News

Apr
01
2021
Reporting medicine use in pregnancy
Just like everyone else, pregnant women sometimes need to take medicines. Sometimes the reason has nothing to do with pregnancy, like headaches, allergies or chronic illness. Sometimes health problems start or get worse when a woman is pregnant, like diabetes, morning sickness or high blood pressure. Sometimes women take medicines before they know that they are pregnant. Often there is not enough evidence to give women trustworthy information about how her particular drug might affect the fetus. This is why women and health-care professionals should always report any medicines taken during pregnancy! Your information can help women make informed decisions about the benefits and risks of different treatments!  | READ MORE >>
Mar
08
2021
Safe medicines for pregnant and breastfeeding mothers
Women who are pregnant and breastfeeding mothers deserve to know if a medicine is safe. The Innovative Medicines Initiative ConcePTION project has a huge and difficult task ahead: Building a system for drug safety in pregnancy and breastfeeding. We bring universities, pharmaceutical companies and the authorities that approve medicines together in partnership: Joining forces to turn data into evidence!  | READ MORE >>
Mar
02
2021
Generating evidence on medicine safety in pregnancy: Elements to consider
To be able to say that it is safe for a pregnant woman to take a particular medicine, we need to know that the safety data is robust. The ConcePTION project is piecing European data together, building a system to generate evidence on medicine safety for pregnant and breastfeeding women. A recent report provides an inventory of the core elements that are needed to generate the evidence that is required. The report guides researchers in performing high quality and meaningful population-based studies: allowing women and their doctors to make informed decisions and weigh the benefits against the risks of treatments. | READ MORE >>
Feb
03
2021
Multiple Sclerosis and pregnancy: First systematic review and meta-analysis!
The ConcePTION project is committed to building safety evidence for women and their doctors. One of our first contributions is a systematic review and meta-analysis of pregnancy and fetal outcomes in women with Multiple sclerosis (also known as MS). The results add to the existing evidence for women with MS considering pregnancy and for neurologists deciding on treatment during pregnancy and counselling women with unplanned pregnancies. The meta-analysis also highlights the need for more studies to address the lack of evidence. The authors are currently performing further studies within IMI ConcePTION to address some of these knowledge gaps.  | READ MORE >>
Feb
01
2021
Predicting how medicines transfer to breast milk
Breastfeeding offers health and wellbeing benefits for both mother and child. Half of new mothers need medicines. Many medicines are likely to be safe, but human lactation studies are challenging to conduct. As a result, women often have to choose between continuing their medical treatment and breastfeeding their infant. In a recent Biomedicine & Pharmacotherapy publication, ConcePTION researchers provide an extensive overview of non-clinical and computational methods that can be used to inform human lactation studies. And how these methods can be combined to enable prediction of medicine transfer into breast milk when human lactation studies cannot be performed. | READ MORE >>
Jan
25
2021
Ten principles for our stakeholder engagement in the ConcePTION project
The ConcePTION project is building much needed knowledge for women and health care professionals. To achieve our goal of building an ecosystem for medicine safety in pregnancy and breastfeeing, we need to engage with women, their partners, their doctors, pharmacists, midwives and nurses, the companies that develop medicines and the authorities that approve them and decide what becomes available to patients. Our goal is to work in an open and inclusive way, with the spirit of mutual respect and trust. We have developed ten principles to ensure we conduct our engagement activities in an ethical way.   | READ MORE >>
Jan
20
2021
MHRA issues guidance for safer medicines in pregnancy and breastfeeding
The information that is available to women and healthcare professionals about medicine use in pregnancy and breastfeeding is often both inconsistent and inadequate. Recently, the UK Safer Medicines in Pregnancy and Breastfeeding Information Consortium published an information strategy. The vision of this strategy is for all women to have access to accurate and accessible information, allowing them to make informed decisions about medicines together with health care professionals.  | READ MORE >>
Dec
21
2020
Season’s greetings from the IMI Conception project
2020 was a challenging year for all of us, having an impact on our work and private lives alike. Despite adapting to a global pandemic, we have made amazing progress in our project and achieved many milestones on our way to improve the information for pregnant and breastfeeding women worldwide. With 88 partners from 22 countries, we should be proud of being part of a unique project that is set out to improve the situation in an orphan and neglected topic!  | READ MORE >>
Dec
16
2020
Empowering women to make informed decisions about medicines in pregnancy
Pregnant women make decisions about medicines based on insufficient, incomplete and randomly available information with varying quality. More than five million European women become pregnant every year. Most of them use at least one medicine during their pregnancy. A recent master thesis from the ConcePTION project shows that giving women easy access to information from sources they can trust can empower them to make decisions about medicines in pregnancy.  | READ MORE >>
Nov
04
2020
Every report counts! A clinician’s perspective on #MedSafetyWeek
