Opioid Prescribing and Opioid Risk Mitigation Strategies in the Veterans Health Administration.

INTRODUCTION: The Veterans Health Administration (VHA) has taken a multifaceted approach to addressing opioid safety and promoting system-wide opioid stewardship. AIM: To provide a comprehensive evaluation of current opioid prescribing practices and implementation of risk mitigation strategies in VHA. SETTING: VHA is the largest integrated health care system in the United States. PROGRAM DESCRIPTION: VHA prescribing data in conjunction with implementation of opioid risk mitigation strategies are routinely tracked and reviewed by VHA's Pharmacy Benefits Management Services (including Academic Detailing Service) and the Pain Management Program Office. Additional data are derived from the Partnered Evidence-Based Policy Resource Center (PEPReC) and from a 2019 survey of interdisciplinary pain management teams at VHA facilities. Prescribing data are reported quarterly until first quarter fiscal year 2020 (Q1FY2020), ending December 31, 2019. PROGRAM EVALUATION: VHA opioid dispensing peaked in 2012 with 679,376 Veterans receiving an opioid prescription, and when including tramadol, in 2013 with 869,956 Veterans. Since 2012, the number of Veterans dispensed an opioid decreased 56% and co-prescribed opioid/benzodiazepine decreased 83%. Veterans with high-dose opioids (≥ 100 mg morphine equivalent daily dose) decreased 77%. In Q1FY2020, among Veterans on long-term opioid therapy (LTOT), 91.1% had written informed consent, 90.8% had a urine drug screen, and 89.0% had a prescription drug monitoring program query. Naloxone was issued to 217,469 Veterans and resulted in > 1,000 documented overdose reversals. In 2019, interdisciplinary pain management teams were fully designated at 68%, partially designated at 28%, and not available at 4% of 140 VA parent facilities. Fifty percent of Veterans on opioids at very high risk for overdose/suicide received interdisciplinary team reviews. IMPLICATIONS: VHA clinicians have greatly reduced their volume of opioid prescribing for pain management and expanded implementation of opioid risk mitigation strategies. IMPACTS: VHA's integrated health care system provides a model for opioid stewardship and interdisciplinary pain care.

Feasibility Study of a Quasi-experimental Regional Opioid Safety Prescribing Program in Veterans Health Administration Emergency Departments.

BACKGROUND: The Veterans Health Administration (VHA) Opioid Safety Initiative (OSI) was implemented in 2013 and was associated with a 25% relative decrease in the dispensing of opioids. Although emergency department (ED) providers play a role in the initiation and continuation of opioids, the incumbent OSI did not target EDs. OBJECTIVE: The goal of this feasibility study was to leverage the existing VHA OSI and test a novel ED-based quality improvement (QI) program to decrease opioid prescribing in multiple ED settings. METHODS: This was a quasi-experimental study of phased-in implementation of a QI ED-based OSI. The general setting for this pilot were four VHA EDs across the Veterans Integrated Services Network (VISN) region 19: Denver, Oklahoma City, Muskogee, and Salt Lake City. We developed and disseminated a dashboard to assess ED-specific prescribing rates and an ED-tailored toolkit to implement the program. Academic detailing pharmacists provided focused audits and feedback with the highest prescribing providers. We measured change in ED-provider prescribing rate of opioids for patients discharged from the ED, by provider and aggregated up to facility level, pre- and postimplementation. RESULTS: Interrupted time-series analysis of provider-level data from the program implementation sites indicated a significant decrease in the trend for proportion of opioid prescriptions relative to the preintervention trend. The results of the analysis suggest that the intervention was associated with accelerating the rate at which ED provider prescribing rates decreased. CONCLUSION: Due to the high volume of patients and the vital role the ED plays in patient treatment and hospital admissions, it is evident that the ED is an important site for QI programs as well as the implementation of opioid safety measures. Given the findings of this pilot, we believe that implementation of a national Veterans Affairs ED OSI implementation is feasible practice.

Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

Variability in opioid prescribing in veterans affairs emergency departments and urgent cares.

