Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Australia.
Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, United States.
Br J Clin Pharmacol. 2022 Feb;88(2):713-722. doi: 10.1111/bcp.15007. Epub 2021 Aug 16.
Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia.
Semi-structured qualitative interviews were carried out with 40 primary care physicians, endocrinologists and other generalist specialists in Boston (USA) and Australia. Coding and analysis were performed inductively and iteratively to identify and examine key factors. Analysis centred around four areas: physicians' awareness of drug safety information, preferred information sources, opinion-forming and sharing of information with patients.
Uncertainty, trust and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the "clinical grapevine" for awareness, and on clinical colleagues, specialists and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs.
Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance and accessibility, and address physicians' needs in communicating risk to patients.
药品监管机构发布上市后安全性警告，以告知新发现的风险，但影响不一。我们旨在确定影响美国和澳大利亚初级保健医生和专科医生使用监管警告的因素。
对波士顿（美国）和澳大利亚的 40 名初级保健医生、内分泌学家和其他普通专科医生进行了半结构式定性访谈。编码和分析是通过归纳和迭代进行的，以确定和检查关键因素。分析集中在四个方面：医生对药物安全信息的认识、首选信息来源、意见形成以及与患者分享信息。
不确定性、信任和临床权威是影响使用咨询意见的因素。尽管监管机构被认为是权威机构，但它们似乎缺乏临床权威，医生会根据其他值得信赖的来源（包括证据、专家意见和经验）来验证监管信息。专家通过专门的文献、使用证据和临床共识来形成意见，了解药物安全问题。初级保健医生处理大量信息，依赖方便、可及的信息来源，包括媒体和“临床传闻”来获取信息，并依赖临床同事、专家和经验来进行解释。向患者传达风险很复杂，因为存在不确定性；医生根据患者的健康素养和信息需求来调整信息。美国医生比澳大利亚医生更了解其国家监管机构在上市后安全方面的作用。
药物安全警告可能没有得到最佳的接收或使用。监管机构应考虑增加信任、临床相关性和可及性的策略，并满足医生向患者传达风险的需求。
