Study identification

PURI

https://redirect.ema.europa.eu/resource/47999

EU PAS number

EUPAS36582

Study ID

47999

Official title and acronym

Overarching Use Case of the German Medical Informatics Initiative MII “POLAR_MI – POLypharmacy, Drug interActions, Risks”

DARWIN EU® study

No

Study countries

Germany

Study description

POLAR uses methods and processes of the German Medical Informatics Initiative (MII) to contribute to the detection of medication related health risks, particularly of polypharmacy in elderly patients with multimorbidity. This is often associated with an increased risk for medication errors and drug-drug or drug-disease interactions, which either reduce or intensify the desired effect of individual active substances or lead to undesired adverse drug effects (ADE). In the light of the aging population, potentially inappropriate medications (PIM), which should be avoided in patients due to an unfavorable risk/benefit-ratio, represent a risk factor. Thus, POLAR focusses on the detection and prevention of medication-related problems in an interdisciplinary approach that creates a health IT infrastructure capable of supporting IT-based medication therapy safety across all four MII health-IT consortia. POLAR therefore involves experts from medical informatics, biometry, epidemiology, pharmacy, pharmacology and health care research from 21 institutions. In POLAR we will: 1. develop and use methods to collect retrospectively available patient related data on prescribed drugs from the hospital information systems of 13 university hospitals via their MII-infrastructures (data integration centres). 2. provide and deploy a set of algorithms, which are able to classify a selected range of medications as "high risk prescriptions”. 3. provide scoring systems to identify patients at high-risk for relevant drug-related problems. 4. identify and quantify the occurrence of major medication-related problems including PIM and contraindicated medications, frequent ADE and ADE-associated out-comes (e.g. new diagnoses, healthcare utilization, readmission, mortality). Special subprojects focus on (a) record linkage regarding 1-year mortality, and medication use and ADE in outpatient care, respectively, and (b) a text corpus for natural language processing with regard to ADE

Study status

Ongoing
Research institutions and networks

Institutions

Leipzig (University, University hospital) Jena (University, University hospital), Aachen (RWTH University, University hospital) University Hospital Hamburg-Eppendorf, Bonn (Rheinische Friedrich Wilhelms University, University hospital) University Hospital Halle, University Hospital Tübingen University Hospital LMU München, University Hospital Kiel University Hospital Heidelberg, University Hospital Gießen University Hospital Freiburg, F. Alexander University Erlangen-Nürnberg University Hospital Erlangen, University Medicine Mannheim Witten/Herdecke University

Networks

German Medical Informatics Initiative (MII)

Contact details

Markus Löffler

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Actual:

Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Other

More details on funding

Federal Ministry of Education and Research
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable