Laura Shane-McWhorter

Health economics and compliance of vials/syringes versus pen devices: a review of the evidence.

BACKGROUND The goal of this review was to assess the state of the published literature on health economics and compliance of vials/syringes versus pen devices. METHODS A literature search was performed using the Embase search engine for publications that linked drug terms (insulin and insulin lispro) to disease terms (insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus) and other terms (accuracy, article, clinical trial, controlled clinical trial, controlled study, cost benefit analysis, drug delivery system, drug dosage form, drug dosage form comparison, drug dose comparison, drug preference, equipment design, force, glycemic control, healthcare cost, human, insulin treatment, needle, patient attitude, patient compliance, patient safety, torque) along with author keywords (Diabetes, Dose accuracy, FlexPen [Novo Nordisk, Bagsvaerd, Denmark], Insulin, Next Generation FlexPen). RESULTS The search yielded 39 articles, of which five articles met our study criteria. The focus of the critical outcomes was patient adherence to insulin pen devices versus insulin vials (syringes), hypoglycemic events, emergency department visits due to hypoglycemic events, and costs associated with diabetes and health care. The observation period, mean age of patients, and data sources differed across the studies. The studies indicated that there was an improved adherence with insulin pen devices as opposed to insulin vials (syringes) and that the associated healthcare resource utilization and costs associated with them were found to decrease with the use of pen devices, compared to vials. CONCLUSIONS The use of pen devices improves the health economics benefits and adherence to insulin therapy.

Providing diabetes education and care to underserved patients in a collaborative practice at a utah community health center.

Many underserved patients in Utah lack insurance coverage for health care and prescription drugs but are provided medical care in community health centers (CHCs). Before June 2000, comprehensive pharmacy services were not provided to these patients at a Utah CHC. As part of a Health Resources and Services Administration grant, a collaborative agreement between the University of Utah College of Pharmacy and Utah CHCs was established so that a faculty clinician who is a certified diabetes educator (CDE) could provide diabetes education and care to underserved patients. The College of Pharmacy faculty clinician (pharmacist CDE) collaborated with physicians and midlevel practitioners to provide diabetes education and care for 176 patients. In addition to initial diabetes education, the pharmacist CDE provided continuing disease management by providing information and feedback to patients and recommendations to providers. The pharmacist CDE conducted continuing chart reviews to track certain parameters, such as laboratory test results for hemoglobin A1c (A1C) and lipid levels, and blood pressure. Patients were followed for 1–3 years. The same outcome data were also collected for 176 patients with diabetes mellitus in another CHC clinic to provide a comparison group. Total cholesterol, low‐density lipoprotein cholesterol, A1C, and triglyceride levels declined significantly from baseline at both sites. However, more patients who were provided care by the pharmacist CDE reached the American Diabetes Association A1C target goal of below 7%.

Dietary Supplements in the Management of Diabetes: Potential Risks and Benefits

A wide range of products claiming to lower blood glucose levels or prevent and treat diabetes complications and comorbidities are marketed to the public. Yet many individuals with diabetes are reluctant to inform their health care providers of complementary therapy use. As the nutrition experts on diabetes care teams, registered dietitians, in conjunction with pharmacists, are uniquely positioned to encourage patients to communicate openly about their use of dietary supplements, provide safety and efficacy information about supplements, and discourage use of dangerous or ineffective products. Areas of concern with dietary supplement use include potential side effects, drug interactions, and lack of product standardization, in addition to the increased costs that patients may incur when they use ineffective therapies or delay treatment with proven therapeutic agents. The science behind dietary supplements is evolving and registered dietitians must fully understand the potential risks and benefits to advise their patients appropriately, yet respect their health care values and beliefs.

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes

Objective:  To quantify adverse events (AEs) associated with the use of metformin (MET), sulphonylureas (SUs) and thiazolidinediones (TZDs) in a usual care setting, and to assess the relationship of AEs to treatment patterns and glycaemic response in patients with type 2 diabetes.

