Although marketing authorization holders (MAHs) are involved in monitoring medication safety, it was unclear how they experience their role and current monitoring activities in pregnancy. Therefore, a qualitative study using online focus groups with MAHs and the Belgian umbrella organisation of MAHs was conducted in June-July 2021. In total, 38 representatives of nine organisations participated. Overall, participants reported multiple difficulties with data collection, including underreporting, collection of incomplete information and loss to follow-up. The limited number of high-quality data collected, the unknown denominator and the lack of comparator data complicate MAHs’ data processing activities, preventing them to timely provide evidence in the pregnancy label. Three ‘conflicts’ inherent to the specific position of MAHs were identified explaining the difficulties they experience, i.e., 1) mistrust from patients and healthcare professionals (HCPs); 2) MAHs’ legal obligations and regulatory framework; 3) MAHs’ position outside the healthcare context. To overcome these barriers, MAHs suggested that data registration should occur in close collaboration with patients and HCPs, organized within the healthcare context and performed by using a user-friendly system. In conclusion, the reported difficulties and underlying conflicts of MAHs highlight the need for more effective, collaborative data collection strategies to generate new evidence on this topic.

There is a need to assess the knowledge of healthcare providers on the use of maternal analgesics during lactation, while a valid instrument is not yet available. This study aimed to develop a valid and reliable questionnaire on the knowledge of analgesics (acetaminophen, ibuprofen, aspirin, tramadol, codeine, oxycodone) during lactation, using a prospective, stepwise approach. To generate a pool of item subgroups, literature was assessed as first step. This preliminary version was subsequently reviewed in two focus groups [midwives (n=4), pediatric nurses (n=6)], followed by an expert panel (n=7, 2 rounds) to confirm content validity [item-level and scale content validity]. This resulted in a instrument consisting of 33 questions, and 5 clincial case descriptions specific for both disciplines. Based on known-groups validity between midwives and pediatric nurses (assuming an a priori difference related to their curricula), high construct validity was subsequently demonstrated in a pilot e-survey (86 midwives, 73 pediatric nurses). We therefore conclude that an instrument to assess knowledge on lactation-related exposure to analgesics was generated, that can be further developed and validated. Furthermore, pilot findings suggest suboptimal knowledge for both professions, so that adaptations in their curricula and postgraduate training are warranted.