Signal Analysis of Pre- and Post- Market Adverse Event Databases: An Overview
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 Dated :
4th April 2012
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An objective and reiterative benefit-risk assessment approach is required to adequately balance the benefit of using a product and its associated and acceptable risks. Acceptable risks should ideally be preventable risks where possible, or at least minimal or manageable risks. Defining the safety profile of a drug or biologics product is based on current and new emerging patterns or on changes in old patterns usually deciphered from adverse event (AE) databases or other sources. Adverse drug reaction (ADR)/AE signal detection and evaluation, a process we refer to in this paper as “Signal analysis” is an important process that includes the traditional medical review approach used to identify and evaluate signals and define the initial safety profile of a drug or biologics product and its continued reassessment. |
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Changing EU Legistation: Mandatory e-Reporting
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 Dated :
28th Feb 2012
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To enhance patient safety and increase transparency, significant changes are being introduced to pharmacovigilance and regulatory affairs business practices. The new EU pharmacovigilance legislation constitutes one of the largest changes in European Drug law since 1995. Consequently, Marketing Authorization Holders (MAHs) that market human medicinal products in the European Union, whether on a centralized, decentralized, mutual recognition or national level, are obliged to provide detailed and structured data to the EudraVigilance Medicinal Product Dictionary (EVMPD) by a new standard. This standard, the Extended EudraVigilance Product Report Message (XEVPRM), must be adopted by July 02, 2012 at the latest. |
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Quantitative Signal Detection within the FDA FOI AERS Database
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Dated :
6th Feb 2012
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Current regulations require that pharmaceutical companies receive, evaluate, and follow up on all safety reports for a marketed drug product. Regulatory agencies and Market Authorization Holders receive and process such safety reports in a post-market safety database, the Adverse Event Reporting System. Regulatory Agencies and Marketing Authorization Holders evaluate adverse events reported in the safety reports for their seriousness, causality and toxicity-related issues, as well as the risk-benefit ratio for the specific population indicated in the drug label. Along with other safety parameters, the nature (usually seriousness) and frequency of the adverse event and how a drug compares with the treatment alternatives are factored into the overall benefit-risk analysis of the drug to determine if a drug is safe enough to remain on the market. This process of safety evaluation is generally executed by country regulatory authorities, guided by detailed and documented internal procedures that they must and do follow. This paper focuses on one of the processes encompassed by the benefit-risk analysis: quantitative signal screening. Specifically, it concentrates on the application of a data mining method, Multi-item Gamma Poison Shrinker (MGPS) in a spontaneous database.
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Developing a Comprehensive Literature Search and Review Process |
Dated :
19th July 2011
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A Marketing Authorization Holder (MAH) must comply with current pharmacovigilance (PV) regulations to ensure appropriate monitoring, collection, processing and evaluation of adverse events in a validated safety database. Literature is one of the sources of post-marketing events and every MAH is required to screen the worldwide scientific literature on a regular basis to identify new, unlabelled, unlisted events by accessing widely used systematic literature review publications or reference databases.
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Visualization-based Signaling Screening Analysis: The Importance of Trends Analysis in Signal Screening of Spontaneous Data
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Dated :
30th April 2011 |
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A visualization-based screening analysis is a form of qualitative signaling analysis that involves use of descriptive algorithms to perform detailed review of data such as spontaneous data. The objective of a typical visualization-based screening analysis of spontaneous data is to detect new safety patterns within a specific dataset that pertain to a drug product. Ultimately, the goal is to generate data-driven scientific hypothesis for further signal evaluation of a reported adverse event.
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Designing an Effective and Efficient Workflow in a Safety Database: A High Level Perspective |
Dated :
30th November 2010 |
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It is a constant struggle for companies to streamline the processing of numerous safety reports that come in regularly, sometimes in unpredictable numbers. For this reason, companies rely on validated safety databases (e.g. ARISg) that comply with regulatory requirements of multiple Health Authorities that have varied timelines for submission of different categories of cases depending on the seriousness and listedness of events. In the document that follows, we will present a high level perspective of how to configure an effective and efficient workflow in a safety database.
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An Efficient and effective Approach to Case Processing of a Safety Report : From a Team Lead Perspectve |
Dated : 15th November 2010 |
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Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.1 The drugs, either undergoing clinical trials or being marketed, are monitored for their safety and efficacy throughout the drugs’ development life cycle. This ensures that Regulatory Authorities approve only safe and efficacious drugs for use and helps the long term marketing success of such drugs. In addition, based on safety data obtained from routine or vigilant PV, patients are provided important safety information about an approved drug to help them make an informed decision while taking a drug and also to be vigilant about known and potential adverse drug reactions.
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Use of a Visualization Tool to Facilitate Medical Review and Evaluation of Spontaneous Data
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Dated : 26th October 2010 |
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Medical review is a critical core of signal screening, a process that may be referred to as signal detection and evaluation. To facilitate medical review of aggregate data and ensure easier and faster signal screening of data, a visualization application may be integrated with a validated safety database, signal application or safety data warehouse from where the datasets will be obtained for analysis. Use of visualization methods is not meant to replace but ease traditional qualitative medical review of Individual Case Safety Report (ICSRs), data listings, (line listings), aggregate data, as well as data from other relevant sources. The focus of this Pharmacovigilance (PV) Quick Reference Note (QRN) is to present the use of a visualization tool , TIBCO Spotfire® to faciliate medical review and evaluation of spontaneous data as a part of routine signal screening of such data.
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