Prospective Cross-Sectional Observational Study on Evaluation of Drug Utilization 90% Study in Cardiovascular Diseases

 

Avinash Khairnar*, Supriya Jamdade

University Department of Interpathy Research & Technology (UDIRT) of Maharashtra University of Health Sciences(MUHS), Nashik, India

*Corresponding Author E-mail: avinashkhairnar@gmail.com

 

ABSTRACT:

Cardiovascular disorder is the leading cause of death worldwide. In India cardiovascular diseases progression is very high and leading cause of mortality. DU is an essential tool for making the health policies and to check the rationality of prescriptions in CVS diseases. DU study also useful to assessment of how drug utilization relates to the effect of drug use, beneficial or adverse. This was observational, prospective, cross-sectional study. Study was conducted at the cardiac OPD, IPD of Private Hospital, Nashik, Maharashtra. Total 100 subjects enrolled in this study. Case Record form filled with the help of prescribed drugs & interview of subjects. Core indicators also studied. DU 90% achieved by drugs Aspirin 39.58%, Clopidogrel 19.5%, Pantoprazole 6.12%, Frusemide 5.44%, Rosuvastatin 4.75%, Atenolol 4.34%, Glyceryl Trinitrate 4.14%, Atorvastatin 4.08%, Chlorthalidone 1.56%, Spiranolactone 1.51%. Average no. of drug per prescription was 4.93, Percentage of drug prescribed by generic name was 0%, 59.37% drugs prescribed from essential drug list. Percentage of antibiotic prescribed was 24%, and percentage of injections prescribed was 22%. Patient care indicator and prescribing indicator should be given importance. The present study found that there were substantial increased in both the utilization of and expenditure for cardiovascular drugs. In this study the incidence of poly pharmacy was high. Trade names were used more often when compared to generic names. Overall, awareness among the physician should be get increased by doing DU studies to make health care society more responsible and satisfies the priority health care needs of population.

 

KEYWORDS: Drug Utilization, Defined Daily Dose, Cardiovascular Diseases, Prescription Pattern, Du 90%

 


 

INTRODUCTION:

Drug Utilization research was defined by WHO in 1977 as “the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences”[1]. The principal aim of drug utilization research is to facilitate rational use of drugs in populations. The DU90% segment reflects the number of drugs that account for 90% of drug prescriptions and adherence to local or national prescription guidelines in this segment [2]. The cardiovascular system constitutes one of the major coordinating and integrating systems of the body. The function of cardiovascular system is to supply oxygen, nutrients and other essential substances to the tissues of the body and to remove carbon dioxide and other metabolic and products from the tissue [3].

 

Cardiovascular disorder commonly consist coronary heart disease, ischemic heart disease, myocardial infarction, angina pectoris, heart failure , hypertensive heart disease, peripheral vascular disease, rheumatic heart disease, valvular heart disease etc. [4].

 

Cardiovascular disorder is the leading cause of death worldwide. CVS is responsible for more deaths annually than any other disease since1900 [5].  It has been proved that cardiovascular diseases are the most fre­quent cause of morbidity and mortality throughout the world It causes major impact on life expectancy [6]. Significantly contribute to morbidity and mortality in middle aged population. Common cause of premature death and contribute to deterioration of quality of life. 50% of population in developed countries die of cardiovascular diseases and the highest coronary mortality is seen at present in north Europe and Scotland, United Kingdom [7]. In India cardiovascular diseases progression is very high and leading cause of mortality in people of age group 25 to 69 year [8]. IHD is the major cause of mortality in India. It is projected that IHD will result in two and one half million Indian deaths up to 2020. Males are affected more than females [9].

 Drug utilization studies are needed to identify the trends as well as to set the priorities, not only in the interest of the regulatory control, but also as a basis of the planning program of education and information[10]. The risk of cardiovascular diseases is being frequently monitored. Hence, it is need to do drug utilization study on cardiovascular disorders. Incidence of CVD, Acute Coronary Syndrome (ACS) is rapidly increasing in India and causes high mortality [11]. Long term survival inpost -ACS patients depends largely on how well post-ACS and post cardiovascular diseases period is managed [9]. Therefore, drug utilization studies, which evaluate, and analyze the medical, social, and economic outcomes of the drug therapy are more meaningful, and observe the prescribing attitude of physicians with the aim to provide drug rationally [12]. Aim for carry drug utilization study is check the Pattern of different drug use (Aspirin - Clopidogrel, Beta blockers, Statins, ACE inhibitors/ Angiotensin Receptor Blockers) dose, regimen, compliance, follow up [13]. How much the prescription conforms to standard treatment guideline. And how much drug prescribed from essential drug list or formulatory [14]

