Critical analysis of antimicrobial and respiratory fixed dose combinations available in Indian market

Shah, Samidh; Patel, Jignesh; Desai, Mira; Dikshit, R K

doi:10.4103/2230-8598.153828

Cited by 6 publications

(9 citation statements)

References 7 publications

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“…This combination is considered rational by other studies also. 6,7 Generally, higher use of medicine has higher brand and market competition. On the other hand, the most used antibiotic cefixime 200 mg and clavulanic acid 125 mg tab had two brands; this combination is not listed in both EML of Nepal and WHO.…”

Section: Discussionmentioning

confidence: 99%

“…The instrument for the study was prepared by reviewing the literature and consultation with senior colleagues. 6,7,10 The designed questionnaire collects demographics (age, gender), FDCs name (brand or generic name), FDC composition and total FDC prescribed. The EML list of Nepal 2016 and World Health Organisation (WHO) 2017 were used for study.…”

Section: Methodsmentioning

confidence: 99%

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An evaluation of fixed dose combinations and it’s practices at medicine department of tertiary care hospital, Nepal

Shrestha

Gurung²

2020

Int J Sci Rep

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Background: A large proportion of fixed dose combinations (FDCs) are manufactured and used widely in Nepal. This study aimed to evaluate the FDCs and its utilization in medicine department of tertiary care hospital.Methods: A cross-sectional study was conducted for 50 days among admitted patients in the medicine department of tertiary care hospital, Nepal. A predesigned form was used to collect the data at the time of patient discharge. Only the oral FDCs were selected for study. Microsoft Excel 2007 was used for statistical analysis and data were presented as number and percentage in tabulated and figure forms. Results: Oral FDCs were used in 27.08% of admitted patients. A total of 295 FDCs were prescribed in 208 patients with 44 FDC items in 58 different brand names. Categorically, the most commonly used FDCs were of analgesics (34.24%) followed by antibiotics (25.76%) and vitamin supplements (22.71%). The 27.27% of FDCs prescribed contain more than two active pharmaceutical ingredients (APIs) up to nine and the highest number of APIs were found in vitamin supplements. All FDCs were prescribed in the brand names. The very few 2.27% and 4.55% of FDCs were prescribed from the essential medicine list of Nepal and world health organization, respectively.Conclusions: The use of FDCs listed in essential medicine list was very poor. Similarly, generic prescribing was also zero. The regulatory body must study the rationality of FDC before production, marketing, importing, and utilization in hospital.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

An evaluation of fixed dose combinations and it’s practices at medicine department of tertiary care hospital, Nepal

Shrestha

Gurung²

2020

Int J Sci Rep

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“…It is defined as the assumed average maintenance dose per day for a drug used for its main indication for adults and is assigned by the WHO collaborating centre using established principles. 11 It is a technical unit of measurement assigned for different drug formulations. DDD's only specifies medicines given in ATC codes.…”

Section: Defined Daily Dosementioning

confidence: 99%

Point Prevalence Study of use and Consumption of Antibiotics by using Anatomical and Therapeutic Chemical Classification and Defined Daily Dose Methodology in Tertiary Care Hospital

Kumar¹,

Krishna²,

Sindusha³

et al. 2020

IJOPP

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Objectives: The aim of this study is to identify the use and consumption of antibiotics in tertiary care hospital by using Anatomical and therapeutic chemical classification and Defined daily dose index. Material and Methods: A point prevalence study was conducted at tertiary care hospital. A total of 640 patients were included in this study and taken from different medical departments. Patient's demographic and biological data was collected from the medical records. Antibacterial drugs were classified according to ATC/ DDD index and antibiotic consumption was measured by DDD/ 100 Patient days. Results: The mean age of 640 patients was 44 (sd 13.53). About 78% of the antibiotics are prescribed from the NLEM (2018-2019). The consumption of antibiotics is higher in departments like surgery (92.18%), Orthopaedics (87.5%) and General medicine (81.25%) followed by Gynaecology (78.13%) and Pulmonology (50.2%). The DDD/ 100 Patient days in Gynaecology were 19.4, in Pulmonology unit 45.2, in surgical unit 24.82, in General medicine unit 33.6 and in Orthopaedics 30.23. Discussion: In our study the rate of utilisation of antibiotics was found to be 78%. Broad spectrum antibiotics like cephalosporin's and aminoglycosides are prescribed frequently in the hospital which leads to increase in the microbial resistance. The DDD of ceftriaxone (1250) and cefixime (400) is higher when compared to aminoglycosides i.e. amikacin (700). Conclusion: The DDD of cephalosporins is higher when compared to other antibiotics. Inappropriate use of antibiotics leads to increase in the microbial resistance. Prescribers are forced to use broad spectrum antibiotics when other antibiotic therapy options are not available.

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“…In addition, their pharmacokinetics must not be widely different 1. Several studies from parts of Asia and Latin America have shown that many FDCs are not rational, and the government of some countries have banned several FDCs 2,4,9,10,11. FDC combinations so far been found to be problematic include several containing antibiotics, cough and cold medicines, antidepressants, Non-Steroidal Anti-inflammatory Drugs and antipsychotics 10-14…”

Section: Introductionmentioning

confidence: 99%

Availability and rationality of fixed dose combinations available in Kaduna, Nigeria

Auwal¹,

Dahiru²,

Abdu-Aguye³

2019

Pharm Pract (Granada)

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Background: Fixed-dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. Despite the advantages obtained from the use of these agents, there is increasing evidence questioning the rationality of several FDCs found in pharmaceutical markets-especially those in developing countries like Nigeria. Objectives: To describe the availability of FDCs in drug retailing outlets located in Kaduna Nigeria, and to assess FDC registration status and inclusion on national and international essential medicines lists (EMLs). Rationality of selected FDCs was also assessed. Methods: A cross-sectional survey was carried out from June to September 2018 in 60 registered pharmacies and patent medicine shops selected through multi-stage sampling. A data collection form was used to obtain information on the generic names and strengths of the active ingredients of the FDCs, their country of manufacture and evidence of registration with the Nigerian drug regulatory agency. To assess rationality, a scoring rubric developed from earlier studies was used. Data collected was coded and entered into a Microsoft excel 2016 spreadsheet for analysis. Descriptive statistics (frequencies and percentages) were used to report the data collected. Results: FDCs encountered included 74 oral tablets/capsules, 52 oral liquids and 23 topical semi solids. Majority of the available FDCs were registered by Nigerian drug regulatory agency (91.5%), although only 8.5% and 6.5% in total were included on the Nigerian EML and the WHO model list respectively. Of the 99 FDCs assessed for rationality, 58 (58.6%) were found to be rational. Irrational FDCs included drugs acting on the respiratory tract (29.3%), analgesics (26.8%) and anti-infectives (22%). Conclusions: A wide variety of FDCs were available in the study area, even though not all of them were rational. There is an urgent need for policy makers within the country to develop better detailed guidelines for FDC registration.

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Critical analysis of antimicrobial and respiratory fixed dose combinations available in Indian market

Cited by 6 publications

References 7 publications

An evaluation of fixed dose combinations and it’s practices at medicine department of tertiary care hospital, Nepal

An evaluation of fixed dose combinations and it’s practices at medicine department of tertiary care hospital, Nepal

Point Prevalence Study of use and Consumption of Antibiotics by using Anatomical and Therapeutic Chemical Classification and Defined Daily Dose Methodology in Tertiary Care Hospital

Availability and rationality of fixed dose combinations available in Kaduna, Nigeria

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