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[Pharmacovigilance in Germany : It is about time]
A Douros1, C Schaefer2,3, R Kreutz2
1Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Deutschland. antonios.douros@charite.de.
Der Internist
|May 27, 2016
Summary
Pharmacovigilance in Germany has stagnated due to a lack of publicly funded healthcare databases and restrictive laws. Addressing these issues is crucial for improving patient safety and medical care.
Area of Science:
- Pharmacovigilance and Drug Safety Research
- Health Informatics
- Public Health Policy
Background:
- Pharmacovigilance, crucial for detecting and preventing adverse drug reactions (ADRs), has seen recent stagnation in Germany.
- Despite a long history, the field faces challenges hindering its progress.
Purpose of the Study:
- To illustrate the various tools used in pharmacovigilance.
- To elucidate the specific reasons behind the observed stagnation of pharmacovigilance in Germany.
Main Methods:
- Analysis of spontaneous reporting systems for ADRs, highlighting their inherent weaknesses like underreporting and data quality issues.
- Examination of the development and utilization of electronic healthcare databases for pharmacovigilance, contrasting approaches in the US with the situation in Germany.
- Assessment of legal restrictions, specifically Section 75, Book 10 of the Code of Social Law, impacting the use of administrative healthcare data.
Main Results:
- Spontaneous reporting systems, while valuable, suffer from significant limitations.
- Germany lacks publicly funded large longitudinal healthcare databases, unlike the US.
- Legal restrictions severely limit the use of administrative healthcare data for pharmacovigilance research in Germany.
Conclusions:
- The absence of publicly funded longitudinal healthcare databases and necessary legal amendments will continue to impede pharmacovigilance research in Germany.
- This stagnation poses a risk to the quality of medical care for the general population.
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