Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016

ObjectivesIn November 2014, the CMDh (a regulatory body representing EU Member States) advised doctors not to prescribe sodium valproate for epilepsy or bipolar disorder in preg nant women, in women who can become pregnant, or in girls unless other treatments are ineffective or not tolerated. This study aimed to determine if this warning led to changes in prescription patterns.Design and settingCohort of 5.4 million women aged between 10 and 50 years identified in electronic health care data from United Kingdom, France, and Italy (2007–2016).Main outcome measuresAnti‐epileptic drug (AED) prescriptions.ResultsThe prevalence of women receiving AED prescriptions in 2016 varied from 12.2 per 1000 to 29 per 1000 in the four regions. The incidence of prescribing any AED (excluding clonazepam, gabapentin, and pregabalin) fell each year on average by 7.5% (95% CI, 7.0%‐8.0%; Emilia Romagna), 9.6% (8.3%‐11.0%; France), 7.1% (6.7%‐7.6%; Tuscany), and 0.4% (0.2%‐1.0%; United Kingdom). The relative odds of prescribing sodium valproate rather than any other AED decreased more after 2014 compared with before the end of 2014 in France (OR = 0.77; 95% CI, 0.60‐0.98), Tuscany (0.81; 0.76‐0.86), Emilia Romagna (0.83; 0.76‐0.90), and the United Kingdom (0.92; 0.80‐1.06; not statistically significant).ConclusionsThere is evidence that the CMDh warning did lead to changes in prescription patterns of sodium valproate in women of childbearing age. There were considerable differences in prescribing practice amongst regions of Europe

The development of a core outcome set for studies of pregnant women with multimorbidity

Acknowledgements We would like to thank the following individuals, organisations and many others for helping with the recruitment of the Delphi surveys: 4M Mentor Mothers, African and Caribbean Support Northern Ireland, Alopecia UK, Ammalife, Association of South Asian Midwives, Attention Deficit Hyperactivity Disorder UK, Autism Connected, Balachandran Kumarendran, Birthrights, Black Female Doctors UK, Black Mothers Matter, Bliss, Breast Cancer Now, Bristol, North Somerset and South Gloucestershire Maternity Voices Partnership, British Adult Congenital Cardiac Nurse Association, British Association of Perinatal Medicine, British Human Immunodeficiency Virus Association, British Intrapartum Care Society, British Maternal and Fetal Medicine Society, British Thyroid Foundation, Cardiff Lupus Support Group, Cardiomyopathy UK, Chelsea and Westminster Maternity Voices Partnership, Community of Cultures Sheffield Maternity Cooperation, Core Outcome Measures in Effectiveness Trials Initiative, Crohn's and Colitis Canada, Crohn's and Colitis UK, Dads Matter, Diabetes UK, Disability Maternity Care (Australia), Elly Charity, E69 MOTIVE Trial, Epilepsy Foundation of America, Epilepsy Society, Fair Treatment for the Women of Wales, Fibromyalgia Action UK, General Practitioners Championing Perinatal Care, Global Kidney Foundation, Graham Mcllroy, Haemophilia Foundation Australia, Hereditary Spastic Paraplegia Support Group, Institute of Health Visiting, International League Against Epilepsy (Africa), Irish Neonatal Health Alliance, Juvenile Diabetes Research Foundation, Katie's Team, Kidney Patient Involvement Network, Kidney Wales, LGBT Mummies, MacDonald Obstetric Medicine Society, Malaysian Obstetric Medicine, Maternity and Midwifery Forum, MIDIRS Midwifery Digest, Midlands Maternal Medicine Network, Milena Forte, MQ Mental Health Research, Multiple Sclerosis Australia, Mums Like Us, Mum's Pride, Mumsnet, Muslim Women's Network UK, National Childbirth Trust, National Human Immunodeficiency Virus Nurses Association, National Kidney Federation, National Rheumatoid Arthritis UK, Newport Yemeni Community Association, Niina Kolehmainen, Obsessive Compulsive Disorder Action, Obstetric Anaesthetists' Association, Organisation for Sickle Cell Anaemia Relief and Thalassaemia Support Birmingham, Parathyroid UK, Parent Voices in Wales, Parents 1st 83 , Positive East, Positive Life Northern Ireland, Postural Tachycardia Syndrome UK, Psoriasis Association, Raham Project, Royal College of Midwives, Royal Surrey County Hospital Maternity Voices Partnership, Scottish 86 Perinatal Network, Scottish Research Nurse, Midwife & Coordinators' Network, Section for Women's Mental Health Institute of Psychiatry, Psychology and Neuroscience (King's College London), Sjogern's India, Society of Obstetric Medicine of Australia and New Zealand, Society of Obstetric Medicine (India), Somerville Heart Foundation, Sophia Forum, South African Nephrology Society, South Asian Health Foundation, South London Applied Research Collaboration Maternal and Perinatal Mental Health Research Patient and Public Involvement, Stockport Foundation Trust, Taraki, The Black Wellbeing Collective, The International Marcé Society for Perinatal Mental Health, The Pituitary Foundation, Thyroid Patients Canada, Tommy's, Turner Syndrome Support Society UK, UK Audit and Research Collaborative in Obstetrics and Gynaecology, UK Preconception Early-and Mid-Career Researchers Network, UK Teratology Information Service, University of Bristol Centre for Academic Primary Care and Patient and Public Involvement Panel, Vasculitis Ireland Awareness, Verity Polycystic Ovarian Syndrome UK, Wales Perinatal Mental Health Network. We would also like to thank Clare Evans for her input in reviewing this manuscript Funding This work was funded by the Strategic Priority Fund “Tackling multimorbidity at scale” programme (grant number MR/W014432/1) delivered by the Medical Research Council and the National Institute for Health Research in partnership with the Economic and Social Research Council and in collaboration with the Engineering and Physical Sciences Research Council. BT was funded by the National Institute for Health Research (NIHR) West Midlands Applied Research Collaboration. The views expressed are those of the author and not necessarily those of the funders, the NIHR or the UK Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer reviewedPublisher PD

From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population

Perception du risque lié à la prise d'AINS pendant le troisième trimestre de la grossesse (enquête auprès de deux cent cinquante femmes enceintes)

L'utilisation des Anti-Inflammatoires Non Stéroïdiens (AINS) est contre-indiquée chez la femme enceinte à partir du 6ème mois de grossesse. Les inhibiteurs de la synthèse des prostaglandines, c'est-à-dire tous les AINS, ont une toxicité fœtale et/ou néonatale cardio-pulmonaire et rénale. Dans une première partie bibliographique, après un rappel des mécanismes de cette toxicité, sont présentées les études épidémiologiques et les cas isolés qui témoignent de cette toxicité. En raison de la gravité des effets potentiels et compte tenu de la banalisation de l'utilisation des AINS, autant en prescription qu'en automédication, nous avons ouvert une enquête auprès de 250 femmes enceintes, qui fera l'objet d'une deuxième partie. Elle nous permettra d'évaluer l'attitude des femmes enceintes par rapport aux AINS : connaissance des médicaments, perception du risque? Les résultats de cette enquête déboucherons sur l'élaboration d'une fiche d'information à l'intention des femmes enceintes.TOULOUSE3-BU Santé-Centrale (315552105) / SudocTOULOUSE3-BU Santé-Allées (315552109) / SudocSudocFranceF

Quels antihypertenseurs chez la femme en âge de procréer et chez la femme enceinte ? Suivi des prescriptions en Midi-Pyrénées en 2007

BORDEAUX2-BU Santé (330632101) / SudocSudocFranceF

Le conseil pharmaceutique à la femme allaitante (enquête auprès de 100 pharmaciens d'officine)

Ce travail concerne la prise en charge de la femme allaitante à l'officine. Dans la première partie, après avoir rappelé les données épidémiologiques et les bénéfices de l'allaitement maternel, est détaillée la prise en charge des complications. La seconde partie expose les résultats obtenus lors d'une enquête menée en octobre 2004 auprès de 100 pharmaciens d'Haute-Garonne et d'Ariège. Les 97 sujets ayant accepté de participer ont répondu à un questionnaire portant sur l'allaitement et ses complications. Les réponses obtenues ont été confrontées avec les données bibliographiques existantes. Ceci nous a permis l'élaboration d'un carnet destiné à être distribué aux pharmaciens ayant participé à l'enquête.TOULOUSE3-BU Santé-Centrale (315552105) / SudocSudocFranceF

Anti-inflammatoires non stéroïdiens et fertilité féminine

To begin with, NSAIDs are all prostaglandins' synthesis inhibitors. Moreover, they are widely used with prescription or by the way of selfmedication and notably by women in childbearing age. At the present time the data are mixed indeed contradictory towards the risks concerning fertility when taking orally NSAIDs. In the first part, after recalling about anatomophysiological of female system, we deal with the epidemiology of fertility. In the second part, we describe the mechanism of action of the NSAIDs. In a third part, experimental studies clinical trials and pharmacoepidemological studies are summarized and give recommendations, to women who would like to be pregnant, and advice about taking NSAIDs.TOULOUSE3-BU Santé-Centrale (315552105) / SudocSudocFranceF