jurisdiction: US

text: b' Department of Veterans Affairs\n Office of Inspector General\n\n\n\n Office of Healthcare Inspections\n\nReport No. 14-00895-163\n\n\n\n\n Healthcare Inspection - VA Patterns \n\n of Dispensing \n\n Take-Home Opioids and Monitoring \n\n Patients on Opioid Therapy \n\n\n\n\n\nMay 14, 2014\n\n Washington, DC 20420\n\x0cTo Report Suspected Wrongdoing in VA Programs and Operations:\n Telephone: 1-800-488-8244\n E-Mail: vaoighotline@va.gov\n Web site: www.va.gov/oig\n\x0cVA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n Glossary\n\n CPG VA/DoD Clinical Practice Guideline for Management\n of Opioid Therapy for Chronic Pain\n DoD Department of Defense\n FDA Food and Drug Administration\n FY fiscal year\n g grams\n mg milligrams\n OEF/OIF Operation Enduring Freedom and Operation Iraqi\n Freedom\n PTSD post-traumatic stress disorder\n SUD substance use disorder\n UDT urine drug test\n VAMC VA Medical Center, which includes all medical\n centers and Community-Based Outpatient Clinics\n that are under the same facility (Director)\n administrative leadership\n VHA Veterans Health Administration\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Table of Contents \n\n Page\nExecutive Summary ................................................................................................... i\n\nIntroduction ................................................................................................................ 1\n\n Purpose .................................................................................................................. 1\n\n Background ............................................................................................................. 1\n\n Pain and Opioid Use.......................................................................................... 1\n\n Adverse Effects of Opioid Therapy .................................................................... 2\n\n Selected Recommendations from the VA/DoD Clinical Practice Guideline for \n\n Management of Opioid Therapy for Chronic Pain (CPG) .............................. 3\n\n Medication Reconciliation .................................................................................. 3\n\n Benzodiazepines ............................................................................................... 4\n\n Acetaminophen.................................................................................................. 4\n\n Scope and Methodology ......................................................................................... 5\n\n Study Population ............................................................................................... 5\n\n Chronic Users and Non-Chronic Users of Opioids ....................................... 6\n\n Data and Study Variables .................................................................................. 6\n\n Prevalence of Patients Dispensed Take-Home Opioids in FY 2012 ............ 7\n\n Baseline Characteristics ............................................................................... 7\n\n Dispensing Patterns ..................................................................................... 9\n\n Screening and Monitoring Patients on Take-Home Opioids ......................... 10\n\n Prevalence of Serious Adverse Effects ........................................................ 13\n\n Psychosocial Treatment for Pain, Pain Clinic Service, and Medication \n\n Management/Pharmacy Reconciliation .................................................... 14\n\n Statistical Analyses ................................................................................................. 15\n\nResults and Conclusions .......................................................................................... 16\n\n 1. Prevalence of VA Patients Dispensed Take-Home Opioids ................................ 16\n\n 2. Baseline Characteristics of VA Take-Home Opioid Patients ............................... 17\n\n 3. VA Dispensing Patterns of Take-Home Opioids ................................................. 20\n\n 4. VA Patterns of Screening and Monitoring Opioid Patients ..................................\t 23\n\n New Patients on Take-Home Opioids ............................................................. 23\n\n Existing Patients on Take-Home Opioids........................................................ 26\n\n Active (Not in Remission) Substance Use Patients ........................................ 31\n\n 5. VA Patterns of Providing Psychosocial Treatment for Pain, Pain Clinic \n\n Service, and Medication Management/Pharmacy Reconciliation for \n\n Take-Home Opioid Patients ............................................................................ 34\n\n 6. Prevalence of Serious Adverse Effects Among Take-Home Opioid Patients ...... 36\n\n Conclusions ............................................................................................................ 37\n\n Recommendations .................................................................................................. 43\n\nAppendixes\n A. Additional Exhibits ............................................................................................ 44\n\n B1. Codes for Identifying Hospice and Palliative Care ........................................... 48\n\n B2. VA Intermediate Product Numbers for Identifying Urine Drug Tests by Test \n\n Substance Type .......................................................................................... 49\n\n C. Under Secretary for Health Comments ............................................................ 50\n\n D. OIG Contact and Staff Acknowledgments ........................................................ 58\n\n E. Report Distribution ........................................................................................... 59\n\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n Executive Summary \n\nIntroduction\nAs requested by the United States Senate Committee on Veterans\xe2\x80\x99 Affairs, the VA\nOffice of Inspector General conducted a study to assess the provision of VA outpatient\n(take-home) opioids and monitoring of patients on opioid therapy (hereinafter referred to\nas opioid patients). Specifically, we described both the prevalence of VA patients who\nfilled any take-home opioid prescriptions at VA in fiscal year (FY) 2012 and their\nbaseline characteristics; evaluated VA dispensing patterns of take-home opioids,\nincluding concurrent (filled) benzodiazepines, filled dose of acetaminophen, and early\nrefills of opioids; and assessed the extent to which VA screens and monitors opioid\npatients in alignment with measures adapted from selected recommendations in the\nVA/Department of Defense Clinical Practice Guideline for Management of Opioid\nTherapy for Chronic Pain (hereinafter referred to as the Clinical Practice Guideline). We\nalso defined VA patterns of providing psychosocial treatment for pain, Pain Clinic\nservice, and medication management/pharmacy reconciliation for take-home opioid\npatients and determined the prevalence of six selected serious clinical adverse effects\namong VA take-home opioid patients that may be reasonably expected to be related to\nopioid therapy.\n\nWe integrated and analyzed the VA administrative files, as well as the Death Master\nFiles of the Social Security Administration, for the population of nearly half a\nmillion VA patients who filled at least 1 oral or transdermal opioid prescription from VA\nfor self-administration at home in FY 2012. We followed retrospectively the\n442,544 patients in the population\xe2\x80\x94who did not receive any hospice or palliative care\nduring the FY or within 1 year prior to their first take-home opioid prescription\xe2\x80\x94for their\nexperience with the provision of VA opioid therapy.\n\nResults and Conclusions\nWe found that 7.7 percent of VA patients were on take-home opioids in FY 2012. The\nVA Medical Center (VAMC)1 prevalence ranged from 0.26 percent to 21.8 percent.\n\nA majority (92.5 percent) of the opioid patients were male, which mirrored the gender\ncomposition of VA patients. The average and the median patient age at their first opioid\nprescription in FY 2012 was 59.4 and 61, respectively. Approximately 1 in every\n16 patients had served in Operation Enduring Freedom and Operation Iraqi Freedom.\nApproximately 87 percent of the opioid patients were diagnosed with primary pain site2\nof non-cancer origin that could result in pain serious enough to warrant an opioid\nmedication. Six out of 10 patients had been diagnosed with mental health issues, one\nthird with mood disorders, 1 of 5 with post-traumatic stress disorder, and 1 of 7 with\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) \n\nadministrative leadership. \n\n2\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk \n\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947. \n\n\n\nVA Office of Inspector General i\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nsubstance use. Nearly 94 percent of the study population had been diagnosed with\neither pain or mental health issues and 58.4 percent with both.\n\nAbout one third of the opioid patients were on take-home opioids for more than 90 days\n(chronic users) in FY 2012. Approximately half of the study population were new\npatients in the sense that they were initiated on take-home opioid therapy during\nFY 2012 after not having been on take-home opioids for at least more than 1 year.\nSeven out of 10 of the non-chronic users were new patients in contrast to 1 in 5 of the\nchronic users. Nearly 41 percent of the study population had been dispensed with\n1 prescription. This 41 percent was composed entirely of the 61.4 percent of\nnon-chronic users because none of the opioids were allowed to be prescribed for more\nthan 90 days in 1 prescription. Patients with 6 or more prescriptions were mainly\nchronic users, which amounted to 69.3 percent of that group.\n\nAlmost all (98.4 percent) patients received their prescriptions from a single VAMC, and\nthree quarters of the patient population had all their (filled) prescriptions issued from a\nsingle prescriber. Most (95.0 percent) of the patients were dispensed with a single type\nof opioid. More than 6 percent of patients received at least 1 long-acting opioid product,\nwith the percentage of chronic users being 4 times that of non-chronic users. Opioid\ndosages with a morphine equivalent of at least 200 milligrams (mg)/day were dispensed\nto 1.2 percent of the study population. We found that refills of opioids at least 7 days\nearly occurred in 23.0 percent of the population, with refills of at least 11 days early in\n14.0 percent of the population.\n\nThe concurrent use of benzodiazepines and opioids can be dangerous because opioids\nand benzodiazepines can depress the central nervous system and thereby affect heart\nrhythm, slow respiration, and even lead to death. We found that take-home\nbenzodiazepines were dispensed to 7.4 percent of the study population, with the\npercentage of chronic opioid users being 1.6 times that of non-chronic users. We\ndetermined that 71 percent of the opioid patients who received take-home\nbenzodiazepines were dispensed benzodiazepines concurrently with opioids. The\npercentage of chronic opioid users with concurrent benzodiazepines was 92.6, and the\npercentage of non-chronic users was 53.6.\n\nAcetaminophen poisoning is a leading cause of liver toxicity. The Clinical Practice\nGuideline specifically recommends not exceeding the maximum recommended daily\ndose of acetaminophen. We determined that take-home acetaminophens were given to\n92.3 percent of the study patients and that 2.0 percent of them were given an average\ndaily dose of 4 g/day or more. We found that 45.5 percent of chronic users were given\nat least 1 day dosage of 4 grams or more of acetaminophen and that 43.5 percent were\ngiven at least 1 day dosage of 4 grams or more concurrently with opioids, which was\nmore than double that (19.4 percent and 13.3 percent, respectively) of non-chronic\nusers.\n\nThe Clinical Practice Guideline calls for a urine drug test (UDT) prior to initiating opioid\ntherapy and a follow-up contact at least every 2\xe2\x80\x934 weeks after any change in\nmedication regimen. We determined that 6.4 percent of the new patients\xe2\x80\x94who were\n\n\nVA Office of Inspector General ii\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\ninitiated take-home opioids in FY 2012 after not having been on take-home opioids for\nat least more than 1 year\xe2\x80\x94received both a UDT prior to and a follow-up within 30 days.\nWe observed broad variation among 140 VAMCs\xe2\x80\x99 practice on this measure, ranging\nfrom 1.1 percent to 32.2 percent, with the middle 50 percent of the VAMCs from\n3.9 percent to 10.2 percent. This very low VA rate of screening and monitoring new\npatients almost exclusively resulted from the very low rate of a UDT. We found that\n7.6 percent of the new patients had a UDT within 30 days prior to initiating therapy.\nEven for the high-risk group of patients who were diagnosed with substance use\ndisorder (SUD) within 1 year prior to the initiation of opioid therapy, a UDT was\nperformed for 1 out of 5 patients.\n\nThe Clinical Practice Guideline requires routine and random UDTs to confirm the\nappropriate use of opioids by patients and a follow-up contact at least once every\n1\xe2\x80\x936 months for the duration of opioid therapy. We determined that 37.0 percent of the\nexisting opioid patients\xe2\x80\x94who were on take-home opioids at least from\nFY 2011\xe2\x80\x94received both an annual UDT and a follow-up contact within 6 months of\neach filled opioid prescription, varying extensively from 4.2 percent to 91.0 percent\namong VAMCs. The low VA rate of monitoring opioid patients resulted mainly from the\nlow rate of an annual UDT. We found that VA conducted an annual UDT for\n37.9 percent of the existing opioid patients. We observed wide variation of VAMCs\xe2\x80\x99\npractice of conducting an annual UDT, ranging from 4.4 percent to 87.6 percent. Even\nfor the chronic opioid users, the annual UDT rate was 40.9 percent.\n\nWe found that 13.1 percent of the study population was diagnosed with active\nsubstance use. The Clinical Practice Guideline specifies that chronic (for more than\n1 month) opioid therapy is absolutely contraindicated in patients with active (not in\nremission) SUDs who are not in treatment. It recommends that active substance use\npatients receive SUD treatment concurrently with urine drug testing as an adjunctive\ntool at regular intervals. For the active substance use patients who had at least 90 days\navailable for follow-up in FY 2012, we determined that 10.5 percent received both a\ntreatment for substance use and a UDT within 90 days of each filled opioid prescription.\nThe percentages of VAMCs varied from 0.00 to 44.8. Even for the subpopulation of\n19,724 active substance use patients who were on opioids for more than 90 days in\nFY 2012, we determined that only 18.8 percent of them received both an SUD treatment\nin the FY and a UDT for each 90 days on opioids, with VAMC percentages ranging from\n0.00 to 82.7.\n\nPsychotherapy, including cognitive behavioral therapy, is recommended to reduce pain\nand improve function in chronic pain patients. We found that 45.2 percent of the opioid\npatients received at least 1 psychosocial treatment for pain and that 35.1 percent of\nthese patients received this treatment after their first filled opioid prescription in\nFY 2012. The VAMC percentages for providing psychosocial treatments for pain\nranged from 26.9 to 93.7 in FY 2012.\n\nTreatment of chronic pain requires care to recover or maintain physical, social, and\noccupational function and may include Pain Clinic service. We determined that\n8.7 percent of the opioid patients received care from a Pain Clinic. Three quarters of\n\n\nVA Office of Inspector General iii\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nthe VAMCs provided Pain Clinic service to 15.0 percent or less of their opioid patients in\nthe FY, although 1 VAMC provided this rehabilitation service to 73.5 percent of its\npatients.\n\nOpioid patients frequently have complex co-morbid conditions, making them more likely\nto be given multiple medications that can interact dangerously with opioid medications.\nA review of medications by a pharmacist or other health care professional can prevent\nharmful interactions between these medications. We found that 38.8 percent of the\nopioid patients received medication management or pharmacy reconciliation during the\nFY, with the percentages varying from 6.4 to 86.5 across the 140 VAMCs.\n\nIncreasing use of opioids has been associated with increasing rates of opioid-related\nserious adverse effects. We determined percentages of opioid patients with evidence of\na serious adverse effect that may be reasonably expected to be related to opioid\ntherapy for the following six serious adverse effects: (1) opioid overdose, (2) sedative\noverdose, (3) drug delirium, (4) drug detoxification, (5) acetaminophen overdose, and\n(6) possible and confirmed suicide attempts. We found that less than 1 percent of the\npopulation experienced each of these adverse effects during the FY, except for the\nadverse effect of possible and confirmed suicide attempts that was evident in\n2.0 percent of the opioid patients.\n\nRecommendations\n1. We recommended that the Under Secretary for Health ensure that the practice of\nprescribing acetaminophen is in compliance with acceptable standards.\n\n2. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s practice\nof routine and random urine drug tests prior to initiating and during take-home opioid\ntherapy to confirm the appropriate use of opioids is in alignment with acceptable\nstandards.\n\n3. We recommended that the Under Secretary for Health ensure that follow-up\nevaluations of patients on take-home opioids are performed timely.