|Year : 2016 | Volume
| Issue : 2 | Page : 106-111
Impact of medication adherence of oral hypoglycemic agents on clinical and economic outcomes: A report from resource-limited settings
Thamineni Rajavardhana, Kadapala Pruthvi Kumar Reddy, Golla Mallikarjuna, Dharmareddy Lakshmanamurthy, Maddirevula Maneesh Kumar Reddy, Easwaran Vigneshwaran
Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research, Anantapuramu, Andhra Pradesh, India
|Date of Web Publication||29-Feb-2016|
Department of Pharmacy Practice, Balaji College of Pharmacy, Anantapuramu, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
Background: Achieving medication adherence is a major obstacle for the management of type II diabetes mellitus. Adherence to the prescribed regimen in terms of dose, frequency, and duration is particularly important to combat the existing clinical condition. The present study settings, being a drought area most of the patients are living under miserable conditions and nonadherence may leave the patients with a huge burden of health care cost. Aim and Objectives: To estimate the effect and to correlate the medication adherence on the clinical and economic outcome of patients with anti-diabetic therapy. Methodology: This study is a prospective cohort study carried out in a secondary care referral hospital. Seventy-six subjects were included and conducted with semi-structured interview for the collection of data. Apart from that, other sources such as medical records, labarotory records, and dispensing records were also used for data collection. The study subjects were divided into two groups' viz. good medication adherence and poor medication adherence groups based on their medication possession ratio (MPR). Results: MPR was found to have strong negative correlation to clinical variables such as gross random blood sugar levels. The mean total cost spent by poor medication adherence group subjects was more than ten folds higher than the good medication adherence group. Conclusion: The good medication adherence group was found to be associated with lesser health care cost and better clinical outcome. Hence, it can be considered as one of the possible ways to reduce economic burden and to manage type II diabetes mellitus patients in resource-limited settings.
Keywords: Cost, diabetes, medication adherence, medication possession ratio
|How to cite this article:|
Rajavardhana T, Reddy KP, Mallikarjuna G, Lakshmanamurthy D, Reddy MM, Vigneshwaran E. Impact of medication adherence of oral hypoglycemic agents on clinical and economic outcomes: A report from resource-limited settings. CHRISMED J Health Res 2016;3:106-11
|How to cite this URL:|
Rajavardhana T, Reddy KP, Mallikarjuna G, Lakshmanamurthy D, Reddy MM, Vigneshwaran E. Impact of medication adherence of oral hypoglycemic agents on clinical and economic outcomes: A report from resource-limited settings. CHRISMED J Health Res [serial online] 2016 [cited 2020 Feb 24];3:106-11. Available from: http://www.cjhr.org/text.asp?2016/3/2/106/177645
| Introduction|| |
Diabetes mellitus is an endocrine disorder which refers to a group of common metabolic disorders, where the therapeutic and economic benefit of drug treatment is not realized in the day to day practice, especially for patients who are partially compliant to their therapy.,, The worldwide prevalence of diabetes mellitus has risen dramatically over the past two decades, from an estimated 30 million cases in 1985–285 million in 2010. Oral hypoglycemic agents are the major treatment options for type 2 diabetes mellitus, and poor medication adherence to these medications may lead to increased burden of diabetes mellitus. It implies that good medication adherence is extremely important for better therapeutic outcomes, but evidence in resource-limited settings are scarce.,,,, And at the same time, economic outcomes were also not measured in these local settings.
Achieving higher medication adherence rate is a major obstacle for the management of any type of disease and this is especially true in the case of chronic debilitating diseases such as diabetes. Adherence to the prescribed regimen is particularly important to combat the existing clinical condition. Most of the times, medication-taking patterns are overlooked by the health care professionals leaving the patients with higher rates of disease progression and emergency visits.,,
Plenty of factors are reported to influence medication adherence and it is clear that full benefit of the medications will be achieved only if patients stringently follow the prescribed treatment regimen. However in our health care system, acute conditions are taken care of in a better way, and medication adherence rates are also higher in acute diseases than chronic diseases.,,
The present study setting being a rural drought area, most of the patients are illiterate (literacy rate 26.73%), economically backward, living in miserable conditions and may not be aware about the importance of regular medicine-taking behavior. This may leave the patients with huge financial burden and increased clinical complications as well. Moreover, the studies pertaining to patient medication adherence are being carried out in developed countries and so the concept of medication adherence is well-understood by healthcare professionals and patients in developed countries., Whereas developing countries like India faces major setbacks due to the paucity of fund resources to conduct studies related to patient medication adherence.,, Hence, the present investigation was undertaken to understand the effect of medication adherence on the clinical and economical outcome and to correlate the medication adherence on the clinical and economic outcome of patients with anti-diabetic therapy.
