BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Pharmacoepidemiol Drug Saf. 2019 Feb;28(2):201-208. doi: 10.1002/pds.4674. Epub 2018 Nov 29.
In Spain, a human papillomavirus (HPV) vaccine was firstly marketed in 2006 and mainly administered in primary care (PC) practices for girls/women or schools. As for all vaccines, a valid data source is required for research on observational effectiveness or safety. The objective of this study is to identify and validate HPV vaccinations recorded among women in The Primary Care Database For Pharmacoepidemiological Research (BIFAP) from 2007.
BIFAP includes a Vaccination File filled by PC practitionners and pediatricians. Information on women with HPV vaccinations recorded at any age was identified and validated according to whether (1) doses adhered to the following standard intervals: 27 to 269 days between first and second doses, >55 days between second and third doses, and <366 between first and third doses, and (2) additional information recorded in clinical records confirmed (through recording the brand, batch, expiring date, administration site, or vaccination comment) or refuted the vaccination and date. The latter was retrieved through manual review of anonymous records randomly selected.
One hundred seventeen thousand seventy-three women with HPV vaccination records were identified (mean age 14.7 years); 82.5% had three jabs, 87.3% in recommended intervals. A sample of 978 patients' records, including 2245 jabs, was reviewed. Of the 363 jabs with additional information, 91% confirmed the vaccination. Confirmatory data was more frequent when doses strictly adhered to recommendations (96.8%-100%) than not (60.0%-85.7%).
In BIFAP, a cohort of women vaccinated against HPV, mostly with three doses in recommended intervals, was identified. Although additional information about the vaccination was scarce, when present, it highly confirmed it, making BIFAP a potential data source for HPV vaccine research.
在西班牙，人乳头瘤病毒（HPV）疫苗于 2006 年首次上市，主要在初级保健（PC）诊所为女孩/妇女或学校接种。对于所有疫苗，都需要有效的数据源来研究观察效力或安全性。本研究的目的是从 2007 年的初级保健药物流行病学研究数据库（BIFAP）中识别和验证女性 HPV 疫苗接种记录。
BIFAP 包含一个由 PC 从业者和儿科医生填写的疫苗接种文件。根据以下标准间隔确定和验证是否记录了女性 HPV 疫苗接种信息：（1）第一剂和第二剂之间的间隔为 27 至 269 天，第二剂和第三剂之间的间隔>55 天，第一剂和第三剂之间的间隔<366 天；（2）通过记录品牌、批次、有效期、接种部位或接种意见等临床记录中额外记录的信息确认（通过记录品牌、批次、有效期、接种部位或接种意见）或反驳疫苗接种和日期。通过随机选择的匿名记录的手动审查检索到后者。
确定了 11703 名 HPV 疫苗接种记录女性（平均年龄 14.7 岁）；82.5%的人接种了三剂疫苗，87.3%的人在推荐的间隔内接种。审查了 978 名患者记录，其中包括 2245 剂疫苗。在有额外信息的 363 剂疫苗中，91%的疫苗得到了确认。当剂量严格遵守建议时（96.8%-100%），确认数据的频率比不遵守建议时（60.0%-85.7%）更高。
在 BIFAP 中，确定了一个针对 HPV 接种疫苗的女性队列，其中大多数人在推荐的间隔内接种了三剂疫苗。尽管关于疫苗接种的额外信息很少，但当存在时，它高度确认了疫苗接种，使 BIFAP 成为 HPV 疫苗研究的潜在数据源。
