Haerskjold Ann, Henriksen Lonny, Way Susanne, Malham Mikkel, Hallas Jesper, Pedersen Lars, Stensballe Lone Graff
The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark ; The Research Unit Women's and Children's Health, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
The Research Unit Women's and Children's Health, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Clin Epidemiol. 2015 May 8;7:305-12. doi: 10.2147/CLEP.S73355. eCollection 2015.
National prescription databases are important tools in pharmacoepidemiological studies investigating potential long-term adverse events after drug use. Palivizumab is a biological pharmaceutical used as passive prophylaxis against severe infection with respiratory syncytial virus in high-risk children.
To assess the registration of palivizumab in the Danish National Prescription Registry (DNPR) and to examine if palivizumab reimbursement data obtained from the Danish Health and Medicines Authority could serve as a supplement to data from the DNPR.
Registration of palivizumab exposure in the DNPR between 1999 and 2010 was compared to two external data sources: registration of palivizumab exposure in medical records, and palivizumab reimbursement data.
During the study period, 182 children with palivizumab exposure were registered in the DNPR. A total of 207 children were registered for palivizumab reimbursement. The sensitivity of palivizumab registration in the DNPR was 26% (20%-34%), and the specificity of no palivizumab registration in the DNPR was 97% (94%-99%), with data from the medical record as the reference. Palivizumab registration sensitivity in reimbursement data was 29% (22%-36%), and the specificity of no palivizumab registration in the DNPR was 97% (94%-99%), with data from the medical record as the reference.
Exposure to palivizumab was underestimated in the DNPR. Reimbursement data are a readily accessible data supplement, which only slightly increased the sensitivity of palivizumab registration in the DNPR. Our findings underline the need to improve DNPR information concerning drugs administered in hospitals.
国家处方数据库是药物流行病学研究中的重要工具，用于调查用药后潜在的长期不良事件。帕利珠单抗是一种生物制药，用于对高危儿童进行呼吸道合胞病毒严重感染的被动预防。
评估帕利珠单抗在丹麦国家处方登记处（DNPR）的登记情况，并检查从丹麦卫生和药品管理局获得的帕利珠单抗报销数据是否可作为DNPR数据的补充。
将1999年至2010年间DNPR中帕利珠单抗暴露的登记情况与两个外部数据源进行比较：病历中帕利珠单抗暴露的登记情况和帕利珠单抗报销数据。
在研究期间，DNPR中登记了182名暴露于帕利珠单抗的儿童。共有207名儿童登记了帕利珠单抗报销。以病历数据为参考，DNPR中帕利珠单抗登记的敏感性为26%（20%-34%），DNPR中未登记帕利珠单抗的特异性为97%（94%-99%）。以病历数据为参考，报销数据中帕利珠单抗登记的敏感性为29%（22%-36%），DNPR中未登记帕利珠单抗的特异性为97%（94%-99%）。
DNPR中帕利珠单抗的暴露情况被低估。报销数据是一种易于获取的数据补充，仅略微提高了DNPR中帕利珠单抗登记的敏感性。我们的研究结果强调需要改进DNPR中有关医院用药的信息。
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