered under Medicare Part D be sent electronically. Taking this as inspiration, many states and private companies have adopted more aggressive policies, choosing to implement electronic prescription requirements prior to the 2021 deadline. In Pennsylvania, where we practice, an EPCS requirement goes into effect in October of this year (2019). National pharmacy chains have also taken a more proactive approach. Walmart, for example, has decided that it will require EPCS nationwide in all of its stores beginning in January of 2020.

Essentially physicians have no choice – if they plan to continue to prescribe controlled substances, they will need to begin doing so electronically. Unfortunately, this may not be a straightforward process. While most EHRs offer some sort of EPCS solution, it is typically far from user friendly. Setting up EPCS can be costly and incredibly time consuming, and the procedure of actually submitting controlled prescriptions can be onerous and add many extra clicks. If vendors are serious about assisting in solving the opioid crisis, they need to make streamlining the steps of EPCS a high priority.
 

A prescription for success

As with so many other topics we’ve written about, we face an ever-increasing burden to provide quality patient care while complying with cumbersome and often unfunded external mandates. In the case of the opioid crisis, we believe we can do better. Our prescription for success? Streamlined workflow, smarter EHRs, and fewer clicks. There is no question that physicians and patients will benefit from effective implementation of the new tools at our disposal, but we need EHR vendors to step up and help carry the load.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

The “opioid epidemic” has become, perhaps, the most talked-about health crisis of the 21st century. It is a pervasive topic of discussion in the health literature and beyond, written about on the front pages of national newspapers and even mentioned in presidential state-of-the-union addresses.

As practicing physicians, we are all too familiar with the ills of chronic opioid use and have dealt with the implications of the crisis long before the issue attracted the public’s attention. In many ways, we have felt alone in bearing the burdens of caring for patients on chronic controlled substances. Until this point it has been our sacred duty to determine which patients are truly in need of those medications, and which are merely dependent on or – even worse – abusing them.

Health care providers have been largely blamed for the creation of this crisis, but we are not alone. Responsibility must also be shared by the pharmaceutical industry, health insurers, and even the government. Marketing practices, inadequate coverage of pain-relieving procedures and rehabilitation, and poorly-conceived drug policies have created an environment where it has been far too difficult to provide appropriate care for patients with chronic pain. As a result, patients who may have had an alternative to opioids were still started on these medications, and we – their physicians – have been left alone to manage the outcome.

Recently, however, health policy and public awareness have signaled a dramatic shift in the management of long-term pain medication. Suddenly, prevention of opioid use and abuse has become a national priority. Significant legislation has been enacted on national, state, and local levels, and parties who are perceived to be responsible for the crisis are being held to task. For example, in August a landmark legal case was decided in an Oklahoma district court. Johnson & Johnson Pharmaceuticals was found guilty of promoting drug addiction through false and misleading marketing and was thus ordered to pay $572 million to the state to fund drug rehabilitation programs. This is likely a harbinger of many more such decisions to come, and the industry as a whole is bracing for the worst.

Physician prescribing practices are also being carefully scrutinized by the DEA, and a significant number of new “checks and balances” have been put in place to address dependence and addiction concerns. Unfortunately, as with all sweeping reform programs, there are good – and not-so-good – aspects to these changes. In many ways, the new tools at our disposal are a powerful way of mitigating drug dependence and diversion while protecting the sanctity of our “prescription pads.” Yet, as with so many other government mandates, we are burdened with the onus of complying with the new mandates for each and every opioid prescription, while our EHRs provide little help. This means more “clicks” for us, which can feel quite burdensome. It doesn’t need to be this way. Below are two straightforward things that can and should occur in order for providers to feel unburdened and to fully embrace the changes.
 

PDMP integration

One of the major ways of controlling prescription opioid abuse is through effective monitoring. Forty-nine of the 50 U.S. states have developed Prescription Drug Monitoring Programs (PDMPs), with Missouri being the only holdout (due to the politics of individual privacy concerns and conflation with gun control legislation). Most – though not all – of the states with a PDMP also mandate that physicians query a database prior to prescribing controlled substances. While noble and helpful in principle, querying a PDMP can be cumbersome, and the process is rarely integrated into the EHR workflow. Instead, physicians typically need to login to a separate website and manually transpose patient data to search the database. While most states have offered to subsidize PDMP integration with electronic records, EHR vendors have been very slow to develop the capability, leaving most physicians with no choice but to continue the aforementioned workflow. That is, if they comply at all; many well-meaning physicians have told us that they find themselves too harried to use the PDMP consistently. This reduces the value of these databases and places the physicians at significant risk. In some states, failure to query the database can lead to loss of a doctor’s medical license. It is high time that EHR vendors step up and integrate with every state’s prescription drug database.

Electronic prescribing of controlled substances

The other major milestone in prescription opioid management is the electronic prescribing of controlled substances (EPCS). This received national priority when the SUPPORT for Patients and Communities Act was signed into federal law in October of 2018. Included in this act is a requirement that, by January of 2021, all controlled substance prescriptions covered under Medicare Part D be sent electronically. Taking this as inspiration, many states and private companies have adopted more aggressive policies, choosing to implement electronic prescription requirements prior to the 2021 deadline. In Pennsylvania, where we practice, an EPCS requirement goes into effect in October of this year (2019). National pharmacy chains have also taken a more proactive approach. Walmart, for example, has decided that it will require EPCS nationwide in all of its stores beginning in January of 2020.

Essentially physicians have no choice – if they plan to continue to prescribe controlled substances, they will need to begin doing so electronically. Unfortunately, this may not be a straightforward process. While most EHRs offer some sort of EPCS solution, it is typically far from user friendly. Setting up EPCS can be costly and incredibly time consuming, and the procedure of actually submitting controlled prescriptions can be onerous and add many extra clicks. If vendors are serious about assisting in solving the opioid crisis, they need to make streamlining the steps of EPCS a high priority.
 

A prescription for success

As with so many other topics we’ve written about, we face an ever-increasing burden to provide quality patient care while complying with cumbersome and often unfunded external mandates. In the case of the opioid crisis, we believe we can do better. Our prescription for success? Streamlined workflow, smarter EHRs, and fewer clicks. There is no question that physicians and patients will benefit from effective implementation of the new tools at our disposal, but we need EHR vendors to step up and help carry the load.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

Near completion of my rounds at a residential substance abuse treatment center, my last patient was a 32-year-old mother. She reported she was there because her newborn had tested positive for cocaine. She stated, “I want to do better. I thought this pregnancy would change things, but it was so hard to stop.” Her admission made me reflect on a proposed bill in my state of Tennessee called the Fetal Assault Bill, which if put into law would affect women such as my patient and her newborn child.

The Tennessee Fetal Assault Bill was originally enacted in 2014, expired in 2016, and failed to pass in 2017. The bill was reintroduced for consideration in February 2019. If enacted, it would subject a woman to prosecution if her illegal use of a substance while pregnant causes her child to be born addicted to or harmed by that drug. However, the mother is protected from prosecution if she “enrolled in an addiction recovery program before the child is born, remained in the program after delivery, and successfully completed the program, regardless of whether the child was born addicted to or harmed by the narcotic drug.”¹ This bill is based on the premise that the unborn fetus has the same rights as a born child, and that the threat of incarceration will deter pregnant women from using illegal substances while pregnant.

Pregnant women may enroll in a drug treatment program prior to delivery to avoid prosecution; however, there is a paucity of addiction treatment centers available to pregnant women. Moreover, there is limited access in areas where babies are more likely to be born affected by the use of illegal substances. Few provisions have been made to address the additional barriers to treatment these women face, such as a lack of insurance or underinsurance for rehabilitation treatment, lack of transportation, and limited finances. Additional barriers include limited social supports, the need for childcare arrangements for existing children, and social stigma.

A 2017 report by Amnesty International regarding the original enactment of the Tennessee Fetal Assault Bill in 2014 noted some mothers who used illegal substances were afraid of prosecution.² This fear caused some to delay prenatal care or evade social services in order to prevent being reported. According to Amnesty International, laws such as the one proposed in Tennessee often show disparities in how they are implemented. Research shows that women of lower socioeconomic status and minorities tend to receive more frequent drug testing and harsher punishments.³

There are benefits to dedicating more resources to addiction treatment and other social services for pregnant women who use illegal substances. Reports show that mothers are motivated to stay abstinent in treatment centers where they are housed with their children. This model of treatment is more cost-effective than incarceration, which includes legal costs, prison costs, and foster care bills. Moreover, a possible felony charge may hinder a woman’s job opportunities and further compound her problems and those of her infant.

In the light of these benefits, instead of re-enacting the 2014 law, which did not yield any conclusive benefits for newborns or mothers who used illegal substances, alternatives should be attempted. Early identification of and interventions for women who are at risk for substance use while pregnant should be implemented. Practical, accessible support services will encourage sobriety, prevent fetal exposure to illegal substances, and improve child health outcomes. Research shows that substance abuse treatment during pregnancy reduces the risk of harm before birth and improves the quality of parental care after birth.⁴ Legislators and clinicians should emphasize improving access to treatment, expanding integrative addiction treatment centers, and encouraging self-reporting early in pregnancy. This goal cannot be achieved with an emphasis on incarcerating mothers.

Near completion of my rounds at a residential substance abuse treatment center, my last patient was a 32-year-old mother. She reported she was there because her newborn had tested positive for cocaine. She stated, “I want to do better. I thought this pregnancy would change things, but it was so hard to stop.” Her admission made me reflect on a proposed bill in my state of Tennessee called the Fetal Assault Bill, which if put into law would affect women such as my patient and her newborn child.

The Tennessee Fetal Assault Bill was originally enacted in 2014, expired in 2016, and failed to pass in 2017. The bill was reintroduced for consideration in February 2019. If enacted, it would subject a woman to prosecution if her illegal use of a substance while pregnant causes her child to be born addicted to or harmed by that drug. However, the mother is protected from prosecution if she “enrolled in an addiction recovery program before the child is born, remained in the program after delivery, and successfully completed the program, regardless of whether the child was born addicted to or harmed by the narcotic drug.”¹ This bill is based on the premise that the unborn fetus has the same rights as a born child, and that the threat of incarceration will deter pregnant women from using illegal substances while pregnant.

Pregnant women may enroll in a drug treatment program prior to delivery to avoid prosecution; however, there is a paucity of addiction treatment centers available to pregnant women. Moreover, there is limited access in areas where babies are more likely to be born affected by the use of illegal substances. Few provisions have been made to address the additional barriers to treatment these women face, such as a lack of insurance or underinsurance for rehabilitation treatment, lack of transportation, and limited finances. Additional barriers include limited social supports, the need for childcare arrangements for existing children, and social stigma.

A 2017 report by Amnesty International regarding the original enactment of the Tennessee Fetal Assault Bill in 2014 noted some mothers who used illegal substances were afraid of prosecution.² This fear caused some to delay prenatal care or evade social services in order to prevent being reported. According to Amnesty International, laws such as the one proposed in Tennessee often show disparities in how they are implemented. Research shows that women of lower socioeconomic status and minorities tend to receive more frequent drug testing and harsher punishments.³

There are benefits to dedicating more resources to addiction treatment and other social services for pregnant women who use illegal substances. Reports show that mothers are motivated to stay abstinent in treatment centers where they are housed with their children. This model of treatment is more cost-effective than incarceration, which includes legal costs, prison costs, and foster care bills. Moreover, a possible felony charge may hinder a woman’s job opportunities and further compound her problems and those of her infant.

