Primary Care Medicine, Population Health Sciences Division, Medical Research Institute, Dundee, Scotland, United Kingdom.
PLoS One. 2013 Jul 17;8(7):e68976. doi: 10.1371/journal.pone.0068976. Print 2013.
Regulatory risk communications are an important method for disseminating drug safety information, but their impact varies. Two significant UK risk communications about antipsychotic use in older people with dementia were issued in 2004 and 2009. These varied considerably in their content and dissemination, allowing examination of their differential impact.
Segmented regression time-series analysis 2001-2011 for people aged ≥65 years with dementia in 87 Scottish general practices, examining the impact of two pre-specified risk communications in 2004 and 2009 on antipsychotic and other psychotropic prescribing.
The percentage of people with dementia prescribed an antipsychotic was 15.9% in quarter 1 2001 and was rising by an estimated 0.6%/quarter before the 2004 risk communication. The 2004 risk communication was sent directly to all prescribers, and specifically recommended review of all patients prescribed relevant drugs. It was associated with an immediate absolute reduction in antipsychotic prescribing of 5.9% (95% CI -6.6 to -5.2) and a change to a stable level of prescribing subsequently. The 2009 risk communication was disseminated in a limited circulation bulletin, and only specifically recommended avoiding initiation if possible. There was no immediate associated impact, but it was associated with a significant decline in prescribing subsequently which appeared driven by a decline in initiation, with the percentage prescribed an antipsychotic falling from 18.4% in Q1 2009 to 13.5% in Q1 2011. There was no widespread substitution of antipsychotics with other psychotropic drugs.
The two risk communications were associated with reductions in antipsychotic use, in ways which were compatible with marked differences in their content and dissemination. Further research is needed to ensure that the content and dissemination of regulatory risk communications is optimal, and to track their impact on intended and unintended outcomes. Although rates are falling, antipsychotic prescribing in dementia in Scotland remains unacceptably high.
监管风险沟通是传播药物安全信息的重要方法，但它们的影响各不相同。2004 年和 2009 年，英国发布了两项关于抗精神病药物在老年痴呆症患者中使用的重要风险沟通。这些沟通在内容和传播方式上有很大的不同，这使得我们可以对它们的差异影响进行研究。
对苏格兰 87 家全科诊所中≥65 岁的痴呆症患者进行 2001-2011 年的分段回归时间序列分析，研究 2004 年和 2009 年两次预先指定的风险沟通对抗精神病药物和其他精神药物处方的影响。
2001 年第一季度，每 100 名痴呆症患者中有 15.9%的人开了抗精神病药物，在 2004 年风险沟通之前，预计每季度增加 0.6%。2004 年的风险沟通直接发送给所有处方医生，并特别建议对所有开相关药物的患者进行审查。它立即导致抗精神病药物的处方绝对减少了 5.9%（95%CI-6.6 至-5.2），随后处方量稳定下来。2009 年的风险沟通以有限流通的公告形式发布，仅特别建议在可能的情况下避免起始治疗。这并没有立即产生影响，但随后的处方量显著下降，这似乎是由于起始治疗的下降所致，开抗精神病药物的患者比例从 2009 年第一季度的 18.4%下降到 2011 年第一季度的 13.5%。没有广泛用其他精神药物替代抗精神病药物。
这两项风险沟通与抗精神病药物使用量的减少有关，这与它们内容和传播方式的显著差异是一致的。需要进一步研究，以确保监管风险沟通的内容和传播方式是最佳的，并跟踪它们对预期和非预期结果的影响。尽管使用率在下降，但苏格兰痴呆症患者的抗精神病药物处方仍然高得令人无法接受。
