PharmaSafe is a multidisciplinary research group dedicated to generating real‑world evidence on the safe and effective use of medications. We specialize in pharmacoepidemiology and health data analyses, with a particular focus on vulnerable populations such as pregnant women and children.
By leveraging large-scale health data sources, including national health and prescription registries, electronic health records, and population-based cohorts, we use advanced epidemiological and biostatistical methods to answer questions that are difficult or impossible to study in randomized controlled trials. Our expertise spans pharmacoepidemiology and drug safety, pharmaco(epi)genetics, biostatistics, causal inference, machine learning, and pharmacotherapy.
Our overarching goal is to produce robust, timely, and actionable evidence that can inform clinical guidelines, regulatory decisions, and patient care, and ultimately improve medication safety and treatment outcomes at both the individual and societal level.
Pharmacoepidemiology and Health Data Analyses
A core focus of PharmaSafe is the use of real‑world health data to evaluate the safety and effectiveness of medications across diverse patient groups and life stages. We routinely link and analyze large, population-based registries covering millions of individuals, often in combination with birth cohorts, clinical trial data, and patient-reported information.
Key research areas include:
Medication use and safety in pregnancy
Pregnant women are rarely included in clinical trials, yet pharmacological treatment is often necessary before and during pregnancy. We study how medication exposure affects pregnancy outcomes such as low birth weight, prematurity, stillbirth, congenital malformations, and perinatal complications. Our work aims to provide evidence-based guidance on the safety of commonly used medications in pregnancy, including psychotropics, analgesics, and antibiotics.
Vaccine safety and effectiveness
We conduct pharmacoepidemiological studies of vaccines, with particular emphasis on pregnant women, infants, and young children. Using linked registry data, we evaluate both the effectiveness of vaccines (for example, preventing infection or severe disease) and their safety, including rare and delayed adverse events.
Methodological innovation
To address the complexity and potential biases inherent in observational health data, we develop and apply advanced statistical and causal inference methods, as well as machine learning techniques tailored to survival and longitudinal data. This includes work on confounding control, bias quantification, and transparent, reproducible analytical pipelines.
We are a partner in the National Research School in Epidemiology, led at the Arctic University of Norway. This research school provides a nationally unified learning environment and academic collaboration in epidemiology.
Clinical Pharmacy and Pharmacotherapy
Complementing our registry- and data-driven research, PharmaSafe also conducts clinical pharmacy and pharmacotherapy studies with a strong patient-centered perspective. We use surveys, interviews, and mixed-methods approaches to investigate:
- Patients’ risk perceptions related to medication use
- Attitudes toward and adherence to treatment across diseases and life stages (e.g., migraine, depression, pregnancy)
- How communication, shared decision-making, and clinical follow-up can optimize safe and effective medication use
As a part of the clinical pharmacy research area, we also conduct human lactation studies on breast milk transfer of various medications.
By integrating population-level data analyses with patient-level insights, PharmaSafe aims to provide a comprehensive understanding of medication safety and effectiveness from biological mechanisms and real‑world outcomes to patient experiences and clinical practice.
Team members at the Department of Pharmacy
- Professor Hedvig Nordeng
- Senior researcher Marleen van Gelder
- Postdoc Emilie Willoch Olstad
- Postdoc Samantha Xavier
- Postdoc Robin Mzati Sinsamala
- Senior researcher Anteneh Assefa Desalegn
- Researcher Saeed Hayati
- Researcher Teferi Mekonnen Yitayew
- Research Coordinator Mina Karkhi
- PhD student Akhila Srinivas Reddy
- PhD student Milica Zugic
- PhD student Alexis Carson
- PhD student Mahmoud Zidan
- PhD student Petrica-Ioan Olteanu
- PhD student Yuan Wang
- Guest researcher Eivind Ystrøm
- Guest researcher Kristina Gervin
- Guest researcher Mollie Wood
- Guest researcher Nhung Trinh
- Guest researcher Lin-Chieh Meng
Collaborations
The research group has close collaborations with:
Norway
- Clinical Pharmacy and Pharmacoepidemiology (IPSUM), The Arctic University of Norway (UiT)
- University hospitals in Norway (OUS, UNN, St. Olav’s hospital, Akershus)
- National Institute of Public Health, Norway (FHI)
- Regional Drug Information Services (RELIS)
International
- Center for Better Beginnings, UC San Diego, USA
- McGill University, Canada
- University of Bordeaux, France
- University of Milano-Bicocca, Italy
- Radboud University Medical Center, the Netherlands
- Federal University of Rio Grande do Sul, Brazil
- University of Copenhagen, Denmark
- University of Southern Denmark, Denmark
- University of North Carolina Chapel Hill, U.S.A.