In the light of these benefits, instead of re-enacting the 2014 law, which did not yield any conclusive benefits for newborns or mothers who used illegal substances, alternatives should be attempted. Early identification of and interventions for women who are at risk for substance use while pregnant should be implemented. Practical, accessible support services will encourage sobriety, prevent fetal exposure to illegal substances, and improve child health outcomes. Research shows that substance abuse treatment during pregnancy reduces the risk of harm before birth and improves the quality of parental care after birth.⁴ Legislators and clinicians should emphasize improving access to treatment, expanding integrative addiction treatment centers, and encouraging self-reporting early in pregnancy. This goal cannot be achieved with an emphasis on incarcerating mothers.

Near completion of my rounds at a residential substance abuse treatment center, my last patient was a 32-year-old mother. She reported she was there because her newborn had tested positive for cocaine. She stated, “I want to do better. I thought this pregnancy would change things, but it was so hard to stop.” Her admission made me reflect on a proposed bill in my state of Tennessee called the Fetal Assault Bill, which if put into law would affect women such as my patient and her newborn child.

The Tennessee Fetal Assault Bill was originally enacted in 2014, expired in 2016, and failed to pass in 2017. The bill was reintroduced for consideration in February 2019. If enacted, it would subject a woman to prosecution if her illegal use of a substance while pregnant causes her child to be born addicted to or harmed by that drug. However, the mother is protected from prosecution if she “enrolled in an addiction recovery program before the child is born, remained in the program after delivery, and successfully completed the program, regardless of whether the child was born addicted to or harmed by the narcotic drug.”¹ This bill is based on the premise that the unborn fetus has the same rights as a born child, and that the threat of incarceration will deter pregnant women from using illegal substances while pregnant.

Pregnant women may enroll in a drug treatment program prior to delivery to avoid prosecution; however, there is a paucity of addiction treatment centers available to pregnant women. Moreover, there is limited access in areas where babies are more likely to be born affected by the use of illegal substances. Few provisions have been made to address the additional barriers to treatment these women face, such as a lack of insurance or underinsurance for rehabilitation treatment, lack of transportation, and limited finances. Additional barriers include limited social supports, the need for childcare arrangements for existing children, and social stigma.

A 2017 report by Amnesty International regarding the original enactment of the Tennessee Fetal Assault Bill in 2014 noted some mothers who used illegal substances were afraid of prosecution.² This fear caused some to delay prenatal care or evade social services in order to prevent being reported. According to Amnesty International, laws such as the one proposed in Tennessee often show disparities in how they are implemented. Research shows that women of lower socioeconomic status and minorities tend to receive more frequent drug testing and harsher punishments.³

There are benefits to dedicating more resources to addiction treatment and other social services for pregnant women who use illegal substances. Reports show that mothers are motivated to stay abstinent in treatment centers where they are housed with their children. This model of treatment is more cost-effective than incarceration, which includes legal costs, prison costs, and foster care bills. Moreover, a possible felony charge may hinder a woman’s job opportunities and further compound her problems and those of her infant.

In the light of these benefits, instead of re-enacting the 2014 law, which did not yield any conclusive benefits for newborns or mothers who used illegal substances, alternatives should be attempted. Early identification of and interventions for women who are at risk for substance use while pregnant should be implemented. Practical, accessible support services will encourage sobriety, prevent fetal exposure to illegal substances, and improve child health outcomes. Research shows that substance abuse treatment during pregnancy reduces the risk of harm before birth and improves the quality of parental care after birth.⁴ Legislators and clinicians should emphasize improving access to treatment, expanding integrative addiction treatment centers, and encouraging self-reporting early in pregnancy. This goal cannot be achieved with an emphasis on incarcerating mothers.

The first death to occur in a patient with severe lung illness associated with e-cigarette product use has been reported in Illinois, officials announced at a Centers for Disease Control and Prevention telebriefing.

The cause for the mysterious lung illnesses has not been determined, but an infectious disease does not appear to be implicated. As of yesterday, 193 potential cases have been identified in 22 states since June 28.

No specific product has been implicated in all cases, and it is unclear if there is a common cause or if these are several diseases with a similar presentation.

Wisconsin and Illinois have asked the CDC to directly assist them in their investigations of cases. Other states are handling their own investigations. Further information is available from the CDC at cdc.gov/e-cigarettes.

There have been 22 cases of the illness in Illinois and an additional 12 individuals are being evaluated as possible cases, according to Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist, Illinois Department of Public Health.

Illinois is working with the CDC and the Food and Drug Administration to investigate devices that affected patients have used. No specific product has been implicated across all cases; all patients have reported vaping in recent months Several patients in Illinois have reported using tetrahydrocannabinol (THC) product oils, but Dr. Layden reiterated the investigations are reliant on information reported by affected patients only.

Mitch Zeller, JD, director, Center for Tobacco Products at the FDA, said product samples from a number of states are being evaluated to determine their contents. The FDA is examining samples sent and trying to identify product contents.

The cases reported to date have been in adults aged 17-38 years and have occurred primarily men. The investigation is in a relatively early stage and is working with incomplete case reports. These will become standardized to include more specific information, such as the name of the product, where it was purchased, and whether it was used as intended or whether other products were added, he said.

As e-cigarettes are not a new product, it’s possible that cases of this illness has been occurring but that the link was not recognized, and the cases were neither captured nor reported, said Brian King, PhD, MPH, deputy director, Research Translation, Office on Smoking and Health, CDC. He noted that e-cigarettes may contain “a variety of constituents that could be problematic in terms of pulmonary illness,” such as ingredients in certain flavorings and ultrafine particulates.

The agencies are now trying to harmonize reporting across all states so cases can be evaluated in a more standardized way. Information on standardized reporting on a national level will be issued in the next few days, according to the CDC.

The CDC notified U.S. health care systems and clinicians about the illnesses and what to watch for via a Clinician Outreach and Communication Activity Clinical Action Message.

In general, patients have reported a gradual onset of symptoms including shortness of breath or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.
 

jremaly@mdedge.com

The first death to occur in a patient with severe lung illness associated with e-cigarette product use has been reported in Illinois, officials announced at a Centers for Disease Control and Prevention telebriefing.

The cause for the mysterious lung illnesses has not been determined, but an infectious disease does not appear to be implicated. As of yesterday, 193 potential cases have been identified in 22 states since June 28.

No specific product has been implicated in all cases, and it is unclear if there is a common cause or if these are several diseases with a similar presentation.

Wisconsin and Illinois have asked the CDC to directly assist them in their investigations of cases. Other states are handling their own investigations. Further information is available from the CDC at cdc.gov/e-cigarettes.

There have been 22 cases of the illness in Illinois and an additional 12 individuals are being evaluated as possible cases, according to Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist, Illinois Department of Public Health.

Illinois is working with the CDC and the Food and Drug Administration to investigate devices that affected patients have used. No specific product has been implicated across all cases; all patients have reported vaping in recent months Several patients in Illinois have reported using tetrahydrocannabinol (THC) product oils, but Dr. Layden reiterated the investigations are reliant on information reported by affected patients only.

Mitch Zeller, JD, director, Center for Tobacco Products at the FDA, said product samples from a number of states are being evaluated to determine their contents. The FDA is examining samples sent and trying to identify product contents.

The cases reported to date have been in adults aged 17-38 years and have occurred primarily men. The investigation is in a relatively early stage and is working with incomplete case reports. These will become standardized to include more specific information, such as the name of the product, where it was purchased, and whether it was used as intended or whether other products were added, he said.

As e-cigarettes are not a new product, it’s possible that cases of this illness has been occurring but that the link was not recognized, and the cases were neither captured nor reported, said Brian King, PhD, MPH, deputy director, Research Translation, Office on Smoking and Health, CDC. He noted that e-cigarettes may contain “a variety of constituents that could be problematic in terms of pulmonary illness,” such as ingredients in certain flavorings and ultrafine particulates.

The agencies are now trying to harmonize reporting across all states so cases can be evaluated in a more standardized way. Information on standardized reporting on a national level will be issued in the next few days, according to the CDC.

The CDC notified U.S. health care systems and clinicians about the illnesses and what to watch for via a Clinician Outreach and Communication Activity Clinical Action Message.

In general, patients have reported a gradual onset of symptoms including shortness of breath or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.
 

jremaly@mdedge.com

The first death to occur in a patient with severe lung illness associated with e-cigarette product use has been reported in Illinois, officials announced at a Centers for Disease Control and Prevention telebriefing.

The cause for the mysterious lung illnesses has not been determined, but an infectious disease does not appear to be implicated. As of yesterday, 193 potential cases have been identified in 22 states since June 28.

No specific product has been implicated in all cases, and it is unclear if there is a common cause or if these are several diseases with a similar presentation.

Wisconsin and Illinois have asked the CDC to directly assist them in their investigations of cases. Other states are handling their own investigations. Further information is available from the CDC at cdc.gov/e-cigarettes.

There have been 22 cases of the illness in Illinois and an additional 12 individuals are being evaluated as possible cases, according to Jennifer Layden, MD, PhD, chief medical officer and state epidemiologist, Illinois Department of Public Health.

Illinois is working with the CDC and the Food and Drug Administration to investigate devices that affected patients have used. No specific product has been implicated across all cases; all patients have reported vaping in recent months Several patients in Illinois have reported using tetrahydrocannabinol (THC) product oils, but Dr. Layden reiterated the investigations are reliant on information reported by affected patients only.

Mitch Zeller, JD, director, Center for Tobacco Products at the FDA, said product samples from a number of states are being evaluated to determine their contents. The FDA is examining samples sent and trying to identify product contents.

The cases reported to date have been in adults aged 17-38 years and have occurred primarily men. The investigation is in a relatively early stage and is working with incomplete case reports. These will become standardized to include more specific information, such as the name of the product, where it was purchased, and whether it was used as intended or whether other products were added, he said.

As e-cigarettes are not a new product, it’s possible that cases of this illness has been occurring but that the link was not recognized, and the cases were neither captured nor reported, said Brian King, PhD, MPH, deputy director, Research Translation, Office on Smoking and Health, CDC. He noted that e-cigarettes may contain “a variety of constituents that could be problematic in terms of pulmonary illness,” such as ingredients in certain flavorings and ultrafine particulates.

The agencies are now trying to harmonize reporting across all states so cases can be evaluated in a more standardized way. Information on standardized reporting on a national level will be issued in the next few days, according to the CDC.

The CDC notified U.S. health care systems and clinicians about the illnesses and what to watch for via a Clinician Outreach and Communication Activity Clinical Action Message.

In general, patients have reported a gradual onset of symptoms including shortness of breath or chest pain that increased over days or weeks before hospital admission. Gastrointestinal symptoms including vomiting, diarrhea, and fatigue have been reported by some.
 

jremaly@mdedge.com

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

aotto@mdedge.com

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

aotto@mdedge.com

The U.S. Food and Drug Administration has proposed warnings for cigarette packs and advertisements on Aug. 15, 2019, that feature graphic, colored images illustrating the harms of smoking, but this could be subjected to legal challenge.

U.S. Food and Drug Administration

Several years ago, tobacco companies filed a lawsuit, which ultimately shut down a similar proposal.

