ABSTRACT
OBJECTIVE: Prompt identification, reporting and management of ADRs during anti tuberculosis treatment can ensure better compliance and treatment outcomes. The study was conducted to identify the gaps and associated factors in reporting of ADRs under RNTCP; assess knowledge, attitude and practice of RNTCP staff regarding pharmacovigilance programme and explore the barriers in reporting of ADRs from provider's perspective. METHODS: Mixed method research with sequential explanatory design was carried out in Tuberculosis Units of RNTCP administrative district of Bangalore city during July to December 2017. Quantitative study was carried out among 222 patients on intensive phase of Category I and Category II DOTS to study the incidence, severity and causality of ADRs; and records of these patients were analysed for gaps in reporting. Knowledge, attitude and practice (KAP) regarding recording and reporting aspect of pharmacovigilance programme was assessed among RNTCP staff. As part of the qualitative study, focus group discussion was carried out among RNTCP staff to study barriers for reporting ADRs from the provider's perspective. RESULTS: Record analysis at the time of recruitment showed documentation of ADRs in only five patients. Subsequent analysis of patient records during the middle and end of the intensive phase (IP) did not show documentation of any ADRs. Simultaneously interviews with patients revealed 116 (52.2%), 72 (32.4%) and 53 (23.8%) patients reported one or more symptoms of ADRs. The commonest ADR symptom reported were fatigability and gastrointestinal symptoms followed by musculoskeletal symptoms. KAP among 25 RNTCP staff showed that 96% of them felt reporting of ADRs was necessary and 92% reported the ADRs to their seniors, however 12% were scared to report. The main reason expressed for non-reporting was 'managing ADRs is more important than reporting' (52%). Also, 32% felt the need for retraining of staff on reporting and documentation. Barriers to reporting of ADRs were both health-system related like insufficient training and inadequate guidelines provided to RNTCP staff and patient-related factors like lack of awareness and reluctance to report ADRs. CONCLUSION: Successful implementation of RNTCP and achievement of TB elimination requires provision of adequate information regarding ADRs to patients and intense follow-up and probing at each contact by programme staff to effectively manage ADRs.
Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Antitubercular Agents/adverse effects , Attitude of Health Personnel , Documentation/statistics & numerical data , Pharmacovigilance , Professional Competence , Tuberculosis, Pulmonary/drug therapy , Adult , Community Health Workers , Drug Eruptions/etiology , Fatigue/chemically induced , Female , Focus Groups , Gastrointestinal Diseases/chemically induced , Humans , India , Male , Middle Aged , Musculoskeletal Diseases/chemically induced , Nervous System Diseases/chemically induced , Nurses, Community Health , Pharmacists , Qualitative Research , Tuberculosis/drug therapy , Vertigo/chemically inducedABSTRACT
OBJECTIVE: To evaluate the efficacy and tolerability of ranolazine as an add-on drug in chronic stable angina patients and the impact of ranolazine on the quality of life in chronic stable angina patients receiving other antianginal medications. MATERIALS AND METHODS: It was a prospective, open-label, hospital-based study involving 144 patients with chronic stable angina. First group received either metoprolol 12.5 or 25 mg/day or other antianginal medications; if the symptoms persist, the dose of metoprolol was increased to 50 mg/day, and to the second group, ranolazine 500 mg BD or 1 g OD was added along with metoprolol or others if the anginal attacks were not subsiding. The patients were followed up to 6 months with electrocardiography, treadmill test, and quality of life questionnaire. Adverse events were recorded at each visit during the study. RESULTS: There was a statistically significant reduction in weekly anginal frequency (P < 0.001) and improvement in an exercise tolerance in both the groups, but more in the ranolazine group. Adverse events reported were mild, infrequent. CONCLUSION: Ranolazine is could be used as an add-on drug in chronic angina patients not improved with metoprolol or antianginal medications.
ABSTRACT
Rheumatoid arthritis (RA) is an autoimmune disease affecting about 1% of people, with the highest incidence between 40 and 70 years. Methotrexate is an anti-folate analogue that has good efficacy and safety in the treatment of RA. Methotrexate (MTX) and non-steroidal anti inflammatory drugs are often concomitantly administered in clinical practice for the treatment of RA. In this case report, a 57-year-old female was treated with oral methotrexate 7.5 mg per week for a diagnosed case of RA. Since her pain persisted after completing six weeks of treatment with methotrexate, oral etoricoxib 60 mg once daily was added to the treatment regimen. Six weeks later, the patient complained of oral ulcerations and blisters on all fours limbs and trunk. The patient was re-evaluated and was diagnosed with Stevens-Johnson syndrome-Toxic epidermal necrolysis (SJS-TEN) overlap. This case highlights the possible pharmacokinetic interaction between methotrexate and etoricoxib that has a significant clinical implication.