\n\n4. We recommended that the Under Secretary for Health ensure that opioid patients\nwith active (not in remission) substance use receive treatment for substance use\nconcurrently with urine drug tests.\n\n5. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s practice\nof prescribing and dispensing benzodiazepines concurrently with opioids is in alignment\nwith acceptable standards.\n\n6. We recommended that the Under Secretary for Health ensure that medication\nreconciliation is performed to prevent adverse drug interactions.\n\n\n\n\nVA Office of Inspector General iv\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nComments\nThe Under Secretary for Health agreed with the findings and recommendations and\nprovided acceptable improvement plans. (See Appendix C, pages 50\xe2\x80\x9357, for the full\ntext of the comments.) We will follow up on the planned actions until they are\ncompleted.\n\n\n\n\n JOHN D. DAIGH, JR., M.D.\n Assistant Inspector General for\n Healthcare Inspections\n\n\n\n\nVA Office of Inspector General v\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n Introduction \n\nPurpose\nAs requested by the United States (U.S.) Senate Committee on Veterans\xe2\x80\x99 Affairs, the\nVA Office of Inspector General (OIG) conducted a study to assess the provision of VA\noutpatient (take-home) opioids and monitoring of patients on opioid therapy (hereinafter\nreferred to as opioid patients). The study objectives were to:\n\n \xe2\x80\xa2 \t Describe both the prevalence of VA patients who filled any take-home opioid\n prescriptions at VA in fiscal year (FY) 2012 and their baseline characteristics.\n\n \xe2\x80\xa2 \t Evaluate VA dispensing patterns of take-home opioids, including concurrent (filled)\n benzodiazepines, filled dose of acetaminophen, and early refills of opioids.\n\n \xe2\x80\xa2 \t Assess the extent to which VA screens and monitors opioid patients in alignment\n with measures adapted from selected recommendations in the VA/Department of\n Defense (DoD) Clinical Practice Guideline for Management of Opioid Therapy for\n Chronic Pain (CPG).\n\n \xe2\x80\xa2 \t Define VA patterns of providing psychosocial treatment for pain, Pain Clinic\n service, and medication management/pharmacy reconciliation for take-home\n opioid patients.\n\n \xe2\x80\xa2 \t Determine the prevalence of six selected serious clinical adverse effects among\n VA take-home opioid patients that may be reasonably expected to be related to\n opioid therapy.\n\nBackground\nPain and Opioid Use. The Institute of Medicine reported that pain affects 100 million\nadults in the U.S. at a cost of up to $635 billion each year in medical treatment and lost\nproductivity.3 The report concluded that to reduce the impact of pain and the resultant\nsuffering required cultural transformation on how pain is perceived and judged by\npeople with pain and health care providers who care for them.\n\nMore than 50 percent of all veterans enrolled and receiving care at VHA are affected by\nchronic pain, which is a much higher rate than in the general adult population.4\nVeterans who suffer from chronic pain also experience much higher rates of other\nco-morbidities (post-traumatic stress disorder (PTSD), depression, traumatic brain\ninjury) and socioeconomic dynamics (disability, joblessness) that may contribute to the\nchallenges of pain management when treated with opioids.\n\n3\n Committee on Advancing Pain Research, Care, and Education; Institute of Medicine (2011). Relieving Pain in\nAmerica: A Blueprint for Transforming Prevention, Care, Education, and Research, The National Academies Press.\n4\n Statement of Dr. Robert L. Jesse, M.D., Principal Deputy Under Secretary for Health, Veterans Health\nAdministration, Before the Subcommittee on Health, U.S. House of Representatives, October 10, 2013.\n\n\nVA Office of Inspector General 1\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nIn 1998, the VHA National Pain Management Strategy was initiated, which established\npain management as a national priority. The overall objective of the strategy is to\ndevelop a comprehensive, integrated system-wide approach to pain management that\nreduces pain and suffering and improves quality of life for veterans experiencing acute\nand chronic pain. In 2009, VHA issued a directive5 for the improvement of pain\nmanagement consistent with the VHA National Pain Management Strategy.\n\nIn 2003, VA and DoD published the first Clinical Practice Guideline for Management of\nOpioid Therapy for Chronic Pain (CPG) to improve pain management, quality of life, and\nquality of care for veterans. The CPG was revised in 2010 to update the evidence base\nof the original CPG.6 Additionally, the scope was widened to include patients with\ncancer who have chronic pain because of cancer or the treatment they are receiving.\n\nOpioid therapy is intended for patients who suffer from moderate to severe chronic pain\nand who have been previously assessed and treated with non-opioid or\nnon-pharmacological therapy with no response or with limited success or response and\nwho may benefit from opioid therapy for pain control. Opioids are powerful medications\nthat can help manage pain when prescribed for the right condition and when used\nproperly. However, if prescribed inappropriately or if used improperly, they can cause\nserious harm, including overdose and death. Patient adherence with the proper use of\nopioids is crucial in the delivery of appropriate opioid therapy. Patient assessments,\nfollow-up evaluations, and urine drug tests (UDTs) are recommended monitoring tools\nfor safe and effective use of opioids.\n\nAdverse Effects of Opioid Therapy. While opioids are useful for managing chronic\npain, adverse effects are potential limitations to their use.7 Therefore, providers need to\nweigh the risks against the benefits of opioid use either alone or in combination with\nother medications that could cause adverse effects, such as benzodiazepines, and\nagainst expected effects such as constipation. For opioid patients taking\nacetaminophen products, providers must be aware of the maximum recommended daily\ndose of acetaminophen.\n\nEven a single large dose of opioids can cause severe respiratory depression or death.\nLong-term use or abuse of opioids can lead to physical dependence, a normal\nadaptation to chronic exposure, and addiction. In cases of long-term use or abuse,\nwithdrawal symptoms may occur if opioids are too rapidly reduced or stopped without\ntapering. These symptoms can include restlessness, muscle and bone pain, insomnia,\ndiarrhea, vomiting, and involuntary leg movements.\n\nIn general, extreme caution must be used when prescribing opioids with other\nsubstances that depress the central nervous system (CNS), such as benzodiazepines,\n\n\n5\n VHA Directive 2009-053, Pain Management, October 28, 2009.\n\n6\n http://vaww1.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_fulltext.pdf. Last accessed \n\nDecember 19, 2013. \n\n7\n Swegle, J. M. and C. Logemann (2006). \xe2\x80\x9cManagement of common opioid-induced adverse effects.\xe2\x80\x9d \n\nAm Fam Physician 74(8): 1347\xe2\x80\x931354. \n\n\n\nVA Office of Inspector General 2\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nbecause in combination, there is an increased risk of life-threatening respiratory\ndepression.8\n\nSelected Recommendations from the VA/DoD Clinical Practice Guideline for\nManagement of Opioid Therapy for Chronic Pain (CPG).9 The CPG provides\neducation and guidance on chronic (more than 1 month) opioid therapy to providers.\nHowever, some CPG recommendations are applicable to all patients on opioid therapy,\nregardless of the length of time. Specifically, the CPG provides the following\nrecommendations for urine drug tests (UDTs), follow-up evaluations, and bowel\nregimen:\n\n \xe2\x80\xa2 \t UDTs. The CPG recommends routine and random UDTs prior to initiation of and\n during opioid therapy (p. 59). The frequency of UDTs should be increased based\n on risk level for aberrant drug-related behaviors and following each dose increase\n (pp. 51 and 60). The risk of opioid misuse in patients on opioid therapy is reported\n to be as high as 30 percent (p. 59), and patients with a history of substance use\n disorder (SUD) are at higher risk of developing problematic drug use, addiction, or\n relapse. UDTs can identify patients using illicit substances and can assist in the\n diagnosis of SUD. They can also help identify patient adherence to opioid therapy\n and drug diversion.\n\n \xe2\x80\xa2 \t Follow-up evaluations. The CPG recommends scheduled follow-up visits at least\n every 2\xe2\x80\x934 weeks after any change in medication regimen and at least once every\n 1\xe2\x80\x936 months for the duration of opioid therapy (p. 82). Patients are to be assessed\n for effectiveness of opioid therapy, adverse effects, and adherence to therapy\n (p. 82). Pertinent laboratory studies are to be performed as necessary. Patients\n with certain medical conditions require more frequent follow-up visits. These\n include patients with significant respiratory depression, asthma, chronic obstructive\n pulmonary disease, obstructive sleep apnea, paralytic ileus, anxiety disorder,\n personality disorder, increased risk of suicide, and SUD history.\n\n \xe2\x80\xa2 \t Bowel regimen. The CPG recommends routine initiation of a bowel regimen that\n includes both a stimulant and a stool softener at the commencement of opioid\n therapy and patient assessment for opioid related adverse effects at every office\n and follow-up visit (p. 70).\n\nMedication Reconciliation. Medication reconciliation ensures the maintenance of\naccurate, safe, effective, and above all, patient centered medication information.10 One\nof the Joint Commission\xe2\x80\x99s national patient safety goals is medication safety by\nmaintaining and communicating accurate patient medication information.11\n\n\n8\n Jones, J. D., S. Mogali, et al. (2012). \xe2\x80\x9cPolydrug abuse: a review of opioid and benzodiazepine combination use.\xe2\x80\x9d \n\nDrug Alcohol Depend 125(1\xe2\x80\x932): 8\xe2\x80\x9318.\n\n9\n http://vaww1.va.gov/PAINMANAGEMENT/docs/CPG_opioidtherapy_fulltext.pdf. Last accessed \n\nDecember 19, 2013. \n\n10\n VHA Directive 2011-012, Medication Reconciliation, March 9, 2011.\n\n11\n The Joint Commission Sentinel Event Alert, Issue 35, January 25, 2006. \n\n\n\nVA Office of Inspector General 3\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nVHA requires that medication reconciliation be performed across the continuum of care,\nincluding outpatient encounters, to prevent adverse drug interactions. VHA also\nrequires that patients be educated about their medications prior to or at the time of\ndispensing according to the patient\xe2\x80\x99s individualized drug regimen.12 Clinicians are\nrequired to discuss necessary drug information, potential drug interactions, and\nnecessary laboratory tests for monitoring medication therapy outcomes and to evaluate\nthe medication order to ensure appropriate dosing, taking into account the renal and\nliver function of the patient. Prior to initiating opioid therapy, the CPG recommends that\nproviders carefully evaluate potential drug interactions (such as methadone with\nbenzodiazepines and fentanyl with alcohol and other CNS depressants) (p. 25).\n\nBenzodiazepines. Benzodiazepines are a type of psychoactive (mind-altering)\nmedication known as tranquilizers that are most often prescribed to treat anxiety, acute\nstress reactions, panic attacks, seizures, and sleep disorders. They are one of the most\nwidely prescribed medications in the U.S., particularly among elderly patients. Familiar\nnames include Valium\xc2\xae and Xanax\xc2\xae. Benzodiazepines act on the CNS to slow its\nfunction and promote relaxation, thereby reducing muscle tension and other physical\nsymptoms of anxiety. Benzodiazepines may cause respiratory depression in\nsusceptible patients. Therefore, they generally should not be used with opioids\nbecause the combination increases the risk of life-threatening respiratory depression.\n\nBenzodiazepines have the potential for abuse. They can be chronically abused, or\nintentionally or accidentally taken in overdose. While death and serious illness rarely\nresult from benzodiazepine abuse alone, the concurrent use of benzodiazepines and\nopioids can be dangerous because both depress the CNS.13 Benzodiazepines have\nbeen strongly associated with death from opioid overdose.14\n\nAcetaminophen. Acetaminophen (for example Tylenol\xc2\xae) is a type of medication used\nto relieve pain and reduce fever. It is among the most commonly used drugs in the U.S.\nIn addition to its availability as an over-the-counter product, acetaminophen is used in\nmany prescription products in combination with other drugs, usually opioids, such as\ncodeine (Tylenol with Codeine\xc2\xae), hydrocodone (Vicodin\xc2\xae), and oxycodone\n(Percocet\xc2\xae). The labels of acetaminophen-containing drug products may not spell out\nthe whole word or may have an abbreviation such as APAP.\n\nAcetaminophen poisoning is a leading cause of liver toxicity.15 In a consumer update\nposted to its website, the Food and Drug Administration (FDA)16 pointed out that\n\n\n\n12\n VHA Handbook 1108.05, Outpatient Pharmacy Services, May 30, 2006. \n\n13\n Jones, J. D., S. Mogali, et al. (2012). \xe2\x80\x9cPolydrug abuse: a review of opioid and benzodiazepine combination use.\xe2\x80\x9d \n\nDrug Alcohol Depend 125(1\xe2\x80\x932): 8\xe2\x80\x9318.\n\n14\n Toblin, R. L., L. J. Paulozzi, et al. (2010). \xe2\x80\x9cMental illness and psychotropic drug use among prescription drug\n\noverdose deaths: a medical examiner chart review.\xe2\x80\x9d J Clin Psychiatry 71(4): 491\xe2\x80\x93496. \n\n15\n Larson, A. M., J. Polson, et al. (2005). \xe2\x80\x9cAcetaminophen-induced acute liver failure: results of a United States \n\nmulticenter, prospective study.\xe2\x80\x9d Hepatology 42(6): 1364\xe2\x80\x931372. \n\n16\n http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM239891.pdf. Last accessed \n\nNovember 27, 2013.\n\n\n\nVA Office of Inspector General 4\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\xe2\x80\x9cOverdoses from prescription products containing acetaminophen account for nearly\nhalf of all cases of acetaminophen-related liver failure in the U.S., many of which result\nin liver transplant or death.\xe2\x80\x9d Aimed at reducing acetaminophen risks, on\nJanuary 13, 2011, the FDA announced its requirement for a boxed warning on all\nprescription acetaminophen products that highlights the potential risk for severe liver\ninjury. Boxed warnings are the FDA\xe2\x80\x99s strongest warnings for prescription drug products\nand are used for calling attention to serious or life-threatening risks.\n\nMost current guidance requires that patients consume no more than 4 grams (g) of\nacetaminophen per day. However, the FDA recommends less than 4 grams per day17\nbecause of concerns about acetaminophen\xe2\x80\x99s widespread availability and because\npatients are often not aware of and may not inform their providers about other\nacetaminophen use.\n\nScope and Methodology\nThe study population contains all VA patients who filled at least 1 oral or transdermal\nopioid prescription from VA for self-administration at home in FY 2012 and who did not\nreceive any hospice or palliative care during the FY or within 1 year prior to their first\ntake-home opioid prescription. In addition to following the patients retrospectively\nthrough the end of the FY, we also looked back to evaluate whether they filled any\nopioid prescriptions for take-home use and whether they experienced certain medical\nconditions during FY 2011. Our study period minimizes background shifts in opioid\nprovision in VA because the VA/DoD Clinical Practice Guideline for Management of\nOpioid Therapy for Chronic Pain was updated in May 2010. The study population\nencompasses some Operation Enduring Freedom and Operation Iraqi Freedom\n(OEF/OIF) era veterans as well as veterans from other service eras (non-OEF/OIF),\nsuch as Operations Desert Shield and Desert Storm. As a result, the outcomes that we\nobserved in this population may be different from those of OEF/OIF veterans only.18\n\nTo address the study objectives, we reviewed pertinent policies, regulations, and\nprocedures on opioid therapy. We also conducted a literature review on opioid use for\npain management. We met and discussed opioid therapy guideline adherence with VA\nsubject matter experts. Additionally, we researched VA administrative databases.\n\nStudy Population. We included all VA patients who filled any oral or transdermal\ntake-home opioid prescriptions from a VA outpatient pharmacy or consolidated mail\noutpatient pharmacy in FY 2012 and who did not receive any hospice or palliative care\nin the FY or within 1 year prior to their first filled prescription.\n\nWe identified the study population using the VA Decision Support System (DSS)\nNational Data Extract (NDE) Pharmacy SAS Datasets, which contain all VA filled\ninpatient and outpatient prescription records. We first identified opioid products using\n\n17\n http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm. Last accessed January 17, 2014. \n\n18\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk \n\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947. \n\n\n\nVA Office of Inspector General 5\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nthe following 10 types of opioids in VA\xe2\x80\x99s National Drug File:19 (1) codeine, (2) fentanyl,\n(3) hydrocodone, (4) hydromorphone, (5) meperidine, (6) methadone, (7) morphine,\n(8) oxycodone, (9) oxymorphone, and (10) tapentadol. We created the opioid list for our\nstudy by including the 1,736 opioid products in the 10 selected opioid types that were\ncategorized as U.S. Drug Enforcement Administration (DEA) schedule II or III controlled\nsubstances in the National Drug File. All the opioids selected for this study are oral\nmedications only except for fentanyl, which also comes in transdermal form.