The Evaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: a randomised controlled trial

Main Article Content

Keywords

Diabetes Mellitus, Type 2, Glycemic Control, Blood Glucose, Glycated Hemoglobin A, Pharmaceutical Services, Pharmacists, Medication Adherence, Disease Management, Program Evaluation, Linear Models, Randomized Controlled Trials as Topic, Malaysia

Abstract

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients.


Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage.


Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively.


Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted.


Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted. 

Downloads

Download data is not yet available.
Abstract 659 | pdf Downloads 224

References

1. Tabish SA. Is Diabetes Becoming the Biggest Epidemic of the Twenty-first Century?. Int J Health Sci (Qassim). 2007;1(2):V-VIII.
2. National Health and Morbility survey Malaysia: Ministry of Health; 2019.
3. World Health Organization. Global Report on Diabetes. Geneva: WHO; 2016.
4. Jokanovic N, Tan EC, Sudhakaran S, et al. Pharmacist-led medication review in community settings: An overview of systematic reviews. Res Social Adm Pharm. 2017;13(4):661-685. https://doi.org/10.1016/j.sapharm.2016.08.005
5. Brown H, Chong L, Edwards S, Gillespi S, Martin G, Petrei N, et al. Guidelines For Pharmacists Providing Home Medication Review (HMR) Services. https://www.ppaonline.com.au/wp-content/uploads/2019/01/PSA-Guidelines-for-Providing-Home-Medicines-Review-HMR-Services.pdf (accessed Feb 29, 2018).
6. White L, Klinner C, Carter S. Consumer perspectives of the Australian Home Medicines Review Program: benefits and barriers. Res Social Adm Pharm. 2012;8(1):4-16. https://doi.org/10.1016/j.sapharm.2010.11.003
7. Home Medication Review Protocol. Malaysia: Ministry of Health; 2011.
8. Mohamad Rb, Haron NHb, Amri Ab. Home Care Pharmacy Services Protocol 2nd ed. Malaysia: Ministry of Health; 2019.
9. Alias NEB. The impact of home medication review in patients with type 2 diabetes mellitus living in rural areas of kuantan [master's thesis]. Malaysia: International Islamic University Malaysia; 2015.
10. Chow EP, Hassali MA, Saleem F, Aljadhey H. Effects of pharmacist-led patient education on diabetes-related knowledge and medication adherence: A home-based study. Health Educ J. 2015;75(4):421-33. https://doi.org/10.1177%2F0017896915597021
11. Papastergiou J, Zervas J, Li W, Rajan A. Home medication reviews by community pharmacists: Reaching out to homebound patients. Can Pharm J (Ott). 2013;146(3):139-142. https://doi.org/10.1177/1715163513487830
12. Mossialos E, Courtin E, Naci H, et al. From "retailers" to health care providers: Transforming the role of community pharmacists in chronic disease management. Health Policy. 2015;119(5):628-639. https://doi.org/10.1016/j.healthpol.2015.02.007
13. Alotaibi HS, Shivanandappa TB, Nagarethinam S. Contribution of community pharmacists in educating the asthma patients. Saudi Pharm J. 2016;24(6):685-688. https://doi.org/10.1016/j.jsps.2015.06.002
14. Tan CLH, Gan VBY. Pharmacy Value Added Services: Early Begininings, Current Implementation, And Challenges From The Malaysian Experience. Indian J Pharm Educ Res. 2016;50(3):335-343. https://doi.org/10.5530/ijper.50.3.4
