Impact of pharmacist-led care on glycaemic control of patients with uncontrolled type 2 diabetes: a randomised controlled trial in Nigeria
Main Article Content
Keywords
Diabetes Mellitus, Type 2, Glycemic Control, Pharmacists, Pharmaceutical Services, Patient Education as Topic, Blood Glucose, Glycated Hemoglobin A, Intention to Treat Analysis, Randomized Controlled Trials as Topic, Nigeria
Abstract
Background: Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals.
Objective: To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 Diabetes
Methods: In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients’ laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms.
Results: All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95%CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes.
Conclusions: Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM.
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References
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21. Garrow JS, Webster J. Quetelet's index (W/H2) as a measure of fatness. Int J Obes. 1985;9(2):147-153.
22. Chan YH. Randomised controlled trials (RCTs)--sample size: the magic number?. Singapore Med J. 2003;44(4):172-174.
23. Taveira TH, Friedmann PD, Cohen LB. Pharmacist-led group medical in type 2 diabetes. Diabetes Educ. 2010;36(1):109-117.
24. Edelman D, Fredrickson SK, Melnyk SD, et al. Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial. Ann Intern Med. 2010;152(11):689-696. https://doi.org/10.7326/0003-4819-152-11-201006010-00001
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29. Pousinho S, Morgado M, Falcão A, Alves G. Pharmacist Interventions in the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials. J Manag Care Spec Pharm. 2016;22(5):493-515. https://doi.org/10.18553/jmcp.2016.22.5.493
30. Korcegez EI, Sancar M, Demirkan K. Effect of a Pharmacist-Led Program on Improving Outcomes in Patients with Type 2 Diabetes Mellitus from Northern Cyprus: A Randomized Controlled Trial. J Manag Care Spec Pharm. 2017;23(5):573-582. https://doi.org/10.18553/jmcp.2017.23.5.573
31. Javaid Z, Imtiaz U, Khalid I, et al. A randomized control trial of primary care-based management of type 2 diabetes by a pharmacist in Pakistan. BMC Health Serv Res. 2019;19(1):409. https://doi.org/10.1186/s12913-019-4274-z
32. Alhabib S, Aldraimly M, Alfarhan A. An evolving role of clinical pharmacists in managing diabetes: Evidence from the literature. Saudi Pharm J. 2016;24(4):441-446. https://doi.org/10.1016/j.jsps.2014.07.008
33. Mikhael EM, Hassali MA, Hussain SA, Nouri AI, Shawky N. Pharmacist-led interventional programs for diabetic patients in Arab countries: A systematic review study. International Journal of Diabetes in Developing Countries. 2019;39(4):600-610. https://doi.org/10.1007/s13410-019-00720-7
34. Nogueira M, Otuyama LJ, Rocha PA, Pinto VB. Pharmaceutical care-based interventions in type 2 diabetes mellitus : a systematic review and meta-analysis of randomized clinical trials. Einstein (Sao Paulo). 2020;18:eRW4686. https://doi.org/10.31744/einstein_journal/2020rw4686
35. Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes. Diabetes Educ. 2011;37(6):801-812. https://doi.org/10.1177/0145721711423980
36. Pinto SL, Bechtol RA, Partha G. Evaluation of outcomes of a medication therapy management program for patients with diabetes. J Am Pharm Assoc (2003). 2012;52(4):519-523. https://doi.org/10.1331/japha.2012.10098
37. Poolsup N, Suksomboon N, Intarates M. Effect of pharmacist’s interventions on glycemic control in diabetic patients: a systematic review and meta-analysis of randomized controlled trials. Mahidol University Journal of Pharmaceutical Sciences. 2013;40(4):17-30.
38. Jack J. Diabetes self-management education research. An international review of intervention methods, theories, community partners and outcomes. Dis Manag Health Outcom. 2003;11(7):415-428.
39. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580-591. https://doi.org/10.1056/nejmoa0706245
40. Nola KM, Gourley DR, Portner TS, et al. Clinical and humanistic outcomes of a lipid management program in the community pharmacy setting. J Am Pharm Assoc (Wash). 2000;40(2):166-173. https://doi.org/10.1016/s1086-5802(16)31060-9
41. Kelly C, Rodgers P. Implementation and evaluation of a pharmacist managed diabetes service. J Manag Care Pharm. 2000;6(6):488-493.