\n\nWe then searched the VA Pharmacy SAS data file to identify VA patients for the study\nby including all those patients who filled at least 1 prescription of the opioids on our list\nin FY 2012 for take-home use. We then linked all these patients with VA administrative\ninpatient and outpatient (including fee basis care) treatment (SAS medical data) files to\nidentify and then exclude those patients who received hospice or palliative care\n(Appendix B1) anytime in FY 2012 or within 1 year of their first take-home opioid\nprescription.\n\nChronic Users and Non-Chronic Users of Opioids. We classified the study population\ninto two subpopulations, chronic users and non-chronic users of opioids, based on the\nnumber of days they were on opioids. We defined patients as chronic users of\nopioids if they were on opioids for more than 90 days in FY 2012 and as non-chronic\nusers if they were on opioids 90 days or less. Rather than a simple sum of the number\nof supply days from all filled prescriptions, we counted overlapping supply days from\ndifferent prescriptions once only for the number of days on opioids. For example, if a\npatient filled 1 prescription that supplied opioids from March 3, 2012, through\nMarch 10, 2012, then filled another prescription that supplied opioids from\nMarch 8, 2012, through March 14, 2012, we counted the number of days on opioids as\n12 instead of 15 after taking into account the overlapping supply days from\nMarch 8, 2012, to March 10, 2012. Exhibit X1 in Appendix A shows our calculation of\ndays on opioids for a patient with 5 filled prescriptions.\n\nData and Study Variables. After we identified the study population, we then linked the\npopulation to FY 2011 and FY 2012 VA administrative SAS medical data files to find\ninformation on VA clinical visits and associated clinical diagnoses, the VA Laboratory\nSAS data files to obtain detailed urine drug test records, and the FY 2011 VA Pharmacy\nSAS data file to check for any filled opioid prescriptions for take-home use during that\nFY.\n\nTo determine patients\xe2\x80\x99 vital status as of the end of FY 2012, we also used the Death\nMaster Files of the Social Security Administration, vital status data from the VA Mini\nVital Status, the Beneficiary Identification Records Locator Subsystem (BIRLS), the\nNational Cemetery System (NCS), and the Patient Treatment File (PTF). We\nconsidered that a patient died in FY 2012 if:\n\n \xe2\x80\xa2 the death date was within the FY, and\n\n19\n The National Drug File lists drugs approved by the FDA and is created and maintained by VA with specific\ninformation, including national drug code, strength, dosage form, unit of measure, and manufacturer.\n\n\nVA Office of Inspector General 6\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n \xe2\x80\xa2 \t after the death date, we did not find any filled take-home prescription records for\n both opioid and benzodiazepine in FY 2012 and did not find any outpatient\n encounters in FY 2012 and FY 2013 (as of April 19, 2013) VA SAS outpatient\n treatment files.\n\nPrevalence of Patients Dispensed Take-Home Opioids in FY 2012. We defined the\nprevalence as the percent of patients who filled any take-home opioids at VA during\nFY 2012. For prevalence by VA Medical Center (VAMC), if a patient received opioid\nprescriptions from different VAMCs, this patient was counted in each of the VAMC\xe2\x80\x99s\nprevalence. However, a patient\xe2\x80\x99s multiple prescriptions from one VAMC were counted\nexactly once for that VAMC\xe2\x80\x99s prevalence.\n\nBaseline Characteristics. We defined a medical condition as a baseline condition if it\nwas diagnosed within 1 year prior to (or at the time of) the patient\xe2\x80\x99s first filled opioid\nprescription in FY 2012. We considered a patient to have a mental health diagnosis if\nthe patient was diagnosed with any specific codes within the category of Mental\nDisorders (290\xe2\x80\x93319) of the International Classification of Diseases, Ninth Revision,\nClinical Modification (ICD-9-CM). The category of Mental Disorders of ICD-9-CM\ncorresponds to the Diagnostic and Statistical Manual of Mental Disorders, Fourth\nEdition, Revised (DSM-IV-R). Except for the category of psychological pain, we used\nHoge\xe2\x80\x99s definitions20 to create the following specific categories of mental health\ndiagnosis based on the following ICD-9-CM diagnostic codes:\n\n \xe2\x80\xa2 A\n \t djustment disorders: 309.0, 309.24, 309.28, 309.3, 309.4, 309.9.\n\n \xe2\x80\xa2 P\n \t ost-traumatic stress disorder (PTSD): 309.81.\n\n \xe2\x80\xa2 \t Anxiety disorders excluding PTSD: 300.00, 300.01, 300.02, 300.21, 300.22,\n 300.23, 300.29, 300.3, 308.3.\n\n \xe2\x80\xa2 \t Mood disorders: 296.0, 296.2\xe2\x80\x93296.7, 296.80, 296.89, 296.90, 300.4, 301.13, 311.\n\n \xe2\x80\xa2 \t Major depression: 296.2, 296.3.\n\n \xe2\x80\xa2 P\n \t ersonality disorders: 301.0, 301.2, 301.4, 301.50, 301.6, 301.7, 301.81\xe2\x80\x93301.84,\n 301.89, 301.9.\n\n \xe2\x80\xa2 \t Psychotic disorders: 295.1\xe2\x80\x93295.4, 295.6, 295.7, 295.9, 297.1, 297.3, 298.8, 298.9.\n\n \xe2\x80\xa2 \t Substance use: 291, 292 (except 292.2), 303\xe2\x80\x93305 (except 305.1 and 305.8).\n\n \xe2\x80\xa2 A\n \t lcohol-related disorders: 291, 303, 305.0.\n\n \xe2\x80\xa2 \t Drug-related disorders: 292 (except 292.2), 304, 305.2\xe2\x80\x93305.7, 305.9.\n\n20\n Hoge, C. W., S. E. Lesikar, et al. (2002). \xe2\x80\x9cMental disorders among U.S. military personnel in the 1990s:\nassociation with high levels of health care utilization and early military attrition.\xe2\x80\x9d Am J Psychiatry 159(9):\n1576\xe2\x80\x931583.\n\n\nVA Office of Inspector General 7\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n \xe2\x80\xa2 \t Psychological pain: 307.80 and 307.89.\n\nWe used Seal\xe2\x80\x99s definitions21 to determine whether a patient was diagnosed with any\nprimary pain. These primary pain site diagnoses included ICD-9-CM non-cancer\ndiagnostic codes that could result in pain serious enough to warrant an opioid\nmedication:\n\n \xe2\x80\xa2 \t Arthritis: 710 (except 710.5), 711, 713, 714, 715, 716, 717, 718, 719.70,\n 719.75\xe2\x80\x93719.79, 720.0, V13.4.\n\n \xe2\x80\xa2 \t Back pain: 720\xe2\x80\x93724 (except 720.0, 723.4, 723.8), 756.1.\n\n \xe2\x80\xa2 \tFractures: 733.1, 733.93\xe2\x80\x93733.98, 800\xe2\x80\x93829, 905.0\xe2\x80\x93905.5, V13.51, V13.52,\n V54.0\xe2\x80\x93V54.2, V66.4, V67.4.\n\n \xe2\x80\xa2 \t Generalized pain: 780.96.\n\n \xe2\x80\xa2 \t Headaches: 307.81, 339, 346 (except 346.6), 784.0.\n\n \xe2\x80\xa2 \t Musculoskeletal pain: 725, 726 (except 726.70, 726.73, 726.79, 726.91), 728.11,\n 728.12, 728.81, 728.83, 728.86, 728.89, 728.9, 729 (except 729.2, 729.3, 729.6,\n 729.81, 729.82), 781.99, 830\xe2\x80\x93848, 905.6, 905.7, V43.6, V43.7, V48.3, V49.6,\n V49.7.\n\n \xe2\x80\xa2 \t Neuropathy: 053.13, 072.72, 337.0, 337.1, 353\xe2\x80\x93357, 377.33, 377.34, 377.41.\n\n \xe2\x80\xa2 \t Other pain: 730, 733.0, 780.96.\n\n \xe2\x80\xa2 \t Reproductive pain: 614, 615, 616.11, 616.2\xe2\x80\x93616.9, 617, 625.1\xe2\x80\x93625.3, 625.5,\n 625.7, 625.8 626.3, 626.5.\n\n \xe2\x80\xa2 \t Visceral pain: 550 (except 550.9), 551.0\xe2\x80\x93551.2, 552.0\xe2\x80\x93552.2, 560.81, 562.01,\n 562.03, 562.11, 562.13, 567.2, 567.8, 569.5, 574, 575.0, 575.1, 577.0, 577.1, 592,\n 594, 596, 788.0, 789.0, 789.6.\n\n \xe2\x80\xa2 \t Wound injury: 860\xe2\x80\x93887 (except 873.63), 890\xe2\x80\x93897, 900\xe2\x80\x93904, 905.8, 905.9, 906,\n 907.2, 908.0\xe2\x80\x93908.4, 925\xe2\x80\x93929, 940\xe2\x80\x93949, 952.\n\nWe determined that a patient was diagnosed with pain of the nervous system and sense\norgans if we found 1 of the following ICD-9-CM diagnostic codes in the category of pain\nof the nervous system and sense organs:\n\n \xe2\x80\xa2 \t Acute pain: 338.1.\n\n \xe2\x80\xa2 \t Chronic pain: 338.2.\n\n\n21\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947.\n\n\nVA Office of Inspector General 8\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n \xe2\x80\xa2 Neoplasm-related pain: 338.3.\n\n \xe2\x80\xa2 Chronic pain syndrome: 338.4.\n\nWe deemed a patient was diagnosed with pain if he or she had a diagnosis of primary\npain site and/or pain of the nervous system and sense organs.\n\nDispensing Patterns. The CPG (p. 18) recommends more careful monitoring of opioid\npatients treated with benzodiazepines as co-administration of these products may result\nin adverse drug interactions. Benzodiazepines have been strongly associated with\ndeath from opioid overdose22 and with an increased risk of death due to methadone\ntoxicity.23 We determined whether the patients were receiving benzodiazepines\nconcurrently with opioids. We defined a patient as having received concurrent\nbenzodiazepine and opioid prescriptions in FY 2012 if the patient had at least 1 filled\ntake-home opioid prescription with supply days that overlapped with the supply days of\nat least 1 filled take-home benzodiazepine prescription. For the study, we included the\n2,112 benzodiazepine products from the National Drug File within the following\n14 types of benzodiazepines: (1) alprazolam, (2) chlordiazepoxide, (3) clorazepate,\n(4) diazepam, (5) estazolam, (6) flurazepam, (7) halazepam, (8) lorazepam,\n(9) midazolam, (10) oxazepam, (11) prazepam, (12) quazepam, (13) temazepam, and\n(14) triazolam. For each patient in the study population, we searched the FY 2012 VA\nPharmacy SAS data file to look for any filled benzodiazepine prescription records based\non our list.\n\nThe CPG specifically recommends (p. 52) that \xe2\x80\x9cWhen using combination products, do\nnot exceed maximum recommended daily doses of acetaminophen, aspirin, or\nibuprofen.\xe2\x80\x9d We evaluated whether the patients were receiving acetaminophen for use\nat home within recommended doses. We first generated a list of drug products\n(including opioids) containing acetaminophen through a string searching the National\nDrug File for \xe2\x80\x9cACETAMINOPHEN,\xe2\x80\x9d \xe2\x80\x9cAPAP,\xe2\x80\x9d and \xe2\x80\x9cACE.\xe2\x80\x9d Next, we removed any drugs\nwith the string \xe2\x80\x9cACETONE\xe2\x80\x9d or \xe2\x80\x9cACETY.\xe2\x80\x9d The list included 9,502 drug products\ncontaining acetaminophen. Then, from the VA Pharmacy SAS data file, we found all\nrecords of take-home acetaminophen prescriptions, if any, filled in FY 2012 for each\npatient in the study. We calculated daily doses based on days on acetaminophen,\nwhich takes into account the overlapping supply days from different acetaminophen\nprescriptions in a similar way as we did for days on opioids.\n\nWe calculated morphine equivalent dose for each filled opioid prescription using the\nformula (Quantity * Strength * Potency factor) to standardize opioid doses across\ndifferent types of opioids.24 The daily morphine equivalent was calculated as the sum of\n\n\n22\n Toblin, R. L., L. J. Paulozzi, et al. (2010). \xe2\x80\x9cMental illness and psychotropic drug use among prescription drug\n\noverdose deaths: a medical examiner chart review.\xe2\x80\x9d J Clin Psychiatry 71(4): 491\xe2\x80\x93496. \n\n23\n Caplehorn, J. R. and O. H. Drummer (2002). \xe2\x80\x9cFatal methadone toxicity: signs and circumstances, and the role of\n\nbenzodiazepines.\xe2\x80\x9d Aust N Z J Public Health 26(4): 358\xe2\x80\x93362; discussion 362\xe2\x80\x93353. \n\n24\n Korff, M. V., K. Saunders, et al. (2008). \xe2\x80\x9cDe facto long-term opioid therapy for noncancer pain.\xe2\x80\x9d\n\nClin J Pain 24(6): 521\xe2\x80\x93527. \n\n\n\nVA Office of Inspector General 9\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nthe morphine equivalents for each filled opioid prescription in FY 2012 divided by the\nnumber of days on opioids during the FY.\n\nWe defined early refill of opioid prescriptions as the same opioid medication\n(standardized based on generic name, route of administration, and dosage form) that\nwas dispensed before the end of any prior prescriptions. As an example, we would not\nconsider CODEINE 60MG/ACETAMINOPHEN 300MG CAP as an early refill if the\nprevious prescription was CODEINE 60MG/ACETAMINOPHEN 300MG TAB, because\nof the different dosage forms\xe2\x80\x94the former is a capsule while the latter is a tablet.\nResearchers have used early refill of more than 7 days as a proxy of high-risk opioid\nbehavior.25 Exhibit X2 in Appendix A compares concurrent use and early refills.\n\nAll opioids cause slowing of intestinal motility; thus, constipation is an anticipated\nnegative outcome of opioid therapy. The CPG strongly recommends initiating a bowel\nregimen for all patients who are prescribed an opioid to prevent and treat constipation\n(pp. 37 and 67). We considered that a bowel regimen was provided to a patient if we\nfound in the FY 2012 VA Pharmacy SAS data file at least 1 filled laxative prescription for\nthat patient from any of these VA drug classes:26 GA201, GA202, GA203, GA204,\nGA205, GA209, and RS300.\nScreening and Monitoring Patients on Take-Home Opioids. The CPG specifies\nscreening and monitoring opioid patients by urine drug tests (UDTs) and patient\nfollow-up contacts. It strongly recommends use of UDTs to assess illicit drug use and\nadherence to prescribed medications. A UDT should be obtained prior to opioid\ninitiation and randomly at follow-up visits to confirm the appropriate use of opioids\n(CPG, p. 37). We searched UDT records in the VA Laboratory SAS data files for each\npatient in the study population to determine whether a patient received any UDTs. A\nurine sample may be used to test for one substance or multiple substances. We\ncategorized a UDT by test substance into one or all of the following three specific types\n(Appendix B2):\n\n (1) Heroin or morphine\n\n (2) Non-morphine opioid compounds\n\n (3) Non-opioid abusable substances\n\nThe CPG specifies (p. 82) that patients should have follow-up contact with their provider\nat least every 2\xe2\x80\x934 weeks after any change in medication regimen and at least once\nevery 1\xe2\x80\x936 months for the duration of opioid therapy. We searched VA administrative\nfiles for each patient in the study population to determine whether a patient received any\n\n25\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk \n\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947. \n\n26\n VHA National Center for Patient Safety and Office of Mental Health Operations. \xe2\x80\x9cOpioid Therapy Guideline \n\nAdherence Report.\xe2\x80\x9d \n\nhttps://securereports3.vssc.med.va.gov/Reports/Pages/Report.aspx?ItemPath=%2fMentalHealth%2fMHOpioid%2f\n\nOpioidMatrixReport. Last accessed December 30, 2013. \n\n\n\nVA Office of Inspector General 10\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nclinical encounters. For follow-up contact, we counted either in-person (inpatient care,\nextended care, or outpatient visits) or telephone encounter. We did not count any\nin-person visits to the emergency room or any encounters for reasons that were unlikely\nrelated to follow-up for opioids, such as for compensation and pension, dental, organ\ndonation, or research.\n\nTo take into account specific CPG recommendations for initiation and duration of opioid\ntherapy, we assessed the extent to which VA screened and monitored opioid patients in\nalignment with CPG recommendations separately by new and existing patients on\ntake-home opioids. We considered a patient as a new patient for FY 2012 if he or she\nwas initiated on take-home opioids in FY 2012 and did not fill any take-home opioid\nprescriptions at VA in FY 2011 (that is, at least 1 year without any take-home opioids\nprior to initiation in FY 2012). We designated a patient as an existing patient if he or\nshe had filled at least 1 take-home opioid prescription at VA in FY 2011.\n\nFor new patients who were initiated on take-home opioids in FY 2012, we determined\nwhether they had received both a:\n\n (1) UDT within 30 days prior to opioid initiation in FY 2012 and\n\n (2) follow-up contact within 30 days of initiation.\n\nAll new patients were included in the UDT (1) analysis. We excluded new patients from\nthe follow-up contact (2) analysis if they died within 30 days of opioid initiation or if they\nfilled their initial prescriptions after September 1, 2012, as they would not have had at\nleast 30 days of available follow-up in the FY.\n\nFor all new opioid patients who had at least 30 days of available follow-up in the FY, we\nperformed the analyses (both (1) and (2)) for all these patients together and also\nanalyzed separately by whether they were diagnosed with baseline substance use.\n\nFor existing patients, we determined whether they had received both:\n\n (1) an annual UDT and\n\n (2) a follow-up contact within 6 months of each filled opioid prescription in FY 2012\n that had at least 6 months available for follow-up contact.\n\nAll existing patients were included in the UDT (1) analysis. We counted patients as\nhaving an annual UDT if we found a UDT record in the FY 2012 VA Laboratory SAS\ndata file. For patients who died in FY 2012 and for whom we did not find a UDT in the\nFY, we also checked for a UDT by looking back in FY 2011 for a period that was\nsufficient to satisfy the 1-year timeframe from the date of death. For example, for a\npatient who died on August 31, 2012, and for whom we did not locate a UDT in\nFY 2012, we looked back to the period of September 1\xe2\x80\x93September 30, 2011, for a UDT\nto make up for the missing month of September in order to satisfy the 1-year timeframe\n(that is, September 1, 2011\xe2\x80\x93August 31, 2012, specifically for this patient).\n\n\n\nVA Office of Inspector General 11\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nWe excluded existing patients from the follow-up contact (2) analysis if they did not\nhave any filled prescriptions that were at least 6 months prior to the end of the follow-up\nperiod (September 30, 2012, or the patient\xe2\x80\x99s date of death if the patient died in\nFY 2012).