| Methodology|| |
A prospective cohort study design was used to study the adherence of patients to oral anti-diabetic treatment regimens for July 2013 to April 2014 at a secondary care referral hospital belonging to nongovernmental charity organization located in resource-limited settings of Anantapuram district, Andhra Pradesh, India, where the patients obtain their own medicines at maximum retail price or subsidized rate based on caste and economic reservation. However, the study subjects included in the present study considered as nonreserved patients, receives their medicine at a maximum retail price.
The present study was approved by institutional review board. The purpose, objective and protocol of the present investigation were clearly explained to the study participants to obtain informed consent to participate in this investigation. A nonprobabilistic convenient sampling was done to recruit the study subjects based on their availability and willingness to participate in study. The type 2 diabetes mellitus patients aged 25 years and above, who are currently under the treatment with oral hypoglycemic agents at least for 2 months were included in the present study. There is no upper age limit for selection of subjects. The criteria for the subjects to recruit this study include fasting blood glucose levels of ≥130 mg/dl and postprandial blood glucose levels of ≥160 mg/dl. Individuals who were diagnosed with juvenile diabetes mellitus and gestational diabetes and who failed in Mini-Mental State Examination (MMSE) were excluded from the study.
The MMSE is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: Orientation, registration, attention and calculation, recall, and language. The maximum score is 30 a score of 23 or lower is indicative of cognitive impairment.
The data was collected through various sources such as patient medical records, laboratory records, dispensing records and through semi-structured interview of subjects. The data includes socio-demographic characteristics, income, frequency of drug intake, and reasons for nonadherence to pharmacotherapy. Medication possession ratio (MPR; days of medication collected as a proportion of days of medication prescribed over a particular period and the proportion of days covered within a given time period), was calculated for each patient and based on it the study subjects were divided into two groups' i.e. good medication adherence and poor medication adherence.
The patients with MPR of ≥0.8 were allotted to good medication adherence group and the remaining to poor medication adherence group. After making it into two groups, the subjects were followed subsequently for 8 months and the follow-up data was collected for every 2 months. The follow-up data includes clinical and economic outcome variables such as gross random blood sugar (GRBS) level, treatment cost, laboratory cost, total cost, and hospitalization details history for each patient.
The data were spread onto Microsoft Excel sheet and exported to Manufacturer :Graphpad InStat version 3.10 Registered to Marilyn L. Getchell, University of Kentucky for statistical analysis. The outcome variables are compared between two groups using Student's t-test (unpaired). Further the association between MPR to clinical and economic outcome variables were estimated using linear (Pearson) correlation analysis. The relative risk (RR) is also calculated between medication nonadherence and subsequent hospitalization. The probability value < 0.05 considered as significant.
| Results|| |
We recruited 76 patients who met all study criterions. Among those identified for study inclusion, subjects with ≥60 years of age were more with a high frequency of male subjects. The study subjects were from a rural background, and most of them are illiterates. The monthly income of the present study population is in the income group of 3001–8000 Indian Rupees (INR) [Table 1].
The variables of interest include GRBS, medication cost, laboratory cost and total cost. Linear correlation analyses of MPR to clinical and economic outcomes are shown in [Table 2] where MPR taken as dependent variable.
|Table 2: Correlation coefficient of medication possession ratio to clinical and cost outcomes**|
Click here to view
The present study results show that MPR was found to have a strong association between all the variables of interest. It reveals that good medication adherence improves clinical condition and decreases economic burden which is evident from a negative correlation between MPR to GRBS and range of healthcare costs. We found that there was a significant difference between two analysis groups in terms of clinical and economic outcome of study subjects. The results also disclosed that the number of hospitalizations and the length of hospital stay was significantly reduced for subjects those who have better medication adherence. Other healthcare costs include medication cost, laboratory cost, and total cost were also significantly lesser in good medication adherence group, and they are detailed in [Table 3].
|Table 3: Comparison of outcome variables between poor and good medication adherence*|
Click here to view
The GRBS score was found to have a significant difference between two groups, and the mean values are 154.37 ± 11.72 mg/dl and 186.93 ± 23.09 mg/dl for good and poor medication groups respectively. The health care cost burden to poor medication adherence is around 1385.93 INR, and it is more than ten-fold higher than good medication adherence group.
