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Research Article | Volume 16 Issue 1 (Jan-Dec, 2024) | Pages 130 - 135
Drug Utilization pattern of Antiasthmatic drugs among Pediatrics at Tertiary Care Teaching Center
 ,
 ,
 ,
 ,
1
Assistant Professor, Department of Pharmacology, Muzaffarpur Nagar Medical College and Hospital India
2
Assistant Professor, Department of Pharmacology, Rama Medical College, Hapur India
3
Associate Professor, Department of Pharmacology, Rama Medical College, Hapur India
4
Assistant professor, Department of Pharmacology, Rama Medical College, Hapur, India
Under a Creative Commons license
Open Access
Received
Oct. 5, 2024
Revised
Oct. 15, 2024
Accepted
Nov. 1, 2024
Published
Nov. 18, 2024
Abstract

Introduction: Asthma is a chronic lung illness marked by reversible airway blockage caused by inflammation of the lungs’ airways and tightness of the muscles around them. The recent Global Initiative for Asthma (GINA) guidelines defined asthma as “a heterogeneous disease, usually characterized by chronic airway inflammation.” Respiratory symptoms such as wheezing, shortness of breath, chest tightness, and cough, as well as fluctuating expiratory airflow limitation, are the characterizations of asthma. The present study aims to assess the various socio-demographic and environmental factors influencing the causation of childhood asthma among patients attending the Paediatric Department.  Materials and methods: This was an observational, cross-sectional study was conducted in the Tertiary Care Teaching Hospital. Children aged between 1-17 years, of either gender and diagnosed with asthma exacerbations defined as episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness, or some combination of these symptoms were included. Result: In this study other class of drugs prescribed along with anti-asthmatic drugs showed that multi-vitamins (38.9%), mucolytic agents (16.7%), proton pump inhibitors (antacids) (14.4%), expectorant (7.8%) and NSAIDs (7.8%) were prescribed as adjuvant therapy. Mucolytic agents and expectorants were mainly given in syrup forms for symptomatic relief. SABA (salbutamol - 61.1%) was the most commonly and frequently prescribed single anti asthmatic drugs followed by methylxanthines (21.1%), corticosteroids (8.9%), anticholinergics (7.8%) and anti-histaminics (1.1%). Majority of the patients were on fixed dose combination (FDCs). Most commonly prescribed FDC of antiasthmatic drug is combination of steroid (ICS) and LABA (71.1%). Out of which, the most common combination used is budesonide and formeterol (60%). Conclusion: Based  on  the  results,  it  was  observed  that most  of  the  patients  were  prescribed  with  multiple  (two, three,  four)  drug  therapy,  out  of  which  inhalational  route was the most preferred one. Anti-asthmatic drugs given as inhalational therapy are more  beneficial  to  the  patients than  systemic  therapy.  Most  frequently  prescribed  single class  anti-asthmatic  drug  was  levosalbutamol  (SABA).

Keywords
INTRODUCTION

Asthma is a chronic lung illness marked by reversible airway blockage caused by inflammation of the lungs’ airways and tightness of the muscles around them. [1] The recent Global Initiative for Asthma (GINA) guidelines defined asthma as “a heterogeneous disease, usually characterized by chronic airway inflammation.” Respiratory symptoms such as wheezing, shortness of breath, chest tightness, and cough, as well as fluctuating expiratory airflow limitation, are the characterizations of asthma. [2]

 

In asthmatics, severe symptoms can develop due to several triggers like cigarette and other smoking, moulds, pollen, dust, animal dander, exercise, cold air, domestic and industrial goods, air pollution, and infections. [3] Both genetic and environmental factors combine and interact to explain the higher asthma rates in some communities. Often, these other factors may cause a disparity, with race or ethnicity being the factor that is easier to detect between different populations. [4]

              

