Rationality Of Fixed Dose Combinations Research Articles

Evaluation of prescribing pattern of fixed-dose combinations in obstetrics and gynecology department of a tertiary care hospital of central India

Background: Improved patient compliance and cost effectiveness are two benefits of fixed-dose combination drugs. Irrational fixed-dose combinations (FDCs) raise the most urgent issue since they put patients at needless risk for negative medication responses. Aims and Objectives: The present study was done with objective of analyzing prescribing pattern of FDCs in department of fixed-dose combination in department of obstetrics and gynecology in a tertiary care hospital of central India. Materials and Methods: This study, which was both prospective and observational, was conducted at the tertiary care hospital of central India. This study comprised the prescriptions of all patients who visited the obstetrics and gynecology Outpatient Department during the study period. Results: In the present study, 1605 prescriptions were analyzed, comprising total 3016 drugs. Out of these 1262 were prescribed as FDCs and 1754 were prescribed as single drugs. On analyzing system-wise prescriptions, it was found that majority drugs were prescribed pertaining to gastrointestinal tract, that is, 1720 prescriptions, of which 722 (38.8%) were prescribed as FDCs. Four hundred and sixty-three drugs were prescribed related to hematological system, of which 97 (14.9%) were FDCs. Four hundred and thirty-three drugs were prescribed related to anti-infective class, comprising 196 (36.6%) FDCs. Among FDCs prescribed in gastrointestinal system, Vitamin D3 + Calcium carbonate was most commonly prescribed, accounting for 644 (51%) prescriptions. Clotrimazole + Clindamycin was most commonly prescribed FDC in anti-infective system comprising 118 (9.3%) patients. Ferrous ascorbate + folic acid was most commonly prescribed hematological FDC, accounting for 49 (3.8%) patients. Dextromethorphan + phenylephrine + Chlorpheniramine was most commonly prescribed FDC in respiratory segment accounting for 39 (2.9%) patients. Conclusion: The present study highlights a considerable number of drugs prescribed as FDCs. FDCs reduce pill burden and also help to improve patient compliance. However, rationality of FDCs should be thought before prescribing it to patients.

Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers.

Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.

Prescription pattern and rationality of fixed dose combinations in a tertiary care hospital – Record-based cross-sectional study

Background: Fixed dose combinations (FDCs) are combinations of two or more active drugs in a single pharmaceutical formulation. The rationality of FDC is a controversial and challenging issue in today’s practice of medicine. Aims and Objectives: The aim of the study was to assess the prescription pattern and rationality of FDCs in a tertiary care hospital. Materials and Methods: This is a record-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College, Thrissur. The data were collected from the case records of 183 patients admitted under various departments during the month of January 2019. The FDCs prescribed were listed and the prescription pattern was assessed. All the FDCs were evaluated for rationality with the help of a comprehensive seven-point criteria by Panda et al. The data were analyzed using Epi info 7. Descriptive statistics were used to analyze the data. Results: Out of 183 case records, 39.3% contained at least one FDC, 13.1% contained two FDCs, and 4.4% contained three FDCs. The different drug classes prescribed as FDCs include anti-infective drugs 45%, vitamins and minerals 33%, analgesics 9%, and miscellaneous drug combinations 13%. The most prescribed anti-infective drug FDC is amoxicillin with clavulanic acid combination (56%). In our study, 92.5% of the antibacterial FDCs prescribed were rational and 7.5% irrational. According to the World Health Organization rationality criteria, 62% of our FDCs are rational and 38% are irrational. Conclusion: The present study showed the increased use of FDCs in tertiary care teaching hospital and the most of the FDCs were rational (62%).

An evaluation of prevalence and prescribing patterns of rational and irrational fixed dose combinations (FDCs): a hospital based study

Background: Fixed-dose combinations (FDCs) are combinations of two or more active drugs produced in a single dosage form and are used in the treatment of a wide range of ailments. Objective: The objective was to find out prevalence, prescribing pattern, and rationality of FDC amongst patients attending out-patients department of medicine in a tertiary care teaching hospital. Materials and Methods: A hospital based prospective cross sectional observational study based on a convenience sample of 620 prescriptions carried out in between May 2015 and July. A seven point tool was developed based on the WHO guideline to evaluate the rationality FDCs. The format for the collection of data were to include patients demographic information such as name, age, sex, social history, family history, as well as medication information, diagnosis, and current treatment regimen given by prescriber. Collected prescriptions were screened for fixed dose combinations and analysed for prevalence, prescribing pattern, and rationality. Result: Prevalence of FDCs in the prescription was 81.31%. Brand names were used in 82.78% of the prescriptions. FDCs containing nutritional supplements containing vitamins and minerals are prescribed for maximum numbers (20.48%). About 70% of FDCs were irrational, where 17.71% were either controversial or banned and 15.83% were rational. Conclusion: The prevalence of irrational prescribing of FDC is high. To minimize the pattern, educating the prescribers about rational prescribing is essential. A relook and rationalization may be required in the use of combination product.

