Praktische Konsequenzen aus Spontanmeldungen von Nebenwirkungen

In addition to the pharmaceutical company, users, doctors, pharmacists, patients and their relatives are also asked to report suspected potential side effects to the competent authorities. It is not so much the obligation to report as the assistance in the safe use of medicines that should motivate the medical profession to report possible side effects.

Reports of potential side effects by the medical profession to the Drug Commission of the German Medical Association (AkdÄ) are processed and analyzed to demonstrate whether they result in new safety risks that have been assessed by the federal authorities (BfArM and PEI) or the EU (assessment of the PRAC). The resulting changes in the approval of medicines that are important for children and adolescents are compiled.

Dimenhydrinate and diphenhydramine must not be given in the case of fever or gastroenteritis. The indications for children under 3 years of age must be strictly defined and the maximum dose is 5 mg/kg body weight per day. Enemas containing phosphates may only be given to children aged 12 years and over and also applies to codeine. Metoclopramide can only be prescribed for chemotherapy and postoperatively as second line. Doxylamine is now a prescription-only drug for children and adolescents.

The change in approval as a result of spontaneous reports of possible side effects and scientific case reports is an important contribution to drug safety in children. This information in the regulation must be made known to the medical profession and has to be implemented.