Reporting Adverse Events - Expert Analysis of Recent Trends
28 September 2006, NetworkPharma Ltd, Oxford, UK have published the latest in their KeywordPharma series of brand new Conference Insights reports, intended for individuals working in and around the global pharmaceutical industry.
Reporting Adverse Events: In-depth report from the SMi conference, London, 24-25 April 2006, written by Dr Richard Wyse, is now available for purchase.
These are challenging times for drug safety professionals. Much is to be done within the profession to gain and maintain public trust by improving drug safety, pharmacovigilance and risk management practices. In the USA, drug-related adverse reactions (ADRs) result in an estimated 100,000 deaths per year, and up to 5% of all hospitalisations involve some of the most widely prescribed drugs. Less than 10% of ADRs are currently reported back to the manufacturer or the regulatory authorities.
Mandatory legislation changes have altered the landscape on both sides of the Atlantic. Product safety is a key element, and the clinical trial process is now more highly regulated. These changes cover applications to ethics committees, clinical trial study monitoring, adverse event reporting during trials, clinical practice audits and inspections, and preparing for marketing authorisation of products. The European Union (EU) Clinical Trials Directive has had a great impact on post-marketing surveillance. It introduced two new terms to the pharmacovigilance vocabulary: SUSAR (a suspected unexpected serious adverse reaction) and SAR (a serious adverse reaction). The pharmacovigilance requirements of the Food and Drug Administration are also evolving, especially in the areas of electronic submissions, pre-marketing safety assessment plans and risk management.
The SMi Reporting Adverse Events conference discussed various tactical and transactional aspects of safety, providing an overview of strategic aspects of risk assessment and risk management. This Conference Insights review provides analysis of the most salient issues raised in selected presentations at the event. These included electronic reporting, signal detection, high-profile drug withdrawals, drug risk-benefit assessments, the implementation of risk management and a glimpse into future developments.
Industry professionals are currently being forced to react to changing regulatory requirements, internal company integration and public/political pressures. This report highlights how the industry is addressing these evolving needs. It concludes that drug safety groups should play a more prominent role not only in the procedures mentioned above but also in strategic aspects of risk-benefi t optimisation.
The author, Dr Richard Wyse, said: "The conference highlighted recent improvements in the use and availability of safety data for both physicians and consumers, which will mean that avoidable adverse drug reactions can be greatly reduced by providing the right drug safety information to doctors and patients, in the right context, at the right time."
All KeywordPharma publications can be purchased from ThePharmYard at www.ThePharmYard.com
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About the author
Formerly senior lecturer in paediatric cardiology at Great Ormond Street Hospital in London, Dr Richard Wyse now has joint commercial and academic careers. He is the author of over 100 medical and scientific papers, and pharmaceutical industry articles in journals. He has also written four industry books, and several independent evidence-based medicine reports in various therapeutic areas. Commercially, he has worked for a CRO as Director of European Health Economics, and as Medical Director for a US pharmaceutical IT company, and a medical device company. He has been involved in a wide variety of industry clinical trials and several other areas of drug development for many years. Academically, he is currently a visiting professor in Saudi Arabia and President-Elect of the Division of Genetics at the Royal Society of Medicine. He is on the editorial board of several journals.
Richard has spoken at many academic and international pharmaceutical and medical device conferences, and has chaired 25 of them. Notably, he was global chairman of a major cardiac patient database initiative that involved 2700 hospitals worldwide, speaking at national conferences in a large number of first- and third-world countries. In this capacity he reported a landmark paper on risk prediction and outcomes in more than 600,000 US patients.
Written by pharmaceutical industry specialists, KeywordPharma publications are designed to be authoritative, relevant, succinct and helpful to pharmaceutical industry executives in their day-to-day work and in their longer term career development. Available to purchase individually as e-documents, they build into a specialist knowledge library for everyone working in and around the global pharmaceutical industry.
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NetworkPharma Ltd is an independent, specialist company founded by Peter Llewellyn, to focus on novel approaches to disseminating information within the global medical and pharmaceutical industries. Peter Llewellyn previously founded and built the leading industry portal site, InPharm, which was subsequently purchased by John Wiley & Sons to manage alongside their other industry services, PharmaFile and Pharmafocus.
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