Main Article Content
Diabetes Mellitus, Type 2, Insulin, Glycated Hemoglobin A, Disease Management, Pharmaceutical Services, Pharmacists, Community Health Centers, Patient Outcome Assessment, Comparative Effectiveness Research, Retrospective Studies, United States
Background: Clinical pharmacists have demonstrated their ability to improve patient outcomes over usual care for patients with type 2 diabetes and glycemic levels above goal, though reasons for this are not well defined. Numerous medications exist for the management of patients with type 2 diabetes and different patterns of medication use by clinical pharmacists may explain these benefits.
Objective: The objective of this study was to compare pharmacotherapy approaches to managing patients with uncontrolled type 2 diabetes receiving basal insulin by a clinical pharmacist versus usual care by a physician or advanced practice provider in a federally qualified health center.
Methods: A retrospective cohort study of patients 18 to 85 years old with type 2 diabetes, A1C ≥9%, receiving basal insulin was conducted. Patients were grouped into two cohorts: (1) those who received clinical pharmacist care and (2) those who received usual care from a physician or advanced practice provider. The primary outcome evaluated the proportion of patients treated with the addition of a non-basal insulin medication. Type of medication changes or additions as well as change in A1C and change in weight were also analyzed. Outcomes were evaluated at six months post-index A1C.
Results: A total of 202 patients were identified (n=129 in the usual care group and n=73 in the clinical pharmacist group). A non-basal insulin medication was added in 29% of patients receiving usual care versus 41% of patients receiving clinical pharmacist care (adjusted p=0.040). Usual care providers more frequently added metformin, sulfonylureas and thiazolidinediones, while clinical pharmacists more frequently added prandial insulin, DPP-4 inhibitors, GLP-1 agonists, and SGLT-2 inhibitors. A1C decreased 1.6% in the clinical pharmacist group versus 0.9% in the usual care group (adjusted p=0.055). No significant change in weight was observed between the clinical pharmacist and usual care group (0.2 kg versus -1.0 kg, respectively; adjusted p=0.175).
Conclusions: Pharmacotherapy approaches to managing patients with uncontrolled type 2 diabetes varied between clinical pharmacists and other clinician providers. For patients already on basal insulin, clinical pharmacists were more likely to intensify therapy with the addition of non-basal insulin, including more frequent initiation of prandial insulin and by adding newer antihyperglycemic agents.
2. American Diabetes Association. Standards of medical care in diabetes - 2019. Diabetes Care. 2019 Jan;42(suppl 1):S1-193.
3. Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2019 executive summary. Endocr Pract. 2019;25(1):69-100. https://doi.org/10.4158/CS-2018-0535
4. Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018;41(12):2669-2701. https://doi.org/10.2337/dci18-0033
5. LeRoith D, Jan Biessels G, Braithwaite SS, Casaneuva FF, Draznin B, Halter JB, Hirsch IB, McDonnell ME, Molitch ME, Murad MH, Sinclair AJ. Treatment of diabetes in older adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104:1520-1574. https://doi.org/10.1210/jc.2019-00198
6. Qaseem A, Wilt T, Kansagara D, Horwitch C, Barry MJ, Forciea MA. Hemoglobin A1C targets for glycemic control with pharmacologic therapy for nonpregnant adults with type 2 diabetes mellitus: a guidance statement update from the American College of Physicians. Ann Intern Med. 2018;168(8):569-576. https://doi.org/10.7326/M17-0939
7. Das SR, Everett BM, Birtcher KK, Brown JM, Cefalu WT, Januzzi JL, Rastogi Kalyani R, Kosiborod M, Magwire ML, Morris PB, Sperling LS. 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease. J Am Coll Cardiol 2018;72(24):3200-3223. https://doi.org/10.1016/j.jacc.2019.09.020
