Are Opioid Risk Evaluation and Mitigation Strategies (REMS) Interrupting Your Sleep?

ABSTRACT

The article entitled “Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics: Considerations for Pain and Palliative Care Practice” that appears in this issue of the journal addresses the important new Food and Drug Administration (FDA) REMS program. This commentary expands on themes introduced by Dr. Gudin, projects future directions for REMS, and discusses possible benefits, limitations, and risks associated with the extended-release long-acting opioid REMS.     

NEWS AND INNOVATIONS

EDITOR'S ABSTRACT

The Food and Drug Administration approved a single shared Risk Evaluation Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl dosage forms in December 2011. This report describes the goals, elements, and restricted distribution system of the REMS designed to reduce risk of abuse, misuse, addiction, and overdose with the drugs. Questions and answers about REMS also are presented.

The U.S. Food and Drug Administration (FDA) announced a shared REMS for all immediate-release transmucosal fentanyl dosage forms on December 29, 2011, to become effective in March 2012. That announcement is accessible at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285345.htm. Concurrently the FDA posted a series of questions and answers on this shared REMS at: http://http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm. Both documents are in the public domain.     

Health Care Resource Use,Costs, and Diagnosis Patterns in Patients With Schizophrenia and Bipolar Disorder: Real-world Evidence From US Claims Databases

Purpose

Schizophrenia (SCZ) and bipolar disorder (BD) are typically viewed as nonconcurrent psychiatric disorders, yet patients may experience mood and SCZ symptoms simultaneously. Several studies have shown overlap between SCZ and BD symptoms and susceptibility genes. This study explored the following: (1) patterns of administrative claims; (2) demographic characteristics and comorbidities; (3) health care resource use; and (4) health care costs in patients with diagnoses of SCZ, type I BD (BD-I), and both in a real-world setting.

我院2011年～2012年抗肿瘤药物注射剂的用药分析

目的分析与评价苏州大学附属第一医院抗肿瘤药物注射剂的使用情况。方法采用金额排序法和用药频度（DDDs）分析法对该院2011年～2012年抗肿瘤药物注射剂的使用情况进行统计分析。结果该院注射用抗肿瘤药物的销售金额呈现快速的上升趋势;各类药物的整体销售金额排序没有变化;植物来源的抗肿瘤药及其衍生物和其他抗肿瘤药及辅助治疗药的销售金额在销售总金额中占据较大比例。结论该院注射用抗肿瘤药物的使用较为稳定,同时新型抗肿瘤药物在临床上的应用发展迅速。     

Utilization of Occupational and Physical Therapy Services in Postacute Care: Findings from the 2006 Health and Retirement Study and Linked Medicare Claims Data

ABSTRACT

Aims: To describe and determine factors predicting utilization of occupational and physical therapy (PT) services in postacute rehabilitation systems over a 1-year period in Medicare beneficiaries. Methods: Data from 1,667 respondents in the 2006 Health and Retirement Study and linked Medicare claims were analyzed. Results: The average length of inpatient rehabilitation stay ranged between 11 and 17 days. Therapeutic procedures were the most commonly claimed Current Procedural Terminology (CPT) codes in outpatient rehabilitation. Very-high level was the mostly claimed resource utilization group (RUG) in skilled nursing facilities. Additionally, the average number of therapy home visit ranged between 31 and 34. Logistic regression analysis showed that greater age and more comorbidities were associated with using therapy services from two or more postacute care (PAC) systems. Conclusion: The study results increase the understanding of the utilization of rehabilitation therapy services across PAC systems and provide basic information for rehabilitation services planning.     

2007～2008年我院妇科口服中成药应用分析

目的：分析妇科口服中成药的用药情况,为临床合理用药提供依据。方法：对我院2007～2008年妇科口服中成药用的种类、用量、销售金额、用药频度、日均费用等进行分析。结果：妇康丸、益母草胶囊、五加生化胶囊临床应用广泛,而宫血宁胶囊受同类西药品种的影响,其用药量呈大幅下降趋势,一些新进药品如大黄蛰虫片使用量呈快速上升趋势。结论：我院妇科口服中成药使用情况基本合理。     

