University of North Texas, 3500 Camp Bowie, Fort Worth, TX, 76107, USA.
Ther Innov Regul Sci. 2020 Mar;54(2):385-389. doi: 10.1007/s43441-019-00066-6. Epub 2020 Jan 6.
Medical information departments are responsible for maintaining standard response letters to address health care providers' inquiries. Several factors, including Food and Drug Administration regulations, insufficient diversity in clinical trials, and stringent exclusion criteria, might limit the information available to respond to unsolicited requests. However, if new data becomes available for an inquiry that was previously unanswered, it is not common practice for medical information departments to provide an updated response to health care providers. Therefore, the purpose of this study is to evaluate the impact of reviewing literature to provide an updated response to health care providers.
We conducted a 1-year retrospective review of medical inquiries regarding a Bristol-Myers Squibb oncology product. We identified medical inquiry responses that were missing data via our metrics reporting software and conducted an internal and external literature search to assess if new data became available.
Of 21,264 unsolicited global inquiries, data were unavailable for 531 (2.7%). The 3 most frequently observed inquiry topics were "use in special populations" (32%), "drug interactions" (27%), and "adverse events and safety" (23%). After performing an internal and external literature review, we developed standard response letters for 30% of medical inquiries that were previously unanswered.
Medical information departments serve as a resource to answer product-related questions for health care providers. However, data are not always available to provide a response. On discovery of new data, if medical information departments followed up with health care providers to share new data, this could potentially increase patient safety, build stronger relationships with health care providers, and obtain insights that could influence strategies in future clinical trials and publications.
医学信息部门负责维护标准回复函，以解答医疗保健提供者的咨询。包括食品和药物管理局的规定、临床试验中多样性不足以及严格的排除标准在内的几个因素，可能会限制回复未答复的询问的可用信息。然而，如果先前未答复的询问有新数据可用，医学信息部门通常不会向医疗保健提供者提供更新后的回复。因此，本研究的目的是评估查阅文献以向医疗保健提供者提供更新后的回复的效果。
我们对 Bristol-Myers Squibb 肿瘤学产品的医学询问进行了为期一年的回顾性研究。我们通过指标报告软件识别出回复中缺少数据的医学询问，并进行内部和外部文献检索，以评估是否有新数据可用。
在 21264 份未请求的全球询问中，有 531 份（2.7%）数据不可用。最常观察到的询问主题是“特殊人群中的使用”（32%）、“药物相互作用”（27%）和“不良反应和安全性”（23%）。在进行内部和外部文献回顾后，我们为 30%以前未答复的医学询问制定了标准回复函。
医学信息部门是为医疗保健提供者解答产品相关问题的资源。但是，并非总是有数据可以提供回复。如果医学信息部门在发现新数据后跟进医疗保健提供者以分享新数据，这可能会提高患者安全性，与医疗保健提供者建立更紧密的关系，并获得可能影响未来临床试验和出版物策略的见解。
