A Cross-Sectional Interventional Study to Evaluate the Drug Utilization Pattern of Anti-Coagulant and Antiplatelet Agents at Tertiary Care Hospital in Dakshina Kannada

Abstract

Antiplatelet inhibit thromboxane formation to prevent clotting, while anticoagulants target clotting factors. Both types of drugs deviate from specificity principles and their expanding use is associated with increased short and long-term mortality due to disrupted antithrombotic effects. Temporary discontinuation poses a high thromboembolic risk. Drug utilization, crucial for detecting irrational drug use, needs periodic review to ensure safety and effectiveness, especially in developing countries like India facing challenges such as varied drug prescribing patterns, delayed adverse reactions, and rising drug costs. To study the drug utilization pattern of anticoagulants and antiplatelet drugs in a tertiary care hospital. A cross-sectional study was conducted, with a sample size of 150 patients prescribed antiplatelet and anticoagulant therapy. Patients were selected based on specific inclusion criteria and obtaining informed consent forms prior to data collection. The data was collected through direct interviews with patients or from patient medical records and analyzed using Microsoft excel. In this study of 150 participants, majority were males (62.6%) aged 60 years and above (60%). Hypertension was the most common comorbidity (62%). Among 125 cardiac cases, stroke was predominant (48%), while among 24 hematological cases, deep vein thrombosis (DVT) was notable (5.3%). Anticoagulants and antiplatelet were used with Heparin (55.5%) and Aspirin (61.70%). Combination therapies were noted in 24.82% of cases. The study identified demographic trends, comorbidities, and treatment patterns in patients receiving antiplatelet and anticoagulant therapy, informing tailored management strategies for thrombotic disorders.

Keywords

Introduction

Figure 1: Operational modality

Figure 2: Gender wise distribution in study population

Out of 150 patients 28.6% females and 31.3%  male patients were found in the range of above 60 years of age (detailed data is illustrated in fig. 4).

Figure 5: Clinical indications for antiplatelet and anticoagulant therapy

In patients taking anticoagulants, out of 29 cardiac cases, 17 (58.6%) patients were administered with Heparin, 6 (20.6%) were administered with Enoxaparin, 3 (10.3%) were administered with Warfarin, 2 (6.8%) were administered with Acenocoumarol and 1 (3.4%) were administered with Dabigatran. Out of 27 non cardiac cases 20 were haematological cases and 7 were non haematological cases. In haematological cases 8 (29.6%) patients were administered with Heparin, 4 (14.8%) patients were administered with Warfarin, 4 (14.8%) patients were administered with Dabigatran, 3 (11.1%) were administered with Enoxaparin and 1 (3.7%) patient were administered with Acenocoumarol.   In patients receiving antiplatelets out of 150 cardiac cases 104 (69.3%) patients were administered with Aspirin, 36 (24%) patients were administered with Clopidogrel, 2 (1.33%) patients were administered with Ticagrelor, and 8 (5.33%) patients were administered with Aspirin-Clopidogrel in combination. Out of 25 non cardiac diseases, 48 were haematological cases and 56 were non haematological cases. In haematological cases 10 (40%) patients were administered with Aspirin and 2 (8%) patients were administered with Clopidogrel. And in non haematological case 1 (4.7%) of patient was prescribed with Aspirin.

DISCUSSION

In the current study of 150 participants, gender distribution showed that male patients were predominant as compared to female patients and age group analysis of patients showed that in this study, the age group 60 years and above was more, and 18 to 30 years were the least. These findings were similar to the study carried out by Kumar V S et al. [10] Hypertension was the most common comorbidity among the study participants. Other comorbidities included Diabetes Mellitus, Infectious disease, Renal disorders, Respiratory disorders, Psychiatric disorders Gastrointestinal disorders, Anaemia, Thyroid disorder, Parkinson’s disorder, Vertigo, Cancer, Osteoarthritis, Liver disorder, this is similar to the study carried out by Merin Kurian et al., in which HTN was the most commonly found comorbidity [4]. 

