A Prospective Observational Study on Prescription Analysis and Drug Related Problems in Type 2 Diabetes Mellitus with or without Comorbidities

Introduction

Diabetes mellitus (DM) is a heterogeneous metabolic disorder characterised by chronic hyperglycemia with disturbances in carbohydrate, fat, and protein metabolism. If the diabetes mellitus is left untreated, it can lead to shock, cardiovascular disease, chronic kidney disease, and retinal detachment. Prescription pattern analysis serves as an insight to existing drug usage to ensure rational drug therapy.¹ There is an alarming rise in disease, from 40 million in 2007 to 70 million by 2025. In India, according to the Diabetes Atlas published by the International Diabetes Federation, every fifth person with diabetes will be an Indian.² For individual patients, rational use of drug implies the prescription of a well documented drug in an optimal dose on the right indication, with correct information and at an affordable price.³ Evaluation of anti-diabetic drug use pattern helps the healthcare professionals to identify early signs of irrational prescribing and to plan intervention to optimise the benefit of treatment regimen.⁴ Medication plays a major role in the cure, palliation, and inhibition of disease, but it also exposes the patient to drug-related problems. According to Pharmaceutical Care Network Europe volume 9.0, drug related problems are events or circumstances involving drug therapy that actually or potentially interferes with desired health outcomes.⁵ Medication adherence is taking medicines as advised and prescribed by health care professionals for a stated duration. Almost half the population suffering from chronic illnesses do not adhere to their medication regimen, and 50% of them indulge in non-adherence after a year of treatment.⁶ There are many methods for evaluating medication adherence, but patient self reporting measures remain the most common approach. The Morisky Medication Adherence Scale ranks the degree of adherence.⁷ Health-Related Quality of Life (HRQoL) is an individual’s perception of the extent to how diseases, disability or disorder affect physical, emotional and social status. It is an important factor that must be taken into consideration when analysing health related outcomes of patients with type 2 diabetes mellitus. Health related quality of life can be measured with a standardised questionnaire for medical outcome studies, the 12-item Short Form Health Survey.⁸

Materials and Methods

A prospective observational study was conducted in the Department of Medicine, Chigateri District Hospital, Davanagere, Karnataka, India. The study was carried out for a duration of six months (April 2022 to September 2022) after receiving clearance and approval from the Institutional Ethics Committee. Patients with type-2 diabetes mellitus and comorbidities were included in our study. Patients with missing or insufficient data, pregnant and lactating women, and patients visiting outpatient departments were excluded from the study. Relevant data was collected on the data collection form, which included patient demographics, laboratory results, diagnosis, comorbid conditions, and prescription analysis. Drug related problems were determined using Pharmaceutical Care Network Europe classification volume 9.0. Information was collected using the Morisky Medication Adherence Scale-8 to evaluate medication adherence and the SF12 questionnaire was used to assess Health-related quality of life (HRQOL). The collected data was analysed using Excel programme. Microsoft Excel was used for the statistical analysis of the results.

Results

Prescription pattern analysis Out of 200 patients enrolled in the study, 50.5% were females and 49.5% were males. The distribution of disease was higher in the age group of 41-60 years (42%) followed by 61-80 years (40%). Hypertension (40.20%) was the most commonly observed comorbid condition followed by cardiovascular disease (17.10%).

Prescription pattern of anti-diabetics

The majority of the patients received insulin as monotherapy (88.1%) (Figure 1). Most prescribed dual therapy was metformin and glimepiride (86.36%) (Figure 2), and triple therapy was metformin + glimepiride + pioglitazone (75%) (Figure 3). Also, combination therapies of insulin with various oral antidiabetic drugs were prescribed (Figure 4).

Drug-related problems in patients with type 2 diabetes mellitus

Of the cases reviewed, 33 drug-related problems (DRP) were identified in 92 patients. The most common of problems recorded were insufficient medication lists (29.34%) and clinical information (19.56%) (Table 1). 

Medication adherence in type 2 DM patients
Out of 200 patients enrolled in the study, 54 (27%) were considered highly adherent, 129 (64.5%) were moderately adherent, and 17 (8.5%) showed low adherence.

