gms | German Medical Science

Background: The new extended definition of ‘adverse reaction’ according to the revision of the pharmaceutical legislation in 2012 explicitly includes noxious and unintended effects resulting from medication errors. The 2010 pharmacovigilance legislation provides the legal basis for the recording, reporting and assessment of suspected adverse reactions (serious and non-serious) associated with an error in the prescribing, dispensing, preparation, administration or monitoring of a medicinal product.

Proposals for definition of ”medication errors” are given by several authors; EU-Guidance as provided in GVP (Good Vigilance Practice) Module VI provides the definition currently in use for regulatory purposes. For drug safety purposes it is important to focus also on “potential medication errors” that have not yet led to clinical consequences but have the potential for their occurrence at every time.

Aims of the AMTS: The task of the group AMTS in BfArM is to collect information on the risks of medication errors as regards patients’ or public health. Usually such information is received from professional organisations, health care professionals or patients and their relatives. The submitted reports are assessed and if there is any change to a medicine’s risk-benefit balance the group consider prevention measures for risk minimisation by taking regulatory action concerning the marketing authorisation as necessary.

Materials and Methods: Statistical investigations show that dosing and administration errors are the most of all Adverse Drug Reactions (ADRs) associated medication errors. Three examples of prevented medication errors (so called near misses) demonstrate also that dosing errors of psychotropic drugs caused by inadequately administration are in fact the most frequent cases of all such reported events.

Conclusion: Reports of so called near misses are informative and may lead to a clear relationship between causes of a medication error and clinical consequences. Therefore preventive regulatory measures can be taken if there a need of modification or amendment of the product information emerges. Examples for preventive measures are the implementation of dosing tables, changing of brand names or restrictions of package sizes as outlined in the presentation.