Among 150 patients indicated with antiplatelet therapy, most of them were cardiac cases. Out of which majority were Stroke, followed by IHD, MI, Angina and RHD (Rheumatic Heart Disease). Some proportions were haematological cases in which maximum were DVT with other comorbid conditions followed by DVT without any comorbid conditions, PE cases, and least were other thrombotic cases. And one patient was indicated for antiplatelet therapy for non-haematological (surgery) case. These findings are similar to the study carried out by Jyothi K et al., in which cardiac cases were more predominant than others [10]. 

Among 150 patients, who were prescribed with anticoagulants, majority were from cardiac cases. Out of which mostly were from Stroke, followed by IHD, MI, Angina and RHD (Rheumatic Heart Disease). In haematological cases anticoagulants were prescribed mostly in DVT, followed by pulmonary thrombus, and DVT with other comorbid conditions, these findings are similar to the study carried out by Vijayakumar T M et al., in which the prevalence of CVD was found to be higher [9]. In this study different categories of anticoagulants were used which included both parenteral and oral anticoagulants. In the parenteral anticoagulants, the most common drugs were

Heparin, Enoxaparin and warfarin. Oral anticoagulants include Warfarin, Acenocoumarol and Dabigatran which was similar to the study conducted by Vijayakumar T M et al., [9] in our study different categories of antiplatelets were used. The most commonly used drugs were Aspirin, Clopidogrel, Ticagrelor. The most prescribed combination therapy used was Aspirin-Clopidogrel which is similar to the study done by Reddy R et al. [8]

CONCLUSION

The study on drug utilization patterns of antiplatelet and anticoagulants sheds light on critical aspects of clinical practice and patient care. It highlights the significance of understanding prescribing trends, patient demographics, comorbidities, and treatment indications. The predominance of male patients and the prevalence of hypertension as the most common comorbidity align with previous research findings. Notably, antiplatelet and anticoagulants are frequently utilized for both treatment and prophylaxis, with prescription patterns largely influenced by clinician judgment. Among the 150 patients included in the study, cardiac cases emerged as the primary indication for both antiplatelet and anticoagulant therapy, with stroke being the most prevalent condition. This observation resonates with existing literature, emphasizing the substantial burden of cardiovascular diseases. Additionally, the study underscores the importance of anticoagulant therapy in hematological conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE), further emphasizing the high prevalence of cardiovascular diseases. The diversity in the types of antiplatelet and anticoagulants used reflects the evolving landscape of pharmacotherapy, with medications such as antiplatelet and anticoagulants. Combination therapies like aspirin-clopidogrel are prevalent, emphasizing the need for personalized treatment approaches as they may pose more risks than benefits to patients.

Overall, this study provides valuable insights into drug utilization patterns, emphasizing the need for evidence-based guidelines to optimize patient care. By addressing prescribing practices, monitoring parameters, adverse reactions, and drug interactions, healthcare providers can enhance treatment efficacy and improve patient outcomes. Future research in this area should focus on refining treatment strategies and evaluating the impact of interventions aimed at improving drug utilization and patient quality of life.

ACKNOWLEDGEMENTS

I am thankful to Research guide, Principal and Management of Srinivas college of Pharmacy, Mangalore for providing all the necessary facilities to carry out this research work.

REFERENCES

1. Antiplatelet are the root for prevention of arterial thrombosis, whereas anticoagulants are effective for venous thrombosis; however, recent molecular investigations suggest the interdependence of platelets and the coagulation system in both forms of thrombosis [1,19]. The antiplatelet prevents the clot formation by inhibiting the thromboxane formation, whereas anticoagulants target clotting factors that are crucial to the blood clotting process. Antiplatelet and anticoagulants deviates from general principle of specificity. Complex associations include chronic comorbidities, disease

   chronicity, ageing of population [1,16]. The expanding indications for the use of antiplatelet agents and anticoagulants which is associated with an increase in short-term and long-term mortality. This increased morbidity and mortality risk may be attributed to disruption of the antithrombotic effect. The thromboembolic risk that follows their temporary discontinuation might be high, even if these agents were stopped [2,17].

