Epidemiology, i3 Drug Safety, Waltham, MA 02451, USA.
Pharmacoepidemiol Drug Saf. 2010 May;19(5):448-56. doi: 10.1002/pds.1918.
Mitoxantrone was approved for treatment of multiple sclerosis (MS) in October 2000. Monitoring and dosing guidelines in the product labeling accompanying this indication include blood counts, liver function, and pregnancy tests at each administration. Due to potential cardiotoxicity, left ventricular ejection fraction (LVEF) testing prior to initial infusion and all infusions at a cumulative dose >or=100 mg/m(2) was recommended until April 2005 when LVEF testing before all infusions was recommended in the approved labeling. We sought to estimate provider adherence to dosing and monitoring guidelines and the effect of changes in LVEF monitoring guidelines.
MS patients who received mitoxantrone between October 2000 and June 2006 were selected from the claims of a large US health insurer. Claims for infusions and for specified tests prior to an infusion determined adherence to guidelines, with medical records providing additional information for a subset.
There were 1827 mitoxantrone infusions to 548 eligible patients; medical records were obtained for 261 patients (1096 infusions). Most mitoxantrone recipients were 30-59 years of age and 73% were female. Adherence to recommended dosing was higher than for recommended monitoring. Blood counts were conducted for most infusions (78-83%), while liver function tests (LFT) were performed less often (47-54% of infusions). Pregnancy tests were performed for 10% or fewer of the infusions administered to reproductive age women. Adherence with LVEF testing guidelines improved following labeling changes.
Adherence to recommended monitoring was incomplete, but amenable to change. Automated assessment through insurance claims supplemented with medical record data provides a balanced means for studying adherence to recommendations.
米托蒽醌于 2000 年 10 月获准用于治疗多发性硬化症（MS）。伴随这一适应证的产品标签中的监测和剂量指南包括每次给药时的血细胞计数、肝功能和妊娠试验。由于潜在的心脏毒性，建议在初始输注前和累积剂量≥100mg/m2 的所有输注前进行左心室射血分数（LVEF）检测，直到 2005 年 4 月，在批准的标签中建议在所有输注前进行 LVEF 检测。我们旨在评估提供者对剂量和监测指南的遵守情况以及 LVEF 监测指南变化的影响。
从一家大型美国健康保险公司的索赔中选择了 2000 年 10 月至 2006 年 6 月期间接受米托蒽醌治疗的 MS 患者。输注和输注前指定测试的索赔确定了对指南的遵守情况，病历为一小部分患者提供了额外信息。
共有 1827 次米托蒽醌输注给 548 名合格患者；获得了 261 名患者（1096 次输注）的病历。大多数米托蒽醌接受者年龄在 30-59 岁之间，73%为女性。建议剂量的依从性高于建议的监测。大多数输注（78-83%）进行了血细胞计数，而肝功能试验（LFT）的检测频率较低（输注的 47-54%）。妊娠试验仅在 10%或更少的给予生育年龄妇女的输注中进行。标签更改后，LVEF 检测指南的依从性得到改善。
建议监测的依从性不完全，但可以改变。通过保险索赔进行自动评估，并辅以病历数据，为研究对建议的依从性提供了一种平衡的方法。
