INTRODUCTION:

India is a large and socioeconomically diverse country, and there could be indication of all the stages of epidemiological transition in the country.¹ Coronary artery disease has emerged as an epidemic in India. CAD is one of the most important causes of mortality and morbidity in the country. It also leads to massive economic burden.² India is also a country with significant drug-use problems. Irrational and unnecessary prescribing is common and antibiotic resistance is widespread and has turn into a major health issue.³ Drug utilization review/evaluation can be used as a tool to detect these drug related problems encountered by the patients while seeking treatment of their illness. Drug utilization research is an collection of descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing, and consumption of medicines, and for the testing of interventions to enhance the quality of these processes.⁴ They are leading exploratory tools to assess whether drug therapy is rational or not and to create a sound socio-medical and economic basis for healthcare decision making.⁵ Drug utilization review combined with fundamentals of disease management expands the focus from only drug-specific problems to an approach that also uses treatment guidelines and algorithms to evaluate the appropriateness of drug therapy in the background of treating particular diseases. This requires reflection of health outcomes and pharmacoeconomic findings.⁶ There are limited drug utilization studies available on coronary artery disease in the Punjab region. Hence, there is limited data available on this topic which the present study aimed to generate.

The objectives of the study were:

1. To do drug utilization evaluation.

2. To assess the rationality of the treatment given to the patients.

3. To assess the adherence of prescription to WHO core prescribing indicators.

MATERIALS AND METHODS:

This prospective observational study was carried out over the duration of nine months between August 2017-April 2018 in Guru Gobind Singh medical college and hospital, Faridkot, Punjab, India with the main aim to assess the drug utilization while accessing the treatment of coronary artery disease during their stay in the hospital. The study was approved by the institutional review board of ISF college of pharmacy (Approval No. ISFCP/JEC/2017/131). All Inpatients who were diagnosed with coronary artery disease and who were willing to participate were included in the study, also written consent was taken from the patients or their caregiver. Data was collected during their stay at the hospital till their discharge in a specially designed data collection form and was analyzed using IBM SPSS Version 25.

RESULTS:

A total 390 patients were recruited in the study based on inclusion and exclusion criteria in which, the majority of them 59%, were found to be males as compared to their female counterparts 41%. The mean age of the study population was found to be 59.89 years, since most of the patients belonged to the age group of 51-60 years. Most of the patients were from urban locality 61.5% and only 38.5% of the patients were from rural locality. The average duration of stay of patients in the hospital was 4.21±1.53 days. Majority of the patients were found to be Sikh religion 48.5%, followed Hindu 29.5%, Muslim 18.2%, Christian 3.8%. Details are shown in table 1.

Table 1: Socio-Demographic profile of the study population

Variable	Parameters	Frequency (n=390)	Percentage (%)
Gender	Male	230	59.0
Gender	Female	160	41.0
Age (In Years)	31-40	68	17.4
	41-50	33	8.5
	51-60‎	154	39.5
	61-70	102	26.2
	71-80	33	8.5
Locality	Rural	150	38.5
Locality	Urban	240	61.5
Religion	Hindu	115	29.5
	Sikh	189	48.5
	Muslim	71	18.2
	Christian	15	3.8

Prescribed drugs:

Figure 1, indicates that only 4% of patients were given a single drug while 14% were given two drugs, 12% were given three drugs. While 26% patients were found to be prescribed with four drugs and 44% more than six drugs respectively. Details are shown in figure 1.

Figure 1: Drug therapy prescribed to the patients

Utilization pattern:

The Utilization pattern of common cardiovascular drug classes used in treatment of CAD are shown in the table 2.

