INTRODUCTION:

Diabetes could be a chronic, metabolic illness characterised by elevated levels of blood sugar, that leads over time to serious harm to the guts, blood vessels, eyes, kidneys, and nerves. The foremost common is type two polygenic disease, typically in adults, that happens once the body becomes immune to hypoglycemic agent or does not build enough hypoglycemic agent. Within the past 3 decades the prevalence of type two polygenic disease has up dramatically in countries of all financial gain levels.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself. ^[1]

DIAGNOSIS:

Diagnostic criteria by the American Diabetes Association (ADA) include the following:

· A fasting plasma glucose (FPG) level of 126mg/dL (7.0 mmol/L) or higher, or

· A 2-hour plasma glucose level of 200mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or

· A random plasma glucose of 200mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycaemic crisis

· Haemoglobin A1c (HbA1c) level

4%-5.6%: Normal

5.7%-6.4%: Pre-diabetic

>6.5%: Diabetic^[2]

COMPLICATIONS:

Short-term complications: hypoglycaemia (very low blood glucose), Hyperosmolar hyperglycemic nonketotic syndrome (HHNS), that is extremely high blood sugar., Long-term complications: Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy and Macrovascular complications[3].

MANAGEMENT:

· Weight loss

· Healthy intake

· Regular exercise

· Blood aldohexose observance

· Diabetic medications or insulin therapy

Oral hypoglycemics (Metformin, Sulphonylureas, Meglitinides, Thiazolidinediones, DDP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors)

MATERIALS AND METHODS:

Study site:

The study was conducted at VGR Diabetic Hospital, Mangalagiri.

Study design:

This was a prospective observational study carried out among the patients with T2DM and its associated complications.

Study duration:

The study was conducted for a duration of 6months (JANUARY 2019-JUNE 2019).

Sample size:

Diabetic patients who were in regular follow-up during the duration of January to June were selected for the study. (n=100)

Ethical approval:

Ethical approval was obtained from the Institutional Ethical Committee (IEC) of VGR Hospital, Mangalagiri.

Study criteria:

The study group consisted of all the diabetic patients with associated complications and those in regular follow-up.

Inclusion criteria:

· All the patients with T₂DM who were in regular follow-up

· Patients with Diabetic complications

· Patients with family history of DM

· Those who were willing to participate within the study

Exclusion criteria:

· Patients who weren’t willing to participate within the study

· T₁DM patients were excluded from our study

· Pregnant and lactating women

· Patients with insufficient data

Sources of data:

· Patient medical records

· Hospital formulary

· Patient medication history interview

Patient case records:

This includes the following

· Patient demographic details

· Family history

· Social history

· Disease duration and associated co-morbidities and complications

· Diagnostic tests (Lipid profile, HbA1c, GRBS, RBS, PPBS, RFT, LFT....)

· Treatment charts

· Progress notes

Study material:

In order to record the necessary data from the above mentioned sources, a separate Patient Data Collection Form was designed based on the data required for the study. It was designed in order to record the treatment pattern, which includes; Demographic details of the patient, risk factors, family history and duration, other co-morbidities and complications, physical examination, laboratory examinations along with drug therapy.

Collection of data:

The data was collected in VGR Diabetic Hospital, Mangalagiri. Patients who came for regular follow-up were identified and data was collected prospectively from medical records for a duration of 6 months (JAN-JUNE, 2019). For data collection each patient’s data were reviewed and data were documented in CRF form prepared for study purpose.

Collected data were evaluated using “SPSS version 20” as follows:

· Age group wise distribution of diabetic and denovo patients

· Status of various diabetic complications along with family history of diabetes

· Study the prescription pattern of drugs like monotherapy, dual therapy and various types of drug combinations

· Prescription pattern of individual class of drugs used in the treatment of diabetes

· Comparison with WHO-INRUD core indicators:

1. Average number of drugs per medical prescription. This indicator helps in investigating poly-medication, that could be a major issue conducive to adverse drug reactions (ADRs) and drug-drug interactions (DDIs). The academic quality informational level of the prescriber may be determined.

2. Percentage of drugs prescribed by generic name. This indicator allows the investigator to calculate the number of prescriptions during which the drugs are prescribed by the generic name. This helps in dominant drug prices within the health service. It additionally evaluates the promoting influence on the person prescribing drugs.

3. Percentage of drugs prescribed from essential drug list or formulary. This indicator helps in measuring the degree to which practices change to the current National Drug Policy (NDP) of Oct 1998. By following essential drug list it guarantees the treatment of the principal diseases of the population besides controlling overall value of medicines.

4. Percentage of encounters with an antibiotic prescribed. This indicator evaluates the utilization of antibiotics in excess that contributes to microorganism dissemination and resistance.

5. Percentage of prescribed injectable medication. This indicator helps to evaluate the injectables in excess, administration of which can have serious consequences once prescribed or applied wrong, corresponding to within the event of hypersensitivity reaction reactions, adverse reactions, necrosis, etc. even though, this indicator helps in analysis of attention given to health fleetly, these indicators don't quantify all the vital aspects of drug use. Studies have indicated that majority of prescriptions in India are of drugs of “doubtful efficacy”. Because of high value of inappropriate use of drugs, developing countries face additional issues due to restricted economic resources and lack of organized drug policy. To promote rational drug use in developing countries, assessment of drug use patterns with the who drug use indicators is turning into progressively necessary.

