Community pharmacist intervention to close statin gaps in diabetes care: The GuIDE-S study.

BACKGROUND: Statin therapy is recommended for people with type 2 diabetes (T2D) to lower cardiovascular risk; however, evidence suggests that significant gaps in statin therapy exist. OBJECTIVE: To evaluate (1) the impact of a community pharmacist-led model for initiating statin therapy in people with type 2 diabetes (T2D) on statin initiation and (2) pharmacists' self-reported perceptions of the intervention feasibility and fidelity to the intervention. METHODS: This was a type 1 hybrid effectiveness-implementation study of 9 intervention and 18 control pharmacies within a community pharmacy chain. Pharmacy staff proactively identified patients with T2D not taking a statin and prescribed a statin via a collaborative practice agreement or facilitated acquisition of a prescription from the patient's preferred prescriber. The eligible population included patients aged 18-84 years with T2D, who had filled ≥60 days' supply of one, noninsulin, diabetes medication in a rolling 6-month period, and who had not filled a statin during the same period. A Cox proportional hazards model was used to compare time to statin initiation. Pharmacists at intervention pharmacies completed a survey at 6 and 12 months after implementation (March and August 2019, respectively) to assess intervention feasibility and fidelity. RESULTS: For the statin initiation analysis, 1670 intervention patients were matched to 3358 control patients. Overall, 26.3% (n=442) of intervention patients and 25.4% (n=854) of control patients initiated a statin within 12 months of their index date. There was no difference in statin initiation likelihood between intervention and control patients (hazard ratio: 1.00; 95% CI: 0.83, 1.21). Fifteen pharmacists completed the 6-month survey (33% response rate), and 12 completed the 12-month survey (26%). The intervention's feasibility score was 4.0 at 6 months and 4.2 at 12 months, indicating an increase in perceived feasibility. Fidelity decreased from 6 to 12 months. CONCLUSION: The community pharmacist-led intervention resulted in more patients initiating statin therapy as compared to usual care; however, the differences were not statistically significant. Pharmacists perceived the intervention to be feasible; however, fidelity decreased over time.

Community pharmacist intervention to optimize statin adherence in diabetes care: The GuIDE-S study.

BACKGROUND: Statin use in people with type 2 diabetes (T2D) reduces cardiovascular events, yet adherence remains suboptimal. OBJECTIVE: This study evaluated the impact of a community pharmacist intervention on statin adherence in new users with T2D. METHODS: As part of a quasi-experimental study, community pharmacy staff proactively identified adult patients with T2D who were not prescribed a statin. When appropriate, the pharmacist prescribed a statin via a collaborative practice agreement or facilitated acquisition of a prescription from another prescriber. Patients received individualized education and follow-up and monitoring for 1 year. Adherence was defined as the proportion of days covered (PDC) by a statin over 12 months. Linear and logistic regression were used to compare the effect of the intervention on continuous and a binary adherence threshold, defined as PDC ≥ 80%, respectively. RESULTS: Overall, 185 patients started statin therapy and were matched to 370 control patients for analysis. Adjusted average PDC was 3.1% higher in the intervention group (95% CI -0.037 to 0.098). Patients in the intervention group were 21.2% more likely to have PDC ≥ 80% (95% CI 0.828-1.774). CONCLUSION: The intervention resulted in higher statin adherence than usual care; however, the differences were not statistically significant.

Early outcomes from a national Train-the-Trainer Interprofessional Team Development Program.

The imperative need to train health professions faculty (educators and clinicians) to lead interprofessional education efforts and promote interprofessional team-based care is widely recognized. This need stems from a growing body of research that suggests collaboration improves patient safety and health outcomes. This short report provides an overview of a Train-the-Trainer Interprofessional Team Development Program (T3 Program) that equips faculty leaders with the skills to lead interprofessional education and interprofessional collaborative practice across the learning continuum. We also describe the history, approach, and early outcomes of this innovative program.

