Tiwari Nupur, Baldwin David S
Southern Health NHS Foundation Trust, University Department of Psychiatry, College Keep, 4-12 Terminus Terrace, Southampton SO14 3DT, UK.
University of Southampton, Southampton, UK.
Ther Adv Psychopharmacol. 2018 Oct 23;10:2045125318795132. doi: 10.1177/2045125318795132. eCollection 2020.
Referral to tertiary services is recommended when patients with mood and anxiety disorders have not responded to multiple treatments in primary or secondary care. Within specialist services, some patients undergo treatment with licensed psychotropic medications outside the narrow terms of their market authorization ('unlicensed applications'). We examined the demographic and clinical characteristics of patients referred to a regional specialist service to determine the extent of and factors associated with recommendations for unlicensed ('off label') prescriptions.
Retrospective examination of demographic and clinical characteristics and treatment recommendations in patients seen within a 5-year period. Patients were allocated to three broad diagnostic clusters (unipolar depressive disorders, bipolar disorder, anxiety disorders), and two groups (with or without comorbid disorders). We compared patients in whom all treatment recommendations were for licensed applications with patients in whom at least one treatment was for an unlicensed application, across a range of variables reflecting illness 'burden' (duration, inpatient treatment, electroconvulsive therapy, nonfatal self-harm, psychosis).
From 177 new referrals, 148 patients (91 females, 57 males) could be placed within one of the three clusters. Many patients with bipolar disorder had not undergone treatment with lithium or formal psychological interventions in secondary care. Treatment recommendations involving unlicensed applications of medications were common (approximately 50%) in all clusters, but there were no significant differences in measures of illness burden between groups of patients, categorized according to licensed or unlicensed prescriptions.
Retrospective examination of notes recorded for other purposes, within a single service, in which treatment recommendations might reflect idiosyncratic practice is a limitation of our findings. Also, examined variables could not provide a comprehensive indication of illness severity or functional impairment.
Our findings confirm that 'off label' prescribing is common in psychiatric practice. Treatment decisions relating to unlicensed applications appear to be influenced by factors other than overall illness burden.
当患有情绪和焦虑障碍的患者在初级或二级护理中对多种治疗均无反应时，建议将其转诊至三级医疗机构。在专科服务机构中，一些患者在超出其市场授权的狭窄范围（“未获许可的应用”）使用有许可的精神药物进行治疗。我们研究了转诊至某地区专科服务机构的患者的人口统计学和临床特征，以确定未获许可（“标签外”）处方建议的程度及相关因素。
对5年内就诊患者的人口统计学、临床特征及治疗建议进行回顾性研究。患者被分为三大诊断类别（单相抑郁症、双相情感障碍、焦虑症）和两组（有或无共病）。我们在一系列反映疾病“负担”（病程、住院治疗、电休克治疗、非致命性自残、精神病）的变量方面，比较了所有治疗建议均为许可应用的患者与至少有一项治疗为未获许可应用的患者。
在177例新转诊患者中，148例患者（91例女性，57例男性）可归入三大类别之一。许多双相情感障碍患者在二级护理中未接受过锂盐治疗或正规心理干预。涉及药物未获许可应用的治疗建议在所有类别中都很常见（约50%），但根据许可或未获许可处方分类的患者组之间，在疾病负担指标方面没有显著差异。
在单一服务机构内对为其他目的记录的病历进行回顾性研究，其中治疗建议可能反映特殊做法，这是我们研究结果的一个局限性。此外，所研究的变量无法全面反映疾病严重程度或功能损害情况。
我们的研究结果证实，“标签外”处方在精神病学实践中很常见。与未获许可应用相关的治疗决策似乎受到总体疾病负担以外因素的影响。
