Evaluation of rationality of FDIs in outpatient medicine department
Journal name: World Journal of Pharmaceutical Research
Original article title: Assessment of rationality of fixed dosed combinations (fdcs) prescribed in medicine outpatient department of a tertiary healthcare institute
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Original source:
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Dr. Abhilasha Rashmi, Dr. Sudhir Pawar, Dr. Swapnil Jamdade and Dr. Pranesh Pawaskar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Assessment of rationality of fixed dosed combinations (fdcs) prescribed in medicine outpatient department of a tertiary healthcare institute
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20189-12184
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Fixed Dose Combinations (FDCs) are defined by the World Health Organization (WHO) as combinations of two or more active ingredients in a fixed dose ratio. The increasing trend of developing these combinations necessitates a thorough evaluation of their clinical efficacy and safety. The study presented in this paper aims to assess the rationality of FDCs prescribed in the outpatient department of a tertiary healthcare institute, focusing on their presence in prescriptions and adherence to established rationality criteria as defined by national and international guidelines.
Rationality Assessment of FDCs
The study analyzed a total of 700 prescriptions, identifying 241 instances (34.4%) where FDCs were used. After review, it was found that only 25.8% of these FDCs were categorized as rational according to the Rationality Scoring Scale, which evaluates combinations based on various pharmacological criteria. The remaining medications were mostly semi-rational (70.9%) or irrational (3.3%). Notably, a significant proportion of the FDCs (32.3%) were not approved by the Drug Controller General of India (DCGI), raising concerns about their clinical application and safety.
Prevalence and Patterns in FDC Prescriptions
The study revealed that the most commonly prescribed FDC was a combination of Diclofenac and Paracetamol. Despite its frequent use, this particular FDC was deemed irrational due to inappropriate dosing of Paracetamol, highlighting an important discrepancy in clinical practice. Antihypertensive medications were found to be the most commonly prescribed category (22.6%), followed by oral antidiabetic drugs and antiplatelet-hypolipidemic combinations, each comprising 16.1% of prescriptions. This suggests a trend in the types of conditions for which FDCs are favored, as well as their possible overuse in certain therapeutic areas.
Implications of Irrational FDCs
The presence of irrational FDCs poses a risk to patients by potentially increasing costs and the likelihood of adverse drug reactions. The study emphasizes the need for stringent regulation of FDCs to ensure that only those combinations with proven efficacy and safety are prescribed. Many FDCs analyzed lacked sufficient evidence supporting their clinical effectiveness, which raises ethical concerns regarding patient care. Additionally, the study found that 68% of the analyzed FDCs were approved by relevant authorities, yet a notable portion remained unapproved, indicating gaps in regulatory oversight.
Conclusion
In summary, while there is a high prevalence of FDCs in the analyzed prescriptions, the study demonstrates a concerning trend of irrational prescriptions. With only a small proportion meeting the rationality criteria, there is a clear need for regulatory bodies to take action against irrational FDCs and promote those combinations with documented therapeutic efficacy. Further research is warranted to better understand the rationality of both approved and unapproved FDCs, with the goal of enhancing patient safety and optimizing pharmaceutical care.
FAQ section (important questions/answers):
What are Fixed Dose Combinations (FDCs)?
FDCs are combinations of two or more active ingredients in fixed doses, used in various clinical practices to enhance efficacy, patient compliance, and potentially reduce costs.
What was the purpose of the conducted study?
The study aimed to assess the rationality of FDCs prescribed in a tertiary healthcare center and their compliance with WHO and CDSCO guidelines.
How were the FDCs evaluated in the study?
FDCs were checked against the CDSCO and WHO essential medicines lists, scoring their rationality based on defined criteria, including drug interactions and dosage appropriateness.
What were the results regarding the rationality of FDCs?
Out of 241 FDCs analyzed, 25.8% were rational, 70.9% semi-rational, and 3.3% irrational, indicating a need for more rational prescribing practices.
What is the significance of rationality in FDC prescriptions?
Rational FDC prescriptions ensure safety, efficacy, and minimize unnecessary costs while preventing adverse drug reactions, crucial for effective patient care.
What actions are suggested for improving FDC prescribing practices?
Regulatory bodies should take steps to limit irrational FDCs' circulation and promote rational combinations backed by evidence for efficacy and safety.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Evaluation of rationality of FDIs in outpatient medicine department”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
Drugs, in the context of this research, refer to chemical substances that can alter physiological functions in the body. The study examines various drugs included in FDCs to determine their appropriateness and rational use in treating conditions, contributing to broader discussions on drug efficacy, safety, and patient compliance.
2) Rashmi (Rasmi):
Rashmi refers to Dr. Abhilasha Rashmi, the lead author of the study on fixed dose combinations (FDCs) in prescriptions. Her role in the study is significant, as she contributes to research in the field of pharmacology, focusing on the rationality and appropriateness of drug combinations prescribed in outpatient settings.
3) Medicine:
Medicines are substances used for therapeutic purposes, including prevention and treatment of diseases. The research evaluates the rationality of FDCs, which are specific types of medicines, by analyzing their components for efficacy, dosage appropriateness, and safety profile, ultimately influencing prescribing patterns in medical practice.