\n\nFor all existing opioid patients who had at least 1 filled prescription that was at least\n6 months prior to the end of the follow-up period in the FY, we performed the analyses\n(both (1) and (2)) for all these patients together and also analyzed separately by chronic\nusers, as well as by UDT test substance type.\n\nFor informational purposes, for existing patients who had received an annual UDT, we\nfurther investigated whether any of their UDTs were conducted while they were on\nopioids. If any UDT was conducted within 7 days of the end of the supply days of any\nfilled opioids, we considered that the UDT was conducted while they were on opioids.\nWe used 7 days to take into account the presence of opioids in the urine for up to\n7 days without any opioid in-take.27\n\nThe CPG specifies that chronic (for more than 1 month, p. 3) opioid therapy is\nabsolutely contraindicated in patients with active (not in remission) substance use\ndisorders (SUDs) who are not in treatment (p. 25) and should be initiated with caution in\npatients receiving treatment for SUDs (p. 24). Active, regular monitoring of illicit\nsubstance use and adherence to the prescribed opioid regimen is strongly\nrecommended for all patients (p. 56) but is crucial in this high-risk subpopulation.\n\nWe designated a patient as with active SUD if we found any of the following ICD-9-CM\ndiagnostic codes for the patient in FY 2012: 291, 292, 303.00\xe2\x80\x93303.02, 303.90\xe2\x80\x93303.92,\n304.00\xe2\x80\x93304.02, 304.10\xe2\x80\x93304.12, 304.20\xe2\x80\x93304.22, 304.30\xe2\x80\x93304.32, 304.40\xe2\x80\x93304.42,\n304.50\xe2\x80\x93304.52, 304.60\xe2\x80\x93304.62, 304.70\xe2\x80\x93304.72, 304.80\xe2\x80\x93304.82, 304.90\xe2\x80\x93304.92,\n305.00\xe2\x80\x93305.02, 305.20\xe2\x80\x93305.22, 305.30\xe2\x80\x93305.32, 305.40\xe2\x80\x93305.42, 305.50\xe2\x80\x93305.52,\n305.60\xe2\x80\x93305.62, 305.70\xe2\x80\x93305.72, 305.80\xe2\x80\x93305.82, 305.90\xe2\x80\x93305.92.\n\nWe considered that an active substance use patient had received treatment for\nsubstance use if we found any of the following VA codes for the patient in FY 2012:\n\n \xe2\x80\xa2 Treating specialty codes: 25\xe2\x80\x9327, 37, 39, 85, 88, 1K, 1L, 1M.\n\n \xe2\x80\xa2 Clinic stop codes: 513, 514, 519, 523, 534, 539, 545, 547, 548, 560.\n\nFor all patients with active SUD in FY 2012, we determined whether they had received\nboth:\n\n (1) treatment for SUD and\n\n (2A) a UDT within 90 days of each filled opioid prescription.\n\n\n\n27\n http://www.paineducation.vcu.edu/documents/UDTimmunoassay.pdf. Last accessed December 23, 2013.\n\n\nVA Office of Inspector General 12\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nFor UDT analysis (2A) we excluded active substance use patients who did not have any\nfilled opioid prescriptions that were at least 90 days prior to the end of the follow-up\nperiod (September 30, 2012, or the patient\xe2\x80\x99s date of death if the patient died in\nFY 2012).\n\nFor the subpopulation of active substance use patients who were on opioids for more\nthan 90 days in FY 2012, we further determined whether they had received both:\n\n (1) treatment for SUD and\n\n (2B) a UDT for every 90 days on opioids.\n\nPrevalence of Serious Adverse Effects. Increasing use of opioids has been associated\nwith increasing rates of opioid-related serious adverse effects.28\xe2\x80\x9335 We determined\npercentages of opioid patients with evidence of a serious adverse effect that may be\nreasonably expected to be related to opioid therapy.36\n\nWe classified a patient with opioid overdose if the patient was diagnosed with an opioid\nor heroin overdose (ICD-9-CM codes: E850.1, E850.2, E935.1, E935.2, E980.0, 965.0,\nE850.0, and E935.0) or had filled any naloxone prescriptions with the following VA\nInternal Entry Numbers (IENs): 02802\xe2\x80\x9302805, 03792, 16015, and 16016.37\n\nWe considered that a patient experienced sedative overdose if the patient was\ndiagnosed with any of these ICD-9-CM codes:37 E851, E852, E853.0\xe2\x80\x93E853.2, E853.8,\nE853.9, E937.0, E937.8, E938.0, E939.1, E939.2, E939.4, E939.5, E980.1\xe2\x80\x93E980.3,\n967.0, 967.8, 968.0, and 969.1\xe2\x80\x93969.5.\n\nWe deemed a patient with an acetaminophen overdose if the patient was\ndiagnosed with any of these ICD-9-CM codes: E850.4, E935.4, and 965.4 or had filled\nany acetylcysteine prescriptions with the following IENs: 06109\xe2\x80\x9306112,\n14944\xe2\x80\x9314955, 17196, 17544, 17876, 18774, and 19801.\n\n\n\n28\n http://www.cdc.gov/about/grand-rounds/archives/2011/pdfs/PHGRRx17feb2011.pdf. Last accessed \n\nJanuary 27, 2014.\n\n29\n Kuehn, B. M. (2010). \xe2\x80\x9cAlarming nonfatal overdose rates found for opioids, sedatives, and tranquilizers.\xe2\x80\x9d \n\nJAMA 303(20): 2020\xe2\x80\x932021. \n\n30\n http://oas.samhsa.gov/2k11/DAWN018/DAWN018_HTML.pdf. Last accessed January 27, 2014. \n\n31\n Clegg, A. and J. B. Young (2011). \xe2\x80\x9cWhich medications to avoid in people at risk of delirium: a systematic\n\nreview.\xe2\x80\x9d Age Ageing 40(1): 23\xe2\x80\x9329. \n\n32\n http://www.uspharmacist.com/content/d/web_exclusive/c/40386/. Last accessed January 27, 2014. \n\n33\n http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6226a3.htm. Last accessed January 27, 2014. \n\n34\n VHA Handbook 1160.04, VHA Programs for Veterans With Substance Use Disorders (SUD), March 7, 2012. \n\n35\n http://www.healthquality.va.gov/sud/sud_full_601f.pdf. Last accessed January 29, 2014. \n\n36\n http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html. Last accessed January 9, 2014. \n\n37\n VHA National Center for Patient Safety and Office of Mental Health Operations. \xe2\x80\x9cOpioid Therapy Guideline \n\nAdherence Report.\xe2\x80\x9d \n\nhttps://securereports3.vssc.med.va.gov/Reports/Pages/Report.aspx?ItemPath=%2fMentalHealth%2fMHOpioid%2f\n\nOpioidMatrixReport. Last accessed December 30, 2013. \n\n\n\nVA Office of Inspector General 13\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nWe designated a patient as having been involved with possible and confirmed suicide\nattempts if the patient was diagnosed with any of these ICD-9-CM codes:37 E950\xe2\x80\x93E959,\nE980.6, E980.8, E981\xe2\x80\x93E984, E988, and V62.84.\n\nWe defined a patient as having experienced drug delirium if the patient was diagnosed\nwith any of these ICD-9-CM codes:37 292.1, 292.2, 292.8, and 292.9.\n\nWe identified a patient as having received drug detoxification if we found ICD-9-CM\nprocedure codes 94.65 or 94.66 for the patient.37\n\nPsychosocial Treatment for Pain, Pain Clinic Service, and Medication\nManagement/Pharmacy Reconciliation. We determined whether our population of\nopioid patients received psychosocial treatment for pain or Pain Clinic service or had\nprescription management encounters anytime in FY 2012 or after the patient\xe2\x80\x99s first\nopioid prescription.\n\nPsychotherapy, including cognitive behavioral therapy, is recommended to reduce pain\nand improve function in chronic pain patients.38 We designated a patient as having\nreceived psychosocial treatment for pain if we found any of the following procedure\ncodes39 for the patient, which would indicate mental health treatment, behavioral\nmedicine or behavioral health treatment, psychotherapy, and stress management:\n\n \xe2\x80\xa2\t Current Procedural Terminology (CPT)40 codes: 90801, 90802, 90804\xe2\x80\x9390829,\n 90845\xe2\x80\x9390857, 96150\xe2\x80\x9396155, 97532, 98960\xe2\x80\x9398962, 99401\xe2\x80\x9399404, 99411, 99412,\n 99510, 4306F.\n\n \xe2\x80\xa2\t ICD-9-CM procedure codes: 94.31, 94.33, 94.37, 94.38, 94.44, 94.49.\n\n \xe2\x80\xa2\t Healthcare Common Procedure Coding System (HCPCS)41 codes: H0002, H0004,\n H0017\xe2\x80\x93H0019, H0023\xe2\x80\x93H0025, H0030, H0031, H0032, H0035, H0046, H2001,\n H2012, H2014, H2017\xe2\x80\x93H2020, H2027, G0177, S9454, T2048.\n\nThus, our data did not take into account patients who were offered psychosocial\ntreatment for pain but declined.\n\nTreatment of chronic pain requires care to recover or maintain physical, social, and\noccupational function and may include Pain Clinic service. We identified a patient as\n\n\n38\n Roditi, D. and M. E. Robinson (2011). \xe2\x80\x9cThe role of psychological interventions in the management of patients \n\nwith chronic pain.\xe2\x80\x9d Psychol Res Behav Manag 4: 41\xe2\x80\x9349. \n\n39\n VHA National Center for Patient Safety and Office of Mental Health Operations. \xe2\x80\x9cOpioid Therapy Guideline \n\nAdherence Report.\xe2\x80\x9d \n\nhttps://securereports3.vssc.med.va.gov/Reports/Pages/Report.aspx?ItemPath=%2fMentalHealth%2fMHOpioid%2f\n\nOpioidMatrixReport. Last accessed December 30, 2013. \n\n40\n CPT is a code set that is used to report medical procedures and services. \n\n41\n HCPCS codes are billing codes used by Medicare and are numbers assigned to every task and service a medical \n\npractitioner may provide to a Medicare patient. \n\n\n\nVA Office of Inspector General 14\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nreceiving care from a Pain Clinic if we found any encounters for the patient with the VA\nClinic Stop Code of 420.\n\nOpioid patients frequently have complex co-morbid conditions, making them more likely\nto be given multiple medications that can interact dangerously with opioid medications.\nA review of medications by a pharmacist or other health care professional can prevent\nharmful interactions between these medications. We classified a patient as\nreceiving medication management/pharmacy reconciliation if we found any39 of these\nCPT codes for the patient: 99605, 99606, 99607, 90862, and 1160F or the Clinic Stop\nCodes 160 or 176. Our data did not take into account medication reconciliation\nperformed by primary care providers during clinic visits if it was not recorded as a CPT\ncode.\n\nExhibit X3 in Appendix A summarizes data files used in our analysis.\n\nStatistical Analyses\nWe performed descriptive data analyses for VA as a whole and separately for each\nVAMC. We summarized variations among VAMC data results using the 5-number\nsummaries: minimum, 25th percentile, median, 75th percentile, and maximum.\n\nFor this study, we used VAMC to refer to medical centers and CBOCs that were under\nthe same VA facility (Director) administrative leadership. Based on the VA Site\nTracking (VAST) file, we designated each medical center and each CBOC to 1 of the\n141 VAMCs using its station number. As of December 31, 2012, VHA consisted of\n141 VAMCs that included 151 medical centers and 827 CBOCs.42\n\nSome patients received take-home opioid prescriptions from more than 1 VAMC during\nFY 2012. For opioid prevalence calculations by VAMC, these patients were counted for\neach VAMC where they received any filled opioid prescriptions. To perform data\nanalyses other than opioid prevalence by VAMC, we designated a patient to the VAMC\nthat issued the most (filled) take-home opioid prescriptions to the patient in FY 2012. If\nmore than one VAMC met this criterion, we assigned the patient to the VAMC (among\nthose VAMCs tied for most filled prescriptions) that issued the last (filled) opioid\nprescription in the FY.\n\nWe performed data analyses using SAS statistical software (SAS Institute, Inc.,\nCary, NC), version 9.3 (TS1M2).\n\nThe study was performed in accordance with Quality Standards for Inspection and\nEvaluation published by the Council of the Inspectors General on Integrity and\nEfficiency.\n\n\n\n\n42\n http://www.va.gov/vetdata/docs/Quickfacts/Homepage_slideshow_03_31_13.pdf. Last accessed\nDecember 30, 2013.\n\n\nVA Office of Inspector General 15\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n Results and Conclusions \n\nVA dispensed take-home opioids to 453,616 patients during FY 2012 for a total of close\nto 1.72 million filled opioid prescriptions (Exhibit 1). We excluded from our analyses a\ntotal of 11,072 patients and 38,045 prescriptions (including the 111 duplicate\nprescription records). This accounted for 2.4 percent of the entire FY 2012 patients\ndispensed with take-home opioids. We excluded the 330 patients who were classified\nas DoD patients. Most (97 percent) of the excluded patients were those who had\nreceived hospice or palliative care in FY 2012 or within 1 year prior to their first\ntake-home opioid prescription in FY 2012. Thus, our study population consists of\n442,544 (non-hospice/palliative care) patients who collectively received approximately\n1.68 million take-home opioid prescriptions in FY 2012. These patients received care\nfrom at least 1 of the 140 VAMCs since Manila VAMC did not have any eligible patients\nfor the study.\n\n Exhibit 1. Exclusions of VA Patients Dispensed with Take-Home Opioids\n in FY 2012\n Patients Prescriptions\n All patients with take-home opioids 453,616 1,718,006\n Exclusions (total) 11,072 38,045\n Duplicate prescription records 0 111\n Patients of Department of Defense 330 752\n Patients with hospice or palliative care1 10,742 37,182\n Study population 442,544 1,679,961\n 1\n One year prior to first opioid prescription or in FY 2012.\n\n\n\n1. Prevalence of VA Patients Dispensed Take-Home Opioids\nThe 442,544 opioid patients accounted for 7.7 percent of all VA (non-hospice/palliative\ncare) patients who had at least 1 outpatient encounter at VA in FY 2012.\nExhibit 2 indicates that the prevalence of patients dispensed with take-home opioids by\nindividual VAMCs ranged from 0.26 percent to 21.8 percent, with the middle 50 percent\nof the VAMCs dispensing opioids to 3.6\xe2\x80\x9310.1 percent of their outpatients.\n\n\n\n\nVA Office of Inspector General 16\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 2. VA Medical Center (VAMC1) Prevalence of Patients Dispensed with \n\n Take-Home Opioids in FY 2012 \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n2. Baseline Characteristics of VA Take-Home Opioid Patients\nExhibit 3 shows the baseline (at the first take-home opioid prescription in FY 2012)\ncharacteristics of the study population combined and separately by whether days on\ntake-home opioids in FY 2012 were 90 or less (non-chronic users) or more than\n90 (chronic users). About one third (33.9 percent) of the patients were chronic users.\n\nA majority (92.5 percent) of the patients were male, which mirrored the gender\ncomposition of VA patients. The average and the median patient age at their first opioid\nprescription in FY 2012 were 59.4 and 61, respectively (see Exhibit 4 for more details\non age distributions).\n\n\n\n\nVA Office of Inspector General 17\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 3. Baseline Characteristics of VA Take-Home Opioid Patients in FY 2012\n All patients with 90 days or less More than 90 days\n take-home on opioids on opioids\n opioids (non-chronic users) (chronic users)\n 442,544 292,693 66.1% 149,851 33.9%\n # % # % # %\nMale 409,324 92.5 269,322 92.0 140,002 93.4\nAge at first opioid prescription in FY 2012\n Mean (standard deviation) 59.4 (0.02) 59.4 (0.03) 59.4 (0.03)\n Median 61.0 61.0 60.0\nOEF/OIF at first opioid prescription in FY 2012 27,752 6.3 21,263 7.3 6,489 4.3\nPain diagnosis within 1 year prior to first opioid prescription 388,745 87.8 253,010 86.4 135,735 90.6\n Primary pain site (of non-cancer origin) 386,082 87.2 251,565 85.9 134,517 89.8\n Pain of the nervous system and sense organs 46,541 10.5 26,622 9.1 19,919 13.3\nMental health diagnosis within 1 year prior to first opioid prescription 284,161 64.2 181,298 61.9 102,863 68.6\n PTSD 88,521 20.0 57,189 19.5 31,332 20.9\n Substance use 65,446 14.8 42,852 14.6 22,594 15.1\nPain or mental health diagnoses within 1 year prior to first opioid\nprescription 414,462 93.7 271,538 92.8 142,924 95.4\nPain and mental health diagnoses within 1 year prior to first opioid\nprescription 258,444 58.4 162,770 55.6 95,674 63.8\n Pain and PTSD 81,888 18.5 52,389 17.9 29,499 19.7\n Pain and substance use 60,384 13.6 39,025 13.3 21,359 14.3\nPrimary pain site and mental health diagnoses within 1 year prior to\nfirst opioid prescription 256,692 58.0 161,848 55.3 94,844 63.3\n Primary pain site and PTSD 81,384 18.4 52,142 17.8 29,242 19.5\n Primary pain site and substance use 60,003 13.6 38,825 13.3 21,178 14.1\nPain of the nervous system and sense organs and mental health\ndiagnoses within 1 year prior to first opioid prescription 36,789 8.3 20,737 7.1 16,052 10.7\n Pain of the nervous system and sense organs and PTSD 13,261 3.0 7,633 2.6 5,628 3.8\n Pain of the nervous system and sense organs and substance use 11,313 2.6 6,566 2.2 4,747 3.2\nDied in FY 2012 7,426 1.7 5,616 1.9 1,810 1.2\n\n\n\n\nExhibit 4. Age (At First Opioid Prescription) Distribution of VA Take-Home Opioid \n\n Patients in FY 2012 \n\n\n\n\n\nApproximately 1 in every 16 patients (6.3 percent) had served in OEF/OIF. Nearly\n88 percent of the patients were diagnosed with pain within 1 year prior to or on their first\nday dispensed with take-home opioids in FY 2012. We observed that 87 percent of the\nopioid patients were diagnosed with primary pain site of non-cancer origin that could\nresult in pain serious enough to warrant an opioid medication. Nearly all (9.9 out of\n10.5 percent) patients diagnosed with pain of the nervous system and sense organs\nwere also diagnosed with primary pain site. As expected, both primary pain site and\n\n\nVA Office of Inspector General 18\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\npain of the nervous system and sense organs were more prevalent among chronic\nusers.\n\nExhibit 5 gives detailed information on pain diagnoses for the study population. It\nshows that a higher percentage of chronic users was diagnosed with chronic pain\n(8.0 percent versus 5.7 percent) and chronic pain syndrome (5.8 percent versus\n3.2 percent)\xe2\x80\x94a complex syndrome that involves multiple factors.