Enhanced Metabolism of Levonorgestrel During Phenobarbital Treatment and Resultant Pregnancy

Levonorgestrel implants (Norplant) are an alternative to oral contraceptives and medroxyprogesterone acetate intramuscular injections. An interaction may exist between levonorgestrel and agents that induce the hepatic microsomal enzyme system. A 21‐year‐old woman with a history of a seizure disorder, treated with phenobarbital, who received levonorgestrel implants became pregnant. After a normal delivery, she took oral contraceptives concomitantly with phenobarbital. Although she was educated about the importance of a backup method of contraception, the woman again became pregnant and delivered twins. A recent national survey of neurologists and obstetricians was conducted evaluating prescriber knowledge of interactions between oral contraceptives and anticonvulsants. Only 4% of neurologists and zero percent of obstetricians knew all the interactions between the six most commonly prescribed anticonvulsants and oral contraceptives. This case supports the importance of continued patient and prescriber education regarding the possibility of drug‐drug interactions in women taking anticonvulsants and hormonal contraceptives.

The role of dehydroepiandrosterone in diabetes mellitus

Much has been written in the lay literature regarding potential benefits of dehydroepiandrosterone (DHEA). Although it was removed from the over‐the‐counter market in 1985, the Dietary Supplement Health Education Act of 1994 allowed the drug to be marketed as a food supplement. Because DHEA no longer falls under the scrutiny of the Food and Drug Administration, many unverified claims have been put forth in the press espousing its therapeutic value. This barrage of “infomercials” has left the average American consumer (and health care professional) curious about DHEA and its possible therapeutic utility. One focus of recent research is to define the role of DHEA in diabetes mellitus. Although it has been claimed that decreased levels of endogenous DHEA are associated with diabetes, impaired glucose tolerance, hyperglycemia, and insulin resistance, much of the information is based on cross‐sectional studies. Other claims correlate decreased endogenous DHEA levels with adverse cardiovascular effects. Some information is contradictory and indicates high doses of exogenous DHEA may produce adverse cardiovascular effects, an undesirable outcome in patients with diabetes mellitus. At this time, its administration in patients with diabetes is not warranted. Long‐term trials evaluating the role of exogenous DHEA and its effect on patients with diabetes should be conducted.

Evaluation of adverse events of oral antihyperglycaemic monotherapy experienced by a geriatric population in a real-world setting: A retrospective cohort analysis

AbstractBackground and objective: To evaluate and compare the risk of adverse events (AEs) associated with the use of metformin, sulfonylureas and thiazolidinediones among geriatric patients in a usual care setting. Methods: An electronic medical record database was utilized to identify geriatric patients with type 2 diabetes mellitus aged ≥65 years from 1996 to 2005. Patients naive to oral antihyperglycaemic drug (OAD) therapy were followed for 395 days post initiation of metformin, sulfonylurea or thiazolidinedione treatment. AEs related to study drugs were evaluated during the follow-up period, and the risks of developing an AE were evaluated and adjusted for differences in baseline characteristics by OAD treatment. Results: A total of 5438 patients (mean age 73.2 [SD 5.08] years, 56.1% female) were identified. During the follow-up period, 12.5% of patients experienced an AE (8.3% of metformin, 13.9% of sulfonylurea and 19.8% of thiazolidinedione recipients). Sulfonylurea (odds ratio [OR] 1.74; 95% CI 1.41, 2.13) and thiazolidinedione (OR 2.86; 95% CI 2.23, 3.65) recipients were more likely to experience an AE than metformin recipients, after adjustment for baseline demographic and co-morbidity differences. The average time to onset of a metformin AE (175 days) was less than that for sulfonylurea or thiazolidinedione treatment (192 and 201 days, respectively). The most common AEs were abdominal pain with metformin (42.3%) and weight gain >4.5 kg for sulfonylureas (63.2%) and thiazolidinediones (68.2%). Hypoglycaemia occurred in 2.6% and 2.2% of sulfonylurea and thiazolidinedione recipients, respectively. Discussion and conclusions: Geriatric patients in a real-world setting experienced AEs with metformin, sulfonylurea and thiazolidinedione therapy, although rates differed from those seen in clinical trials, particularly for weight gain and hypoglycaemia. Lactic acidosis occurred at a higher rate with metformin therapy than has been reported in clinical trials, but our results were in the same range for abdominal pain and lower for diarrhoea, nausea/vomiting and dyspepsia. AEs related to sulfonylurea therapy were in the same range as in clinical trials for weight gain but lower for hypoglycaemia, dizziness and headaches. AEs related to thiazolidinedione therapy were more common in our study than in clinical trials, and within the same range for weight gain and elevated liver enzymes but lower for hypoglycaemia and oedema. While AE reporting is likely to be different in a real-world setting than in clinical trials, the observed variances may also be due to the aetiology of diabetes and the physiological response to hypoglycaemia in an older population.