Worldwide more than 300 million people have asthma. Among children, it is one of the top 20 chronic conditions for the global ranking of disability-adjusted life years, with a mortality rate ranging from 0.0–0.7 per 100,000. [5] In India, the prevalence of asthma was reported to be ranging from 2% to 23% which may be due to the enormous geographical and environmental variations across the country. [6] In a recent study, it was found as 10.4% in Assam. [6, 7]

 

Asthma in children causes recurrent respiratory symptoms of wheezing, cough, difficulty breathing and chest tightness and can lead to chronic asthma if not treated adequately. Childhood asthma may increase school absenteeism, decrease active participation in work and thus significantly impair the quality of life of the affected child. [8]

 

Prescribing pattern studies  as  a  part  of drug  utilization studies,  plays  crucial  role  in  promoting  and  practicing rational use of medicines. Rational use of drugs is defined as providing medications in  appropriate  dose,  duration, frequency, indication, patients, and at appropriate cost the community  can  afford.[9] Prescription  patterns  explains about the pattern and extent of drug use, quality of drugs prescribed,  compliance  with  regional,  state  or  national guidelines  like  standard  treatment  guidelines,  usage  of drugs  from  essential  medicine  list  and  use  of  generic drugs. [10]

 

Despite advanced understanding and therapeutic strategies, a dramatic increase in prevalence, morbidity and mortality of childhood asthma has been noted in recent years, necessitating a further understanding of asthma pathogenesis for efficient asthma management. Although many research works are happening in different parts of India, minimal research has been conducted in this underdeveloped region of the north-eastern part of India. [11]

              

The study aims to assess the various socio-demographic and environmental factors influencing the causation of childhood asthma among patients aged 3–12 years attending the paediatric department.

METHODS

This was an observational, cross-sectional study was conducted in the Tertiary Care Teaching Hospital.

 

Inclusion criteria: Children aged between 1-17 years, of either gender and diagnosed with asthma exacerbations defined as episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness, or some combination of these symptoms were included.

 

Exclusion criteria: Children with other systemic disorders, suppressed immunity, co-morbidities like TB, diabetes, renal disease, etc., and those unwilling to participate were excluded.

Prescriptions that were not written legibly and in which drugs were not readable were also excluded.

 

Majority of the asthmatic patients that visited our tertiary care center were managed on Outpatient Department basis and only 30 children were hospitalised for asthmatic exacerbation during the above-mentioned period. After thorough explanation of the study, a written Informed consent form was obtained from parents/guardians of patients and additionally assent was obtained from children above 7 years of age.

 

Patient’s demographic details (age, sex, family history, duration of hospitalisation) and details of prescribed drugs (name, dose, therapeutic class, dosage form, route of administration, dosing frequency, etc.,) were retrieved from in-patient case files and recorded in a specially designed case record form. Details of standard intravenous fluids, oxygen, vaccines and blood transfusion were not recorded. Prescription pattern was assessed using WHO’s core prescribing indicators.

 

STATISTICAL ANALYSIS Data

was compiled in a Microsoft excel spreadsheet and presented as mean, SD and percentage.

 

RESULTS

Out of 90 cases of bronchial asthma, 51 were boys and remaining 39 were girls. This difference is not statistically significant (p value 0.65). Demographic details of cases are given in table 1.

 

Table-1: Demographic details of Asthmatic children

Demographic feature

Number (90)

Gender

 

Male

51

Female

39

Age (years)

 

1 – 4

32

5 – 11

52

12 -14

6

Residence

 

Rural

41

Urban

49

Socioeconomic status

 

Upper

6

Middle

54

Lower

30

Time of Diagnosis

 

Previously diagnosed

69

Newly diagnosed

21

 

Majority of the cases, 56.7% (51/90) belonged to 5-11 years age group. 35.6% (32/90) cases belonged to 1- 4 yr and 6.7% (6/90) belonged to 12-14 years age group. The mean age of children with asthma was 6.42 years. Most of the cases were from urban areas. Out of 90 cases, 54.4% (49/90) were from urban area and 45.6% cases were from rural area. In the study, 60% cases belonged to middle class, 33.3% cases belonged to lower class and 6.7% cases belonged to upper class.