Many women need medication during pregnancy and breastfeeding in order to treat health conditions. However, they often choose to stop their medication. I meet these women in my clinical practice. Many of them have underlying medical problems, anything from common ailments (such as headaches or heartburn) to autoimmune diseases, to heart and kidney disease or even an organ transplant. Naturally, they worry about the medicines they are taking for fear that they might harm their baby. Ken Hodson, Head of the UK Teratology Information Service (www.uktis.org) and consultant obstetrician with a specialist interest in medical problems in pregnancy in Newcastle upon Tyne, UK shares his thoughts on this year's #MedSafetyWeek!  | READ MORE >>
Nov
02
2020
Every report counts! ConcePTION and #MedSafetyWeek 2-8 November
This week, the Innovative Medicines Initiative project, ConcePTION, is part of the fifth annual social media campaign called #MedSafetyWeek. The purpose is to raise awareness about the importance of reporting suspected side effects from medicines to national health authorities, registries and drug manufacturers. This year, ConcePTION is adding an important message to this campaign. We are calling on women and health care professionals to report any medications used during pregnancy and breastfeeding. This is important, even if you do not think you are experiencing any side effects. Why? Because information about medicine safety for pregnant and breastfeeding women is desperately lacking. Every report counts, and adds knowledge about how safe medicines are for both mums and babies! | READ MORE >>
Oct
20
2020
Follow #ConcePTIONvirtual2020 on 21-22 October
Like many others, the ConcePTION project had to cancel all face-to-face events this year and move online. This week we discuss our progress at the ConcePTION virtual general assembly. We look forward to two full days of progress reporting and constructive discussion. We are beginning to answer the question of how we can move beyond pregnancy registries to better understand disease-related pregnancy outcomes, medication use medicine safety in pregnancy. We also celebrate steps in the establishment of a non-commercial, Europe-wide breast milk biobank and platform to analyse samples. And a lot more! Want to know more? Join us at #ConcePTIONvirtual2020 on Twitter on 21-22 October!  | READ MORE >>
Oct
14
2020
ConcePTION and Safe Motherhood Week 2020
This year, ConcePTION is part of the annual online event organised by the Motherhood Collective Impact Programme (MCIP). Here, Helena Harnik, MCIP programmes director from the Synergist, explains how ConcePTION plays a role in addressing some of the most challenging issues in maternal health: building knowledge about how safe women’s medicines are in pregnancy and nursing. And why this knowledge matters.  | READ MORE >>
May
04
2020
Maternity, mental health, medicines and pregnancy
This week is Maternal Mental Health Awareness week, highlighting an important issue for all pregnant women and new mothers. Worldwide at least 1 in every 10 pregnant women experience a mental health disorder, including depression and anxiety. Many of these women will need treatment with medicines.  | READ MORE >>
Mar
16
2020
NEW: WHO issues interim guidance for clinicians involved in care of adult, pregnant and pediatric patients with suspected COVID-19
On 13 March 2020, the WHO issued the second edition of their interim guidance for clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected.  | READ MORE >>
Feb
03
2020
PhD student position in clinical pharmaceutical sciences
The Lausanne University Hospital (CHUV) is one of five Swiss university hospitals. Through its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the EPFL, CHUV plays a leading role in the areas of medical care, medical research and training. The drug in real life unit is part of the new Centre de Recherche et Innovation en Sciences Pharmaceutiques Cliniques – CRISP. Its research activities focus on how drugs are used once they are on the market and how their use can be improved. | READ MORE >>
Nov
12
2019
Interview with our project leads during the Safe Motherhood Week
The Motherhood Collective Impact program (MCIP) is a not-for-profit partnership that aims to address the most challenging issues in maternal health by taking a new, co-impact and systems-based approach. From 14th - 20th October 2019 they held their annual Safe Motherhood week. The theme of this year was: Accessibility to quality maternal care and safe medication. MCIP spoke with our project leads (Dr. Ida Niklson, (Novartis) & Prof. Dr. Miriam Sturkenboom (UMC Utrecht)) on how ConcePTION will bridge the knowledge gap for pregnant and breastfeeding women. | READ MORE >>
Oct
31
2019
Ending the pregnancy pause; an interview with two Work Packges leaders.
Uppsala Monitoring Centre is the WHO collaborating Centre for International Drug Monitoring with members in more than a network 150 countries. Which profides a global network for pharmacovigilance. In the recent issue of their magazine Reports they focus on the needed search for drug safety facts for pregnant and breastfeeding women with a lengthy interview of two partners of ConcePTION. | READ MORE >>
Oct
17
2019
Job opportunities in ConcePTION
Several consortium partners currently have job opportunities related to the ConcePTION project. Would you like to contribute to our important mission? Please have a look at the current vacancies below. | READ MORE >>
Oct
14
2019
Survey on Women's information needs and preferences during pregnancy and breastfeeding
On September, IMI ConcePTION has successfully launched the first of two surveys to collect information on women’s needs and preferences on information about the medicines or drugs used during pregnancy and breastfeeding. | READ MORE >>
May
05
2019
ConcePTION press release
ConcePTION: ‘Building a pan-European ecosystem for generating, monitoring, and providing robust information on medication safety in pregnancy and breastfeeding’  | READ MORE >>
Apr
01
2019
ConcePTION has started
On 1-April 2019 the IMI project ConcePTION officially started. The project will tackle many of the research gaps related to medicine used by pregnant and breastfeeding women. | READ MORE >>