Table 2: Utilization patterns of common cardiovascular drug classes in CAD

Drug classes (as per ATC 3rd & 4th levels)

Overall (n=390)

Vitamin-K antagonists [B01AA]

Heparin group [B01AB]

151

Platelet aggregation inhibitors [BO1AC]]

139

Enzymes [B01AD

Other antithrombotic agents [B01AX]

122

130

Antiarrythmics-class [C01BD]

Digitalis [C01AA]

138

Adrenergic & dopaminergic agents [C01CA] Organic nitrates [C01DA]

Other vasodilators used In cardiac disease [C01DX]

Other cardiac preparations [C01EB]

166

180

110

115

Diuretics

Thiazides [C03A]

Low ceiling diuretics excl thiazides [C03B] High Ceiling Diuretics [C03C]

157

112

115

130

Aldosterone antagonists [C03D]

Beta-blockers [C07]

Non-selective beta-blockers [C07AA] Selective beta-blockers [C07AB]

Alpha and beta-blocking [C07AG]

189

147

114

120

Calcium channel blockers [C08]

Selective CCBs with mainly vascular effects [C08C]

Selective CCB with direct cardiac effects [C08D]

192

150

142

ACE inhibitors [C09AA]

Angiotensin II antagonists [C09CA]

Statins [C10AA]

140

148

Observed DDD/100/Day:

Observed DDD of some drugs that were given to the patients for management of CAD is shown in table 3 below along with ATC classification and DDD given by WHO.

Table 3: DDD of some drugs used in management of CAD

Drugs	ATC Classification	DDD given by WHO	Observed DDD/100/ day
Isosorbiddinitrate	C01DA08	60 mg O	21.256
Glyceryltrinitrate	C01DA02	5 mg P	4.753
Aspirin	B01AC06	1 tab O	55.353
Clopidogrel	B01AC04	75 mg O	56.869
Enalapril	C09AA02	10 mg O	5.315
Metoprolol (O)	C07AB02	0.15 gm O	3.452
Amlodipine	C08CA01	5 mg O	4.957
Atenolol	C07AB03	75 mg O	2.258
Digoxin (P)	C01AA05	0.25 mg P	2.526
Digoxin(O)	C01AA05	0.25 mg O	1.314
Furosemide (O)	C03CA01	40 mg O	4.857
Furosemide(P)	C03CA01	40 mg P	0.479
Atorvastatin	C10AA05	10 mg O	24.602

Rationality of therapy:

The rationality of therapy given to the CAD patients was determined based on appropriateness and inappropriateness by comparing the therapy to latest AHA and other standard guidelines. It was found that the route of administration in 99 drugs used was appropriate, while dosing or frequency prescribed was in 74% cases rational and in 26% was irrational. In case of prescribed dose majority of the drugs 65% had appropriate dose, Only 35% prescribed drugs had Irrational dose. Details are shown in table 4 below.

Table 4: Rational and Irrational used of Drugs used in CAD

Prescribed	Appropriateness and Inappropriateness	Drugs used For CAD (%)
Route of Administration	Rational	99
Route of Administration	Irrational	1
Dosing/Frequency Prescribed	Rational	74
Dosing/Frequency Prescribed	Irrational	26
Prescribed Dose	Rational	65
Prescribed Dose	Irrational	35

Drug related problems (DRPs) identified:

On analyzing the therapy given to the patient for drug related problems. It was observed that the most common drug related problem was class duplication 32% followed by drug use without indication 30%, improper drug selection 20%, untreated indication 18% respectively. Details are shown in figure 2.

Figure 2: Drug related problems identified in the pharmacotherapy given to the study population

Other drug utilization parameters:

The drug utilization pattern of treatment given to the CAD patients according to WHO standards showed that 19.16% drugs administered to the study participants were Fixed dose combinations (FDCs), 46.66% were drugs from the National Essential Medicine List (NEML) which was almost half as compared to 100% of WHO standard. Up to 78.50% of drugs were prescribed by brand names as compared to 0% of WHO standard. 21.50% of drugs were prescribed by generic names as compared to 100% of WHO standard. 49% of drug therapy had encounters with an antibiotic which was prescribed twice as compared to WHO standard of 20-26.8%. Average no. of Drugs per prescription were 8.53 which is four times as compared to WHO standard of 1.6-1.8 drugs per prescription. 76.16% prescriptions were with an injection as compared to WHO standard of 13.4-24.1%. Details are shown in table 5.