 

Out of 90 cases, 69 cases were previously diagnosed and being treated for bronchial asthma and 21 cases were newly diagnosed. 40% cases had family history of atopic diseases like asthma or allergic rhinitis. Maximum number of cases were reported in rainy and winter seasons i.e. in the months of August (15%), September (14%), October (19%) and November (10%). In the present study, presenting symptoms were cough, wheeze and difficulty in breathing. Cough was the predominant symptom found in 94.4% of cases followed by wheeze seen in 88.9% and difficulty in breathing in 81.1% of cases. In children of 14 years and 5-11 years, cough was more common than wheeze whereas in children in 12-14 years age wheeze was the commonest presenting symptom as depicted in table 2.

 

Table-2: Presenting symptoms of bronchial asthma

Symptoms

1-4years

5-11 years

12 and above

Total

Cough

32

50

3

85(94.4%)

Wheeze

29

45

6

80(88.9%)

Difficulty in breathing

30

41

2

73(81.1%)

 

Majority (36.7%) of the cases of bronchial asthma were of moderate persistent severity. intermittent type of asthma was found in 24.4%, mild persistent asthma in 25.6% of cases and Severe persistent asthma in 13.3% of cases as shown in table 3.

 

Table-3: Classification of children with bronchial asthma based on severity

Asthma severity

1-4 years

5-11years

12-14 years

Total

Intermittent

6/32(18.75%)

16/52(30.8%)

0

22/90(24.4%)

Mild persistent

8/32(25%)

14/52(26.9%)

1/6(16.7%)

23/90(25.6%)

Moderate persistent

16/32(50%)

14/52(26.9%)

3/6(50%)

33/90(36.7%)

Severe persistent

2/32 (6.25%)

8/52(15.4%)

2/6(33.3%)

12/90(13.3%)

Total

32/90

52/90

6/90

100

 

Table 4: Other class of drugs prescribed along with anti-asthmatic medications.

Therapeutic class

Drugs used

Number of prescriptions

N (%)

Mucolytic agents

Ambroxol, acetylcysteine

15 (16.7)

Expectorant

Guainefenesin

7 (7.8)

Antitussive

Dexomethorphan

4 (4.4)

Antacids

Esmoprezole, omeprazole, rabiprazole, pantoprazole

13 (14.4)

Antiemetic

Domperidone

2 (2.2)

Vitamin minerals antioxidants

Vitamin A, D, E, B complex, selenium, zinc, copper

35 (38.9)

Calcium supplements

Cholecalciferol, calcium carbonate, vitamin D3

3 (3.3)

Iron supplements

Ferrous ascorbate, ferrous sulphate

4 (4.4)

NSAIDs

Paracetamol, ibuprofen, aceclofenac

7 (7.8)

 

Other class of drugs (Table 4) prescribed along with anti-asthmatic drugs showed that multi-vitamins (38.9%), mucolytic agents (16.7%), proton pump inhibitors (antacids) (14.4%), expectorant (7.8%) and NSAIDs (7.8%) were prescribed as adjuvant therapy. Mucolytic agents and expectorants were mainly given in syrup forms for symptomatic relief.

 

Table 5: Commonly prescribed single class of anti- asthmatic drug.

Drugs

Number of prescriptions

N (%)

SABA (β2 agonist)

55 (61.1)

Anticholinergic

7 (7.8)

Methylxanthines

19 (21.1)

Corticosteroids

8 (8.9)

Antiallergic (antihistaminics)

1 (1.1)

SABA (salbutamol - 61.1%) was the most commonly and frequently prescribed single anti asthmatic drugs followed by methylxanthines (21.1%), corticosteroids (8.9%), anticholinergics (7.8%) and anti-histaminics (1.1%) as shown in Table 6.

 

Table 6: Prescribed FDCs of anti-asthmatic drugs.