Health-related quality of life

In SF12, the highest score was in the mental component summary (55.71), while the lowest was in the physical component summary (52.71) (Table 2).

Discussion

A total of 200 diabetic patients with or without comorbidities admitted in General Medicine from April 2022 to September 2022 were enrolled in the study. According to the results obtained, female patients accounted for 50.5% of the total sample, which is concordance with the results reported by Nazrina S et al. (2018).⁹ In the present study, type 2 DM was found to be most prevalent in the age group of 41-60 years, as suggested by the results of the study conducted by Das A et al. (2021). Of the two hundred type 2 DM patients evaluated, hypertension was the most common co-existing condition (40.2%) observed, similar to the study conducted by Ogbonna B et al. (2014).¹⁰ In our study, insulin was the most commonly received monotherapy, which is in concordance with the results of the study conducted by Mahmood M et al. (2017).¹

Of the cases reviewed, 33 drug related problems were identified in 92 patients. Of the 92 patients, 13.04% patients received inappropriate drugs, 2.16% patients received drugs without indication which is similar to that reported by Sharma A et al. (2018).⁵ It was revealed that among 92 patients, high dose prescription was observed only in one patient (1.08%), prescribed drugs were not available as suggested in a similar study conducted by Zazuli Z et al. (2017).¹¹ The next DRP observed was inappropriate timing of administration or dosing interval in one patient (1.08%), similar to a study conducted by Mechessa D et al. (2020).¹² The another DRP observed was patient taking lower quantities of drug than prescribed or not take the drug at all (11.94%). The most common of problems recorded were insufficient medication list (29.34%) and clinical information (19.56%), which is in agreement with the study conducted by Al Azzam S et al. (2016).¹³

We estimated from our study that 54 (27%) patients were highly adherent, 129 (64.5%) were moderately adherent, and 17 (8.5%) showed low adherence to the prescribed medications. However, Elsous A et al. (2017) conducted a study in Gaza Strip, Palestine, and reported higher medication adherence than noted in our study.¹⁴ The majority of study participants had both good PCS and MCS, which was consistent with the study conducted by Rwegerera G et al. (2018).¹⁵

Conclusion

Though DM is a manageable disease, it is highly prevalent around the world. We conducted a prospective study in tertiary care to assess prescription pattern, DRP, medication adherence, and HRQoL among type 2 diabetes patients. The present study showed that diabetes was higher among females compared to males. The distribution of disease was found to be higher in the age group between 41 and 60 years, and the majority suffered from at least one comorbidity. In this study, the majority of patients were observed to be managed with insulin monotherapy as well as the current prescribing trends of oral anti-diabetic drugs to attain optimal glycemic control. Combination therapies of insulin with various oral anti-diabetic drugs (OADD) were prescribed for proper glycemic control at severe glycemic levels. The study concluded that anti-diabetic drugs are prescribed purely according to American Diabetes Association Guidelines showing a rational prescribing pattern. With a thorough understanding of the prevailing prescribing patterns, attempts can be made to improve the quality and efficiency of drug therapy. In our study, a total of 33 DRP were identified in 92 type 2 DM patients. The three most prevalent DRPs were: no updated medication list available, insufficient clinical information about the patient, and inappropriate drugs. Findings suggest that there is a need for clinical pharmacists in the hospital to reduce DRP in patients. This study found that more than half of the participants were adherent to anti-diabetic medications and that HRQoL scores were associated with the level of patient adherence. There is a necessity to plan and implement awareness and counselling programmes and regular follow-up to educate patients to improve adherence to recommended treatment and lifestyle regimens and thereby enhance their HRQoL.

Ethics clearance

The protocol was verified and approved by the Institutional Ethics Committee of SCS College of Pharmacy, Harapanahalli, Karnataka, India on April 15, 2022.

Conflict of interest

Nil

Acknowledgement

We would like to express our sincere gratitude to all teaching and non-teaching staff of SCS College of Pharmacy, Harapanahalli, who has been always helping and encouraging us.