RESUMO
Objective: Hospital-based ADR (Adverse drug reaction) monitoring and reporting programmes are useful for identifying and minimizing preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The objective of this study was to evaluate and analyze the spontaneously reported adverse drug events from various departments of Shree Krishna Hospital, Karamsad. Methods: This was a retrospective study and data was analyzed for adverse drug events reported during the period of April 2018 to March 2019 from various departments of Shree Krishna Hospital, Karamsad. Analysis was done on the basis of the demographic profile of patients, health care professionals who have reported and drugs causing ADRs, with their causality assessment using WHO probability scale. Results: Out of 36 patients, 20 (55.55%) were males and 16 (44.44%) were females. Antibiotics were the most common culprit group of drugs for reported ADRs in 21 patients. The number of ADRS related to the skin was 21 (58.33%) followed by GIT 11 (30.55%), cardiovascular 2(5.55%) and neuronal 2(5.55%). According to WHO causality assessment scale 01 (2.77%) of the suspected ADR was certain, 27(75%) were probable and 8 (22.22%) were possible. Conclusion: Our study concluded that the most commonly reported ADRs were dermatological reactions like itching and rashes. Antimicrobials were the most common drug group involved in causing ADRs. Even though there were continuous efforts for adverse drug event reporting awareness, still there is need to sensitize health care professionals to improve reporting.
RESUMO
Objective: Many Fix Dose Combinations (FDCs) being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, pediatric formulations of nimesulide+paracetamol. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. The aim of the present work was to evaluate the efficacy and safety of FDCs in non-steroidal anti-inflammatory drugs in the orthopedic department at a tertiary care teaching hospital. To study the effectiveness and safety parameters of fixed-dose combinations of Non-Steroidal Anti-inflammatory Drugs. Methods: This prospective, observational study was conducted among 150 out-patients of the orthopedic ward over a period of July 2013 to December 2013(Each combination with 50 patients). Three fixed-dose combinations utilized were paracetamol+diclofenac, paracetamol+ibuprofen and paracetamol+nimesulide. The effectiveness was analyzed by using Visual Analogue Scale (VAS) and Disease Activity Scale (DAS) and the safety criteria were analyzed by using the WHO probability scale and Naranjo scale. 150 orthopedic patients attending Out Patient Department were included. 50 participants for each of the combinations of fixed-dose combination (FDCs) of NSAIDs. Results: Out of 150 patients 33 patients developed adverse effects, and 17(51.51%) adverse effects due to the combination of Paracetmol+Nimuselide, 11(33.34%) adverse effects due to the Paracetamol+Ibuprofen and 5 (15.15%) were due to the combination of Paracetamol+Diclofenac. The maximum effectiveness (3.55±0.208) showed in the combination of paracetamol+diclofenac compared to the other two combinations. Conclusion: It was concluded from this study that the effectiveness and safety profile of PCM+DICLO is better than the other two FDCs.