Number Of Fixed Dose Combinations Research Articles

Prescription Analysis and Evaluation of Potential Drug–Drug Interactions among Patients Attending the Geriatric Unit at a Tertiary Care Hospital

Abstract Background: The elderly stand a greater risk of drug-drug interactions (DDIs). This study was an earnest attempt at in-depth prescriptions analysis and evaluating the potential DDIs (pDDIs) among patients in the geriatric outpatient department (OPD). Aims and Objectives: The aim is to conduct prescriptions analysis of patients and to evaluate the pDDIs among patients in the geriatric OPD. Materials and Methods: A retrospective observational study began after Institutional Review Board approval. Demographic details, clinical profile, and drugs prescribed were recorded. The prescription analysis was done by prespecified criteria and pDDIs were identified using various tools. Results: Prescriptions of 202 patients with a mean age of 68.76 years were collected. Mean drugs prescribed were 6.07. Total number of fixed-dose combinations (FDCs) and over-the-counter drugs were 669 (40.50%) and 430 (26.03%), respectively. 129 (63.9%) prescriptions were incomplete in terms of dose, duration, frequency, or dosage form. Maximum interactions - 367 (34.42%) were found with aspirin followed by cardiovascular drugs. Total prescriptions with pDDIs were 137 (67.82%) Out of 34 (3.82%) serious interactions, pharmacodynamic pDDIs were seen with aspirin and enalapril/ramipril and pharmacokinetic were between omeprazole/rabeprazole and clopidogrel. Consequences of common pDDIs were identified as deterioration in renal function and hyperkalemia. The number of interactions was positively correlated with number of FDCs and number of drugs prescribed (r = 0.427, P = 0.0001 and r = 0.189, P = 0.0001, respectively). Conclusion: Prespecified prescription analysis criteria were one of the most useful tools to improve prescribing patterns. Drug interactions can be reduced by prescribing minimum drugs in elderly, alteration in time of dosing and fractionation of dose along with amalgamating the use of online DDI checker in hospital information system. Training of prescribers especially in geriatric patients is the need of the hour.

A utilization study of fixed-dosed combinations in dermatologic practice

Background: Skin diseases are a common problem in community. Fixed-dose combinations (FDCs) are defined as a combination of two or more active ingredients within a single dosage form. In skin diseases, FDCs are used frequently in different dosage forms. Aim and Objective: This study aims to study and assess the prescribing pattern and cost analysis with emphasis on FDCs in dermatologic practice. Materials and Methods: A cross-sectional, observational study was carried out at the outpatient Department of Dermatology at GCS Medical College, Hospital and Research Centre. Prescriptions of 500 patients were analyzed for common skin conditions and prescribing patterns. All the data were compiled into Microsoft Office Excel and a descriptive statistical analysis was carried out. Results: Males and females were 259 (51.8%) and 241 (48.2%), respectively, with a mean age of 33 ± 16.6 years. Most of them had infectious diseases (26%). Out of total 1933 prescribed drugs, 724 (37.4%) were FDCs and 1209 (62.5%) were single drug. The average number of FDCs per prescription was 1.44 ± 0.61. Out of 724 FDCs, oral formulations were 245 (33.8%) and topical was 479 (66.1%). Vitamins and minerals were the most common class of drugs prescribed (22.6%) as FDCs. In comparison, the mean cost of FDCs was found to be significant as with single drugs (P < 0.05). Conclusion: Infectious diseases are the most common skin ailments. Use of FDCs in skin conditions is very common, particularly in topical formulations. Similarly, nutrients prescribed in skin conditions are also usually in the form of FDCs.

