International Journal of Risk & Safety in Medicine - Volume 17, issue 1-2

Authors: Lisman, John A. | Lekkerkerker, J. Frits F.

Article Type: Research Article

Abstract: This article gives an overview of the development of the European regulatory system. In 1965 the First Directive on medicinal products was adopted. In 2005 a total revision of the system will come into force. How effective the European Union legislation and regulatory system has been and why has the focus of regulation changed over the years? A famous philosopher said that to know the future, the past has to be explored. From the history of EU pharmaceutical legislation it becomes clear why the law has become as it is.

Citation: International Journal of Risk and Safety in Medicine, vol. 17, no. 1-2, pp. 73-79, 2005

Authors: Hider, Phil | Lay-Yee, Roy | Davis, Peter | Briant, Robin | Scott, Alastair

Article Type: Research Article

Abstract: Aim: To describe the prevalence, characteristics and impact of community-based adverse events severe enough to warrant hospital admission in New Zealand, to compare them to in-hospital adverse events (AEs) and to consider their potential as a tool to monitor the quality of primary care. Methods: Two-stage retrospective review of 6579 medical records, selected by systematic list sample from admissions for 1998 in 13 generalist hospitals providing acute care. After initial screening, medical records were reviewed by trained medical practitioners using a standardised protocol. Results: Approximately 2.5% of all admissions (12,800 hospitalisations in 1998) to public hospitals in New Zealand may …be associated with community-based adverse events. Nearly 20% of all AEs occurred in the community most often in a doctor's office, patient home, or rest home. Patients who sustained a community-based AE were usually elderly, and most frequently related to medications. System issues were important for both inpatient and community-based AEs. AEs regardless of location were most frequently related to the musculoskeletal system. Conclusions: Community-based AEs are a significant public health and hospital workload issue in New Zealand and other Western countries. Urgent attention needs to be directed at developing systems to identify their presence and monitor the effect of interventions to prevent their occurrence. Hospital-based information systems can generate useful data about AEs in the community and can provide an important review of primary care prescribing. Compared to in-hospital events, community-based AEs were most often related to medications, and were more frequently preventable. Show more

Keywords: Primary care, adverse events

Citation: International Journal of Risk and Safety in Medicine, vol. 17, no. 1-2, pp. 81-89, 2005

Article Type: Other

Citation: International Journal of Risk and Safety in Medicine, vol. 17, no. 1-2, pp. 91-92, 2005