Drug Utilization and Evaluation of Gestational Diabetes Mellitus

 

Maheshwari. P, Guna. B, Ranjith Kumar M, Renugadevi. S

Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University (VISTAS) Pallavaram, Chennai-600117, Tamilnadu, India,

*Corresponding Author E-mail: mahe.mpharm@gmail.com

 

ABSTRACT:

Aim and Objectives: The aim of the study is to analyse and utilize regarding the gestational diabetes in the prescription given in the Gynaecology department of a tertiary care Hospital .To get an insight into the current pattern of prescriptions in Gestational Diabetes.

Materials and Methods: A Prospective study has been carried out for a period of 6 months(December 2016- April2017) in a Tertiary Care Hospital Tamilnadu Maternity Government Hospital located at Chennai.50 patients were  diagnosed with Gestational Diabetes .The case sheets of the patients are thoroughly studied.

Results and Discussion: Total of 50 gestational diabetes patients were studied. Among the study population age was ranging from 20-30 years. The number of patients ranging from 20-30 years were 37 (74%), and the number of patients ranging from 30-40 years were 13 (26%).The Route of Administration in GDM are done by two routes. The oral dosage Form (22%) and another is subcutaneous dosage form (88%).The Trimester of GDM are found among Patients.

Conclusion: According to the survey GDM mainly occurs in the age ranging from 20-30 years and also they are more commonly affected in the Second Trimester (3-6 months) of Pregnancy. Insulin is found to be more safe than compered to oral Hypoglycaemic drugs because the drugs which contain Molecular Weight less than 500 Da crosses the Placental barrier. Insulin molecular weight is greater than 1000 Da, so it do not cross the placenta. The study found that insulin are potent and safe. So, they are prescribed in extensively in GDM. 

 

KEYWORDS: Drug Utilization, Gestational Diabetes Mellitus (GDM), Hypoglycaemic, Insulin, Placenta


 

 

INTRODUCTION:

Gestational Diabetes Mellitus is defined as the Glucose intolerance of various degrees that is first detected during pregnancy. GDM is detected through the screening of pregnant women for clinical risk factors and among at risk-women, testing for abnormal glucose tolerance that is usually, but not variably, mild and asymptomatic (1). GDM affects between 2% and 5% of pregnant women. Pregnancy confers a state of insulin resistance and hyperinsulinemia that may predispose some women to develop gestational diabetes.

 

Gestational Diabetes Mellitus occurs when a women’s pancreatic function is not sufficient to overcome the diabetogenic environment of pregnancy.

 

The amount of GDM varies in direct proportion to the prevalence of type II diabetes.(2) In GDM “Glucose intolerance resulting in the Hyperglycaemia with variable severity with onset or first recognition during pregnancy”. Insulin Pregnancy is a potentially glucose intolerant condition. Sensitivity decreases as the pregnancy advances. At later stage of pregnancy, some women develop Gestational diabetes Mellitus (GDM) particularly obese with pre-existing insulin resistance. Insulin is recognised as the “gold standard” for the treatment of GDM(3). Insulin resistance increase in the normal pregnancy due to progressively rising levels of foetal-placental hormones such as progesterone, cortisol, Growth Hormone, Prolactin and Human placental lactogen. The Pancreas normally compensates by increasing insulin secretion, but when it fails or insulin secretion declines the beta-cell function impairment, then Gestational Diabetes develops(4).

 

GDM is diabetes diagnosed in the second or third trimester of pregnancy. The hormonal changes of pregnancy cause insulin resistance, most mother compensate by increasing insulin secretion. GDM is also associated with many maternal (preeclampsia, birth injuries) and fetal problems (macrosomia, hypoglycaemia). After delivery patients with GDM are at risk of developing type II DM in the mother and childhood obesity in the neonate. Screening of GDM can be done by:1) Clinical risk Factors, 2) glucose challenge Test (GCT), 3) OGTT.(5)

 

Pregnancy is a diabetogenic condition characterized by insulin resistance with a compensatory increase in β-cell response and hyperinsulinemia .Insulin resistance usually begins in the second trimester and progresses throughout the reminder of the pregnancy. nsulin sensitivity is reduced by as much as 80%. Placental secretion of Hormones, such as progesterone, cortisol, placental lactogen, prolactin ,and growth hormone. The insulin resistance seen in the pregnancy.