Knowledge, attitude, practice of rational use of medicines among junior residents in a tertiary care hospital

Background: Irrational use of prescribing is on the rise due to many factors like false beliefs, following a prescribing pattern of senior doctors, inadequate knowledge, ignorance, promotional activities for the profit of professionals by pharmaceutical industry and lack of enforcement of regulations by regulatory authorities. Junior residents are exposed to variety of prescribing patterns in the first year and are the future physicians and specialists. There are very few studies among JRs, hence the present study was conducted to assess the knowledge, attitude and practice of junior residents about rational use of medicines.Methods: This was a cross-sectional, questionnaire based study conducted among JRs at a tertiary care hospital in South India in June 2015. The participants were explained about the study and consent was taken. Permission was obtained from institutional ethics committee. Identity of the residents was kept confidential. A self-developed, pre-validated, semi-structured questionnaire consisting of both open-ended and closed-ended items was used. Questionnaire was designed to obtain information about the knowledge, attitude and practice of RUM. The data was recorded and analyzed using Microsoft Excel (2013 version) and the results are explained in frequency and percentage.Results: The knowledge related to essential medicines list (EML), P drugs and schedule H drugs was limited. Participants had limited knowledge about the revision of EML list, number of fixed dose combinations (FDCs)in EML, STEP criteria for choosing a P drug and advantages of choosing a P drug Most of the JRs frequently prescribed drugs from EML. Trade name and newer drugs were prescribed around 50%. The prescription of FDCs from EML was very low (6%). Around 50% of JRs prescribe medicines with both generic and brand name.Conclusions: Majority of JRs were aware about various issues concerned with RUM but the knowledge related to EML, P drugs, schedule H drugs and number of FDCs in EML was limited. As junior residents are future prescribers, they need to be aware of all the aspects of RUM. Inadequate/improper knowledge in the above areas is a matter of concern and needs to be addressed.

Indian Scenario on Fixed Dose Combinations

The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. For chronic diseases and HIV/AIDS infections FDCs are justified for the sake of patient compliance. They are also useful in areas of cardiology, oncology, neurological and respiratory infections. The basic rationale of making FDCs is either to improve adherence or to benefit from the added effects of the two medicinal products given together. Growing number of FDCs are launched by pharmaceutical companies worldwide and there are no particular guidelines for their approval. In India to approve FDCs, permission from State Licensing Authority and Drug Controller General of India is essential. It is a current hot topic of deliberation in Indian pharma industry, Drug Controller general of India and pharma trade. A critical review and rationalization of FDCs is required. As popularity of FDCs is increasing rapidly, drug regulatory authorities should pay attention to make standards to evaluate them by conducting extensive study so that those FDCs can be continued for patients benefit and this is the basis of this article.

Drug utilization study in genitourinary infections used as a teaching tool for rational therapy for MBBS students in a Medical College at Dehradun, Uttarakhand

Background: There is a need to introduce clinical pharmacology at the undergraduate level in order to improve rational prescribing of medicines. The present study was undertaken to analyze drug utilization pattern of genitourinary infections to teach certain basic skills to MBBS students which will form an integral component of practicing rational therapeutics.Methods: The retrospective study was conducted by Pharmacology Department in Shri Guru Ram Rai Institute of Medical and Health Sciences (SGRRIM and HS). A total of 92 prescriptions were collected by second professional MBBS students and randomly evaluated for prescribing pattern using WHO drug indicators.Results: A total of 92 prescriptions were analyzed. Male:female ratio was 1.96:1. Age wise distribution was done: 0-15 years were 14 (15.21%), 16-30 years were 26 (28.26%), 31-45 years were 24 (26.08%), 46-60 years were 19 (20.65%), and &gt;60 years were 9 (9.78%). A total of 260 drugs were prescribed. 116 (44.61%) antimicrobials, 70 (26.92%) antacids and antiemetics, 40 (15.38%) analgesics, 11 (4.23%) urinary alkalizers, 9 (3.23%) antifibrinolytics, and 14 (5.38%) miscellaneous drugs were prescribed. 144 (55.38%) injectable and 116 (44.61%) oral drugs were prescribed. Numbers of fixed-dose combinations were 32 (34.78%). 2.82 drugs per prescription were prescribed. 171 (65.76%) drugs were prescribed from National List of Essential Medicines 2013 (NLEM 2013). Majority of drugs were prescribed by brand names.Conclusion: Majority of drugs were prescribed from NLEM 2013. The main purpose of undergraduate medical curriculum is to develop the requisite diagnostic and therapeutic skills of a basic doctor. It is only by drug utilization studies that burden of diseases and corresponding utilization of drugs can be measured.