OBJECTIVE: The Veterans Health Administration (VHA) is the largest integrated health care system in the U.S., serving approximately 2.5 million Veterans in the Emergency Department/Urgent Care Centers (ED/UCC) each year. Variation in opioid prescribing by ED/UCC providers in the VHA is described. METHODS: This is an observational study using administrative data from the VHA Pharmacy Benefits Management Services database to assess ED/UCC providers' opioid prescribing rates between October 1st, 2014 to June 30th, 2017 in 121 U.S. facilities. The opioid prescribing rate was defined as the number of opioid prescriptions written by the provider divided by the number of patients discharged from the ED/UCC by that provider, by quarter. A regression analysis was performed to estimate the association between time and prescribing rates by provider. RESULTS: Overall, the national trend in median prescribing rates decreased by 25.5% (p value = 0.00) from 9.1% ([range 1.5%-25.6%] to 6.4% [range 0.8%-21.8%]). The greatest rates of decline occurred between January 1st, 2016 to June 30th, 2017. The rate of provider opioid prescribing demonstrated wide variability between facilities (range: 0.5% to 39.1%). The prescribing rate for ED/UCC providers ranged from 0.2% to 100%. Between June 2016 and May 2017, 24 VHA ED/UCC providers were the highest opioid prescribers nationally in at least two of the four quarters (22%-70%), with rates two- to three-fold higher than their peers. CONCLUSION: ED/UCC providers in the VHA system nationally vary considerably in rates of opioid prescribing. A focused initiative tailored for ED/UCC providers is needed to decrease opioid prescribing variability.

Opioid overdose education and naloxone distribution: Development of the Veterans Health Administration's national program.

OBJECTIVES: To prevent opioid-related mortality, the Veterans Health Administration (VHA) developed a national Opioid Overdose Education and Naloxone Distribution (OEND) program. SETTING: VHA's OEND program sought national implementation of OEND across all medical facilities (n = 142). PRACTICE DESCRIPTION: This paper describes VHA's efforts to facilitate nationwide health care system-based OEND implementation, including the critical roles of VHA's national pharmacy services and academic detailing services. PRACTICE INNOVATION: VHA is the first large health care system in the United States to implement OEND nationwide. Launching the national program required VHA to translate a primarily community-based public health approach to OEND into a health care system-based approach that distributed naloxone to patients with opioid use disorders as well as to patients prescribed opioid analgesics. Key innovations included developing steps to implement OEND, pharmacy developing standard naloxone rescue kits, adding those kits to the VHA National Formulary, centralizing kit distribution, developing clinical guidance for issuing naloxone kits, and supporting OEND as a focal campaign of academic detailing. Other innovations included the development of patient and provider education resources (e.g., brochures, videos, accredited training) and implementation and evaluation resources (e.g., technical assistance, clinical decision support tools). EVALUATION: Clinical decision support tools that leverage VHA national data are available to clinical staff with appropriate permissions. These tools allow staff and leaders to evaluate OEND implementation and provide actionable next steps to help them identify patients who could benefit from OEND. RESULTS: Through fiscal year 2016, VHA dispensed 45,178 naloxone prescriptions written by 5693 prescribers to 39,328 patients who were primarily prescribed opioids or had opioid use disorder. As of February 2, 2016, there were 172 spontaneously reported opioid overdose reversals with the use of VHA naloxone prescriptions. CONCLUSION: VHA has successfully translated community-based OEND into health care system-based OEND targeting 2 patient populations. There is a tremendous amount that can be learned from VHA's experience implementing this novel health care innovation nationwide.

Medication-use evaluation with a Web application.

