The impact of federal warnings on publically funded desmopressin utilization among children in Ontario

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• 作者：Tara Gomes^a ; ^b ; ^{tara.gomes@ices.on.ca} ; David N. Juurlink^a ; ^c ; ^d ; ^e ; ^f ; Ian Moore^g ; Jonathon L. Maguire^e ; ^f ; ^h ; Muhammad M. Mamdani^a ; ^b ; ^d ; ^f ; ⁱ ; ^j ; ^k
• 关键词：Pharmacoepidemiology ; Urology ; Health policy
• 刊名：Journal of Pediatric Urology
• 出版年：2012
• 期刊代码：191_14775131
• 类别：med
• 出版时间：June, 2012
• 卷：8
• 期：3
• 页码：249-253
• 文件大小：316 K

摘要

Objective

To determine whether safety warnings issued by health regulatory agencies regarding desmopressin treatment influenced treatment rates among children.

Patient population and methods

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.

Results

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.

Conclusion

Safety warnings issued by regulatory agencies dramatically influenced desmopressin use among Ontario鈥檚 children.