42. Jarab AS, Alqudah SG, Mukattash TL, Shattat G, Al-Qirim T. Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm. 2012;18(7):516-526. https://doi.org/10.18553/jmcp.2012.18.7.516
43. Okoro RN, Nmeka C, Erah PO. Utilization study of antidiabetes medicines at a tertiary care hospital in Nigeria. Future J Pharm Sci. 2018;4(2):109-115. https://doi.org/10.1016/j.fjps.2017.11.004
44. Okonta JM, Nduka SO, Idodo VE. Prescribing pattern of antihypertensive and antidiabetic agents in a secondary healthcare institution in Nigeria. J Pharm Sci Res. 2013;5(1):12-17.
45. Ganiyu KA, Erah PO. Medication management of hypertension and diabetes mellitus at two referral health institutions in Bayelsa State, Nigeria: a prospective study. J Pharm Allied Sci. 2017;14(3):2559-2569.
46. Ukwe CV, Ubaka CM, Antihypertensive drug prescribing in a tertiary hospital in Eastern Nigeria. Trop J of Pharm Res. 2012:11(2):297-305.
47. Oamen TE, Osemene KP. Drug Utilization Evaluation of Medications Used by Hypertensive Patients in Hospitals in Nigeria. Hosp Top. 2021;[ahead of print]. https://doi.org/10.1080/00185868.2021.1916416
48. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560-2572. https://doi.org/10.1001/jama.289.19.2560
49. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. https://doi.org/10.1001/jama.2013.284427
2. International Diabetes Federation. IDF Diabetes Atlas, 9th ed. Brussels: International Diabetes Federation; 2019.
3. Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019;157:107843. https://doi.org/10.1016/j.diabres.2019.107843
4. Uloko AE, Musa BM, Ramalan MA, et al. Prevalence and Risk Factors for Diabetes Mellitus in Nigeria: A Systematic Review and Meta-Analysis. Diabetes Ther. 2018;9(3):1307-1316. https://doi.org/10.1007/s13300-018-0441-1
5. Jeong S, Lee M, Ji E. Effect of pharmaceutical care interventions on glycemic control in patients with diabetes: a systematic review and meta-analysis. Ther Clin Risk Manag. 2018;14:1813-1829. https://doi.org/10.2147/tcrm.s169748
6. Afable A, Karingula NS. Evidence based review of type 2 diabetes prevention and management in low and middle income countries. World J Diabetes. 2016;7(10):209-229. https://doi.org/10.4239/wjd.v7.i10.209
7. Pousinho S, Morgado M, Plácido AI, Roque F, Falcão A, Alves G. Clinical pharmacists´ interventions in the management of type 2 diabetes mellitus: a systematic review. Pharm Pract (Granada). 2020;18(3):2000. https://doi.org/10.18549/pharmpract.2020.3.2000
8. Inasu ST, Kumudavalli MV. Pharmacist-Led Interventions on Improving Outcomes in Patients with Diabetes Mellitus: Evidence from the Literature, J Drug Delivery Ther. 2020; 10(4):49-58. http://doi.org/10.22270/jddt.v10i4.4195
9. Desse TA, Vakil K, Mc Namara K, Manias E. Impact of clinical pharmacy interventions on health and economic outcomes in type 2 diabetes: A systematic review and meta-analysis. Diabet Med. 2021;38(6):e14526. https://doi.org/10.1111/dme.14526
10. Correia JC, Lachat S, Lagger G, et al. Interventions targeting hypertension and diabetes mellitus at community and primary healthcare level in low- and middle-income countries:a scoping review. BMC Public Health. 2019;19(1):1542. https://doi.org/10.1186/s12889-019-7842-6
11. O'Donoghue G, O'Sullivan C, Corridan I, et al. Lifestyle Interventions to Improve Glycemic Control in Adults with Type 2 Diabetes Living in Low-and-Middle Income Countries: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs). Int J Environ Res Public Health. 2021;18(12):6273. https://doi.org/10.3390/ijerph18126273
12. Negash Z, Berha AB, Shibeshi W, Ahmed A, Woldu MA, Engidawork E. Impact of medication therapy management service on selected clinical and humanistic outcomes in the ambulatory diabetes patients of Tikur Anbessa Specialist Hospital, Addis Ababa, Ethiopia. PLoS One. 2021;16(6):e0251709. https://doi.org/10.1371/journal.pone.0251709
13. Ipingbemi AE. Pharmacist-led Intervention in Treatment Non-adherence in Southwestern Nigeria. https://www.clinicaltrials.gov/ct2/show/NCT04712916 (accessed July 5, 2021).