8. Skinner JS, Poe B, Hopper R, Boyer A, Wilkins CH. Assessing the effectiveness of pharmacist-directed medication therapy management in improving diabetes outcomes in patients with poorly controlled diabetes. Diabetes Educ. 2015;41(4):459-465. http://doi.org/10.1177/0145721715587563
9. Salvo MC, Brooks AM. Glycemic control and preventive care measures of indigent diabetes patients within a pharmacist-managed insulin titration program vs standard care. Ann Pharmacother. 2012;46(1):29-34. http://doi.org/10.1345/aph.1Q512
10. Chung N, Rascati K, Lopez D, Jokerst J, Garza A. Impact of a clinical pharmacy program on changes in hemoglobin HbA1c, diabetes-related hospitalizations, and diabetes-related emergency department visits for patients with diabetes in an underserved population. J Manag Care Spec Pharm. 2014;20(9):914-919. http://doi.org/10.18553/jmcp.2014.20.9.914
11. Congdon HB, Dowling TC, Cheng I, Truong HA. Impact of medication therapy management on underserved, primarily Hispanic patients with diabetes. Ann Pharmacother. 2013;47(5):665-670. http://doi.org/10.1345/aph.1R648
12. Rodis JL, Sevin A, Awad MH, Porter B, Glasgow K, Hornbeck Fox C, Pryor B. Improving chronic disease outcomes through medication therapy management in federally qualified health centers. J Prim Care Community Health. 2017;8(4):324-331. http://doi.org/10.1177/2150131917701797
13. Health Resources & Services Administration. Federally Qualified Health Centers – Eligibility. Available from https://www.hrsa.gov/opa/eligibility-and-registration/health-centers/fqhc/index.html (accessed Sep 26, 2019).
14. Health Resources & Services Administration. 2016 Health Center Profile. Available from: http://bphc.hrsa.gov/uds/datacenter.aspx?q=d&year=2016&state=CO#glist (accessed Jun 13, 2019).
15. Health Resources & Services Administration. Uniform Data System (UDS) resources. Available from: http://bphc.hrsa.gov/datareporting/reporting/index.html (accessed Jun 13, 2019).
16. Phillips LS, Branch Jr. WT, Cook CB, Doyle JP, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001;135(9):825-834. http://doi.org/10.7326/0003-4819-135-9-200111060-00012
17. Okemah J, Peng J, Quinones M. Addressing clinical inertia in type 2 diabetes mellitus: a review. Adv Ther. 2018;35(11):1735-1745. http://doi.org/10.1007/s12325-018-0819-5
18. Reach G, Pechtner V, Gentilella R, Corcos A, Ceriello A. Clinical inertia and its impact on treatment intensification in people with type 2 diabetes mellitus. Diabetes Metab. 2017;43(6):501-511. https://doi.org/10.1016/j.diabet.2017.06.003
19. Ziemer DC, Miller CD, Rhee MK, Doyle JP, Watkins C, Cook CB, Gallina DL, El-Kebbi IM, Barnes CS, Dunbar VG, Branch WT, Phillips LS. Clinical inertia contributes to poor diabetes control in a primary care setting. Diabetes Educ. 2005;31(4):564-571. http://doi.org./10.1177/0145721705279050
20. Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care. 2005;28(3):600-606. http://doi.org/10.2337/diacare.28.3.600
21. Saseen JJ, Ripley TL, Bondi D, Burke JM, Cohen LJ, McBane S, McConnell KJ, Sackey B, Sanoski C, Simonyan A, Taylor J, Vande Griend JP. ACCP clinical pharmacist competencies. Pharmacotherapy. 2017;37(5):630-636. http://doi.org/10.1002/pharm.1923
22. Mcbane SE, Dopp AL, Abe A, Benavides S, Chester EA, Dixon DL, Dunn M, Johnson MD, Nigro SJ, Rothrock-Christian T, Schwartz AH, Thrasher K, Walker S. Collaborative drug therapy management and comprehensive medication management – 2015. Pharmacotherapy. 2015;35(4):e39-e50. http://doi.org/10.1002/phar.1563
23. Bailey CJ. Under-treatment of type 2 diabetes: causes and outcomes of clinical inertia. Int J Clin Prac. 2016;70(12):988-995. http://doi.org/10.1111/ijcp.12906
24. Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams Sr. KA, Yeboah J, Ziaeian B. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Sep 10;74(10):1376-1414. http://doi.org/10.1016/j.jacc.2019.03.009