Smith Meredith Y, Irish William, Wang Jianmin, Haddox J David, Dart Richard C
Purdue Pharma LP, Stamford, CT, USA.
Pharmacoepidemiol Drug Saf. 2008 Nov;17(11):1050-9. doi: 10.1002/pds.1658.
The recent rise in the non-medical use of opioid analgesics in the US has underscored the importance of comprehensive post-marketing surveillance of these products. To assist pharmacovigilance efforts, we developed a methodology for detecting geo-specific "signals" of potential outbreaks of prescription drug abuse by 3-digit ZIP (3DZ) code.
The number of intentional exposure calls involving nine specific opioid analgesics were obtained from eight regional poison control centers between first quarter 2003 and fourth quarter 2004. The unit of analysis was a combination of drug-quarter/year-3DZ. We fitted an empirical Bayes mixed effects Poisson-Gamma regression model that adjusted for differences across 3DZs in opioid analgesic exposure. A relative report rate (RR) >or=3 at a probability of >0.95 was the signal threshold criterion.
A total of 15,769 valid drug-time-3DZ combinations were identified. Of these, 1.9% (n = 294) met the signal threshold criterion. The number of signals generated per drug-quarter/year-3DZ combination ranged from 0 to 13. The largest number of signals were those involving methadone (n = 71), hydrocodone (n = 57), and branded oxycodone extended-release (n = 45). Signals for methadone and branded oxycodone extended-release were predominantly clustered in Appalachia. Hydrocodone-related signals showed less geographic clustering with approximately 26% reported from California, and the remainder from other regions in the US.
Our results show marked regional differences in reported abuse of specific opioid analgesics. Additional research is needed to determine the sensitivity and specificity of signals obtained using this spatial mixed effect Poisson regression model.
近期美国阿片类镇痛药非医疗用途的增加凸显了对这些产品进行全面上市后监测的重要性。为协助药物警戒工作,我们开发了一种通过3位邮政编码(3DZ)检测特定地区处方药滥用潜在暴发“信号”的方法。
获取了2003年第一季度至2004年第四季度期间八个地区毒物控制中心涉及九种特定阿片类镇痛药的故意暴露呼叫数量。分析单位是药物-季度/年份-3DZ的组合。我们拟合了一个经验贝叶斯混合效应泊松-伽马回归模型,该模型针对阿片类镇痛药暴露在不同3DZ之间的差异进行了调整。相对报告率(RR)≥3且概率>0.95是信号阈值标准。
共识别出15769个有效的药物-时间-3DZ组合。其中,1.9%(n = 294)符合信号阈值标准。每个药物-季度/年份-3DZ组合产生的信号数量从0到13不等。信号数量最多的是涉及美沙酮(n = 71)、氢可酮(n = 57)和品牌缓释羟考酮(n = 45)的情况。美沙酮和品牌缓释羟考酮的信号主要集中在阿巴拉契亚地区。与氢可酮相关的信号地理聚集性较低,约26%来自加利福尼亚州,其余来自美国其他地区。
我们的结果显示了特定阿片类镇痛药报告滥用情况的显著区域差异。需要进一步研究以确定使用这种空间混合效应泊松回归模型获得的信号的敏感性和特异性。