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首页> 外文期刊>Pharmacoepidemiology and drug safety >How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.
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How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

机译：制药公司如何处理消费者药品不良反应报告？概述基于对法国药物安全管理人员和管理人员的调查。

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It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.
机译：令人惊讶的是，在过去的几年中，欧洲消费者不良药物反应（ADR）的报告一直在不断增加。这可能是由于美国市场的影响，在这种情况下，患者感觉有理由直接致电制药公司询问有关其治疗的信息，因此是合理的。消费者接触到的越来越多的替代信息源（例如，健康和流行杂志，广播和电视上的广告等）也增加了这种增长。患者与医生之间关系的不断变化也可能导致这种现象。然后，有趣的是评估制药公司当前处理消费者ADR报告的方式。通过向46家跨国制药公司的法国药物安全经理和药物安全官员（DSO）发送调查问卷，调查了消费者ADR报告的管理。对调查的分析强调了一个事实，即制药公司应准备好面对不断增加的消费者ADR报告数量。显然，打电话记录副作用的消费者应该转到具有医学或药学背景并且通过特定培训获得的沟通技能的经过培训的DSO。此人还应该能够发布自己公司认可的足够的产品信息。美国市场的影响似乎正在改变制药公司处理消费者ADR报告的方式。如今，大多数公司将这些报告输入到药物安全数据库中，而无需事先联系患者的全科医生（GP）或专家进行医学确认。最后，咨询过的药物安全管理人员和DSO对于呼叫中心和电子邮件作为ADR报告工具的实用性存在分歧。但是，这两种工具在全球范围内都被制药公司拒绝作为可靠的报告手段。如本文所述，通过电子邮件报告ADR会对药品安全部门造成实际问题。最后，他们认为电话呼叫中心应仅限于特定的沟通问题，例如危机管理或亲爱的博士来信。

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