DRUG UTILISATION PATTERN IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN A TERTIARY CARE TEACHING HOSPITAL

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1 Page6258 Indo American Journal of Pharmaceutical Research, 2016 ISSN NO: DRUG UTILISATION PATTERN IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN A TERTIARY CARE TEACHING HOSPITAL Vikneswari 1,2, T. Tamizh Mani *1 1 Bharathi College of Pharmacy, Bharathi Nagar, Mandya, Karnataka, India. 2 Faculty of Pharmacy, PG studies, Pacific University, Udaipur, Rajasthan, India. ARTICLE INFO Article history Received 26/07/2016 Available online 04/08/2016 Keywords COPD, Drug Utilization, Inhalational Therapy. ABSTRACT Chronic Respiratory Diseases (CRD) such as Chronic Obstructive Pulmonary Disease (COPD) may account for an estimated burden of about 100 million individuals in India. The technique of drug utilization review (DUR) can provide useful means of determining whether drug use is as appropriate in treatment of individual patients. This was a Prospective study with the aim of analyse the drug prescribing pattern in Chronic obstructivepulmonary disease patients and the prescribing parameters in the collected prescription. The study has been conducted on male and female patients who were satisfying the inclusion criteria. A suitably designed case record form was prepared and used to record all the necessary and relevant data from the medical records of patients. A total of 250 patients were analysed in our study. Out of that 188 were males and 62 were females. The prescription of more than 3 drugs for one patient may be attributed to the possibility of some patients presenting with acute and chronic exacerbation of COPD with or without co-morbid conditions, which requires antibiotic and corticosteroid treatment. Antibiotics were mostly prescribed (19.2%), followed by anticholinergics (18.70%). Inhalation route (38.32%) was more preferred over parenteral (37.98%) and oral route (23.70%). In our study, we observed that the incidence of COPD was more common in males when compared to females. The majority of patients have intermittent exacerbations of COPD due to the inadequate pattern of drug use. GOLD guidelines can be properly followed for prescribing drugs for COPD and can be achieve total control of COPD. Corresponding author Dr. T. Tamizh Mani Principal and Professor Bharathi College of Pharmacy Bharathi Nagar, Mandya Karnataka, India avikneswari11@gmail.com, ttmani@rediffmail.com Please cite this article in press as Dr. T. Tamizh Mani et al. Drug Utilisation Pattern in Chronic Obstructive Pulmonary Disease in a Tertiary Care Teaching Hospital. Indo American Journal of Pharmaceutical Research.2016:6(07). Copy right 2016 This is an Open Access article distributed under the terms of the Indo American journal of Pharmaceutical Research, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