 

Drugs

Number of prescriptions

N (%)

Steroid and LABA

Budesonide and formoterol

54 (60)

Fluticasone and salmeterol

8 (8.9)

Fluticasone and formoterol

2 (2.2)

SABA and anticholinergic

Levo-salbutamol and ipratropium bromide

8 (8.9)

LTRA and antihistamines

Montelukast and levocetrizine

50 (55.6)

Montelukast and fexofenadine

10 (11.1)

Etofylline and theophylline

5 (5.6)

Majority of the patients were on fixed dose combination (FDCs). Most commonly prescribed FDC of antiasthmatic drug is combination of steroid (ICS) and LABA (71.1%). Out of which, the most common combination used is budesonide and formeterol (60%) as shown in Table 7.

 

Table 7: Different dosage forms used by asthmatic patients.

Oral (%)

Inhalational (%)

25

75

Inhalational route (75%) was the most preferred one over oral route (25%) as shown in Table 8.

DISCUSSION

In this study, the majority (57.7%) of the children diagnosed to have bronchial asthma belonged to the age group of 5-11 years, that is in school going age group. Only 32% had bronchial asthma in 1-4 years age group. The reported prevalence of ever having asthma increased among 6-11-year-old children between the first and second (1976 to 1980) National Health and Nutrition Examination Surveys in United States. [12] A survey conducted in 106 centres in 56 countries among children of 13–14 years of age and in 66 centres in 37 countries in children of age 6–7 years of age reported to have had asthma at some time in their lives increased by 0.28% per year in the 13–14 year age group and by 0.18% per year in the 6–7 year age group. [13]

 

Recent studies confirm the disturbing trend toward increased morbidity and mortality from childhood asthma and offer some insights into possible contributing factors. [14] Asthmatic children had a higher prevalence of other allergies (42.6% v 13.2%, P < .01) and of allergen skin test reactivity (44.5% v 20.7%, P < .01) than nonasthmatic children, and most asthmatics had their first asthmatic episode before their third birthday. [15]

 

In a multivariate analysis, close indoor animal contact, outdoor animal contact, and exclusive breastfeeding for at least 6 months were associated with lower atopic sensitization; mud flooring was associated with lower self-reported wheezing. [16] The severity of asthma was related to concomitant exposure to endotoxin in house dust, since the concentration of house dust endotoxin. [17] Study by Leonard B et al shows, when asthma severity was based on the higher severity of asthma symptom frequency or medication use, asthma was mild intermittent in 6.9% of participants, mild persistent in 27.9%, moderate persistent in 22.4%, and severe persistent in 42.9%. [18] In our study, the majority of the cases are moderate persistent (36.7%) and intermittent (24.4%) in severity. 

 

In this study, the exposure to dust, cold, and exercise were found to be the major factors which trigger the exacerbation. Common allergens that are known to trigger asthma were detected in all school environments, where asthma prevalence rates were high. [19] Avoidance of asthma triggers may reduce exacerbation rates and improve asthma-related quality of life in patients with severe or difficult-to-treat asthma. [20] Adequate asthma management depends on an accurate identification of asthma triggers. [21]

CONCLUSION

The severity of bronchial asthma increases mainly at the level of school entry, especially in 5-11 years age group. Most of the cases have positive bronchial asthma or allergic rhinitis family history. Exacerbation of bronchial asthma is associated with triggering factors which can be better avoided. Early identification of children with persistent asthma, along with proper classification of severity and medication will help to overcome the childhood asthma morbidity and mortality. Based  on  the  results,  it  was  observed  that most  of  the  patients  were  prescribed  with  multiple  (two, three,  four)  drug  therapy,  out  of  which  inhalational  route was the most preferred one. Anti-asthmatic drugs given as inhalational  therapy  are  more  beneficial  to  the  patients than  systemic  therapy.  Most  frequently  prescribed  single class  anti-asthmatic  drug  was  levosalbutamol  (SABA).

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