Elizabeth G Hogan*
*University of Arizona College of Pharmacy
**El Rio Health Center
Type 2 diabetes mellitus (DM-2) is a huge and ever-increasing health problem in the USA, as well as throughout the world.(1) This disease represents both a significant economic burden and incalculable patient suffering.(2) By all estimates, the prevalence of DM-2 will only increase, at least in the short term.(3)
The complications of DM-2 are traditionally categorised as microvascular and macrovascular.(4) The progression of both types of complications is almost surely reduced by tight plasma glucose control (euglycaemia).(5,6)
The majority of patients with DM-2 are cared for by generalist primary care providers. Guidelines are available in the USA, published and updated by the American Diabetes Association.(7) Unfortunately, standard care often falls short of the rigour recommended in such guideline documents.(8) This situation provides stimulus and rationale for specially trained pharmacists to provide chronic care to patients with DM-2, so as to improve the quality of their care.(9) While preliminary work has been published in this area, it is limited in scope and methodology.(10)
Currently, the state of Arizona allows collaborative practice between pharmacists and physicians such that physician- referred patients may have chronic care provided by pharmacists. These Collaborative Drug Therapy Management (CDTM) arrangements require development of mutually agreed upon criteria and protocols, specific to what the pharmacist may do, and when physician contact is required. Several other states in the USA have passed similar legislation in an effort to improve the scope and quality of care for many patients with chronic diseases that are managed primarily by drug therapy.
This analysis was based on a retrospective review of patients’ records. Two patient population settings were utilised. The first one consisted of patients from an outpatient clinic Collaborative Practice site (the Collaborative Practice Group; CPG), where patients are referred by a physician to a specially trained pharmacist who provides ongoing care for diabetes. The second one comprised patients from an outpatient clinic of a nearby hospital (the Standard Care Group; SCG), where ongoing care is provided by physicians and internal medicine residents. Eligibility requirements were that subjects be adults with an established diagnosis of DM-2, enrolled in the same insurance plan that serves primarily indigent patients, and with at least six months of medical records available. The primary outcome to be evaluated was the change in HbA(1c) over at least six months. Secondary outcome measures were lipid values (total cholesterol, HDL, LDL and TG), again over at least six months.
The statistical analysis consisted of the student’s t-test for the outcome variables of HbA1c and lipid values. The mean and standard deviations were calculated for descriptive variables, and the Chi- squared test was used for their comparison.
The demographic characteristics of the groups are shown in Table 1. Both groups were primarily Hispanic (82% vs 81%), similar in average age (58 vs 57), a majority of them being women (67% vs 63%; p>0.05 for all comparisons). HbA(1c) levels at baseline for the CPG (9.8±1.99) were significantly higher than HbA(1c) levels for the SCG (8.8±2.26; p<0.001). At the end of the six-month period, HbA1c was significantly lower for the CPG (7.8±1.95) than for the SCG (8.9±1.6; p<0.001). HbA(1c) increased slightly (from 8.8 to 8.9) over the six months for the SCG, although the difference was not significant. The effects on lipid levels are shown in Table 2. Total cholesterol, triglycerides and LDL decreased significantly (p<0.001) for the CPG. LDL also decreased significantly for the SCG (p=0.002); total cholesterol and triglycerides increased (p>0.1), and HDL increased significantly (p<0.001). HDL decreased significantly (p<0.001) for the CPG.
The primary finding of this study was that a Collaborative Practice model involving pharmacists could improve outcomes for patients with DM-2. The Collaborative Practice patients had significantly higher HbA(1c) levels at the beginning of the study. However, after six months, they had significantly lower HbA(1c) levels, while HbA(1c) levels for Standard Care patients were slightly higher. The effects were mixed for cholesterol levels; all types of cholesterol levels, including HDL levels, decreased significantly in the CPG. Overall, however, the Collaborative Practice patients fared much better, as indicated by HbA(1c) and cholesterol levels. This study is limited in that it involved only two clinics that serve a primarily indigent Hispanic population, so the findings may not be generalisable to other populations. The study is also limited in that it was a retrospective chart review rather than a randomised controlled trial.
This study demonstrates that a Collaborative Practice model that includes pharmacists can substantially improve outcomes, as indicated by HbA1c levels in patients with DM-2.
- American Diabetes Association. Economic consequences of diabetes mellitus in the US in 2002. Diabetes Care 2003;26:917-32.
- Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2003. Atlanta (GA): US Department of Health and Human Services, Centers for Disease Control and Prevention; 2003. Available from: http://www.cdc.gov/diabetes/pubs/factsheet.htm
- Boyle JP, Honeycutt AA, Narayan KM, et al. Projection of diabetes burden through 2050: impact of changing demography and disease prevalence in the US. Diabetes Care 2001;24:1936-40.
- Caro JJ, Ward AJ, O’Brien JA. Lifetime costs of complications resulting from type 2 diabetes in the US. Diabetes Care 2002;25:476-81.
- The Diabetes Control and Complications Trial Research Group. 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.
- 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;321:405-12.
- Nowak SN, Singh R, Clarke A, Campbell E, Jaber LA. Metabolic control and adherence to American Diabetes Association Practice Guidelines in a pharmacist-managed diabetes clinic. Diabetes Care 2002;25:1479-80.
- Yawn B, Gotler RS, Zyzanski SJ, et al. Is diabetes treated as an acute or chronic illness in community family practice? Diabetes Care 2001;24:1390-6.
- Coast-Senior EA, Kroner BA, Kelley CL, Trilli LE. Management of patients with type 2 diabetes mellitus by pharmacists in primary care clinics. Ann Pharmacother 1998;32:636-41.
- Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc 2003;43:173-84.