2 Page6259 INTRODUCTION Chronic Obstructive Pulmonary Disease (COPD) has been a major public health problem during this century, and will remain a challenge for the future. Worldwide COPD is in spotlight, because of its high prevalence, morbidity and mortality create powerful challenges for healthcare systems [1]. The global prevalence of COPD in adults aged >40years was approximately 9-10 per cent and the overall prevalence of Chronic Bronchitis in adults >35years alone was 3.49%. COPD may develop due to multiple factors and the risk factors can be genetic or environmental [2]. In chronic respiratory disease like COPD, it becomes very essential to create awareness among the patients about medication and disease. The technique Of Drug Utilization Review (DUR) can provide useful means of determining whether drug use is as appropriate in treatment of individual patients. According to World Health Organization (WHO), drug utilisation can be defined as the marketing, distribution, prescription and use of drugs in a society emphasising its medical, social, and economic consequences [3]. DUR can be used for the description of drug use pattern; early signals of irrational use of drugs; interventions to improve drug use; quality control cycle; continuous quality improvement [4]. Bad prescribing habits lead to ineffective and unsafe treatment, exacerbation or prolongation of illness, distress and harm to the patient and higher costs. Monitoring of prescriptions and drug utilization studies can identify the problems and provide feedback to prescribers so as to create awareness about irrational use of drugs [5]. The practice of DUE is usually applied by the pharmacist to check the appropriateness of drugs prescribed, as a prescription is considered to be an abstract of physician understands of disease and management through drugs. Apart from the rational use of drug, DUE can play an important role in assisting the physician s prescribing attitude in accordance with the predetermined standards by allocating them with the feed-back. This information may also helpful in improvising the prescribing and dispensing practices by designing, conducting and imparting educational programmes for healthcare providers. Hence Drug utilization studies provide useful insights into current prescribing practices an can thus help in reforming and updating practices in clinical medicine and pharmacotherapy [6]. COPD is usually under diagnosed and under treated. Hence it is the fifth cause of morbidity and mortality in the developed world [7]. All COPD patients with breathlessness when walking at their own pace on level ground appear to benefit from rehabilitation and maintenance of physical activity. An exacerbation of COPD is an acute event characterized by a worsening of the patient s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication. COPD often coexists with other diseases (co morbidities) that may have a significant impact on prognosis [8].The respiratory condition of the subjects was improved upon prescribed with an antibiotic for 3-5 days [ 9]. Hence the present study has planned to evaluate the utilization of the medications that were prescribed for treating the patients with COPD in tertiary care teaching hospital. MATERIALS AND METHOD A prospective, observational study was planned with aim to evaluate drug utilizing pattern in COPD in MIMS teaching hospital and research centre. The study was conducted in the general medicine department for 6 month duration, after getting approval from the institutional ethics committee of MIMS teaching hospital. The patients were recruited based on the inclusion and exclusion criteria. Inclusion criteria: The subjects included in this study were both sex and aged above 40 years and above, who have been diagnosed with COPD with or without comorbidities and admitted in the general medicine ward during the study period. Exclusion criteria: 1. All patients who has undergone cardiovascular surgery. 2. All pregnant women with Obstructive Lung diseases The purpose of the study was explained to the patients and collected inform consent from them. A suitably designed Case Record Form was prepared and used to record all the necessary and relevant data from the medical records of patients which mainly included admission sheets, patient history notes, patient treatment charts, laboratory data reports, progress sheets, prescriptions, doctor s orders. We asked different queries to patients/ representatives regarding their present complaints, and addictive habits which were not available in their case sheets. The treatment details were recorded from their case sheets RESULTS This study was conducted in General Medicine Department of Mandya Institute of Medical Science Teaching Hospital, Mandya. A total of 250 COPD patients admitted in Mandya Institute of Medical Science teaching hospital were enrolled in the study based on study criteria. The required details from the patient case sheet were recorded in a suitably designed case report form. The patients were categorised on the basis of age, gender, social history and disease condition. Among 250 COPD cases, there were 64 patients who were having only COPD and 186 patients with co-morbid conditions. (Table 1).

3 Page6260 Table 1: Demographic Parameters. DEMOGRAPHIC PARAMETERS Mean Age+ SD Smoking history Smokers Non smokers Ex-smokers Alcoholic History Alcoholic Non-Alcoholic Ex Alcoholic Disease condition COPD COPD Infective exacerbation COPD + Corpulmonale COPD + Multiple Disease 52% 44% 3.2% 16% 83% 0.8% 25.6% 04.8% 12.8% 56.8% PATIENT DISTRIBUTION BASED ON AGE AND GENDER The prescription data of 250 patients were analysed in the current study, out of which 188 were males (75.2%) and 62 were females (24.8%). The mean age of all patients was found to be years being and years in male and female respectively. The male to female ratio was found to be 3.03 from the study. (Table 2, Fig. 1) Table 2: Patient Distribution based on Age and Gender. Gender No. Of Patients, N (%) Mean Age+ SD (Years) Total Male 188 (75.2%) Female 62 (24.8 %) Fig 1: Patient Distribution based on Gender. PATIENT DISTRIBUTION BASED ON SOCIAL HISTORY We divided 250 patients based on their addictive habits such as smoking and alcoholism. 130 patients (52%) were found to be smokers and 40 were alcoholics (16%). 110 patients were non-smokers (44%) and 208 were non-alcoholics (83%). 10 were exsmokers (4%) and 2 was ex-alcoholic (0.8%). (Table 3, Fig 2)