Prescription pattern parameters:

Parameters which were evaluated for the standardization prescription pattern are shown in table 6.

Table 6: Parameters to Evaluate Standardization Prescription Pattern

S. No	Parameters to be Evaluated	Percentage Observed
1	Name of patient was mentioned	97%
2	Age of patient was mentioned	85%
3	Sex of patient was mentioned	90%
4	Address of patient was mentioned	10%
5	Rx sign was present in prescription	68%
6	Name of drug was mentioned	100%
7	Dose of drug was mentioned	70%
8	Dosage form of drug was mentioned	75%
9	Directions of dosage ware given	88%
10	No. of drugs to be dispensed was mentioned	45%
11	Instructions about use were given	15%
12	Name of prescriber was mentioned	99%
13	Address of prescriber was mentioned	99%

DISCUSSION:

In the study population most of the patients 59% were males. Similar observations were reported by various studies conducted in India.^7–14 The mean age of the study population was found to be 59.89 years, literature from various studies also suggests that CAD is more frequent in population of 51-60 years age group.^15–17 Most of the patients were from urban locality 61.5%, similar findings were reported in India heart watch study ¹⁸. The average duration of stay of patients in the hospital was 4.21±1.53 days, similar observations were made by other studies.^2,16,18–23 Test of proportion showed that CAD was more prevalent in Sikhs 48.5%, followed Hindu 29.5%, Muslim 18.2%, Christian 3.8%. This might be due to demographics it is a well known fact that majority of population in Punjab is Sikh by religion. During past few years numerous research studies have been conducted worldwide to determine the safe and effective drug utilization indicating that inappropriate drug use is a universal phenomenon.²⁴ To examine the use of drugs in a society, trend of drug utilization studies has been raised globally in different health setups. Such types of drug utilization studies are helpful to determine the pattern of prescription and for setting the priorities to avoid the irrational drug use.²⁵ The treatment for IHD includes drug categories such as antiplatelet drugs, antianginal drugs, anticoagulants, beta-blockers, calcium channel blockers, ACE inhibitors/angiotensin II receptor blockers (ARBs), diuretics, etc. Financially developed countries have effective strategies for screening, evaluation, and management of IHD, but these strategies are not fully established in India.²⁶ Test of proportion for combinations of drug therapy given to the patients showed that the majority of the patients 44%, were prescribed more than six drugs respectively this indicates Polypharmacy only 4%, were prescribed single drug. Utilization pattern of CAD drugs in this study showed that antiplatelet drugs, antianginal drugs, anticoagulants, beta-blockers, calcium channel blockers and diuretics were mostly prescribed drugs in management of CAD which was similar to observations made by a study conducted in Karnataka.²⁷ For most patients with ACS, ACC/AHA/ESC/JBS guidelines recommend a combination of dual anti-platelet agents, a beta-blocker, an ACEI or ARB and a statin unless any of these is contraindicated.^28–31 Guidelines based on evidence from randomized controlled trials recommend that aspirin, beta-adrenergic blockers, ACE inhibitors and 3-hydroxy-3-methylglutaryl–coenzyme A reductase inhibitors (statins) can be used in all patients with symptomatic chronic stable angina or asymptomatic survivors of acute myocardial infarction and following percutaneous coronary intervention or coronary bypass surgery for secondary prevention of myocardial infarction, stroke, and death. It has been postulated that if used together these agents could reduce the long-term risk of cardiovascular events and mortality by as much as 75%.²⁸ However literature suggests patients with either CAD risk factors only, known prior MI, or known CAD without MI, the use of beta-blockers is associated with a lower risk of composite cardiovascular events.³²

