In Reply

The Safety of Drug Therapy in Children by Stefan Wimmer, PD Dr. rer. nat. Antje Neubert, and Prof. Dr. med. Dr. h.c. Wolfgang Rascher in issue 46/2015

The general statement, about the importance of developing awareness for reporting possible adverse drug reactions is valid. However, the cited sources documenting the low reporting rate of vaccine adverse events (which are not from Germany) are more than 25 years old (1), a time before the introduction of statutory reporting about any adverse effects potentially resulting from vaccinations. The most recent reports and reporting rates for suspected vaccine adverse effects were unfortunately not cited (2, 3). These works show that the reporting rate has risen gradually since 2001, when legally mandatory reporting of suspected adverse effects or vaccination complications was introduced (2). In 2013, the Paul-Ehrlich-Institute reported 3299 suspected cases, with 12 278 adverse reactions (3). No other drug class has such a high rate of physicians reporting as do vaccines, allowing us to conclude that the legal reporting requirement contributes to vaccine safety. Unfortunately, physicians rarely report adverse events for other drugs. These spontaneous reports however are essential for allowing early detection of new signs of risk.

DOI: 10.3238/arztebl.2016.0364b

Prof. Dr. med. Dr. h.c. Wolfgang Rascher

Kinder- und Jugendklinik,
Friedrich-Alexander-Universität-Erlangen-Nürnberg

Conflict of interest statement

Prof Rascher has received funding (third party funding) for commissioned clinical studies and for running an infectious disease epidemiological
GLP laboratory by Pfizer Vaccines Research, US, and study funding (third party funding) from Novartis Pharma and Vertex Pharmaceuticals.
He was involved as principal investigator in clinical studies sponsored by the companies Alexion, Novartis, and Shire.

References

1. Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al.: Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA 1990; 263: 1785–8

2. Weißer K, Meyer C, Petzold D, Mentzer D, Keller-Stanislawski B: Verdachtsfälle von Komplikationen nach dem Infektionsschutzgesetz und Verdachtsfälle von Nebenwirkungen (von Impfstoffen) nach dem Arzneimittelgesetz vom 1.1.2004 bis zum 31.12.2005. Bundesgesundheitsbl Gesundheitforsch Gesundheitsschutz 2007; 50: 1404–17

3. Mentzer D, Stanislawski B: Daten zur Pharmakovigilanz von Impfstoffen aus dem Jahr 2013. Bulletin zur Arzneimittelsicherheit 2015; 1: 12–20.

4. Wimmer S, Neubert A, Rascher W: The safety of drug therapy in children. Dtsch Arztebl Int 2015; 112: 781–7