The warnings focus on lesser-known complications – including diabetes, cataracts, gangrene, stroke, bladder cancer, erectile dysfunction, and obstructive pulmonary disease – and would take up the top half of the front and back of cigarette packs, and at least the top 20% of print advertisements. Each pack and ad would be required to carry 1 of the 13 proposed warnings, according to the announcement.

The approach would be similar to, but not as aggressive as Canada’s. For years, cigarettes packs sold in Canada have included disturbing photographs of diseased lungs, rotted teeth, and dying patients. The lasting impact of such imagery has been demonstrated in the literature (for example, Am J Prev Med. 2007 Mar;32[3]:202-9).

The new proposal is the FDA’s second attempt to enact something comparable in the United States, after being directed to do so by the Tobacco Control Act of 2009.

The first effort to add strong, illustrated warnings to cigarette packs was widely backed by medical groups, but challenged in the courts by R.J. Reynolds and other tobacco companies, and blocked on appeal in 2012 as an abridgment of commercial free speech. The federal government dropped the case in 2013.

The American Lung Association and other public health groups subsequently sued the FDA in 2016 to enact the Tobacco Act mandate. Subsequently, a federal judge ordered the agency to publish a new rule by August 2019, and issue a final rule in March 2020.

This time around, the FDA “took the necessary time to get these new proposed warnings right ... based on – and within the limits of – both science and the law,” the agency said. The new images, though graphic, are less disturbing than those used in Canada and the agency’s previous proposals, which included an apparent corpse with a sternotomy. The 1-800-Quit-Now cessation hotline number, which was a sticking point in the 2012 ruling, has also been dropped.

When asked about the new efforts, R.J. Reynolds spokesperson Kaelan Hollon said, “We are carefully reviewing FDA’s latest proposal for graphic warnings on cigarettes. We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers.”

Warnings on U.S. cigarettes haven’t changed since 1984, when the risks of lung cancer, heart disease, emphysema, and pregnancy complications were added to the side of cigarette packs. With time, the FDA said the surgeon general’s warnings have become “virtually invisible” to consumers.

The American Lung Association, American Academy of Pediatrics, and other plaintiffs in the 2016 suit called the new proposal a “dramatic improvement” over the current situation and “long overdue” in a joint statement on Aug. 15.

Although rates have declined substantially in recent decades, about 34.3 million U.S. adults and almost 1.4 million teenagers still smoke. The habit kills about a half million Americans every year, at a health cost of more than $300 billion, the FDA said.

Comments on the proposed rule are being accepted through Oct. 15. The agency is open to suggestions for alternative text and images.
 

aotto@mdedge.com

The U.S. Preventive Services Task Force recommends for the first time that primary care clinicians screen adults aged 18 years and older for illicit drug use, according to a draft recommendation statement now available for public comment.

andrewsafonov/Thinkstock

The statement defines illicit drug use as “use of illegal drugs and the nonmedical use of prescription psychoactive medications (i.e., use for reasons, for duration, in amounts, or with frequency other than prescribed or use by persons other than the prescribed individual).”

The guidelines do not apply to individuals younger than 18 years, for whom the USPSTF found insufficient evidence to recommend routine screening, or to adults currently diagnosed or in treatment for a drug use disorder.

In the draft recommendation statement, available online, the USPSTF noted that several screening tools are available for use in primary care practices, including the BSTAD (Brief Screener for Tobacco, Alcohol, and Other Drugs) that consists of six questions. The task force noted that they have found “adequate evidence” that these screening tools can detect illicit drug use. In addition, they wrote that no studies offer evidence of benefits versus harms of these screening tools, and evidence of harms associated with screening are limited.

Screening intervals can be simplified by screening young adults whenever they seek medical services and when clinicians suspect illicit drug use, the USPSTF said.

When the draft recommendation is finalized, it will replace the 2008 recommendation, which found insufficient evidence for screening in adults, as well as in adolescents. New evidence since 2008 supports the value of screening for adults aged 18 years and older, including pregnant and postpartum women.

The draft recommendations are based on the results of two systematic evidence reviews that assessed the accuracy and harms of routine illicit drug use screening. The USPSTF’s review included 12 studies on the accuracy of 15 screening tools. Overall, the sensitivity of direct screening tools to identify “unhealthy use of ‘any drug’ (including illegal drugs and nonmedical use of prescription drugs) in the past month or year” ranged from 0.71 to 0.94, and the specificity ranged from 0.87 to 0.97.

Based on the current evidence, the USPSTF assigned drug screening for adults a grade B recommendation, defined as “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.”

For treatment, the Task Force found evidence to support strategies including pharmacotherapy with naltrexone, buprenorphine, and methadone, as well as for psychosocial interventions.

The USPSTF acknowledged that many factors may affect a clinicians’ decision of whether to implement the drug screening recommendation. “In many communities, affordable, accessible, and timely services for diagnostic assessment and treatment for patients with positive screening results are in limited supply or unaffordable. Providers should be aware of any state requirements for mandatory screening or reporting of screening results to medicolegal authorities and understand the positive and negative implications of reporting,” they wrote.

The draft recommendations also identified several research gaps including the effectiveness of screening for illicit drug use in adolescents, the optimal screening interval for all patients, the accuracy of screening tools for detecting opioids, the accuracy of screening within the same population, the benefits of naloxone as rescue therapy, and nonmedical use of other prescription drugs, as well as ways to improve access to care for those diagnosed with drug use disorders.

The draft recommendation is available for public comment until Sept. 9, 2019, at 8 p.m. EST.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

The U.S. Preventive Services Task Force recommends for the first time that primary care clinicians screen adults aged 18 years and older for illicit drug use, according to a draft recommendation statement now available for public comment.

andrewsafonov/Thinkstock

The statement defines illicit drug use as “use of illegal drugs and the nonmedical use of prescription psychoactive medications (i.e., use for reasons, for duration, in amounts, or with frequency other than prescribed or use by persons other than the prescribed individual).”

The guidelines do not apply to individuals younger than 18 years, for whom the USPSTF found insufficient evidence to recommend routine screening, or to adults currently diagnosed or in treatment for a drug use disorder.

In the draft recommendation statement, available online, the USPSTF noted that several screening tools are available for use in primary care practices, including the BSTAD (Brief Screener for Tobacco, Alcohol, and Other Drugs) that consists of six questions. The task force noted that they have found “adequate evidence” that these screening tools can detect illicit drug use. In addition, they wrote that no studies offer evidence of benefits versus harms of these screening tools, and evidence of harms associated with screening are limited.

Screening intervals can be simplified by screening young adults whenever they seek medical services and when clinicians suspect illicit drug use, the USPSTF said.

When the draft recommendation is finalized, it will replace the 2008 recommendation, which found insufficient evidence for screening in adults, as well as in adolescents. New evidence since 2008 supports the value of screening for adults aged 18 years and older, including pregnant and postpartum women.

The draft recommendations are based on the results of two systematic evidence reviews that assessed the accuracy and harms of routine illicit drug use screening. The USPSTF’s review included 12 studies on the accuracy of 15 screening tools. Overall, the sensitivity of direct screening tools to identify “unhealthy use of ‘any drug’ (including illegal drugs and nonmedical use of prescription drugs) in the past month or year” ranged from 0.71 to 0.94, and the specificity ranged from 0.87 to 0.97.

Based on the current evidence, the USPSTF assigned drug screening for adults a grade B recommendation, defined as “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.”

For treatment, the Task Force found evidence to support strategies including pharmacotherapy with naltrexone, buprenorphine, and methadone, as well as for psychosocial interventions.

The USPSTF acknowledged that many factors may affect a clinicians’ decision of whether to implement the drug screening recommendation. “In many communities, affordable, accessible, and timely services for diagnostic assessment and treatment for patients with positive screening results are in limited supply or unaffordable. Providers should be aware of any state requirements for mandatory screening or reporting of screening results to medicolegal authorities and understand the positive and negative implications of reporting,” they wrote.

The draft recommendations also identified several research gaps including the effectiveness of screening for illicit drug use in adolescents, the optimal screening interval for all patients, the accuracy of screening tools for detecting opioids, the accuracy of screening within the same population, the benefits of naloxone as rescue therapy, and nonmedical use of other prescription drugs, as well as ways to improve access to care for those diagnosed with drug use disorders.

The draft recommendation is available for public comment until Sept. 9, 2019, at 8 p.m. EST.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

The U.S. Preventive Services Task Force recommends for the first time that primary care clinicians screen adults aged 18 years and older for illicit drug use, according to a draft recommendation statement now available for public comment.

andrewsafonov/Thinkstock

The statement defines illicit drug use as “use of illegal drugs and the nonmedical use of prescription psychoactive medications (i.e., use for reasons, for duration, in amounts, or with frequency other than prescribed or use by persons other than the prescribed individual).”

The guidelines do not apply to individuals younger than 18 years, for whom the USPSTF found insufficient evidence to recommend routine screening, or to adults currently diagnosed or in treatment for a drug use disorder.

In the draft recommendation statement, available online, the USPSTF noted that several screening tools are available for use in primary care practices, including the BSTAD (Brief Screener for Tobacco, Alcohol, and Other Drugs) that consists of six questions. The task force noted that they have found “adequate evidence” that these screening tools can detect illicit drug use. In addition, they wrote that no studies offer evidence of benefits versus harms of these screening tools, and evidence of harms associated with screening are limited.

Screening intervals can be simplified by screening young adults whenever they seek medical services and when clinicians suspect illicit drug use, the USPSTF said.

When the draft recommendation is finalized, it will replace the 2008 recommendation, which found insufficient evidence for screening in adults, as well as in adolescents. New evidence since 2008 supports the value of screening for adults aged 18 years and older, including pregnant and postpartum women.

The draft recommendations are based on the results of two systematic evidence reviews that assessed the accuracy and harms of routine illicit drug use screening. The USPSTF’s review included 12 studies on the accuracy of 15 screening tools. Overall, the sensitivity of direct screening tools to identify “unhealthy use of ‘any drug’ (including illegal drugs and nonmedical use of prescription drugs) in the past month or year” ranged from 0.71 to 0.94, and the specificity ranged from 0.87 to 0.97.

Based on the current evidence, the USPSTF assigned drug screening for adults a grade B recommendation, defined as “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.”

For treatment, the Task Force found evidence to support strategies including pharmacotherapy with naltrexone, buprenorphine, and methadone, as well as for psychosocial interventions.

The USPSTF acknowledged that many factors may affect a clinicians’ decision of whether to implement the drug screening recommendation. “In many communities, affordable, accessible, and timely services for diagnostic assessment and treatment for patients with positive screening results are in limited supply or unaffordable. Providers should be aware of any state requirements for mandatory screening or reporting of screening results to medicolegal authorities and understand the positive and negative implications of reporting,” they wrote.

The draft recommendations also identified several research gaps including the effectiveness of screening for illicit drug use in adolescents, the optimal screening interval for all patients, the accuracy of screening tools for detecting opioids, the accuracy of screening within the same population, the benefits of naloxone as rescue therapy, and nonmedical use of other prescription drugs, as well as ways to improve access to care for those diagnosed with drug use disorders.

The draft recommendation is available for public comment until Sept. 9, 2019, at 8 p.m. EST.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

Despite a large increase in the number of naloxone prescriptions dispensed since 2012, too little of the drug is being made available to patients who need it, according to the Centers for Disease Control and Prevention.

