SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER REVISED NATIONAL TB CONTROL PROGRAMME

1
SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER
REVISED NATIONAL TB CONTROL PROGRAMME
Mrs Leelavathi D Acharya Selection Grade
Lecturer Dept. of Pharmacy Practice MCOPS,
Manipal
2
CONTENTS

• Introduction
• Objectives
• Methodology
• Results and discussion
• Conclusion

3
INTRODUCTION

• The WHO declared tuberculosis a
• global emergency in 1993.
• To intensify efforts to control TB,
• Government of India gradually replaced
• NTP by the Directly Observed
• Treatment Short course (DOTS)
• programme
• Revised National TB Control Programme (RNTCP)

4

• 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

5
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

6
METHODOLOGY
Definition
Ethical Clearance
WHO definition of ADRs
Ethical committee of Kasturba Hospital, Manipal,
approved the study.
Study Sites
Study Duration and Design

1. Department of Tuberculosis and Respiratory
   Diseases, KasturbaHospital, Manipal
2. DOTS centre Kasturba Hospital, Manipal
3. DOTS centre Government Hospital, Udupi.

Study Duration 1st October 2005 to 31st May
2006. Study Design Prospective study carried out
on In-patients
7

• Identification of ADRs
• Participation in ward rounds
• Review of patient case files
• Interviewing patients
• Documentation
• Follow-up

8

• Demographic of the patient
• Type of TB Patient, type of TB, Type of
• DOTS treatment
• Incidence of ADR
• Most common ADRs
• Predisposing factors
• Type of ADRs
• Time of onset
• Management and outcome
• Causality and severity

9
RESULTS AND DISCUSSION

• Total Number of patients ? 94
• DOTS centre, Kasturba Hospital,
• Manipal ? 7
• Govt. Hospital, Udupi ? 87
• Total number of ADRs ? 21

10
RESULTS AND DISCUSSION

1. Demographic Characteristics of TB
   Patients

1 b) Age-group wise distribution of patients
1 (a) Gender wise distribution of patients
Age group (years) No. of patients ()
18-40 49 52
41-60 33 35
61 and above 12 13
11
2. Type of TB patients
3. Type of Tuberculosis
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
12
4. Type of DOTS treatment

13
5. Incidence of Adverse Drug Reactions
The study showed high incidence of 17.02 of ADRs
14
6. Most Common ADRs
S.No Symptom Number of reactions ()
1 Gastritis 7 33.33
2 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

15
7. Predisposing Factors

16
8. Type of ADRs
Type No. of ADRs ()
Type A 6 28.57
Type B 15 71.43
17
9. Time of Onset of ADRs
S.No. Suspected ATT drug/drugs DOTS Category Type 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.
18
Time of onset -continued
S.NO Suspected ATT drug/drugs DOTS 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 II Peripheral neuropathy Fifth 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.
19
10. Management of ADRs
11. Outcome of ADRs
S.N0 Manage ment Treatment Given Treatment Given Treatment Given
S.N0 Manage ment Speci fic Symptomatic Nil
1. Drug withdrawn n3 1 2 0
2. Dosage reduced n0 0 0 0
3. No change n18 0 9 9
Outcome Number of cases ()
Recovery 13 61.90
Continuing 6 28.57
Unknown 2 9.52
Fatal 0 0
20
12. Causality Assessment
WHO Probability Scale n 61 Naranjos algorithm n 61
Certain / Definite 5 0
Probable 2 2
Possible 47 54
Unassessable / Unclassifiable 7 NA
Unlikely 0 5
Conditional / Unclassified 0 NA
21
13. Severity Assessment of ADRs by Hartwig et. al
. Severity Scale
22
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.

23
REFERENCES

• Maher.D, Raviglione.M. Global Epidemiology of
  Tuberculosis. Clinics in Chest medicine 2005
  26167-182.
• Shashikant.Control of tuberculosis. In
  Sharma.S.K, Mohan, Tuberculosis. New DelhiJaypee
  Brothers ,2004558-556.
• Hong Kong chest service/Tuberculosis research
  centre, Madras /British medical research
  council .A controlled trial of 3-month, 4- month
  and 6 month regimens of chemotherapy for sputum
  smear-negative pulmonary tuberculosis. Results
  at 5 years .Am Rev Respir Dis 1989 139871-6.
• Hong Kong chest service/ British medical research
  council. Controlled trial of four thrice-weekly
  regimens and a daily regimen all given for 6
  months for pulmonary tuberculosis. Lancet 1981,
  1171-4.
• Zierski.M, Bek .E. Side effects of drug regimens
  used in short course chemotherapy for pulmonary
  tuberculosis .A controlled clinical study.
  Tubercle 198061 41-49.
• Poole.G, Stradling .P, Worlledge. S.Potentially
  serious side effects of High-dose twice-weekly
  rifampicin. BMJ-1971 3,343-347.

24
(No Transcript)