14. Adibe MO, Aguwa CN, Ukwe CV. Cost-Utility Analysis of Pharmaceutical Care Intervention Versus Usual Care in Management of Nigerian Patients with Type 2 Diabetes. Value Health Reg Issues. 2013;2(2):189-198. https://doi.org/10.1016/j.vhri.2013.06.009
15. Adibe MO, Ukwe CV, Aguwa CN. The Impact of Pharmaceutical Care Intervention on the Quality of Life of Nigerian Patients Receiving Treatment for Type 2 Diabetes. Value Health Reg Issues. 2013;2(2):240-247. https://doi.org/10.1016/j.vhri.2013.06.007
16. Oparah AC, Famakinde AJ, Adebayo OJ. Outcomes of Pharmacists’ Interventions in the Collaborative Care of Patients with Diabetes. Pharm Educ. 2009;9(1):18-22.
17. Essien O, Otu A, Umoh V, Enang O, Hicks JP, Walley J. Intensive Patient Education Improves Glycaemic Control in Diabetes Compared to Conventional Education: A Randomised Controlled Trial in a Nigerian Tertiary Care Hospital. PLoS One. 2017;12(1):e0168835. https://doi.org/10.1371/journal.pone.0168835
18. Ogbonna BO, Opara AC, Odili VU. Pharmaceutical care activities in Nigeria from 1970 to 2018: A Narrative Review. EC Pharmacol Toxicol. 2019:7(8):789-805.
19. Bonora E, Tuomilehto J. The pros and cons of diagnosing diabetes with A1C. Diabetes Care. 2011;34 Suppl 2(Suppl 2):S184-S190. https://doi.org/10.2337/dc11-s216
20. Introduction: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S1-S2. https://doi.org/10.2337/dc18-sint01
21. Garrow JS, Webster J. Quetelet's index (W/H2) as a measure of fatness. Int J Obes. 1985;9(2):147-153.
22. Chan YH. Randomised controlled trials (RCTs)--sample size: the magic number?. Singapore Med J. 2003;44(4):172-174.
23. Taveira TH, Friedmann PD, Cohen LB. Pharmacist-led group medical in type 2 diabetes. Diabetes Educ. 2010;36(1):109-117.
24. Edelman D, Fredrickson SK, Melnyk SD, et al. Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial. Ann Intern Med. 2010;152(11):689-696. https://doi.org/10.7326/0003-4819-152-11-201006010-00001
25. 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
26. Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010;25(5):1388-1393. https://doi.org/10.1093/ndt/gfp732
27. Lenhard W, Lenhard A. Calculation of effect sizes. https://www.psychometrica.de/effect_size.html (accessed Jun 1, 2020).