Although the CDC recommends that clinicians consider prescribing naloxone, which can reverse the effects of an opioid overdose, to patients who receive high-dose opioid prescriptions, one naloxone prescription was dispensed in 2018 for every 69 such patients, according to a Vital Signs investigation published Aug. 6 in the Morbidity and Mortality Weekly Report.

Approximately 9 million more naloxone prescriptions could have been dispensed in 2018 if every patient with a high-dose opioid prescription were offered the drug, according to the agency. In addition, the rate at which naloxone is dispensed varies significantly according to region.

“Thousands of Americans are alive today thanks to the use of naloxone,” said Alex M. Azar, secretary of Health and Human Services, in a press release. “Giving people a chance to survive an opioid overdose and safely enter recovery is one of the five key pillars of our HHS strategy for ending the overdose epidemic. With help from Congress, the private sector, state, and local governments and communities, targeted access to naloxone has expanded dramatically over the last several years, but today’s CDC report is a reminder that there is much more all of us need to do to save lives.”

Investigators examined retail pharmacy data

In 2017, 47,600 (67.8%) drug overdose deaths in the United States involved opioids. For decades, emergency medical service providers have administered naloxone to patients with suspected drug overdose. A major focus of public health initiatives intended to address the opioid overdose crisis has been to increase access to naloxone through clinician prescribing and pharmacy dispensing. The CDC recommends considering prescribing naloxone to patients with a history of overdose or substance use disorder, those receiving opioid dosages of 50 morphine milligram equivalents per day or greater (that is, high-dose prescriptions), and those who are using benzodiazepines concurrently.

Investigators at the CDC examined retail pharmacy data from IQVIA, a company that maintains information on prescriptions from approximately 50,400 retail pharmacies. They extracted data from 2012 through 2018 to analyze naloxone dispensing by region, urban versus rural status, prescriber specialty, and recipient characteristics (for example, age group, sex, out-of-pocket costs, and method of payment).

Dispensations doubled from 2017 to 2018

Naloxone dispensing from retail pharmacies increased from 0.4 prescriptions per 100,000 in 2012 to 170.2 prescriptions per 100,000 in 2018. From 2017 to 2018 alone, the number of prescriptions dispensed increased by 106%.

Despite consistency among state laws, naloxone dispensation varied by region. The average rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 0.2 in the lowest quartile to 2.9 in the highest quartile. In 2018, the rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 1.5 in metropolitan counties and 1.6 in the Northeast to 1.2 in rural counties and 1.3 in the Midwest. Rural counties were nearly three times more likely to be low-dispensing counties, compared with metropolitan counties.

The rate of naloxone prescriptions per 100 high-dose opioid prescriptions also varied by provider specialty. This rate was lowest among surgeons (0.2) and highest among psychiatrists (12.9).

Most naloxone prescriptions entailed out-of-pocket costs. About 71% of prescriptions paid for by Medicare entailed out-of-pocket costs, compared with 43.8% of prescriptions paid for by Medicaid, and 41.5% of prescriptions paid for by commercial insurance.

Centers for Disease Control and Prevention

More can be done

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths,” said Robert R. Redfield, MD, director of the CDC, in a press release. “The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention. As we aggressively confront what is the public health crisis of our time, CDC will continue to stress with health care providers the benefit of making this overdose-reversing medicine available to patients.”

“While we’ve seen these important increases [in naloxone prescriptions], we are not as far along as we’d like to be,” said Anne Schuchat, MD, principal deputy director of the CDC, during a press conference. “Cost is one of the issues, but I think awareness is another.” These data should prompt pharmacies to make sure that they stock naloxone and remind clinicians to consider naloxone when they prescribe opioids, she added. Patients and their family members should be aware of naloxone and ask their health care providers about it. “We’d really like to see the increase [in naloxone prescriptions] move much more rapidly,” she concluded.

The investigators disclosed no potential conflicts of interest.

egreb@mdedge.com

SOURCE: Guy GP et al. MMWR Morb Mortal Wkly Rep. 2019 Aug 6.

Despite a large increase in the number of naloxone prescriptions dispensed since 2012, too little of the drug is being made available to patients who need it, according to the Centers for Disease Control and Prevention.

Although the CDC recommends that clinicians consider prescribing naloxone, which can reverse the effects of an opioid overdose, to patients who receive high-dose opioid prescriptions, one naloxone prescription was dispensed in 2018 for every 69 such patients, according to a Vital Signs investigation published Aug. 6 in the Morbidity and Mortality Weekly Report.

Approximately 9 million more naloxone prescriptions could have been dispensed in 2018 if every patient with a high-dose opioid prescription were offered the drug, according to the agency. In addition, the rate at which naloxone is dispensed varies significantly according to region.

“Thousands of Americans are alive today thanks to the use of naloxone,” said Alex M. Azar, secretary of Health and Human Services, in a press release. “Giving people a chance to survive an opioid overdose and safely enter recovery is one of the five key pillars of our HHS strategy for ending the overdose epidemic. With help from Congress, the private sector, state, and local governments and communities, targeted access to naloxone has expanded dramatically over the last several years, but today’s CDC report is a reminder that there is much more all of us need to do to save lives.”

Investigators examined retail pharmacy data

In 2017, 47,600 (67.8%) drug overdose deaths in the United States involved opioids. For decades, emergency medical service providers have administered naloxone to patients with suspected drug overdose. A major focus of public health initiatives intended to address the opioid overdose crisis has been to increase access to naloxone through clinician prescribing and pharmacy dispensing. The CDC recommends considering prescribing naloxone to patients with a history of overdose or substance use disorder, those receiving opioid dosages of 50 morphine milligram equivalents per day or greater (that is, high-dose prescriptions), and those who are using benzodiazepines concurrently.

Investigators at the CDC examined retail pharmacy data from IQVIA, a company that maintains information on prescriptions from approximately 50,400 retail pharmacies. They extracted data from 2012 through 2018 to analyze naloxone dispensing by region, urban versus rural status, prescriber specialty, and recipient characteristics (for example, age group, sex, out-of-pocket costs, and method of payment).

Dispensations doubled from 2017 to 2018

Naloxone dispensing from retail pharmacies increased from 0.4 prescriptions per 100,000 in 2012 to 170.2 prescriptions per 100,000 in 2018. From 2017 to 2018 alone, the number of prescriptions dispensed increased by 106%.

Despite consistency among state laws, naloxone dispensation varied by region. The average rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 0.2 in the lowest quartile to 2.9 in the highest quartile. In 2018, the rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 1.5 in metropolitan counties and 1.6 in the Northeast to 1.2 in rural counties and 1.3 in the Midwest. Rural counties were nearly three times more likely to be low-dispensing counties, compared with metropolitan counties.

The rate of naloxone prescriptions per 100 high-dose opioid prescriptions also varied by provider specialty. This rate was lowest among surgeons (0.2) and highest among psychiatrists (12.9).

Most naloxone prescriptions entailed out-of-pocket costs. About 71% of prescriptions paid for by Medicare entailed out-of-pocket costs, compared with 43.8% of prescriptions paid for by Medicaid, and 41.5% of prescriptions paid for by commercial insurance.

Centers for Disease Control and Prevention

More can be done

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths,” said Robert R. Redfield, MD, director of the CDC, in a press release. “The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention. As we aggressively confront what is the public health crisis of our time, CDC will continue to stress with health care providers the benefit of making this overdose-reversing medicine available to patients.”

“While we’ve seen these important increases [in naloxone prescriptions], we are not as far along as we’d like to be,” said Anne Schuchat, MD, principal deputy director of the CDC, during a press conference. “Cost is one of the issues, but I think awareness is another.” These data should prompt pharmacies to make sure that they stock naloxone and remind clinicians to consider naloxone when they prescribe opioids, she added. Patients and their family members should be aware of naloxone and ask their health care providers about it. “We’d really like to see the increase [in naloxone prescriptions] move much more rapidly,” she concluded.

The investigators disclosed no potential conflicts of interest.

egreb@mdedge.com

SOURCE: Guy GP et al. MMWR Morb Mortal Wkly Rep. 2019 Aug 6.

Despite a large increase in the number of naloxone prescriptions dispensed since 2012, too little of the drug is being made available to patients who need it, according to the Centers for Disease Control and Prevention.

Although the CDC recommends that clinicians consider prescribing naloxone, which can reverse the effects of an opioid overdose, to patients who receive high-dose opioid prescriptions, one naloxone prescription was dispensed in 2018 for every 69 such patients, according to a Vital Signs investigation published Aug. 6 in the Morbidity and Mortality Weekly Report.

Approximately 9 million more naloxone prescriptions could have been dispensed in 2018 if every patient with a high-dose opioid prescription were offered the drug, according to the agency. In addition, the rate at which naloxone is dispensed varies significantly according to region.

“Thousands of Americans are alive today thanks to the use of naloxone,” said Alex M. Azar, secretary of Health and Human Services, in a press release. “Giving people a chance to survive an opioid overdose and safely enter recovery is one of the five key pillars of our HHS strategy for ending the overdose epidemic. With help from Congress, the private sector, state, and local governments and communities, targeted access to naloxone has expanded dramatically over the last several years, but today’s CDC report is a reminder that there is much more all of us need to do to save lives.”

Investigators examined retail pharmacy data

In 2017, 47,600 (67.8%) drug overdose deaths in the United States involved opioids. For decades, emergency medical service providers have administered naloxone to patients with suspected drug overdose. A major focus of public health initiatives intended to address the opioid overdose crisis has been to increase access to naloxone through clinician prescribing and pharmacy dispensing. The CDC recommends considering prescribing naloxone to patients with a history of overdose or substance use disorder, those receiving opioid dosages of 50 morphine milligram equivalents per day or greater (that is, high-dose prescriptions), and those who are using benzodiazepines concurrently.

Investigators at the CDC examined retail pharmacy data from IQVIA, a company that maintains information on prescriptions from approximately 50,400 retail pharmacies. They extracted data from 2012 through 2018 to analyze naloxone dispensing by region, urban versus rural status, prescriber specialty, and recipient characteristics (for example, age group, sex, out-of-pocket costs, and method of payment).

Dispensations doubled from 2017 to 2018

Naloxone dispensing from retail pharmacies increased from 0.4 prescriptions per 100,000 in 2012 to 170.2 prescriptions per 100,000 in 2018. From 2017 to 2018 alone, the number of prescriptions dispensed increased by 106%.

Despite consistency among state laws, naloxone dispensation varied by region. The average rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 0.2 in the lowest quartile to 2.9 in the highest quartile. In 2018, the rate of naloxone prescriptions per 100 high-dose opioid prescriptions ranged from 1.5 in metropolitan counties and 1.6 in the Northeast to 1.2 in rural counties and 1.3 in the Midwest. Rural counties were nearly three times more likely to be low-dispensing counties, compared with metropolitan counties.

The rate of naloxone prescriptions per 100 high-dose opioid prescriptions also varied by provider specialty. This rate was lowest among surgeons (0.2) and highest among psychiatrists (12.9).

Most naloxone prescriptions entailed out-of-pocket costs. About 71% of prescriptions paid for by Medicare entailed out-of-pocket costs, compared with 43.8% of prescriptions paid for by Medicaid, and 41.5% of prescriptions paid for by commercial insurance.