The study of drug utilization is a component evaluates prescribing practices & recommends necessary modifications to achieve rational drug use [15]. An attempt to delineate essential drug information requirements relevant to cardiovascular diseases for the benefit of physicians is one of the objectives of this study. Previously lots of drug utilization study done on cardiovascular diseases. Study gives important data about cardiovascular disorder. Standard treatment, drug available for cardiovascular diseases for drug utilization study prescription based survey is considered to be one of the most effective methods which have been used to assess and evaluate the prescribing attitude of physicians [16].

 

Though there are many study carried out and drug therapy has improved over time but incidence of cardiovascular diseases is not controlled as expected. And in which large proportion of population is suffered. Incidence rate, morbidity and mortality rate is not reduced as expected because lack of awareness of disease, poor knowledge of about best treatment option and it’s easily availability, poorly follow the guidelines of drug utilization. Morbidity and mortality of cardiovascular diseases is controlled by good managing post cardiovascular diseases period. It majorly included appropriate utilization of drug. Essential drug list give idea about the drug use and it’s easily availability. It satisfies the priority health care needs of population. They are selected with due regards to public health relevance, evidence on efficacy and safety and comparative cost effectiveness. Drugs are intended to be available within the context of functioning health system at all times and in adequate amount. Aim of this study is to study drug utilization pattern in post cardiovascular diseases  patients in their follow up visit and in admitted patients. And how much drug prescribed from essential drug list or formulatory. Study of drug utilization in cardiovascular diseases is very necessary for controlling morbidity and mortality rate in worldwide and also in India.  DU is an essential tool for making the health policies and to check the rationality of prescriptions in CVS. The overuse of drug causes adverse Effect on health of patient and under use may lead exaggerated and uncontrolled disease. And DU 90% has appeared as a very good quality indicator for drug prescription in this condition.

 

MATERIALS AND METHODOLOGY:

This is an observational prospective cross sectional study. Study was conducted in compliance with the protocol, ICH GCP, Schedule ‘Y’ guidelines and Indian regulatory requirements. Approval of Institutional ethics committee was taken prior to initiation of study. Enrollement of patient was done as per inclusion and exclusion criteria. Before collecting the data or observing a prescription, signed dated written informed consent was taken from all subjects after providing them with patient information sheet and informed consent form before screening. It was the study of prescriptions among the patient of cardiovascular diseases. Data from prescriptions was collected at the cardiac OPD, IPD of Private Hospital Nashik, Maharashtra, from the patients of age group above 18 years.

 

Total 100 prescriptions were collected from the patient and data from prescription were recorded in Case Record Form with the help of interview of patient. Core indicators were also studied, with help core indicators we can make out the pattern of drug use in cardiovascular diseases. Formula for core indicator is given below. The data collected from each prescription were summarized. Analysis from the whole data, appropriate statistical methods applied   according to the objectives. Prescriptions were studied and analysis was done as per WHO drug utilization study guidelines. After obtaining the Statistical analysis discussion & conclusion were drawn.

 


 

Core Indicators:

I) prescribing indicator:

a) Average number of drugs per encounter =     Total number of drugs prescribed

                                                                        Total number of drugs encounters surveyed

 

b) Percentage of drugs prescribed by generic name =  Drugs prescribed by generic name              x 100

                                                                                              Total number of drugs prescribed                                                                          

 

c) Percentage of encounters with an antibiotic prescribed = Total number of patients having more antibiotics   x 100

                                                                                                              Total number of encounters

d)  Percentage of encounters with an injection prescribed = Number of patients received one or more injections  x 100

                                                                                                                   Total number of encounters

 

e) Percentage of drugs prescribed from essential drug list =Number of products prescribed from Essential drug list  x 100                                                                                                                                                                                                                           Total number of drugs prescribed

 

II) Patient care indicator:

a) Average consulting time =   Total time for a series of consultations

                                                 Actual number of consultations 

 

b) Average dispensing time =     Total time for dispensing drugs to a series of patients 

                                                                 Total number of encounters

 

c) Percentage of drugs actually dispensed = Number of drugs actually dispensed at the health facility x 100                                                                   

                                                                                 Total number of drugs prescribed

 

d) Patients knowledge of correct dosage =    Total number of patients reporting correct dosage   x 100                                                                   