Study of Prescription Patterns of Fixed Dose Combinations Prescribed by Medical Interns

Introduction: Illogical habits of prescribing irrational drug combinations have been deteriorating the health of the various communities. There are several benefits of fixed dose combinations (FDCs) but prescribing irrational combinations may be responsible for inadequate or incorrect treatment of patients even after correct diagnosis. The interns will constitute the major portion of the health care providers in our country in near future and irrational practices of prescribing FDCs among them will deteriorate the condition further in future. There is lack of research among these budding doctors will result in ineffective policy regarding teaching and training. Objectives: 1. To study the prescription trends. 2. To study the various prescription patterns of FDCs. 3. To find out the rationality of FDCs in a tertiary care hospital. Methodology: Prescription audit study to study the trends, patterns and rationality of prescriptions made by a batch of 92 Interns posted in various departments in a tertiary care teaching hospital, Bareilly, UP, India. The prescriptions by the 52 interns during two months of their posting were analyzed using R Studio and Policy guidelines-2013, for approval of fixed dose combinations in India. Results: Out of total 994, 64.29% prescriptions contained any kind of fixed dose combinations. The maximum FDCs (27.34%) belonged to antimicrobial class. Only 13.31% FDCs were rational. Ninety five percent FDCs were prescribed by the brand names. Conclusion: The prescription habits of one batch of interns of a teaching hospital are ringing alarm bell to develop effective training program to them and develop a national policy regarding FDCs.

Evaluation of rationality of fixed-dose combinations prescribed in psychiatric patients

Background: There is a growing concern about the increasing number of irrational fixed-dose combinations (FDCs), which impose unnecessary financial burden, increase the occurrence of adverse drug reactions, and ultimately reduce the quality of life. Aims and Objective: To study the prescribing frequency of FDCs and to evaluate the rationality of FDCs prescribed in psychiatric patients. Materials and Methods: This prospective study was carried out in Pharmacology and Psychiatry Department of a tertiary care teaching hospital in Rajasthan, India. The data were collected in a case record form from patients of all ages and from either sex, who visited the outpatient department of psychiatry. Data were analyzed with the help of well-known comprehensive seven-point criteria by Panda et al, which were developed by carefully studying the guidelines of the World Health Organization and Committee for Proprietary Medicinal Products, Europe. Result: Total 383 drug formulations were prescribed in 200 patients of which 107 (27.93%) were in the form of FDCs. Most frequently prescribed FDC was escitalopram + clonazepam (22.44%), followed by amitriptyline + chlordiazepoxide (13.08%). The maximum score for the seven-point criteria for assessing the rationality of FDCs was 14, with each criterion carrying a score of 2. Scores obtained in this study ranged between 5 and 14 with an average of 8.79. Conclusion: Most of the FDCs were irrational according to the criteria used and only 28.57% of the FDCs were found to be rational considering safety and efficacy as the most important criteria for rationality. So, drug regulatory bodies should take urgent action to stop the free flow of irrational FDCs.

Evaluation of the rationality of some FDCs: Focus on antihypertensive drugs

The use of fixed-dose combinations is a widespread clinical practice in the treatment of various cardiovascular disorders. These fixed-dose combinations are valuable only when they have been developed based on sound rational pharmacokinetic and pharmacodynamic criteria, and when claims for their benefits have been supported by evidence-based data and well-designed clinical studies. However, a look at the available fixed-dose combinations reveals that there are combinations which do not meet these basic criteria, and hence their clinical benefit is debatable. In this context, several stakeholders have put forward their views on the rationality of some of the fixed-dose combinations. The situation has become more complicated as there are very limited reports to assess and describe the rationality of fixed-dose combinations on an individual basis. In the present study, a thorough evaluation of 44 fixed-dose combinations used in various cardiovascular disorders using comprehensive criteria has been completed. This evaluation has demonstrated that a large number of fixed-dose combinations are rational, based on the criteria used. Finally, there seems to be enough reason to re-investigate six of them, which did not match the criteria as well as others. These six combinations could be the subject of study by the clinicians and/or pharmaceutical companies to assess their clinical benefit.