Most breastfeeding individuals take at least one prescription drug, yet limited data from lactation studies are available to inform the safety of these drugs during breastfeeding. As a result, healthcare providers (HCPs) rely on available information about safety of drugs used during pregnancy or on personal experiences to inform prescribing/counseling decisions for breastfeeding individuals. To improve risk communication regarding drugs used during lactation, the U.S. Food and Drug Administration published the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, which added a narrative summary of available risk information to the lactation section of Prescribing Information (PI). Prior studies on labeling in PLLR format revealed that although HCPs found these details valuable, they regarded the narrative as too long to support decision-making during patient encounters. This qualitative study's objective was to assess the utility of adding a concise summary to the Lactation subsection of PI to complement the narrative and succinctly communicate to busy HCPs a drug's risks when used during lactation. The concise summary consisted of a bolded headline, bulleted descriptions of available study findings and potential adverse reactions, and recommendations for risk mitigation. Twenty-five online focus groups were conducted with five segments of HCPs to obtain their feedback on the concise summary and discuss their prescribing/counseling decisions for four fictitious prescription drugs including one vaccine. HCPs utilized the concise summary to make initial prescribing/counseling decisions. Many also used the labeling narrative for a comprehensive benefit-risk assessment. The findings indicate a need to continue to improve communication about safety of drugs used during lactation, and that the concise summary may help facilitate this communication. The study also highlights the need to educate HCPs about PI limitations when clinical data are lacking and the need to encourage clinical studies to be conducted to support actionable recommendations about use of prescription drugs during lactation.

中文翻译：

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医疗保健提供者使用简明摘要为哺乳期患者开处方

大多数母乳喂养的人至少服用一种处方药，但哺乳期研究的数据有限，无法告知这些药物在母乳喂养期间的安全性。因此，医疗保健提供者 (HCP) 依靠有关怀孕期间使用的药物安全性的现有信息或个人经验来为母乳喂养者制定处方/咨询决策。为了改善哺乳期药物的风险沟通，美国食品和药物管理局于 2015 年发布了妊娠和哺乳期标签规则 (PLLR)，在处方信息 (PI) 的哺乳期部分添加了可用风险信息的叙述性摘要。先前对 PLLR 格式标签的研究表明，尽管 HCP 认为这些细节很有价值，但他们认为叙述太长，无法支持患者在就诊期间做出决策。这项定性研究的目的是评估在 PI 的哺乳期部分添加简明摘要的效用，以补充叙述并简洁地向忙碌的 HCP 传达哺乳期间使用药物的风险。简明摘要包括粗体标题、现有研究结果和潜在不良反应的项目符号描述以及风险缓解建议。与五个部分的 HCP 进行了 25 个在线焦点小组，以获取他们对简明摘要的反馈，并讨论他们对四种虚构处方药（包括一种疫苗）的处方/咨询决定。医疗保健专业人员利用简明摘要做出初步处方/咨询决定。许多人还利用标签叙述进行全面的利益-风险评估。研究结果表明需要继续改善有关哺乳期药物安全性的沟通，而简明的总结可能有助于促进这种沟通。该研究还强调，在缺乏临床数据时，需要对 HCP 进行有关 PI 限制的教育，并需要鼓励进行临床研究，以支持有关哺乳期间使用处方药的可行建议。