The Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
J Pediatr Urol. 2012 Jun;8(3):249-53. doi: 10.1016/j.jpurol.2011.06.001. Epub 2011 Jul 20.
To determine whether safety warnings issued by health regulatory agencies regarding desmopressin treatment influenced treatment rates among children.
We conducted a time-series analysis using health administrative data from Ontario, Canada, between January 1, 2003 and March 31, 2010. We examined desmopressin prescribing rates among children (<13 years) and investigated the impact of a United States Food and Drug Administration warning (December 2007) and a subsequent Health Canada warning (July 2008) on these rates. A secondary analysis stratified rates according to route of administration.
On average, quarterly desmopressin treatment rates were 29.8% lower following the two warnings (4.7 per 1000 population) compared with the period prior to warnings being issued (6.7 per 1000 population). Structural break analyses identified a significant decrease in overall desmopressin prescribing rates in Q3 2008, with the 95% confidence interval (CI) spanning both safety warnings (Q4 2007 to Q1 2009). A secondary analysis of prescribing rates for oral formulations found consistent results (structural break Q4 2008, 95% CI Q2 2007 to Q2 2009). The average quarterly prescribing rate of intranasal formulations declined by 73.1% following the warnings compared with the period preceding the warnings.
Safety warnings issued by regulatory agencies dramatically influenced desmopressin use among Ontario's children.
确定卫生监管机构发布的有关去氨加压素治疗的安全警示是否会影响儿童的治疗率。
我们使用加拿大安大略省的健康管理数据进行了时间序列分析，时间范围为 2003 年 1 月 1 日至 2010 年 3 月 31 日。我们检查了儿童（<13 岁）使用去氨加压素的处方率，并研究了美国食品和药物管理局的一项警告（2007 年 12 月）和随后的加拿大卫生部警告（2008 年 7 月）对这些比率的影响。一项次要分析根据给药途径对比率进行分层。
平均而言，在发布这两项警告后（4.7 例/1000 人），每季度去氨加压素治疗率比发布警告前（6.7 例/1000 人）低 29.8%。结构断裂分析确定，2008 年第三季度总体去氨加压素处方率显著下降，95%置信区间（CI）跨越了两项安全警告（2007 年第四季度至 2009 年第一季度）。对口服制剂的处方率进行的二次分析得出了一致的结果（结构断裂 Q4 2008，95%CI Q2 2007 至 Q2 2009）。与发布警告前的时期相比，警告发布后，鼻内制剂的平均每季度处方率下降了 73.1%。
监管机构发布的安全警示极大地影响了安大略省儿童使用去氨加压素的情况。
