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SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER REVISED NATIONAL TB CONTROL PROGRAMME Mrs Leelavathi D Acharya Selection Grade Lecturer Dept. of Pharmacy.

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Presentation on theme: "SAFETY EVALUATION OF ANTITUBERCULAR THERAPY UNDER REVISED NATIONAL TB CONTROL PROGRAMME Mrs Leelavathi D Acharya Selection Grade Lecturer Dept. of Pharmacy."— Presentation transcript:

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 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) programme programme Revised National TB Control Programme (RNTCP) 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 WHO definition of ADRs Study Sites 1.Department of Tuberculosis and Respiratory Diseases, Kasturba Hospital, 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 1 st October 2005 to 31 st May 2006. Study Design Prospective study carried out on In-patients

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

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

9 RESULTS AND DISCUSSION Total Number of patients 94 Total Number of patients 94 DOTS centre, Kasturba Hospital, DOTS centre, Kasturba Hospital, Manipal 7 Manipal 7 Govt. Hospital, Udupi 87 Govt. Hospital, Udupi 87 Total number of ADRs 21 Total number of ADRs 21

10 Age group (years) No. of patients (%) 18-4049 52 41-603335 61 and above 1213 1 b) Age-group wise distribution of patients 1 (a) Gender wise distribution of patients 1. Demographic Characteristics of TB Patients RESULTS AND DISCUSSION

11 2. Type of TB patients Type of patientsNo. of patients(%) New4143.61 Relapse3031.91 Transfer in00 Failure1010.63 Treatment after default 1212.76 Other11.06 3. Type of Tuberculosis

12 4. Type of DOTS treatmentType 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.NoSymptom Number of reactions (%) 1Gastritis7 33.33 2Skin reactions314.28 3Hepatitis29.52 4Anorexia14.76 5Dizziness14.76 6Insomnia14.76 7Ototoxicity14.76 8Peripheral neuropathy14.76 9Psychosis14.76 10Vertigo14.76 11Weakness14.76 12Arthralgia14.76

15 7. Predisposing Factors

16 8. Type of ADRs TypeNo. of ADRs(%) Type A628.57 Type B1571.43

17 S.No. Suspected ATT drug/drugs DOTS Category Type of ADR Onset of ADR (Within) 1.HREPIGastritisa day 2.HRIIISkin rash a week 3.SIISkin rash a week 4.HREPIIGastritis a day 5.RHIIDizziness a week 6.SIIOtotoxicitySixth week 7.HREPIIGastritisSecond week 8.HREPSIIInsomniaThird week 9.HREPIGastritisSecond week 10.RHIWeaknessSecond week H: Isoniazid, R: Rifampicin, P: Pyrazinamide, S: Streptomycin. 9. Time of Onset of ADRs

18 S.NO Suspected ATT drug/drugs DOTS CategoryType of ADROnset of ADR 11.HREPIAnorexiaa week 12.HREPIHepatitisSecond week 13.PIIIHepatitisSecond week 14.HII Peripheral neuropathy Fifth week 15.HREPISkin rasha week 16.HIIPsychosisa week 17.SIIVertigoFourth week 18.HREPIIGastritisThird week 19.HREPIGastritisThird week 20.HREPIGastritisa week 21.HEPIArthralgiaSecond week H: Isoniazid, R: Rifampicin, P: Pyrazinamide, S: Streptomycin. Time of onset -continued

19 10. Management of ADRs S.N 0 Manage ment Treatment Given Speci fic Sympto matic Nil 1. Drug withdrawn n=3120 2. Dosage reduced n=0000 3. No change n=18099 11. Outcome of ADRs Outcome Number of cases (%)Recovery1361.90 Continuing628.57 Unknown29.52 Fatal00

20 12. Causality Assessment WHO Probability Scale n =61 Naranjos algorithm n =61 Certain / Definite 50 Probable22 Possible4754 Unassessable / Unclassifiable 7NA Unlikely05 Conditional / Unclassified 0NA

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 1.Maher.D, Raviglione.M. Global Epidemiology of Tuberculosis. Clinics in Chest medicine – 2005; 26:167-182. 2.Shashikant.Control of tuberculosis. In: Sharma.S.K, Mohan, Tuberculosis. New Delhi:Jaypee Brothers,2004;558-556. 3.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; 139:871-6. 4.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, 1:171-4. 5.Zierski.M, Bek.E. Side effects of drug regimens used in short course chemotherapy for pulmonary tuberculosis.A controlled clinical study. Tubercle –1980:61; 41-49. 6.Poole.G, Stradling.P, Worlledge. S.Potentially serious side effects of High- dose twice-weekly rifampicin. BMJ-1971: 3,343-347.

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