A cross sectional study of knowledge, attitude and practices related to fixed dose combinations use among clinicians and resident doctors at a tertiary care teaching hospital in India
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20174366Keywords:
Irrational fixed dose combinations, Prescription, Rational prescribingAbstract
Background: In the year 2016, Government of India had banned 350 fixed dose combinations (FDCs) for the safety and efficacy purpose. The present study was conducted to assess the knowledge, attitude and practices of the clinicians and residents about the use of FDCs at a tertiary care hospital.
Methods: A questionnaire based study was conducted at a tertiary care hospital after getting approval from institutional ethics committee. A pre-validated questionnaire comprising of 30 items was distributed to 100 participants. The questionnaire focused on the prescribing behaviour, knowledge on therapeutic efficacy, advantages and limitations of FDC use, clinician perception regarding FDC use and the strategies to improve the awareness about the regulatory updates of the marketed drugs.
Results: Total 52/100 clinicians responded. Out of these, 88% prescribed FDCs in their practice, 62% prescribed FDCs only after ensuring therapeutic efficacy and 50% prescribed WHO approved FDCs. 64% were aware of the recent ban on some FDCs by DCGI. Internet was the most common source of latest updates on the regulatory status of the drug, as stated by 55% clinicians. All clinicians agreed that efforts are needed to ensure that prescribers remain up to date about the post-marketing regulatory status of the drugs.
Conclusions: Even though many clinicians prescribe FDCs regularly, they appreciated the step of banning some FDCs; however, the clinicians need to be trained to update themselves regularly. The source and relevance of these updates should be taught to the undergraduate students during their training period which can be reemphasized during post graduate training period.
References
WHO drug information: World Health Organization (Geneva). 2003;17(3):85. Available at: http://apps.who.int/medicinedocs/en/d/Js4955e
Sreedhar D, Subramanian G, Udupa N. Combination drugs: are they rational? Curr Sci. 2006;91:406.
Panda J, Tiwari P, Uppal R. Evaluation of rationality of some FDC: Focus on antihypertensive drugs. Indian J Pharm Sci. 2006;68:649-52.
Balat JD, Gandhi AM, Patel PP, Dikshit RK. A study of use of fixed dose combinations in Ahmedabad, India. Indian J Pharmacol. 2014;46:503-9.
Amitava S, Indian market's fixation with fixed dose combinations (Editorial) Rational Drug Bulletin. 2002;12:1.
World Health Organization (WHO) Model List of Essential Medicines. 17th list (updated), March 2011. Available at: http://www.who.int/medicines/publications/essentialmedicines/en/index.html [Last accessed on 10th April 2016]
National list of essential medicines; 2003. Available at: http://www.serowho.int/linkfiles/essential drugs and medicines india.pdf [Last accessed on 10th April 2016].
World Health Organization. The Use of Essential Drugs. WHO Technical Report Series 850. Geneva: World Health Organization; 1995.
Rayasam SP, Dudhgaonkar SS, Dakhale GN, Hire RC, Deshmukh PS, Gaikwad NN. The irrational fixed dose combinations in the Indian drug market: an evaluation of prescribing pattern using WHO guidelines. Int J Basic Clin Pharmacol. 2013;2:452-7.
Baiardini I, Guerra L, Pasquali M, Bonadonna P, Pasalaqua G, Canonica GW. Quality of Life in Patients with Adverse Reactions to Drugs: Preliminary Results from a New Questionnaire. J Allergy ClinImmunol. 2004;113(2):s70.
Gautam CS, Aditya S. Irrational drug combination: need to sensitize undergraduates. Ind J Pharmacol. 2006;38:167-70.
Tripathi KD (ed). Appendix 2. Drugs and fixed dose combinations banned in India. In: Essentials of medical pharmacology, 5th Edn. New Delhi: Jaypee Brothers; 2004:847-848.
Drugs banned in India. Available at: http://www.cdsco.nic.in/drugs%20banned%20in% 20th ed. 20country.pdf [Last accessed on 20th April 2016]
Prohibition of Fixed Dose Combination Drugs for Human Use Under Section 26A of Drugs and Cosmetics Act, 1940; 2016. Available at: http://www.cdsco.nic.in/writereaddata/SKM_12 03 2016.pdf)
Goswami N, Gandhi A, Patel P, Dikshit R. An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors. Perspect Clin Res. 2013;4:130-5.
George B. Evaluation of awareness about Fixed Dose Combination among the practitioners in Dentistry: A Question based study. Int. J. Chem. And Life Sci. 2014;3(05):1322-24.
Sharma K, Sharma A, Singh V, Pilania D, Sharma Y. Irrational Fixed Dose Combinations & Need for Intervention: Understanding of Dental Clinicians and Residents. Journal of Clinical and Diagnostic Research. 2014;8(12):ZC49-52.
Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian J Pharmacol. 2016;48:347-9.