28. Adibe MO, Obinna UP, Uchenna IN, Michael UC, Aguwa CN. Effects of additional pharmaceutical care intervention versus usual care on clinical outcomes of type 2 diabetes patients in Nigeria: A comparative study. Sci Res Essay. 2014;9(12):548-556. https://doi.org/10.5897/SRE2013.5558
29. Pousinho S, Morgado M, Falcão A, Alves G. Pharmacist Interventions in the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials. J Manag Care Spec Pharm. 2016;22(5):493-515. https://doi.org/10.18553/jmcp.2016.22.5.493
30. Korcegez EI, Sancar M, Demirkan K. Effect of a Pharmacist-Led Program on Improving Outcomes in Patients with Type 2 Diabetes Mellitus from Northern Cyprus: A Randomized Controlled Trial. J Manag Care Spec Pharm. 2017;23(5):573-582. https://doi.org/10.18553/jmcp.2017.23.5.573
31. Javaid Z, Imtiaz U, Khalid I, et al. A randomized control trial of primary care-based management of type 2 diabetes by a pharmacist in Pakistan. BMC Health Serv Res. 2019;19(1):409. https://doi.org/10.1186/s12913-019-4274-z
32. Alhabib S, Aldraimly M, Alfarhan A. An evolving role of clinical pharmacists in managing diabetes: Evidence from the literature. Saudi Pharm J. 2016;24(4):441-446. https://doi.org/10.1016/j.jsps.2014.07.008
33. Mikhael EM, Hassali MA, Hussain SA, Nouri AI, Shawky N. Pharmacist-led interventional programs for diabetic patients in Arab countries: A systematic review study. International Journal of Diabetes in Developing Countries. 2019;39(4):600-610. https://doi.org/10.1007/s13410-019-00720-7
34. Nogueira M, Otuyama LJ, Rocha PA, Pinto VB. Pharmaceutical care-based interventions in type 2 diabetes mellitus : a systematic review and meta-analysis of randomized clinical trials. Einstein (Sao Paulo). 2020;18:eRW4686. https://doi.org/10.31744/einstein_journal/2020rw4686
35. Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes. Diabetes Educ. 2011;37(6):801-812. https://doi.org/10.1177/0145721711423980
36. Pinto SL, Bechtol RA, Partha G. Evaluation of outcomes of a medication therapy management program for patients with diabetes. J Am Pharm Assoc (2003). 2012;52(4):519-523. https://doi.org/10.1331/japha.2012.10098
37. Poolsup N, Suksomboon N, Intarates M. Effect of pharmacist’s interventions on glycemic control in diabetic patients: a systematic review and meta-analysis of randomized controlled trials. Mahidol University Journal of Pharmaceutical Sciences. 2013;40(4):17-30.
38. Jack J. Diabetes self-management education research. An international review of intervention methods, theories, community partners and outcomes. Dis Manag Health Outcom. 2003;11(7):415-428.
39. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580-591. https://doi.org/10.1056/nejmoa0706245
40. Nola KM, Gourley DR, Portner TS, et al. Clinical and humanistic outcomes of a lipid management program in the community pharmacy setting. J Am Pharm Assoc (Wash). 2000;40(2):166-173. https://doi.org/10.1016/s1086-5802(16)31060-9
41. Kelly C, Rodgers P. Implementation and evaluation of a pharmacist managed diabetes service. J Manag Care Pharm. 2000;6(6):488-493.
42. Jarab AS, Alqudah SG, Mukattash TL, Shattat G, Al-Qirim T. Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm. 2012;18(7):516-526. https://doi.org/10.18553/jmcp.2012.18.7.516
43. Okoro RN, Nmeka C, Erah PO. Utilization study of antidiabetes medicines at a tertiary care hospital in Nigeria. Future J Pharm Sci. 2018;4(2):109-115. https://doi.org/10.1016/j.fjps.2017.11.004
44. Okonta JM, Nduka SO, Idodo VE. Prescribing pattern of antihypertensive and antidiabetic agents in a secondary healthcare institution in Nigeria. J Pharm Sci Res. 2013;5(1):12-17.
45. Ganiyu KA, Erah PO. Medication management of hypertension and diabetes mellitus at two referral health institutions in Bayelsa State, Nigeria: a prospective study. J Pharm Allied Sci. 2017;14(3):2559-2569.
46. Ukwe CV, Ubaka CM, Antihypertensive drug prescribing in a tertiary hospital in Eastern Nigeria. Trop J of Pharm Res. 2012:11(2):297-305.
47. Oamen TE, Osemene KP. Drug Utilization Evaluation of Medications Used by Hypertensive Patients in Hospitals in Nigeria. Hosp Top. 2021;[ahead of print]. https://doi.org/10.1080/00185868.2021.1916416
48. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560-2572. https://doi.org/10.1001/jama.289.19.2560
49. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. https://doi.org/10.1001/jama.2013.284427
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David EA, Soremekun RO, Abah IO, Aderemi-Williams RI. Impact of pharmacist-led care on glycaemic control of patients with uncontrolled type 2 diabetes: a randomised controlled trial in Nigeria. Pharm Pract (Granada) [Internet]. 2021 Aug. 15 [cited 2023 Mar. 27];19(3):2402. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/2402
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