Evaluation of prescribing pattern and rationality of fixed dose combinations in patients of general medicine department
Keywords:FDCs, ADRs, Rationality, Banned
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 anti-infectives 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.
Upadhyay D, Singh A, Joshi HA, et.al. Study of prescription patterns of fixed dose combinations prescribed by medical interns. Int J Biomed Res. 2016;7:624-8.
Gupta KY, Suganthi SR. Fixed dose drug combinations: issues and challenges in India. Indian J Pharmacol. 2016;48(4):347-9.
Mohanty BK, Aswini M, Hasamnis A, Patil SS, Mutry KSN, Jena SK, et al. Prescription pattern in the department of medicine of a tertiary care hospital in south India. J Clin Diagnos Res. 2010;3:2047-51.
Panda J, Tiwari P, Uppal R. Evaluation of rationality of some FDCs: Focus on anti-hypertensive drugs. Int J Pharma Sci. 2006;68(5):649-53.
Drugs.com. Drug Interaction Report. Available at: https://www.drugs.com/interactions-check.php? drug_list=844-0,1964-0,2257-0. Accessed on 3 October 2019.
Hendeles L, Hatton RC. Over-the-Counter Oral Phenylephrine: A Placebo for Nasal Congestion. J Allergy Clin Immunol. 2015;3(5):279-80.
Rubin BK. Mucolytics, expectorants, and mucokinetic medications. J Respiratory Care. 2007;52(7):859-64.
Mattoo SK, Basu D, Sharma A, Balaji M, Malhotra A. Abuse of codeine-containing cough syrups: a report from India. Society Study Addiction J. 1997;92(12):1783-7.
Thehindubusinessline.com. (2016). Who banned my cough syrup? And why? Available at: https://www. thehindubusinessline.com/specials/pulse/who-banned-my-cough-syrup-and-why/article 8371387.ece Accessed on 3 October 2019.
Pharmabiz.com. (2014). Lowering of paracetamol to 325 mg applicable to FDC with other analgesic/anti-inflammatory drugs only: DCGI. Retrieved from http://www.pharmabiz.com/NewsDetails.aspx?aid=79911&sid=1. Accessed on 3 October 2019.
NEXT DT. (2019). Top 10 commonly used medication now banned in India. Available at: https://www.dtnext.in/Preview/Wellbeing/2016/03/17133641/Top-10-commonly-used-medication-now-banned-in-India.vpf. Accessed on 3 October 2019.
Balsubramaniam R, Hariharan D, Pamulapati TV, Devrajan V, Shanmugam S, Manjuladevi AS. A study on evaluation of rationality of fixed dose combinations. Am J Pharm Res. 2013;3(5):538-47.
Pradhan S, Panda A, Behera JP. An evaluation of prevalence and prescribing patterns of rational and irrational fixed dose combinations (FDCs): a hospital based study. Int J Med Sci Public Health. 2017;6(1):58-62.
Poudel A, Izham M, Mishra P, Palaian S. Assessment of utilization pattern of fixed dose drug combinations in primary, secondary and tertiary healthcare centers in Nepal: a cross-sectional study. BMC Pharmacol Toxicol. 2017;18(69).
Manjunatha CH, Rohith V, Maheshwari R, Topno I. Prescription Pattern of fixed dose drug combinations in obstetrics and gynecology department of a tertiary care hospital in Puducherry, India: an observational study. Int J Basic Clin Pharmacol. 2018;7(11).
Dhande P, Patel H, Gupta A. Prescribing trend of fixed dose combinations (FDCs) in a tertiary care teaching hospital in western India. Euro J Biomed Pharma Sci. 2015;2(5):429-39.
Yadav AK, Jeenger J, Panwar D. Evaluation of rationality of fixed dose combinations prescribed in psychiatric patients. National J Physiol Pharma Pharmacol. 2016;6(2):150-4.
Gupta R, Malhotra A, Malhotra P. Assessment of rational use of fixed dose combinations in hypertension in a tertiary care teaching hospital in north India. Int J Adv Med. 2018;5(5):1263-67.
Nazmi A, Umme A. Prescribing trends of fixed dose combination using WHO guidelines. J Biological Chem. 2015;32(2):471-7.
Balat JD, Gandhi AM, Patel PP, Dikshit RK. A study of use of fixed dose combinations in Ahmedabad, India. Indian J Pharmacol. 2014;46(5):503-9.
Gor AP, Shah BK. Evaluation of prescribing pattern and adverse effects of fixed dose combination of non-steroidal anti-inflammatory drugs. Int J Basic Clin Pharmacol. 2016;5(3):1029-33.
Sudhakar K, Deepa Latha C, Baloju D, Malahat AR, Vijayalakshmi G. Study to evaluate use of irrational fixed dose combinations. Int J Current Pharma Res. 2017;9(5):64-6.
Mukherjee S, Era N, Saha B, Tripathi SK. Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in eastern India. Indian J Pharmacol. 2017;49(3):223-8.
Shende TR, Siddiqui RA, Mahajan HM. A drug utilization study of fixed dose combinations used in hypertension in rural tertiary healthcare centre of central India. Int J Current Res Rev. 2016;8(12):30-4.
Tahir A, Gulati K, Lalit M, Shinoy S, Patil N. Evaluation of prescribing pattern of fixed dose combination of drugs in outpatients of cardiology in tertiary care hospital. World J Pharm Pharma Sci. 2014;3(11):623-2.