4 Page6261 Table 3: Patient Distribution Based On Social History. SMOKING HISTORY SMOKERS NON- SMOKERS (52%) (44%) EX- SMOKERS 10 (4%) ALCOHOLISM ALCOHOLIC NON- ALCOHOLIC (16%) (83%) EX- ALCOHOLIC 02 (0.8%) Figure 2: Patient Distribution Based On Social History. COMMONLY PRESCRIBED DRUGS BY CLASS Among 250 prescriptions, it has been seen that all the prescriptions contained more than 3 drugs. The prescription of more than 3 drugs for one patient may be attributed to the possibility of some patients presenting with acute and chronic exacerbation of COPD with or without co-morbid conditions, which requires antibiotic and corticosteroid treatment. In COPD the class of drugs observed, antibiotics were mostly prescribed (19.2%), followed by anticholinergics (18.70%), Short acting beta-2 agonists (18.10%), inhaled corticosteroids (17.20%), Methylxanthines (15.50%), systemic corticosteroids (6.90%), Long acting beta-2 agonist (4.10% )and secretolytic agents (0.30%). (Fig 3). Figure 3: Percentage of Drugs Prescribed by Class. PATIENT DISTRIBUTION BASED ON MONOTHERAPY Out of 250 prescriptions, Deriphylline was the drug which was given for majority of patients as single drug (71.20%), followed by Budesonide (64.80%), Ceftriaxone (56%), Cefotaxim (34%), Hydrocortisone (24%), Dexamethasone (22.40%), CPM (13.60%), Salbutamol (12%), Aminophylline (9.60%), Levofloxacin (6%), and Azithromycin (4%). (Table 4, Fig 4)

5 Page6262 Table 4: Percentage of Drugs Prescribed As Monotherapy. DRUG PERCENTAGE Deriphylline 71.20% Ceftriaxone 56% Cefotaxim 34% Levofloxacin 6% Azithromycin 4% Dexamathasone 22.40% Hydrocortisone 24% Budesonide 64.80% Aminophylline 9.60% CPM 13.60% Salbutamol 12% Figure 4: Percentage of Drugs Prescribed As Monotherapy. PATIENT DISTRIBUTION BASED ON FIXED DOSE COMBINATION Majority of the patients were prescribed with combination therapy. Salbutamol sulphate + Ipratropium Bromide (23.19%), Salbutamol sulphate + Ipratropium Bromide + Budesonide (42.23%), Budesonise + Formeterol (5.90%), Etophylline + Theophylline (19.47%), Dextromethorphen + HBr + Phenylephrine + Cpm + Menthol (0.87%), Bromhexine + Guaiphenesin + Terbutaline + Menthol (4.15%), Beclomethasone + Levosalbutamol (0.21%), Ambroxol + Levosalbutamol (0.87%), Theophylline + Ethylenediamine (2.61%) were the drugs prescribed in combination. (Fig 5). Figure 5: Percentage Of Drug Used as Combination Therapy. PATIENT DISTRIBUTION BASED ON ROUTE OF ADMINISTRAION Our study also revealed that inhalation route (38.32%) was more preferred over parenteral (37.98%) and oral route (23.70%). (Table 5, Fig 6)

6 Page6263 Table 5: Percentage of Drugs Prescribed in Different Dosage Forms. DOSAGE FORMS PERCENTAGE ORAL % PARENTERAL % INHALATION % Figure 6: Percentage of Drugs Prescribed in Different Dosage Form. DISCUSSION A lot of population are suffering from these chronic respiratory diseases. Hence it became very essential to spread a thorough awareness among patients in relation to medication and disease itself. So evaluation of drug utilisation pattern in asthma and COPD will provide a powerful tool in order to find depth of awareness in patients and physician.a prescription based study is considered one of the scientific methods to evaluate the rationality of the prescription. Drug utilization research is an essential part of pharmacoepidemiology as it describes the extent, nature and determinants of drug exposure. Drug use is a complex process. In any country a large number of socio-cultural factors contribute to the ways drugs [10]. A total of 250 patients were analysed in our study. Out of that 188 were males and 62 were females.the patients were categorised according to their age and gender. The age group being kept at interval of 10 years. The maximum numbers of male patients are found in range of years and minimum numbers of patients are found in year age group. Whereas for female, maximum number of patients are in years age group and minimum in years. The risk of COPD was found more in elderly than in younger patients. Globally, COPD by 2020 is expected to rise to the 3rd position as a cause of death and at 5th position as the cause of loss of disabilityadjusted life years (DALYs) according to the baseline projections made in the Global Burden of Disease Study (GBDS). The largest increase in the tobacco related mortality is estimated to occur in India, China and other Asian countries [11]. The patients were categorised on the basis of their Social history, disease conditions.250 patients were categorised based on their addictive habits such as Smoking and Alcoholism. 130 patients (52%) were found to be smokers and 40 were alcoholics (16%).110 patients were non-smokers (44%) and 208 were non-alcoholics (83%). 10 were ex-smokers (3.2%) and 2 was ex-alcoholic (0.8%). Among 250 prescriptions, it has been seen that all the prescriptions contained more than 3 drugs. The prescription of more than 3 drugs for one patient may be attributed to the possibility of some patients presenting with acute and chronic exacerbation of COPD with or without co-morbid conditions, which requires antibiotic and corticosteroid treatment. Antibiotics were mostly prescribed (19.2%), followed by anticholinergics(18.70%), Short acting beta-2 agonists (18.10%), inhaled corticosteroids(17.20%), Methylxanthines(15.50%), systemic corticosteroids (6.90%), Long acting beta-2 agonist(4.10% )and secretolytic agents(0.30%).deriphylline was the drug which was given for majority of patients as single drug (71.20%). Our study also revealed that inhalation route (38.32%) was more preferred over parenteral (37.98%) and oral route (23.70%). CONCLUSION In our study, we observed that the incidence of COPD was more common in males when compared to females. Majority of the patients were from the age group of years. Obstructive Lung diseases are more prominent in smokers when compared to non-smokers. Most of the patients were prescribed with multiple drug therapy out of which inhalation route was the most preferred one. The inhalation route to lungs causes a high local concentration in the lungs with a low systemic delivery, significantly improves the therapeutic effectiveness and minimizes the systemic side effect. Even though Methyl xanthine was the most commonly prescribed class of drug for monotherapy, they could have been avoided due to their adverse effects and instead could have used other safe antiasthmatics which are available.