                                                                              Total number of patient interviewed 

 

DDD/1000/day:                                                                                       

DDD was calculated as per guidelines for ATC classification and DDD assignment (2000) as given by WHO collaborating centre for drug statistics methodology, Oslo, Norway DDD/1000 population/day

                           =      Total no. of dosage units prescribed X Strength of each dose unit X 1000

DDD (ATC) X Duration of study in weeks X Total sample size

 

DDD% =                            DDD/1000/DAY of particular drug x 100                                                                                   

                                          Sum of DDD/1000/DAY Total drugs

 

Study Duration:10 Weeks

 

Sample size:- 100

 

Primary Objective:

1) To evaluate drug utilization 90% in Private Hospital for cardiovascular diseases.

2) To evaluate the percentage of drug utilization from essential drug list for cardiovascular diseases.                    

 

Secondary Objective:

1) To assess that the drug utilization of antibiotics that used in cardiovascular diseases.

2) To determine percentage of Generic and Branded Medicines prescribed cardiovascular diseases.

 


RESULT:

Total 100 patients according to selection criteria were selected for present study of which 24 % were female patients and 76% were male patients. Total number of prescription which analyzed was 100 and total number of drugs prescribed was 493. From collected data for Drug Utilization pattern for the treatment of cardiovascular diseases in private hospital DU 90%was achieved. Table no.1 showed name of drug utilized for cardiovascular diseases, ATC code of drugs, DDD / 1000 / Day of each drug and then calculated DDD%. Table no. 1 stated that total 32 drugs studied in DU 90% in cardiovascular diseases. All drugs were studied and calculate DDD/1000/day and DDD% for each drug. The DDD% was higher for Aspirin (39.58%) and lower for the drug Amoxicillin (0.01%). Figure no.1 shows name and DDD% of that drug which achieved DU 90%. Following drugs were included in DU 90% Aspirin 39.58%, Clopidogrel 19.5%, Pantoprazole 6.12%, Frusemide 5.44%, Rosuvastatin 4.75%, Atenolol 4.34%, Glyceryl Trinitrate

4.14%, Atorvastatin 4.08%, Chlorthalidone 1.56%, Spiranolactone 1.51%. Figure no.2 showed result of drugs prescribed from Essential drug list. Total 59.37% drugs prescribed from essential drug list. Aspirin was first rank drug which were prescribed 91% of prescriptions, second rank Clopidogrel 44%, third rank Atorvastatin 36%, fourth rank Glyceryl trinitarte and Pantoprazole 27%, Frusemide fifth rank 24% prescribed from Essential drug list. Cefotaxime prescribed less frequently that is only 1%. Total 32 drugs were studied out of which 19 drugs prescribed from essential drug list. Table no.2 showed result for core indicator which were related to Prescribing indicator. Average no. of drug per prescription was 4.93, Percentage of drug prescribed by generic name was 0% all the drug prescribed by brand name only. Percentage of antibiotic prescribed was 24%, and percentage of injections prescribed was 22%. Table no.3 showed result for Patient care indicator. Average consultation time was 5 minutes and 48 seconds; Average dispensing time was 4 minutes and 02 seconds. Percentage of drug s actually dispensed was 100% and percentage of patients knowledge on correct dosage was 94%.


Table no. 1:-Percentage of Drug Prescribed for Drug Utilization in CVS Diseases

Sr. No.

