|Year : 2021 | Volume
| Issue : 2 | Page : 193-198
Effect of pharmacist-led intervention on progression of diabetic complications at two tertiary care hospitals of Malaysia
Muhammad Zahid Iqbal1, Amer Hayat Khan2, Syed Azhar Syed Sulaiman3, Aznita Ibrahim4, Nor Shaffinaz Binti Yusoff Azmi5, Muhammad Shahid Iqbal6, Fahad I Al-Saikhan6, Salah-Ud-Din Khan7, Eldowaik Mohamed Salah Saad8
1 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia; Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, AIMST University, Penang, Malaysia
2 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia
3 Department of Clinical Pharmacy, School of Pharmaceutical Sciences; Advanced Medical and Dental Institute, Sains at Bertam, Universiti Sains Malaysia, Penang, Malaysia
4 Physician for Endocrinology, Ministry of Health Malaysia, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia
5 Physician for Endocrinology, Ministry of Health Malaysia, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia
6 Department of Clinical Pharmacy, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-kharj, 11942, Saudi Arabia
7 Department of Biochemistry, College of Medicine, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
8 Department of Hospital and Clinical Pharmacy, Faculty of Pharmacy, University of Cyberjaya, Cyberjaya, Malaysia
|Date of Submission||25-Aug-2020|
|Date of Decision||30-Sep-2020|
|Date of Acceptance||13-Oct-2020|
|Date of Web Publication||26-May-2021|
Dr. Muhammad Shahid Iqbal
Department of Clinical Pharmacy, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj, 11942
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background and Objective: Diabetes mellitus is a chronic disease which can lead to different complications in patients if not treated properly. An appropriate intervention from health care providers is needed to stop and decrease the progression of diabetic complication in diabetic patients. This study aimed to measure the effect of pharmacist intervention on improvement in sign and symptoms and progression of diabetic complications in diabetic patients. Methodology: Diabetic patients were randomly selected and divided into two groups from two tertiary care hospitals. Control group contained those 200 patients who were receiving usual treatment from hospitals. In contrast, the intervention group included those 200 patients who were receiving conventional treatment from hospitals together with separate counselling sessions with pharmacists from Diabetes Medication Therapy Adherence Clinic departments. The study continued for 1 year and two follow-up visits for both groups. A prevalidated data collection form was used to measure the improvement in sign and symptoms and progression of diabetic complication in diabetic patients. Statistical Package for the Social Sciences (SPSS) version 24 was used to analyze the data. Results: The average hemoglobin A1c (HbA1c) values decreased up to 1.43% in the control group and 2.82% in the intervention group. The intervention group showed significant improvement in HbA1c between groups (P < 0.05). The results of univariate and multivariate regression analysis showed that a statistically significant (P < 0.001) improvement was observed in all the predictors of diabetic complications among in the intervention group when compared with the control group. Conclusion: Statistically significant reduction in the sign and symptoms of diabetic complications was observed in the intervention group at the end of 1 year. The progression of diabetic neuropathy was significantly reduced in the pharmacist intervention group.
Keywords: Diabetes mellitus, diabetic complications, nephropathy, neuropathy, pharmacist intervention, retinopathy, vasculopathy
|How to cite this article:|
Iqbal MZ, Khan AH, Sulaiman SA, Ibrahim A, Azmi NS, Iqbal MS, Al-Saikhan FI, Khan SU, Saad EM. Effect of pharmacist-led intervention on progression of diabetic complications at two tertiary care hospitals of Malaysia. J Pharm Bioall Sci 2021;13:193-8
|How to cite this URL:|
Iqbal MZ, Khan AH, Sulaiman SA, Ibrahim A, Azmi NS, Iqbal MS, Al-Saikhan FI, Khan SU, Saad EM. Effect of pharmacist-led intervention on progression of diabetic complications at two tertiary care hospitals of Malaysia. J Pharm Bioall Sci [serial online] 2021 [cited 2022 May 21];13:193-8. Available from: https://www.jpbsonline.org/text.asp?2021/13/2/193/316932
| Introduction|| |
Diabetes mellitus is a progressive disease which is linked with many microvascular and macrovascular complications. These complications can be diabetic neuropathy, nephropathy, retinopathy and vasculopathy. The occurrence and progression of these complications are directly associated with the control of glycemic levels in patients. The prevalence of diabetes mellitus is continuously increasing in all over the globe, especially in middle and low-income countries. Because in these countries, it remains underdiagnosed in patients for many years as the general population is not aware of the disease. Thus, at the time of diagnosis itself, the patients need treatment of diabetes along with diabetic complications.