\n\n Exhibit 5. Percent of Patients Diagnosed with Pain within 1 Year Prior to First \n\n Take-Home Opioid Prescription in FY 2012 \n\n All patients with 90 days or less on opioids More than 90 days on\n take-home opioids (non-chronic users) opioids (chronic users)\n 442,544 292,693 149,851\n Pain 87.8 86.4 90.6\n Primary pain site 87.2 85.9 89.8\n Back pain 54.6 50.8 62.0\n Arthritis 52.9 52.2 54.3\n Musculoskeletal pain 27.5 27.8 27.0\n Neuropathy 13.8 13.3 14.8\n Visceral pain 13.1 13.9 11.4\n Headaches 9.9 10.0 9.9\n Fractures 5.7 6.1 4.9\n Wound injury 4.0 4.0 3.9\n Other pain 2.9 2.8 3.0\n Reproductive pain 0.39 0.46 0.25\n Generalized pain 0.38 0.36 0.40\n Pain of the nervous system\n and sense organs 10.5 9.1 13.3\n Chronic pain 6.5 5.7 8.0\n Chronic pain syndrome 4.1 3.2 5.8\n Acute pain 0.83 0.90 0.68\n Neoplasm-related pain 0.13 0.14 0.11\n\n\nExhibit 6 gives detailed information on mental health diagnoses. It indicates that more\nthan half (64.2 percent) of the opioid patients had been diagnosed with mental health\nissues at the first take-home opioid prescription. Approximately one third (35 percent)\nof the patients had been diagnosed with mood disorders, 1 of 5 with PTSD, and 1 of\n7 (14.8 percent) with substance use. We observed that higher percentages of chronic\nusers were consistently diagnosed with each category of the mental health issues\nexcept for alcohol-related disorders, which was 10.0 percent for chronic users but\n10.7 percent for their counterparts of non-chronic users. While almost 15 percent of the\nentire study population had been diagnosed with substance use, 4 percent43 of the\npopulation had been diagnosed with both alcohol and drug related disorders.\n\n\n\n\n43\n This was calculated by adding alcohol-related disorders (10.4 percent) plus drug-related disorders (8.4 percent)\nand subtracting substance use (14.8 percent).\n\n\nVA Office of Inspector General 19\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nExhibit 6. Percent of Patients Diagnosed with Mental Health Issues within 1 Year \n\n Prior to First Take-Home Opioid Prescription in FY 2012 \n\n All patients with 90 days or less on opioids More than 90 days on\n take-home opioids (non-chronic users) opioids (chronic users)\n 442,544 292,693 149,851\nMental health 64.2 61.9 68.6\n Adjustment disorders 5.0 4.9 5.1\n Anxiety disorders excluding PTSD 14.0 13.2 15.6\n PTSD 20.0 19.5 20.9\n Mood disorders 35.0 33.3 38.5\n Excluding major depression 29.9 28.4 32.6\n Major depression 11.3 10.8 12.2\n Personality disorders 1.9 1.9 2.0\n Psychotic disorders 3.1 3.1 3.2\n Psychological pain 1.1 0.87 1.6\n Substance use 14.8 14.6 15.1\n Alcohol-related disorders 10.4 10.7 10.0\n Drug-related disorders 8.4 8.2 8.8\n\n\nNearly 94 percent of the study population had been diagnosed with pain or mental\nhealth issues and 58.4 percent of patients with both (Exhibit 3). The percentages of\npatients being diagnosed with both pain and mental health issues were 8 points higher\nfor chronic users than their counterparts of non-chronic users.\n\n3. VA Dispensing Patterns of Take-Home Opioids\nApproximately half (52.2 percent) of the study population were new patients in the\nsense that they were initiated on take-home opioid therapy in FY 2012 after not being\non take-home opioids for at least more than 1 year (Exhibit 7). Seven out of\n10 (69.1 percent) non-chronic users were new patients in contrast to 1 in\n5 (19.1 percent) of their counterparts of chronic users. Nearly 41 percent of the patients\nhad been dispensed with 1 prescription, which was composed entirely of the\n61.4 percent of non-chronic users because none of the opioids were allowed to be\nprescribed for more than 90 days in 1 prescription. Patients with 6 or more\nprescriptions were mainly chronic users, which amounted to 69.3 percent of that group.\nAlmost all (98.4 percent) patients received their prescriptions from a single VAMC, and\nthree quarters of the patient population had all their (filled) prescriptions issued from a\nsingle prescriber.\n\n\n\n\nVA Office of Inspector General 20\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 7. VA Dispensing Patterns of Take-Home Opioids in FY 2012\n All patients with 90 days or less on opioids More than 90 days on\n take-home opioids (non-chronic users) opioids (chronic users)\n 442,544 292,693 66.1% 149,851 33.9%\n # % # % # %\nNo take-home opioids in FY 2011 (new patients) 230,975 52.2 202,282 69.1 28,693 19.1\nOnly one opioid prescription per patient 179,677 40.6 179,677 61.4 0 0.00\nSix or more opioid prescriptions per patient 105,145 23.8 1,289 0.44 103,856 69.3\nOnly one type of opioids 420,632 95.0 284,253 97.1 136,379 91.0\n 1\nAll opioid prescriptions from same VAMC 435,327 98.4 290,029 99.1 145,298 97.0\nAll opioid prescriptions from same prescriber 332,856 75.2 252,050 86.1 80,806 53.9\nMorphine equivalent 200 mg/day or more 5,155 1.2 1,278 0.44 3,877 2.6\nLong-acting opioid products 27,920 6.3 9,186 3.1 18,734 12.5\n 2\nEarly refills (of opioids at least 7 days early) 101,805 23.0 19,829 6.8 81,976 54.7\n 7\xe2\x80\x9310 days early 39,742 9.0 8,019 2.7 31,723 21.2\n 11\xe2\x80\x9314 days early 24,815 5.6 4,725 1.6 20,090 13.4\n More than 14 days early 37,248 8.4 7,085 2.4 30,163 20.1\n 3\xe2\x80\x935 early refills 16,750 3.8 196 0.07 16,554 11.0\n More than 5 early refills 1,488 0.34 8 0.00 1,480 1.0\n 2\nEarly refills (of opioids at least 11 days early) 62,063 14.0 11,810 4.0 50,253 33.5\n 3\xe2\x80\x935 early refills 4,255 1.0 73 0.02 4,182 2.8\n More than 5 early refills 215 0.05 6 0.00 209 0.14\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n2\n Prescription of same opioid medication (generic name, route of administration, and dosage form) that was dispensed prior to finishing previous\n supply of the opioid.\n\n\nMost (95.0 percent) of the patients were dispensed with a single type of opioid. More\nthan 6 percent of the patients received at least 1 long-acting opioid product, with the\npercentage of chronic users being 4 times that of non-chronic users. Opioid dosages\nwith a morphine equivalent at least 200 mg/day were dispensed to 1.2 percent of the\nstudy population, which accounted for 2.6 percent of chronic users and 0.44 percent of\nnon-chronic users.\n\nRefills of opioids at least 7 days early occurred in 23.0 percent of the population, with\nrefills of at least 11 days early in 14.0 percent of the population. As expected, early\nrefills occurred (at least 8 times) more likely and more frequently among chronic users\nthan non-chronic users.\n\nExhibit 8 indicates that take-home benzodiazepines were dispensed to 7.4 percent of\nthe study population, with the percentage of chronic opioid users being 1.6 times that of\nnon-chronic users. We determined that 71 percent of the opioid patients who received\ntake-home benzodiazepines were dispensed benzodiazepines concurrently with\nopioids. The percentage of chronic opioid users with concurrent benzodiazepines was\n92.6, and the percentage of non-chronic users was 53.6.\n\n\n\n\nVA Office of Inspector General 21\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 8. VA Pattern of Dispensing Take-Home Opioids with Concurrent\n\n Benzodiazepines and Acetaminophen in FY 2012\n\n All patients with 90 days or less on opioids More than 90 days on\n take-home opioids (non-chronic users) opioids (chronic users)\n 442,544 292,693 66.1% 149,851 33.9%\n # % # % # %\nTake-home benzodiazepine prescription 32,833 7.4 18,198 6.2 14,635 9.8\n 1\n Concurrent benzodiazepine and opioid prescriptions 23,314 71.0 9,763 53.6 13,551 92.6\nTake-home acetaminophen prescription 408,347 92.3 278,273 95.1 130,074 86.8\n 2\n Average daily dose at least 4 grams 8,028 2.0 4,271 1.5 3,757 2.9\n 2\n At least 1 day dose 4 grams or more 113,275 27.7 54,063 19.4 59,212 45.5\n 2\n At least 1 day dose 4 grams or more while on opioids 93,598 22.9 37,042 13.3 56,556 43.5\n 2\n Average daily dose exceeding 4 grams 6,724 1.6 3,116 1.1 3,608 2.8\n 2\n At least 1 day dose exceeding 4 grams 70,498 17.3 34,076 12.2 36,422 28.0\n 2\n At least 1 day exceeding 4 grams while on opioids 55,929 13.7 21,809 7.8 34,120 26.2\n1\n Percentages based on patients with take-home benzodiazepine prescriptions.\n2\n Percentages based on patients with take-home acetaminophen prescriptions.\n\n\nAcetaminophen was given to 92.3 percent of the study patients. We found that\n2.0 percent of them were given an average daily dose of 4 g/day or more. We observed\nthat the percentage points of chronic users given either at least 1 day of\n4 grams or more of acetaminophen or at least 1 day of 4 grams or more concurrently\nwith opioids were more than double those of non-chronic users.\n\nIn terms of dose exceeding 4 grams (dosages exclude exactly 4 grams) per day, we\ndetermined that 1.6 percent of the study patients were given an average daily dose that\nexceeded 4 grams. Percentages were reduced over 10 points from 27.7 percent and\n22.9 percent to 17.3 percent and 13.7 percent for at least 1 day that exceeded 4 grams\nand at least 1 day that exceeded 4 grams concurrently with opioids, respectively.\n\nThe Clinical Practice Guideline recommends a bowel regimen for all opioid patients\n(pp. 37 and 67) to manage opioid-related constipation. Exhibit 9 reveals that\n27.9 percent of the patients were dispensed with a laxative in FY 2012 and that\n23.5 percent of the patients were given a laxative on or after the date of their first opioid\nprescription. The practice of dispensing a laxative to opioid patients varied among\n140 VAMCs from 17.6 percent to 61.6 percent for the entire FY 2012 and from\n12.7 percent to 56.0 percent at or after patients\xe2\x80\x99 first opioid prescription.\n\n Exhibit 9. Variations of VA Medical Center (VAMC1) Percentages Dispensing a \n\n Laxative to Take-Home Opioid Patients in FY 2012 \n\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\nPrescribed a laxative any time in FY 2012 17.6 24.3 30.0 35.5 61.6 27.9\nPrescribed a laxative on or after the date of first\nopioid dispensing in FY 2012 12.7 20.1 25.2 29.0 56.0 23.5\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 22\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n4. VA Patterns of Screening and Monitoring Opioid Patients\nNew Patients on Take-Home Opioids. The Clinical Practice Guideline calls for a urine\ndrug test (UDT) prior to initiating opioid therapy (p. 37) and a follow-up visit at least\nevery 2\xe2\x80\x934 weeks after any change in medication regimen (p. 82). We determined that\nonly 6.4 percent of the new patients (that is, patients who were not given any take-home\nopioids in FY 2011, which is at least 1 year before initiating their take-home opioid\ntherapy) received both a UDT prior to and a follow-up within 30 days of initiating opioid\ntherapy in FY 2012 (Exhibit 10).\n\n Exhibit 10. Variations of VA Medical Center (VAMC1) Percentages Conducting a \n\n Urine Drug Test Prior to and/or a Follow-Up within 30 Days of Initial Opioid \n\n Prescription, New Patients on Take-Home Opioids in FY 2012 \n\n Number of Variations in VAMC percentages\n VA\n VA eligible 25th 75th\n average\n patients Minimum percentile Median percentile Maximum\nConducted both a urine drug test prior to\nand a follow-up within 30 days of\ninitiating opioid therapy 209,843 1.1 3.9 6.1 10.2 32.2 6.4\nConducted a urine drug test within\n30 days prior to initiating opioid therapy 230,975 1.6 4.6 7.3 11.9 32.2 7.6\n 2\n Patients with substance use disorder 33,564 4.4 13.7 19.3 26.3 57.1 20.2\n Patients without substance use disorder 197,411 0.00 2.9 5.0 8.5 28.6 5.4\nReceived a follow-up within 30 days of\ninitiating opioid therapy 209,843 60.4 71.1 75.6 80.8 94.9 74.0\nReceived a follow-up in-person visit\nwithin 30 days of initiating opioid therapy 209,843 53.7 68.0 72.7 77.5 94.9 71.2\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n2\n Diagnosed within 1 year of opioid initiation.\n\n\nThe very low (6.4 percent) rate of screening and monitoring patients at opioid initiation\nalmost exclusively resulted from the very low rate of a UDT. We found that within\n30 days of initiating opioid therapy, nearly three quarters of the patients received a\nfollow-up, including 2.8 percent of the patients who received a follow-up call encounter\nalone (without any in-person visits). However, VA conducted a UDT for only 7.6 percent\nof new opioid patients within 30 days prior to initiating the therapy. Even for the\nhigh-risk group of patients who were diagnosed with baseline substance use disorder\n(SUD), a UDT was performed for only one out of five of them. A UDT was conducted\nfor 1 out of 20 patients without SUD.\n\nExhibit 11a shows UDT test rates for new patients prior to initial prescription by days on\nopioids. The rates increased from 6.8 percent for those who were on non-chronic opioid\ntherapy (30 days or less) to 9.1 percent for those who were on chronic opioid therapy\n(more than 30 days) to 11.1 percent for chronic users (more than 90 days).\n\nFor UDTs conducted within 60 or 90 days of initiating opioid therapy, rates increased to\n10.3 percent and 12.5 percent (Exhibit 11b), respectively.\n\n\n\n\nVA Office of Inspector General 23\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 11a. Distribution of VA Medical Center (VAMC1) Percentages Conducting \n\n a Urine Drug Test on Patient within 30 Days Prior to Initial Prescription in \n\n FY 2012, New Take-Home Opioid Patients, by Days on Opioids \n\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\n30 days or less on opioids 0.88 4.3 6.2 9.5 36.6 6.8\nMore than 30 days on opioids 1.0 5.4 9.3 15.0 36.8 9.1\nMore than 90 days on opioids 0.00 6.5 11.6 19.0 100.0 11.1\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\n Exhibit 11b. Variations of VA Medical Center (VAMC1) Percentages Conducting a \n\n Urine Drug Test within 60 or 90 Days Prior to Initial Opioid Prescription, \n\n New Patients on Take-Home Opioids in FY 2012 \n\n Number of Variations in VAMC percentages\n VA\n VA eligible 25th 75th\n average\n patients Minimum percentile Median percentile Maximum\nConducted a urine drug test within 60 days\nprior to initiating opioid therapy 230,975 2.1 6.7 9.9 15.8 38.3 10.3\n 2\n Patients with substance use disorder 33,564 5.8 19.4 25.8 34.0 63.6 26.7\n Patients without substance use disorder 197,411 0.00 4.2 6.8 11.2 33.6 7.5\nConducted a urine drug test within 90 days\nprior to initiating opioid therapy 230,975 2.6 8.3 12.1 18.3 45.5 12.5\n 2\n Patients with substance use disorder 33,564 9.1 23.7 30.7 40.3 71.4 31.8\n Patients without substance use disorder 197,411 0.00 5.5 8.0 13.8 44.7 9.2\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n2\n Diagnosed within 1 year of opioid initiation.\n\n\nWe observed broad variation among 140 VAMCs\xe2\x80\x99 practice on this measure, ranging\nfrom 1.1 percent to 32.2 percent, with the middle 50 percent of the VAMCs from\n3.9 percent to 10.2 percent (Exhibits 10 and 12). See Exhibits 13\xe2\x80\x9316 for more details.\n\nExhibit 12. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\nUrine Drug Test Prior to and a Follow-Up within 30 Days of Initial Prescription in \n\n FY 2012, New Patients on Take-Home Opioids \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 24\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nExhibit 13. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\n Follow-Up within 30 Days of Initiating Take-Home Opioid Therapy in FY 2012, \n\n New Patients on Take-Home Opioids \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExhibit 14. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\n Urine Drug Test within 30 Days Prior to Initiating Take-Home Opioid Therapy in \n\n FY 2012, New Patients on Take-Home Opioids \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 25\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nExhibit 15. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\n Urine Drug Test on Patient within 30 Days Prior to Initiating Take-Home Opioid \n\n Therapy in FY 2012, New Take-Home Opioid Patients with a \n\n Substance Use Disorder \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExhibit 16. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\nUrine Drug Test on Patient within 30 Days Prior to Initial Prescription in FY 2012, \n\n New Take-Home Opioid Patients without a Substance Use Disorder \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExisting Patients on Take-Home Opioids. The Clinical Practice Guideline recommends\na UDT randomly at follow-up visits to confirm the appropriate use of opioids (p. 37) and\na follow-up visit at least once every 1\xe2\x80\x936 months for the duration of therapy (p. 82). We\n\n\nVA Office of Inspector General 26\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\ndetermined that only 37.0 percent of the existing opioid patients received both an\nannual UDT and a follow-up within 6 months of each filled opioid prescription, varying\nextensively from 4.2 percent to 91.0 percent among VAMCs (Exhibits 17 and 18).\n\n Exhibit 17. Variations of VA Medical Center (VAMC1) Percentages Conducting a \n\nFollow-Up within 6 Months of Each Opioid Prescription in FY 2012 and an Annual \n\n Urine Drug Test, Existing Patients on Take-Home Opioids (175,403 Patients), \n\n by Test Substance Type \n\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\nFollow-up within 6-months and any annual urine drug test 4.2 24.9 37.6 50.3 91.0 37.0\nFollow-up within 6-months and test for morphine or heroin 0.85 20.3 32.8 47.8 86.8 33.2\nFollow-up within 6-months and test for non-morphine opioid\n compound 0.51 8.8 21.7 39.4 84.1 20.7\nFollow-up within 6-months and test for other non-opioid\n abusable substance 4.2 24.7 36.6 50.2 90.8 36.8\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExhibit 18. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\nFollow-Up within 6 Months of Each Opioid Prescription in FY 2012 and an Annual \n\n Urine Drug Test, Existing Patients on Take-Home Opioids \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nThe low rate of monitoring opioid patients using both an annual UDT and\n6-month follow-up resulted mainly from the low rate of annual UDT (Exhibit 19). We\nobserved that 93.2 percent (including 1.6 percent of the patients who had only follow-up\ncalls) of existing patients had a follow-up within 6 months of each filled opioid\nprescription, ranging from 83.8 percent to 100.0 percent among 140 VAMCs.