   Drug utilization is defined by World Health Organization (WHO) in 1977 as the marketing, distribution, prescription and use of drugs in a society, with special importance on the resulting medical, social and economic consequences [1,14]. Drug utilization is essential for detection of irrational use of drugs, making interventions to improve drug use and to improve quality of life.

   This requires an intermittent review to ensure safe and effectiveness of pattern of drug utilization. As the developing countries such as India is in the health care burdens due to multitudinous factors such as availability of more new drugs in the market, wide variation in the patterns of drug prescribing and consumption, concern about delayed adverse drug reactions (ADRs) and escalating drug costs [1,18].

   OBJECTIVES

   To study the drug utilization pattern of anticoagulants and antiplatelets drugs in a tertiary care hospital.

   MATERIALS AND METHODS

   STUDY DESIGN: A cross-sectional interventional study was performed on drug utilization pattern in inpatients of various department in the Hospital. The study was completed in the period of 6 months at Srinivas Institute of Medical Science & Research Centre, Mukka, Mangalore.

   SAMPLE SIZE: 150[7]

   STUDY CRITERIA:

   Inclusion Criteria: 

   • Patients of age ranging from 18 to 90 years, belonging to both genders.
   • Inpatients with or without comorbid conditions receiving antiplatelet or anticoagulant drugs.

   Exclusion Criteria:

   • Subjects who are unable to communicate such as severely ill patients, unconscious patients, and psychiatric patients 
   • Subjects who are not willing to participate

   SOURCE OF DATA COLLECTION: 

   Patients and Medical Records.

   STUDY PERIOD:

   The study period was divided into 3 phases:

   PHASE 1: 

   1. Preparation for the study: 

   Preparation of Patient’s Data Collection form: 

   Data collection form includes patient’s demographic details, past medical and medication history, current medications given, any DRPs found in prescription and lab parameters, it also includes questionnaires regarding knowledge on antiplatelets and anticoagulants

   2. Institutional Ethics committee approval:

   Ethical Clearance was obtained from the Institutional Ethics Committee (IEC) of Srinivas Institute of Medical Science and Research Centre (SIMS & RC), Mukka, Mangalore.

   PHASE 2:

   Patient selection: The patients for the study was selected based on the inclusion and exclusion criteria. 

   Obtaining inform consent: During the hospital visit, we explained the study participants about the study and obtained the consent for collecting data. The data was collected by personal discussion with the participants.

   PHASE 3: 

   Data review: During the course of Study, required data was collected from the medical records, best possible medication history and interaction with healthcare Professionals and collected data was analyzed in fulfillment with the objectives made in this study.

   STATISTICAL ANALYSIS:

   Statistical analysis involves collecting and scrutinizing every data sample in a set of items from which samples can be drawn and a suitable statistical test was applied to analyze the data. The collected data were analyzed using Microsoft Excel and SPSS software.

   OPERATIONAL MODALITY :

    

    

   

    

   Figure 1: Operational modality

    

   RESULT AND DISCUSSION

   RESULTS

   1. Demographic details of patient who were on antiplatelet and anticoagulants

   1.1 Gender wise distribution of the patients 

    

    

   

    

   Figure 2: Gender wise distribution in study population

    

   In the present study, 150 patients were administered with antiplatelet and anticoagulants. Out of 150 patients, 94 (62.6%) of them were males and 56 (37.3%) were females as shown in fig.2

   1.2 Age wise distribution of the patients

   Table 1: Age wise distribution of the patients

   Age	No. of patients (%),  n = 150
   Age (Mean ± SD)	64.1±40.3
   18-30	2(1.30%)
   31-45	10 (6.60%)
   46-60	48(32%)
   Above 60	90 (60%)

    

    

   

    

    

   The patients were categorized into age groups which showed, 90 (60%) were belonging to age group of 60 years and above which covered the majority of patients in the study followed by 48 (32%) patients in the age group between to 46 to 60 years, 10(6.60%) patients in the age group between 31-45 years and 18 to 30 years were found to be 2 (1.30%) respectively. Out of 150 patients who are on antiplatelet and anti-coagulant therapy, majority of them were observed to be males and he mean age was 64.1±40.3.

