Banned Fixed Drug Combinations of NSAIDS:An Update for Dentists in India

2019 ◽  
Vol 10 (12) ◽  
pp. 1009
Author(s):  
R. Bhargavi ◽  
V. T. Hemalatha ◽  
A. Amudhan ◽  
T. Sarumathi ◽  
T. Manigandan
Keyword(s):  
Drug Combinations ◽  
Fixed Drug

scholarly journals STUDY TO EVALUATE USE OF IRRATIONAL FIXED DRUG COMBINATIONS

2017 ◽  
pp. 64-66
Author(s):  
Sudhakar K. ◽  
C. Deepa Latha ◽  
Deepika Baloju ◽  
A. R. Malahat ◽  
G. Vijayalakshmi
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Workers ◽  
Prospective Observational Study ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Care ◽  
Drug Combinations ◽  
Drug Reactions ◽  
Care Workers ◽  
Fixed Drug ◽  
Awareness Programs

Objective: To identify fixed drug combinations causing the adverse drug reactions both rational and irrational.Methods: A prospective observational study was carried out over a period of 6 mo (between June 2016 to December 2016) to evaluate adverse drug reactions related to fixed drug combinations in a tertiary care teaching hospital using suspected adverse drug reaction reporting form.Results: A total number of 64 adverse drug reactions were reported during this period. Of the total adverse drug reactions reported, 27 (42%) were due to fixed drug combinations. 6 (28.5%) were serious and 21(71.5%) were non-serious. Causality was certain in 4 (14.8%) cases and probably in remaining 23 (85.2%) cases. 19(70%) irrational fixed drug combinations were reported.Conclusion: The above results show that irrational fixed drug combinations contribute major extent to adverse drug reactions. Hence, awareness programs should be conducted for all the health care workers to improve the rationality of prescription and to decrease adverse drug reactions.

scholarly journals Quality assurance of rifampicin-containing fixed-drug combinations in South Africa: dosing implications

2018 ◽  
Vol 22 (5) ◽  
pp. 537-543 ◽  
Author(s):  
R. Court ◽  
M. T. Chirehwa ◽  
L. Wiesner ◽  
B. Wright ◽  
W. Smythe ◽  
...  
Keyword(s):  
South Africa ◽  
Quality Assurance ◽  
Drug Combinations ◽  
Fixed Drug

scholarly journals Approaches to Clinical Development of Combination Medicines in the Russian Federation and the Eurasian Economic Union in view of the Requirements of the Current Legislation

2019 ◽  
Vol 9 (1) ◽  
pp. 14-27
Author(s):  
A. V. Dobrovolskiy
Keyword(s):  
Russian Federation ◽  
Clinical Studies ◽  
Clinical Development ◽  
Drug Combinations ◽  
Sufficient Information ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Fixed Drug ◽  
The Russian Federation ◽  
Economic Union

In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation. 

scholarly journals Triple fixed drug combinations in type 2 diabetes

2015 ◽  
Vol 19 (3) ◽  
pp. 311 ◽  
Author(s):  
Mathew John ◽  
Sanjay Kalra ◽  
Deepa Gopinath
Keyword(s):  
Type 2 Diabetes ◽  
Drug Combinations ◽  
Fixed Drug

A viewpoint on rational and irrational fixed-drug combinations

2018 ◽  
Vol 11 (8) ◽  
pp. 761-771 ◽  
Author(s):  
Barbara Błaszczyk ◽  
Barbara Miziak ◽  
Piotr Czuczwar ◽  
Ewa Wierzchowska-Cioch ◽  
Ryszard Pluta ◽  
...  
Keyword(s):  
Drug Combinations ◽  
Fixed Drug

scholarly journals Topical antifungal-corticosteroid fixed-drug combinations: Need for urgent action

2021 ◽  
Vol 53 (1) ◽  
pp. 82
Author(s):  
Vandana Roy ◽  
Proteesh Rana ◽  
Manik Ghadlinge
Keyword(s):  
Drug Combinations ◽  
Fixed Drug ◽  
Urgent Action

scholarly journals Prescription Pattern of fixed dose drug combinations in obstetrics and gynecology department of a tertiary care hospital in Puducherry, India: an observational study

2018 ◽  
Vol 7 (11) ◽  
pp. 2122
Author(s):  
Manjunatha C. H. ◽  
Rohith V. ◽  
Maheshwari R. ◽  
Isabella Topno
Keyword(s):  
Anatomical Therapeutic Chemical ◽  
Tertiary Care ◽  
Drug Combinations ◽  
Fixed Dose ◽  
National Database ◽  
Obstetrics And Gynecology ◽  
Care Hospital ◽  
Prescription Pattern ◽  
Advantages And Disadvantages ◽  
Fixed Drug

Background: Fixed drug combinations (FDCs)have various advantages and disadvantages. In countries like India there are numerous irrational prescriptions as highlighted by the recent banning of FDCs in October 2018. Studying the prescription pattern helps in developing national database which can be used to promote rational use of drugs.Methods: All the Outdoor Patient Department (OPD) prescriptions from department of Obstetrics and Gynecology (OBG) during the study period were used for the study. The drugs were classified according to Anatomical Therapeutic Chemical (ATC) classification. Other data studied were the number of FDCs and the number of currently banned combinations which were used during the study period.Results: The 41% of the drugs prescribed as FDCs. Most FDCs belonged to alimentary system followed by anti-infectives and blood and blood forming organs group. Vitamin D3 and Calcium combination was the most commonly prescribed FDC. Approximately 20% of these prescribed drugs are currently banned.Conclusions: A significant number of drugs are being prescribed as FDCs which also includes various irrational combinations.

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