OBJECTIVES To explore the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database (which is maintained by the Food and Drug Administration and has a mandatory reporting requirement) for systemic analysis of cochlear implant complications and treatments and, in so doing, analyze trends in cochlear implant complications for 2 periods, 2002 and pre-1998. DATA SO...

Observed-to-expected (OE) analyses, together with data mining algorithms1–7 and pharmacoepidemiological studies,8 are part of the quantitative pharmacovigilance toolkit for vaccines. While data mining algorithms generate hypotheses about potential safety concerns and pharmacoepidemiological studies test specific hypotheses or measure associations, OE analyses stand in between. The role of OE an...

BACKGROUND Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limita...

critical thinking is necessary to read the scientific literature. however, in addition to questions about the science, often one must also question the meaning of the text. this article provides an example of the analyses needed to understand a single sentence. in so doing, it raises several interesting issues of meaning, measurement, statistical analyses, and the form in which results are pres...

INTRODUCTION In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pha...

We implemented an automated vaccine adverse event surveillance and reporting system based in an ambulatory electronic medical record to improve underreporting and incomplete reporting that prevails in spontaneous systems. This automated system flags potential vaccine adverse events for the clinician when a diagnosis is entered, prompts clinicians to consider the vaccine as a cause of the condit...

Spontaneous reporting of ADRs enhances detection of serious, unexpected and unusual ADRs. Healthcare professionals play an integral role in the success of safety surveillance of drugs. This study aimed to investigate knowledge, practice and factors affecting ADR reporting among clinicians. Cross sectional study was carried out among clinicians of a tertiary care centre irrespective of their gen...

A web-based survey was conducted by the Federation of Veterinarians of Europe with the support of the European Medicines Agency to gain a better insight into the adverse event reporting habits of veterinary practitioners and the level of information on reported adverse events that flows back to them. It was completed by 3545 veterinarians. The findings indicate marked under-reporting and that t...

BACKGROUND Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, with many being identified post-marketing. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. OBJECTIVES To evaluate methods to improve ADR reporting via a systematic literature review. METHODS Data sour...

Background: Spontaneous reporting is an important tool in pharmacovigilance. Underreporting of adverse drug reactions (ADRs) is a common problem. In order to improve the ADR reporting, it is essential to improve the knowledge, attitude and practice (KAP) of the healthcare professionals. Various factors are related with the KAP of under reporting of ADR. Objectives: The present study was underta...