Achieving optimal care for women of childbearing age living with chronic diseases

The lack of evidence around medication use in pregnancy leaves many women with chronic diseases facing difficult choices about whether, and how, to start a family.

Achieving optimal care for women of childbearing age living with chronic diseases

The lack of evidence around medication use in pregnancy leaves many women with chronic diseases facing difficult choices about whether, and how, to start a family.

Context

Medication is rarely tested in pregnant women, so evidence to drive clinical decisions is often lacking.

Without robust data, clinical decisions are often based on fear of potentially harming the unborn child. This affects not only pregnant women, but any woman who could potentially become pregnant – in other words, all women of childbearing age.

Women living with chronic diseases are particularly affected, as they may require ongoing medication to manage their health. There is often a tendency to view treatment as potentially harmful to the fetus, but risk is relative: leaving a disease untreated may also cause harm woman, the unborn child or both of them. This dilemma may lead healthcare professionals to give conflicting information, leaving women feeling that they must choose between managing their disease and having a child.

Despite the lack of evidence, almost half of all pregnant women will take at least one medication over the course of their pregnancy. Recent years have seen some progress in research around pregnancy, and it is now time for clinical practice to follow. All stakeholders must work together to shift mindsets, revise ethical and regulatory frameworks and create innovative partnerships to collect evidence to guide clinical care.

%

44% of pregnant women take at least one medicine during pregnancy

‘When data are limited, pregnant women lose. They may be dosed incorrectly, or medicines can be withheld from them. Wrongful assumptions are made in the absence of data.’

Dr Anne Lyerly

Founder, Second Wave Initiative, US

What we achieved

HPP worked with a group of experts from across Europe and the US to develop a policy report on achieving optimal care for women of childbearing age living with chronic diseases. We identified four pillars of action required to improve care for this group of women:

  • Develop a revised ethical framework for research and care
  • Support data collection
  • Train healthcare professionals on person-centred care and clinical recommendations
  • Increase awareness of these issues among women, healthcare professionals and policymakers

The lack of research or regulatory clarity means healthcare professionals do not have enough evidence on the use of medication before and during pregnancy. This leads to clinical decisions being based largely on precaution and anecdotal evidence, which often results in care that does not align with women’s fertility goals. This report details the actions required within each pillar to break this cycle and provide optimal, evidence-based care for all women.

Key partners and stakeholders

We are grateful to the following experts for sharing their knowledge in interviews and providing comments to a working draft:

  • Silvia Fernandez Barrio, Member at Large, International Federation of Psoriasis Associations (IFPA) Board, Sweden; President, Asociación Civil para el Enfermo de Psoriasis, Argentina
  • Nele Caeyers, Patient Research Partner and former Chair (2017–19), European League Against Rheumatism (EULAR) Standing Committee of People with Arthritis/Rheumatism in Europe (PARE); Communications Manager and Patient expert, ReumaNet, Belgium
  • Sophie Dupont, Head of the Neurological Rehabilitation Unit, University Hospitals Pitié Salpêtrière, France
  • Rebecca Fischer-Betz, Deputy Director, Department of Rheumatology & Hiller‑Research Unit Rheumatology, Medical Faculty, Heinrich-Heine‑University Düsseldorf; Project Lead, European Network of Pregnancy Registers in Rheumatology (EuNeP), Germany
  • Rieke van der Graaf, Associate Professor Medical Ethics, University Medical Center Utrecht, Julius Center, Netherlands
  • Maxine Lancelot, Scientific Officer, IFPA, Sweden
  • Juan Antonio Martínez López, Rheumatologist, Hospital Universitario Fundación Jiménez Díaz; Coordinator, Working group AFRODITA (on rheumatic diseases in women of childbearing age) of the Spanish Society of Rheumatology, Spain
  • Anne Lyerly, Professor of Social Medicine and Associate Director, Center for Bioethics, University of North Carolina, Chapel Hill; Founder, Second Wave Initiative, US
  • Joan Morris, Professor of Medical Statistics, Population Health Research Institute, St George’s University of London; member of the Steering Group, EUROmediCAT; Scientific Leader, EUROCAT, UK
  • Manuel Toledo, Neurologist, Vall d’Hebron University Hospital; member of the Steering Committee, Spanish Epilepsy Society; Secretary, Epilepsy Group for the Spanish Neurology Society, Spain; member of the Steering Committee, International Bureau for Epilepsy
  • Patrik Vuorio, Executive Director, IFPA, Sweden
  • Monika Østensen, Rheumatologist, Department of Rheumatology, Sörlandet Hospital, Kristiansand, Norway

The work was proposed and financially supported by UCB. The opinions and conclusions expressed or implied in the report are those of the authors and/or quoted experts, and do not necessarily reflect those of UCB. The material has gone through a courtesy review by UCB.