title: [Improvement of medication safety by identification of genetically predisposed subjects. Personalized clinical strategies and regulatory advices].
abstract: BACKGROUND
  Because adverse drug events (ADEs) have a high socio-economic impact there is an urgent need for effective prevention. In addition to process-related avoidable errors personalised approaches for the prevention of ADEs should also focus on genetic polymorphisms as potential causative agents.
  
  
  OBJECTIVE
  Using five case reports as examples therapeutic modalities are described to illustrate the clinical impact of prospective testing aimed at estimating the individual risk of susceptible subjects.
  
  
  METHODS
  The role of the HLA system, the cytochrome P450 family, other metabolic enzymes and transport proteins are described to illustrate the broad range of genetic susceptibility. It is shown, why, when and for whom pretherapeutic tests on genetic polymorphisms are recommended to reduce the risk of ADEs.
  
  
  RESULTS
  The determination of genetic susceptibility is already implemented in clinical practice prior to (1) carbamazepine therapy in south-east Asians and (2) treatment with abacavir independent of ethnicity. Before prescribing carbamazepine or abacavir, it is recommended that therapeutic decisions be based on these test results.
  
  
  CONCLUSIONS
  The broad application of personalised medicine used as an effective tool for minimizing ADE risks is limited by the evidence-based benefit for the patient on the one hand and the costs of the test on the other hand.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: Lux
authors.forename: S
authors.initials: S
authors.lastname: Wärntges
authors.forename: S
authors.initials: S
authors.lastname: Bergner
authors.forename: B
authors.initials: B
authors.lastname: Kütting
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000235:genetics* / Q000517:prevention & control*; D019317:Evidence-Based Medicine; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D010597:Pharmacogenetics / Q000592:standards*; D057285:Precision Medicine / Q000592:standards*