Current inclination of the clinicians for prescribing various fixed dose combinations: A retrospective, obsevational study in medicine outpatient department at a tertiary care hospital in Jaipur

Introduction: Rational use of drugs is mandatory for improving the quality of life, optimal utilization of our meagre financial resources, and better community healthcare fulfilling the rule of right and need, efficacy, suitability, safety, and affordability criteria. Despite this many irrational fixed dose combinations (FDCs) are continuously springing up in the Indian pharmaceutical market. Hence, it becomes crucial to evaluate the prescribing patterns of FDCs - the current trends and the loopholes. Methodology: This study was carried out in the outpatient department of medicine at Mahatma Gandhi Medical College and Hospital, Jaipur. Total 500 prescriptions were collected for the duration of 6 months, starting from February 2014 and assessed. The data was analyzed using Microsoft Office Excel; version 2007. Results: The data analysis reflected that 60% of prescriptions analyzed contained FDCs; revealing that significantly high number of patients received FDCs. The total number of FDCs in a prescription was also greater (mean = 1.82). Out of 60 FDCs prescribed only three of them were enlisted in the Essential Medicine List of World Health Organization and Government of India. Conclusion: The increased trend in using irrational FDC warrants a drug regulatory body in every hospital to ameliorate the free flow of irrational FDCs. Awareness programs focusing on deleterious consequences related to irrational use of medicines should be made.

The irrational fixed dose combinations in the Indian drug market: an evaluation of prescribing pattern using WHO guidelines

Background: Evaluation of the pattern of fixed dose combinations (FDCs) prescribing amongst the practitioners in a tertiary care hospital in Central India. Methods: Nine hundred and ninety four prescriptions, containing 639 FDCs were scrutinized in the tertiary care hospital. After excluding the total and the interdepartmental repetitions, the numbers of FDCs were 278, which were considered for final analysis. Inclusion criteria were FDCs from the major out-patient department (OPD) of the tertiary care hospital from January 2011 to December 2011. FDCs from the wards, casualty, infectious disease unit, intensive cardiac care unit (ICCU), tuberculosis and chest and HIV unit were excluded from the study. FDCs were analysed for the different pattern of prescribing and rationalism. Results were expressed as percentages. Results: Out of 639 FDCs, the most commonly prescribed FDCs were B complex (12.20%), pantoprazole plus domperidone (9.55%) and amoxicillin plus clavulanic acid (7.35%). Seventy percent of the FDCs were prescribed to the age group of 21-60 years. The FDCs were maximum from the department of medicine (25.59%), followed by surgery (15.47%) and ENT 13.69%. Out of 278 FDCs, only 5.4% were rational, and rest of the FDCs were irrational. Ninety five percent of all FDCs were brand names. The physicians were unaware of the active pharmacological ingredients (APIs) of 20.86% FDCs. Ninety two percent FDCs were available as over the counter (OTCs). Forty eight percent FDCs were costing from Rs. 0-50. There were 2.87% FDCs whose price was above Rs. 500. Conclusions: Irrational FDCs are prescribed by all the departments. Physicians were ignorant about the essential drugs and FDCs. Patients didn’t have access to rational medicines. Therefore, physicians and regulators should be alerted in time. Regulatory actions or government laws should be made mandatory. Availability and access to 348 essential medicines for basic health care should be the priority of the government. Implementation of central drug standard control organisations (CDSCO) guidelines on industries for manufacture of FDCs must be made compulsory.

Now or Never: Optimal Antihypertensive Therapy in the Elderly

Hypertension control rates in the elderly, particularly for systolic hypertension, are poor and lower than control rates in other age groups. Older patients often require treatment with specific antihypertensive drugs because of concomitant conditions and usually need > or =2 drugs to control blood pressure. Combining drugs with complementary mechanisms of action may improve both blood pressure control and the tolerability of individual drugs. A number of fixed-dose combinations have shown efficacy in older patients and in stage 2 hypertension, including various combinations involving diuretics and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.

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.