\nExhibit 19 gives the distribution of VAMC rates on conducting a follow-up within\n6 months of each filled opioid prescription in FY 2012.\n\n\n\n\nVA Office of Inspector General 27\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nExhibit 19. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\n Follow-Up within 6 Months of Each Opioid Prescription in FY 2012, \n\n Existing Patients on Take-Home Opioids \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nIn contrast, we found that VA conducted an annual UDT for only 37.9 percent of existing\nopioid patients (Exhibits 20 and 21), which accounted for 40.9 percent of the chronic\nopioid users and 33.7 percent of the non-chronic users. We observed wide variation of\nVAMCs practice on an annual UDT, ranging from 4.4 percent to 87.6 percent.\n\n Exhibit 20. Variations of VA Medical Center (VAMC1) Percentages Conducting an \n\n Annual Urine Drug Test, FY 2012 Existing Patients on Take-Home Opioids, \n\n by Test Substance Type and Days on Opioids \n\n Variations in VAMC percentages\n VA\n 25th 75th\n average\n Minimum percentile Median percentile Maximum\nAll patients (211,569)\nAny urine drug tests 4.4 25.7 39.5 51.7 87.6 37.9\n Test for morphine or heroin 0.95 21.2 33.4 48.0 87.1 33.8\n Test for non-morphine opioid compound 0.45 8.2 22.4 40.1 82.8 21.1\n Test for other non-opioid abusable substance 4.4 25.3 38.4 51.3 87.6 37.7\nPatients on opioids more than 90 days (121,158)\nAny urine drug tests 3.4 27.0 41.1 57.9 93.1 40.9\n Test for morphine or heroin 0.80 22.5 36.7 55.7 92.0 37.0\n Test for non-morphine opioid compound 0.00 9.2 23.3 43.8 90.3 23.9\n Test for other non-opioid abusable substance 2.5 27.0 40.6 57.0 93.1 40.7\nPatients on opioids 90 days or less (90,411)\nAny urine drug tests 3.6 23.7 34.1 44.7 81.9 33.7\n Test for morphine or heroin 0.75 18.3 30.7 42.6 81.9 29.5\n Test for non-morphine opioid compound 0.35 6.5 20.5 35.4 78.6 17.4\n Test for other non-opioid abusable substance 3.6 23.6 33.9 44.2 81.9 33.6\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 28\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 21. Distribution of VA Medical Center (VAMC1) Percentages Conducting\n an Annual Urine Drug Test, FY 2012 Existing Patients on Take-Home Opioids\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nAlthough most annual UDTs included all three test substance types, the test for\nnon-morphine opioid compound was least performed when compared with the test for\nmorphine or heroin and the test for other non-opioid abusable substance. We found\nthat approximately 60 percent of the UDTs were conducted while patients were on\nopioids, regardless of test substance type (Exhibit 22). Exhibits 21 and 23\xe2\x80\x9325 give\nmore details on VAMC patterns of conducting an annual UDT.\n\n Exhibit 22. Variations of VA Medical Center (VAMC1) Percentages Conducting an \n\n Annual Urine Drug Test, FY 2012 Existing Take-Home Opioid Patients Who \n\n Received an Annual Urine Drug Test While on Opioids, by Test Substance Type \n\n Number of Variations in VAMC percentages\n VA\n VA eligible 25th 75th\n average\n patients Minimum percentile Median percentile Maximum\nAny urine drug tests 80,095 19.2 51.5 59.0 68.4 88.9 59.6\n Test for morphine or heroin 71,480 4.5 47.4 58.2 67.6 88.6 60.1\n Test for non-morphine opioid compound 44,612 10.0 47.0 57.4 70.2 90.4 61.7\n Test for other non-opioid abusable substance 79,739 18.9 51.7 59.0 67.9 88.8 59.5\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 29\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 23. Distribution of VA Medical Center (VAMC1) Percentages Conducting\n an Annual Urine Drug Test, FY 2012 Existing Take-Home Opioid Patients Who\n Were on Opioids More than 90 Days\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n Exhibit 24. Distribution of VA Medical Center (VAMC1) Percentages Conducting\n an Annual Urine Drug Test, FY 2012 Existing Take-Home Opioid Patients Who\n Were on Opioids 90 Days or Less\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 30\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 25. Distribution of VA Medical Center (VAMC1) Percentages Conducting\n an Annual Urine Drug Test, FY 2012 Existing Take-Home Opioid Patients Who\n Received an Annual Urine Drug Test While on Opioids\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nActive (Not in Remission) Substance Use Patients. The Clinical Practice Guideline\nrecommends that active (not in remission) substance use patients receive SUD\ntreatment concurrently with urine drug testing as an adjunctive tool at regular intervals\n(p. 90). Among the study population, 13.1 percent were diagnosed with active\nsubstance use (Exhibit 26). For the active substance use patients who filled 1 or more\ntake-home opioid prescriptions at least 90 days prior to the end of follow-up, we\ndetermined that only 10.5 percent received both treatment for substance use and a UDT\nwithin 90 days of each filled opioid prescription (Exhibit 27). The percentages of\nVAMCs treating active substance use patients and performing at least 1 UDT within\n90 days of each filled opioid prescription varied from 0.00 to 44.8.\n\n\n\n\nVA Office of Inspector General 31\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nExhibit 26. Distribution of VA Medical Center (VAMC1) Percentages of Take-Home \n\n Opioid Patients Who Were Diagnosed with Active Substance Use in FY 2012 \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nThe low rate for treating substance use and conducting UDTs regularly for active\nsubstance use patients resulted from both low rates of treatment and UDT. We found\nthat 31.2 percent of the active substance use patients received an SUD treatment in\nFY 2012, with treatment percentages ranging from 8.3 to 59.5 among 140 VAMCs\n(Exhibits 27 and 28); 19.2 percent of the patients received at least 1 UDT within 90 days\nof every (filled) prescription of take-home opioids (Exhibits 27 and 29), with the test\npercentages varying from 2.2 to 52.3 among VAMCs.\n\n Exhibit 27. Variations of VA Medical Center (VAMC1) Percentages Treating \n\n Patients for Substance Use and Conducting at Least 1 Urine Drug Test within \n\n 90 Days of Each Filled Opioid Prescription in FY 2012, \n\n Active Substance Use Patients \n\n Number of Variations in VAMC percentages\n VA\n VA eligible 25th 75th\n average\n patients Minimum percentile Median percentile Maximum\nTreating active substance use patients\nand conducting a urine drug test within\n90 days of each filled opioid prescription 47,736 0.00 6.2 9.6 13.7 44.8 10.5\nTreating active substance use patients 57,966 8.3 24.9 30.5 37.0 59.5 31.2\nConducting a urine drug test within\n90 days of each filled opioid prescription 47,736 2.2 13.2 18.0 24.1 52.3 19.2\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 32\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 28. Distribution of VA Medical Center (VAMC1) Percentages Treating \n\n Patients for Substance Use in FY 2012, Active Substance Use Patients \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExhibit 29. Distribution of VA Medical Center (VAMC1) Percentages Conducting at \n\n Least 1 Urine Drug Test within 90 Days of Each Filled Opioid Prescription in \n\n FY 2012, Active Substance Use Patients \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nEven for the subpopulation of 19,724 active substance use patients who were on\nopioids for more than 90 days in FY 2012, we determined that only 18.8 percent of them\nreceived both substance use treatment and regular 90-day UDTs, and the percentages\nof VAMCs both treating active substance use and performing at least 1 UDT for every\n90 days of opioids varied from 0.00 to 82.7 (Exhibit 30). In particular, 55.2 percent of\nthis subpopulation of active substance use patients received at least 1 UDT per 90 days\n\n\nVA Office of Inspector General 33\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nof take-home opioids (Exhibits 30 and 31), with the VAMCs\xe2\x80\x99 test percentages varying\nfrom 13.3 to 100.0. The percent of this subpopulation receiving an SUD treatment was\n26.5, with treatment percentages ranging from 5.4 to 85.3 among 140 VAMCs\n(Exhibit 30).\n\n Exhibit 30. Variations of VA Medical Center (VAMC1) Percentages Treating\n Patients for Substance Use and Conducting at Least 1 Urine Drug Test for Every\n 90 Days on Opioids in FY 2012, Active Substance Use Patients Who Were on\n Take-Home Opioids More than 90 Days in FY 2012 (19,724 Patients)\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\nTreating active substance use patients and\nconducting a urine drug test for every 90 days\non opioids 0.00 12.5 17.7 22.8 82.7 18.8\nTreating active substance use patients 5.4 18.4 25.5 31.1 85.3 26.5\nConducting a urine drug test for every 90 days\non opioids 13.3 42.6 57.1 69.4 100.0 55.2\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nExhibit 31. Distribution of VA Medical Center (VAMC1) Percentages Conducting a \n\n Urine Drug Test for Every 90 Days on Opioids, Active Substance Use Patients \n\n Who Were on Take-Home Opioids More than 90 Days in FY 2012 \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\n5. VA Patterns of Providing Psychosocial Treatment for Pain, Pain\nClinic Service, and Medication Management/Pharmacy Reconciliation\nfor Take-Home Opioid Patients\nExhibit 32 gives summaries, and Exhibits 33\xe2\x80\x9335 show the distributions of VAMCs\nproviding psychosocial treatment for pain, Pain Clinic service, and medication\nmanagement/pharmacy reconciliation for the study population. In FY 2012,\n45.2 percent of the opioid patients received at least 1 psychosocial treatment for pain,\n\n\nVA Office of Inspector General 34\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nand 35.1 percent received this treatment after their first opioid prescription. Although up\nto 93.7 percent of the patients were provided psychosocial treatments for pain by\nVAMCs, three quarters of the VAMCs gave this treatment to 26.9\xe2\x80\x9352.1 percent of their\npatients in FY 2012.\n\n Exhibit 32. Variations of VA Medical Center (VAMC1) Percentages Providing \n\n Psychosocial Treatment for Pain, Pain Clinic Service, and Medication \n\n Management/Pharmacy Reconciliation for Take-Home Opioid Patients in FY 2012 \n\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\nAnytime in FY 2012\n Psychosocial treatment for pain 26.9 41.2 45.6 52.1 93.7 45.2\n Pain Clinic 0.34 4.7 9.4 15.0 73.5 8.7\n Medication management/pharmacy reconciliation 6.4 30.8 40.7 54.7 86.5 38.8\nAfter first opioid prescription in FY 2012\n Psychosocial treatment for pain 12.1 30.7 35.8 41.4 79.8 35.1\n Pain Clinic 0.24 3.6 7.3 11.7 62.2 6.8\n Medication management/pharmacy reconciliation 5.2 21.6 29.4 40.8 75.0 29.2\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\nThree quarters of the VAMCs provided Pain Clinic service to 15.0 percent or less of\ntheir opioid patients in the FY, although 1 VAMC provided this service to 73.5 percent of\nits patients. Across the VAMCs, 8.7 percent of the patients received the service.\n\nNearly 40 (38.8) percent of the patients received medication management or pharmacy\nreconciliation during the FY, with the percentages varying from 6.4 to 86.5 across the\nVAMCs. The middle half of the VAMCs provided the service to 30.8\xe2\x80\x9354.7 percent of\ntheir patients.\n\n Exhibit 33. Distribution of VA Medical Center (VAMC1) Percentages Providing \n\n Psychosocial Treatment for Pain for Take-Home Opioid Patients in FY 2012 \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nVA Office of Inspector General 35\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n Exhibit 34. Distribution of VA Medical Center (VAMC1) Percentages Providing \n\n Pain Clinic Service for Take-Home Opioid Patients in FY 2012 \n\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n Exhibit 35. Distribution of VA Medical Center (VAMC1) Percentages Providing\nMedication Management/Pharmacy Reconciliation for Take-Home Opioid Patients\n in FY 2012\n\n\n\n\n 1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\n6. Prevalence of Serious Adverse Effects Among Take-Home Opioid\nPatients\nExhibit 36 shows the prevalence of serious adverse effects among the opioid patients\nthat may be reasonably expected as a negative consequence of opioid therapy. Less\n\n\nVA Office of Inspector General 36\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nthan 1 percent of the population experienced each of these adverse effects anytime\nduring the FY except for the adverse effect of possible and confirmed suicide attempts,\nwhich was evident for 2.0 percent of the opioid patients.\n\n Exhibit 36. Variations of VA Medical Center (VAMC1) Percentages of Serious \n\n Adverse Effects in Patients Dispensed with Take-Home Opioids in FY 2012 \n\n Variations in VAMC percentages\n 25th 75th VA average\n Minimum percentile Median percentile Maximum\nAnytime in FY 2012\nAny of the following adverse effects 1.0 2.5 3.4 4.2 9.6 3.3\n Opioid overdose 0.00 0.23 0.40 0.72 4.0 0.49\n Sedative overdose 0.00 0.00 0.09 0.16 0.72 0.10\n Drug delirium 0.00 0.45 0.70 0.96 3.8 0.85\n Drug detoxification 0.00 0.04 0.12 0.26 2.2 0.16\n Acetaminophen overdose 0.00 0.10 0.24 0.46 2.6 0.30\n Possible and confirmed suicide attempts 0.40 1.5 2.0 2.6 5.9 2.0\nAfter first opioid prescription\nAny of the following adverse effects 0.63 1.5 2.2 2.9 7.4 2.2\n Opioid overdose 0.00 0.17 0.29 0.50 2.5 0.33\n Sedative overdose 0.00 0.00 0.05 0.11 0.72 0.07\n Drug delirium 0.00 0.23 0.43 0.67 2.5 0.55\n Drug detoxification 0.00 0.02 0.08 0.18 1.1 0.11\n Acetaminophen overdose 0.00 0.04 0.14 0.27 2.2 0.19\n Possible and confirmed suicide attempts 0.11 0.85 1.3 1.8 4.4 1.3\n1\n Includes all medical centers and Community-Based Outpatient Clinics that are under the same facility (Director) administrative leadership.\n\n\n\n\nConclusions\nWe integrated and analyzed the VA administrative files, as well as the Death\nMaster Files of the Social Security Administration, for the population of nearly half a\nmillion VA patients who filled at least 1 oral or transdermal opioid prescription from VA\nfor self-administration at home in FY 2012. We followed retrospectively the\n442,544 patients in the population\xe2\x80\x94who did not receive any hospice or palliative care\nduring the FY or within 1 year prior to their first take-home opioid prescription\xe2\x80\x94for their\nexperience with the provision of VA opioid therapy. This population encompassed\nsome OEF/OIF era veterans, as well as veterans from other non-OEF/OIF service eras,\nsuch as Operations Desert Shield and Desert Storm. As a result, the outcomes that we\nobserved in this population may be different from those of OEF/OIF veterans only.44\n\nIn this large-scale, population-based study of take-home opioid patients who did not\nreceive any hospice or palliative care during FY 2012 or within 1 year prior to their first\nfilled take-home opioid prescription in the FY, we found that 7.7 percent of VA patients\nwere on take-home opioids in FY 2012. The VAMC prevalence ranged from\n0.26 percent to 21.8 percent. Because the decision to prescribe take-home opioids\nshould reflect individual patients\xe2\x80\x99 clinical needs, higher VAMC prevalence alone does\nnot necessarily indicate overprescribing by the VAMC.\n\nApproximately 87 percent of the opioid patients were diagnosed with primary pain site of\nnon-cancer origin that could result in pain serious enough to warrant an opioid\n\n44\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947.\n\n\nVA Office of Inspector General 37\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nmedication. Nearly all (9.9 out of 10.5 percent) patients diagnosed with pain of the\nnervous system and sense organs were also diagnosed with primary pain site. Six out\nof 10 patients had been diagnosed with mental health issues, one third with mood\ndisorders, 1 of 5 with post-traumatic stress disorder (PTSD), and 1 of 7 with substance\nuse. Nearly 94 percent of the study population had been diagnosed with either pain or\nmental health issues and 58.4 percent with both. We defined pain as either primary\npain site of non-cancer origin that could result in pain serious enough to warrant an\nopioid medication or pain of the nervous system and sense organs, which might not\ncontain every pain diagnosis.\n\nApproximately half of the study population were new patients in the sense that they\nwere initiated on take-home opioid therapy during FY 2012 after not having been on\ntake-home opioids for at least more than 1 year. Seven out of 10 of the non-chronic\n(90 days or less on take-home opioids in FY 2012) users were new patients in contrast\nto 1 in 5 of the chronic users (more than 90 days on take-home opioids in FY 2012).\nNearly 41 percent of the study population had been dispensed with 1 prescription, which\nwas composed entirely of the 61.4 percent of non-chronic users because none of the\nopioids were allowed to be prescribed for more than 90 days in 1 prescription. Patients\nwith 6 or more prescriptions were mainly chronic users, which amounted to 69.3 percent\nof that group. Thus, defining long-term opioid therapy as 6 filled prescriptions45 would\ninclude approximately only 70 percent of the chronic users and very few non-chronic\nusers.\n\nOpioid dosages with a morphine equivalent of at least 200 mg/day were dispensed to\n1.2 percent of the study population, which accounted for 2.6 percent of chronic users\nand 0.44 percent of non-chronic users. Because the goal of pain management is to\ndecrease pain to a level that allows the patient to continue routine activities, and there is\nno maximum dose of opioids, the right dose of opioids is the dose that controls pain so\nthat the patient is functional. An opioid dosage of at least 200 mg/day morphine\nequivalent alone is not an indicative of inappropriate prescribing.