S.I.P. (Italian Society of Paediatrics), Molise, Italy.
Ital J Pediatr. 2010 Jan 15;36:4. doi: 10.1186/1824-7288-36-4.
Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions.The lack of reliable data in the paediatric population is associated with specific problems including: limited availability of safety data due to the lack of clinical trials in the paediatric population; under- or over-dosing in some age groups due to the lack of pharmacokinetics data or dose-finding studies; maturation, growth and development of the paediatric population susceptible to drug-induced growth and development disorders as well as to delayed ADRs not findable in adults.Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Spontaneous reporting of suspected ADRs become an important means to promote reasonable warning signs.Therefore some ADRs may be known in their qualitative aspect and quantitative aspect only after successful marketing and use in the population during a "normal" use. When the drug is used in clinical practice in large unselected populations, epidemiological post-marketing studies are useful as they find their major confirmation in recalling all the events that occur during monitoring, with estimates of incidence of ADRs that can not be obtained by spontaneous reports.In these studies a significant role can be played by the Family Pediatricians with the participation to active pharmacovigilance projects.
许多药物在儿科人群中被未经许可或“超适应证”使用，因为它们尚未经过充分的测试和/或配制，并且未被授权用于适当的儿科年龄组。监管机构还需要提醒卫生专业人员，他们在报告药物不良反应方面对儿科药物警戒过程的重要贡献。儿科人群中缺乏可靠数据与特定问题相关，包括：由于儿科人群中缺乏临床试验，安全性数据有限；由于缺乏药代动力学数据或剂量探索研究，某些年龄组存在剂量不足或过量；儿科人群的成熟、生长和发育易受药物诱导的生长和发育障碍以及在成年人中找不到的延迟不良反应的影响。上市前试验能够提供有关药物益处的信息，但无法确定安全性概况。疑似不良反应的自发报告成为促进合理警告信号的重要手段。因此，一些不良反应可能在成功上市并在人群中“正常”使用后，仅在定性和定量方面为人所知。当药物在大的未选择人群中在临床实践中使用时，上市后流行病学研究很有用，因为它们通过回忆监测期间发生的所有事件来找到主要的确认，并且可以估计通过自发报告无法获得的不良反应发生率。在这些研究中，家庭儿科医生可以通过参与主动药物警戒项目发挥重要作用。
