Sex differences in adverse drug reactions

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Before a new drug enters the market, its efficacy and safety is extensively investigated in animals and in randomised controlled trials with healthy people and patients. More information about the drug is collected after its market approval, due to e.g. a relatively low number and selected group of patients included in trials.

It is important to continue to collect information about drugs including adverse drug reactions (ADRs). The burden of ADRs can range from not burdensome to unbearable for patients. ADRs can reduce treatment adherence, lower treatment efficacy and quality of life, and may increase healthcare costs. Women generally more often experience ADRs than men. An overview of the differences at the level of specific drugs and specific ADRs has been developed to guide further actions for improving the outcomes of drugs in individual patients. 

Interdisciplinary team

Members of the group Real world studies in PharmacoEpidemiology, -Genetics, -Economics, & -Therapy (PEGET) within GUIDE performed a study funded by ZonMw to assess sex differences in ADRs for all drugs as reported to the Netherlands pharmacovigilance center (Lareb).

The project team consisted of members affiliated to various organisations, including the Netherlands pharmacovigilance center, the University Medical Center Groningen, the Dutch Medicines Evaluation Board, the University of Groningen, the Dutch College of General Practitioners, and the Medical Research Group Langerhans.

The project members combined expertise from the fields of medicine, pharmacy, pharmacology, and psychology, as well as on drug regulations and practice guidelines. This diversity was required for a methodologically sound execution of the study and for the interpretation and discussion about possible explanations for observed sex differences, which can be due to sex- and/or gender-related factors. Sex‐related factors refer to biological differences between women and men, whereas gender‐related factors refer to psychosocial, behavioural or cultural differences.

Overview of sex differences 

The study resulted in an overview of sex differences in the drug-ADR combinations reported to the Netherlands pharmacovigilance center. The results were published in a scientific paper (De Vries S.T. et al. Br J Clin Pharmacol 2019), presented during various national and international meetings, and were discussed in a meeting with relevant stakeholders (e.g. regulators, clinicians, researchers). During the stakeholder meeting, it was concluded that the creation of this overview was a first important step to show in which specific drugs and ADRs there are differences, and that it warrants more detailed investigations to explain the observed differences. The project members communicated about the study in their organisations and in their wider network, for instance, via their social media accounts. 

Furthermore, the study has resulted in a video and article focusing on healthcare professionals (in respectively medicijnjournaal and Pharmaceutisch Weekblad), and in articles for patients and the general public (articles in Libelle and Hartbrug magazine). Also, the results of the study have been used in publications about guidelines for the design and conduct of human clinical trials (Hermida et al., Chronolobiology international 2021), and in a tutorial for analysing and reporting sex differences in cardiovascular associations (Woodward, Heart 2019).

Ultimately, explanations for the observed sex differences in ADRs can be used to tailor drug treatment and management in clinical practice, which will be an important step in personalised medicine.
 

Interested in the approach of the: ‘Real world studies in PharmacoEpidemiology, -Genetics, -Economics, & -Therapy’ group to investigate sex differences in ADRs?