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.

Over a period of 3 years, the European Union’s Innovative Medicines Initiative WEB-RADR project has explored the value of social media (i.e., information exchanged through the internet, typically via online social networks) for identifying adverse events as well as for safety signal detection. Many patients and clinicians have taken to social media to discuss their positive and negative experiences of medications, creating a source of publicly available information that has the potential to provide insights into medicinal product safety concerns. The WEB-RADR project has developed a collaborative English language workspace for visualising and analysing social media data for a number of medicinal products. Further, novel text and data mining methods for social media analysis have been developed and evaluated. From this original research, several recommendations are presented with supporting rationale and consideration of the limitations. Recommendations for further research that extend beyond the scope of the current project are also presented.

Over a period of 3 years, the European Union’s Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper. There is a presumption amongst at least some patients and healthcare professionals that information ought to be accessed and reported from any setting, including mobile apps. WEB-RADR has focused on the use of such technology for reporting suspected adverse drug reactions and for broadcasting safety information to its users, i.e. two-way risk communication. Three apps were developed and publicly launched within Europe as part of the WEB-RADR project and subsequently assessed by a range of stakeholders to determine their value as effective tools for improving patient safety; a fourth generic app was later piloted in two African countries. The recommendations from the development and evaluation of the European apps are presented here with supporting considerations, rationales and caveats as well as suggested areas for further research.

IntroductionMedication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors.ObjectiveThis study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002–2015 before the release of EU good practice guidance.MethodsCase reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA®) term is reported and included in the Standardised MedDRA® Query (SMQ) for medication errors. These case reports were further categorised by MedDRA® terms, geographical region, patient age group and Anatomical Therapeutic Chemical classification system of suspect medicinal product(s).ResultsA total of 147,824 case reports were retrieved, 41,355 of which were from the European Economic Area (EEA). Approximately 60% of these case reports were retrieved with the narrow SMQ. The absolute number of medication error case reports and the proportion to the total number of reports in EudraVigilance increased during the study period, with peaks seen around 2005 and 2012 for cases with EEA origin. Fifty-two percent of case reports in which age was provided occurred in adults, 30% in the elderly and 18% in children, with almost half of these in children aged 2 months to 2 years.ConclusionCase reports of medication errors in EudraVigilance steadily increased between 2005 and 2015, the reasons for which may be multifactorial, including increased awareness, changes to the MedDRA® terminology and the 2012 EU pharmacovigilance legislation and associated guidance for stakeholders, or a generally increased risk for errors as more medications become available.

IntroductionSpontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form.ObjectiveThe objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.MethodsThe app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis.ResultsHigher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78–85%, reference: 78–98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled.ConclusionThe WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0679-6) contains supplementary material, which is available to authorized users.