Clinical Pharmacy & Epidemiology

Research

Our research group, the Basel Pharmacoepidemiology Unit, conducts observational research using large electronic databases. We have worked primarily with the UK-based Clinical Practice Research Datalink for more than 20 years, however,  we also work with Swiss electronic claims databases, such as the claims database of the Swiss health insurance Helsana group. We have a close research collaboration with the Boston Collaborative Drug Surveillance Program (www.bcdsp.org) in the United States and our Director, Christoph Meier, has worked for the BCDSP since 1995; he holds a position as research pharmacoepidemiologist at the BCDSP. Our focus of interest is drug safety, but we also conduct studies in the area of disease epidemiology and drug utilization. We apply state-of-the-art methodology used in epidemiological research. In addition to conducting research using large automated databases, we are heavily involved in teaching at the University of Basel, where we are mainly engaged in the Bachelor in Pharmaceutical Sciences and in the Master in Pharmacy, as well as in supervising numerous students in their Master and PhD theses.

Clinical Practice Research Datalink

The UK-based CPRD (www.cprd.com) is one of the largest and best-validated primary care databases for observational research in the world. It was established around 1987 and currently encompasses some 11.3 million people who are enrolled with selected general practitioners (GPs) in the UK, covering more than 79 million patient-years of follow-up. The patients enrolled in the CPRD are representative of the UK population with regard to age, sex, and ethnicity. GPs have been trained to record medical information including demographic data, medical diagnoses, hospitalizations, deaths and drug prescriptions using standard software and coding systems. The GPs generate prescriptions electronically; this information is automatically transcribed into the electronic medical record, including the name of the preparation, route of administration, dose, and number of tablets for each prescription. The recorded information on drug exposure and diagnoses has been validated and proven to be of high quality. The CPRD has been the source of numerous studies published in peer-reviewed journals over decades. All our study protocols require approval by ISAC, the Independent Scientific Advisory Committee for MHRA database research.

Drug safety

A major focus of our pharmacoepidemiologic research is the evaluation of drug safety. Pre-marketing randomized controlled trials (phase 3 studies) often provide limited information regarding rare and delayed adverse drug reactions, due to relatively small study populations and short follow up. Large automated databases allow following large groups of drug users over a long period to detect and quantify rare adverse drug reactions. This type of research takes place in the so-called "post-marketing study phase" or "Phase IV" after a drug has entered the market. We follow-up on interesting and timely safety issues and are currently conducting studies on a broad range of drugs, such as for example antidiabetic drugs, lipid-lowering agents, antidepressant drugs, analgesics, and cardiovascular drugs.

Disease epidemiology

Pharmacoepidemiology is also increasingly involved in the evaluation of drug safety during the early phases of drug development, before a medication enters the market. Whenever a drug is associated with certain safety issues in the early phases of development, or if its mechanism of action suggests that certain adverse reactions may occur later, it is also important to learn more about this disease in more detail (i.e. the indication for this drug). For example, if an immuno-modulating drug is being developed for rheumatoid arthritis and is expected to be linked to lymphoma in spontaneous reports once the drug is used by a large number of patients, it is important to quantify background rates of lymphomas in patients with rheumatoid arthritis before this drug is on the market. These background rates allow putting future spontaneous reports into perspective of how many new cases of lymphoma have to be expected in this group of patients, independent of the newly launched drug.