PHARMACOVIGILANCE FOR PRACTICAL BEGINNERS

A Practical Guide on Pharmacovigilance for BeginnersFirst EditionAPRACTICALGUIDE ONPHARMACOVIGILANCE FORBEGINNERSDR.S.GUNASAKARAN, MBBS, MDR.SATHEESH KUMAR, M.PHARM

A Practical Guide on Pharmacovigilance for BeginnersA Practical Guide on Pharmacovigilance for BeginnersFirst Edition, 2010Copyright Gunasakaran & Satheesh kumar, 2010.All rights reserved. No part of this publication may be reproduced ordistributed in any form or by any means (electronic, mechanical,photocopying, recording or otherwise), or stored in a database or retrievalsystem, without the written permission from the authors.The authors have made a conscientious effort to ensure that theinformation contained in this book is accurate and in accordance withthe accepted standards at the time of publication. However, in thisrapidly changing world guidelines and practices are subject to changewithout prior notification, therefore readers are advised to confirm theseas and when required.Rs. 350 (INR)Printed in IndiaPrinted at:Taramani Magalir Co-operative Press,Royapettah,Chennai,Tamilnadu, India.

A Practical Guide on Pharmacovigilance for BeginnersPREFACEThe Authors are pleased to present the First edition of “A PracticalGuide on Pharmacovigilance for Beginners”. This book is sketched toprovide a concise introduction along with practical applications ofpharmacovigilance that medical students, post graduates inpharmacology, pharmacy students and life science graduates canimpart during their academics as well as during their industrialexposures. This book is expected to provide basic knowledge about thedifferent aspects concerning adverse event reporting and will be an eyeopener for beginners who step into the field of pharmacovigilance.This book details the global and domestic aspects ofpharmacovigilance, various drug regulatory bodies guidelinesgoverning the pharmacovigilance, and different reporting systemsprevailing among various regulatory agencies along with detaileddescription of the standard terminologies used in the field ofpharmacovigilance. It also covers interesting case scenarios to ignitethe minds of bibliomaniacs – the future critiques of this book.Each chapter is thoughtfully developed to help the reader understandthe fundamentals of pharmacovigilance. We are greatly honor-bound toour colleagues who showed interests, encouragement & enthusiasm bydevoting their precious time in shape the dream into reality.Further suggestions, criticisms and elucidation are always welcomefrom the students and readers, which may be addressed to theauthor’s desk atDr.S.Gunasakaran, MBBS, MDPh : 91 98413 12609Email : drgunasakaran@gmail.com(Or)Mr. Satheesh kumar, M.PharmPh : 91 94431 60516Email : satheesh r2001@yahoo.com

A Practical Guide on Pharmacovigilance for BeginnersAUTHOR’S tigiousMadrasMedical College and with a couple of yearsexperience in the Pharmacovigilance field, Ihave desired to pen down my nce to the beginners. Thoughseveral books are available in the meadow ofpharmacovigilance, I tried to define this bookwith much versatility and significance.Every person who reads would get their feet wet and definitely persuadein the field of Pharmacovigilance. The book is concise, influencing thebeginners to understand the concept meticulously.This book intends to motivate the students for exploring the depth of thisfield by answering the ample case studies which will give basic insights toassess an adverse event and mode of reporting to the regulatory agencies.The supporting concept of this book is that, it provides answers to allexercise based questions and case scenarios.My contribution may be a drop to the ocean of pharmacovigilance but theentire journey of collecting knowledge to exhibit this book flooded me withan ocean of knowledge and clarity about Pharmacovigilance.The students and professionals who are yet to step into the industrialendeavors may not sense the feel of aliens and may outburst theignorance in the course of reading this book.The major objective of writing this book is to present the basic informationabout pharmacovigilance in a lucid, coherent, condensed and consistentform to furnish the innovative minds of graduates and post graduates ofpharmacy, life sciences and medical fields.

A Practical Guide on Pharmacovigilance for BeginnersAUTHOR’S DESKFrom the knowledge acquired through my Mastersin Pharmacy from the esteemed AnnamalaiUniversity and with my experience in the field ofPharmacovigilance, I preferred to share myknowledge in the field of Pharmacovigilance to theyoung scientists who would like to establish theircareer in Pharmacovigilance.Though several resources are available to gainknowledge in Pharmacovigilance, I felt that therewas a space left between the beginners and theresources available. This thought provoked me to author a book whichwould be a big boon for the beginners.This book contains the fundamentals of Pharmacovigilance, guidance toaccess the essential resources and exercises to provide hands onexperience on various aspects of Pharmacovigilance.This way I would like to differentiate this book “Practical Guide onPharmacovigilance for Beginners” from the other resources available. Aperson who grazes through the book would develop an idea of establishinghis / her career in the field of Pharmacovigilance.This book helps the beginnersPharmacovigilance scrupulously.tounderstandtheconceptsofThe passion for persuading in the Pharmacovigilance field for students willincrease as they go through the various case studies dealing from thebasic concepts of Pharmacovigilance through assessment and reporting ofadverse events to various regulatory authorities This process is madeeasy by providing answers to all exercise based questions.

