A Study on Insulin use, Prescription Pattern and its Regimens in a Tertiary Care Hospital

 

Abubaker Siddiq1*, Bharathi DR1, Rojin Raj2, Janet Benny2, Shethal Saji2, Sree Lakshmi P2

1Department of Pharmacology, SJM College of Pharmacy, Chitradurga-577502, Karnataka, India

2Department of Pharmacy Practice, SJM College of Pharmacy, Chitradurga-577502, Karnataka, India

*Corresponding Author E-mail: siddiq.pharma@rediffmail.com

 

ABSTRACT:

Objectives: Achieving good glycemic control is of paramount importance in the reduction of diabetes mellitus associated morbidity and mortality. The role of insulin in the management of diabetes mellitus cannot be overemphasized and people with diabetes, use combinations of different types of insulin to better control and manage their condition. The objective of the present work was to evaluate prescribing pattern of insulin and its regimen with dosing frequency and their clinical characteristics. Materials and Methods: A Prospective, observational clinical study was carried out in a tertiary care hospital. A total of 338 patients on various insulin regimens alone or in combination with oral drugs were enrolled and studied for 36 months. Results: The study explored that insulin use is more in males than in females, with a higher use of insulin among elderly patients and with a major incidence in the age group of > 60 years. Most of the study subjects have their normal body mass and few were overweight. The duration of diabetic patients who are on insulin is more between 0-5 years and less in above 15 years. Among the study population greater proportion were using insulin from past 5 years with more twice daily and thrice daily insulin dosing. Furthermore, Human Actrapid was the common human insulin used, followed by fixed dose combination. Conclusion: The use of insulin analogues is very less which are more expensive than human insulin. The use of insulin is important to effectively control the disease process in patients with diabetes mellitus and insulin adherence has been especially proven to be associated with good long term metabolic control.

 

KEYWORDS: Insulin, Age, Human Actrapid, Glycaemic control, Prospective.

 

 


INTRODUCTION:

Diabetes mellitus (DM) is the most common endocrine disorder recognized as the major public health problems and main threats to human health that is affecting the population of both developed and non-developing countries. This can virtually affect every system of the human body leading to micro vascular and macro vascular complications1. According to WHO, the prevalence of diabetes has been increasing rapidly over the last decades and at present time the estimated global prevalence of diabetes is around 9%2.

 

 

 

The International Diabetes Federation projections predict that the prevalence of diabetes will increase to 8.8% by 2035 worldwide3. Good glycaemic control is of utmost importance in reducing the burden of disease attributable to diabetes mellitus. Optimal management of DM is a key factor in reducing the afore mentioned scenario. Management of DM includes the employment of non pharmacological and pharmacological interventions of which insulin therapy plays a prominent role. Although oral antidiabetic drugs (OADs) remain the mainstay in the treatment of type 2 diabetes mellitus, insulin therapy becomes inevitable in a substantial number of patients as the disease progresses4. Insulin therapy is used in the management of diabetes mellitus of all types and the need for insulin depends on the balance between insulin secretion and insulin resistance5. Therefore, the present study was carried out to establish current prescribing pattern of insulin in In-patients of general medicine and paediatric department of a teaching hospital.

 

MATERIALS AND METHODS:

The study was carried out at a teaching hospital at Chitradurga district, Karnataka. The institutional Ethical Committee approval was obtained prior to the study. This was a prospective observational study carried out for a period of three years from January 2015 to December 2017. This study aims at evaluation of the Prospective Patients data for Insulin use, its prescription pattern and its regimen for treatment of Diabetes Mellitus in In-Patients admitted at study site. The data was collected to study prescribing pattern of insulin and its types, dose of insulin, duration of diabetes, duration and frequency of insulin use and clinical characteristics of study subjects. All the necessary and relevant information were collected from Case records after obtaining informed consent. The collected data were analysed by using the Microsoft excel 2007.

 

Statistical analysis:

Data obtained from this study were grouped and analysed by tables using Statistical Package for social sciences (SPSS) version 21.0. Categorical variables were described as frequencies with percentages for the total sample.