用儿童药物利用指数评价儿科用药剂量合理性的思考与探索

目的儿科用药缺证据、缺适宜剂型、品种规格和科学折算的标准与方法,导致儿童用药剂量不合理已成为儿科用药中最突出的问题。科学合理地建立儿科用药剂量评价方法、监测儿科药物治疗的合理性,成为全球儿童药物治疗领域亟待解决的问题。基于"解剖化学分类/限定日剂量"(ATC/DDD)体系的"药物利用指数"(Drug Utilization Index,DUI)评价方法已广泛用于成人用药剂量合理性评价。2009年韩璐等依据DUI评价原理首次提出"儿童限定日剂量"(Children De ned Daily Dose,cDDD)和"儿童药物利用指数"(Children Utilization Index,cDUI)的概念,并用于评价汶川地震0～1岁儿科伤员用药剂量合理性。本文旨在探讨cDUI用于儿科用药剂量合理性评价的方法学问题。方法基于课题组前期研究,探讨cDUI用于儿科用药剂量合理性的如下问题:①cDDD的含义;②标准体系建立;③儿科用药剂量的分类评价。结果①cDDD的定义虽参考限定日剂量的形式,但其内涵与后者有本质区别。与DDD作为用药评价的测量单位不同,设立cDDD的目的是以其为标准,衡量儿科用药剂量的合理性。因此,cDDD应为儿科临床实际选用的标准剂量。②cDDD标准体系应用于儿科常见或重大疾病且已广泛使用的药品,接受时间和实践检验;针对药品的不同适应症分别设定相应儿童限定日剂量;对同种药物不同给药途径分别设立标准用药剂量。③评价体系应考虑年龄、体重、疾病种类与病情轻重对用药剂量的影响,采用分类评价的方法,对上述因素分别赋予相应权重,客观、综合地评价用药剂量。结论规范儿科用药剂量对提高儿科医疗质量,保障儿童用药的安全、有效与经济具有重要意义。cDUI方法体系的建立作为一种积极探索,为该领域的研究提供有益的思路与经验。尽管现有方法体系和已有评价研究存在缺陷,但前期研究实践表明,该方法原理在儿科用药剂量合理性评价领域的应用具有可行性。     

2008年～2010年神经康复科住院患者用药分析

目的分析本院神经康复科住院患者药物应用情况及特点。方法统计本院2008年~2010年神经康复科用药数据,分别就用药种类、用药金额、用药频度(DDDs)、日均药费(DDC)进行统计分析。结果神经康复科用药金额、DDDs逐年递增,用药金额的前3位为改善神经功能药及促智药,DDDs前3位为促进脑代谢及促智药。DDC值较小的药品为甲钴胺片、硝苯地平控释片和阿司匹林肠溶片。结论我院神经康复科用药基本符合神经康复专科特点。     

Queen Mary Utilization of Antihypertensive Drugs Study: side-effects of antihypertensive drugs

BACKGROUND AND OBJECTIVE: Effective prevention of cardiovascular events in hypertensive patients requires good control of blood pressure. Side-effects of antihypertensive drugs affect tolerability and compliance. Accordingly, we surveyed side-effects in the hypertension outpatient clinic. METHODS: A total of 228 patients (109 men, 119 women) were interviewed in April-May 2004 in the Queen Mary Utilization of Antihypertensive Drugs Study. RESULTS: The percentage of patients receiving no drug (life-style modification), one, two, three and over three drugs were 3, 30, 40, 22 and 6% respectively. The proportion of patients taking calcium channel blockers, beta-blockers (BB), angiotensin-converting enzyme inhibitors, thiazide diuretics, alpha-blockers and angiotensin receptor blockers were 65, 64, 33, 24, 4 and 7% respectively. Blood pressure on treatment was 144+/-21/82+/-11 mmHg. Among patients on antihypertensive drug therapy, 34% reported adverse effects: dizziness (9%), ankle swelling (7%), headache (5%), fatigue (4%), chest discomfort (3%) and cough (3%). Fewer patients on BBs reported side-effects (OR 0.46, P=0.008). The likelihood of experiencing side-effects was unrelated to sex, age, weight, BMI, years of treatment, number of drugs used, heart rate on treatment or compliance. CONCLUSIONS: To achieve good blood pressure control, multiple drugs are used. Thiazides are underused whereas BBs are popular. The popularity of the latter may be related to its tolerability.     

