RESUMO
Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.
RESUMO
Background: Between 2006 and 2015, the prevalence of MDR-TB has been found to be as high as 39.9% in some states. Approximately 35.8% of all previously treated patients developed MDR-TB. The objective of the present study was to identify demographic and health characteristics of patients as well as incidence and pattern of the adverse drug reactions caused by antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This 12 months study of observational study was conducted at a DOTS centre. MDR-TB diagnosed patients treated with DOTS Plus regimen were enrolled after getting informed consent. Patient information was recorded. Patient follow-up was conducted to identify the incidence and pattern of ADRs.Results: A total of 115 patients were enrolled. Maximum number of cases were in the 31-40 age group (25.21%) followed by the 41-50 age group (20.86%). 76 (66.08%) were males and 39 (33.91%) were females. 52 patients (45.21%) had concomitant diseases, out of which 15 (13.04%) were HIV positive and 21 (18.26%) were diabetic. 70 patients (60.86%) developed ADRs. The adverse drug reaction that were seen are -38 (38.76%) cases of gastrointestinal adverse drug reactions, 8 (8.16%) jaundice/hepatitis, 7 (7.14%) impaired hearing/vertigo, 21 (21.24%) central nervous system adverse drug reaction, 6 (6.12%) peripheral neuropathy, 6 (6.12%) rash and itching, 5 (5.10%) arthralgia, 3 (3.06%) renal impairment, 2 (2.04%) hypothyroidism and 2 (2.04%) blurred vision.Conclusions: Determining which population groups are affected most by ADRs can help physicians to better monitor and make an early diagnosis to reduce ADR-related morbidity and mortality.
RESUMO
Background: The study was performed to analyze the extent of price variation amongst branded antihypertensive drugs in India and the relation of this price variation to number of pharmaceutical companies manufacturing/marketing these drugs. Methods: Price of different brands of antihypertensive drugs was collected from authentic sources. The data were segregated and the percentage price variation was calculated applying suitable statistical tools. Results: A total of 116 formulations from different companies representing 38 antihypertensive drugs were analyzed. Maximum price variation (3233.33%) was seen with 10 mg dose of propranolol. In general the price variations are proportionally correlated to the number of pharmaceutical companies. Conclusions: Price variation of great extent was found among many formulations. Physicians should be aware of these variations for choosing the appropriate brand for rational therapeutics. This will reduce the burden on patients and family.