ADRs in medicine

A Study of Adverse Drug Reactions In The In-Patients of Medicine Department of Guru Gobind Singh Hospital, Jamnagar, Gujarat : 

A Study of Adverse Drug Reactions In The In-Patients of Medicine Department of Guru Gobind Singh Hospital, Jamnagar, Gujarat Dr.Mukeshkumar B. Vora, Assistant Professor, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat E-mail: voramb2007@rediffmail.com 13/12/2008 1

Introduction : 

Introduction 13/12/2008 2

Adverse Drug Reaction (ADR) : 

Adverse Drug Reaction (ADR) DEFINITION According to WHO An adverse drug reaction defined as “ A response to a drug which is noxious and unintended which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function excluding failure to accomplish the intended purpose.” 13/12/2008 3

Serious Adverse Drug Reaction : 

Serious Adverse Drug Reaction A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: Result in death Is life threatening Requires in patient hospitalization or prolongation of existing hospitalization Result in persistent or significant disability/incapacity Is a congenital anomaly / birth defects Required intervention to prevent permanent impairment or damage 13/12/2008 4

Epidemiology : 

Epidemiology Patients hospitalized due to ADRs: 2% - 20% In-hospitalized patients suffering ADRs: 10% - 20% 4th to 6th leading cause of mortality in USA. 13/12/2008 5

Aims and Objectives : 

Aims and Objectives 13/12/2008 6

Aims and Objectives : 

Aims and Objectives To identify major life threatening/ seriousness of adverse drug reactions in Medicine wards. Identify particular group of patients having greater risk of ADRs than others. Incidence rate of ADRs in-hospitalized patients & hospital admission due to ADRs of particular in medicine wards. 13/12/2008 7

Material and Method : 

Material and Method 13/12/2008 8

Selection criteria : 

Selection criteria Inclusion criteria: All patients of either sex or age > 12 years admitted in medicine wards, Patients transfer from ICU to medicine wards, Patients refer to higher center, abscond, & Discharged against medical advice with known outcome of ADRs. 13/12/2008 9

Selection criteria : 

Selection criteria Exclusion Criteria: Patients refer to higher center, abscond, Discharged against medical advice with outcome of ADRs are unknown, Patients directly admitted to ICU, Dialysis unit, TB & chest ward, Isolation ward and those patients not in our inclusion criteria that excluded from the study. 13/12/2008 10

Method of Data Collection : 

Method of Data Collection 13/12/2008 11

Method of Data Collection : 

Method of Data Collection A prospective study of six months duration carried out in medicine wards, Guru Gobind Singh Hospital , Jamnagar. Pilot study was done. Performa should be finalized and used throughout study. Visits all the patients daily in medicine wards. Information of all patients and drugs related were noted daily till the patients discharged from the hospital. 13/12/2008 12

Method of Data Collection : 

Method of Data Collection Any ADRs observed by the investigator or treating physician was noted in ADRs reporting Performa Any untoward event was labeled as ADR only after discussed with the treating physician. Treating physician opinion was considered as final. In this study only ADRs were reported. We have also analyzed as per WHO criteria of grade of ADRs like definite, probable, possible…etc. 13/12/2008 13

Method of Data Collection : 

Method of Data Collection We have also noted management of ADRs and outcome of ADRs after manage the reactions. For statistical analysis Chi-Square test should be applied. P value < 0.05 has considered as significant and P value < 0.01 considered highly significant. 13/12/2008 14

Observations and Results : 

Observations and Results 13/12/2008 15

Observations and Results : 

Observations and Results Information of total 860 patients collected from medicine ward during period of study. Out of this patients, 30 patients were excluded from the study because it has not in our inclusion criteria. 13/12/2008 16

1) Incidence of ADRs : 

1) Incidence of ADRs 13/12/2008 17

2) Age groups of patients and ADRs : 

2) Age groups of patients and ADRs 13/12/2008 18

3) Sex of Patients and ADRs : 

3) Sex of Patients and ADRs 13/12/2008 19

4) Grades of ADRs : 

4) Grades of ADRs 13/12/2008 20

Grades of ADRs : 

Grades of ADRs 13/12/2008 21

Seriousness of ADRs : 

Seriousness of ADRs 13/12/2008 22

5) Seriousness of ADRs : 

5) Seriousness of ADRs 13/12/2008 23

Management of ADRs : 

Management of ADRs 13/12/2008 24

Management of ADRs : 

Management of ADRs 13/12/2008 25

Outcome of Management of ADRs : 

Outcome of Management of ADRs 13/12/2008 26

Outcome of Management of ADRs : 

Outcome of Management of ADRs 13/12/2008 27

ADRs cause to hospital admission and ADRs during Hospitalization : 

ADRs cause to hospital admission and ADRs during Hospitalization 13/12/2008 28

Conclusion : 

Conclusion 13/12/2008 29

Conclusion : 

Conclusion ADRs in hospitalized patients were less than those encountered in the patients who get admitted to hospital because of ADRs. It may be due to prescribed rationally and given under supervision. In hospital admission of patients due to ADRs may occurred due to self medication and Over the Counter drugs used by patient particularly adult age group (Group – 2 (21-50 years). 13/12/2008 30

Slide 31: 

THANK YOU 13/12/2008 31