在瑞典处方药登记系统中，帕利珠单抗的使用情况被低估了——对基于登记系统的药物研究的影响。

Use of palivizumab is underestimated in the Swedish Prescribed Drug Register - implications for register-based drug studies.

作者信息

Linder Marie, Byström Camilla, Kieler Helle, Bergman Gunnar, Haerskjold Ann

机构信息

Centre for Pharmacoepidemiology, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden.

Stockholm-Uppsala Department of Pediatric Cardiology, Astrid Lindgren Children's Hospital, Karolinska University Hospital and Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.

出版信息

Clin Epidemiol. 2014 Dec 29;7:45-51. doi: 10.2147/CLEP.S73337. eCollection 2015.

DOI:10.2147/CLEP.S73337

PMID:25565893

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4284043/

Abstract

BACKGROUND

Register studies are a valuable tool, when monitoring the safety of drugs. The Swedish Prescribed Drug Register (PDR) was established in 2005 and keeps records of all prescribed drugs dispensed in community pharmacies. Drugs prescribed in-hospital are not registered on an individual level, which may hamper the validity of register-based studies on drugs potentially administered in-hospital.

OBJECTIVE

The objective was to assess the ability of the PDR to identify children treated with the monoclonal antibody palivizumab, which is used for prophylaxis against respiratory syncytial virus (RSV) infection in children.

METHODS

Palivizumab exposure as filled prescriptions recorded in the PDR was assessed by indication of treatment (preterm-born children, bronchopulmonary dysplasia, or hemodynamically significant heart disease) and presented as numbers and proportions. For a random sample of children with an indication for treatment and without record of palivizumab exposure in the drug register, numbers and proportions by indication of treatment as noted in medical records were presented. The extent of underreporting in the drug register was estimated by indication for treatment.

RESULTS

Through the national health registers, 2,317 children were identified as being at risk for severe infection with RSV infection and 75% had no records indicating palivizumab exposure in the PDR. In a random sample of 176 children at high risk for RSV infection and with no records of palivizumab prescription fills in the PDR, 47% had been treated with palivizumab according to medical records. The PDR underestimated palivizumab treatment with 49% in children born preterm, 42% in children with bronchopulmonary dysplasia, and 23% in those with a hemodynamically significant heart disease.

CONCLUSION

Our findings underline the need of improving the information in the Swedish national registers concerning drugs administered in-hospital.

摘要

背景

在监测药物安全性时，注册研究是一种有价值的工具。瑞典处方药登记册（PDR）于2005年建立，记录了社区药房分发的所有处方药。医院开具的药物未在个体层面进行登记，这可能会妨碍基于登记册的潜在医院用药研究的有效性。

目的

目的是评估PDR识别接受单克隆抗体帕利珠单抗治疗的儿童的能力，该抗体用于预防儿童呼吸道合胞病毒（RSV）感染。

方法

通过治疗指征（早产儿、支气管肺发育不良或血流动力学显著的心脏病）评估PDR中记录为已配药的帕利珠单抗暴露情况，并以数字和比例呈现。对于有治疗指征但在药物登记册中无帕利珠单抗暴露记录的儿童随机样本，按病历中记录的治疗指征列出数字和比例。通过治疗指征估计药物登记册中漏报的程度。

结果

通过国家健康登记册，确定2317名儿童有严重RSV感染风险，75%在PDR中无帕利珠单抗暴露记录。在176名RSV感染高危且PDR中无帕利珠单抗处方记录的儿童随机样本中，根据病历，47%曾接受帕利珠单抗治疗。PDR低估了帕利珠单抗治疗情况，早产儿中低估49%，支气管肺发育不良儿童中低估42%，血流动力学显著心脏病儿童中低估23%。