Centers for Disease Control and Prevention

More can be done

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths,” said Robert R. Redfield, MD, director of the CDC, in a press release. “The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention. As we aggressively confront what is the public health crisis of our time, CDC will continue to stress with health care providers the benefit of making this overdose-reversing medicine available to patients.”

“While we’ve seen these important increases [in naloxone prescriptions], we are not as far along as we’d like to be,” said Anne Schuchat, MD, principal deputy director of the CDC, during a press conference. “Cost is one of the issues, but I think awareness is another.” These data should prompt pharmacies to make sure that they stock naloxone and remind clinicians to consider naloxone when they prescribe opioids, she added. Patients and their family members should be aware of naloxone and ask their health care providers about it. “We’d really like to see the increase [in naloxone prescriptions] move much more rapidly,” she concluded.

The investigators disclosed no potential conflicts of interest.

egreb@mdedge.com

SOURCE: Guy GP et al. MMWR Morb Mortal Wkly Rep. 2019 Aug 6.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Curing hepatitis C virus (HCV) infection without addressing the high rate of alcohol use disorder in many patients may undermine the benefits of treatment to long-term liver health, according to the results of a large cohort study.

Katarzyna Bialasiewicz/Thinkstock

Because excess alcohol use is known to accelerate liver disease progression, researchers Risha Irvin, MD, and her colleagues from Johns Hopkins University, Baltimore, examined the prevalence of alcohol use in HCV-infected people who inject drugs (PWID). Their study examined the prevalence and associated correlates of alcohol use (Addictive Behaviors 2019;96:56-61).

They followed a large cohort of 1,623 HCV-antibody positive PWID from 2005 to 2013 from the AIDS Linked to the Intravenous Experience (ALIVE) study. They characterized alcohol use with the Alcohol Use Disorders Identification Test (AUDIT-C) questionnaire. Multivariable logistic regression with generalized estimated equations was used to examine sociodemographic, clinical, and substance use correlates of alcohol use.

At baseline, the median age was 47 years, 67% were men, 81% were black, and 34% were HIV positive. The majority (60%) reported injection drug use in the prior 6 months, while 46% reported noninjection cocaine or heroin, 31% reported street-acquired prescription drugs, and 22% reported marijuana use in the same time period. According to the AUDIT-C results, 41% of the patients reported no alcohol use, 21% reported moderate alcohol use, and 38% reported heavy alcohol use at their baseline visit.

The factors that were significantly associated with heavy alcohol use included male sex, black race, income of $5,000 or less, a Center for Epidemiologic Studies Depression Scale (range 0-60) score of 23 or greater, being homeless, being incarcerated, marijuana use, use of street-acquired prescription drugs, noninjection cocaine/heroin, injection drug use, and cigarette smoking. In a model that included the composite summary variable for substance use intensity, one drug type (adjusted odds ratio, 1.92), two drug types (AOR, 2.93), and three drug types (AOR, 3.65) were significantly associated with heavy alcohol use.

“While clinicians are undoubtedly concerned about any level of alcohol use in the setting of HCV infection due to the acceleration of liver fibrosis, there is particular concern for individuals with heavy alcohol use and their increased risk for cirrhosis and liver failure even after HCV cure. Without intervention, alcohol use will persist after HCV is cured with the potential to undermine the benefit of HCV cure. Therefore, our data point to the need to invest in and develop programs that effectively address alcohol use and co-occurring substance use in this population of PWID with HCV,” the researchers concluded.

The study was supported by the U.S. National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases, and the National Institute on Alcohol Abuse and Alcoholism. The authors declared that they had no conflicts.

mlesney@mdedge.com

SOURCE: Irvin R et al. Addictive Behaviors. 2019;96:56-61.

Urine drug tests (UDTs) are useful clinical tools for assessing and monitoring the risk of misuse, abuse, and diversion when prescribing controlled substances, or for monitoring abstinence in patients with substance use disorders (SUDs). However, UDTs have been underutilized, and have been used without systematic documentation of reasons and results.^1,2 In addition, many clinicians may lack the knowledge needed to effectively interpret test results.^3,4 Although the reported use of UDTs is much higher among clinicians who are members of American Society of Addiction Medicine (ASAM), there is still a need for improved education.⁵

The appropriate use of UDTs strengthens the therapeutic relationship and promotes healthy behaviors and patients’ recovery. On the other hand, incorrect interpretation of test results may lead to missing potential aberrant behaviors, or inappropriate consequences for patients, such as discontinuing necessary medications or discharging them from care secondary to a perceived violation of a treatment contract due to unexpected positive or negative drug screening results.⁶ In this article, we review the basic concepts of UDTs and provide an algorithm to determine when to order these tests, how to interpret the results, and how to modify treatment accordingly.

Urine drug tests 101

Urine drug tests include rapid urine drug screening (UDS) and confirmatory tests. Urine drug screenings are usually based on various types of immunoassays. They are fast, sensitive, and cost-effective. Because immunoassays are antibody-mediated, they have significant false-positive and false-negative rates due to cross-reactivity and sensitivity of antibodies.⁷ For example, antibodies used in immunoassays to detect opioids are essentially morphine antibodies, and are not able to detect semisynthetic opioids or synthetic opioids (except hydrocodone).⁷ However, immunoassays specifically developed to detect oxycodone, buprenorphine, fentanyl, and methadone are available. On the other hand, antibodies can cross-react with molecules unrelated to proto-medicines or drug metabolites, but with similar antigenic determinants. For example, amphetamine immunoassays have high false-positive rates with many different classes of medications or substances.⁷

Urine drug tests based on mass spectrometry, gas chromatography/mass spectrometry (GC/MS), and liquid chromatography/mass spectrometry (LC/MS) are gold standards to confirm toxicology results. They are highly sensitive and specific, with accurate quantitative measurement. However, they are more expensive than UDS and usually need to be sent to a laboratory with capacity to perform GC/MS or LC/MS, with a turnaround time of up to 1 week.⁸ In clinical practice, we usually start with UDS tests and order confirmatory tests when needed.

When to order UDTs in outpatient psychiatry

On December 12, 2013, the ASAM released a white paper that suggests the use of drug testing as a primary prevention, diagnostic, and monitoring tool in the management of addiction or drug misuse and its application in a wide variety of medical settings.⁹ Many clinicians use treatment contracts when prescribing controlled substances as a part of a risk-mitigation strategy, and these contracts often include the use of UDTs. Urine drug tests provide objective evidence to support or negate self-report, because many people may underreport their use.¹⁰ The literature has shown significant “abnormal” urine test results, ranging from 9% to 53%, in patients receiving chronic opioid therapy.^2,11

The CDC and the American Academy of Pain Medicine recommend UDS before initiating any controlled substance for pain therapy.^12,13 They also suggest random drug testing at least once or twice a year for low-risk patients, and more frequent screening for high-risk patients, such as those with a history of addiction.^12,13 For example, for patients with opioid use disorder who participate in a methadone program, weekly UDTs are mandated for the first 90 days, and at least 8 UDTs a year are required after that.

However, UDTs carry significant stigma due to their association with SUDs. Talking with patients from the start of treatment helps to reduce this stigma, and makes it easier to have further discussions when patients have unexpected results during treatment. For example, clinicians can explain to patients that monitoring UDTs when prescribing controlled substances is similar to monitoring thyroid function with lithium use because treatment with a controlled substance carries an inherent risk of misuse, abuse, and diversion. For patients with SUDs, clinicians can explain that using UDTs to monitor their abstinence is similar to monitoring HbA_1c for glucose control in patients with diabetes.

Continue to: Factors that can affect UDT results

 

 

Factors that can affect UDT results

In addition to knowing when to order UDT, it is critical to know how to interpret the results of UDS and follow up with confirmatory tests when needed. Other than the limitations of the tests, the following factors could contribute to unexpected UDT results:

• the drug itself, including its half-life, metabolic pathways, and potential interactions with other medications
• how patients take their medications, including dose, frequency, and pattern of drug use
• all the medications that patients are taking, including prescription, over-the-counter, and herbal and supplemental preparations
• when the last dose of a prescribed controlled substance was taken. Always ask when the patient’s last dose was taken before you consider ordering a UDT.

To help better understand UDT results, Figure 1¹⁴ and Figure 2¹⁵ demonstrate metabolic pathways of commonly used benzodiazepines and opioids, respectively. There are several comprehensive reviews on commonly seen false positives and negatives for each drug or each class of drugs in immunoassays.^16-21 Confirmatory tests are usually very accurate. However, chiral analysis is needed to differentiate enantiomers, such as methamphetamine (active R-enantiomer) and selegiline, which is metabolized into L-methamphetamine (inactive S-enantiomer).²² In addition, detection of tetrahydrocannabivarin (THCV), an ingredient of the cannabis plant, via GC/MS can be used to distinguish between consumption of dronabinol and natural cannabis products.²³ The Table^16-21 summarizes the proto­type agents, other detectable agents in the same class, and false positives and negatives in immunoassays.

Interpreting UDT results and management strategies

Our Algorithm outlines how to interpret UDT results, and management strategies to consider based on whether the results are as expected or unexpected, with a few key caveats as described below.

Expected results

If there are no concerns based on the patient’s clinical presentation or collateral information, simply continue the current treatment. However, for patients taking medications that are undetectable by UDS (for example, regular use of clonazepam or oxycodone), consider ordering confirmatory tests at least once to ensure compliance, even when UDS results are negative.

Unexpected positive results, including the presence of illicit drugs and/or unprescribed licit drugs

Drug misuse, abuse, or dependence. The first step is to talk with the patient, who may acknowledge drug misuse, abuse, or dependence. Next, consider modifying the treatment plan; this may include more frequent monitoring and visits, limiting or discontinuing prescribed controlled substances, or referring the patient to inpatient or outpatient SUD treatment, as appropriate.

Continue to: Interference from medications or diet

Interference from medications or diets. One example of a positive opioid screening result due to interference from diet is the consumption of foods that contain poppy seeds. Because of this potential interference, the cutoff value for a positive opioid immunoassay in workplace drug testing was increased from 300 to 2,000 ug/L.²⁴ Educating patients regarding medication and lifestyle choices can help them avoid any interference with drug monitoring. Confirmatory tests can be ordered at the clinician’s discretion. The same principle applies to medication choice when prescribing. For example, a patient taking bupropion may experience a false positive result on a UDS for amphetamines, and a different antidepressant might be a better choice (Box 1).

Box 1

Urine sample tampering. Consider the possibility that urine samples could be substituted, especially when there are signs or indications of tampering, such as a positive pregnancy test for a male patient, or the presence of multiple prescription medications not prescribed to the patient. If there is high suspicion of urine sample tampering, consider observed urine sample collection.

When to order confirmatory tests for unexpected positive results.

Order a confirmatory test if a patient adamantly denies taking the substance(s) for which he/she has screened positive, and there’s no other explanation for the positive result. Continue the patient’s current treatment if the confirmatory test is negative. However, if the confirmatory test is positive, then modify the treatment plan (Algorithm).

Special circumstances.

A positive opioid screen in a patient who has been prescribed a synthetic or semisynthetic opioid indicates the patient is likely using opioids other than the one he/she has been prescribed. Similarly, clonazepam is expected to be negative in a benzodiazepine immunoassay. If such testing is positive, consider the possibility that the patient is taking other benzodiazepines, such as diazepam. The results of UDTs can also be complicated by common metabolites in the same class of drugs. For example, the presence of hydromorphone for patients taking hydrocodone does not necessarily indicate the use of hydromorphone, because hydromorphone is a metabolite of hydrocodone (Figure 2¹⁵).