If diabetes mellitus remains uncontrolled inside the body of the patients for a few years, it can affect the eyes, resulting in diabetic retinopathy, it can be kidneys, resulting in diabetic nephropathy, and nerves resulting in diabetic neuropathy., It has been proven that diabetic complications are strongly associated with the presence of chronic hyperglycemia in patients. The results of many randomized trials have proven the fact that early and tight glycemic control can reduce the onset and the progression of these diabetic complications., This strict glucose control cannot be achieved without patient compliance with the given treatment as reported by many trials. Patient compliance can only be increased if the patients are having proper knowledge about the disease and its complication later on.
Many studies throughout the globe have confirmed that patient counselling and patient education is having a positive impact on the control of diabetes mellitus in diabetic patients. The involvement of pharmacist is directly associated with an increase in patient education about disease and ultimately will result in better outcomes of diabetes mellitus.
The Malaysian health-care system is one of the best health-care systems in the world; therefore, in Malaysia the pharmacist directly collaborates with physicians in tertiary hospitals by the help of Diabetes Medication Therapy Adherence Clinic (DMTAC). In this system, physicians prescribe the best medication regimens and the pharmacists educate the patient about diabetes mellitus, its complications, its medication, dosage regimens, and proper use as well as storage of insulin devices. Once proper treatment given to patients, the outcomes of that given therapy can be measure by various methods. The current study was conducted to evaluate the impact of pharmacist educational intervention on the sign and symptoms, along with the effect of these interventions on the progression of various diabetic complications. The hemoglobin A1c (HbA1c) was used as the clinical outcome measure of diabetes mellitus as HbA1c is a recommended predictor for diabetic complication as per the Malaysian guideline for diabetes mellitus.
| Methodology|| |
Study population and approvals
The current study was conducted at outpatient clinics of two tertiary hospitals in Kedah Malaysia. The present study was prospective nonclinical, multicenter randomized control study. The current study was registered with the National Medical Research Register (NMRR) with registration number NMRR-17-2381-38042. It was approved by both hospital authorities as well as the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia approval reference (KKM/NIHSEC/P18-1307 ). The sample size was calculated using the previous data from Butt et al. to compare the mean of HbA1c between the intervention and control group. A total of 65 patients in each study group were needed to detect the difference of 0.79% (8.47% vs. 9.26% HBA1c) with 80% certainty (power) and using an alpha level of 0.05 and standard deviation (SD) is σ = 1.61. The type I error probability associated with the test of this null hypothesis is 0.05. With an additional 20% dropout rate, the sample size was about 80 samples per group. The inclusion criterion of study was diabetes mellitus for minimum of 5 years, HbA1c more than 8.0%, and receiving medicine from any selected hospital of the study.
Procedure and randomization
Initially, a total of 150 patients from each hospital signed the informed consent form. Then the patient's hospital registration number from each selected hospital was listed as a control group and similarly an interventional group. Upon completion of 150 registration numbers of patients in control and intervention group this list was entered into Microsoft Excel. The randomization was carried out by Microsoft Excel to select randomly 100 patients from 150 hospital registration numbers as the final participants of the study from each group.
The control group includes adult outpatients of diabetes mellitus who were receiving treatment from diabetic clinics in selected hospitals and the intervention group includes adult patients of diabetes mellitus who were receiving treatment from diabetic clinics with the intervention of pharmacist from selected hospitals.
Baseline data were taken for the control group and intervention group from each selected hospital. Then follow-ups were made for these patients after every 6 months in both the control group and intervention group. After baseline, a total of two follow-ups were made for both control groups and intervention groups in each hospital. At every follow-up, the laboratory parameters and the sign and symptoms of various diabetic complications were documented on data collection forms. The total duration of the study was 1 year for every patient after recruitment.
For collecting the patients' information, a prevalidated data collection tool was used. The contents and face validation of the data collection form was done by experts consisting of members of diabetic clinic specialists and academic experts in pharmaceutical sciences faculties of different universities. They were requested to check the issues such as readability, clarity, grammatical, and typo mistakes. The final data collection form was finalized after a series of discussions with experts.
The data analysis was done using Statistical Package for the Social Sciences (SPSS) IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp. Descriptive data were expressed as mean ± SD. The normality of the data was checked by SPSS using skewness and kurtosis testing. The univariate and multivariate regression analysis was used to evaluate the association between independent variables and pharmacist intervention in the current study. A value of P < 0.05 was considered statistically significant.
| Results|| |
Overall, 26.5% (intervention arm: 29.5% vs. control arm: 23.5%) patients dropped out of the study due to various known and unknown reasons.
