|Year : 2019 | Volume
| Issue : 2 | Page : 105-111
Drug utilization study in patients with bronchial asthma of a tertiary care hospital in Western Maharashtra
Ruchi Doongarshi Shah1, Shreyas Ramchandra Burute2, Sunita Jaiprakash Ramanand2, Mangala Bhaskar Murthy2, Nami Dungarshi Shah3, Arvind Vitthal Kumbhar2
1 Department of Medical Affairs, Wockhardt Pharmaceuticals, Mumbai, Maharashtra, India
2 Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India
3 Department of Pathology, Metropolis Laboratories, Mumbai, Maharashtra, India
|Date of Submission||06-May-2019|
|Date of Acceptance||25-Oct-2019|
|Date of Web Publication||28-Jan-2020|
Dr. Shreyas Ramchandra Burute
Department of Pharmacology, Government Medical College, Pandharpur Rd, Maji Sainik Vasahat, Miraj - 416 410, Sangli, Maharashtra
Source of Support: None, Conflict of Interest: None
BACKGROUND: Drug utilization studies (DUS) are necessary for knowing the extent of drug use and identify variability in drug use among different regions. Bronchial asthma is known to be one of the major causes of morbidity and mortality in India. There is paucity of Indian data which evaluate the pattern of drug utilization in bronchial asthma over its entire spectrum and varying severity. Hence, the present study was designed to assess the drug utilization pattern in all bronchial asthma patients at a tertiary care hospital to understand the current prescription trends and to determine areas in need of further research.
MATERIALS AND METHODS: A prospective, observational study for a period of 1 year from February 2014 to January 2015 was conducted at the outpatient and inpatient departments of medicine and pediatrics, government teaching tertiary care hospital, Maharashtra. The WHO's prescribing indicators were used for evaluating DUS. Assessment of the overall pattern of drug use and antiasthmatic drugs was done. Data were analyzed using descriptive studies.
RESULTS: Data of 250 asthma patients showed a male preponderance (males vs. females 52.8% vs. 47.2%). The average number of drugs per encounter was 6.10. Only 33.9% of the drugs were prescribed by generic name, and a higher percentage (64.8%) of antibiotics were prescribed. Nearly 69.44% of the prescribed drugs were from essential drug list. The overall pattern of drug use showed that β2 agonists (100% and 97.33%) and corticosteroids (92.57% and 94.66%) were the most common classes of antiasthmatic drugs prescribed in medicine and pediatric departments, respectively. One important finding was that inhaled salbutamol and inhaled corticosteroid were prescribed less commonly.
CONCLUSIONS: The present study identifies the need for prescription by generic name and improvement in prescribing practices with current recommendations or guidelines for the management of bronchial asthma. This will help ensure rational use of drugs.
Keywords: Bronchial asthma, corticosteroids, drug utilization study, Global Initiative for Asthma, salbutamol
|How to cite this article:|
Shah RD, Burute SR, Ramanand SJ, Murthy MB, Shah ND, Kumbhar AV. Drug utilization study in patients with bronchial asthma of a tertiary care hospital in Western Maharashtra. Indian J Allergy Asthma Immunol 2019;33:105-11
|How to cite this URL:|
Shah RD, Burute SR, Ramanand SJ, Murthy MB, Shah ND, Kumbhar AV. Drug utilization study in patients with bronchial asthma of a tertiary care hospital in Western Maharashtra. Indian J Allergy Asthma Immunol [serial online] 2019 [cited 2020 Nov 27];33:105-11. Available from: https://www.ijaai.in/text.asp?2019/33/2/105/276949
| Introduction|| |
Drug utilization studies (DUS) are necessary for knowing the extent of drug use, identifying variability in drug use among different regions or within the region, and developing interventions to improve rational drug use. DUS are thus considered a tool to evaluate health-care system and are the need of the hour. DUS are more importantly required in resource-poor countries like ours so as to ensure that the scarce resources are utilized effectively.
