Table of Contents
Declarations •...••.•...•....•...•.••••.•••••.•.•.•.•••.•.•..•.•..........•.•.....................................................................•.•.....•...•• i
Approval •..•••.••.••.••.•.••.•••.•.•.•.••••••.••..•.•.•.•.•.•...•.••••.•.•.•.••.•.•.•.•.•.•.•..•..•.....•.•.•....•.•.•.•.•.•..••...•.•..•.•.•.•.•.....•.•.•.•.• ii
LIST OF ABBREVIATIONS ...................................................................................................................... iii
List of figu.res ............................................................................................................................................. viii
ABSTRACT ................................................................................................................................................. ix
CHAPTER ONE ......................................................................................................................................... 1
IN'TRODUCTION ........................................................................................................................................ 1
1.1Background •••.••.••......••.•.•.•••..••..•••.••..•.•.••.••.••.•..•.................................•.....•.•.•.••.....•••.•.•.•.•.•.•.•...........•..••• 1
1.2 Statement of the problem ........................................................................................................................ 3
1.3 Objectives ............................................................................................................................................... 3
1.3.1Main objective ...................................................................................................................................... 3
1.3 .2 Specific objectives ............................................................................................................................... 3
1.4 Research questions .................................................................................................................................. 4
1.5 Justification of the study ......................................................................................................................... 4
1.6 Conceptual framework. ........................................................................................................................... 5
CHAPTER TWO ........................................................................................................................................ 6
LITERA.TURE REVIEW . ............................................................................................................................ 6
2.0 Introduction ............................................................................................................................................. 6
2.1 Knowledge on Pharmacovigilance .......................................................................................................... 6
2.3 Attitude on Pharmacovigilance ............................................................................................................... 7
2.4 Practices on Pharmacovigilance .............................................................................................................. 8
CHAPTER 3 .............................................................................................................................................. 10
METHODOLOGY ..................................................................................................................................... 10
3.1 Study design .......................................................................................................................................... 10
3.2 Study area .............................................................................................................................................. 10
3.3 Selection criteria ................................................................................................................................... 10
3.3.1Inclusion criteria. ................................................................................................................................ 10
3.3.2 Exclusion criteria ........................................................................................................ ....................... 10
iv
3.4Study population and requirements ........................................................................................................ 10
3.5 Sample size ........................................................................................................................................... 11
3.6 Sampling technique ............................................................................................................................... 11
3.7 Data collection procedures .................................................................................................................... 11
3.8 Data management. ................................................................................................................................. 11
3.9 Data analysis ......................................................................................................................................... 12
3.10 Quality control. ................................................................................................................................... 12
3.11 Plans for dissemination of research .................................................................................................... 12
3 .12 Ethical considerations ......................................................................................................................... 13
3.13 Limitations to the study ...................................................................................................................... 13
CHAPTER FOUR ..................................................................................................................................... 14
RESULT PRESENTATION ....................................................................................................................... 14
4. 0 Introduction ........................................................................................................................................... 14
4.1 Social Demographic factors .................................................................................................................. 14
4.2 Knowledge on ADRs ............................................................................................................................ 15
4.2.1 Is ADR reporting a professional obligation? ..................................................................................... 16
4.2.2 Regulatory body responsible for ADR reporting ............................................................................... 17
4.3.1 Necessity of ADRs reporting ............................................................................................................. 18
4.3.2 Teaching Pharmacovigilance in detail to healthcare professionals .................................................... 19
4.3 .3 Article on prevention of ADRs .......................................................................................................... 19
4.3.4 Opinion on establishing ADR monitoring system in your hospital ................................................... 20
4.3 .5 Attitude based on socio demographic factors .................................................................................... 20
4.4 Practices on Pharmacovigilance among HCP at IAH ........................................................................... 21
CHAPTER FIVE ...................................................................................................................................... 22
DISCUSSION, CONCLUSION AND RECOMME:l'.TDA TIONS .............................................................. 22
5.1 Introduction ........................................................................................................................................... 22
5 .1 Discussion ............................................................................................................................................. 22
5. 4 Recommendations ................................................................................................................................. 24
REFERENCE .............................................................................................................................................. 25
ABSTRACT Background: In the sub-Saharan Africa 6.3% of hospital admissions were a direct result of adverse drug reactions and 4.5% admissions on medical ward in Kabale regional referral hospital were suspected to be due to adverse drug reactions. Thus this study was aimed at assessing the knowledge, attitude and practice ofPharmacovigilance among health workers at IAH. Methodology: A prospective cross sectional study was used and the study was carried out at Ishaka Adventist Hospital (IAH).Only health practitioners that consented were eligible to answer the questionnaires. A sample size of 100 pmticipants was used determined using Slovene's formula and data was collected with help of questionnaires. The collected data was entered into SPSS version 25. Analyzed and presented inform of tables and graphs. Results: Majority were 57(54.0%) females and 46(46%) were males. Majority 71(69.6%) were aged 18-30 years, 24(23.5%) were aged 31-40 years and 4(3.9%) were aged 41-50 years. Most, 74(72.5%) were nurses, and the least 2(2.0%) were mid wives. Majority 71(69.6%) defined Pharmacovigilance as the study of medicine whereas 19(18.6%) defined Pharmacovigilance as the detection, assessment, understanding and prevention of adverse effects. Conclusion: A low percentage of18.6% could defme Pharmacovigilance atld ADRs reporting was seen as an obligation of he3l.th workers. The National drug authority was a regulatory body responsible for ADRs monitoring. A large percentage of 60.8% had ever heard of ADRs and the main source of this information was television followed by radio. A high percentage of90.0% had good attitude towards rep01ting of ADRs since they thought reporting adverse drug reactions is necessary. More to this majority (95.0%) suggested teaching Pham1acovigilance in detail to healthcare professionals would be of great inlportance and 58.0% had ne·1er read any article on prevention of ADRs. Though majority (85.0%) of the health workers gave an opinion that ADR monitoring system would be of great inlportance. Majority (50.0%) of the health workers had ever experienced ADRs in their patients during their professional practice. 73.0% had never reported ADRs to the Pharmacovigilance center and health workers who had never reported ADRs to the Pharmacovigilance center 35.0% found difficult to decide whether an ADR had occurred or not and 45.0% said it was because of lack of finances to meet costs involved in reporting ADRs.