The RR and healthcare utilization cost of medication nonadherence are tabulated in [Table 4]. It was found to be high for in-patient admission (RR: 3.954) and it is 2.929 for casualty admissions. Huge financial burden was associated to in-patients (3005.50 INR), followed by outpatients due to medication nonadherence (1735.53 INR).
|Table 4: Relative risk of medication non adherence to patient health care utilization|
Click here to view
| Discussion|| |
In this study, we investigated the impact of medication adherence to oral hypoglycemic on clinical and economic outcomes. For the majority of chronic diseases, poor medication adherence reduces the drug benefits and will have a negative impact on the clinical and economic outcome., Hence increased medication adherence may lead to a better clinical outcome, which will have an impact on the reduction of risk of complications, hospitalization, and reduced health care cost. Further, lower income is more frequently associated with decreased medication adherence. A study reported that a medication adherence will have a direct impact and association to a clinical outcomes such as HbA1C level and low-density lipoproteins cholesterol level in patients with diabetes.,
Although evidence are available in the form of published literature stating that medication nonadherence may lead to negative consequences, there is little evidence available for their applicability in resource-limited settings.
The current study has provided empirical evidence that medication adherence in the form of MPR was found to have association with GRBS level and other costs include medical cost and laboratory cost. It also reveals that laboratory cost and medication cost were severely increased for poor medication adherence subjects. These results are coinciding with other research studies stating that medication adherence is associated with savings of total healthcare costs for diabetes, hypertension, and hypercholesterolemia. For people with diabetes, total health care cost reduces simultaneously as adherence with oral hypoglycemic drugs increases. This is probably due to the effects of improved glycemic control which in turn reduces the need of medical services by preventing or reducing the severity of other related conditions (e.g., microvascular diseases, neuropathy, etc.).,,,
The present study has very few numbers of therapy adherent subjects and this medication nonadherence may results in poor treatment outcome among those patients. These results are consistent with other retrospective and prospective studies, where they have provided an evidence that medication nonadherence subjects had a poor therapeutic outcome.,,
Even though, relationship between hospitalization and medication nonadherence is not well-established for diabetic patients, still hospitalizations are the largest component of medical costs in many of the research studies. So changes in the hospitalization risks are a primary goal to cost savings can also be achieved through higher levels of adherence.,, Lack of usage and over-usage of primary care clinics, comorbid conditions, and medication nonadherence is associated with great risk of subsequent hospitalization after treatment.,,
The RR of hospitalization of the poor adherent group was high for different segments, which implies that increased adherence may reduce the economic burden indirectly in terms of decreased hospitalization. The decrease in hospitalization rate decreases the economic burden to the patients.,,
Overall, the strong association between poor medication adherence to increased health care cost and negative clinical outcome stands similar to previously published evidence.,
This study has few limitations that being an observational study and having smaller in sample size. In addition to that the present study site is charity hospital where the patients are provided with both subsidized and nonsubsidized rates (maximum retail price) for health care based on caste and economic reservation. However, this study included only the nonreserved patients that those who are receiving health care at a nonsubsidized rate, thus the results derived in this study is having a lacuna of generalized application.
| Conclusion|| |
Medication adherence may improve the patient's outcomes in both clinical and economic aspects. It also reduces the health care costs in the management of type II diabetes mellitus.
The good medication adherence group was found to be associated with lesser health care cost than poor medication adherence group. Poor medication adherence might increase the treatment costs and associated with poor clinical outcomes. Hence, medication adherence is an important aspect needs to be considered in the management of type II diabetes mellitus preferably in resource-limited setting.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Frier BM, Fisher M. Diabetes mellitus. In: Colledge NR, Walker BR, Hunter JA, editors. Davidson's Principles and Practice of Medicine. 20th
ed. Toronto: Churchill Livingstone; 2008. p. 805-47.
Powers AC. Diabetes mellitus. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, et al
., editors. Harrisons Principles of Internal Medicine. 18th
ed. New York: McGraw Hill; 2012. p. 2968-3002.
Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care 2005;43:521-30.
Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS, Yoon KH, et al.
Diabetes in Asia: Epidemiology, risk factors, and pathophysiology. JAMA 2009;301:2129-40.
Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: Its importance in cardiovascular outcomes. Circulation 2009;119:3028-35.
Mahesh PA, Parthasarathi G. Medication adherence. In: Parthasarathi G, Hansen KN, Nahata MC, editors. A Textbook of Clinical Pharmacy Practice Essential Concepts and Skills. 2nd
ed. Hyderabad: Universities Press; 2012. p. 74-90.