Nonpalpable lymph nodes of the neck: Assessment with US and US-guided fine-needle aspiration biopsy

Ultrasound (US) and US-guided fine-needle aspiration biopsy (FNA) were performed in 91 nonpalpable neck nodes of 70 patients, 93% of which had known malignancy. Various sonographic findings were evaluated for predicting malignancy. The accuracy of US-guided FNA for detecting malignancy was 88%, with 96% sensitivity and 94% specificity. The ratio of minimal to maximal axial diameters of a node was most valid for predicting malignancy with US. A ratio of more than 0.55 yielded the highest accuracy (80%) (92% sensitivity, 63% specificity). Addition of any other factors to this criterion did not improve its accuracy. US and US-guided FNA are accurate for the assessment of nonpalpable neck nodes. Lymph nodes with a round configuration should be biopsied in patients with known malignancy. © 1997 John Wiley & Sons, Inc. J Clin Ultrasound 25:283–292, 1997     

应用FMEA降低全自动清洗机故障风险

目的 探讨失效模式与效应分析(failure mode and effect analysis,FMEA)在消毒供应中心全自动清洗机故障风险防控中的应用效果.方法 运用FMEA,查找全自动清洗机故障潜在的失效模式,从失效模式发生的严重度、发生频率、不易探测度3个维度评估,计算事先风险数(risk priority number,RPN);风险由高到低排序;根据分析结果对RPN值排序前5位的失效模式进行前瞻性的行为干预,比较应用FMEA管理1年前后全自动清洗机的故障风险值及发生频次.结果 实施FMEA管理1年后排序前5位失效模式的RPN值较实施前明显下降,差异有统计学意义(P<0.05);全自动清洗机故障发生频次从2014年的22次降到2015年的12次.结论 应用FMEA有助于降低消毒供应中心全自动清洗机故障风险,减少故障发生频次.     

Assessment of Resident Professionalism Using High-fidelity Simulation of Ethical Dilemmas

OBJECTIVES: To examine the responses of emergency medicine residents (EMRs) to ethical dilemmas in high-fidelity patient simulations as a means of assessing resident professionalism. METHODS: This cross-sectional observational study included all EMRs at a three-year training program. Subjects were excluded if they were unable or unwilling to participate. Each resident subject participated in a simulated critical patient encounter during an Emergency Medicine Crisis Resource Management course. An ethical dilemma was introduced before the end of each simulated encounter. Resident responses to that dilemma were compared with a professional performance checklist evaluation. Multi-response permutation procedure analysis was used to compare performance measures between resident classes, with the a priori hypothesis that mean performance should increase as experience increases. RESULTS: Of the 30 potential subjects, 90% (27) participated. The remaining three residents were unavailable due to scheduling conflicts. It was observed that senior residents (second and third year) performed more checklist items than did first-year residents (p < 0.028 for each senior class). Omnibus comparison of mean critical actions completed across all three years was not statistically significant (p < 0.13). Residents performed a critical action with 100% uniformity across training years in only one ethical scenario ("Practicing Procedures on the Recently Dead"). Residents performed the fewest critical actions and overall checklist items for the "Patient Confidentiality" case. CONCLUSIONS: Senior residents had better overall performance than incoming interns, suggesting that professional behaviors are learned through some facet of residency training. Although limited by small sample size, the application of this performance-assessment tool showed the ability to discriminate between experienced and inexperienced EMRs with respect to a variety of aspects of professional competency. These findings suggest a need for improved resident education in areas of professionalism and ethics.     

Validation of the Work-Disability Physical Functional Assessment Battery

Objective

To examine the validity of the self-report Work-Disability Functional Assessment Battery (WD-FAB) physical function scales relative to clinician ratings of function and a performance-based functional capacity evaluation called the Physical Work Performance Evaluation (PWPE).

Utilization of Rehabilitation Services in Stroke: A Study Utilizing the Health and Retirement Study With Linked Medicare Claims Data

ObjectivesTo describe Medicare fee-for-service beneficiaries who used poststroke rehabilitation services and identified the strongest predictors of utilization after the initial stroke care episode.DesignPooled, cross-sectional design using data from 1998 to 2010 from the Health and Retirement Study (HRS) with linked Medicare claims data.SettingNA.ParticipantsStroke survivors who were Medicare fee-for-service beneficiaries and participated in the HRS were included (N=515).Main Outcome MeasureUtilization of rehabilitation services up to 10 years poststroke was the primary outcome with logistic regression used to predict utilization. Covariates included demographic factors, baseline functional status, health conditions, personal lifestyle factors, and social support.ResultsRehabilitation service utilization was 21.6%, 6.8%, 15.8%, 16.5%, and <16% in years 2, 4, 6, 8, and 10, respectively. Age was the primary factor predicting use of rehabilitation in the first 10 years poststroke (odds ratio: 1.14; P=.001). Recurrent stroke (odds ratio: 1.64; P=.051) was also significantly associated with utilization, whereas unspecified incident stroke at incident trended toward significance (odds ratio: 2.17; P=.077). None of the other factors was a significant predictor of participation in rehabilitation services in this period.ConclusionA small number of Medicare fee-for-service beneficiaries who are stroke survivors utilize rehabilitation services in the first 10 years poststroke. Of those who do, age is the primary driver of utilization. We analyzed a multitude of factors that might influence utilization, but other factors not available in these data also need to be explored.     