15. Bardet JD, Vo TH, Bedouch P, Allenet B. Physicians and community pharmacists collaboration in primary care: A review of specific models. Res Social Adm Pharm. 2015;11(5):602-622. https://doi.org/10.1016/j.sapharm.2014.12.003
16. Population Distribution by Local Authority Areas and Mukims. Malaysia: Department of Statistics 2010.
17. National Diabetes Registry Report. Malaysia: Ministry of Health; 2013.
18. Schnedl WJ, Krause R, Halwachs-Baumann G, Trinker M, Lipp RW, Krejs GJ. Evaluation of HbA1c determination methods in patients with hemoglobinopathies. Diabetes Care. 2000;23(3):339-344. https://doi.org/10.2337/diacare.23.3.339
19. Kuo IC, Lin HY, Niu SW, et al. Glycated Hemoglobin and Outcomes in Patients with Advanced Diabetic Chronic Kidney Disease. Sci Rep. 2016;6:20028. https://doi.org/10.1038/srep20028
20. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405-412. https://doi.org/10.1136/bmj.321.7258.405
21. International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009;32(7):1327-1334. https://doi.org/10.2337/dc09-9033
22. Management of Type 2 Diabetes Mellitus Malaysia: Ministry of Health; 2015.
23. Classification for Drug related problems. http://www.pcne.org/upload/files/230_PCNE_classification_V8-02.pdf (accessed Feb 29, 2018).
24. Kalogianni A. Factors affect in patient adherence to medication regimen Health Sci J. 2011;5(3):157-158.
25. Wu P, Johnson BA, Nachega JB, et al. The combination of pill count and self-reported adherence is a strong predictor of first-line ART failure for adults in South Africa. Curr HIV Res. 2014;12(5):366-375. https://doi.org/10.2174/1570162x1205141121102501
26. Butt M, Mhd Ali A, Bakry MM, Mustafa N. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm J. 2016;24(1):40-48. https://doi.org/10.1016/j.jsps.2015.02.023
27. Group TE. EQ-5D-5L User Guide. https://euroqol.org/publications/user-guides/ (accessed Dec 20, 2020).
28. Shafie AA, Vasan Thakumar A, Lim CJ, Luo N, Rand-Hendriksen K, Md Yusof FA. EQ-5D-5L Valuation for the Malaysian Population. Pharmacoeconomics. 2019;37(5):715-725. https://doi.org/10.1007/s40273-018-0758-7
29. Qahtani LA, Alqarni A, S. M, Mohamud, Masuadi E, Aldhubayee M. Michigan Diabetes Knowledge Test: translation and validation study of the Arabic version. Int J Acad Sci Res. 2016;4(1):121-125.
30. Al‐Qazaz H, Hassali M, Shafie A, Sulaiman S, Sundram S. The 14-item Michigan Diabetes Knowledge Test: Translation and validation study of the Malaysian version. Pract Diabetes Int. 2010;27:238-241. https://doi.org/10.1002/pdi.1495
31. Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: who, what, when, why, how?. Can J Surg. 2010;53(5):345-348.
32. Latif A. Community pharmacy Medicines Use Review: current challenges. Integr Pharm Res Pract. 2017;7:83-92.
33. Stewart D, Whittlesea C, Dhital R, Newbould L, McCambridge J. Community pharmacist led medication reviews in the UK: A scoping review of the medicines use review and the new medicine service literatures. Res Social Adm Pharm. 2020;16(2):111-122. https://doi.org/10.1016/j.sapharm.2019.04.010
34. Aguiar PM, Brito Gde C, Lima Tde M, Santos AP, Lyra DP Jr, Storpirtis S. Investigating Sources of Heterogeneity in Randomized Controlled Trials of the Effects of Pharmacist Interventions on Glycemic Control in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis. PLoS One. 2016;11(3):e0150999. https://doi.org/10.1371/journal.pone.0150999