Name of  drug

ATC Code

DDD

DDD/1000/Day

DDD %

1

Aspirin

C07AB03

1 Tab

8718.75

39.58

2

Clopidogrel

B01AC04

75 mg

4312.5

19.57

3

Pantoprazole

A02BC02

40 mg

1350

6.12

4

Frusemide

C03CA01

40 mg

1200

5.44

5

Rosuvastatin

C10AA07

10 mg

1050

4.75

6

Atenolol

C07AB03

75 mg

958

4.34

7

Glyceryl Trinitrate

C05AE01

5 mg

912.6

4.14

8

Atorvastatin

C10AA05

20 mg

900

4.08

9

Chlorthalidone

C03BA04

25 mg

343.75

1.56

10

Spiranolactone

C03DA01

75 mg

333.33

1.51

11

Losartan Potassium

C09CA01

50 mg

312.5

1.41

12

Olmesartan

C09CA08

20 mg

275

1.24

13

Isosorbid Mononitrate

C01DA14

40 mg

275

1.24

14

Bisoprolol

C07AB07

10 mg

212.5

0.96

15

Telmisartan

C09CA07

40 mg

150

0.68

16

Amlodipin

C08CA01

5 mg

137.5

0.62

17

Heparin

B01AB01

10 TU

137.5

0.62

18

Hydrochlorothiazide

C03AB03

25 mg

125

0.56

19

Rabeprazole

A02BC04

20 mg

100

0.45

20

Metoprolol

C07AB02

0.15 g

88.54

0.40

21

Piperacillin

J01CA12

14 g

34.28

0.15

22

Ceftriaxon

J01DD04

2 g

30

0.13

23

Nicorandil

C01DX16

40 mg

28.12

0.12

24

Ramipril

C09AA05

2.5 mg

15.62

0.07

25

Cefuroxime

J01DC02

3 g

14.06

0.06

26

Amoxicillin

J01CA04

1 g

4.375

0.01

27

Levofloxacin

J01MA12

0.5 g

3.75

 

28

Digoxin

C01AA05

0.25 mg

1.875

 

29

Sulbactum

J01CG01

1 g

1.25

 

30

Cefotaxime

J01DD01

4 g

0.83

 

31

Clonazepam

N03AE01

8 mg

0.74

 

32

Alprazolam

N05BA12

1 mg

0.62

 

Total

 

22027.98

99.81

DU 90%                    


Figure no. 1:Defined Daily Doses in Percentage Which Achieved DU 90%

 

CORE INDICATORS:

Table no. 2: Details for Prescription Indicator in patients prescriptions

Name of Indicator

Result

Average no. of drugs per prescription

4.93

Percentage of drug prescribed by generic name

00%

Percentage of antibiotic prescribed

24%

Percentage of injection prescribed

22%

Percentage of drugs from essential drug list

59.37%

 

Figure no. 2:Name of Drugs Prescribed from Essential Drug List and their frequency

 

Table no. 3: Details for Patient Care Indicator in patients prescriptions

Name of Indicator

Result

Average consultation Time

5.48 min

Average Dispensing Time

4.02 min

Percentage of drugs actually dispensed

100 %

Percentage of patients knowledge on correct dosage

94 %

 

DISCUSSION:

Drugs play an important role in improving human health and promoting well being. To produce the desired effect, they have to be safe and efficacious and also have to be used rationally. In modern clinical practice, analyzing drug utilization is an important tool for achieving rational drug therapy in any clinical setting [17]. It is necessary for identification of a problem, and then for following effectiveness of corrective interventions, undertaken by management of health facility. The irrational use of drugs is a common occurrence throughout the world. Drug prescriptions form a very important point of contact between doctors and patients. The cardiovascular diseases burden increased worldwide as well as in India [5]. Total 100 patients according to selection criteria were selected for present study of which 24 % were female patients and 76% were male patients. The common cardiovascular diseases found in this study were IHD, Hypertension, CCF, Angina pectoris, MI etc. IHD was the major cardiovascular disease found in most of study participant. To treat the IHD and to maintain good blood supply to heart antiplatelet aggregating drugs utilized most commonly and frequently. Aspirin was oral antiplatelet aggregating drug utilized 39.58 % and Clopidogrel utilized 19.57% for same indication. The Clopidogrel combination therapy with Aspirin may offer benefits over either drug used alone. Clopidogrel and Aspirin decrease the rate of combined end point of cardiovascular deaths, non fatal MI or stroke by 20% in patients with acute coronary syndromes previous study found same result [18]. The patient of Hypertension and CCF were treated with Diuretics like Frusemide, Chlorthalidone, spiranolactone. Drug utilization of Frusemide was 5.44%, Chlorthalidone 1.56%, spiranolactone 1.51% in this study which was increased as same as the previous study in Delhi [19]. Most of hypertensive patients had hyperacidity so that they were treated with Proton pump inhibitor drug like Pantoprazole which was utilized 6.12%.Rosuvastatin and Atorvastatin these lipid lowering agents utilized more and they achieved DU 90% the same result stated in previous study [20]. Atenolol anti hypertensive drug was utilized 4.34% which was beta blocker drug. Antianginal drug Glyceryl trinitrate utilized 4.14%. In cardiovascular diseases antibiotics was utilized 24%.Total 493 drugs were prescribed for cardiovascular diseases in private hospital. The Percentage of drugs prescribed from essential drug list was 59.37% Which was less from previous study [11]. observed that 75 % drugs prescribed from essential drug list. All the 493 drugs were prescribed by brand name only means 100% drugs prescribed by brand name. Branded medicines were more costly than generic medicines hence cost burden of diseases were increased on patients treated in private hospital due to branded medicines and consultation charges. The average consultation time in private hospital was 5 minutes 48 seconds so number of patients gave sufficient time for history taking, clinical finding, and examination. The percentage of patients knowledge on correct dosage was 94% which was high because patients visited to private hospital were well educated and having awareness and compliance with medication. The drug utilization of Diuretics for hypertension was increased as compare to other antihypertensive drugs. Diuretics like Frusemide, Chlorthalidone, Spiranolactone achieved DU 90%. Diuretics are said to be superior to α-blockers, CCBs, and ACEIs in preventing one or more forms of CVDs, including stroke and heart failure [21]. Most of prescriptions were got prescribed with knowing drug indication and therefore drugs got prescribed relevant to symptoms and diagnosis of patients. Private hospital was show rational prescribing pattern with proper examination as well as consultation of patients. And also had knowledge of drug action, duration, frequency, dose etc. Antibiotic and injectable drugs were prescribed as symptoms and necessity of patients with proper combination and monitoring. Present study showed that there was need for improvement in prescription writing for prescribed more generic medicines as compare to branded medicines for the benefits and safety of patients and society.