 

Study design:

A Prospective observational study

 

Inclusion Criteria:

·      Patients of either sex who was admitted to general medicine and Paediatric wards for the treatment of Diabetes were included in the study

·      With atleast one Anti-diabetic drug

·      Admitted with co-morbidities

·      Willing to give informed consent

 

Exclusion Criteria: 

·      Gestational Diabetes

·      Malignancy with Diabetes

·      Psychiatric illness with Diabetes

 

Sources of data:

·      Patient’s Case records during Hospital stay

·      Medication Charts and Lab reports

 

RESULTS:

The 338 Patients with diabetes mellitus who were on insulin solely or in combination with oral hypoglycaemic agents were enrolled in the study, out of which 178 were males and 160 were females. Among the study population, the greatest number of patients were in the age group of > 60 years. Demographic details of enrolled patients are presented in Table No 1 and 2.

 

Table No. 1: Sex Wise Distribution of Patients

Sl. No

Sex

Number of Patients (n=338)

(%)

1

Male

178

53%

2

Female

160

47%

 

Table No.2: Age Distribution of Patients

Sl. No

Age group in Years

Total no of Patients

(n=338)

% distribution

1

< 20

05

1.5

2

21-30

10

3

3

31-40

31

9.5

4

41-50

75

22

5

51-60

89

26

6

> 60

128

38

 

Most of the enrolled patients who are on insulin use were Normal in their body mass in which 126 and 56 Patients were Overweight and obese respectively. The clinical characteristics of patients suggested that greater proportion of patients had a history of the disease of 0-5 years followed by 41 from past 6-10 years, 21 patients between 11-15 years and 19 above 15 years. The details of characteristics of study subjects are presented in Table No 3.


 

 

 

Table No.3: Clinical characteristics of study subjects

Sl. No

Body mass index (kgm2)

No. of Patients (n=338)

Percentage (%)

Duration of Diabetes

No. of Patients (n=338)

Percentage (%)

1

Under weight (< 18.5)

01

0.5

0-5 years

206

61

2

Normal (18.5-24.9)

155

46

6-10 years

69

20

3

Over weight (25-30)

126

37

11-15 years

34

10

4

Obese (> 30)

56

16.5

> 15 years

29

09

 


Among 338 patients majority were using insulin as a treatment from past 5 years in which insulin dosing regimen ranged from one to four times daily. 32% study subjects were using insulin three times a day followed by 48% twice daily and very less on once and four times daily. The Details of duration of insulin use and distribution of the dosing frequency of insulin is shown in Table No 4.


 

 

 

 

Table No.4: Duration and frequency of Insulin use

Sl. No.

Duration

No. of Patients (n=338)

Percentage %

Frequency of Insulin dosing

Frequency distribution

of daily Insulin dosing %

1

0-5 years

109

57

Once Daily

15%

2

6-10 years

41

22

Twice Daily

48%

3

11-15 years

21

11

Thrice Daily

32%

4

> 15 years

19

10

Four times Daily

05%

 


Human insulin was the commonly used insulin with Actrapid preparation taking the lead. It follows premixed preparations like biphasic Isophane insulin which is a combination of short and intermediate acting insulin. The use of insulin analogues for the treatment is very less as compared to human insulin. The results are depicted in Table No.5.


 

Table No. 5: Pattern of Insulin use

Type of Insulin

 

No. of Insulin Prescribed (n=338)

Percentage %

Human Insulin

Regular (Human Actrapid)

124

65

Biphasic Isophane insulin (30% short acting + 70% Intermediate acting)

41

22

Mixture of Regular + NPH insulin (Human Mixtard)

31

16

Human Insulatard

09

05

Insulin Analogues

Glargine

03

02

 


DISCUSSION:

The role of insulin in the management of diabetes mellitus cannot be overemphasized and people with diabetes use combinations of different types of insulin to better control and manage their condition6,7. A total of 338 patients were enrolled in the study who are on insulin alone or in combination with oral drugs. The study showed that insulin use is more in males than in females. The study also found a higher use of insulin was among elderly patients, with a high incidence in the age group of > 60 years, which is in concordance with the earlier published studies in india which showed majority of the patients with diabetes mellitus belongs to age group greater than 60 years of age8 This implies that these subjects develop DM in the most productive years of their life, because of their lifestyle modification, increase in stress rates and various physical changes in the body. So this age group also has a great chance of developing various other chronic complications associated with diabetes. The burden of diabetes is mainly due to consequence of long term complications like macrovascular and microvascular complications of disease9. Duration of diabetes mellitus plays an important role in its management with patients who have diabetes of less than 1-5 years could usually be managed with single oral hypoglycaemic agent or insulin. Whereas patients with more 5-10 years duration of diabetes may require combination of oral hypoglycaemic agents or insulin with oral hypoglycaemic agents for its management. In our study we found, more than two third of the patients had a history of Diabetes mellitus for less than 10 years. These findings was similar to the observation made in previous studies10. According to the results obtained from our study, we observed more patients either obese or overweight. Boffetta et al., reported that there is a strong association between BMI and the prevalence of diabetes in Asian populations11. This study showed human Actrapid was the common human insulin used in most of the patients which is followed by fixed dose combination. The use of insulin analogues is very less which are more expensive than human insulin. The use of insulin is important to effectively control the disease process in patients with diabetes mellitus and insulin adherence has been especially proven to be associated with good long term metabolic control. There was also a higher prescribing percentage of insulin therapy, Insulin preparations help in decreasing the insulin resistance effectively hence lead to better Glycemic control12. Hence, it is observed that long term glycaemic control in patients with diabetes is poorer who show non adherence to prescribed insulin.