Unexpected negative results

Prescribed medications exist in low concentration that are below the UDS detection threshold. This unexpected UDS result could occur if patients:

• take their medications less often than prescribed (because of financial difficulties or the patient feels better and does not think he/she needs it, etc.)
• hydrate too much (intentionally or unintentionally), are pregnant, or are fast metabolizers (Box 2)
• take other medications that increase the metabolism of the prescribed medication.

Box 2

Continue to: Further inquiry will...

Further inquiry will clarify these concerns. Clinicians should educate patients and manage accordingly. Confirmatory tests may be ordered upon clinicians’ discretion.

Urine sample tampering. Dilution or substitution of urine samples may lead to unexpected negative results. Usually, the urine sample will have abnormal parameters, including temperature, pH, specific gravity, urine creatinine level, or detection of adulterants. If needed, consider observed urine sample collection. Jaffee et al²⁵ reviewed tampering methods in urine drug testing.

Diversion or binge use of medications. If patients adamantly deny diverting or binge using their medication, order confirmatory tests. If the confirmatory test also is negative, modify the treatment plan accordingly, and consider the following options:

• adjust the medication dosage or frequency
• discontinue the medication
• conduct pill counts for more definitive evidence of diversion or misuse, especially if discontinuation may lead to potential harm (for example, for patients prescribed buprenorphine for opioid use disorder).

When to order confirmatory tests for unexpected negative results.

Because confirmatory tests also measure drug concentrations, clinicians sometimes order serial confirmatory testing to monitor lipophilic drugs after a patient reports discontinuation, such as in the case of a patient using marijuana, ketamine, or alprazolam. The level of a lipophilic drug, such as these 3, should continue to decline if the patient has discontinued using it. However, because the drug level is affected by how concentrated the urine samples are, it is necessary to compare the ratios of drug levels over urine creatinine levels.²⁶ Another use for confirmatory-quantitative testing is to detect “urine spiking,”^27,28 when a patient adds an unconsumed drug to his/her urine sample to produce a positive result without actually taking the drug (Box 3).

Box 3

When to consult lab specialists

Because many clinicians may find it challenging to stay abreast of all of the factors necessary to properly interpret UDT results, consulting with qualified laboratory professionals is appropriate when needed. For example, a patient was prescribed codeine, and his UDTs showed morphine as anticipated; however, the prescribing clinician suspected that the patient was also using heroin. In this case, consultation with a specialist may be warranted to look for 6-mono-acetylemorphine (6-MAM, a unique heroin metabolite) and/or the ratio of morphine to codeine.

Continue to: In summary...

In summary, UDTs are important tools to use in general psychiatry practice, especially when prescribing controlled substances. To use UDTs effectively, it is essential to possess knowledge of drug metabolism and the limitations of these tests. All immunoassay results should be considered as presumptive, and confirmatory tests are often needed for making treatment decisions. Many clinicians are unlikely to possess all the knowledge needed to correctly interpret UDTs, and in some cases, communication with qualified laboratory professionals may be necessary. In addition, the patient’s history and clinical presentation, collateral information, and data from prescription drug monitoring programs are all important factors to consider.

The cost of UDTs, variable insurance coverage, and a lack of on-site laboratory services can be deterrents to implementing UDTs as recommended. These factors vary significantly across regions, facilities, and insurance providers (see Related Resources). If faced with these issues and you expect to often need UDTs in your practice, consider using point-of-care UDTs as an alternative to improve access, convenience, and possibly cost.

Bottom Line

Urine drug tests (UDTs) should be standard clinical practice when prescribing controlled substances and treating patients with substance use disorders in the outpatient setting. Clinicians need to be knowledgeable about the limitations of UDTs, drug metabolism, and relevant patient history to interpret UDTs proficiently for optimal patient care. Consult laboratory specialists when needed to help interpret the results.

Related Resources

• Islam FA, Choudhry Z. Urine drug screens: Not just for job applicants. Current Psychiatry. 2018;17(12):43-44.
• HealthCare.gov. Health benefits & coverage: Mental health & substance abuse coverage. www.healthcare.gov/coverage/mental-health-substance-abuse-coverage/.

Drug Brand Names

Alprazolam • Xanax
Amphetamine • Adderall
Atomoxetine • Strattera
Buprenorphine • Subutex
Buprenorphine/naloxone • Suboxone, Zubsolv
Bupropion • Wellbutrin, Zyban
Chlordiazepoxide • Librium
Chlorpromazine • Thorazine
Clonazepam • Klonopin
Desipramine • Norpramin
Dextroamphetamine • Dexedrine, ProCentra
Diazepam • Valium
Doxepin • Silenor
Dronabinol • Marinol
Efavirenz • Sustiva
Ephedrine • Akovaz
Fentanyl • Actiq, Duragesic
Flurazepam • Dalmane
Hydrocodone • Hysingla, Zohydro ER
Hydromorphone • Dilaudid, Exalgo
Labetalol • Normodyne, Trandate
Lamotrigine • Lamictal
Lisdexamfetamine • Vyvanse
Lithium • Eskalith, Lithobid
Lorazepam • Ativan
Meperidine • Demerol
Metformin • Fortamet, Glucophage
Methadone • Dolophine, Methadose
Methylphenidate • Ritalin
Midazolam • Versed
Morphine • Kadian, MorphaBond
Nabilone • Cesamet
Naltrexone • Vivitrol
Oxaprozin • Daypro
Oxazepam • Serax
Oxycodone • Oxycontin
Oxymorphone • Opana
Phentermine • Adipex-P, Ionamin
Promethazine • Phenergan
Quetiapine • Seroquel
Ranitidine • Zantac
Rifampicin • Rifadin
Selegiline • Eldepryl, Zelapar
Sertraline • Zoloft
Temazepam • Restoril
Thioridazine • Mellaril
Tramadol • Conzip, Ultram
Trazodone • Desyrel
Triazolam • Halcion
Venlafaxine • Effexor
Verapamil • Calan, Verelan
Zolpidem • Ambien

Urine drug tests (UDTs) are useful clinical tools for assessing and monitoring the risk of misuse, abuse, and diversion when prescribing controlled substances, or for monitoring abstinence in patients with substance use disorders (SUDs). However, UDTs have been underutilized, and have been used without systematic documentation of reasons and results.^1,2 In addition, many clinicians may lack the knowledge needed to effectively interpret test results.^3,4 Although the reported use of UDTs is much higher among clinicians who are members of American Society of Addiction Medicine (ASAM), there is still a need for improved education.⁵

The appropriate use of UDTs strengthens the therapeutic relationship and promotes healthy behaviors and patients’ recovery. On the other hand, incorrect interpretation of test results may lead to missing potential aberrant behaviors, or inappropriate consequences for patients, such as discontinuing necessary medications or discharging them from care secondary to a perceived violation of a treatment contract due to unexpected positive or negative drug screening results.⁶ In this article, we review the basic concepts of UDTs and provide an algorithm to determine when to order these tests, how to interpret the results, and how to modify treatment accordingly.

Urine drug tests 101

Urine drug tests include rapid urine drug screening (UDS) and confirmatory tests. Urine drug screenings are usually based on various types of immunoassays. They are fast, sensitive, and cost-effective. Because immunoassays are antibody-mediated, they have significant false-positive and false-negative rates due to cross-reactivity and sensitivity of antibodies.⁷ For example, antibodies used in immunoassays to detect opioids are essentially morphine antibodies, and are not able to detect semisynthetic opioids or synthetic opioids (except hydrocodone).⁷ However, immunoassays specifically developed to detect oxycodone, buprenorphine, fentanyl, and methadone are available. On the other hand, antibodies can cross-react with molecules unrelated to proto-medicines or drug metabolites, but with similar antigenic determinants. For example, amphetamine immunoassays have high false-positive rates with many different classes of medications or substances.⁷

Urine drug tests based on mass spectrometry, gas chromatography/mass spectrometry (GC/MS), and liquid chromatography/mass spectrometry (LC/MS) are gold standards to confirm toxicology results. They are highly sensitive and specific, with accurate quantitative measurement. However, they are more expensive than UDS and usually need to be sent to a laboratory with capacity to perform GC/MS or LC/MS, with a turnaround time of up to 1 week.⁸ In clinical practice, we usually start with UDS tests and order confirmatory tests when needed.

When to order UDTs in outpatient psychiatry

On December 12, 2013, the ASAM released a white paper that suggests the use of drug testing as a primary prevention, diagnostic, and monitoring tool in the management of addiction or drug misuse and its application in a wide variety of medical settings.⁹ Many clinicians use treatment contracts when prescribing controlled substances as a part of a risk-mitigation strategy, and these contracts often include the use of UDTs. Urine drug tests provide objective evidence to support or negate self-report, because many people may underreport their use.¹⁰ The literature has shown significant “abnormal” urine test results, ranging from 9% to 53%, in patients receiving chronic opioid therapy.^2,11

The CDC and the American Academy of Pain Medicine recommend UDS before initiating any controlled substance for pain therapy.^12,13 They also suggest random drug testing at least once or twice a year for low-risk patients, and more frequent screening for high-risk patients, such as those with a history of addiction.^12,13 For example, for patients with opioid use disorder who participate in a methadone program, weekly UDTs are mandated for the first 90 days, and at least 8 UDTs a year are required after that.

However, UDTs carry significant stigma due to their association with SUDs. Talking with patients from the start of treatment helps to reduce this stigma, and makes it easier to have further discussions when patients have unexpected results during treatment. For example, clinicians can explain to patients that monitoring UDTs when prescribing controlled substances is similar to monitoring thyroid function with lithium use because treatment with a controlled substance carries an inherent risk of misuse, abuse, and diversion. For patients with SUDs, clinicians can explain that using UDTs to monitor their abstinence is similar to monitoring HbA_1c for glucose control in patients with diabetes.

Continue to: Factors that can affect UDT results

 

 

Factors that can affect UDT results

In addition to knowing when to order UDT, it is critical to know how to interpret the results of UDS and follow up with confirmatory tests when needed. Other than the limitations of the tests, the following factors could contribute to unexpected UDT results:

• the drug itself, including its half-life, metabolic pathways, and potential interactions with other medications
• how patients take their medications, including dose, frequency, and pattern of drug use
• all the medications that patients are taking, including prescription, over-the-counter, and herbal and supplemental preparations
• when the last dose of a prescribed controlled substance was taken. Always ask when the patient’s last dose was taken before you consider ordering a UDT.

To help better understand UDT results, Figure 1¹⁴ and Figure 2¹⁵ demonstrate metabolic pathways of commonly used benzodiazepines and opioids, respectively. There are several comprehensive reviews on commonly seen false positives and negatives for each drug or each class of drugs in immunoassays.^16-21 Confirmatory tests are usually very accurate. However, chiral analysis is needed to differentiate enantiomers, such as methamphetamine (active R-enantiomer) and selegiline, which is metabolized into L-methamphetamine (inactive S-enantiomer).²² In addition, detection of tetrahydrocannabivarin (THCV), an ingredient of the cannabis plant, via GC/MS can be used to distinguish between consumption of dronabinol and natural cannabis products.²³ The Table^16-21 summarizes the proto­type agents, other detectable agents in the same class, and false positives and negatives in immunoassays.