Strengthening pandemic preparedness through pharmacy and public health collaborations: Findings from a facilitated discussion exercise.

BACKGROUND: Community pharmacists are key partners to public health agencies during pandemics and other emergencies. Community pharmacy and public health agencies can establish memoranda of understanding (MOUs) for dispensing and administering medical countermeasures and providing related services to affected population(s) during a public health incident. OBJECTIVE: The objective of this facilitated discussion exercise was to identify the strengths and opportunities associated with the activation of a statewide pharmacy-public health agencies MOU with community pharmacists on the basis of a simulated pandemic influenza event. METHODS: A facilitated discussion exercise was held in the Puget Sound region of the State of Washington in May 2017. The participants included pharmacists from 2 community pharmacy organizations, emergency preparedness officials from 2 local health departments and the state health department, staff of the state pharmacy association, and faculty from a school of pharmacy. The evaluators recorded the discussions and observations, augmented by a postexercise telephone call with participants from each of the participating community pharmacy organizations. Key themes from the exercise are reported. RESULTS: Five themes were identified during the facilitated discussion exercise. Two themes described the strengths of the MOU and its operational plan: (1) collaboration strengthens preparedness and response planning, and (2) an MOU provides a framework for effective collaboration. Three themes acknowledged the opportunities to optimize activation of the existing MOU: (1) early and active engagement between health department personnel and community pharmacists, (2) establishing pharmacy policies and procedures to support readiness and response, and (3) addressing the training or other educational needs of community pharmacists. CONCLUSION: This exercise provided community pharmacists and public health agency personnel an opportunity to better plan for responding to a pandemic. The open dialogue in this facilitated discussion allowed the exercise participants to identify the strengths, priorities, and perspectives as well as the gaps in the MOU operational plan. The lessons learned in this exercise can inform the community pharmacy and public health response to the coronavirus disease pandemic.

Enhancing adult immunization care by community pharmacists: A qualitative analysis of Project VACCINATE.

BACKGROUND: Project VACCINATE was a 1-year demonstration project conducted in 70 community pharmacies in Washington from September 1, 2016 to August 31, 2017 aimed at increasing adult vaccination and documentation in the state immunization information system (IIS). Key intervention features aligned with the Standards for Adult Immunization Practices and included incorporation of an immunization interface to facilitate proactive immunization screenings, patient engagement regarding vaccine needs, and vaccine documentation in the IIS as enhancements to the vaccination workflow. OBJECTIVE: The objective of this qualitative study, a subanalysis of Project VACCINATE, was to identify community pharmacy staff members' perceptions of work system factors that influenced the implementation of key intervention features. METHODS: Pharmacy staff at all Project VACCINATE locations were eligible to participate and were recruited by e-mail. Key informant interviews lasting 15-30 minutes were conducted by telephone using a semistructured interview guide. Interview transcripts were thematically analyzed using the Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 model of work systems. RESULTS: A total of 7 interviews were conducted with pharmacists from different pharmacy locations from September to December 2017. Nine factors emerged across all domains of the SEIPS 2.0 model regarding the implementation of the key intervention features. These factors were pharmacist-patient relationships, team culture, individualized patient education, technician involvement, electronic access to vaccine records, pharmacy layout, staff training, immunization documentation in other care settings, and insurance coverage. CONCLUSIONS: Several key factors were identified that, when addressed, can enable the incorporation of proactive immunization screenings, patient engagement, and vaccine documentation as enhancements to the community pharmacy-based vaccination process. Community pharmacy organizations should consider incorporating the described factors into existing immunization programs when assessing the unique dynamics of their work system.

Impact of an immunization platform in community pharmacies.

