EVALUATION OF PRESCRIPTION PATTERN AND RATIONALITY OF FIXED DRUG COMBINATIONS (FDCS) IN A TERTIARY CARE TEACHING HOSPITAL: RETROSPECTIVE OBSERVATIONAL STUDY
Main Article Content
Keywords
Fixed drug combinations, rationality, CDSCO,, WHO guidelines, prescription pattern, pharmacovigilance
Abstract
Background:
Fixed drug combinations (FDCs) are widely prescribed to improve patient compliance, enhance therapeutic efficacy, and minimize pill burden. However, irrational and indiscriminate use of FDCs can lead to adverse drug reactions, drug interactions, and antimicrobial resistance.
Objective:
To evaluate the prescription pattern, rationality, and regulatory status of fixed drug combinations prescribed in a tertiary care teaching hospital with reference to WHO and Central Drugs Standard Control Organization (CDSCO) guidelines.
Methods:
A retrospective observational study was conducted over six months (January–June 2023) among 400 prescriptions collected from the outpatient departments (OPDs) of Medicine, Surgery, ENT, and Dermatology. Data were analysed for FDC usage, drug class, indication, rationality (as per WHO criteria), and approval status from CDSCO.
Results:
Out of 400 prescriptions, 220 (55%) contained at least one FDC. The average number of FDCs per prescription was 1.4 ± 0.6.
Commonly prescribed FDC categories included:
- Antimicrobial combinations: 28% (Amoxicillin + Clavulanic acid most common)
- Analgesic/antipyretic combinations: 22% (Paracetamol + Ibuprofen)
- Antihypertensive and antidiabetic combinations: 18% (Amlodipine + Telmisartan, Metformin + Sitagliptin)
- Gastrointestinal agents: 16% (Pantoprazole + Domperidone)
- Respiratory agents: 10% (Levosalbutamol + Ambroxol)
- Vitamins/mineral combinations: 6%
Rationality assessment (WHO criteria):
- Rational FDCs: 72%
- Irrational/unapproved combinations: 18%
- Insufficient data to judge: 10%
Adverse events were reported in 6% of patients, mainly gastritis and mild hypersensitivity.
Conclusion:
FDCs were widely prescribed, particularly for infectious and chronic conditions. While most combinations were rational and CDSCO-approved, the presence of irrational or non-approved FDCs underscores the need for continuous prescription audit and clinician education to ensure safe and rational use.
References
2. CDSCO. Fixed Dose Combinations approved by DCGI. Govt. of India; 2023.
3. Hazra A, et al. Rationality of fixed-dose combinations: An Indian perspective. Indian J Pharmacol. 2020;52(5):341–347.
4. Tripathi KD. Essentials of Medical Pharmacology. 9th ed. Jaypee Brothers; 2022.
5. Ministry of Health and Family Welfare. Ban on irrational FDCs in India: Gazette Notification, 2022.
6. Shankar PR, et al. Fixed-dose combination use in clinical practice: Trends and challenges. Int J Basic Clin Pharmacol. 2021;10(3):201–208.
7. Gupta R, et al. Pattern of fixed dose combination prescriptions in India. J Family Med Prim Care. 2022;11(4):1331–1336.
8. Chatterjee S, et al. Prescribing pattern of FDCs in a tertiary hospital: A cross-sectional study. Indian J Pharm Pract. 2020;13(1):25–30.
9. Banerjee S, et al. Evaluation of FDC rationality using WHO criteria. Int J Pharm1. World Health Organization. Rational use of drugs: report of the conference of experts. Nairobi: WHO; 1985.
2. CDSCO. Fixed Dose Combinations approved by DCGI. Govt. of India; 2023.
3. Hazra A, et al. Rationality of fixed-dose combinations: An Indian perspective. Indian J Pharmacol. 2020;52(5):341–347.
4. Tripathi KD. Essentials of Medical Pharmacology. 9th ed. Jaypee Brothers; 2022.
5. Ministry of Health and Family Welfare. Ban on irrational FDCs in India: Gazette Notification, 2022.
6. Shankar PR, et al. Fixed-dose combination use in clinical practice: Trends and challenges. Int J Basic Clin Pharmacol. 2021;10(3):201–208.
7. Gupta R, et al. Pattern of fixed dose combination prescriptions in India. J Family Med Prim Care. 2022;11(4):1331–1336.
8. Chatterjee S, et al. Prescribing pattern of FDCs in a tertiary hospital: A cross-sectional study. Indian J Pharm Pract. 2020;13(1):25–30.
9. Banerjee S, et al. Evaluation of FDC rationality using WHO criteria. Int J Pharm Sci Rev Res. 2022;74(2):49–55.
10. Sharma M, et al. Regulatory assessment of fixed-dose combinations: Indian scenario. Clin Ther. 2021;43(9):1592–1600.
11. WHO. Model List of Essential Medicines: Guidance on fixed-dose combinations. Geneva: WHO; 2023.
12. Deshpande K, et al. Adverse drug reactions associated with FDCs: A pharmacovigilance perspective. J Clin Pharmacol. 2022;62(11):1378–1384.
Sci Rev Res. 2022;74(2):49–55.
10. Sharma M, et al. Regulatory assessment of fixed-dose combinations: Indian scenario. Clin Ther. 2021;43(9):1592–1600.
11. WHO. Model List of Essential Medicines: Guidance on fixed-dose combinations. Geneva: WHO; 2023.
12. Deshpande K, et al. Adverse drug reactions associated with FDCs: A pharmacovigilance perspective. J Clin Pharmacol. 2022;62(11):1378–1384.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Dr Syed Sujat pasha
Assistant professor, Department of pharmacology, Alameen medical college, Vijayapur, Karnataka, India
Dr Lakshmipathi B S
Associate Professor, Department of Pharmacology, Koppal Institute of Medical Sciences, Koppal, Karnataka, India
Dr Sha Naseeruddin Makandar
Assistant professor, Department of Pharmacology, Kanachur institute of medical sciences, Natekal, Mangalore, Karnataka, India