Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention

Abstract

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article describes the key concepts of the EU good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors. This guidance should contribute to the safe and effective use of medicines for the benefit of patients and public health.

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

“…The primary goal of efforts to increase communication about drug-related problems is to facilitate medication error reporting and subsequently learn from those errors in order to contribute to the safe and effective use of medicines for the benefit of patients and public health 27.…”

Good practice guidance to support safe oral medication preparation and administration through feeding tubes

“…After implementation of system improvements, there was reduction of nonconformities to 70%, especially regarding the crushing of enteric coated pills. They also found that, after utilizing the good practice Thus, it was observed that recommendations of the guide contributed to improvements in the care practice of elderly patients (Goedecke et al, 2016) (Bourdenet et al, 2015).…”

“…It also includes the reduction and mitigation of unsafe acts within the healthcare system, as well as the use of good practices to achieve optimal outcomes for patients. In this context, it is fundamental to standardize the techniques of drug preparation and administration feeding tube through good practice guidance (Goedecke et al, 2016).…”

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

“…The high rate of products with ME safety concerns in this period may be due to several reasons. First, this high rate of products may reflect a high awareness of the seriousness and importance of MEs and the need to minimise these risks [5,6]. In recent years, several actions have been taken by the EMA to increase awareness of MEs and to provide tools to reduce the risk of MEs, e.g.…”

“…For example, if reconstitution and preparation of the final product are complicated and pose challenges already in the strictly controlled environment of the clinical trial, the pharmaceutical company should improve product preparation, whenever feasible, because the risk in daily practice might be even larger. In 2015, the European Medicines Agency (EMA) released guidance describing common areas of risks to be considered by industry and regulators before authorisation [5,6]. It is highlighted here that the focus regarding MEs should not only be on withinproduct risks but also between-product risks, such as name similarity with already licensed products.…”