 

CONCLUSION:

The present study found that there were substantial increased in both the utilization of and expenditure for cardiovascular drugs. In this study the incidence of poly pharmacy was high. Trade names were used more often when compared to generic names. If only generic names are used the financial burden on the patient can decrease. Overall, awareness among the physician should be get increased by doing DU studies to make health care society more responsible and satisfies the priority health care needs of population. Further studies from time to time are required in drug utilization pattern and standard treatment guidelines to be circulated among practicing physicians.

 

REFERENCES:

1)      WHO, 2007, Introduction to drug utilization research, printed in Oslo, Norway, 6-172.

2)      WHO, 2007, Collaborating Centre for Drug Statistics Methodology(ed.). Guidelines for ATC Classification and DDD Assignment, Oslo, Norway.

3)      Labu, Z, Sultana, R, Bake,A, et al, April 2013, Surveillance on prescribed cardiovascular drugs by generic names in Dhaka city of Bangladesh,  International journal of pharmacy and life sciences, ISSN:0976-7126.

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5)      Maarten, L, President ESC, 2000-2003, Cardiovascular disease in Europe, challenge for the medical profession, European Heart Journal, vol.24, pg no. 8-12.

6)      Andrew, P, Eugene, B, 2006, Drug utilization study on Ischemic heart disease, McGraw Hill medical publication division, pg no.1434-44.

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10)    Laporte, J, Baksaas, M, 1993, General background drug utilization studies methods and uses, WHO regional publication, European series no. 45.

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14)    American Heart Association, American College of Cardiology, 2007 guideline.

15)    Gupta N., Sharma D., Garg S.K. and Bhargava V.K. (1997) Indian Journal of pharmacology, 29, 411-415.

16)    Tiwari, H, Kumar, A, Kulkarni, 2004, Prescription monitoring of antihyper­tension drug utilization at the Punjab university health care in India, Singapore Med. Journal, vol.45, pg no.117-20.

17)    Dukes M. Drug utilization studies. WHO, Reg Off, European series, 2004; 45:p10-14: 97-110.

18)    Tasneem Sandozi and Fouzia Nausheen, 2010, Drug utilization study in ischemic heart diseases associated with diabetes and hypertension, International Journal of Pharma and Biosciences, vol. 1, ISSN 0975- 6299.

19)    Khurshid,F,et al, 2012, Antihypertensive medication prescribing pattern in university teaching hospital in south Delhi, International Journal of Pharmaceutical Sciences and Research, Vol.3(7): 2057-2063.

20)    Muntwyler F, et al, 2003, National survey on prescription of cardiovascular drugs among out patients with coronary artery disease in Switzerland, Swiss med wkly 133: 88-92.

21)    Ukwe C, Ukaba C, 2012, Antihypertensive drug prescribing in tertiary hospital in eastern Nigeria, Tropical Journal of Pharmaceutical Research 11(2): 297-305.

 

 

 

 

Received on 27.06.2014                Modified on 15.07.2014

Accepted on 25.07.2014                © RJPT All right reserved

Research J. Pharm. and Tech. 7(9): Sept. 2014  Page 981-986