35. Ifeanyi Chiazor E, Evans M, van Woerden H, Oparah AC. A Systematic Review of Community Pharmacists' Interventions in Reducing Major Risk Factors for Cardiovascular Disease. Value Health Reg Issues. 2015;7:9-21. https://doi.org/10.1016/j.vhri.2015.03.002
36. Newman TV, San-Juan-Rodriguez A, Parekh N, et al. Impact of community pharmacist-led interventions in chronic disease management on clinical, utilization, and economic outcomes: An umbrella review. Res Social Adm Pharm. 2020;16(9):1155-1165. https://doi.org/10.1016/j.sapharm.2019.12.016
37. Fink RM, Mooney EV, Saseen JJ, Billups SJ. A comparison of clinical pharmacist management of type 2 diabetes versus usual care in a federally qualified health center. Pharm Pract (Granada). 2019;17(4):1618. https://doi.org/10.18549/pharmpract.2019.4.1618
38. Sidek NN, Xin LH, Nurul W, et al. Impact of Pharmacists’ Involvement in Home Medication Review (HMR) Among Stroke Patients in Terengganu, Malaysia. Int J Pharm Pharm Res. 2017;11(1):77-86.
39. Mun TY. Evaluation of the impact of Home Medication Review Program on adherence among patients diagnosed with schizophrenia at Kinta district, Malaysia. Malaysia: USM; 2015.
40. Hatah E, Braund R, Tordoff J, Duffull SB. A systematic review and meta-analysis of pharmacist-led fee-for-services medication review. Br J Clin Pharmacol. 2014;77(1):102-115. https://doi.org/10.1111/bcp.12140
41. MUR premises requirements. http://archive.psnc.org.uk/pages/mur_premises_requirements.html (accessed Dec 20, 2020).
42. Bennett MS, Chater RW, Croley KS, et al. Medication therapy management in pharmacy practice: core elements of an MTM service model. Washington: American Pharmacist Association; 2008.
43. Australian Government. Program Rules Home Medicines Review. https://www.ppaonline.com.au/wp-content/uploads/2019/01/HMR-Program-Rules.pdf (accessed Dec 20, 2020).
44. The Pharmacy Guild of Australia. Implementing and evaluating a parallel post-discharge Home Medication Review (HMR) model. http://6cpa.com.au/wp-content/uploads/Implementing-and-Evaluating-a-Parallel-Post-discharge-Home-Medicines-Review-HMR-Model-Full-Final-Report.pdf (accessed Dec 20, 2020).
45. Andrade CS, Ribeiro GS, Santos CAST, Neves RCS, Moreira ED Jr. Factors associated with high levels of glycated haemoglobin in patients with type 1 diabetes: a multicentre study in Brazil. BMJ Open. 2017;7(12):e018094. https://doi.org/10.1136/bmjopen-2017-018094
46. Asif M. The prevention and control the type-2 diabetes by changing lifestyle and dietary pattern. J Educ Health Promot. 2014;3:1. https://doi.org/10.4103/2277-9531.127541
47. Hardavella G, Aamli-Gaagnat A, Frille A, Saad N, Niculescu A, Powell P. Top tips to deal with challenging situations: doctor-patient interactions. Breathe (Sheff). 2017;13(2):129-135. https://doi.org/10.1183/20734735.006616
48. Cai Lian T, Bonn G, Si Han Y, Chin Choo Y, Chee Piau W. Physical Activity and Its Correlates among Adults in Malaysia: A Cross-Sectional Descriptive Study. PLoS One. 2016;11(6):e0157730. https://doi.org/10.1371/journal.pone.0157730
49. Cheah YK, Lim HK, Kee CC. Demographic and lifestyle determinants of time spent in physical activity among Malaysian adolescents [published correction appears in Int J Pediatr Adolesc Med. 2020 Dec;7(4):212]. Int J Pediatr Adolesc Med. 2018;5(2):49-54. https://doi.org/10.1016/j.ijpam.2018.02.001
50. Hami R. Older people physical activity assessment in Kelantan, Malaysia. Int J Public Health Clin Sci. 2017;4:357.