Balkrishnan R, Rajagopalan R, Camacho FT, Huston SA, Murray FT, Anderson RT. Predictors of medication adherence and associated health care costs in an older population with type 2 diabetes mellitus: A longitudinal cohort study. Clin Ther 2003;25:2958-71.
Urquhart J. Role of patient compliance in clinical pharmacokinetics. A review of recent research. Clin Pharmacokinet 1994;27:202-15.
Sharma T, Kalraj J, Dhasman DC, Basera H. Poor adherence to treatment: A major challenge in diabetes. J Indian Acad Clin Med 2014;15:26-9.
Hay J. Health care costs and outcomes: How should we evaluate real world data? Value Health 1999;2:417-9.
Salas M, Hughes D, Zuluaga A, Vardeva K, Lebmeier M. Costs of medication nonadherence in patients with diabetes mellitus: A systematic review and critical analysis of the literature. Value Health 2009;12:915-22.
Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care 2004;27:1218-24.
Osterberg L, Blaschke T. Drug therapy adherence to medication. N Engl J Med 2005;353:487-97.
Kalyango JN, Owino E, Nambuya AP. Non-adherence to diabetes treatment at Mulago Hospital in Uganda: Prevalence and associated factors. Afr Health Sci 2008;8:67-73.
Reddy MG, Kumar KA. Political economy of tribal development: A case study of Andhra Pradesh. Vol. 85. Begumpet, Hyderabad: Centre for Economic and Social Studies; 2010. p. 01-54.
Lau DT, Nau DP. Oral antihyperglycemic medication nonadherence and subsequent hospitalization among individuals with type 2 diabetes. Diabetes Care 2004;27:2149-53.
Schectman JM, Nadkarni MM, Voss JD. The association between diabetes metabolic control and drug adherence in an indigent population. Diabetes Care 2002;25:1015-21.
Hiligsmann M, Rabenda V, Bruyère O, Reginster JY. The clinical and economic burden of non-adherence with oral bisphosphonates in osteoporotic patients. Health Policy 2010;96:170-7.
Pladevall M, Williams LK, Potts LA, Divine G, Xi H, Lafata JE. Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care 2004;27:2800-5.
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-98.
García-Pérez LE, Alvarez M, Dilla T, Gil-Guillén V, Orozco-Beltrán D. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther 2013;4:175-94.
Peterson AM, Nau DP, Cramer JA, Benner J, Gwadry-Sridhar F, Nichol M. A checklist for medication compliance and persistence studies using retrospective databases. Value Health 2007;10:3-12.
Cramer JA, Benedict A, Muszbek N, Keskinaslan A, Khan ZM. The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: A review. Int J Clin Pract 2008;62:76-87.
Offord S, Lin J, Mirski D, Wong B. Impact of early nonadherence to oral antipsychotics on clinical and economic outcomes among patients with schizophrenia. Adv Ther 2013;30:286-97.
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-86.
Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ 1998;317:703-13.
Wagner EH, Sandhu N, Newton KM, McCulloch DK, Ramsey SD, Grothaus LC. Effect of improved glycemic control on health care costs and utilization. JAMA 2001;285:182-9.
Rubin RJ, Dietrich KA, Hawk AD. Clinical and economic impact of implementing a comprehensive diabetes management program in managed care. J Clin Endocrinol Metab 1998;83:2635-42.
Shobhana R, Begum R, Snehalatha C, Vijay V, Ramachandran A. Patients' adherence to diabetes treatment. J Assoc Physicians India 1999;47:1173-5.
Donnan PT, MacDonald TM, Morris AD. Adherence to prescribed oral hypoglycaemic medication in a population of patients with type 2 diabetes: A retrospective cohort study. Diabet Med 2002;19:279-84.
Balkrishnan R, Norwood GJ, Anderson A. Outcomes and cost benefits associated with the introduction of inhaled corticosteroid therapy in a medicaid population of asthmatic patients. Clin Ther 1998;20:567-80.
Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. The SOLVD Investigators. N Engl J Med 1991;325:293-302.
Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, et al.
Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med 2006;166:1836-41.
Ronksley PE, Ravani P, Sanmartin C, Quan H, Manns B, Tonelli M, et al.
Patterns of engagement with the health care system and risk of subsequent hospitalization amongst patients with diabetes. BMC Health Serv Res 2013;13:399.
[Table 1], [Table 2], [Table 3], [Table 4]