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CHAPTER ONE

 

INTRODUCTION

 

1.1 BACKGROUND OF THE STUDY

Every day, a large number of drugs are introduced onto the market around the world. Nevertheless, due to a lack of understanding, the safety of medicines remains a key worry for many demographic groups. An adverse drug reaction (ADR) is defined by the World Health Organization (WHO) as “any deleterious, inadvertent, and unwanted reaction to drugs when used for prevention, diagnosis, or treatment at therapeutic doses or for the modification of physiological malfunction that prevents accidental or deliberate overdosage or drug maladministration” (Aspinall,2002). Predictable and dose-related ADRs, unpredictable and nondose-related ADRs, both dose and time-related ADRs, time-related (delayed reactions), withdrawal reactions, and unanticipated reactions owing to treatment failure are all examples of ADRs.

Modern pharmaceuticals have significantly altered illness treatment strategies, resulting in better treatment outcomes in a variety of medical disorders. Adverse drug reactions, on the other hand, are a common cause of morbidity, hospitalizations, extended hospital stays, disability, and even death (kessler,1993). Not only do they have a considerable influence on public health, but they also diminish patients’ quality of life and cost the health-care system a significant amount of money (Inne, 2006).

ADR monitoring has a long history, dating back to the milestone of the thalidomide disaster, which caused phocomelia in thousands of children in several countries (Edwards and Annson 2000). The science and activity of pharmacovigilance is concerned with the identification, assessment, understanding, and prevention of adverse effects or other drug-related problems (kessler,1993).

ADR reporting is linked to health care providers’ knowledge and attitude, according to findings from numerous research (HCPs). All Ethiopian HCPs must report suspected adverse drug reactions to the Ethiopian Food and Drug Administration (EFDA) so that urgent and appropriate actions can be taken to avoid or limit future medicine-related harm to other patients (Oliver,2001).

All ADRs, from minor to severe, should be documented, with a special focus on ADRs to new drugs, serious adverse drug reactions, unexpected reactions, and potentially serious or clinically significant drug interactions. Furthermore, the lack of knowledge about the causal association between medicine and ADR should not be used as an excuse to not report (CSA, MCA).

In Ethiopia, underreporting of ADRs by HCPs to the appropriate authorities has long been a problem. A search of the literature for knowledge, attitude, and practice (KAP) of HCPs toward ADR reporting in the study areas yielded no results. Thus, it was deemed necessary to conduct this study to investigate the gaps in KAP of HCPs regarding ADR reporting and to identify factors that contribute to insufficient knowledge.

 

1.2 STATEMENT OF THE PROBLEM

Physicians throughout the world deal with adverse drug reactions (ADRs) on a daily basis and approximately 95% of such cases go unreported worldwide. While they are under-reported globally, they are even less so in Nigeria. According to studies, adverse drug reactions (ADR) are the fourth to sixth leading cause of death in the United States (Mllar, 2001). According to studies conducted in industrialized nations, roughly 5% of hospitalized patients are admitted as a result of an adverse drug reaction, and 6-10% of inpatients encounter a major ADR during their hospitalization. ADR-related hospital admissions account for about 10% of all hospital admissions in some countries, and ADR treatment costs health care a lot of money (15-20%). According to Med Watch, the Food and Drug Administration’s (FDA’s) Office of Drug Risk Assessment claims that these figures are grossly understated, claiming that just 1% of ADRs are reported. The goal of ADR reporting is to lower the risk of prescription and administering medications, resulting in better patient care, safety, and treatment outcomes.

In order to increase ADR monitoring and reporting in Nigeria, the National Agency for Food, Drug Administration and Control (NAFDAC) introduced pharmacovigilance in 2004. Unfortunately, due to inadequate reporting of adverse drug reactions (ADRs), there is relatively little information regarding them in developing countries, including Nigeria. Because of several factors that may influence a patient’s response, the information we get on adverse drug effects from other nations may not be appropriate for Nigeria. (Primoh,1998)

• Disease and prescribing practices;

• Treatment seeking behavior g. self medication;

• Genetics,Diet, Traditions of people g. high carbohydrate, fat, kola nut consumption rate etc.

• The drug manufacturing process is used to influence pharmaceutical quality and composition.

• Drug distribution and use, including indications, dose, storage, and availability;

• The use of traditional and complementary drugs (e.g. herbal remedies) may pose specific toxicological problems when used alone or in combination with other drugs; and

• Racial

The purpose of this study was to investigate the level of awareness, attitude, and practice of ADR reporting among health care workers in Asaba, Delta state, with the goal of encouraging them to perceive ADR monitoring and reporting as a professional obligation. ADR-related morbidity, mortality, and deaths will be dramatically decreased if ADR reporting improves in this area.

 

1.3 OBJECTIVE OF THE STUDY

 

The overall goal of the research is to:

1.        Find out what factors influence health professionals’ reporting of ADR in Asaba Delta state.

2.        To determine the level of awareness of the national Adverse Drug Reaction Reporting Scheme/Guideline among health professionals in Asaba Delta state

3.        Find out how health professionals in Asaba Delta state (Health posts, Primary Health Centres (PHC), Private Hospitals, and Tertiary Health Institutions) feel about reporting ADR.

 

 1.4 RESEARCH QUESTIONS

The following research questions guide the objective of the study:

1.      What are the factors that influence health professionals’ reporting of ADR in Asaba Delta state?

2.      What is the level of awareness of the national Adverse Drug Reaction Reporting Scheme/Guideline among health professionals in Asaba Delta state?

3.      How do health professionals in Asaba Delta state (Health posts, Primary Health Centres (PHC), Private Hospitals, and Tertiary Health Institutions) feel about reporting ADR?

 

1.5 SIGNIFICANCE OF THE STUDY

The overall goal of this study is to Critically Examine The Awareness, Attitude, And Practice Of Health Care Professionals To Adverse Drug Reaction Reporting In Asaba, Delta State. This study will contribute to the current literature in this field and will also serve as a resource for academics, researchers, and students who may want to do future research on this or a comparable issue.

 

1.6 SCOPE OF THE STUDY

This research covered The Awareness, Attitude, And Practice Of Health Care Professionals To Adverse Drug Reaction Reporting In Asaba, Delta State.

 

1.7 LIMITATION OF STUDY

The study was limited due to lack of study materials and also the budget and study duration were also constraints.

 

1.8 DEFINITION OF TERMS

HealthCare Professionals: Health professionals maintain health in humans through the application of the principles and procedures of evidence-based medicine and care.

Adverse Drug Reaction Reporting: Adverse drug reaction reporting helps the drug monitoring system detect the unwanted effects of those drugs which are already on the market.