7 Page6264 Our study has some potential limitations. First, due to the limited time duration, we were unable to carry out this study in large population. Second, certain data were obtained using medical record review and some of the quality deficit may be due to under-documentation. This study recommend for the further study to identify drug interaction and poly pharmacy. From our study, we found that the total control of COPD was not achieved. The majority of patients had intermittent exacerbations of COPD. The pattern of drug use is inadequate. GOLD guidelines can be properly followed for prescribing drugs for COPD and can be achieve total control of COPD. ACKNOWLEDGEMENT We thank to IEC of MIMS teaching hospital for giving approval to conduct this study. We are also grateful to the faculty of General Medicine for extending all their help to us during this study. List of abbreviation CRD -Chronic Respiratory Disease COPD -Chronic Obstructive Pulmonary disease DUR -Drug Utilisation Review DUE -Drug Utilization Evaluation REFERENCE 1. Joan B, Soriano, Roberto Rodriguez-Roisin. Chronic obstructive pulmonary disease overview epidemiology, risk factors, and clinical presentation. Proc Am Thorac Soc. 2011; 8: V.K. Vijayan. Chronic obstructive pulmonary disease; Indian J Med Res.2013; 137: R. D. Shimpi, P. S. Salunkhe, S. R. Bavaskar, G. P. Laddha, A. Kalam, A. Khalik Patel. Drug utilization evaluation and prescription monitoring in asthmatic patients. Int. J. Pharm. Biol. Sci.2012; 2(1): Sharon Sunil, Arya Gigi, Prince Hepzhiba, Dr. Mahesh N. M, MrudulaGiri, Dr.Ajoy Krishnamurthy. Drug utilization evaluation in chronic obstructive pulmonary disease patients - A prospective study. World J Pharm Sci.201;5(1): Pushpender Sharma, B. Kapoor. Study of prescribing pattern for rational drug therapy; from the Department of Pharmacology, Government medical college, Jammu (J&K) India.2003;5(3): AswathyUnni, Akshaya K Jayaprakash, Yadukrishnan MC, Uma Devi P. Drug utilization pattern in chronic obstructive pulmonary disease inpatient at a tertiary care hospital. Int J Pharm Sci.2015;7(11): G. Viegi, F. Pistelli, D.L. Sherrill, S. Maio, S. Baldacci, L. Carrozzi. Definition, epidemiology and natural history of COPD. Eur Respir J. 2007;30: World Health Organization Global Initiative for Chronic Obstructive Lung Disease, Pocket Guide to COPD Diagnosis, Management and Prevention. Available from 9. AleemuddinNM, Farahbahmed, Mohammed Shakeel Mohammed Bashir, Aamir Ali, Salma Khatoon, MdMohib Hussain, AfshanKhatoon. A cross-sectional study on prescribing patterns on patients suffering from respiratory disorders in a teaching hospital of south India. J Cont Med A Dent. 2014; 2(1): Sachdeva,P.D., and Patel,B.G. Drug utilization studies- scope and future perspectives. IJPBR 2010:1(1) Hurd S. The impact of COPD in lung health worldwide: Epidemiology and incidence. Chest 2000; 117: 1S-4S