Interpreting UDT results and management strategies

Our Algorithm outlines how to interpret UDT results, and management strategies to consider based on whether the results are as expected or unexpected, with a few key caveats as described below.

Expected results

If there are no concerns based on the patient’s clinical presentation or collateral information, simply continue the current treatment. However, for patients taking medications that are undetectable by UDS (for example, regular use of clonazepam or oxycodone), consider ordering confirmatory tests at least once to ensure compliance, even when UDS results are negative.

Unexpected positive results, including the presence of illicit drugs and/or unprescribed licit drugs

Drug misuse, abuse, or dependence. The first step is to talk with the patient, who may acknowledge drug misuse, abuse, or dependence. Next, consider modifying the treatment plan; this may include more frequent monitoring and visits, limiting or discontinuing prescribed controlled substances, or referring the patient to inpatient or outpatient SUD treatment, as appropriate.

Continue to: Interference from medications or diet

Interference from medications or diets. One example of a positive opioid screening result due to interference from diet is the consumption of foods that contain poppy seeds. Because of this potential interference, the cutoff value for a positive opioid immunoassay in workplace drug testing was increased from 300 to 2,000 ug/L.²⁴ Educating patients regarding medication and lifestyle choices can help them avoid any interference with drug monitoring. Confirmatory tests can be ordered at the clinician’s discretion. The same principle applies to medication choice when prescribing. For example, a patient taking bupropion may experience a false positive result on a UDS for amphetamines, and a different antidepressant might be a better choice (Box 1).

Box 1

Urine sample tampering. Consider the possibility that urine samples could be substituted, especially when there are signs or indications of tampering, such as a positive pregnancy test for a male patient, or the presence of multiple prescription medications not prescribed to the patient. If there is high suspicion of urine sample tampering, consider observed urine sample collection.

When to order confirmatory tests for unexpected positive results.

Order a confirmatory test if a patient adamantly denies taking the substance(s) for which he/she has screened positive, and there’s no other explanation for the positive result. Continue the patient’s current treatment if the confirmatory test is negative. However, if the confirmatory test is positive, then modify the treatment plan (Algorithm).

Special circumstances.

A positive opioid screen in a patient who has been prescribed a synthetic or semisynthetic opioid indicates the patient is likely using opioids other than the one he/she has been prescribed. Similarly, clonazepam is expected to be negative in a benzodiazepine immunoassay. If such testing is positive, consider the possibility that the patient is taking other benzodiazepines, such as diazepam. The results of UDTs can also be complicated by common metabolites in the same class of drugs. For example, the presence of hydromorphone for patients taking hydrocodone does not necessarily indicate the use of hydromorphone, because hydromorphone is a metabolite of hydrocodone (Figure 2¹⁵).

Unexpected negative results

Prescribed medications exist in low concentration that are below the UDS detection threshold. This unexpected UDS result could occur if patients:

• take their medications less often than prescribed (because of financial difficulties or the patient feels better and does not think he/she needs it, etc.)
• hydrate too much (intentionally or unintentionally), are pregnant, or are fast metabolizers (Box 2)
• take other medications that increase the metabolism of the prescribed medication.

Box 2

Continue to: Further inquiry will...

Further inquiry will clarify these concerns. Clinicians should educate patients and manage accordingly. Confirmatory tests may be ordered upon clinicians’ discretion.

Urine sample tampering. Dilution or substitution of urine samples may lead to unexpected negative results. Usually, the urine sample will have abnormal parameters, including temperature, pH, specific gravity, urine creatinine level, or detection of adulterants. If needed, consider observed urine sample collection. Jaffee et al²⁵ reviewed tampering methods in urine drug testing.

Diversion or binge use of medications. If patients adamantly deny diverting or binge using their medication, order confirmatory tests. If the confirmatory test also is negative, modify the treatment plan accordingly, and consider the following options:

• adjust the medication dosage or frequency
• discontinue the medication
• conduct pill counts for more definitive evidence of diversion or misuse, especially if discontinuation may lead to potential harm (for example, for patients prescribed buprenorphine for opioid use disorder).

When to order confirmatory tests for unexpected negative results.

Because confirmatory tests also measure drug concentrations, clinicians sometimes order serial confirmatory testing to monitor lipophilic drugs after a patient reports discontinuation, such as in the case of a patient using marijuana, ketamine, or alprazolam. The level of a lipophilic drug, such as these 3, should continue to decline if the patient has discontinued using it. However, because the drug level is affected by how concentrated the urine samples are, it is necessary to compare the ratios of drug levels over urine creatinine levels.²⁶ Another use for confirmatory-quantitative testing is to detect “urine spiking,”^27,28 when a patient adds an unconsumed drug to his/her urine sample to produce a positive result without actually taking the drug (Box 3).

Box 3

When to consult lab specialists

Because many clinicians may find it challenging to stay abreast of all of the factors necessary to properly interpret UDT results, consulting with qualified laboratory professionals is appropriate when needed. For example, a patient was prescribed codeine, and his UDTs showed morphine as anticipated; however, the prescribing clinician suspected that the patient was also using heroin. In this case, consultation with a specialist may be warranted to look for 6-mono-acetylemorphine (6-MAM, a unique heroin metabolite) and/or the ratio of morphine to codeine.

Continue to: In summary...

In summary, UDTs are important tools to use in general psychiatry practice, especially when prescribing controlled substances. To use UDTs effectively, it is essential to possess knowledge of drug metabolism and the limitations of these tests. All immunoassay results should be considered as presumptive, and confirmatory tests are often needed for making treatment decisions. Many clinicians are unlikely to possess all the knowledge needed to correctly interpret UDTs, and in some cases, communication with qualified laboratory professionals may be necessary. In addition, the patient’s history and clinical presentation, collateral information, and data from prescription drug monitoring programs are all important factors to consider.

The cost of UDTs, variable insurance coverage, and a lack of on-site laboratory services can be deterrents to implementing UDTs as recommended. These factors vary significantly across regions, facilities, and insurance providers (see Related Resources). If faced with these issues and you expect to often need UDTs in your practice, consider using point-of-care UDTs as an alternative to improve access, convenience, and possibly cost.

Bottom Line

Urine drug tests (UDTs) should be standard clinical practice when prescribing controlled substances and treating patients with substance use disorders in the outpatient setting. Clinicians need to be knowledgeable about the limitations of UDTs, drug metabolism, and relevant patient history to interpret UDTs proficiently for optimal patient care. Consult laboratory specialists when needed to help interpret the results.

Related Resources

• Islam FA, Choudhry Z. Urine drug screens: Not just for job applicants. Current Psychiatry. 2018;17(12):43-44.
• HealthCare.gov. Health benefits & coverage: Mental health & substance abuse coverage. www.healthcare.gov/coverage/mental-health-substance-abuse-coverage/.

Drug Brand Names

Alprazolam • Xanax
Amphetamine • Adderall
Atomoxetine • Strattera
Buprenorphine • Subutex
Buprenorphine/naloxone • Suboxone, Zubsolv
Bupropion • Wellbutrin, Zyban
Chlordiazepoxide • Librium
Chlorpromazine • Thorazine
Clonazepam • Klonopin
Desipramine • Norpramin
Dextroamphetamine • Dexedrine, ProCentra
Diazepam • Valium
Doxepin • Silenor
Dronabinol • Marinol
Efavirenz • Sustiva
Ephedrine • Akovaz
Fentanyl • Actiq, Duragesic
Flurazepam • Dalmane
Hydrocodone • Hysingla, Zohydro ER
Hydromorphone • Dilaudid, Exalgo
Labetalol • Normodyne, Trandate
Lamotrigine • Lamictal
Lisdexamfetamine • Vyvanse
Lithium • Eskalith, Lithobid
Lorazepam • Ativan
Meperidine • Demerol
Metformin • Fortamet, Glucophage
Methadone • Dolophine, Methadose
Methylphenidate • Ritalin
Midazolam • Versed
Morphine • Kadian, MorphaBond
Nabilone • Cesamet
Naltrexone • Vivitrol
Oxaprozin • Daypro
Oxazepam • Serax
Oxycodone • Oxycontin
Oxymorphone • Opana
Phentermine • Adipex-P, Ionamin
Promethazine • Phenergan
Quetiapine • Seroquel
Ranitidine • Zantac
Rifampicin • Rifadin
Selegiline • Eldepryl, Zelapar
Sertraline • Zoloft
Temazepam • Restoril
Thioridazine • Mellaril
Tramadol • Conzip, Ultram
Trazodone • Desyrel
Triazolam • Halcion
Venlafaxine • Effexor
Verapamil • Calan, Verelan
Zolpidem • Ambien

Urine drug tests (UDTs) are useful clinical tools for assessing and monitoring the risk of misuse, abuse, and diversion when prescribing controlled substances, or for monitoring abstinence in patients with substance use disorders (SUDs). However, UDTs have been underutilized, and have been used without systematic documentation of reasons and results.^1,2 In addition, many clinicians may lack the knowledge needed to effectively interpret test results.^3,4 Although the reported use of UDTs is much higher among clinicians who are members of American Society of Addiction Medicine (ASAM), there is still a need for improved education.⁵

The appropriate use of UDTs strengthens the therapeutic relationship and promotes healthy behaviors and patients’ recovery. On the other hand, incorrect interpretation of test results may lead to missing potential aberrant behaviors, or inappropriate consequences for patients, such as discontinuing necessary medications or discharging them from care secondary to a perceived violation of a treatment contract due to unexpected positive or negative drug screening results.⁶ In this article, we review the basic concepts of UDTs and provide an algorithm to determine when to order these tests, how to interpret the results, and how to modify treatment accordingly.

Urine drug tests 101

Urine drug tests include rapid urine drug screening (UDS) and confirmatory tests. Urine drug screenings are usually based on various types of immunoassays. They are fast, sensitive, and cost-effective. Because immunoassays are antibody-mediated, they have significant false-positive and false-negative rates due to cross-reactivity and sensitivity of antibodies.⁷ For example, antibodies used in immunoassays to detect opioids are essentially morphine antibodies, and are not able to detect semisynthetic opioids or synthetic opioids (except hydrocodone).⁷ However, immunoassays specifically developed to detect oxycodone, buprenorphine, fentanyl, and methadone are available. On the other hand, antibodies can cross-react with molecules unrelated to proto-medicines or drug metabolites, but with similar antigenic determinants. For example, amphetamine immunoassays have high false-positive rates with many different classes of medications or substances.⁷

Urine drug tests based on mass spectrometry, gas chromatography/mass spectrometry (GC/MS), and liquid chromatography/mass spectrometry (LC/MS) are gold standards to confirm toxicology results. They are highly sensitive and specific, with accurate quantitative measurement. However, they are more expensive than UDS and usually need to be sent to a laboratory with capacity to perform GC/MS or LC/MS, with a turnaround time of up to 1 week.⁸ In clinical practice, we usually start with UDS tests and order confirmatory tests when needed.

