Lumanity Value, Access & Outcomes’ Post

New research from our own Eline Houben highlights the importance of coordination between general practitioners (GPs) and obstetricians/gynecologists in the provision of routine medical care during pregnancy. Of 140,976 pregnancies in the Netherlands between 2004 and 2020, registration in The Teratology Information Service, the knowledge centre of Lareb on safety of drugs used before and during pregnancy and during breastfeeding, was only available for 13%. The limited registration introduces a risk of prescribing teratogenic medications and increases the likelihood of pregnant women experiencing an adverse event. Registration rates appear to improve in later years. Increased collaboration between GPs and midwives is strongly encouraged. Read the full research brief in English at https://lnkd.in/eq7SVzgj or in Dutch at https://lnkd.in/eh-9pwig   #realworldevidence #realworlddata #carecoordination #drugsafety #adversevent #adverseventmonitoring #pharmacovigilance #teratogenic #riskmanagement #publichealth

Patients and healthcare professionals have expressed the need to have access to more information on the safety of medicines during pregnancy and breastfeeding. In its Regulatory Science Strategy to 2025, the EMA highlights their commitment to advance medicines use in pregnancy and breastfeeding, throughout the product lifecycle. The EMA has recently released a concept paper on the on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling. Since the adoption of the guideline EMEA/CHMP/203927/2005 in 2008, several developments in the non-clinical field of data in relation to use of medicines during pregnancy and breastfeeding. The concept paper outlines the areas in this guideline to be updated. Comments can be provided until 31 August 2024. #clinical research #pregnant #lactating #breastfeeding #guideline

With 5,000,000 pregnancies each year in Europe alone, there is a pressing need to fill the knowledge gap in medicine safety during pregnancy and breastfeeding. ConcePTION has spent 5 years working to set up an ecosystem for pharmacovigilance in pregnancy and breastfeeding. The LifeSaver Project (Living Impact on Fetal Evolution) is just getting started on the journey towards advancing risk assessment for drugs and chemicals in pregnancy. Together, we work to fill the knowledge gaps. On 14 May 2024, we shared what we do and how we complement each other in a joint webinar. Read all about it by following the link below. https://lnkd.in/g-yvdFYk Innovative Health Initiative (IHI)

The answer to yesterday’s #ClinicalChallenge question is: C. In a multivariate analysis of pregnancies in patients with systemic lupus erythematosus (SLE), patients who experienced flare during pregnancy were more likely to have a low C4 during each trimester compared with patients who did not flare. Pregnant SLE patients with a low C4 may benefit from closer disease monitoring throughout pregnancy. The presence of anti-Ro/SSA and/or anti-La/SSB antibodies indicates fetal risk for congenital complete heart block and neonatal lupus. View the related What's New topic in #UpToDate: https://ow.ly/mVCf50PXmbI #rheumatology #MedEd

❓ DYK? Very little is known about what medication can be safely taken during pregnancy, despite the fact that nearly all pregnant women use at least one medicine. Many countries store information about the medicines that women use during pregnancy (PregPV datasets) but the format of these datasets and the way they are collected vary from country to country. The IMI ConcePTION project outlined a framework to optimise and standardise the way that this data is collected, analysed and reported. The work was published in the journal Drug Safety. Read more 👉 https://europa.eu/!9mmFCC #EUResearch #PregnancyHealth #DrugSafety #HealthData

In this MEDtalk, Dr. Christian Selinger presents a systematic review that his research group conducted into reproductive safety issues of novel small molecules for the treatment of inflammatory bowel disease. The study aimed to describe the reproductive outcomes of the JAK inhibitors tofacitinib, filgotinib, and upadacitinib and the S1P inhibitor ozanimod regarding their effects on pregnancy outcomes. #IBD #Pregnancy #JAKInhibitors

In this MEDtalk, Dr. Christian Selinger presents a systematic review that his research group conducted into reproductive safety issues of novel small molecules for the treatment of inflammatory bowel disease. The study aimed to describe the reproductive outcomes of the JAK inhibitors tofacitinib, filgotinib, and upadacitinib and the S1P inhibitor ozanimod regarding their effects on pregnancy outcomes. #IBD #Pregnancy #JAKInhibitors

In this MEDtalk, Dr. Christian Selinger presents a systematic review that his research group conducted into reproductive safety issues of novel small molecules for the treatment of inflammatory bowel disease. The study aimed to describe the reproductive outcomes of the JAK inhibitors tofacitinib, filgotinib, and upadacitinib and the S1P inhibitor ozanimod regarding their effects on pregnancy outcomes. #IBD #Pregnancy #JAKInhibitors

In this MEDtalk, Dr. Christian Selinger presents a systematic review that his research group conducted into reproductive safety issues of novel small molecules for the treatment of inflammatory bowel disease. The study aimed to describe the reproductive outcomes of the JAK inhibitors tofacitinib, filgotinib, and upadacitinib and the S1P inhibitor ozanimod regarding their effects on pregnancy outcomes. #IBD #Pregnancy #JAKInhibitors

Weed Laced Tobacco or Weed & Tobacco While Pregnant – Bad for Baby! #cannabisculture #StonerFam Risk of Adverse Neonatal Outcomes After Combined Prenatal Cannabis and Nicotine Exposure Conclusions and Relevance: These findings suggest that co-occurring maternal use of cannabis and nicotine products in pregnancy is associated with an increased risk of infant and neonatal death and maternal and neonatal morbidity compared with use of either substance alone. Given the increasing prevalence of combined cannabis and nicotine use in pregnancy, these findings can help guide health care practitioners with preconception and prenatal counseling, especially regarding the benefits of cessation. (Source: https://lnkd.in/gpzBVuKG )