There are about 334 million patients with asthma affecting all age groups, across the world, and about 17–30 million patients suffer from asthma in India., Asthma is known to be one of the major causes of morbidity and mortality in India, comprising 3%–11% of adults and 3%–5% of pediatric population, and its prevalence varies from place to place., As per the Global Initiative for Asthma guidelines, mainly two categories of drugs are used, namely controllers (inhaled and systemic glucocorticoids and inhaled long-acting beta-agonists [LABA] in combination used with inhaled corticosteroid (ICS), leukotriene modifiers, sustained–release theophylline, cromones, and anti-immunoglobulin E) and relievers (inhaled and oral beta-2 agonists, short-acting anticholinergics, and short-acting theophylline). These drugs can be used alone or in conjunction with other antiasthmatic drugs.
There is paucity of Indian data which evaluate the pattern of drug utilization in bronchial asthma over its entire spectrum and varying severity. Hence, the present study was conducted to assess the drug utilization pattern in all bronchial asthma patients at the outpatient department (OPD) and inpatient department (IPD) of medicine and pediatrics at a tertiary care hospital.
| Materials and Methods|| |
The study was a prospective observational study conducted for a period of 1 year from February 2015 to January 2016 at the OPD and IPD of medicine and pediatrics in a government tertiary care hospital with the approval from the institutional ethics committee. A written informed consent of patients of either sex above the age of 5 years was obtained from parents/guardians, and assent was obtained from children above the age of 7 years. Previously and newly diagnosed patients of bronchial asthma of varied duration were included in the study, whereas patients with coexistent respiratory disorders such as bronchitis or emphysema (chronic obstructive pulmonary disease), fibrosis, and any other known lung disease were excluded from the study.
Demographic profiles of patients along with present and past history were recorded on a predesigned case record form. The patients were classified into different socioeconomic classes based on Kuppuswamy Socioeconomic Status Scale.
The detailed information about drugs prescribed during the entire hospital stay such as number of drugs prescribed per prescription, number of antibiotics prescribed, number of injections prescribed, use of generic/brand names, drug dose, drug dosage form, and the frequency and duration of treatment was retrieved from patients, parents/guardians, and medical and nursing charts. The overall pattern of drug use and detailed utilization pattern of antiasthmatic drugs according to the route of administration were also assessed.
The WHO's core drug use prescribing indicators used were as follows:
- Average number of drugs per encounter
- Percentage of drugs prescribed by generic name
- Percentage of encounters with an antibiotic prescribed
- Percentage of encounters with an injection prescribed
- Percentage of drugs prescribed from essential drug list.
The National List of Essential Medicines, 2015, and Indian Academy of Pediatrics List of Essential Medicines for Children of India, 2011, were considered  for calculating percentage of drugs prescribed from essential drug list.
Data were entered in a predesigned Microsoft ® Excel 2008 worksheet. Data were analyzed using descriptive statistics.
| Results and Discussion|| |
The data of 250 patients were analyzed in the present study. The demographic data shown in [Table 1] indicate that the mean age of these patients was 37.56 ± 22.87 years with a range of 6–83 years. The percentage of male patients (52.8%) was greater than that of female patients (47.2%). The mean weight of the patients in the present study was 47.24 ± 17.75 kg. The mean length of inpatient stay in the present study was 4.10 ± 1.21 days, which is similar to the studies by Hoskins et al. (4.04 days) and Soyiri et al. (3 days). Majority of the patients (50.4%) in the present study belonged to lower socioeconomic class. This is probably because the study setting is in a semi-urban area and caters mostly to the health needs of people belonging to lower middle to lower socioeconomic class. This finding is concurrent with other studies where majority of the patients belonged to lower socioeconomic class., Their study setting also was similar to that of the present study, and hence it is difficult to interpret the association of lower socioeconomic class with asthma. The mean duration of asthma in the present study was 10.56 ± 9.22 years.
Assessment of the WHO core drug use prescribing indicators
The WHO's core drug use indicators are a quick and efficient means of assessing potential problems in drug use in many health-care settings. [Table 2] summarizes the assessment of WHO's core drug use prescribing indicators. The overall value of the average number of drugs per encounter was higher (6.10) than the standard value of 1.6–1.8. Other Indian studies have also reported higher value of this indicator – Michael et al. (5.95), Aleemuddin et al. (13.25), Rajathilagam et al. (3.632), Kumar et al. (3.5), and Garje et al. (2.96). In the present study, drugs received for comorbidities and/or patients with exacerbations of asthma were included, thus explaining the possibility of the increased number of drugs and/or polypharmacy. This inference is in accordance with the above-cited studies where the authors have inferred that multiple drugs were required for asthma symptom control.
