基于时间序列分析法的静脉用药调配工作量波动分析及预测

目的 探讨静脉用药调配中心（pharmacy intravenous admixture services，PIVAS）长期医嘱工作量的波动特征，构建以日为单位频次的工作量波动预测模型，为PIVAS工作模式的调整提供参考。方法 选取复旦大学附属中山医院东院区PIVAS2020年7月至2021年6月长期医嘱日工作量数据，采用时间序列分析法分析工作量波动特征并构建预测模型，通过拟合参数及预测结果验证模型精度。结果 PIVAS长期医嘱日工作量数据波动具有周期性、短期缓慢上升和不规则变动等特征；采用温特斯乘法模型拟合序列，Ljung-Box统计量的显著性值（P值）为 0.060（P > 0.05），R² = 0.777，拟合值与实际值的平均绝对误差为4.45%，表明模型拟合精度高；预测结果与实测结果平均相对偏差为3.81%，说明模型预测有效。结论 时间序列分析法可用于PIVAS长期医嘱工作量的分析预测，但因医嘱工作量存在周期性、不规则变动等波动规律，故需根据工作量波动特征及预测结果调整工作模式，以保障PIVAS高效运营。     

Epistaxis and other haemorrhagic events associated with the smoking cessation medicine varenicline: a case series from two national pharmacovigilance centres

Purpose

To present a case series of haemorrhagic events associated with varenicline identified from the New Zealand (NZ) and Netherlands national pharmacovigilance centres and propose a possible mechanism for these adverse events.

Methods

Reports of epistaxis and other haemorrhagic events (in all system organ classes excluding gynaecological) associated with varenicline were identified and assessed in both the NZ Intensive Medicines Monitoring Programme (IMMP) and the Netherlands Pharmacovigilance Centre Lareb (Lareb). Additional reports were identified from the World Health Organisation Uppsala Monitoring Centre (WHO-UMC) datasets, and these also underwent causality assessment.

Results

A total of 30 reports of haemorrhagic events were identified by the NZ IMMP (16 reports) and Lareb (14 reports). Six cases of epistaxis were identified, and four patients had a positive dechallenge on withdrawal of varenicline, suggesting a causal association. Another five reports of gingival bleeding were identified, with three patients having a positive dechallenge. Another patient who experienced haemoptysis while taking varenicline had a positive dechallenge and a positive rechallenge. In the WHO datasets, a further 49 reports of epistaxis, 39 reports of haemoptysis and 21 reports of thrombocytopenia were identified. A plausible mechanism for haemorrhagic events associated with varenicline may be a result of interaction with the serotonin (5-HT) receptor system and transporter.

Conclusions

This is the first specific investigation of haemorrhagic events associated with varenicline. The results of our assessment of reports identified by two national pharmacovigilance centres suggest that there may be causal relationship between varenicline and these adverse events.     

Impact of routine opt-out HIV/HCV screening on testing uptake at a syringe services program: An interrupted time series analysis

BackgroundHepatitis C (HCV) is the most common infectious disease among people who inject drugs (PWID). Engaging PWID in harm reduction services, such as syringe service programs (SSPs), is critical to reduce HCV and HIV transmission. Additionally, testing for HIV and HCV among PWID is important to improve diagnosis and linkage to care. On March 1, 2018, Florida's only legal SSP implemented bundled opt-out HIV/HCV testing at enrollment. We aimed to examine the differences in HIV/HCV testing uptake before and after the implementation of the opt-out testing policy.MethodsMultivariable logistic regression was used to assess predictors of accepting HIV/HCV tests, controlling for opt-in and opt-out policy. Monthly estimates of the percent of participants accepting an HIV test, HCV test, or both were generated. Interrupted Time Series (ITS) analysis evaluated the immediate policy impact on level of uptake and trend in uptake over time for bundled HIV/HCV testing before and after the opt-out testing policy.ResultsThe total study period was 37 months between December 2016–January 2020 with 512 SSP participants 15 months prior and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing. Significant predictors of accepting both HIV/HCV tests were cocaine injection (aOR = 2.36), self-reported HIV positive status (aOR = 0.39) and self-reported HCV positive status (aOR = 0.27). Based on the ITS results, there was a significant increase in uptake of HIV/HCV testing by 42.4% (95% CI: 26.2%–58.5%, p < 0.001) immediately after the policy change to opt-out testing.ConclusionBundled opt-out HIV/HCV testing substantially increased the percentage of SSP clients who received HIV and HCV rapid tests at enrollment into the program, and the effect remained stable across the 22 months post opt-out testing policy. Future investigation must assess PWID-level perspective of testing preferences and examine whether this testing approach improves HIV/HCV detection among PWID previously unaware of their status.