OBJECTIVES: To assess the impact of incorporating a bidirectional immunization forecasting and reporting platform in the workflow of a regional community pharmacy chain with the use of time and motion methodologies. SETTING: Six Bartell Drugs Pharmacies in Seattle, Washington. PRACTICE DESCRIPTION: Bartell Drugs is a 63-store family-owned regional community pharmacy chain that offers all routine vaccinations and travel vaccinations. PRACTICE INNOVATION: Six pharmacies were selected based on immunization performance the previous year. These pharmacies were divided into 3 immunization performance groups. Within each performance group, one store had implemented the bidirectional immunization forecasting and reporting platform (intervention) and the other had not (control). EVALUATION: Observations were conducted for 4 to 8 hours at each store to determine the time required for each immunization encounter. Each encounter was divided into 7 time subcategories, which were assigned to the pharmacist, technician, or patient. Time and motion methodologies were used to estimate total pharmacist and technician time and the number of immunizations administered per patient encounter. All data were analyzed with the use of descriptive statistics. RESULTS: Ten vaccinations were administered during 5 patient encounters in the intervention group compared with 8 vaccinations during 8 patient encounters in the control group. The average time spent on each patient encounter in the intervention group was 24.8 minutes, compared with 18.5 minutes in the control group. In the intervention group, pharmacists spent an average of 9.3 minutes per patient encounter compared with 7.6 minutes in the control group. In the intervention group, technicians spent an average of 10.8 minutes per encounter compared with 9.1 minutes in the control group. CONCLUSION: Incorporation of a bidirectional immunization platform into the workflow of a community pharmacy increased staff time but also resulted in a greater number of immunizations per patient, suggesting enhanced immunization care in the intervention pharmacies.

Interprofessional education and practice guide: interprofessional team writing to promote dissemination of interprofessional education scholarship and products.

Collaborations to develop, implement, evaluate, replicate, and write about interprofessional education (IPE) activities within and across institutions are wonderful opportunities to experience teamwork, team communication, ethics and values, and the roles and responsibilities of interprofessional team writing. Just as effective communication in interprofessional team-based care is essential for providing safe, high-quality health care, similar communication strategies are necessary to produce high-quality scholarship of IPE curricula and activities. Relationship and communication issues that affect health care teams' abilities to work together effectively (e.g., hierarchy, exclusion, assumptions, non-responsiveness, biases, stereotypes and poor hand-offs of information) can also occur in interprofessional team writing. Between 1970 and 2010, interprofessional practice research publications increased by 2293%. Although there has been tremendous growth in the IPE literature, especially of articles that require collaborative writing, there have not been any papers addressing the challenges of interprofessional team writing. As more teams collaborate to develop IPE, there is a need to establish principles and strategies for effective interprofessional team writing. In this education and practice guide, a cross-institutional team of faculty, staff, and graduate students who have collaborated on externally funded IPE grants, conferences, products, and workshops will share lessons learned for successfully collaborating in interprofessional team writing.

Comparison of two training methods in community pharmacy: Project VACCINATE.

OBJECTIVE: To compare the impact of a whole-staff training strategy with a train-the-trainer strategy on 1) the number of influenza, pneumococcal, herpes zoster, and pertussis vaccines administered by community pharmacists to adults; 2) staff confidence; and 3) fidelity to the intervention. SETTING: Eight Quality Food Centers (QFC) Pharmacies in Seattle, Washington. PRACTICE DESCRIPTION: QFC Pharmacy is a grocery store division of The Kroger Co. with 30 pharmacies located in Washington State. QFC provides all routine and travel vaccines to adolescents and adults and has a culture of improving vaccine access to its community. PRACTICE INNOVATION: Pharmacists and pharmacy technicians from 8 QFC pharmacies received training to enhance their immunization care for adults. The entire staff from 4 pharmacies received whole-staff training, and staff members from the other 4 pharmacies received a train-the-trainer approach. The whole-staff training group had all staff members attend a live, 2-hour training. The train-the-trainer group sent 1 pharmacist and 1 pharmacy technician champion to attend the live training and then return to their pharmacy to train the other staff members. EVALUATION: The number of immunizations administered, staff confidence, and self-reported fidelity to the intervention were measured before and after training. All data were analyzed using descriptive statistics. RESULTS: The number of total influenza, pneumococcal, herpes zoster, and pertussis vaccines administered increased 12.6% in the whole-staff training group and 15.2% in the train-the-trainer group. Both training strategies increased confidence in identifying patients eligible for vaccines, talking to patients about vaccine needs, and using the bidirectional immunization platform. Pharmacy staff members in both groups indicated fidelity to key steps in the intervention process. CONCLUSION: Both whole-staff training and train-the-trainer approaches were associated with an improvement in the number of vaccines administered, staff confidence, and fidelity to the intervention. Community pharmacy organizations could use either training strategy when implementing enhancements to an existing patient care service. The train-the-trainer strategy may be less resource intensive.

