Naloxone prescription for Opioid Safety Evaluation (NOSE)

描述(申请人提供)：药物过量现在是美国成年人伤害死亡的主要原因。这一戏剧性的变化被归因于阿片类止痛剂过量；自2003年以来，阿片类止痛剂导致的死亡人数超过了海洛因和可卡因过量死亡人数的总和。解决阿片类药物过量问题与白宫将药物引起的发病率和死亡率降低15%的目标是一致的。旧金山是一个历史上阿片类药物使用率和相关发病率和死亡率都很高的城市，2004年在全市范围内分发纳洛酮(短效阿片类拮抗剂)，这与海洛因相关死亡人数的大幅下降有关。然而，在此期间，旧金山阿片类止痛剂过量死亡人数有所增加。从2010年到2012年初，261例阿片类药物过量死亡中有253例是由阿片类镇痛剂引起的，其中47%是旧金山公共卫生部(DPH)的初级保健患者。其中四分之三的死者开了慢性阿片类药物的处方，因此有资格获得目前在选定诊所维持的所有接受慢性阿片类药物的患者的“疼痛管理登记”(PMR)。DPH正在启动一项从初级保健诊所获得带回家的纳洛酮处方的计划，这为评估针对阿片类止痛药使用者的纳洛酮计划的实施提供了一个独特的机会。虽然生态学和流行病学研究已经证明了纳洛酮在减少非法阿片类药物过量方面的明显效果，但还没有研究 评估了执行和评估针对阿片类止痛药使用者的基于临床的纳洛酮处方的能力。我们提出了一项探索性研究，以衡量在安全网医疗系统中来自多个提供者初级保健诊所的纳洛酮处方的可行性，患者和提供者对纳洛酮处方的接受程度，以及电子病历(EMR)作为评估此类计划的手段的有效性。为了最大限度地提高纳洛酮的摄入量，并使推广过程中纳洛酮的传输质量标准化，训练有素的研究人员将向诊所和相关药房的工作人员提供技术援助和能力建设，以便在实施以临床为基础的纳洛酮计划之前和期间。这些培训将教育主要利益相关者了解该计划，提供支持和解决与推广有关的问题(例如，药房的可用性、适应症知识等)，并优化以临床为基础的纳洛酮处方的实施。该计划将在六家DPH诊所以交错方式实施，数据将按“阶梯”进行分析--与每个诊所纳洛酮推出前和推出后的日期相对应的时间段。主要结果将是PMR患者在开始日期的3次就诊内在每个诊所使用纳洛酮的比例。结果还将包括对患者的详细调查，以及对处方医生和药剂师关于纳洛酮处方可接受性的简要调查。最后，将评估电子病历数据用于评估该计划的有效性，将ICD-9编码的结果与患者急诊科就诊的直接图表审查进行比较。

DESCRIPTION (provided by applicant): Drug overdose is now the leading cause of injury death among adults in the U.S. This dramatic shift has been attributed to opioid analgesic overdose; deaths from opioid analgesics have exceeded the combined overdose deaths from heroin and cocaine since 2003. Addressing opioid overdose is consistent with the White House goal of reducing drug-induced morbidity and mortality by 15%. San Francisco, a city with historically high rates of opioid use and related morbidity and mortality, implemented city-wide distribution of naloxone (the short- acting opioid antagonist) in 2004, which has been associated with a substantial decline in heroin-related death. However, during this period opioid analgesic overdose deaths have increased in San Francisco. From 2010 to early 2012, 253 out of 261 opioid overdose deaths were due to opioid analgesics and 47% of these decedents were primary care patients of the San Francisco Department of Public Health (DPH). Three-quarters of those decedents were being prescribed chronic opioids and thus were eligible for a "Pain Management Registry" (PMR) of all patients receiving chronic opioids now maintained in selected clinics. DPH is initiating a program for prescription of take-home naloxone from primary care clinics, providing a unique opportunity to assess the implementation of a naloxone program targeting opioid analgesic users. While ecologic and epidemiologic studies have demonstrated the apparent effectiveness of naloxone distribution in reducing illicit opioid overdose, no studies have evaluated the capacity to implement and evaluate clinic-based naloxone prescription targeting opioid analgesic users. We propose an exploratory study to measure the feasibility of naloxone prescription from multi-provider primary care clinics in a safety net health care system, the acceptability to patients and providers of naloxone prescription, and the validity of electroni medical records (EMR) as a means to evaluate such programs. To maximize naloxone uptake and standardize quality of naloxone delivery during roll-out, trained research staff will provide technical assistance and capacity building to staff in clinics and associated pharmacies leading up to, and during, the execution of the clinic-based naloxone program. These trainings will educate key stakeholders about the program, provide support and problem-solve issues with the rollout (i.e., availability at the pharmacy, knowledge of indications, etc.), and optimize implementation of clinic-based naloxone prescription. The program will be implemented in a staggered fashion across six DPH clinics and data will be analyzed in "steps"-time periods corresponding with dates of pre- and post-rollout periods of naloxone at each clinic. The primary outcomes will be the proportion of PMR patients prescribed naloxone within 3 visits of the start date in each clinic. Results will also include a detailed survey of patients and brief surveys of prescribers and pharmacists regarding acceptability of naloxone prescription. Finally, an assessment of the validity of EMR data for evaluating this program will be conducted, comparing results by ICD-9 coding to direct chart review of patient emergency department visits.