Evaluation of prescribing pattern and adverse effects of fixed dose combination of non-steroidal anti-inflammatory drugs

Gor, Alpa; Shah, Bharat K

doi:10.18203/2319-2003.ijbcp20161564

Cited by 2 publications

(2 citation statements)

References 4 publications

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“…GI-related adverse reaction observed in 28 participants. It was found that eighty percent of the adverse reaction was possible in nature [12], which supported our study results.…”

Section: Discussionsupporting

confidence: 91%

Effectiveness and Safety Assessment of Fixed Dose Combination of Non-Steroidal Antiinflammatory Drugs Prescribed for Orthopedic Patients

Solanki

Gor

Parmar

2019

Int J Pharm Pharm Sci

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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.

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“…GI-related adverse reaction observed in 28 participants. It was found that eighty percent of the adverse reaction was possible in nature [12], which supported our study results.…”

Section: Discussionsupporting

confidence: 91%

Effectiveness and Safety Assessment of Fixed Dose Combination of Non-Steroidal Antiinflammatory Drugs Prescribed for Orthopedic Patients

Solanki

Gor

Parmar

2019

Int J Pharm Pharm Sci

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“…Likewise a study by Gor et al had 80% of possible ADRs with the majority being mild, as the rechallenge and dechallenge may not have occurred in the patients administering the non-steroidal anti-inflammatory drugs. 21 Different outcome in terms of causality assessment in the study done by Sudhakar et al showed majority of probable ADRs (85.2%); because even if it is not possible to actually perform rechallenge and dechallenge because of ethical concern, withdrawal of medicine after the occurrence of ADR and consequent decrease in ADR intensity can validate the probable causality assessment. 22 Differing in case of causality but similar in case of severity, the study done by Mukherjee et al had 83.03% probable/likely ADRs with majority ADRs being mild (83.33%).…”

Section: Discussionmentioning

confidence: 96%

Evaluation of prescribing pattern and rationality of fixed dose combinations in patients of general medicine department

Joshi¹,

Falke²,

Saji³

et al. 2019

Int J Basic Clin Pharmacol

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Background: Fixed dose combinations are widely used in India, they are either irrational or prescribed irrationally. Moreover, the government has recently banned over 300 fixed dose combinations (FDCs) because of a lack of therapeutic justification. This study was conducted to study the prescribing pattern of FDCs in a tertiary care teaching hospital and to highlight the rationality of FDCs, and adverse drug reactions (ADRs) associated with them.Methods: In the present prospective observational study, a total of 500 inpatients were evaluated for prescribing pattern, cost analysis, and adverse drug reactions (ADRs) of FDCs. The FDCs were assessed for their rationality. The ADRs and severity were assessed using the WHO causality scale, Hartwig severity scale respectively.Results: Out of total 103 FDCs, 58 were approved, 86 were rational and 17 were irrational. 5 FDCs were banned and irrational. 48.54% of rational FDCs had rationality score from 7 to 9. The most commonly prescribed FDCs belonged to the anatomic therapeutic and chemical class of respiratory system, followed by the in younger age group and cardiovascular FDCs in the elderly. The 886 ADRs occurred in 500 patients with a mean of 1.81±1.9. Banned FDCs contributed to 76 ADRs. According to causality and severity assessment, most of the ADRs were possible (62.53%) and mild (70.77%) respectively.Conclusions: Although FDCs were rational in most cases but banned FDCs were also prescribed. As these FDCs were associated with ADRs, monitoring of patients is necessary. Knowledge and attitude of healthcare professionals can be assessed through awareness programs.

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Evaluation of prescribing pattern and adverse effects of fixed dose combination of non-steroidal anti-inflammatory drugs

Cited by 2 publications

References 4 publications

Effectiveness and Safety Assessment of Fixed Dose Combination of Non-Steroidal Antiinflammatory Drugs Prescribed for Orthopedic Patients

Effectiveness and Safety Assessment of Fixed Dose Combination of Non-Steroidal Antiinflammatory Drugs Prescribed for Orthopedic Patients

Evaluation of prescribing pattern and rationality of fixed dose combinations in patients of general medicine department

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