PURPOSE: A Web-based application for coordinating medication-use evaluation (MUE) initiatives within the Veterans Affairs (VA) health care system is described. SUMMARY: The MUE Tracker (MUET) software program was created to improve VA's ability to conduct national medication-related interventions throughout its network of 147 medical centers. MUET initiatives are centrally coordinated by the VA Center for Medication Safety (VAMedSAFE), which monitors the agency's integrated databases for indications of suboptimal prescribing or drug therapy monitoring and adverse treatment outcomes. When a pharmacovigilance signal is detected, VAMedSAFE identifies "trigger groups" of at-risk veterans and uploads patient lists to the secure MUET application, where locally designated personnel (typically pharmacists) can access and use the data to target risk-reduction efforts. Local data on patient-specific interventions are stored in a centralized database and regularly updated to enable tracking and reporting for surveillance and quality-improvement purposes; aggregated data can be further analyzed for provider education and benchmarking. In a three-year pilot project, the MUET program was found effective in promoting improved prescribing of erythropoiesis-stimulating agents (ESAs) and enhanced laboratory monitoring of ESA-treated patients in all specified trigger groups. The MUET initiative has since been expanded to target other high-risk drugs, and efforts are underway to refine the tool for broader utility. CONCLUSION: The MUET application has enabled the increased standardization of medication safety initiatives across the VA system and may serve as a useful model for the development of pharmacovigilance tools by other large integrated health care systems.

Monitoring adverse drug reactions across a nationwide health care system using information technology.

PURPOSE: The improvement and linkage of two Department of Veterans Affairs (VA) databases for monitoring adverse drug reactions (ADRs) are described, with a discussion of the potential implications for improved medication safety within the VA health care system. SUMMARY: Before 2007, VA had limited capability to track and evaluate ADRs across its nationwide network of health care facilities. Since then, VA has established a standardized monitoring system that has improved the reporting, analysis, and trending of ADRs reported by providers and pharmacists at individual VA facilities. The enhanced system has two components with distinct but complementary functions: the Adverse Reaction Tracking database, which is derived by extracting text-based, patient-specific information entered into the VA electronic medical record system by clinicians at the point of care; and the VA Adverse Drug Event Reporting System (VA ADERS), an external web-based portal that contains aggregated data from 146 VA facilities, with standardized coding of reported events. Both databases allow for ADR reporting at the local, regional, and national levels. The VA ADERS database permits rapid electronic reporting of certain ADRs to the federal MedWatch program. The two databases can be used in tandem for more comprehensive assessments of ADR patterns and reporting rates and to generate a wide range of benchmarking data. CONCLUSION: In recent years, the refinement of two databases for ADR reporting has increased VA's capability to systematically monitor, track, and report ADRs across its national network of health care facilities. Linking the two databases has further strengthened those capabilities, enhancing medication safety practices and aiding in pharmacovigilance.

Quality improvement toward decreasing high-risk medications for older veteran outpatients.

OBJECTIVES: To examine the effectiveness of a quality improvement program to decrease prescribing of high-risk medications. DESIGN: Single cohort, pre- and postintervention. SETTING: Regional network of Department of Veterans Affairs medical facilities. PARTICIPANTS: Outpatient veterans aged 65 and older who received one or more high-risk medications and the prescribing clinicians. INTERVENTION: A two-stage intervention was implemented. First, a real-time warning message to prescribers appeared whenever one of the high-risk drugs was ordered; second, a personally addressed letter from the Chief Medical Officer asking prescribers to consider discontinuing the high-risk medication along with a copy of the Beers criteria article, a list of suggested alternatives to high-risk medications, and a list of older patients receiving the high-risk medications who had upcoming appointments with these prescribers. MEASUREMENTS: The primary outcome was the absence of prescribed high-risk medications for all patients in the cohort during the postintervention period. For a subgroup of the cohort whose prescribers received the second-stage intervention, an additional outcome was the absence of prescribed high-risk medications within the subgroup. RESULTS: Two thousand seven hundred fifty-three unique patients were identified in the cohort; 1,396 (50.7%) had high-risk medications discontinued, resulting in a significant decrease in the number of patients prescribed high-risk medications from the preintervention period to the postintervention period (P<.001). Of the 801 patients in the subgroup, 72.0% (n=577) had high-risk medications discontinued (P<.001). CONCLUSION: This multimethod intervention significantly decreased prescribing of high-risk medications to older patients. Further studies are needed to confirm the findings.