 

CONCLUSION:

From the foregoing Prospective observational study on insulin use and its prescription pattern was carried out on 338 patients and it is concluded that use of insulin is more in males with higher use among elderly patients. Human actrapid was the most frequently used insulin due to less cost compare to insulin analogues.  Insulin preparations help in decreasing the insulin resistance effectively, hence lead to better Glycemic control.

 

ACKNOWLEDGEMENT:  

The authors are thankful to the management of SJM vidyapeetha, Chitradurga through the Principals of SJM College of pharmacy and Basveshwara medical college & hospital for providing necessary facilities, support and encouragement throughout the study.

 

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

 

REFERENCES:

1.     Javedh S, Jennifer F, Samaga LN, Dilnasheen, Anisty MJ. Profile and prescribing pattern of antidiabetic drugs in patients with diabetes mellitus in a tertiary care teaching hospital at dakshin kannada district, Karnataka. European journal of pharmaceutical and medical research 2015; 2(4): 1079-1091.

2.     Adil S, Alibek K, Aliya K, Talgat N, Zhaxybay Z, Anne P and et.al. Diabetes prevalence, awareness and treatment and their correlates in older persons in urban and rural population in the Astana region, Kazakhstan. Diabetes Res Clin Pract. 2015; 6513: 1-7.

3.     Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence in adults for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014; 103(2): 137-49.

4.     Baruah MP, Kalra S, Bose S, Deka J. An audit of insulin usage and insulin injection practices in a large Indian cohort. Indian Journal of Endocrinology and Metabolism 2017; 21(3):443-52.

5.     Anthonia OO and Sonny FK. Insulin use, prescription patterns, regimens and costs-a narrative from a developing country. Diabetology and Metabolic syndrome 2012; 4(50): 1-6.

6.     King H: Insulin: availability, affordability, and harmonization. WHO Drug 1998; 4:219–223.

7.     Makame MH and DERI Study Group: Childhood Diabetes, Insulin, and Africa. Diabet Med 1992; 9:571–573.

8.     Desai P, Desai C, Panchal A, Desai SA. A drug prescribing pattern study in Diabetes mellitus: An outpatient study. J Pharm Sci Bioscientific Res. 2014; 5(1): 115-118.

9.     Mahmood M, Charitha Reddy R, Soumya Lahari JR, Fatima S, Shinde P, Anand Reddy S et al, Prescription Pattern Analysis of Antidiabetic Drugs in Diabetes Mellitus and associated comorbidities. Clinical investigation 2017; 8(1): 5-12.

10.   Soumya MA, Sreelekshmi BS, Smitha S, Jiji KN, Arun SM, Uma DP. Drug Utilization pattern of anti-diabetic drugs among diabetic outpatients in a tertiary care hospital. Asian J Pharm Clin Res 2015; 8(2): 144-146.

11.   Boffetta P, McLerran D, Chen Y, Inoue M, Sinha R, He J, et al., Body mass index and diabetes in Asia: A cross‑sectional pooled analysis of 900,000 individuals in the Asia Cohort Consortium. PLoS One 2011; 6:e 19930.

12.   Donnelly LA, Morris AD, Evans JM. Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes. QJM 2007; 100(6): 345-350.

 

 

 

 

 

 

 

 

 

Received on 08.03.2019          Modified on 30.03.2019

Accepted on 20.04.2019        © RJPT All right reserved

Research J. Pharm. and Tech. 2019; 12(5):2079-2082.

DOI: 10.5958/0974-360X.2019.00344.5