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.

Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain.

The safe and effective prescribing of opioid therapy for chronic pain has become a significant health care priority over the last several years. Substantial research has focused on patient-oriented interventions toward preventing problematic use, but provider and system level factors may be more amenable to quality improvement approaches. Here, we outline administrative data-based metrics that are intended to assess adherence to key practices outlined in the 2010 Department of Veterans Affairs/Department of Defense Clinical Practice Guideline for management of opioid therapy for chronic pain. In addition to the metrics, we discuss their development process, which was done in consultation with experts on chronic opioid therapy.

Facilitators and barriers in implementing buprenorphine in the Veterans Health Administration.

Opioid dependence is a chronic, relapsing disorder that deleteriously influences the health of those afflicted. Sublingual buprenorphine opioid agonist treatment (OAT) has been shown to be safe, effective, and cost-effective for the treatment of opioid dependence in nonspecialized, office-based settings, including the Veterans Health Administration (VHA). We sought to examine and describe provider-, facility-, and system-level barriers and facilitators to implementing buprenorphine therapy within the VHA. From June 2006 to October 2007, we conducted semistructured telephone interviews of key personnel at a national sample of VHA facilities with high prevalence of opioid dependence and without methadone OAT programs. Sites were categorized based on the number of veterans receiving buprenorphine prescriptions: More Buprenorphine (MB, >40 prescriptions, 5 sites), Some Buprenorphine (SB, 5-40 prescriptions, 3 sites), and No Buprenorphine (NB, 0-5 prescriptions, 9 sites). Interviews were taped, transcribed, and coded; consensus of coding themes was reached; and data were evaluated using grounded theory. Sixty-two staff members were interviewed. For NB sites, perceived patient barriers included lack of need and attitudes/stigma associated with opioid dependence. Provider barriers included lack of interest, stigma toward the population, and lack of education about buprenorphine-OAT. Prominent facilitators at MB sites included having established need, provider interest, and resources/time available for buprenorphine-OAT. The presence of a champion/role-model for buprenorphine care greatly facilitated its implementation. We conclude that factors that enable or impede buprenorphine-OAT vary by facility. Strategies and policies to encourage implementation of buprenorphine should be adaptable and target needs of each facility.

Effectiveness of antiepileptic drugs for the treatment of bipolar disorder: findings from a systematic review.

Bipolar disorder is characterized by chronic and recurrent symptoms including mania, hypomania, and depressive and mixed episodes, with approximately 5.7 million Americans over age 18, or 2.6% of the U.S. population, suffering from the illness. The prevalence of the disorder may be higher due to its chronic and recurrent nature. Individuals with bipolar disorder often first present in general medical settings with depressive symptomatology. Long-term management typically occurs in mental health settings by psychiatrists or other mental health specialists. While there have been major advances in pharmacotherapy for bipolar disorder, evidence-based information on drug effectiveness is not always easily accessible to prescribers in daily practice. Available information has sometimes led to inappropriate use of various classes of drugs, specifically antiepileptic drugs (AEDs), for bipolar disorder. Originally approved in 1993 by the U.S. Food and Drug Administration (FDA) only for adjunctive treatment of partial complex seizures, the manufacturer of gabapentin (Neurontin), an AED, promoted its off-label use for treatment of psychiatric disorders, including bipolar disorder. The efficacy of the drug for this indication had not been demonstrated, nor had the manufacturer sought FDA approval for the indication. In 2004, 50 Attorneys General settled consumer protection claims regarding alleged deceptive off-label marketing practices of Pfizer subsidiary Warner-Lambert. At about the same time, a consortium of State Medicaid agencies funded a drug class review to compare effectiveness and adverse event profiles of AEDs in the treatment of bipolar mood disorder, neuropathic pain, and fibromyalgia. This article presents a summary of the findings from the drug class review related to prescription of the AEDs in bipolar disorder.

Gabapentin in the treatment of mental illness: the echo chamber of the case series.