   1.3 Distribution of patients based on gender and age

    

    

    

   

    

    

   Out of 150 patients 28.6% females and 31.3%  male patients were found in the range of above 60 years of age (detailed data is illustrated in fig. 4).

   2. Social habits and comorbid conditions found among the patients 

   Hypertension was the commonest comorbidity among the study population. Out of 150 study population, 93 (62%) were hypertensive. Other common comorbidities included Diabetes Mellitus 52 (34.6%), Infectious disease 21 (40%), Renal disorders 10 (6.66%), Respiratory disorders 10 (6.66%), Psychiatric disorders 10 (6.66%), Gastrointestinal disorder 5 (3.33%), Anaemia 5 (3.33%), Thyroid disorder 5 (3.33%), Parkinson’s disorder 4 (2.66%), Vertigo 3 (2%), Cancer 2 (1.33%), Osteoarthritis 2 (1.33%), Liver disorder 1 (0.66%). Out of 150 patients 10 (6.66%) were smokers, while 11 (7.33%) were alcoholic.

   Table 2: Social habits and comorbid conditions found among the patients

   Condition	No. of patients (%) n=150
   Hypertension	93 (62%)
   Diabetes Mellitus	52 (34.6%)
   Infectious disease	21 (40%)
   Renal disorders	10 (6.66%)
   Respiratory disorders	10 (6.66%)
   Psychiatric disorders	10 (6.66%)
   Gastrointestinal disorder	5 (3.33%)
   Anaemia	5 (3.33%)
   Thyroid disorder	5 (3.33%)
   Parkinson’s disorder	4 (2.66%)
   Vertigo	3 (2%)
   Cancer	2 (1.33%)
   Osteoarthritis	2 (1.33%)
   Liver disorder	1 (0.66%)
   Social Habits	21(14%)
   Smoking	10 (6.66%)
   Alcoholic	11(7.33%)

   3. Indications for antiplatelets and anticoagulants among the study population

   Table 3: Clinical indications for antiplatelet and anticoagulant therapy

   Clinical Indications	Antiplatelet therapy	Anticoagulant therapy
   Diagnosis	No. of patients, (%) n= 150
   Cardiac
   Stroke	72 (48%)	10 (6.6%)
   IHD, MI, Angina	51 (34%)	9 (6%)
   Rheumatic heart disease	2 (1.33%)	1 (0.6%)
   Haematological
   Deep vein thrombosis with other co-morbid conditions	8 (5.3%)	3 (2%)
   Deep vein thrombosis	7 (4.6%)	9 (6%)
   Pulmonary embolism	5 (3.3%)	4 (2.6%)
   Others thrombotic case	4 (2.6%)	-
   Non-haematological
   Surgery cases	1 (0.6%)	-

    

    

   

    

   Figure 5: Clinical indications for antiplatelet and anticoagulant therapy

    

   In patients taking antiplatelets, 125 (83.3%) were from cardiac cases. Out of which 72 (48%) were from Stroke, followed by 51 (34%) from IHD, MI, Angina and 2 (1.33%) RHD (Rheumatic Heart Disease) patients. Out of 150 patients 24 (16%) were hematological cases in which 8 (5.3%) were DVT with other comorbid conditions, 7 (4.6%) were DVT cases, 5 (3.3%) were PE cases, 4 (2.6%) were other thrombotic cases. Among 150 patients 1 (0.6%) was non-haematological (surgery) case. Among patients taking anticoagulants, 20 (13.3%) were from cardiac cases. Out of which 10 (6.6%) were from Stroke, followed by 9 (6%) were IHD, MI, Angina and 1 (0.6%) RHD (Rheumatic Heart Disease) patients. Out of 150 patients 16 (10.6%) were haematological cases in which 9 (6%) were DVT cases, 4 (2.6%) were pulmonary thrombus cases, 3 (2%) were DVT with other comorbid conditions. 