After comparing the drugs under the parameter of the observed and expected DDD/100/days, it was observed that there were some drugs had 2 times dose given or some had less than half dose as compared to DDD given by WHO which resembles the findings reported by another study.³³ The DDD methodology does not indicate the exact number of patients who have been treated with drugs. This concept assumes that every person who is prescribed a particular drug is taking the specific DDD every day, ignoring the alteration of the dosage for each disease and the patient related factors.³⁴ Rational drug prescribing is defined as the use of the least number of drugs, to obtain the best possible effects in the shortest period at a reasonable cost.³⁵ While analyzing rationality of therapy given to the CAD patients. It was found that the route of administration in 99 drugs used was appropriate, while dosing or frequency prescribed was in 74% cases rational and in 26% was irrational. In case of the prescribed dose majority of the drugs 65% had appropriate dose, Only 35% prescribed drugs had Irrational dose. Even though 26% or 35% may sound like not much, but we must not forget the consumer is a human being. Each and every drug can do more harm than good if given in any wrong way. The reason behind this irrational therapy can be due to the lack of availability of rationalized and reliable drug information for the prescribers. Irrational drug prescribing pattern indicate a very important health related problem and is considered to be a major challenge for doctors.³⁶ Similar observations was reported by a study conducted in Pakistan.³⁷

On analyzing the therapy given to the patient for Drug Related Problems (DRPs). It was found that the most common drug related problems was class duplication 32% followed by drug use without indication 30% which was also observed in a study conducted in Karnataka³⁸, improper drug selection 20% which was also reported by similar study.³⁹ The WHO core prescribing measures the performance of health care providers in several key proportions related to the proper use of drugs³⁸. Average number of drugs per prescription is an important index of the standard of prescribing. In present study, the average no. of Drugs per prescription were 8.53 which is five times as compared to WHO standard of 1.6-1.8 drugs per prescription.⁴⁰ Similarly, this value is higher than the results of other studies.⁴¹ Polypharmacy often leads to a high chances of drug-drug interactions, toxic drug effects and high cost of the treatment. The reason for Polypharmacy may that the patients arrive at ICU have multiple diseases and they are in serious condition. The need for quick managing the condition and stabilization of patient leaves little time to think about the Polypharmacy to the prescriber. Essential Medicine List (EML) of any country identifies those drugs, that fulfill the need of maximum number of patients in any country. WHO gives a great emphasis on development of EML, and to follow its concept in true sense. If there is a brief number of drugs that are usually prescribed, it would be easy to maintain and control the full inventory of those drugs. This study reveals that only 46.66% were drugs from National Essential Medicine List (NEML) which was almost half as compared to 100% of WHO standard.⁴⁰ This number is very low when compared with WHO Standard value, i.e. 100% as well as that found in other countries, such as Jordan⁴², where this percentage was 93% and in Nepal, 75% of the of the drugs are prescribed from EML.⁴³ Generic prescribing has several advantages as well as disadvantages. But in case of generic prescribing, the benefits overweigh the losses. So a huge emphasis is laid by WHO on prescribing of the drugs by their generic name. According to the WHO standards, 100% of the drugs should be prescribed generically. An alarmingly low number of the drugs were mentioned by their generic names. During this study, only 21.50% of drugs were prescribed by generic names and 78.50% of drugs were prescribed by brand names. These results are better than other study such as in Lucknow⁴⁴, only 27.1% of the drugs were mentioned by the generic name. Hence, there is a need to implement the policy of generic prescribing in Punjab, as it reduces the cost of the drug, both to the patient and pharmacies and also reduces the chances of generic duplication, that may lead to hazardous side effects and drug induced toxicity. This will also help to minimize unethical marketing strategies adopted by some industries.