BACKGROUND: Bipolar disorder is a common and debilitating psychiatric illness. Several antiepileptic drugs (AEDs) have been approved for the treatment of bipolar disorder. Gabapentin gained a large market share of AED use in the late 1990s in spite of a lack of randomized clinical trial (RCT) evidence and no labeled indication from the U.S. Food and Drug Administration for its use in psychiatric illness. This article describes the results of a literature review, the purpose of which was to examine the characteristics of studies conducted in humans concerning the efficacy of gabapentin in bipolar disorder. METHODS: Publications relevant to this topic were identified based on a PUBMED search as well as an examination of references from a published systematic review and citations from relevant review articles. RESULTS: The search located 29 studies published between 1997 and 2007, with the greatest number of articles published in 1998 and 1999. Of these 29 publications, 15 involved uncontrolled case series, while 6 were single case reports. The sample size in the studies was generally small, and often we could not identify the funding source. Despite the generally weak study design in the identified publications, the authors of the articles often commented on the promising nature of gabapentin therapy for bipolar disorder. However, 4 small, randomized trials in heterogeneous populations demonstrated little if any evidence of such efficacy. Nine letters to the editor demonstrated a similar pattern. CONCLUSIONS: The large number of case series concerning gabapentin is striking. The number of reports and their distribution in many different journals created a type of "echo chamber" effect, through which the sheer number of publications and citations may give legitimacy to the practice of using gabapentin for bipolar disorder. Although the case series were generally of poor quality, their publication in peer-reviewed journals may have been partially responsible for the widespread use of an ineffective medication.

Implementation of buprenorphine in the Veterans Health Administration: results of the first 3 years.

BACKGROUND: Compared to non-veterans, veterans are disproportionately diagnosed with opioid dependence. Sublingual buprenorphine provides greater access to opioid agonist therapy. To understand the diffusion of this innovative treatment within a large healthcare system, we describe the introduction of buprenorphine within the Veterans Health Administration (VHA) during the first 3 years of its approval as a VHA non-formulary medication. METHODS: Using VHA pharmacy databases, we examined the number of physicians who have prescribed buprenorphine and the number of veterans who have received office-based buprenorphine within VHA veterans integrated service networks (VISN) from fiscal years (FY) 2003 through FY 2005 (October 2002 through September 2005). RESULTS: From FY2003 through FY2005 the number of veterans with opioid dependence increased from 25,031 to 26,859 (>7.3%) and the number of veterans prescribed office-based buprenorphine increased from 53 to 739. During this interval, 16 of 21 VISNs had prescribed buprenorphine. In FY2005, two VISNs accounted for 31% of buprenorphine prescriptions. The number of buprenorphine prescriptions varied widely by VISN, but increased from 212 to 7076 from FY2003 through FY2005. During this interval, prescriptions per patient increased from 4.0 to 9.6 and physicians prescribing buprenorphine increased from 14 to 170. The ratio of patients prescribed buprenorphine to providers prescribing buprenorphine increased from 3.8 to 4.3 with an average increase of 15.1-41.6 of prescriptions per provider. CONCLUSIONS: VHA increased, but not uniformly, the non-formulary use of office-based buprenorphine during the first 3 years of availability.

Best practices: comparing medication treatments in mental health: drug class reviews and policy challenges.

Advances in the number and type of medications for psychiatric illness have substantially aided physicians. However, as the number of available medications within a class increases, so does the complexity in decision making for provider and patient. Systematic review of a class of medications can assist providers in drug choice. The purpose and methods of such drug class reviews are described. Critical elements of a quality review include the choice of the question, explicit eligibility criteria, systematic search of the literature, article abstraction, and sometimes pooling of the data by using meta-analysis with direct or indirect comparison of study findings. Best practices are suggested for clinicians, administrators, and policy makers to consider when using drug class reviews in clinical organizations. The number of drug class reviews is increasing, and they have the potential to significantly assist providers, patients, and payers.