FOOD AND DRUG AUTHORITY IN SAUDI ARABIA

Food And Drug Authority In Saudi Arabia: The case of Avandia

Abstract

Saudia Arabia has banned new shipments of the diabetes drug Avandia for at least six months as a result of concerns over Avandia side effects, which could increase the risk of heart attacks, congestive heart failure, fractures and other injuries. The Saudi Food and Drug Authority (SFDA) announced an Avandia ban on March 17, 2010, saying that the Avandia health risks appear to outweigh the benefits provided by the type 2 diabetes drug and that there are safer alternatives. The country has suspended GlaxoSmithKline PLC's ability to market the drug in the country and has halted new shipments, but the medication will still be available in pharmacies while supplies last. This research assess the support that SFDA provides to the pharmacists regarding adverse drug reactions it also tries to assess the attitude and behavior of community pharmacists in Saudi Arabia regarding the reporting of adverse drug reactions (ADR).

Table of Contents

ABSTRACT2

TABLE OF CONTENTS3

CHAPTER 16

INTRODUCTION6

Aims7

Objectives7

CHAPTER 28

LITERATURE REVIEW8

Saudi Arabia Pharmaceutical Industry11

ADR and Saudi Food and Drug Authority12

Education, training and access to reliable information13

Communication with health professionals17

Linking clinical findings with research and policy19

Avandia in Saudi Arabia20

CHAPTER 322

METHODOLOGY22

Research Tool23

Inclusion criteria:24

Exclusion criteria:24

Critical justification of methodology24

Ethical consideration25

CHAPTER 426

RESULTS AND DISCUSSION26

Familiarity with the reporting system:28

Attitude28

Behaviour28

Barriers29

CHAPTER 537

CONCLUSION AND RECOMMENDATIONS37

Establishment of a Pharmacovigilance System38

Management of Pharmacovigilance Data38

Spontaneous Reporting Systems38

General Principles of Spontaneous Reporting Systems (SRS)39

Case Report Collection and Validation40

Case Report Collection40

Case Report Validation41

Case Report Storage42

Data Entry42

Case Report Processing: Evaluation of Seriousness/Expectedness and Presentation for Transmission43

Evaluation of Data in Individual Cases44

Management of Duplicate Reports44

Identification of Individual Cases Requiring Specific Handling44

Individual Case Presentation for Transmission45

Aggregate Case Processing and Alert Identification45

Information46

Quality Control and Quality Assurance46

Confidentiality and Security46

Company Derived Pharmacovigilance Data Introduction47

Individual Adverse Reaction Reports47

Periodic Safety Update Reports (PSURs)48

Company Sponsored Post-Marketing Safety Studies48

Communication between MAHs and SFDA49

Pharmacovigilance Data from Other Sources49

Intensive Monitoring Schemes49

Data on Misuse/Abuse of Drugs49

Other Pharmacovigilance Data50

Chapter 1

Introduction

The drug Avandia which was used in the treatment of Diabetes Mellitus 2 was recently suspended in Saudi Arabia for a period of six months because of the element of risk associated with it, as it had caused heart failure in a small number of patients. In association with this move, the Saudi Food and Drug Authority (SFDA), which was responsible for this move, has also taken steps to circulate information publicly on the dangers of the drug. In addition the Ministry of Health has offered some tentative guidelines on the drug for those who are treating patients and for pharmacists issuing the drug, on the manner in which the drug should be handled and on advice which should be given.

This research study proposed to undertake an examination of the problem associated with the use of the Avandia in Saudi Arabia. It proposed to use a survey method to gather information from pharmacists on the extent of their knowledge about the use of the drug. The context of this study is therefore to examine the post surveillance atmosphere of the suspension of the drug Avandia and whether or not the Saudi ...