   4. Utilization of anticoagulants and antiplatelets in study population

   4.1 Categories of antiplatelets and anticoagulants used in the study population

    

    

    

    

   Table 4: Categories of antiplatelet and anticoagulants used in the study population

   Class	No. of patients, (%) n=150
   	ANTIPL ATELETS
   Cyclooxygenase inhibitors
   Aspirin	125 (88.6%)
   ADP receptor antagonist
   Clopidogrel	42 (29.7%)
   Ticagrelor	3(1.7%)
   Aspirin + Clopidogrel	9(6.38%)
   	ANTICOAGULANTS
   Heparin	29 (51.78%)
   Low molecular weight heparin
   Enoxaparin	9 (16.07%)
   Coumarin Derivatives
   Warfarin	8 (14.28%)
   Acenocoumarol	3 (5.35%)
   Direct thrombin inhibitors
   Dabigatran	8 (14.28%)

   In our study different categories of anticoagulants were used which included both parenteral and oral anticoagulants. In the parenteral anticoagulants, the most found drugs were Heparin, Enoxaparin and warfarin. Oral anticoagulants include Warfarin, Acenocoumarol and Dabigatran (detailed data is illustrated in Table 4) the most used antiplatelet drugs were Aspirin, Clopidogrel, and Ticagrelor. The most common combination therapy used was Aspirin-Clopidogrel. 

   5. Utilization of antiplatelets and anticoagulants with the clinical condition

    

   Table 5: Antiplatelet and anticoagulant utilization with clinical condition among the study population

   Drugs	Cardiac diseases No. of patients, (%) (n=150)	Non cardiac diseases No. of patients, (%) (n=21)
   ANTIPLATELET		Haematological (n=20)	Non- Haematological (n=1)
   Aspirin	104 (69.3%)	10 (40%)	1(4.7%)
   Clopidogrel	36 (24%)	2 (8%)	0
   Ticagrelor	2 (1.33%)	0	0
   Aspirin - Clopidogrel	8(5.33%)	0	0
   ANTICOAGULANT	(n=29)	(n=20)	(n=0)
   Heparin	17 (58.6%)	8 (29.6%)	0
   Enoxaparin	6 (20.6%)	3 (11.1%)	0
   Warfarin	3 (10.3%)	4 (14.8%)	0
   Acenocoumarol	2 (6.8%)	1 (3.7%)	0
   Dabigatran	1 (3.4%)	4 (14.8%)	0

    

   In patients taking anticoagulants, out of 29 cardiac cases, 17 (58.6%) patients were administered with Heparin, 6 (20.6%) were administered with Enoxaparin, 3 (10.3%) were administered with Warfarin, 2 (6.8%) were administered with Acenocoumarol and 1 (3.4%) were administered with Dabigatran. Out of 27 non cardiac cases 20 were haematological cases and 7 were non haematological cases. In haematological cases 8 (29.6%) patients were administered with Heparin, 4 (14.8%) patients were administered with Warfarin, 4 (14.8%) patients were administered with Dabigatran, 3 (11.1%) were administered with Enoxaparin and 1 (3.7%) patient were administered with Acenocoumarol.   In patients receiving antiplatelets out of 150 cardiac cases 104 (69.3%) patients were administered with Aspirin, 36 (24%) patients were administered with Clopidogrel, 2 (1.33%) patients were administered with Ticagrelor, and 8 (5.33%) patients were administered with Aspirin-Clopidogrel in combination. Out of 25 non cardiac diseases, 48 were haematological cases and 56 were non haematological cases. In haematological cases 10 (40%) patients were administered with Aspirin and 2 (8%) patients were administered with Clopidogrel. And in non haematological case 1 (4.7%) of patient was prescribed with Aspirin.

