Fixed dose drug combinations: Issues and challenges in India

Gupta, Yogendra Kumar; Ramachandran, Suganthi S.

doi:10.4103/0253-7613.186200

Cited by 63 publications

(75 citation statements)

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“…It claims that many of the Fixed Dose Combinations that are marketed are largely irrational and, even if it is rational, it is limited by pharmacokinetic incompatibility of the drugs. 6 In a recent analysis, out of the 264 FDCs approved in India, only 54 FDCs were found to be rational and for the remaining FDCs, the safety and effectiveness remains a matter of investigation. 7 To be noted, although recently in March 2016, more than 324 Fixed Dose Combinations marketed in India are banned, still many of them are commonly prescribed and available as over the counter.…”

Section: Introductionmentioning

confidence: 99%

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Ravichandran¹,

Balamurugan

Shankareshwari³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Fixed dose combination (FDC) are currently most prescribed and misused drug forms. Although fixed dose combinations are clinically better than single dosage forms, improper prescription and large amounts of irrational FDC flooding leads to unwanted financial burden and increased resistance. Therefore a study was carried out to know about the existing scenario about Knowledge Attitude and Practice of Fixed dose combinations among the resident doctors and devise some suggestions for improving the rationality. The objective of the study was to evaluate the knowledge, attitude and prescriptional practice regarding fixed dose combinations among resident doctors working in a Government Theni medical college, Theni.Methods: A cross-sectional descriptive study involving 100 resident doctors was conducted using a pre validated questionnaire containing 21 questions to evaluate the knowledge and prescriptional practice of Fixed Dose Combination among the study participants.Results: Ninety-five percent of the study participants were aware of the Fixed dose combination. Increased compliance and synergistic drug effect are the commonly cited advantages, whereas difficulty in dose adjustment and increased side effects were the commonly told disadvantages. Only 13% of the participants could name a single banned drug. Antibiotics (63%), NSAIDS (18%) were the commonly prescribed FDCs among study participants. Internet (58%), followed by textbook (42%) and colleagues (37%) were the common sources of knowledge about FDCs. Increasing awareness about Essential Medicines List (63%), regular CME (55%) and prior notification (50%) are some of the measures recommended by study participants to improve the awareness.Conclusions: Although the participants are aware of basic knowledge of fixed dose combinations are acceptable, prescribing FDC them often, many of the study participants lack knowledge about the rationality of these drugs. From our study, conducting regular CME’s about new Fixed dose combinations in the medical colleges and periodic notification of FDC’s are some of the suggested approaches to improve the rationality of prescription. Since Internet is listed as the most common source of knowledge about FDC, information about FDC can be sent through mails, text messages, which will play a part in improving the rationality of FDC.

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Section: Introductionmentioning

confidence: 99%

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Ravichandran¹,

Balamurugan

Shankareshwari³

et al. 2017

Int J Basic Clin Pharmacol

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“…Periodic surveillance must be carried out to screen irrational preparations and for content adequacy analysis of approved preparation. Over the counter sale of drugs must be discouraged, reluctant approach to nutraceuticals use by physicians and misuse by consumer must be curtailed by legal and educational measures [12][13][14][15].…”

Section: Discussionmentioning

confidence: 99%

Rationality Assessment of Zinc Formulations Available in India

Chary

Bhaskaran

2017

Int J Pharm Pharm Sci

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Objective: To critically analyze the essentiality and irrational zinc preparations available in Indian market. Methods:This was conducted as cross-sectional analysis by department of pharmacology of our tertiary care hospital between June and December 2016. Data regarding various formulations of zinc were retrieved from current index of medical sciences and drug India database. Rationality assessment was done using prescribed guidelines and approved formulations of zinc by Central drug standard control organisation. Essentiality was checked using National list of essential medicine India, 2013 and latest version of WHO list essential medicine bulletin. Dosage regulation was assessed using Indian pharmacopeia guidelines, National institute of nutrition, India recommendation and upper daily intake toxicity intake, United States of America (USA) Results: Our study results showed wide variation in the number of zinc preparation. Total number of formulation available in the market is 335. Among zinc preparation, the preparation that contains 20 mg of zinc as recommended by various guidelines is 10 in number. About 325 preparations of zinc are added with one or more nutraceuticals. None of these fixed dose combination of zinc containing preparation is recommended as essential fixed regimen. Conclusion:Zinc has lot of relevance in treating recurrent diarrhoeal illness, especially in paediatric cases; however legal, regulatory and educational measures should be followed to curtail all the irrational zinc prescription development, promotion, marketing and prescription.

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“…The concept of essential drug list was introduced by WHO in 1977 which is updated every two years. Out of the 414 medicines included in the19th list of WHO EML, 27 are FDCs 9 . In India, a variety of combinations of drugs are available that are irrational and not included in WHO EML 10 .…”

Section: Discussionmentioning

confidence: 99%

Untitled

2016

IJPSR

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Objective:To evaluate the knowledge, attitude and practice, regarding Fixed Dose Combinations (FDCs) among Postgraduate medical students of Bangalore Medical College and Research Institute, Bengaluru. Materials and methods:The questionnaire based study was conducted among 150 Postgraduate medical students of BMCRI, Bengaluru. The data obtained was analyzed using descriptive statistics. Results: Out of the 150 postgraduate students, 74% were aware about the advantages and disadvantages of FDCs. The knowledge regarding the WHO Essential Medicine List (EML) was 63%. Knowledge about banned FDCs and rationality of various FDCs were 62% and 32% respectively. The common sources of information were textbooks and journals. 10% of them opined that FDCs should not be allowed to be marketed. The most commonly prescribed FDC was amoxicillin + clavulanic acid and the most common indication was respiratory tract infection. Conclusion: It was observed that there was a lack of awareness about rationality of FDCs among postgraduate students. Hence, there is a need to sensitize them regarding the efficacy, safety, suitability and rationality of FDCs.

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Fixed dose drug combinations: Issues and challenges in India

Cited by 63 publications

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Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Rationality Assessment of Zinc Formulations Available in India

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