Masterarbeit

Medication errors - new challenges for pharmaceutical industry, authorities and health care professionals including the guides "EMA/762563/2014" and "EMA/606103/2014" and selected drug therapy safety projects ***

Barbara Wiglinghoff (2017)

Summary
Medication errors are a burden for the individual who may experience harm but also for the public health system that bears the arsing costs for the possible consequences of the errors. Medication errors may occur during the whole drug treatment process and affect patients, HCPs (especially physicians, pharmacists and caregivers), pharmaceutical companies, competent authorities, patient safety organisation and the health insurance system. Taking into account that medication errors are considered preventable, the burden can be reduced. By the new EU pharmacovigilance legislation from 2010 which came into force in 2012, the awareness for medication errors has been increased remarkably among the different stakeholders. The extension of the definition of ADRs led to the requirement that ADRs caused by medication errors have become reportable ICSRs. From a regulatory point of view, especially the good practice guide on medication errors (i.e. the "Good practice guide on recording, coding, reporting and assessment of medication errors" and the "Good practice guide on risk minimisation and prevention of medication errors") coming into effect in November 2015, provides substantial recommendations for regulators and pharmaceutical companies for the processing and prevention of medication errors.
But also projects of HCPs and patient organisations support the improvement of drug therapy safety and thus the reduction of medication errors.
The collaboration of the different stakeholders is essential for the primary aim – the prevention of medication errors. The foundations have been laid; future investigation must confirm the effectiveness of the implemented measures and projects.
Pages: 101; Annexes: pages: 17