4) Study (Studying):
The term study refers to the systematic investigation conducted to assess the rationality of fixed dose combinations (FDCs) prescribed in a healthcare setting. The study analyzed prescriptions, categorized drug combinations, and evaluated their safety and efficacy, contributing valuable data to the field of pharmacology and rational drug use.
5) Pharmacology:
Pharmacology is the branch of medicine that focuses on the study of drugs, their effects, mechanisms, and how they interact with biological systems. This discipline is essential in evaluating fixed dose combinations, as it helps in understanding the pharmacokinetics and pharmacodynamics that inform rational prescribing practices in clinical settings.
6) Tilak:
Tilak refers to Lokmanya Tilak Municipal Medical College, the institution associated with the research. The college is significant as it provides the setting for the study, with its outpatient department supplying valuable data on FDC prescriptions, thus playing a crucial role in advancing pharmacological research and education.
7) Abhilasa (Abhilasha):
Abhilasha refers to Dr. Abhilasha Rashmi, the primary investigator of the study on FDC-based prescriptions. Her expertise and leadership in pharmacology are pivotal for the study's conclusions about the rationality and approval status of various drug combinations, reflecting her contributions to enhancing healthcare practices.
8) Disease:
A disease is a pathological condition characterized by specific symptoms and signs. The study's focus on FDCs indicates that these combinations are prescribed to treat various diseases, making it crucial to assess their rationality for ensuring effective intervention, minimizing adverse effects, and improving patient outcomes.
9) Table:
Table in this context refers to the statistical data representation detailing various fixed dose combinations, their classifications, dosages, approval years, and rationality scores. This structured information aids in the analysis and provides a clear comparison of FDCs, facilitating better understanding of prescribing trends and clinical effectiveness.
10) Rami:
Rami refers to Ramipril, an antihypertensive drug included in several fixed dose combinations examined in the study. As a component of these combinations, Rami's effectiveness, dosing, and safety profile contribute to the overall assessment of the rationality of the respective FDCs, impacting treatment strategies for hypertension.
11) Pharmacotherapy:
Pharmacotherapy is the treatment of diseases and conditions using pharmaceutical drugs. The study analyzes the appropriateness of FDCs from a pharmacotherapeutic perspective, ensuring that prescribed combinations effectively address patient needs, enhance therapeutic outcomes, and comply with established safety and efficacy guidelines.
12) Pharmacological:
Pharmacological relates to the pharmacology of drugs, including their properties, effects, mechanisms, and interactions. This aspect is vital in the study as it evaluates fixed dose combinations for their clinical relevance, drug-drug interactions, and overall rationality, which are foundational for safe and effective medication regimens.
13) Discussion:
Discussion refers to the section of the study where findings are interpreted, and implications are analyzed. It involves critically evaluating the data regarding the rationality of FDCs, addressing concerns about prescribing practices, and suggesting recommendations for improving the clinical use of these drug combinations.
14) Antibiotic (Antibacterial):
An antibiotic is a type of medication that fights bacterial infections. In the study, various antibiotics are included in FDCs evaluated for their rationality and efficacy. Understanding their role in FDCs aids in ensuring optimal treatment strategies, minimizing the risk of resistance and ensuring effective management of infections.
15) Activity:
Activity in this context refers to the pharmacological effect or action of drugs when administered. The study assesses the activity of various fixed dose combinations to determine their therapeutic viability, contributing to the overarching goal of ensuring rational and effective patient care through appropriate medication.
16) Bleeding:
Bleeding is an adverse effect that can occur with certain medications, particularly in antiplatelet therapies. The risk of bleeding is a significant consideration in the discussion of FDCs that include such drugs, emphasizing the importance of evaluating safety profiles and potential complications associated with irrational combinations.
17) Surface:
Surface refers to the cell surface interactions that certain drugs engage in to exert their effects. In the study, understanding surface-level mechanisms is crucial for analyzing drug interactions and ensuring that FDCs have favorable pharmacokinetic and pharmacodynamic profiles, impacting their overall safety and efficacy.
18) Indian:
Indian refers to the context in which the study was conducted, highlighting the healthcare practices, drug regulations, and cultural aspects related to pharmacotherapy in India. The uniqueness of this setting affects the rationality of FDC prescriptions and reveals insights into the pharmaceutical landscape of the country.
19) Aceta:
Aceta refers to acetaminophen, an analgesic included in some of the evaluated fixed dose combinations. Understanding its use and appropriate dosing within these combinations is essential for assessing efficacy, considering its common use in managing pain and its implications regarding safety when combined with other drugs.
20) Sah:
Shah refers to one of the authors of previous studies cited in the research regarding FDCs. The reference to Shah's work helps contextualize the current study within the broader research landscape on fixed dose combinations, providing foundational knowledge and highlighting trends in the rational use of medications.
21) Hand:
Hand typically refers to the practice of medicine and the holistic approach to patient care. In the context of this study, the 'hand' may symbolize the integration of various healthcare disciplines and the necessity for healthcare providers to balance clinical judgment, patient needs, and pharmacological knowledge when prescribing FDCs.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Evaluation of rationality of FDIs in outpatient medicine department’. Further sources in the context of Science might help you critically compare this page with similair documents:
Combination therapy, Department of Pharmacology, Antihypertensive drug, Public health implication, Appropriate dose.