When to order UDTs in outpatient psychiatry

On December 12, 2013, the ASAM released a white paper that suggests the use of drug testing as a primary prevention, diagnostic, and monitoring tool in the management of addiction or drug misuse and its application in a wide variety of medical settings.⁹ Many clinicians use treatment contracts when prescribing controlled substances as a part of a risk-mitigation strategy, and these contracts often include the use of UDTs. Urine drug tests provide objective evidence to support or negate self-report, because many people may underreport their use.¹⁰ The literature has shown significant “abnormal” urine test results, ranging from 9% to 53%, in patients receiving chronic opioid therapy.^2,11

The CDC and the American Academy of Pain Medicine recommend UDS before initiating any controlled substance for pain therapy.^12,13 They also suggest random drug testing at least once or twice a year for low-risk patients, and more frequent screening for high-risk patients, such as those with a history of addiction.^12,13 For example, for patients with opioid use disorder who participate in a methadone program, weekly UDTs are mandated for the first 90 days, and at least 8 UDTs a year are required after that.

However, UDTs carry significant stigma due to their association with SUDs. Talking with patients from the start of treatment helps to reduce this stigma, and makes it easier to have further discussions when patients have unexpected results during treatment. For example, clinicians can explain to patients that monitoring UDTs when prescribing controlled substances is similar to monitoring thyroid function with lithium use because treatment with a controlled substance carries an inherent risk of misuse, abuse, and diversion. For patients with SUDs, clinicians can explain that using UDTs to monitor their abstinence is similar to monitoring HbA_1c for glucose control in patients with diabetes.

Continue to: Factors that can affect UDT results

 

 

Factors that can affect UDT results

In addition to knowing when to order UDT, it is critical to know how to interpret the results of UDS and follow up with confirmatory tests when needed. Other than the limitations of the tests, the following factors could contribute to unexpected UDT results:

• the drug itself, including its half-life, metabolic pathways, and potential interactions with other medications
• how patients take their medications, including dose, frequency, and pattern of drug use
• all the medications that patients are taking, including prescription, over-the-counter, and herbal and supplemental preparations
• when the last dose of a prescribed controlled substance was taken. Always ask when the patient’s last dose was taken before you consider ordering a UDT.

To help better understand UDT results, Figure 1¹⁴ and Figure 2¹⁵ demonstrate metabolic pathways of commonly used benzodiazepines and opioids, respectively. There are several comprehensive reviews on commonly seen false positives and negatives for each drug or each class of drugs in immunoassays.^16-21 Confirmatory tests are usually very accurate. However, chiral analysis is needed to differentiate enantiomers, such as methamphetamine (active R-enantiomer) and selegiline, which is metabolized into L-methamphetamine (inactive S-enantiomer).²² In addition, detection of tetrahydrocannabivarin (THCV), an ingredient of the cannabis plant, via GC/MS can be used to distinguish between consumption of dronabinol and natural cannabis products.²³ The Table^16-21 summarizes the proto­type agents, other detectable agents in the same class, and false positives and negatives in immunoassays.

Interpreting UDT results and management strategies

Our Algorithm outlines how to interpret UDT results, and management strategies to consider based on whether the results are as expected or unexpected, with a few key caveats as described below.

Expected results

If there are no concerns based on the patient’s clinical presentation or collateral information, simply continue the current treatment. However, for patients taking medications that are undetectable by UDS (for example, regular use of clonazepam or oxycodone), consider ordering confirmatory tests at least once to ensure compliance, even when UDS results are negative.

Unexpected positive results, including the presence of illicit drugs and/or unprescribed licit drugs

Drug misuse, abuse, or dependence. The first step is to talk with the patient, who may acknowledge drug misuse, abuse, or dependence. Next, consider modifying the treatment plan; this may include more frequent monitoring and visits, limiting or discontinuing prescribed controlled substances, or referring the patient to inpatient or outpatient SUD treatment, as appropriate.

Continue to: Interference from medications or diet

Interference from medications or diets. One example of a positive opioid screening result due to interference from diet is the consumption of foods that contain poppy seeds. Because of this potential interference, the cutoff value for a positive opioid immunoassay in workplace drug testing was increased from 300 to 2,000 ug/L.²⁴ Educating patients regarding medication and lifestyle choices can help them avoid any interference with drug monitoring. Confirmatory tests can be ordered at the clinician’s discretion. The same principle applies to medication choice when prescribing. For example, a patient taking bupropion may experience a false positive result on a UDS for amphetamines, and a different antidepressant might be a better choice (Box 1).

Box 1

Urine sample tampering. Consider the possibility that urine samples could be substituted, especially when there are signs or indications of tampering, such as a positive pregnancy test for a male patient, or the presence of multiple prescription medications not prescribed to the patient. If there is high suspicion of urine sample tampering, consider observed urine sample collection.

When to order confirmatory tests for unexpected positive results.

Order a confirmatory test if a patient adamantly denies taking the substance(s) for which he/she has screened positive, and there’s no other explanation for the positive result. Continue the patient’s current treatment if the confirmatory test is negative. However, if the confirmatory test is positive, then modify the treatment plan (Algorithm).

Special circumstances.

A positive opioid screen in a patient who has been prescribed a synthetic or semisynthetic opioid indicates the patient is likely using opioids other than the one he/she has been prescribed. Similarly, clonazepam is expected to be negative in a benzodiazepine immunoassay. If such testing is positive, consider the possibility that the patient is taking other benzodiazepines, such as diazepam. The results of UDTs can also be complicated by common metabolites in the same class of drugs. For example, the presence of hydromorphone for patients taking hydrocodone does not necessarily indicate the use of hydromorphone, because hydromorphone is a metabolite of hydrocodone (Figure 2¹⁵).

Unexpected negative results

Prescribed medications exist in low concentration that are below the UDS detection threshold. This unexpected UDS result could occur if patients:

• take their medications less often than prescribed (because of financial difficulties or the patient feels better and does not think he/she needs it, etc.)
• hydrate too much (intentionally or unintentionally), are pregnant, or are fast metabolizers (Box 2)
• take other medications that increase the metabolism of the prescribed medication.

Box 2

Continue to: Further inquiry will...

Further inquiry will clarify these concerns. Clinicians should educate patients and manage accordingly. Confirmatory tests may be ordered upon clinicians’ discretion.

Urine sample tampering. Dilution or substitution of urine samples may lead to unexpected negative results. Usually, the urine sample will have abnormal parameters, including temperature, pH, specific gravity, urine creatinine level, or detection of adulterants. If needed, consider observed urine sample collection. Jaffee et al²⁵ reviewed tampering methods in urine drug testing.

Diversion or binge use of medications. If patients adamantly deny diverting or binge using their medication, order confirmatory tests. If the confirmatory test also is negative, modify the treatment plan accordingly, and consider the following options:

• adjust the medication dosage or frequency
• discontinue the medication
• conduct pill counts for more definitive evidence of diversion or misuse, especially if discontinuation may lead to potential harm (for example, for patients prescribed buprenorphine for opioid use disorder).

When to order confirmatory tests for unexpected negative results.

Because confirmatory tests also measure drug concentrations, clinicians sometimes order serial confirmatory testing to monitor lipophilic drugs after a patient reports discontinuation, such as in the case of a patient using marijuana, ketamine, or alprazolam. The level of a lipophilic drug, such as these 3, should continue to decline if the patient has discontinued using it. However, because the drug level is affected by how concentrated the urine samples are, it is necessary to compare the ratios of drug levels over urine creatinine levels.²⁶ Another use for confirmatory-quantitative testing is to detect “urine spiking,”^27,28 when a patient adds an unconsumed drug to his/her urine sample to produce a positive result without actually taking the drug (Box 3).

Box 3

When to consult lab specialists

Because many clinicians may find it challenging to stay abreast of all of the factors necessary to properly interpret UDT results, consulting with qualified laboratory professionals is appropriate when needed. For example, a patient was prescribed codeine, and his UDTs showed morphine as anticipated; however, the prescribing clinician suspected that the patient was also using heroin. In this case, consultation with a specialist may be warranted to look for 6-mono-acetylemorphine (6-MAM, a unique heroin metabolite) and/or the ratio of morphine to codeine.

Continue to: In summary...

In summary, UDTs are important tools to use in general psychiatry practice, especially when prescribing controlled substances. To use UDTs effectively, it is essential to possess knowledge of drug metabolism and the limitations of these tests. All immunoassay results should be considered as presumptive, and confirmatory tests are often needed for making treatment decisions. Many clinicians are unlikely to possess all the knowledge needed to correctly interpret UDTs, and in some cases, communication with qualified laboratory professionals may be necessary. In addition, the patient’s history and clinical presentation, collateral information, and data from prescription drug monitoring programs are all important factors to consider.

The cost of UDTs, variable insurance coverage, and a lack of on-site laboratory services can be deterrents to implementing UDTs as recommended. These factors vary significantly across regions, facilities, and insurance providers (see Related Resources). If faced with these issues and you expect to often need UDTs in your practice, consider using point-of-care UDTs as an alternative to improve access, convenience, and possibly cost.

Bottom Line

Urine drug tests (UDTs) should be standard clinical practice when prescribing controlled substances and treating patients with substance use disorders in the outpatient setting. Clinicians need to be knowledgeable about the limitations of UDTs, drug metabolism, and relevant patient history to interpret UDTs proficiently for optimal patient care. Consult laboratory specialists when needed to help interpret the results.

Related Resources

• Islam FA, Choudhry Z. Urine drug screens: Not just for job applicants. Current Psychiatry. 2018;17(12):43-44.
• HealthCare.gov. Health benefits & coverage: Mental health & substance abuse coverage. www.healthcare.gov/coverage/mental-health-substance-abuse-coverage/.

Drug Brand Names

Alprazolam • Xanax
Amphetamine • Adderall
Atomoxetine • Strattera
Buprenorphine • Subutex
Buprenorphine/naloxone • Suboxone, Zubsolv
Bupropion • Wellbutrin, Zyban
Chlordiazepoxide • Librium
Chlorpromazine • Thorazine
Clonazepam • Klonopin
Desipramine • Norpramin
Dextroamphetamine • Dexedrine, ProCentra
Diazepam • Valium
Doxepin • Silenor
Dronabinol • Marinol
Efavirenz • Sustiva
Ephedrine • Akovaz
Fentanyl • Actiq, Duragesic
Flurazepam • Dalmane
Hydrocodone • Hysingla, Zohydro ER
Hydromorphone • Dilaudid, Exalgo
Labetalol • Normodyne, Trandate
Lamotrigine • Lamictal
Lisdexamfetamine • Vyvanse
Lithium • Eskalith, Lithobid
Lorazepam • Ativan
Meperidine • Demerol
Metformin • Fortamet, Glucophage
Methadone • Dolophine, Methadose
Methylphenidate • Ritalin
Midazolam • Versed
Morphine • Kadian, MorphaBond
Nabilone • Cesamet
Naltrexone • Vivitrol
Oxaprozin • Daypro
Oxazepam • Serax
Oxycodone • Oxycontin
Oxymorphone • Opana
Phentermine • Adipex-P, Ionamin
Promethazine • Phenergan
Quetiapine • Seroquel
Ranitidine • Zantac
Rifampicin • Rifadin
Selegiline • Eldepryl, Zelapar
Sertraline • Zoloft
Temazepam • Restoril
Thioridazine • Mellaril
Tramadol • Conzip, Ultram
Trazodone • Desyrel
Triazolam • Halcion
Venlafaxine • Effexor
Verapamil • Calan, Verelan
Zolpidem • Ambien