Irrational use of antibiotics is always associated with a vast number of side effects and emergence of resistant strains of microbes. Antibiotics should be prescribed after culture sensitivity report and complete course of antibiotic for a particular infection should be ensured. In India, antibiotics are usually prescribed abundantly and irrationally. In current study, it was observed that 49% of the prescriptions were carrying one or more antibiotic(s) prescribed in them. According to the standard values given by WHO, the number of prescriptions carrying antibiotics prescribed should be between 20.0% and 26.8%.⁴⁰ So the value observed during the current study is much more than the standard one. Injections need a great care to be employed while administration to the patient. Although injectable formulations have various benefits, but they need expertise and great precautions to be taken while administration. They also increase the cost of therapy and burden on the patient or society. In current study, 76.16% prescriptions were with an injection in them. According to WHO standards, 13.4-24.1% of the prescriptions may contain injectable items in them.⁴⁰ Prescription writing is a skill as it demonstrates the instructions provided by the physician to the patient.⁴⁵ There are no global standards for the prescription writing but World health Organization states that some important things should be written in a prescription so not much can go wrong. These are name and address of the prescriber, with telephone number (if possible), date of the prescription, name and strength of the drug, dosage form and total amount, prescriber's initials or signature, name and address of the patient; age (for children and elderly) & Information for the package label.⁴⁶ In our study, it was observed that most prescription doesn't contained address of the patient, number of drugs to be dispensed was not mention in majority of them also instructions about use were not given.

RECOMMENDATIONS:

· There is a need for the regulatory agencies to develop a standard prescription format, and implement it throughout the country. Also, it was observed during the study that irrational practices of prescribing the drugs are quite common. There is a poor compliance of the physicians with WHO Core Prescribing Indicators. Irrational prescribing is quite common, that is usually associated with various undesired drug effects, toxicities, tolerances and resistance. Poly-pharmacy is quite common and the concept of generic prescribing is. Strict conditions must be implemented about the prescription and administration of the injectable drugs and their use should be minimized to the extent possible.

· There is also a need to emphasise the physicians about prescribing the drugs from the National Essential Medicine List. Availability of National Formulary and NEML should be ensured.

· Excessive use of antibiotics is common, that is leading towards the emergence of resistant strains of microbes. Injectable drugs prescription is within the standard limits according to this study. There is a poor trend of prescribing the drugs from NEML. Regulatory agencies should arrange seminars, workshops and regular training programs in order to get the values of these core prescribing indicators within the range of standard values laid by the WHO. Regulations regarding the prescribing of drugs by generic names should be made and strictly implemented. Well established standard treatment guidelines are already in place, but they need to be implemented by the regulatory agencies.

· There is a need to appoint a clinical pharmacist to ensure rational treatment is given to the patient and avoidance of drug related problems which will lead to reduced hospital stay of the patients and decreased cost of treatment and well as effective use of the hospital resources by preventing wastages.

CONCLUSION:

Male gender, urban locality, age group of 51-60 was found to be more.The mean duration of stay was found to be 4.21±1.53 days. Majority of the patients were given Polypharmacy. Utilization pattern of CAD drugs in this study showed that antiplatelet drugs, antianginal drugs, anticoagulants, beta-blockers, calcium channel blockers and diuretics were mostly prescribed drugs in management of CAD. After comparing the drugs under the parameter of the observed and expected DDD/100/days, it was observed that there were some drugs had 2 times dose given or some had less than half dose as compared to DDD given by WHO. It was found that dosing or frequency prescribed in 26% was irrational. Most common drug related problems was class duplication. The average no. of Drugs per prescription were 8.53 which is five times as compared to WHO standard of 1.6-1.8 drugs per prescription This study reveals that only 46.66% were drugs from National Essential Medicine List (NEML). An alarmingly low number of the drugs were mentioned by their generic names.

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Received on 04.09.2018 Modified on 13.10.2018

Research J. Pharm. and Tech 2019; 12(1): 149-155.

DOI: 10.5958/0974-360X.2019.00028.3

Drug Utilization Pattern	(n=1800 drugs)	Percentage (%)	WHO Standard (%)
Fixed dose combinations (FDCs)	345	19.16
Drugs from National Essential Medicine List (NEML)	840	46.66	100
Drugs prescribed by brand names	1416	78.50	0
Drugs prescribed by generic names	384	21.50	100
Percentage of encounters with an antibiotic prescribed	884	49	20-26.8
Average no. of Drugs per prescription	8.53		1.6-1.8
Prescriptions with an injection	1371	76.16	13.4-24.1