 

Women with GDM have a greater severity of insulin resistance compared to the insulin resistance seen in normal pregnancies. They also have an impairment of the compensatory increase in insulin secretion, particularly first-phase insulin secretion. This decrease in first-phase insulin release may be a marker of deterioration of β-cell function (6).

 

The most common risk factors are obesity, older maternal age, strong family history of diabetes of GDM, increased incidence of hypertensive disorders during pregnancy, including gestational hypertension, preclampsia and eclampsia.

 

Excessive fetal growth remains an important perinatal concern in GDM. Consequence of excessive fetal growth include birth trauma, maternal morbidity from caesarean deliveries, shoulder dystocia, and neonatal hypoglycaemia(7).

 

Screening for GDM should be performed between the 24th and 28th weeks of gestation that are of average to high risk of developing diabetes. The main purpose of identifying GDM is to detect women at risk of adverse perinatal outcomes. Approximately 4% of all pregnancies are complicated by GDM while the prevalence may range from 1-14% of all pregnancies depending on the population and the method of screening. Women with GDM should perform home blood glucose monitoring. Blood glucose levels are usually monitoring in the fasting state and 1-2 hours after meals(8).

 

It is generally accepted that dietary therapy is the cornerstone of treatment of GDM.  Therefore all women with GDM should receive counselling from a specialist dietician. When treatment targets are not achieved by dietary means, then insulin is required. A basal-bolus regimen of insulin gives the most effective glucose control, and produces better foetal outcomes than a twice daily regime. The required dosage of insulin usually increased gradually over the third trimester of pregnancy.

 

For many years, fast-acting (regular) insulin, and intermediate-acting (isophane) insulin have been the preferred insulin for the treatment of GDM. Human insulin does not normally cross the placenta. There is now increasing evidence that the newer rapid acting analogueslispro and aspart are also safe in pregnancy, and indeed, they are commonly used. The oral antibiotic agents in gestational diabetes mainly used are Metformin, Glyburide, Acarbose and Primidone(9).

 

The GDM group had a higher incidence of complications, including macrosomia, hypoglycaemia, hyperbillirubinemia, hypocalcaemia and polycythaemia. Most neonatal complications readily respond to theraphy if diagnosed and treated early and promptly. Macrosomia can have a detrimental effect on delivery (trauma) and later long-term implications during childhood. Tight metabolic control with diet and, when indicated, insulin treatment may be advantageous in reducing fetal birth weight(10).

 

MATERIALS AND METHOD:

A Prospective study was carried out for 6 months (December 2016-May 2017) in a Tertiary Care Hospital TamilNadu Maternity Government Hospital which is located at Chennai. The department selected for the study is Gynaecology.50 patients of prescription were collected and who were diagnosed with Gestational Diabetes N=50 based on the inclusion and Exclusion criteria .In this study the Data Collection and Data Analysis were done. In Data Collection, the collection of prescription details of the patients from the physician in the Tertiary Care Hospital and in Data Analysis, the obtained data were analysed and was categorised based on the type of cause and its Treatment. Patient Medical History is maintained. The study was conducted with the expert guidance of physician of the department selected for the study in the hospital. The author was permitted to utilize the hospital facilities to make a follow up prescription, in selected departments. The study also includes the utilization of the drugs. An extensive literature study was carried out regarding prescription analysis of Gestational diabetes.

 

RESULTS AND DISCUSSION:

Among the 50 gestational diabetes patients, population age was ranging from 20-30 years. The number of patients ranging from 20-30 years were 37(74%) and the number of patients ranging from 30-40 years were 13(26%). (Table 1)

 

In Gestational diabetes, Insulin are the main medication prescribed. And the types of Insulin used in GDM are Actrapid Insulin (20.5%), Human Mixtard (17.9%), Novorapid (15.3%), Insulatard (12.8%), Human Insulin N(7.6%), Levemir (7.6%).(Table 2)

 

The oral dosage forms used in GDM were identified. The oral dosage form mainly prescribed is Metformin 500 mg (81.81%), Acarbose (18.18%). (Table 3)

 

The Route of Administration in GDM is done by two Routes. One is Oral dosage form (22%) and another is subcutaneous form (88%). (Table no.4)

 

The Trimester of GDM are found among patients, The number of patients in first Trimester were 16(32%), in Second Trimester were 26 (32%) and, in third Trimester were 8 (16%).(Table no.5)