RESULTS AND DISCUSSION:

In our study it has been observed that the patients between the age groups 41-50 and 51-60 were more prevalent for diabetes and deNovo patient were also more prevalent in the age groups of 41-50 and 51-60 diabetes. This indicates age is a risk factor for diabetes. (Table No.1)

When taken long term complications of diabetes into consideration it was found that diabetic neuropathy and foot ulcers were more prevalent when compared to diabetic nephropathy and hypoglycaemic episodes with nil significance if diabetic retinopathy. Family history is also a factor for diabetic complications and it is significant in different associate complications. Out of all foot ulcers and diabetic neuropathy was found to be having more significant role of family history. (Table No 2)

In our study a total of 100 prescriptions were analysed and the most prescribed therapy was insulin therapy (63%). When coming to oral hypoglycaemic drugs Sulphonylureas (7%) and biguanides (7%) were more frequently prescribed which indicates their significant role in pharmacotherapy of diabetes. (Table No 3)

Out of 100 prescriptions, most of the prescriptions were prescribed in combinations in which dual therapy (87%) was most prescribed followed by triple therapy (13%). This pattern indicates that diabetes and its complications need to be treated with multiple category of drugs. (Table No 4)

WHO released drug core indicators for better compliance of prescriptions. All the prescriptions were analysed for their compliance to WHO drug core indicators. For indicator-1 (Average number of drugs prescribed per encounter) optimal level is ≤3whereas our study has shown 4.93% which indicates a no of drugs for prescription is more than the optimal level.Indicator-2(percentage of drugs prescribed by generic name) optimal level is 100% whereas our study has shown 2% which indicates that the physicians should implement the practice of prescribing by generic name. Indicator-3(Percentage of patient encounter’s with an Antibiotic prescribed) optimal level is ≤30% and value in our study was found to be 4.20% which indicates limited use of antibiotics; Indicator-4(Percentage of patient encounters with an injection prescribed) the value is ≤10% and our value is 9.90% which indicates rational use of parenteral preparations. Indicator-5(Percentage of drugs prescribed from National-EDL or Facilty’s formulary drug use (%) in hospital) our study values are in adherence. So it indicates that prescribed from EDL or National Formulary (Table no.5)

Table 1: Age Wise Prevalence of Diabetic and Denovo Pateints

S. No.	Age	Dm	Denovo
1	31-40	10	2
2	41-50	27	7
3	51-60	26	6
4	61-70	20	0
5	71-80	1	0
6	81-90	1	0

Table 2: Prevalence of Diabetic Complications Along with Family History of Diabetes

Complications	Nephropathy	Neuropathy	Retinopathy	Hypoglycemic Episodes	Foot Ulcers
	5	16	0	7	15
Family History Of DM	2	12	0	5	10

Table 3: Evaluation of Prescribing Pattern

Drug Category	Generic Name	No. of Prescription	% Use
DDD-4 inhibitors	Teneligliptin, linagliptin	2	2
Sulphonyl ureas	Glipizide, glimepride	7	7
Thiazolidinedione	Pioglitazone	5	5
Biguanide	Metformin	7	7
Alpha-glucosidase inhibitor	Acarbose	1	1
Insulin		63	63

Table 4: Polypharmacy

No of Drugs

Combination

No of Prescriptions

Dual therapy

Glipizide + metformin

Glibenclamide + metformin

Teneligliptin + metformin

Pioglitazone + metformin

Glimepride + metformin

Gliclazide + metformin

Metformin + vidagliptin

Sitagliptin + metformin

Glimepride + pioglitazone

Insulin + OHG

87%

Triple therapy

Glibenclamide + metformin + pioglitazone

Glimepride + metformin + pioglitazone

Glimepride + metformin + voglibose

Insulin (short and long acting) + OHG

13%

Table 5: Compliance to who Drug Core Indicators

S. No.	Who Indicators	No of Drugs	Incidence Level	Optimal Level	Odds Ratio
1	Average number of drugs prescribed per encounter	4.93	4.93%	≤3	0.01
2	Percentage of drugs prescribed by generic name	10	2%	100%	0.05
3	Percentage of patient encounters with an antibiotic prescribed	21	4.20%	≤30%	0.01
4	Percentage of patient encounters with an injection prescribed	49	9.90%	≤10%	0.2
5	Prescription of drugs prescribed from the national EDL or the facility’s formulary	493	100%	100%	0.00

*Odds ratio can be applied by using by Variate Linear Regression Method in IBM-SPSS software

CONCLUSION:

The study provides an overview about utilization of anti-diabetic drugs among our study patients in the hospital, the results implies that there is an increased need for prescribing generically as it is cost effective and has less potential for errors. Therefore it is advisable for all prescribers to prescribe generically.

ACKNOWLEDGEMENT:

The authors are thankful to Nirmala College of pharmacy Mangalagiri, Guntur, Andhra Pradesh, India for providing necessary facilities to carry out the research work.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

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Received on 12.11.2019 Modified on 27.02.2020

Research J. Pharm. and Tech. 2020; 13(12):5881-5884.

DOI: 10.5958/0974-360X.2020.01025.2