A Practical Guide on Pharmacovigilance for BeginnersACKNOWLEDGEMENTSIt is with great pleasure, we record our deep respects, gratitude andindebtedness to Dr. Vikas soni, MD, Orchid Chemicals andPharmaceuticals, for his remarkable guidance, encouragement andselfless support which enabled us to pursue the work withperseverance and a skillful mind to view and analyze things. Hiscontagious enthusiasm was a source of energy to us in successfullycompleting this book under this generous guidance.We wish to express our sincere and heartful thanks to Mr.Ragavendra Rao, Managing Director, Orchid Chemicals andPharmaceuticals and Dr. C.B.Rao, Deputy Managing Director, OrchidChemicals and Pharmaceuticals for their untiring support,continuous suggestions and enduring encouragement in writing thisbook.We extend our sincere thanks and gratitude to our contributoryauthor Dr. Praveena Pearl, MD for her contribution in writing thechapter “Global perspective of Pharmacovigilance“.Our wholehearted thanks and gratitude to Dr. Abdul Hameed Khan,Mr. Srinivasa Reddy, Mrs. Narmadha Vijayaraja, Ms. Veena and Dr.Mohammad Shahid for their encouragement and continuous help inbringing out this book.We also extend our sincere thanks to our family members(Mrs.Radha Sambandan, Er.Inbasakaran, BE, ME, Mrs.PriyadarsiniInbasakaran, Mrs. Sakthi Satheesh & Ms. Deeksha) and our friendsfor their appropriate suggestions, moral support and timelyadjustments in bringing out this book.We also extend our personal thanks and gratefulness to all professorsand directors who enlightened us during our graduation and postgraduation studies.

A Practical Guide on Pharmacovigilance for BeginnersContentsPage no1. Standard Terms & Definitions inPharmacovigilance . 32. Global perspective of Pharmacovigilance . 213. Domestic perspective of Pharmacovigilance . 294. Guidelines and laws governing Pharmacovigilance . 415. Global Adverse Event Reporting systems andReporting forms 596. Individual Case Safety Reports . 1157. Periodic Safety Update Reports . 2618. Answers for Case studies 2679. Answers for Exercise based Questions . 272

A Practical Guide on Pharmacovigilance for BeginnersCHAPTER 1

A Practical Guide on Pharmacovigilance for BeginnersCHAPTER 1STANDARD TERMS AND DEFINITIONS INPHARMACOVIGILANCEThis chapter discuss in detail about the various standardterminologies and definitions used in adverse event reportingsystem and pharmacovigilance. The standard terms aredefined based on various drug regulatory guidelines and modified forbetter ease of understanding to the readers. The glossary of termsdescribed here covers most of the terminologies which are in use inthe field of pharmacovigilance and risk management.PharmacovigilanceWHO defines Pharmacovigilance as “the science and activitiesrelating to the detection, assessment, understanding and preventionof adverse effects or any other drug related problems.”Pharmacovigilance is the process and science of monitoring the safetyof medicines and taking action to reduce risks and increase benefitsfrom medicines.DrugA drug includes any substance or mixturemanufactured, sold or represented for use in:ofsubstances the diagnosis, treatment, mitigation or prevention of adisease, disorder or abnormal physical state, or its symptoms, in human beings oranimals, restoring, correcting or modifying organic functions in humanbeings or animals, or disinfection in premises in which food ismanufactured, prepared or kept.

A Practical Guide on Pharmacovigilance for BeginnersAdverse Event (or Adverse Experience)Any untoward medical occurrence in a patient or clinicalinvestigation subject administered a pharmaceutical product andwhich does not necessarily have to have a causal relationship withthis treatment.An adverse event (AE) can therefore be any unfavorable andunintended sign (including an abnormal laboratory finding, forexample), symptom, or disease temporally associated with the use ofa medicinal product, whether or not considered related to themedicinal product.Adverse Drug Reaction (ADR)In the pre-approval clinical experience with a new medicinal productor its new usages, particularly as the therapeutic dose(s) may not beestablished:all noxious and unintended responses to a medicinal product relatedto any dose should be considered adverse drug reactions.The phrase "responses to a medicinal product" means that a causalrelationship between a medicinal product and an adverse event is atleast a reasonable possibility, i.e., the relationship cannot be ruledout.Regarding marketed medicinal products, a well-accepted definition ofan adverse drug reaction in the post-marketing setting is found inWHO Technical Report 498 [1972] and reads as follows:A response to a drug which is noxious and unintended and whichoccurs at doses normally used in man for prophylaxis, diagnosis, ortherapy of disease or for modification of physiological function.Unlisted / Unexpected Adverse Drug ReactionAn adverse reaction, the nature or severity of which is not consistentwith the applicable product information (e.g., Investigator's Brochurefor an unapproved investigational medicinal product and prescribinginformation / Summary of Product Characteristics (SmPC) formarketed products).Listed / Expected Adverse Drug ReactionAn ADR whose nature, severity, specificity, and outcome areconsistent with the information in the CCSI.