 

Abbreviations:

GDM-Gestational Diabetes Mellitus

GTI-Glucose Tolerance Test

GCT-Glucose challenge Test

OGTT-Oral Glucose Tolerance Test

Da-Dalton

 

TABLES

Table 1-Age wise distribution of Gestational Diabetes in Patients

Age

No. of Patients (n=50)

% of Patients

20-30 Years

37

74%

30-40 Years

13

26%

 

Table 2-Types of Insulin used in GDM

Insulin

No. of patients N=39

% of patients

Human Insulin N

3

7.6%

Human Mixtard

7

17.9%

Novorapid

6

15.3%

Levemir

3

7.6%

Novomix

3

7.6%

Actrapid

8

20.5%

Insulatard

5

12.8%

Humalog Mix

4

10.2%

 

Table 3-Types of Oral dosage forms used in GDM

Oral Dosage Form

No. of  Patients(N=11)

% of the Patients

Metformin 500mg

9

81.81%

Acarbose

2

18.18%

 

Table 4-Route of Administration in GDM

Dosage Forms

No. of Patients (N=50)

% of Patients

Oral

11

22%

Subcutaneous

39

78%

 

 

Table 5-Trimester of GDM

Trimester

No of Patients(N=50)

% of Patients

First Trimester

16

32 %

Second Trimester

26

52%

Third Trimester

8

16%

 

CONCLUSION:

According to the survey GDM mainly occurs in women who conceive in the age group of 20-30 years (74%) and also they more commonly affected in Second Trimester (3-6 months) of Pregnancy. The Medication prescribed includes Insulin and Hypoglycaemic drugs. Among Insulin, Actrapid (Insulin Regular) is most commonly prescribed. Among Hypoglycaemic drugs, Metformin is most commonly prescribed.  Insulin is found to be more safe than compared to oral Hypoglycaemic drugs because the drugs which contains Molecular weight less than 500 Da cross the placental barrier .Insulin Molecular weight greater than 1000 Da, so do not cross the placenta. The study found that the insulin is potent and safe .Hence, Insulin is prescribed in extensively in GDM.

 

REFERENCES:

1.       Thomas A. Buchanan, AnnyH. Xiang .Gestational diabetes Mellitus .The Journal of clinical Investigation. 115 (3); 2005: 485-491.

2.       Amanda ‘Bird’ HoffertGilmartin, Serdar H Ural, John T Repke. Gestational Diabetes Mellitus Rev obstet Gynecol. 1(3); 2008: 129-134.

3.       ASM Towhidualn Alam, ShahedAhemed, Metformin. A drug of choice for Gestational Diabetes Mellitus. Chattagram Maa-O-Shishu Hospital Medical College Journal. 14(2); 2015: 13-19.

4.       Ryan EA, EnnesL. Role of Gestational Hormones in the induction of Insulin resistance J. Clin Endocrine Metab. 67; 1988: 341-347.

5.       Mukesh M Agarwal .Gestational Diabetes Mellitus: Screening with Fasting Plasma Glucose. World Journal of Diabetes. 7(14); 2016: 279-289.

6.       Tracy L. Setji, MD, Annj. Brown, MD and mark N. Feinglos, MD, CM, Gestational Diabetes Mellitus, Clinical Diabetes. 23(1); 2005: 17-24.

7.       EmanM. Alfadhlei, Gestational Diabetes Mellitus journal .Saudi Medical Journal. 36(4); 2015: 399-406.

8.       Malik Mumtaz, Gestational Diabetes Mellitus .The Malaysian Journal of Medical Sciences. 7(1); 2000: 4-9.

9.       N WahCheung, The Management of Gestational Diabetes. National Center for Biotechnology I nformation. 5; 2009: 153-164.

10.     Moshe Hod, Paul Merlob, Shmuel Friedman, Alex Schoenfeld, and Jardena Ovadia, Gestational Diabetes Mellitus: A Survey Of Perinatal Complications Diabetes. 40 (2); 1991: 74-78.

 

 

 

 

 

Received on 26.05.2017          Modified on 06.07.2017

Accepted on 20.08.2017        © RJPT All right reserved

Research J. Pharm. and Tech 2017; 10(12): 4206-4208.

DOI: 10.5958/0974-360X.2017.00768.5