The Utah Remote Monitoring Project: Improving Health Care One Patient at a Time

BACKGROUND The expanding role of technology to augment diabetes care and management highlights the need for clinicians to learn about these new tools. As these tools continue to evolve and enhance improved outcomes, it is imperative that clinicians consider the role of telemonitoring, or remote monitoring, in patient care. This article describes a successful telemonitoring project in Utah. SUBJECTS AND METHODS This was a nonrandomized prospective observational preintervention-postintervention study, using a convenience sample. Patients with uncontrolled diabetes and/or hypertension from four rural and two urban primary care clinics and one urban stroke center participated in a telemonitoring program. The primary clinical outcome measures were changes in hemoglobin A1C (A1C) and blood pressure. Other outcomes included fasting lipids, weight, patient engagement, diabetes knowledge, hypertension knowledge, medication adherence, and patient perceptions of the usefulness of the telemonitoring program. RESULTS Mean A1C decreased from 9.73% at baseline to 7.81% at the end of the program (P<0.0001). Systolic blood pressure also declined significantly, from 130.7 mm Hg at baseline to 122.9 mm Hg at the end (P=0.0001). Low-density lipoprotein content decreased significantly, from 103.9 mg/dL at baseline to 93.7 mg/dL at the end (P=0.0263). Other clinical parameters improved nonsignificantly. Knowledge of diabetes and hypertension increased significantly (P<0.001 for both). Patient engagement and medication adherence also improved, but not significantly. Per questionnaires at study end, patients felt the telemonitoring program was useful. CONCLUSIONS Telemonitoring improved clinical outcomes and may be a useful tool to help enhance disease management and care of patients with diabetes and/or hypertension.

Pharmacist-provided diabetes management and education via a telemonitoring program.

OBJECTIVE To assess clinical outcomes (glycosylated hemoglobin [A1C], blood pressure, and lipids) and other measurements (disease state knowledge, adherence, and self-efficacy) associated with the use of approved telemonitoring devices to expand and improve chronic disease management of patients with diabetes, with or without hypertension. SETTING Four community health centers (CHCs) in Utah. PRACTICE DESCRIPTION Federally qualified safety net clinics that provide medical care to underserved patients. PRACTICE INNOVATION Pharmacist-led diabetes management using telemonitoring was compared with a group of patients receiving usual care (without telemonitoring). INTERVENTIONS Daily blood glucose (BG) and blood pressure (BP) values were reviewed and the pharmacist provided phone follow-up to assess and manage out-of-range BG and BP values. EVALUATION Changes in A1C, BP, and low-density lipoprotein (LDL) at approximately 6 months were compared between the telemonitoring group and the usual care group. Patient activation, diabetes/hypertension knowledge, and medication adherence were measured in the telemonitoring group. RESULTS Of 150 patients, 75 received pharmacist-provided diabetes management and education via telemonitoring, and 75 received usual medical care. Change in A1C was significantly greater in the telemonitoring group compared with the usual care group (2.07% decrease vs. 0.66% decrease; P <0.001). Although BP and LDL levels also declined, differences between the two groups were not statistically significant. Patient activation measure, diabetes/hypertension knowledge, and medication adherence with antihypertensives (but not diabetes medications) improved in the telemonitoring group. CONCLUSION Pharmacist-provided diabetes management via telemonitoring resulted in a significant improvement in A1C in federally qualified CHCs in Utah compared with usual medical care. Telemonitoring may be considered a model for providing clinical pharmacy services to patients with diabetes.

Pharmacist scope of practice, standards of practice, and standards of professional performance for diabetes educators

In 2005, the American Association of Diabetes Educators (AADE) published “The Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes Educators,” written by a multidisciplinary team. Nurses and dietitians developed and published complementary, discipline-specific documents. Similarly, this document addresses the specific role of the pharmacist in the delivery of diabetes education and is meant to complement the AADE “Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes Educators.” The purposes of this document are