51. Khalid JM, Raluy-Callado M, Curtis BH, Boye KS, Maguire A, Reaney M. Rates and risk of hospitalisation among patients with type 2 diabetes: retrospective cohort study using the UK General Practice Research Database linked to English Hospital Episode Statistics. Int J Clin Pract. 2014;68(1):40-48. https://doi.org/10.1111/ijcp.12265
52. Bussell JK, Cha E, Grant YE, Schwartz DD, Young LA. Ways Health Care Providers Can Promote Better Medication Adherence. Clin Diabetes. 2017;35(3):171-177. https://doi.org/10.2337/cd016-0029
53. Cheen MHH, Goon CP, Ong WC, et al. Evaluation of a care transition program with pharmacist-provided home-based medication review for elderly Singaporeans at high risk of readmissions. Int J Qual Health Care. 2017;29(2):200-205. https://doi.org/10.1093/intqhc/mzw150
54. van Onzenoort HA, Verberk WJ, Kessels AG, et al. Assessing medication adherence simultaneously by electronic monitoring and pill count in patients with mild-to-moderate hypertension. Am J Hypertens. 2010;23(2):149-154. https://doi.org/10.1038/ajh.2009.207
55. Bekker CL, Gardarsdottir H, Egberts ACG, Bouvy ML, van den Bemt BJF. Pharmacists' Activities to Reduce Medication Waste: An International Survey. Pharmacy (Basel). 2018;6(3):94. https://doi.org/10.3390/pharmacy6030094
56. Lin LK, Sun Y, Heng BH, Chew DEK, Chong PN. Medication adherence and glycemic control among newly diagnosed diabetes patients. BMJ Open Diabetes Res Care. 2017;5(1):e000429. https://doi.org/10.1136/bmjdrc-2017-000429
57. Elliott RA, Boyd MJ, Salema NE, et al. Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service. BMJ Qual Saf. 2016;25(10):747-758. https://doi.org/10.1136/bmjqs-2015-004400
58. Marín-Peñalver JJ, Martín-Timón I, Sevillano-Collantes C, Del Cañizo-Gómez FJ. Update on the treatment of type 2 diabetes mellitus. World J Diabetes. 2016;7(17):354-395. https://doi.org/10.4239/wjd.v7.i17.354
59. Nowakowska M, Zghebi SS, Ashcroft DM, et al. The comorbidity burden of type 2 diabetes mellitus: patterns, clusters and predictions from a large English primary care cohort. BMC Med. 2019;17(1):145. https://doi.org/10.1186/s12916-019-1373-y
60. Walker IF, Garbe F, Wright J, et al. The Economic Costs of Cardiovascular Disease, Diabetes Mellitus, and Associated Complications in South Asia: A Systematic Review. Value Health Reg Issues. 2018;15:12-26. https://doi.org/10.1016/j.vhri.2017.05.003
61. Abu-Rmeileh NME, Ghandour R, Mataria A, Awawda S, Jabr S, O'Flaherty M. Time to act on diabetes mellitus prevention in the West Bank, oPt: Current and future direct cost of diabetes and its complications. Obesity Medicine. 2017;6:18-22. https://doi.org/10.1016/j.obmed.2017.04.001
62. Zaman Huri H, Chai Ling L. Drug-related problems in type 2 diabetes mellitus patients with dyslipidemia. BMC Public Health. 2013;13:1192. https://doi.org/10.1186/1471-2458-13-1192
63. Gangwar SS, Monisha N, Nachiya J, Narasingarao K, Parimalakrishnan S, Singh SP. Impact of medication and psychological behaviour assessment by community pharmacists in type 2 diabetes mellitus patients after hospital stay. Afr Health Sci. 2014;14(3):539-550. https://doi.org/10.4314/ahs.v14i3.7
64. Mitchell B, Armour C, Lee M, et al. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011;83(3):288-294. https://doi.org/10.1016/j.pec.2011.04.027
65. National Health and Morbidity Survey. Malaysia: Ministry of Health; 2015.
66. Data Asas 2015-2016. Kelantan: Kelantan State Government; 2016.