Johansson Kristina, Olsson Sten, Hellman Björn, Meyboom Ronald H B
WHO Collaborating Centre for International Drug Monitoring, Uppsala, SwedenDivision of Toxicology, Uppsala University, Uppsala, Sweden.
Drug Saf. 2007;30(10):883-9. doi: 10.2165/00002018-200730100-00006.
The Internet provides novel ways for communication and data exchange between national regulators. One innovation was the introduction of Vigimed, an e-mail discussion forum for national pharmacovigilance centres (NPCs). We reviewed a sample of Vigimed messages to learn more about this new tool and about the problems encountered in everyday pharmacovigilance and how these are handled.
We analysed the contents of 100 subsequent questions and the corresponding responses as stored in the Vigimed datafile.
To the 100 questions circulated through Vigimed, 575 answers were received; mean number of answers per question 6, range 0-20. Fifty-five (77%) of the 71 collaborating countries and 88 (43%) of the 204 individuals who had access in the study period had submitted at least one question or answer. These countries were in all parts of the world and in various phases of development. A total of 38% of the questions concerned the regulatory status of a drug; 30% safety issues; 13% regulatory actions under consideration; and 10% drug use-related problems (more than one category possible). Of the questions, 89% concerned established drugs; 11% were classified as new. A total of 90% of the questions concerned specific active substances or drug groups. Of the drugs, 73% were classified as 'orthodox' and 9% as herbal; 4% were vaccines and 4% excipients. Emerging drug groups (anatomical therapeutic chemical codes) were NSAIDs and analgesics (M01, N02), antibacterials (J01), antiobesity drugs (A08), psychotropic drugs (N05) and antihistamines (R06).
NPCs operate in a restricted environment and there is little published information about the daily practices and experiences at NPCs. Our study concerned a sample in a limited period in time. In the meantime, the use of Vigimed has greatly expanded. The data in the Vigimed records are subjected to confidentiality in regard to the identities of countries, staff members, drug products and pharmaceutical companies, which limits the presentation of data in a publication. For information about the actions taken to manage the matters and problems raised in Vigimed it would have been necessary to contact the NPCs and acquire follow-up data.
The Vigimed e-mail discussion group was rapidly incorporated into the routines at NPCs in many countries around the world. When two or more persons per country have access, participation increases. The matters raised predominantly refer to regulatory policy, safety concerns and drug use-related problems, and mainly concern established drugs. The latter emphasises the need for persistent monitoring of all drugs. New safety concerns are often sensitive and uncertain; the timely and efficient communication of such suspicions benefits from an environment of confidentiality. The Vigimed records give a unique view of real-life pharmacovigilance, of the matters addressed, the problems encountered, the data needed and the ways in which NPCs help each other. Such information can help make pharmacovigilance more efficient and effective.
互联网为各国监管机构之间的沟通和数据交换提供了新途径。一项创新举措是引入了Vigimed，这是一个面向各国药品不良反应监测中心（NPCs）的电子邮件讨论论坛。我们审查了Vigimed信息样本，以更多地了解这一新工具以及日常药品不良反应监测中遇到的问题及其处理方式。
我们分析了Vigimed数据文件中存储的100个后续问题及相应回复的内容。
通过Vigimed发布的100个问题共收到575个答案；每个问题的平均答案数为6个，范围为0至20个。在研究期间能够访问的71个合作国家中的55个（77%）以及204名个人中的88个（43%）提交了至少一个问题或答案。这些国家分布在世界各地，处于不同的发展阶段。总共38%的问题涉及药品的监管状态；30%涉及安全问题；13%涉及正在考虑的监管行动；10%涉及与药物使用相关的问题（可能有多个类别）。在这些问题中，89%涉及已上市药品；11%被归类为新药。总共90%的问题涉及特定的活性物质或药物类别。在这些药物中，73%被归类为“传统”药物，9%为草药；4%为疫苗，4%为辅料。新兴药物类别（解剖学治疗化学代码）为非甾体抗炎药和镇痛药（M01、N02）、抗菌药（J01）、减肥药（A08）、精神药物（N05）和抗组胺药（R06）。
各国药品不良反应监测中心在受限的环境中运作，关于其日常工作和经验的公开信息很少。我们的研究涉及特定时间段内的一个样本。与此同时，Vigimed的使用已大幅扩展。Vigimed记录中的数据在国家、工作人员、药品和制药公司的身份方面进行了保密，这限制了在出版物中呈现数据。为了获取有关处理Vigimed中提出的事项和问题所采取行动的信息，有必要联系各国药品不良反应监测中心并获取后续数据。
Vigimed电子邮件讨论组迅速被世界许多国家的药品不良反应监测中心纳入日常工作。当每个国家有两个或更多人能够访问时，参与度会提高。提出的事项主要涉及监管政策、安全问题和与药物使用相关的问题，且主要涉及已上市药品。后者强调了对所有药品进行持续监测的必要性。新的安全问题往往敏感且不确定；在保密环境下有助于及时、高效地交流此类怀疑。Vigimed记录提供了对实际药品不良反应监测的独特视角，包括所处理的事项、遇到的问题、所需的数据以及各国药品不良反应监测中心相互帮助的方式。此类信息有助于提高药品不良反应监测的效率和效果。
