RESUMO
Background: Amantadine is found to be effective for the treatment of complications associated with traumatic brain injury. Drug-related side effects are common with Amantadine especially when combined with other drugs. Comprehensive information about the incidence and severity of these adverse effects is not available. Aim and Objectives: The aim of the study was to analyze the pattern of occurrence of adverse drug reactions (ADRs) in patients receiving Amantadine for traumatic brain injury in a tertiary care hospital. We also assessed the causality, severity and preventability of ADRs. Materials and Methods: This prospective cohort study was conducted among patients taking Amantadine for a continuous period of 1 month for traumatic brain injury in neurosurgery department between June 2020 and December 2020. Tools used were ADR Reporting form of National Pharmacovigilance Centre, WHO causality scale, Hartwig and Siegel scale, and Schumock and Thornton scale. Descriptive statistics were used and the values were expressed in numbers and percentages. Results: ADRs were experienced in 55 patients (36.7%) out of 150 patients and all the patients were on combination therapy. ADR was present more in male patients (63.6%) compared to females (36.4%). The most common ADRs were headache, ankle edema and dry mouth. Majority of ADRs belonged to the possible category according to the WHO causality assessment scale. Majority of the ADRs (61.9%) were mild level 1 according to severity scale. All the ADRs came under the definitely or probably preventable category. Conclusion: ADRs with Amantadine are common but mild and preventable.
RESUMO
Background: Fixed dose combinations (FDCs) are combinations of two or more active drugs in a single pharmaceutical formulation. The rationality of FDC is a controversial and challenging issue in today’s practice of medicine. Aims and Objectives: The aim of the study was to assess the prescription pattern and rationality of FDCs in a tertiary care hospital. Materials and Methods: This is a record-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College, Thrissur. The data were collected from the case records of 183 patients admitted under various departments during the month of January 2019. The FDCs prescribed were listed and the prescription pattern was assessed. All the FDCs were evaluated for rationality with the help of a comprehensive seven-point criteria by Panda et al. The data were analyzed using Epi info 7. Descriptive statistics were used to analyze the data. Results: Out of 183 case records, 39.3% contained at least one FDC, 13.1% contained two FDCs, and 4.4% contained three FDCs. The different drug classes prescribed as FDCs include anti-infective drugs 45%, vitamins and minerals 33%, analgesics 9%, and miscellaneous drug combinations 13%. The most prescribed anti-infective drug FDC is amoxicillin with clavulanic acid combination (56%). In our study, 92.5% of the antibacterial FDCs prescribed were rational and 7.5% irrational. According to the World Health Organization rationality criteria, 62% of the FDCs prescribed were rational and 38% were irrational. Conclusion: The present study showed the increased use of FDCs in tertiary care teaching hospital and most of the FDCs prescribed were rational (62%).