SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER REVISED NATIONAL TB CONTROL PROGRAMME Mrs...
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Transcript of SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER REVISED NATIONAL TB CONTROL PROGRAMME Mrs...
SAFETY EVALUATION OF ANTITUBERCULAR THERAPY
UNDER REVISED NATIONAL TB CONTROL PROGRAMME
Mrs Leelavathi D Acharya
Selection Grade Lecturer
Dept. of Pharmacy Practice
MCOPS, Manipal
CONTENTS
Introduction
Objectives
Methodology
Results and discussion
Conclusion
INTRODUCTION
The WHO declared tuberculosis a The WHO declared tuberculosis a
global emergency in 1993.global emergency in 1993.
To intensify efforts to control TB, To intensify efforts to control TB,
Government of India gradually replaced Government of India gradually replaced
NTP by the Directly Observed NTP by the Directly Observed
Treatment Short course (DOTS) Treatment Short course (DOTS)
programmeprogramme
Revised National TB Control Programme Revised National TB Control Programme (RNTCP)(RNTCP)
Various studies on DOTS / daily regimen conducted till date evaluated the efficacy of dosage regimen
There are studies evaluating the safety in regular regimen however few studies have been done till date to evaluate the same in patients on DOTS regimen
There is a need to study the safety of patients on DOTS through monitoring of
ADRs in a hospital set-up
OBJECTIVES
To evaluate the safety of Antitubercular Therapy in patients on DOTS by monitoring adverse drug reaction
To determine the incidence and pattern of ATT induced ADRs in the patients on DOTS
To analyze the various parameters like causality and severity of reported ADRs
METHODOLOGY
Definition
WHO definition of ADRs
Study Sites
1.Department of Tuberculosis and Respiratory Diseases, KasturbaHospital, Manipal
2.DOTS centre Kasturba Hospital, Manipal
3.DOTS centre Government Hospital, Udupi.
Ethical Clearance
Ethical committee of Kasturba Hospital, Manipal, approved the study.
Study Duration and Design
Study Duration
1st October 2005 to 31st May 2006.
Study Design
Prospective study carried out on In-patients
Identification of ADRsIdentification of ADRs
Participation in ward roundsParticipation in ward rounds Review of patient case filesReview of patient case files Interviewing patientsInterviewing patients
DocumentationDocumentation
Follow-upFollow-up
Demographic of the patientDemographic of the patient Type of TB Patient, type of TB, Type of Type of TB Patient, type of TB, Type of
DOTS treatmentDOTS treatment
Incidence of ADRIncidence of ADR
Most common ADRsMost common ADRs
Predisposing factorsPredisposing factors
Type of ADRsType of ADRs
Time of onsetTime of onset
Management and outcomeManagement and outcome
Causality and severityCausality and severity
RESULTS AND DISCUSSION
Total Number of patients → 94Total Number of patients → 94
DOTS centre, Kasturba Hospital, DOTS centre, Kasturba Hospital,
Manipal → 7Manipal → 7
Govt. Hospital, Udupi → 87Govt. Hospital, Udupi → 87
Total number of ADRs → 21Total number of ADRs → 21
28 (30%)
66 (70%)
Female Male
Age group (years)
No. of patients
(%)
18-40 49 52
41-60 33 35
61 and above
12 13
1 b) Age-group wise distribution of patients
1 (a) Gender wise distribution of patients
1. Demographic Characteristics of TB Patients
RESULTS AND DISCUSSION
2. Type of TB patients
Type of patients No. of patients (%)
New 41 43.61
Relapse 30 31.91
Transfer in 0 0
Failure 10 10.63
Treatment after default
12 12.76
Other 1 1.06
3. Type of Tuberculosis
92,( 96%)
4, (4%)
Pulmonary Extra-pulmonary
4. Type of DOTS treatment
4, (4%)38,
( 40%)
52,( 56%)
Category-I Category-II Category-III
5. Incidence of Adverse Drug Reactions
5,( 31%)
11,( 69%)
Patients with more than two ADRs
Patients with one ADR
The study showed high incidence of 17.02% of ADRs
6. Most Common ADRs
S.No SymptomNumber of reactions
(%)
1 Gastritis 7 33.332 Skin reactions 3 14.28
3 Hepatitis 2 9.52
4 Anorexia 1 4.76
5 Dizziness 1 4.76
6 Insomnia 1 4.76
7 Ototoxicity 1 4.76
8 Peripheral neuropathy 1 4.76
9 Psychosis 1 4.76
10 Vertigo 1 4.76
11 Weakness 1 4.76
12 Arthralgia 1 4.76
7. Predisposing Factors
38.09%
14.28%
38.09%
4.76% 4.76%
0
1
2
3
4
5
6
7
8
Nu
mb
er
of A
DR
s
Multipledrug
therapy
Age Nil Alcoholic Dose
8. Type of ADRs
Type No. of ADRs (%)
Type A 6 28.57
Type B 15 71.43
S.No.Suspected ATT
drug/drugsDOTS
CategoryType of ADR
Onset of ADR(Within)
1. HREP I Gastritis a day
2. HR III Skin rash a week
3. S II Skin rash a week
4. HREP II Gastritis a day
5. RH II Dizziness a week
6. S II Ototoxicity Sixth week
7. HREP II Gastritis Second week
8. HREPS II Insomnia Third week
9. HREP I Gastritis Second week
10. RH I Weakness Second week
H: Isoniazid, R: Rifampicin, P: Pyrazinamide, S: Streptomycin.
9. Time of Onset of ADRs
S.NO
Suspected ATT
drug/drugsDOTS Category Type of ADR Onset of ADR
11. HREP I Anorexia a week
12. HREP I Hepatitis Second week
13. P III Hepatitis Second week
14. H IIPeripheral
neuropathyFifth week
15. HREP I Skin rash a week
16. H II Psychosis a week
17. S II Vertigo Fourth week
18. HREP II Gastritis Third week
19. HREP I Gastritis Third week
20. HREP I Gastritis a week
21. HEP I Arthralgia Second week
H: Isoniazid, R: Rifampicin, P: Pyrazinamide, S: Streptomycin.
Time of onset -continued
10. Management of ADRs
S.N0
Management
Treatment Given
Specific
Symptomatic
Nil
1.1.Drug Drug withdrawnwithdrawnn=3n=3
11 22 00
2.2.Dosage Dosage reducedreducedn=0n=0
00 00 00
3.3.No No changechangen=18n=18
00 99 99
11. Outcome of ADRs
OutcomeNumber of
cases(%)
RecoveryRecovery 1313 61.9061.90
ContinuingContinuing 66 28.5728.57
UnknownUnknown 22 9.529.52
FatalFatal 00 00
12. Causality AssessmentWHO Probability
Scalen =61
Naranjo’s algorithmn =61
Certain / DefiniteCertain / Definite 55 00
ProbableProbable 22 22
PossiblePossible 4747 5454
Unassessable / Unassessable / UnclassifiableUnclassifiable 77 NANA
UnlikelyUnlikely 00 55
Conditional / Conditional / UnclassifiedUnclassified 00 NANA
13. Severity Assessment of ADRs by Hartwig et. al . Severity Scale
0,( 0%) 30,
( 49%)
31,( 51%)
Mild Moderate Severe
CONCLUSION
Although incidences of ADRs were
high as 17.02%, most of them were
mild and moderate, which shows that
DOTS therapy is safer as compare to
daily regimen. However monitoring of
ADRs is needed for drug safety and
patient compliance in DOTS.
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