Reporting medicine use in pregnancy

x
Apr
01
2021

Just like everyone else, pregnant women sometimes need to take medicines. Sometimes the reason has nothing to do with pregnancy, like headaches, allergies or chronic illness. Sometimes health problems start or get worse when a woman is pregnant, like diabetes, morning sickness or high blood pressure. Sometimes women take medicines before they know that they are pregnant. Often there is not enough evidence to give women trustworthy information about how her particular drug might affect the fetus. This is why women and health-care professionals should always report any medicines taken during pregnancy! Your information can help women make informed decisions about the benefits and risks of different treatments!

There are several ways to report that a woman has used a particular medicine. The different registries are interested in what is often called exposures (when a woman used a particular medicine). The ConcePTION project will build a system where this information can be with other important pregnancy information such as miscarriages, stillbirth and malformations, and how children develop. Every report counts!

If you are a pregnant woman

If you used a medicine during your pregnancy (regardless of whether there are unwanted effects or not), you can ask your doctor or midwife to report for you, or report it yourself. There are three different ways to report, but remember to only report each medicine once, and through one of the routes. If you prefer not to ask you healthcare provider, you could:

  • Report that you have taken a medicine during pregnancy to the company who makes the medicine (Marketing Authorization Holder). You can find the information on where and how to notify them either in the information leaflet included in the product packaging, or by visiting the company website.
  • In some Europeans countries, you can report through specialized, country specific centers called Teratology Information Services. To find out if this service is available in your country, please visit https://www.entis-org.eu/centers.
  • You could also report to what is called national competent authorities, which is another name for the authorities that approve medicines (regulators). For EU & EEA countries, you can find a list here: national competent authorities of the EU and EEA on the European Medicines Agency website.

If you are a health care provider

If you prescribe a medicine to a pregnant patient, whether or not it is associated with an adverse drug reaction, you should report the exposure to either the Marketing Authorization Holder of the product, or a national Teratology Information Service centre (if there is such a service in your country). As always, you are required to report adverse events through regular routes. It is particularly important to report any problems that result in hospitalization, significant disability, or death”.

If you are reporting exposure (without adverse events), you can find a list of national competent authorities here: national competent authorities of the EU and EEA on the European Medicines Agency website. Your report will likely feed into the EudraVigilance database, a collaboration between different actors in Europe. These include the European Medicines Agency, different National Competent Authorities (national regulatory authorities), the Market Authorisation Holders (companies that make the medicines), and different sponsors of clinical trials (including physicians, academic centres, non-governmental organisations. To find out if there is a Teratology Information Service center in your country, please visit https://www.entis-org.eu/centers.

Want to know how some of these systems work?

Christine Taeter, Head of Immunology Patient Safety Unit at UCB presents the perspective of Marketing Authorization Holders on monitoring the safety of medicines use during pregnancy.

Jonathan Luke Richardson from the UK Teratology Information Service (UKTIS), Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom presents an overview of how ENTIS monitors medication use in pregnancy.

Helen Dolk, Professor of Epidemiology & Health Services Research at Ulster University presents how the EUROmediCAT network works to optimise the use of congenital anomaly registries and healthcare databases for medication safety monitoring.