The relationship between neuropsychological assessment, numeracy, and functional status in older adults with type 1 diabetes.

While data are accumulating on the association between neuropsychological performance and real-world endpoints, less is known about the association with medical self-management skills. The self-management of type 1 diabetes (T1D) is often complex, and mismanagement can result in hypoglycaemia and hyperglycaemia and associated morbidity and mortality. The T1D Exchange conducted a case-control study evaluating factors associated with severe hypoglycaemia in older adults (≥ 60 years old) with longstanding T1D (≥ 20 years). A battery of neuropsychological and functional assessments was administered, including measures of diabetes-specific self-management skill (diabetes numeracy) and instrumental activities of daily living (IADL). After adjusting for confounding variables, diabetes numeracy was related to memory and complex speeded attention; while IADL were associated with simple processing speed, executive functioning, complex speeded attention and dominant hand dexterity. The severity of overall cognitive deficit was uniquely associated with both diabetes numeracy and IADL, when controlling for age, education, frailty and depression. This study demonstrates that the cognitive deficits in older adults with T1D have functional implications for both diabetes management and IADL. Further research is needed to determine specific interventions to maximise diabetes self-management in older adults with declining cognition.

Impact of the COVID-19 Pandemic on the Community Pharmacy Workforce.

This study sought to describe the impact of the COVID-19 pandemic on community pharmacy practice and its workforce. Interviews were conducted with 18 key informants from pharmacy associations and community pharmacists representing chain and independent pharmacy organizations across the United States from January to May 2022. Interview notes were analyzed using a rapid content analysis approach. Four themes resulted: (a) patient care at community pharmacies focused on fulfilling COVID-19 response needs; (b) pharmacists' history as immunizers and scope of practice expansions facilitated COVID-19 response efforts; (c) workforce supply shortages impeded COVID-19 response efforts and contributed to burnout; and (d) maintaining community pharmacy workforce's readiness will be critical to future emergency preparedness and response efforts. Formalizing scope of practice expansion policies and reimbursement pathways deployed during the COVID-19 pandemic could facilitate the community pharmacy workforce's ability to address ongoing public health needs and respond to future public health emergencies.

Medication adherence program: adherence challenges and interventions in type 2 diabetes.

OBJECTIVES: To describe medication adherence problems for adults with type 2 diabetes and to assess the nature and frequency of pharmacist activities in addressing them and proximate outcomes. DESIGN: Pre-post analysis. SETTING: Four community chain pharmacies located in Seattle, WA, from April 2008 to October 2009. PATIENTS: 120 patients (mean age >60 years) with type 2 diabetes taking oral diabetes medications and who were 6 or more days late for refills. INTERVENTION: Pharmacist telephone-initiated adherence support. MAIN OUTCOMES MEASURES: Nature and frequency of adherence-related problems and intervention activities and impact on reduction in refill gaps. RESULTS: The primary adherence challenge was difficulty taking medications (27.1%). Failure to remember doses and forgetting refills were reported by 24.6% and 26.3% of patients at baseline, respectively. Pharmacists provided support through some form of patient education (35.6% of encounters) or other adherence support (40.7%). Pharmacist time averaged slightly greater than 5 minutes per intervention and 12.6 ± 10.7 minutes (mean ± SD) over 12 months, with 3.4 ± 2.4 interventions per patient. Patient-specific education and adherence support by pharmacists and total intervention time were positively correlated, with a modest but significant reduction in refill gaps during 12 months of follow-up. CONCLUSION: Not remembering to refill medications was the most commonly reported problem. Patient encounters averaged 4 to 6 minutes for the first visit and 12 to 13 minutes over 12 months. Phone calls by pharmacists to adults who were late for oral diabetes medication refills were effective in identifying adherence-related problems and developing support strategies to promote medication self-management in busy urban community chain pharmacy settings.