\n\nWe defined early refill of opioid prescriptions as the same opioid medication\n(standardized based on generic name, route of administration, and dosage form) that\nwas dispensed before the end of any prior prescriptions. Researchers have used early\nrefill of more than 7 days as a proxy of high-risk opioid behavior.46 We found that refills\nof opioids at least 7 days early occurred in 23.0 percent of the population, with refills of\nat least 11 days early occurring in 14.0 percent of the population. As expected, early\nrefills were (at least 8 times) more likely and occurred more frequently among chronic\nusers than non-chronic users.\n\nThe concurrent use of benzodiazepines and opioids can be dangerous because opioids\nand benzodiazepines can depress the central nervous system and thereby affect heart\nrhythm, slow respiration, and even lead to death. Benzodiazepines have been strongly\n45\n Krebs, E. E., D. C. Ramsey, et al. (2011). \xe2\x80\x9cPrimary care monitoring of long-term opioid therapy among veterans\n\nwith chronic pain.\xe2\x80\x9d Pain Med 12(5): 740\xe2\x80\x93746. \n\n46\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk \n\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947. \n\n\n\nVA Office of Inspector General 38\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nassociated with death from opioid overdose47 and with an increased risk of death due to\nmethadone toxicity.48 We found that take-home benzodiazepines were dispensed to\n7.4 percent of the study population, with the percentage of chronic opioid users being\n1.6 times that of the non-chronic users. We determined that 71 percent of the opioid\npatients who received take-home benzodiazepines were dispensed benzodiazepines\nconcurrently with opioids. The percentage of chronic opioid users with concurrent\nbenzodiazepines was 92.6, and the percentage of non-chronic users was 53.6.\n\nAcetaminophen poisoning is a leading cause of liver toxicity,49 and \xe2\x80\x9cOverdoses from\nprescription products containing acetaminophen account for nearly half of all cases of\nacetaminophen-related liver failure in the U.S., many of which result in liver transplant or\ndeath.\xe2\x80\x9d50 We determined that take-home acetaminophens were given to 92.3 percent of\nthe study patients and that 2.0 percent of them were given an average daily dose of\n4 g/day or more. We found that 45.5 percent of chronic users were given at least 1 day\ndosage of 4 grams or more of acetaminophen and that 43.5 percent were given at least\n1 day dosage of 4 grams or more concurrently with opioids, which were more than\ndouble those (19.4 percent and 13.3 percent, respectively) of non-chronic users.\n\nThe Clinical Practice Guideline recommends a bowel regimen for all opioid patients to\nmanage opioid-related constipation. We found that 27.9 percent of the patients were\ndispensed with a laxative in FY 2012 and that 23.5 percent of the patients were given a\nlaxative on or after the date of their first opioid prescription. The practice of dispensing\na laxative to opioid patients varied among 140 VAMCs, from 17.6 percent to\n61.6 percent for the entire FY 2012 and from 12.7 percent to 56.0 percent at or after\npatients\xe2\x80\x99 first opioid prescription.\n\nPatients sometimes do not take opioids as prescribed or use non-prescribed opioids. A\nurine drug test (UDT) is useful for assessing adherence to therapy and detecting illicit\ndrug use. The Clinical Practice Guideline calls for a UDT prior to initiating opioid\ntherapy and a follow-up contact at least every 2\xe2\x80\x934 weeks after any change in\nmedication regimen. We measured whether new opioid patients\xe2\x80\x94who were initiated\ntake-home opioids in FY 2012 after not having been on take-home opioids for at least\nmore than 1 year\xe2\x80\x94received both a UDT prior to and a follow-up within 30 days of\ninitiating their opioid therapy in FY 2012. We determined that only 6.4 percent of the\nnew patients received both a UDT prior to and a follow-up within 30 days. We observed\nbroad variation among 140 VAMCs\xe2\x80\x99 practice on this measure, ranging from 1.1 percent\nto 32.2 percent, with the middle 50 percent of the VAMCs from 3.9 percent to\n10.2 percent.\n\n\n47\n Toblin, R. L., L. J. Paulozzi, et al. (2010). \xe2\x80\x9cMental illness and psychotropic drug use among prescription drug\n\noverdose deaths: a medical examiner chart review.\xe2\x80\x9d J Clin Psychiatry 71(4): 491\xe2\x80\x93496. \n\n48\n Caplehorn, J. R. and O. H. Drummer (2002). \xe2\x80\x9cFatal methadone toxicity: signs and circumstances, and the role of\n\nbenzodiazepines.\xe2\x80\x9d Aust N Z J Public Health 26(4): 358\xe2\x80\x93362; discussion 362\xe2\x80\x93353. \n\n49\n Larson, A. M., J. Polson, et al. (2005). \xe2\x80\x9cAcetaminophen-induced acute liver failure: results of a United States \n\nmulticenter, prospective study.\xe2\x80\x9d Hepatology 42(6): 1364\xe2\x80\x931372. \n\n50\n http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM239891.pdf. Last accessed \n\nNovember 27, 2013.\n\n\n\nVA Office of Inspector General 39\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nThis very low (6.4 percent) VA rate of screening and monitoring patients almost\nexclusively resulted from the very low rate of a UDT. Although nearly three quarters of\nthe patients received a follow-up contact within 30 days of initiating opioid therapy, only\n7.6 percent of the patients had a UDT within 30 days prior to initiating therapy. Even for\nthe high-risk group of patients who were diagnosed with substance use disorder (SUD)\nwithin 1 year prior to the initiation of opioid therapy, a UDT was performed for only 1 out\nof 5.\n\nThe Clinical Practice Guideline requires routine and random UDTs to confirm the\nappropriate use of opioids by patients and a follow-up contact at least once every\n1\xe2\x80\x936 months for the duration of opioid therapy. We measured whether existing opioid\npatients\xe2\x80\x94who were on take-home opioids at least from FY 2011\xe2\x80\x94received both an\nannual UDT and a follow-up contact within 6 months of each filled opioid prescription.\nWe determined that only 37.0 percent of the existing opioid patients received both an\nannual UDT and a follow-up contact within 6 months of each filled opioid prescription,\nvarying extensively from 4.2 percent to 91.0 percent among VAMCs.\n\nThe low (37.0 percent) VA rate of monitoring opioid patients using both an annual UDT\nand a 6-month follow-up contact resulted mainly from the low rate of an annual UDT.\nWe found that 93.2 percent of the existing patients had at least 1 follow-up contact\nwithin 6 months of each filled opioid prescription. In contrast, VA conducted an annual\nUDT for only 37.9 percent of the existing opioid patients. We observed wide variation of\nVAMCs\xe2\x80\x99 practice of conducting an annual UDT, ranging from 4.4 percent to\n87.6 percent. Even for the chronic (more than 90 days on take-home opioids in\nFY 2012) opioid users, the annual UDT rate was only 40.9 percent, which was about\n7 percentage points higher than the rate for the non-chronic (90 days or less on\ntake-home opioids in FY 2012) users (33.7 percent).\n\nWe found that 13.1 percent of the study population was diagnosed with active\nsubstance use. The Clinical Practice Guideline specifies that chronic (for more than\n1 month) opioid therapy is absolutely contraindicated in patients with active (not in\nremission) SUDs who are not in treatment. It recommends that active substance use\npatients receive SUD treatment concurrently with urine drug testing as an adjunctive\ntool at regular intervals. For the active substance use patients who had at least 90 days\navailable for follow-up in FY 2012, we measured whether they received both a treatment\nfor substance use and a UDT within 90 days of each filled opioid prescription. We\ndetermined that only 10.5 percent received both a treatment for substance use and a\nUDT within 90 days of each filled opioid prescription. The percentages of VAMCs\nvaried from 0.00 to 44.8.\n\nThe low (10.5 percent) VA rate for treating substance use and conducting regular UDTs\nfor active substance use patients resulted from both low rates of treatment and UDTs.\nWe found that 31.2 percent of the active substance use patients received an SUD\ntreatment in FY 2012, ranging from 8.3 percent to 59.5 percent among 140 VAMCs.\nWe determined that 19.2 percent of the patients received at least 1 UDT within 90 days\nof each filled prescription of take-home opioids, with the UDT percentages varying from\n2.2 to 52.3 among VAMCs. Even for the subpopulation of 19,724 active substance use\n\n\nVA Office of Inspector General 40\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\npatients who were on opioids for more than 90 days in FY 2012, we determined that\nonly 18.8 percent of them received both an SUD treatment in the FY and a UDT for\neach 90 days on opioids, with VAMC percentages ranging from 0.00 to 82.7.\n\nPsychotherapy, including cognitive behavioral therapy, is recommended to reduce pain\nand improve function in chronic pain patients. We found that 45.2 percent of the opioid\npatients received at least 1 psychosocial treatment for pain and that 35.1 percent of\nthese patients received this treatment after their first filled opioid prescription in\nFY 2012. The VAMC percentages for providing psychosocial treatments for pain\nranged from 26.9 to 93.7 in FY 2012. If patients were offered psychosocial treatment\nfor pain but declined, our data did not capture this.\n\nTreatment of chronic pain involves a stepped care approach oriented toward recovering\nor maintaining physical, social, and occupational function. This approach requires\nincreasing levels of expertise dependent upon the complexity of the pain concerns of\nthe individual veteran. In the most complex cases, such care will involve a broad array\nof specialty rehabilitation, pain medicine, surgical, and complementary and alternative\nmedicine services. Referral to a Pain Clinic may be another approach to care. We\ndetermined that 8.7 percent of the VA patients who had been prescribed opioids\nreceived care from a VA Pain Clinic in FY 2012. Three quarters of the VAMCs provided\nPain Clinic service to 15.0 percent or less of their opioid patients in the FY, although\n1 VAMC provided this specialty Pain Clinic service to 73.5 percent of its patients. Our\ndata did not capture all information about the broad array of specialty pain management\nservices, including consultative input from a Pain Clinic, if they were not coded as Pain\nClinic service.\n\nOpioid patients frequently have complex co-morbid conditions, making them more likely\nto be given multiple medications that can interact dangerously with opioid medications.\nA review of medications by a pharmacist or other health care professional can prevent\nharmful interactions between these medications. We found that 38.8 percent of the\nopioid patients received medication management or pharmacy reconciliation during the\nFY, with the percentages varying from 6.4 to 86.5 across the 140 VAMCs. The middle\nhalf of the VAMCs provided the service to 30.8\xe2\x80\x9354.7 percent of their opioid patients.\n\nIncreasing use of opioids has been associated with increasing rates of opioid-related\nserious adverse effects. We determined percentages of opioid patients with evidence of\na serious adverse effect that may be reasonably expected to be related to opioid\ntherapy for the following six serious adverse effects: (1) opioid overdose, (2) sedative\noverdose, (3) drug delirium, (4) drug detoxification, (5) acetaminophen overdose, and\n(6) possible and confirmed suicide attempts. We found that less than 1 percent of the\npopulation experienced each of these adverse effects during the FY, except for the\nadverse effect of possible and confirmed suicide attempts that was evident in\n2.0 percent of the opioid patients.\n\nWe defined days on opioids (or acetaminophen or benzodiazepines) by counting\noverlapping supply days from different prescriptions once only rather than just taking a\nsimple sum of the number of supply days from all filled prescriptions as in the\n\n\nVA Office of Inspector General 41\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\nliterature.51,52 Although the computation is much more complex, our definition of days\non opioids better reflects the physical days a patient should be on opioids through\ntaking into account both partially and totally overlapping prescriptions. Totally\noverlapping prescriptions may result from either intentional combination use of different\ntypes of opioids (for example, morphine and hydrocodone) or unintentional combination\nuse of the same type of opioids to attain dosages that are not readily available by\nmanufacturers (for example, to reach a daily dose of 85 mg methadone, a patient may\nbe given both a filled prescription of 3 tablets of METHADONE HCL 5MG TAB and a\nfilled prescription of 7 tablets of METHADONE HCL 10MG TAB simultaneously).\nBecause days on opioids are less than or equal to the simple sum of the supply days,\nour calculated daily doses using days on opioids (as the denominator) are greater than\nor equal to those calculated based on just a simple sum of the supply days. Similarly,\nour numbers of chronic users (more than 90 days on opioids) are less than or equal to\nthose calculated based on just a simple sum of the supply days.\n\nWe counted a clinical encounter as a follow-up contact for opioid therapy whether or not\npatients were assessed for effectiveness of opioid therapy, adverse effects, and\nadherence to therapy. These encounters were either in-person (inpatient care,\nextended care, or outpatient visit) or by telephone. They did not include any in-person\nvisits to the emergency room or any encounters for reasons that were unlikely related to\nfollow-up for opioids, such as for compensation and pension, dental, organ donation, or\nresearch.\n\nWe assessed VA FY 2012 patterns of dispensing take-home opioids and monitoring\npatients who were treated with take-home opioids. This cross-sectional evaluation\nprovided us with a snapshot of VA FY 2012 practice for the population of all\nnon-hospice/palliative care patients who had at least 1 take-home opioid fill in the FY,\nregardless of the difference in time when they were initiated on and ended take-home\nopioid therapy. Because of the nature of cross-sectional data, our definition of chronic\nusers of opioids (more than 90 days) is relevant only to the given time period. For\nexample, the non-chronic (90 days or less) users in FY 2012 would really be chronic\nusers if they were initiated on opioid therapy during the 4th quarter of FY 2012 (that is,\nnew patients in FY 2012) and continued the therapy through FY 2013. This would also\napply to the non-chronic users in FY 2012 if they were initiated on and continued with\ntherapy through FY 2011 (that is, existing patients in FY 2012) but ended prior to the\n2nd quarter of FY 2012. Similarly, chronic users in FY 2012 would not be chronic users\nin FY 2013 if they were on take-home opioids for 90 days or less in FY 2013. (See\nExhibit X4 in Appendix A for examples.) Our results by chronic and non-chronic users\nshould be viewed within the context of this limitation that is common to cross-sectional\nstudies. For this reason, this study included all patients, whether on chronic (more than\n1 month as defined by the CPG, p. 3) or non-chronic take-home opioid therapy.\n\n\n51\n Seal, K. H., Y. Shi, et al. (2012). \xe2\x80\x9cAssociation of mental health disorders with prescription opioids and high-risk \n\nopioid use in US veterans of Iraq and Afghanistan.\xe2\x80\x9d JAMA 307(9): 940\xe2\x80\x93947. \n\n52\n Edlund, M. J., B. C. Martin, et al. (2010). \xe2\x80\x9cRisks for opioid abuse and dependence among recipients of chronic \n\nopioid therapy: results from the TROUP study.\xe2\x80\x9d Drug Alcohol Depend 112(1-2): 90\xe2\x80\x9398. \n\n\n\nVA Office of Inspector General 42\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\nRecommendations\n1. We recommended that the Under Secretary for Health ensure that the practice of\nprescribing acetaminophen is in compliance with acceptable standards.\n\n2. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s practice\nof routine and random urine drug tests prior to initiating and during take-home opioid\ntherapy to confirm the appropriate use of opioids is in alignment with acceptable\nstandards.\n\n3. We recommended that the Under Secretary for Health ensure that follow-up\nevaluations of patients on take-home opioids are performed timely.\n\n4. We recommended that the Under Secretary for Health ensure that opioid patients\nwith active (not in remission) substance use receive treatment for substance use\nconcurrently with urine drug tests.\n\n5. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s practice\nof prescribing and dispensing benzodiazepines concurrently with opioids is in alignment\nwith acceptable standards.\n\n6. We recommended that the Under Secretary for Health ensure that medication\nreconciliation is performed to prevent adverse drug interactions.\n\n\n\n\nVA Office of Inspector General 43\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix A\n\n Appendix A. Additional Exhibits\n\n Exhibit X1. Calculation of Days on (Opioid) Prescriptions\n\n\n\n\nVA Office of Inspector General 44\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n\n Exhibit X2. Concurrent Use and Early Refills\n\n\n\n\nVA Office of Inspector General 45\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n Exhibit X3. Data Files Used in OIG Statistical Analysis\n\n\n\n\nVA Office of Inspector General 46\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n\n Exhibit X4. Chronic (> 90 days) Users in Cross-Sectional Study\n\n\n\n\nVA Office of Inspector General 47\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix B1\n\n Codes for Identifying Hospice and Palliative Care\n\nICD-9-CM diagnostic code: V66.7. \n\n\nTreating specialty codes: 96, 1F. \n\n\nCPT/HCPS codes: G9054, G0182, G0337, Q5001\xe2\x80\x93Q5010, S0255, S0271, S9126, \n\nT2042, T2043, T2045, T2046.