Report with landscape analysis

Task 5.1: Landscape analysis of available information sources about drug use in pregnancy (M1-24) (UOSL, NVS, LAREB, ENTIS, SCC, the Synergist, EIWH, AbbVie, UCB, Pfizer, Sanofi). The aim in this task is to compile an inventory of key information sources that are available to HCPs and women of child bearing age about drug use before and during pregnancy and during the breastfeeding period and to explore their preferences in receiving/accessing such information. The task is subdivided in three subtasks: Sub-task 5.1.1: Inventory Rationale: Different stakeholders (government, regulatory agencies, TIS, researchers, PV centres, HCP organisations, pharmacists, industry) are disseminating (different kinds of information) about the safety of drug use during pregnancy and lactation utilizing different delivery methods and with different purposes. Objective: To collect information on the current communication methods Methods: For different categories of stakeholders an overview will be made of: 1. The target group(s) of the communication; 2. The scope and purpose of the information; 3. The method(s) of information dissemination; 4. The process and methodology of interpretation of scientific research and how is this translated into up to date knowledge; and 5. Justification for and transparency about which sources are used The data will be collected using the most suitable data collection method including but not limited to desk research, interviews, surveys and digital channels. If stakeholder input is needed, this will be collected during a stakeholder event organised by WP6 in the beginning of the project. The task group will develop a briefing document for that meeting. Sub-task 5.1.2: Information discrepancies Rationale: A wide variety of information sources on medicines is available for women before and during pregnancy and during the breastfeeding period and the general public (which includes the women’s partners). Objective: assessing information discrepancies/conflicts Methods: Based on the landscape analysis above an assessment of the frequency and nature of information discrepancies, including discrepancies in the label, as well as the quality and health literacy level of the information between different sources will be made for at least 10 drugs in at least 3 different countries. The selection of drugs will be made by WP5 participants and stakeholder feedback (see 5.1.1) Sub-task 5.1.3: End-Users’ experiences Objective: To collect information on end users’ experience with the currently available information about the safety of drug use during pregnancy and lactation and to assess what their preferences would be in receiving such information in the future, both regarding content of the information and how it is delivered/made accessible to them. Methods: A survey and/or focus group discussions (in collaboration with stakeholders through WP6), with a good geographical spread within the European countries, with at least two groups (HCPs and patients) in at least 4 countries will be carried out on the following topics: 1) information needs about drug use during pregnancy and lactation and the risks of untreated disease; 2) preferences for receiving this information; 3) perception on the importance of this information 4) channels do they use to access this information; 5) if there is information accessible, how understandable and useful it is; 6) if they use multiple information sources, how do they interpret conflicting information; and 7) socio-demographic, lifestyle, health literacy and health factors related to understanding and perception of this information.