   DISCUSSION

   In the current study of 150 participants, gender distribution showed that male patients were predominant as compared to female patients and age group analysis of patients showed that in this study, the age group 60 years and above was more, and 18 to 30 years were the least. These findings were similar to the study carried out by Kumar V S et al. [10] Hypertension was the most common comorbidity among the study participants. Other comorbidities included Diabetes Mellitus, Infectious disease, Renal disorders, Respiratory disorders, Psychiatric disorders Gastrointestinal disorders, Anaemia, Thyroid disorder, Parkinson’s disorder, Vertigo, Cancer, Osteoarthritis, Liver disorder, this is similar to the study carried out by Merin Kurian et al., in which HTN was the most commonly found comorbidity [4]. 

   Among 150 patients indicated with antiplatelet therapy, most of them were cardiac cases. Out of which majority were Stroke, followed by IHD, MI, Angina and RHD (Rheumatic Heart Disease). Some proportions were haematological cases in which maximum were DVT with other comorbid conditions followed by DVT without any comorbid conditions, PE cases, and least were other thrombotic cases. And one patient was indicated for antiplatelet therapy for non-haematological (surgery) case. These findings are similar to the study carried out by Jyothi K et al., in which cardiac cases were more predominant than others [10]. 

   Among 150 patients, who were prescribed with anticoagulants, majority were from cardiac cases. Out of which mostly were from Stroke, followed by IHD, MI, Angina and RHD (Rheumatic Heart Disease). In haematological cases anticoagulants were prescribed mostly in DVT, followed by pulmonary thrombus, and DVT with other comorbid conditions, these findings are similar to the study carried out by Vijayakumar T M et al., in which the prevalence of CVD was found to be higher [9]. In this study different categories of anticoagulants were used which included both parenteral and oral anticoagulants. In the parenteral anticoagulants, the most common drugs were

   Heparin, Enoxaparin and warfarin. Oral anticoagulants include Warfarin, Acenocoumarol and Dabigatran which was similar to the study conducted by Vijayakumar T M et al., [9] in our study different categories of antiplatelets were used. The most commonly used drugs were Aspirin, Clopidogrel, Ticagrelor. The most prescribed combination therapy used was Aspirin-Clopidogrel which is similar to the study done by Reddy R et al. [8]

    

   CONCLUSION

   The study on drug utilization patterns of antiplatelet and anticoagulants sheds light on critical aspects of clinical practice and patient care. It highlights the significance of understanding prescribing trends, patient demographics, comorbidities, and treatment indications. The predominance of male patients and the prevalence of hypertension as the most common comorbidity align with previous research findings. Notably, antiplatelet and anticoagulants are frequently utilized for both treatment and prophylaxis, with prescription patterns largely influenced by clinician judgment. Among the 150 patients included in the study, cardiac cases emerged as the primary indication for both antiplatelet and anticoagulant therapy, with stroke being the most prevalent condition. This observation resonates with existing literature, emphasizing the substantial burden of cardiovascular diseases. Additionally, the study underscores the importance of anticoagulant therapy in hematological conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE), further emphasizing the high prevalence of cardiovascular diseases. The diversity in the types of antiplatelet and anticoagulants used reflects the evolving landscape of pharmacotherapy, with medications such as antiplatelet and anticoagulants. Combination therapies like aspirin-clopidogrel are prevalent, emphasizing the need for personalized treatment approaches as they may pose more risks than benefits to patients.

   Overall, this study provides valuable insights into drug utilization patterns, emphasizing the need for evidence-based guidelines to optimize patient care. By addressing prescribing practices, monitoring parameters, adverse reactions, and drug interactions, healthcare providers can enhance treatment efficacy and improve patient outcomes. Future research in this area should focus on refining treatment strategies and evaluating the impact of interventions aimed at improving drug utilization and patient quality of life.

   ACKNOWLEDGEMENTS

   I am thankful to Research guide, Principal and Management of Srinivas college of Pharmacy, Mangalore for providing all the necessary facilities to carry out this research work.

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