The sociodemographic characteristics of finally included 299 patients are presented in [Table 1].
|Table 1: Demographics and clinical characteristics of patients at baseline|
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The baseline characteristics of the intervention and control group can be seen in [Table 2].
The inclusion criteria used in logistic regression to enter the data into multivariate regression from the univartiate regression was the adjusted odds ratio < 0.09.
[Table 2] shows at the baseline, in demographic variables of the control and intervention group, there was no statistical difference (P < 0.05) observed in any predictor of the included diabetic complications in patients.
[Table 3] shows at the follow-up 1, in demographic variables of the intervention group, there was some statistical difference (P < 0.05) observed in few predictors of the included diabetic complications in patients.
|Table 3: Diabetic complications determinants after 6 months of baseline (n=294)|
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[Table 4] shows at the follow-up 2, in demographic variables of the intervention group, there was a statistical difference (P < 0.05) observed in all predictors of the included diabetic complications in patients, which shows the effect of pharmacist intervention on diabetic complications at the end of the study.
|Table 4: Diabetic complications determinants after 1 year of baseline (n=294)|
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[Table 5] shows that the HbA1c decreased continuously in every follow-up visit in both of the study groups.
| Discussion|| |
The current study intended to measure the effect of pharmacist intervention on the progression of diabetic complications from the improvement in signs and symptoms of these complications in type 2 diabetic patients. This study had proven that if the patient education about the disease is increased by pharmacist intervention, then ultimately, the outcomes of the disease will be better.
In the current study, the mean HbA1c lowered from baseline to the end of the study in the control group was 0.38% only. In contrast, the mean decrease in HbA1c in the intervention group with the involvement of pharmacist was 1.07% which is statistically significant from the control group. The result of our study was supported by a randomized prospective study by Lim et al., in Malaysia, where the reduction of mean HbA1c in the intervention group was 0.90%, and the control group 0.08% only and was significant (P = 0.011) in both study groups.
In diabetic neuropathy. At baseline, all the predictors of sign and symptoms of diabetic neuropathy were statistically insignificant between study groups. At 6-month follow-up, symptoms of numbness and tingling were improved. At 1-year follow-up, all the predictors of sign and symptoms of diabetic neuropathy were statistically improved in the intervention group as compared with the control group. These results were comparable to the findings of a study conducted by Keban et al., in India, according to which the patients' knowledge about diabetic neuropathy was improved by pharmacist intervention resulted in the improvement of diabetic neuropathy symptoms in patients. Similar results were also reported by a pilot study conducted in India.
In the progression of diabetic retinopathy. At baseline, statistically, the nonsignificant difference was observed between both of the study groups, but at 6-month and 1-year follow-up, the improvement in the intervention group was started producing significant effects in the intervention group. The current study findings have supported a study conducted in the United States by Weber et al., according to which pharmacists-managed care has a potential role in protecting the patients from diabetic retinopathy and reduce its progression. The current study shows the improvement in retinopathy signs and symptoms was started from “blurred vision” and “trouble in night vision” predictor with P = 0.021 and 0.039, respectively. Then at the 1-year follow-up, the results of univariate and multivariate regression analysis showed significant association in all signs and symptoms predictors of diabetic retinopathy. The reason behind is the education provided by the pharmacist to the patients; once the patients knew the complications of the disease, they became more conscious about the daily activities and diet modification.
The current study showed the improvement in nephropathy signs and symptoms of “polyuria” and “swelling of feet” predictor with P = 0.023 and 0.098 at 6-month follow-up. In the 1-year follow-up, the results of univariate and multivariate showed that it became statistically significant in all nephropathy signs and symptoms in the pharmacist-led intervention group as compared with the control group. These findings are strongly supported by a study conducted in France in which community pharmacist-provided the educational interventions to renal impairment patients, and improvement in sign and symptoms was observed at the end of the study.
The results of the present study showed that the pharmacist intervention resulted in improvement in the progression of the diabetic foot also. The total number of patients with “callus” and “infection” was only one with each symptom in the intervention group that proved the pharmacist educational intervention resulted in an improved outcome of diabetic foot in all the included patients with a diabetic foot. These findings of the current study are supported by a retrospective study by Stading et al., which proves the impact of the pharmacist on diabetic foot complication.
| Conclusion|| |
Overall, pharmacist-led educational intervention has a positive impact on the progression of diabetic complications. This study findings gave evidence for the effectiveness of DMTAC program in Malaysia and would like to suggest that pharmacist services should enhance especially to patients with uncontrolled diabetes to avoid further diabetic complications.
The authors would like to thank the Deanship of Scientific Research at Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia, for the support in the publication of this manuscript. The authors would like to convey thanks to the Director-General of Health Malaysia too for kind permission to publish this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]