The overall percentage of drugs prescribed by generic name in the present study was less (33.9%) compared to the standard value of 100%. It was lowest in pediatric outpatients (12.94%). The major advantage of generic medicine is the cost benefit which increases compliance of the patients, especially with chronic diseases such as asthma and in turn leading to therapeutic efficiency. Olurishe andMohammed in their study have also observed that 45.5% of drugs were prescribed by generic name in asthma.
The overall percentage of encounters with an antibiotic prescribed is higher (64.8%) compared to the standard value of 20%–26.8%. Other studies have reported the value of this indicator as much lower, i.e., 9% in the study by Bhandare et al., 19% in the study by Garje et al., and 36.06% in the study by Kumar et al. Thus, the findings of the present study may possibly indicate (1) inadequate control of asthmatic symptoms predisposing the patients to infection and exacerbation and/or (2) scope for improvement with regard to rational prescribing of antibiotics.
The overall percentage of encounters with an injection prescribed was higher (71.6%) as compared to the standard value of 13.4%–24.1%. In a study done by Bhandare et al., it was 92% and in the study by Olurishe andMohammed, it was 28.4%. This value is understandably high in the present study due to inclusion of inpatients as well as the use of injection in medicine OPD patients.
The overall percentage of drugs prescribed from essential drug list was lower (69.44%) as compared to the standard value of 100%. This reinforces a need for the implementation of rational drug use policy.
Overall pattern of drug use and utilization pattern of antiasthmatic drugs
[Table 3] summarizes the overall pattern of drug use in medicine patients, and [Table 4] summarizes the detailed utilization pattern of antiasthmatic drugs prescribed to medicine patients along with the route of administration. As shown in [Table 4], the most common antiasthmatic drugs prescribed were β2 agonists mostly salbutamol by oral route in 70.86% of patients (n = 124 [31 IPD and 93 OPD]) and/or nebulization route in 68% of patients (n = 119 [49 IPD and 70 OPD]), whereas salbutamol was prescribed by inhalation route only in 21% of OPD patients. The use of LABA was in about 26% of OPD patients, and it was in combination with corticosteroid. The use of β2 agonists is in accordance with other studies by Kamath and Kulkarni  (100%), Patel et al. (90% in urban patients and 84% in rural patients), Rajathilagam et al. (68%), and Arumugam et al. (66%). Other studies by Pandey et al. (40%), Anandhasayanam et al. (33%), Jagadeesan  (20%), and Michael et al. (6.53%) have reported lower use of β2 agonists. In the present study, the high use of oral and nebulized salbutamol even in OPD indicates that patients might have been treated on day-care basis for exacerbations. This inference can be further corroborated by (i) high use of injection hydrocortisone (51%) and nebulized budesonide (67%) in OPD patients [Table 4] and (ii) high use of injection theophylline in OPD patients [Table 4]. Overall, the use of oral and nebulized salbutamol, injection hydrocortisone, nebulized budesonide, and injection as well as oral theophylline was also high in IPD patients. The use of injection hydrocortisone was similar to that of the studies by Bhandare et al. (81%), Jayadeva and Panchaksharimath  (61%), and Aleemuddin et al. (42.86%). In the present study, anticholinergics were prescribed in approximately 27.14% of patients, all in combination with salbutamol. The use of ipratropium bromide nebulized together with salbutamol in acute asthma has been shown to have an additive effect on bronchodilatation. As shown in [Table 4], many patients presenting to OPD may have exacerbations, and the role of montelukast, a leukotriene inhibitor in exacerbation, is minimal [Table 3]. Another significant finding was the minimal use of inhaled salbutamol (21%), inhaled budesonide (25%), and inhaled LABA + ICS (26%) in OPD [Table 4]. This could be possibly because inhalers are not available in drug store of government hospitals. Other reasons could be that prescribers prefer other routes or that the level of acceptance of inhalers by patients is low due to cost consideration of inhalers, noncompliance, and/or problem with the technique of inhaler use. It is also observed from [Table 3] that higher percentage (65.14%) of patients were prescribed antimicrobial agents. The possible implication has been discussed earlier while discussing [Table 2]. This is similar to a study by Rajathilagam et al. (65.6%) but is high as compared to other studies by Anandhasayanam et al. (12%), Patel et al. (32% in urban patients and 36% in rural patients), Michael et al. (35.29%), and Bhandare et al. (9%). The other classes of drugs were antacids and antireflux agents (28.57%), antihistaminics (20%), vitamins and minerals (15.43%), antidiabetics (9.71%), and antihypertensives (9.14%). Similar observations were seen in a study by Michael et al. (antacids – 33.33%, multivitamins – 24.83%) and Kamath and Kulkarni  (antireflux agents – 26%, antihistaminics – 30%, antidiabetics – 15%, and antihypertensives – 12.5%).