Utilization of antithrombotic therapy for stroke prevention in atrial fibrillation: a cross‐sectional baseline analysis in general practice

What is known and objective: Antithrombotics for stroke prevention in atrial fibrillation (AF) are reportedly underutilised. Since the burden of care lies within general practice, attention must be paid to identifying and addressing practice gaps in this setting. The objective of this study was to determine the contemporary utilisation of antithrombotic therapy for stroke prevention in AF within Australian general practice (GP). Methods: Data pertaining to AF patients’ (aged ≥65 years) were collected from GP surgeries in New South Wales, Australia, using purpose‐designed data collection forms; extracted data comprised patients’ medical histories, current pharmacotherapy, and relevant characteristics. Results and Discussion: Data pertaining to 393 patients (mean age 78·0 ± 7·0 years) were reviewed. Overall, most (98·5%) patients received antithrombotic therapy. Among the 387 patients using antithrombotics, most (94·1%) received mono‐therapy. “Warfarin ± antiplatelet” was most frequently used (81·7%); 77·5% used “warfarin” as a monotherapy, followed by “dabigatran ± clopidogrel” (11·6%), “aspirin” (5·9%) and “clopidogrel” alone (0·8%). High stroke risk and low bleeding risk were associated with increased use of “warfarin ± antiplatelet” therapy. Older patients (≥80 years) were more likely to receive ‘nil therapy’ (P = 0·04), and less likely to receive dual and triple antithrombotic therapy. Conclusion: We found an encouraging improvement compared to previous studies in the utilisation of antithrombotic therapy for stroke prevention in AF within general practice. Warfarin is now utilised as the mainstay therapy, followed by aspirin, although the novel oral anticoagulants are entering the spectrum of therapies used. Consideration needs to be given to the potential impact of the newer agents and their scope of use.     

Timing of palliative care team referrals for inpatients receiving rapid response services: A retrospective pilot study in a US hospital

Background/objectivesResearch indicates up to one-third of rapid response team calls relate to end-of-life symptoms. The CriSTAL criteria were developed as a screening tool to identify high risk of death within three months. The primary purpose of this pilot study was to investigate the timing of palliative care referrals in patients receiving rapid response team services, and patients’ CriSTAL criteria score on admission. The potential feasibility of using the CriSTAL tool to stimulate earlier Palliative Care Team (PCT) referral served as an underlying goal, and investigation of a relationship between specific CriSTAL criteria and the prediction of in-hospital death was a secondary objective.DesignA retrospective chart review of rapid response calls made in 2015 was used to identify patient risk of death on admission based on the CriSTAL criteria. The presence and timing of PCT referral as well as patient survival status to hospital discharge were documented for comparison.Setting/participantsA sample of 183 charts from 584 inpatients involved in over 600 RRT events recorded in 2015. The study was undertaken in a 676-bed teaching hospital in the Midwestern U.S.Methods/resultsNinety-one patients died during the hospital stay while 92 patients from the 493 individuals who survived were randomly selected for full analysis. Applying CriSTAL criteria to the 141 individuals aged 50 years or older indicated that frailty (OR = 1.43, 95%CI 1.08–1.89, p = 0.012), being a male (OR = 3.14; 95%CI 1.40–7.05, p = 0.006), and the presence of two or more comorbidities (OR = 3.71, 95%CI 1.67–8.24, p = 0.001) were the most significant predictors of in-hospital death after adjusting for age. A CriSTAL score of 6 was the optimal cut-off for high-risk of in-hospital death. Palliative care consultations within the high-risk population occurred for 45.2% of the deceased and 40.4% of the survivors. Consultation often occurred within two days of the RRT event and many patients (46.8%) died within one day of the consultation.ConclusionA positive relationship was found between the CriSTAL score, palliative care referral, and in-hospital mortality in patients who received RRT services. The study indicates a need for earlier PCT referral, showcases the potential to identify high risk of in-hospital death upon admission and supports the feasibility of using the CriSTAL criteria tool to encourage earlier PCT referrals.