Sieluk Jan, Palasik Brittany, dosReis Susan, Doshi Peter
Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, USA.
University of Utah Hospitals and Clinics, Salt Lake City, UT, USA.
Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):274-284. doi: 10.1002/pds.4164. Epub 2017 Jan 13.
Regulators approve written medical information for healthcare professionals and consumers, but the consistency of these sources has not been studied. We investigated the consistency of information regarding four cardiovascular risks of attention-deficit/hyperactivity disorder (ADHD) medications approved in four countries.
Professional and consumer product labeling for five ADHD medications approved in Australia, Canada, the UK, and the USA were obtained in March/April 2016. Language describing the relationship between medication and elevated blood pressure and/or heart rate, myocardial infarction, stroke, and sudden death was extracted verbatim and classified into one of four categories based on the described relationship between medication and adverse event: "confirmed," "unconfirmed," "mixed," and "not mentioned." We judged the consistency of messages delivered to healthcare professionals and consumers as either "consistent" or "inconsistent."
We obtained 20 healthcare professional labels and 20 corresponding consumer labels for the five ADHD medications registered in all four countries. Not all professional and consumer labeling contained language regarding all four adverse events. Of the 80 theoretically evaluable drug-risk pairs, 38 (48%) were not evaluable because of absence of mention of the adverse event in the consumer label. For the remaining 42, the potential causal relationship was expressed consistently in professional and consumer labeling in 25 (60%) cases. The cardiovascular risk profile was not described consistently across all four countries for any of the five drugs.
Product labeling provides healthcare professionals and consumers with inconsistent messages regarding the potential causal relationship between stimulant use and specific cardiovascular risks in children and adolescents. Copyright © 2017 John Wiley & Sons, Ltd.
监管机构批准了针对医疗保健专业人员和消费者的书面医学信息，但这些信息来源的一致性尚未得到研究。我们调查了四个国家批准的注意力缺陷多动障碍（ADHD）药物的四种心血管风险信息的一致性。
2016年3月/4月获取了在澳大利亚、加拿大、英国和美国批准的五种ADHD药物的专业和消费者产品标签。逐字提取描述药物与血压升高和/或心率、心肌梗死、中风及猝死之间关系的语言，并根据所描述的药物与不良事件之间的关系将其分为四类之一：“已证实”、“未证实”、“混合”和“未提及”。我们将传达给医疗保健专业人员和消费者的信息一致性判断为“一致”或“不一致”。
我们获取了在所有四个国家注册的五种ADHD药物的20份医疗保健专业人员标签和20份相应的消费者标签。并非所有专业和消费者标签都包含有关所有四种不良事件的语言。在理论上可评估的80对药物 - 风险组合中，有38对（48%）因消费者标签中未提及不良事件而无法评估。对于其余42对，潜在因果关系在专业和消费者标签中一致表达的有25对（60%）。这五种药物中的任何一种在所有四个国家的心血管风险概况描述都不一致。
产品标签就兴奋剂使用与儿童和青少年特定心血管风险之间的潜在因果关系向医疗保健专业人员和消费者提供了不一致的信息。版权所有© 2017约翰威立父子有限公司。