|Table 4: Utilization pattern of antiasthmatic drugs prescribed to medicine patients (n=175)|
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[Table 5] summarizes the overall pattern of drug use in pediatric patients. [Table 6] summarizes the detailed utilization pattern of antiasthmatic drugs prescribed to pediatric patients along with the route of administration. Similar to results seen in medicine patients [Table 3], the most common antiasthmatic drugs prescribed in pediatric patients were β2 agonists (97.33%), followed by corticosteroids (94.66%). This finding is consistent with that of previous studies by Sayedda et al. (β2 agonists – 100% in exacerbations and corticosteroids – 100% in persistent asthma), Garje et al. (β2 agonists – 81% and corticosteroids – 93%), and Kumar et al. (β2 agonists – 83.6% and corticosteroids – 40.98%). As shown in [Table 6], the use of oral and nebulized salbutamol, systemic steroids, and nebulized budesonide is greatly limited to IPD patients. A higher percentage of pediatric patients were prescribed anticholinergics (58.66%) [Table 5] as compared to medicine patients [Table 3], and this was mainly ipratropium bromide in combination with salbutamol. A significantly different finding from medicine patients was the use of magnesium sulfate in 43.64% of patients in pediatric IPD. It is recommended that magnesium sulfate may be used parenterally in severe exacerbations of asthma not responding to initial treatment, thus indicating that these patients may be suffering from severe exacerbations. In a study done by Sayedda et al., prescription of anticholinergics (32.4%) and magnesium sulfate (1.6%) was seen to be less as compared to the present study. This discrepancy could be because another bronchodilator aminophylline was also prescribed in their study. Aminophylline was not prescribed in pediatric patients of the present study. Similar to the results seen in medicine patients [Table 3], the use of leukotriene inhibitors is minimal (5.33%) and consistent to the results observed by Pandey et al. (4.4%). Antimicrobial agents were prescribed to a higher percentage (64%) of pediatric patients in the present study, which is again similar to the medicine patients [Table 3]. Garje et al. observed antibiotic prescription in 19% and Kumar et al. observed it in 36.06% of pediatric patients. The higher use of antimicrobials may be due to the inadequate control of asthmatic symptoms predisposing the patients to infection and exacerbation. The other classes of drugs were expectorants (30.66%) which were prescribed to only pediatric patients in this study and antihistaminics (17.33%). This observation was in accordance with that of Kumar et al. (antitussives – 39.34% and antihistaminics – 21.31%). Many expectorants contain terbutaline which is a β2 agonist, and hence, it reflects increased prescription of drugs being used for bronchodilatation.
|Table 6: Utilization pattern of antiasthmatic drugs prescribed to pediatric patients (n=75)|
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The important limitation of the present study was that most of the patients visiting the study setup belonged to lower to lower middle socioeconomic class and who are dependent on their medication needs on the hospital dispensary. Consequently, the drug utilization observed in these patients cannot be generalized to other health sectors offering different levels of health care or catering to patients from higher socioeconomic strata. The present study substantiates the need for the management of bronchial asthma in accordance with guidelines for better patient outcomes. The knowledge obtained from the present study can further help to plan interventions needed to improve the effective management of bronchial asthma.
We thank our seniors and colleagues from the Department of Pharmacology, Medicine, and Paediatrics, Government Medical College, Miraj, who provided insight and expertise that greatly assisted the research.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]