\n\n\nClinic stop codes: 351, 353. \n\n\n\n\n\nVA Office of Inspector General 48\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix B2\n\n VA Intermediate Product Numbers for Identifying \n\n Urine Drug Tests \n\n by Test Substance Type \n\n\nTests for heroin or morphine: 00467, 00537, 00753, 00754, 00755, 49338, 49339,\n82227\xe2\x80\x9382229, 82231, 83304, 83455, and 83510.\n\nTests for non-morphine opioid compounds: 00608, 00664, 00710, 00711, 00721,\n00727, 00734, 00759, 00780, 00784, 00786, 00788, 00808, 00864, 49340, 49355,\n57854, 73744, 81952, 81996, 82166, 82230, 82232\xe2\x80\x9382236, 82448, 82449, 82458,\n82972, 83005, 83162, 83261, 83402, 83439, 83462, 83506, 83508, 83509, 83511,\n83727, 83859, 83862, 84383, 84398, 91141, 91210, and 91211.\n\nTests for non-opioid abusable substances: 00466, 00470, 00499, 00523, 00525,\n00562, 00575, 00580, 00584, 00596\xe2\x80\x9300601, 00606, 00607, 00611\xe2\x80\x9300614, 00660,\n00661, 00663, 00675, 00684\xe2\x80\x9300688, 00700, 00724, 00729, 00730, 00732, 00735,\n00737, 00738, 00742, 00745, 00769, 00779, 00785, 00790, 00803, 00811, 00821,\n00832, 00846, 00856\xe2\x80\x9300863, 45095, 45110, 49337, 49350, 49353, 53008, 54720,\n56922, 62505, 63308, 65398, 66031, 69135, 81882, 81997, 82019, 82031, 82092\xe2\x80\x93\n82094, 82225, 82441, 82451\xe2\x80\x9382456, 82997, 83000\xe2\x80\x9383003, 83009\xe2\x80\x9383011, 83022,\n83027, 83028, 83160, 83246, 83252, 83262, 83281, 83588, 83638, 83704, 83713,\n83730, 83773, 83796, 83798, 83889, 83927, 83931, 83945, 83967, 84064, 84075,\n84098, 84099, 84100, 84101, 84112, 84172, 84173, 84175, 84336, 84388, 85161,\n91156, and 91157.\n\n\n\n\nVA Office of Inspector General 49\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix C\n Under Secretary for Health Comments\n\n\n Department of\n Veterans Affairs Memorandum\n\n\n Date: April 22, 2014\n\n From: Under Secretary for Health (10)\n\n Subject: \t OIG Draft Report, VA Patterns of Dispensing Take-Home\n Opioids and Monitoring Patients on Opioid Therapy\n (Project No. 2014-00895-HI-0378) (VAIQ 7462279)\n\n To: Assistant Inspector General for Healthcare Inspections (54)\n\n 1. I have reviewed the draft report and concur with the report\xe2\x80\x99s\n recommendations. Attached is the Veterans Health Administration\xe2\x80\x99s\n corrective action plan for recommendations 1\xe2\x80\x936.\n\n 2. OIG\xe2\x80\x99s report provides important baseline data for understanding how\n VHA practitioners were prescribing opioids 2 years ago. Since that\n time, VHA has initiated several new modalities for improving pain care,\n including: pain schools, tele-pain schools, smartphone type\n applications and web based modules for patient and family education,\n case based audio conferences, Nation-wide community of practice\n calls, self-management strategies, and complementary and integrative\n medicine modalities.\n\n 3. Compared to October 2012, as of November 2013:\n \xef\x82\xb7 39,088 fewer Veterans received an opioid prescription from VA;\n \xef\x82\xb7 80,294 more Veterans who had been prescribed opioids underwent\n urine drug screens; and\n \xef\x82\xb7 9,609 fewer Veterans were receiving prescriptions for both\n benzodiazepines and opioids.\n VA expects these trends to continue as it promotes the safe and\n effective pharmacologic and non-pharmacologic stepped care model of\n pain management.\n\n\n\n\nVA Office of Inspector General 50\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n\n 4. This year VHA issued the Opioid Safety Initiative (OSI) requirements to\n all Veterans Integrated Service Networks (VISN). The purpose of the\n initiative is to ensure pain management is addressed thoughtfully,\n compassionately, and safely. The nine goals of OSI are:\n\n Goal 1 Educate prescribers of opioid medication regarding effective\n use of urine drug screening;\n Goal 2 Increase the use of urine drug screening;\n Goal 3 Facilitate the use of state prescription databases;\n Goal 4 Establish safe and effective tapering programs for the\n combination of benzodiazepines and opioids;\n Goal 5 Develop tools to identify higher risk patients;\n Goal 6 Improve prescribing practices around long-acting opioid\n formulations;\n Goal 7 Review treatment plans for patients on high doses of\n opioids;\n Goal 8 Offer Complementary and Alternative Medicine (CAM)\n modalities for chronic pain at all facilities; and\n Goal 9 Develop new models of mental health and primary care\n collaboration to manage prescribing of opioids and\n benzodiazepines in patients with chronic pain.\n\n 5. Through promulgation of new regulations, VHA providers can now\n access the state Prescription Drug Monitoring Programs (PDMP).\n These programs, with appropriate health privacy protections, provide\n VHA prescribers with access to information on prescribing and\n dispensing of controlled substances that Veterans obtain from outside\n the VA health care system. Participation in PDMPs helps VHA\n providers identify potentially vulnerable at-risk individuals and offers\n them greater opportunities to talk with patients about whether opioids\n are effective in managing their pain.\n\n 6. As of January 2014, VHA has 10 sites with Commission on\n Accreditation of Rehabilitation Facilities (CARF); 11 more sites are\n actively preparing or applying for CARF status. These Centers have\n the capacity for providing advanced pain medicine diagnostics, surgical\n and interventional procedures, and intensive, integrated chronic pain\n rehabilitation for Veterans with complex, co-morbid, or treatment\n refractory conditions. In 2009, there were only two CARF sites in VHA.\n\n 7. I am confident that the work VHA is doing coupled with the important\n information in OIG\xe2\x80\x99s report will result in more accessible, safe, and\n effective pain care that will be responsive to the needs of Veterans and\n will enhance the quality of their lives.\n\n\n\n\nVA Office of Inspector General 51\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n\n 8. Thank you for the opportunity to review the draft report. \tIf you have\n any questions, please contact Karen Rasmussen, M.D., Director,\n Management Review Service (10AR) at (202) 461-6643 or by email at\n VHA10ARMRS2@va.gov.\n\n\n\n\n Attachment\n\n\n\n\nVA Office of Inspector General 52\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n\n\n Under Secretary for Health\xe2\x80\x99s Comments\n to Office of Inspector General\xe2\x80\x99s Report\n\n\n OIG Draft Report, Healthcare Inspection: VA Patterns of Dispensing\n Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n Date of Draft Report: April 6, 2014\n\n Recommendations/ Status Completion Date\n Actions\n\n OIG Recommendations\n\n 1. We recommended that the Under Secretary for Health ensure that the\n practice of prescribing acetaminophen is in compliance with acceptable\n standards.\n\n VHA Comments\n\n Concur\n\n The Office of Inspector General (OIG) review found that some patients\n who were prescribed acetaminophen could have exceeded the maximum\n recommended dosage of 4 grams per day. The Veterans Health\n Administration (VHA) agrees that safe prescribing of all medications,\n including acetaminophen, is an essential aspect of patient safety.\n\n The Department of Veterans Affairs (VA) has taken steps to enhance\n prescribing and prescription fulfillment processes to prevent the types of\n situations described by OIG and to meet OIG\xe2\x80\x99s intent to ensure safe\n prescribing of acetaminophen. VA developed a software system called\n Medication Order Check Healthcare Application (MOCHA) that notifies a\n prescriber when the single maximum dose ordered of any drug, including\n acetaminophen, exceeds the Food and Drug Administration\n recommended standards. MOCHA alerts prescribers when more than one\n medication containing acetaminophen is ordered to prevent cumulative\n excessive doses. VA\xe2\x80\x99s Office of Information and Technology (OI&T)\n started deploying MOCHA maximum dosage checks to VA medical\n centers in March 2014, and expects the system to be fully deployed by\n end of fiscal year (FY) 2014.\n\n\n\n\nVA Office of Inspector General 53\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n VHA is concerned that OIG didn\xe2\x80\x99t consider the instructions for use on the\n prescription label, which is one of the critical elements of safe prescribing.\n Additionally, the report may have overestimated the number of patients\n whose prescriptions could have exceeded the maximum recommended\n dose because the study methodology of tracking dispensing does not take\n into account the delivery lag time required to mail prescriptions to patients.\n Prescription dispensing is purposely overlapped so the patient does not\n run out of medications while waiting for the next refill in the mail. Once\n VA\xe2\x80\x99s consolidated mail outpatient pharmacy (CMOP) fills a prescription, it\n enters the mail stream for delivery, which on average takes 2.5 days to\n reach the patient; CMOP dispenses approximately 80 percent of all VA\n prescriptions.\n\n To address this recommendation, VHA will:\n\n \xef\x82\xb7\t Work with VA\xe2\x80\x99s OI&T to complete full implementation of MOCHA\n maximum dosing checks to all medical centers by the end of FY 2014.\n\n \xef\x82\xb7\t Pharmacy Benefits Management (PBM) Services office will educate\n providers about the vulnerabilities associated with patients exceeding\n the maximum recommended acetaminophen dosage using newsletters\n or other communications.\n\n To complete this action, VHA will provide documentation of:\n\n 1) Certification that VA\xe2\x80\x99s OIT has deployed MOCHA across the entire\n VHA health care system; and\n 2) PBM communications to providers about exceeding maximum\n recommended dose of acetaminophen.\n In process \t September 30, 2014\n\n 2. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s\n practice of routine and random urine drug tests prior to initiating and\n during take-home opioid therapy to confirm the appropriate use of opioids\n is in alignment with acceptable standards.\n\n VHA Comments\n\n Concur\n\n Although VHA\xe2\x80\x99s current acceptable standard of practice does not initiate\n Urine Drug Tests (UDTs) for the short term use of opioid analgesics for\n acute pain when there is no intent for long-term (greater than 90 days)\n opioid prescribing, VHA concurs with the recommendation to initiate UDTs\n in chronic opioid therapy for chronic pain.\n\n\n\n\nVA Office of Inspector General 54\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n The National Program Director for Pain (Specialty Care Services) will work\n with other offices to advise the lead office, the Assistant Deputy Under\n Secretary for Health (ADUSH) for Clinical Operations, to develop and\n disseminate interim guidance to the field. Veterans Integrated Service\n Networks (VISN) and facilities will monitor adherence to the guidance\n through the routine review of data from the Opioid Safety Initiative (OSI)\n Dashboard, and will provide feedback on outliers where needed.\n\n To complete this action, VHA will provide documentation of:\n\n 1) The Deputy Under Secretary for Health for Operations and\n Management issuance of interim guidance to the field on the practice\n of routine and random UDTs prior to initiating and during take-home\n long-term opioid therapy;\n 2) One quarter of data demonstrating monitoring of interim guidance on\n UDTs from the OSI dashboard and feedback on adherence to outliers\n through the Opioid Safety Initiative; and\n 3) Two examples of corrective action plans.\n\n In process February 28, 2015\n\n 3. We recommended that the Under Secretary for Health ensure that\n follow-up evaluations of patients on take-home opioids are performed\n timely.\n\n VHA Comments\n\n Concur\n\n The Pain Management Program Office will coordinate with Primary Care\n Services to develop clinical guidance recommendations for dissemination\n to field. The clinical guidance recommendations for facilities will help to\n ensure timely follow-up evaluations of patients prescribed take-home\n opioid analgesics, depending on the Veteran\xe2\x80\x99s specific clinical status such\n as pain severity, clinical complexity (e.g., medical and psychiatric\n co-morbidities), and risk.\n\n The Pain Management Program Office will coordinate with Primary Care\n Services to disseminate the clinical recommendations through VHA\n Primary Care Services and Patient Aligned Care Team (PACT)\n educational programs, the VHA Pain Management Program\xe2\x80\x99s VISN and\n facility points of contact, and the VHA\xe2\x80\x99s pain web site.\n\n To complete this action, VHA will provide documentation of:\n\n 1) Clinical guidance recommendations regarding timely follow-up of\n patients on take-home opioids, and\n\n\n\nVA Office of Inspector General 55\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n 2) Dissemination of the recommendations through VHA Primary Care\n Services, PACT Education Programs, VHA Pain Management\n Programs, VISN and facility points of contacts, and VHA\xe2\x80\x99s pain web\n site.\n\n In process December 31, 2014\n\n 4. We recommended that the Under Secretary for Health ensure that\n opioid patients with active (not in remission) substance use receive\n treatment for substance use concurrently with urine drug tests.\n\n VHA Comments\n\n Concur\n\n The Pain Management Program Office, Pharmacy Benefits Management\n Office, and Mental Health Office will work with the Office of the ADUSH for\n Clinical Operations to develop the capability to monitor whether patients\n using opioid analgesics for chronic pain, who also are diagnosed with\n substance use disorder (not in remission), are provided appropriate UDTs\n and also provided access to appropriate addiction/mental health specialty\n care.\n\n To complete this action, VHA will provide documentation of guidance to\n the field on UDTs for patients prescribed opioids for chronic pain also with\n substance abuse disorder not in remission, by December 2014.\n\n In process February 28, 2015\n\n 5. We recommended that the Under Secretary for Health ensure that VA\xe2\x80\x99s\n practice of prescribing and dispensing benzodiazepines concurrently with\n opioids is in alignment with acceptable standards.\n\n VHA Comments\n\n Concur\n\n VHA will use the OSI Project Dashboard to identify patient\xe2\x80\x99s co-prescribed\n benzodiazepines and opioids, and will provide clinically appropriate and\n safe tapering programs when clinically indicated. In coordination with OSI,\n VHA will develop a plan to provide guidance that supports safe and\n effective tapering when clinically indicated.\n To complete this action, VHA will provide documentation of:\n 1) Regular monitoring of co-prescribing;\n 2) Use of specialty support to providers;\n 3) Reduced new starts on co-prescribed opioids and benzodiazepines;\n and\n\n\nVA Office of Inspector General 56\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n\n\n 4) Over-all reduction of co-prescribed opioids and benzodiazepines.\n\n In process December 31, 2014\n\n 6. We recommended that the Under Secretary for Health ensure that\n medication reconciliation is performed to prevent adverse drug\n interactions.\n\n VHA Comments\n\n Concur\n\n Medication reconciliation has been an evolving aspect of VA clinical care\n that is now standardized in accordance with the Medication Reconciliation\n Directive (VHA Directive 2011-012). The Essential Medication Information\n Standards Directive (VHA Directive 1164, currently in concurrence) will\n provide further direction by outlining essential patient medication\n information for management, communication, and review. The process of\n medication reconciliation is being monitored via a Medication\n Reconciliation External Peer Review Program as a quality indicator for VA\n care. Internally, Medication Reconciliation is measured by facilities often\n with tracer methodologies. A VA Medication Reconciliation/Patient\n Medication Information Overarching Strategy is under development for\n submission to VHA leadership.\n\n To complete this action, VHA will provide documentation of:\n\n 1) Publication of the Essential Medication Information Directive\n (VHA 1164, currently in concurrence); and\n 2) Leadership\xe2\x80\x99s briefing regarding the VA Medication\n Reconciliation/Patient Medication Information Overarching Strategy\n recommendations.\n\n In process February 28, 2015\n\n\n\n\n Veterans Health Administration\n April 2014\n\n\n\n\nVA Office of Inspector General 57\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix D\n\n OIG Contact and Staff Acknowledgments\nContact For more information about this report, please contact the OIG at\n (202) 461-4720.\nContributors Limin X. Clegg, Ph.D., Director\n Daisy Arugay-Rittenberg, MT\n Elizabeth Bullock\n Nathan McClafferty, MS\n Ronald R. Penny, BS \n\n Patrick Smith, M. Stat \n\n\n\n\n\nVA Office of Inspector General 58\n\x0c VA Patterns of Dispensing Take-Home Opioids and Monitoring Patients on Opioid Therapy\n Appendix E\n\n Report Distribution\nVA Distribution\n\nOffice of the Secretary\nVeterans Health Administration\nAssistant Secretaries\nOffice of General Counsel\n\nNon-VA Distribution\n\nSenate Committee on Veterans\xe2\x80\x99 Affairs\nHouse Committee on Veterans\xe2\x80\x99 Affairs\nSenate Appropriations Subcommittee on Military Construction, Veterans Affairs, and\n Related Agencies\nSenate Committee on Homeland Security and Governmental Affairs\nHouse Appropriations Subcommittee on Military Construction, Veterans Affairs, and\n Related Agencies\nHouse Committee on Oversight and Government Reform\nNational Veterans Service Organizations\nGovernment Accountability Office\nOffice of Management and Budget\n\n\nThis report is available on our web site at www.va.gov/oig.\n\n\n\n\nVA Office of Inspector General 59\n\x0c'