RISKBASE – Analysis of adverse drug reactions

Drug interactions can be divided into pharmacokinetic interactions, leading to a change of the exposure of one or several of the drugs involved, and pharmacodynamic interactions, involving a change of the effects of the drug at the receptor, target organ or, as adverse effects on other physiological systems. The drug interaction warning system INXBASE, based on individual drug pairs, is not suitable for creating warnings against all possible pharmacodynamic interactions, as this information would create a significant amount of over-alerting, when integrated to electronic health record systems. RISKBASE is a complementary database to INXBASE presenting a risk profile of patient’s medication based on pharmacodynamic properties (comprehensive medication review). RISKBASE contains over 13000 evaluations of the risk profile of about 1500 drugs with regard to 9 clinically relevant adverse effects:

  • Anticholinergic effect
  • Constipation
  • Sedation
  • Orthostatism
  • Risk of bleeding
  • Serotonergic effect
  • Risk of seizures
  • QT-prolongation
  • Renal toxicity

Each adverse effect has been rated with the scale from 0 to 3 (except from specific organ toxicity such as renal toxicity which receives only score 0/1). Each adverse effect is defined by an algorithm indicating how the different drugs in patient’s drug list are handled – e.g. as sum of scores (anticholinergic effect) or maximum value (risk of seizures). The warnings are triggered based on adverse effect –specific threshold levels. Accordingly, the scores can give different type of warnings and the figures among the different adverse effects are NOT comparable with each other. For each adverse effect a standard, but severity-specific phrase for consequence and recommendation is given. RISKBASE is suitable for portal solutions e.g. in the same user interface with INXBASE or integrated to electronic health record systems or CDSS to produce comprehensive medication reviews with other Medbase databases.

All this information is offered in the XML-export file of RISKBASE. RISKBASE is quarterly updated (weeks 11, 24, 38 and 50).