Drug Safety Enhancement among the Elderly with the Help of Active Surveillance of Observational Healthcare Data

By

ACKNOWLEDGEMENT

I would like to take this opportunity to thank my dissertation supervisor who has always shown confidence in me. He has offered his patience, remarks, propositions and understanding. Here I would also like to mention my parents who have always believed in me for all my hard work. My family, including my parents, brother and sister has endlessly supported me during my life and academics. This has helped me in making positive decisions for my life. I would also mention my peers and co-workers and appreciate their collaboration and expert advice on every circumstance. I am also grateful towards my University and my Department, the administrators, faculty members and fellow students for their support throughout this study.

DECLARATION

I declare that the material stated in this dissertation/thesis is original and does not present work of any other scholar or research study conducted in the past. Material in this study is not partially or completely published elsewhere and collected only for the purpose of this study. I also acknowledge that I have complete understanding of the requirements, guidelines, regulations and procedures of the University with respect to the endowment of higher education degree and my research work. Here, I would also like to take the opportunity to declare that I have almost exclusively followed the requirements, guidelines, regulations and procedures of the University regarding this research study.

I certify that the work presented in the dissertation is my own unless referenced

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ABSTRACT

Safety assessment of medical products involves a wide array of information. Prior to regulatory approval, pre-clinical toxicology studies, pharmacology experiments and clinical trials provide initial assessment of adverse drug reactions, but are limited both in generalizability to real-world populations and in size for detection of less common events or reactions with modest increased risks from background observed rates. In the post approval setting, spontaneous adverse event reporting offers the opportunity for patients and providers to notify FDA and product manufacturers of adverse experiences post-exposure. An improved drug surveillance system would enable a more comprehensive and timelier understanding of the safety of medicines. Such information will support patients and providers in therapeutic decision-making to minimize risks and improve the quality of care. The results of this study will inform decisions about the appropriateness and utility of analyzing observational data as part of a future drug safety surveillance process. The primary purpose for this study was to examine how drug safety among the elderly can be enhanced with the help of active surveillance of observational healthcare data.

TABLE OF CONTENTS

ACKNOWLEDGEMENTII

DECLARATIONIII

ABSTRACTIV

CHAPTER ONE: INTRODUCTION1

Background of the Study1

Adverse drug reaction surveillance4

Individual case safety reports4

The WHO database6

Adverse drug reaction signal detection7

Purpose of the Study9

Research Aims and Objectives11

Rationale11

Motivation for study13

Significance of the Study15

Structure of the thesis16

Chapter One: Introduction16

Chapter Two: Literature Review17

Chapter Three: Methodology17

Chapter Four: Analysis and Discussion18

Chapter Five: Conclusion18

CHAPTER TWO: LITERATURE REVIEW20

Overview20

Increasing Importance of Drug Safety in the Quality of Healthcare22

History of FDA's response to drug safety24

Approaches for evaluating drug safety issues26

Approaches for identifying potential drug safety issues38

An ...