Impact of Pre-Advanced Pharmacy Practice Experience (APPE) Curriculum on Student Pharmacists' Professional Identity Formation.

OBJECTIVE: To (1) evaluate changes in student pharmacists' professional identity during a curriculum prior to advanced pharmacy practice experiences (APPEs) and (2) describe the components of a pre-APPE curriculum that positively and negatively influenced students' professional identity formation (PIF). METHODS: The University of Washington School of Pharmacy launched a new curriculum in 2019 featuring components intentionally designed to support students' PIF. The Macleod-Clark Professional Identity Scale (MCPIS) was administered to the class of 2023 before starting pharmacy school (pre) and upon completion of the pre-APPE curriculum (post). The postsurvey also contained 2 open-response questions asking students to identify the most positive and negative influences on their PIF. Mean pre- and post-responses were calculated for all MCPIS items and each MCPIS item and compared using paired t tests. Responses to the open-ended questions were sorted into categories using inductive thematic analysis and frequencies were calculated. RESULTS: A total of 99 students (96%) completed both surveys. Mean MCPIS pre-scores and post-scores were both 3.3, indicating no statistically significant change in professional identity. The most frequently reported positive influences on PIF were didactic coursework (40%), experiential learning (30%), and student organizations (27%). The most frequently reported negative influences were didactic coursework (27%), none (25%), and perceptions of the pharmacy profession (22%). CONCLUSION: Students' overall professional identity, as measured by the MCPIS, did not change during the pre-APPE curriculum. Didactic coursework had the most common positive and negative influence on professional identity prior to APPEs.

MAP study: RCT of a medication adherence program for patients with type 2 diabetes.

OBJECTIVE: To evaluate the impact of a community pharmacy-based medication adherence detection and intervention protocol on medication adherence for patients with diabetes. DESIGN: Randomized controlled trial. SETTING: Four community chain pharmacies in the Seattle, WA, area from April 2008 to October 2009. PATIENTS: Patients with diabetes (n = 265) who were taking oral diabetes medications and late for refills by 6 days or more. INTERVENTION: Telephone-initiated adherence support by pharmacists following computer-generated missed refill alerts. Patients were randomized at the pharmacy level with pharmacists blinded to randomization. MAIN OUTCOMES MEASURES: Changes in medication adherence (i.e., days late at first refill, percent with a refill gap of 6 days or more at first refill, medication possession ratio [MPR] at 6 and 12 months) measured during three time periods. RESULTS: Baseline MPR (previous 12 months) of oral diabetes medications for study versus control participants was relatively high and similar (0.86 and 0.84, respectively). At 12 months, MPR was significantly improved for the study group ( P = 0.004) compared with the control group (difference between groups, P = 0.01). The intervention showed greater effect for patients with baseline MPR less than 80% (difference between groups, P = 0.02). The likelihood of MPR above 80% at the 12-month follow-up for any patient significantly favored the intervention group (odds ratio 4.77 [95% CI 2.00-11.40]). CONCLUSION: A brief missed refill intervention program involving urban community chain pharmacies was effective in achieving improved diabetes medication adherence, particularly among individuals with baseline MPR of 0.80 or less.

School of pharmacy-based medication therapy management program: development and initial experience.

OBJECTIVE: To describe a school of pharmacy-community pharmacy collaborative model for medication therapy management (MTM) service and training. SETTING: University of Washington (UW) School of Pharmacy (Seattle), from July to December 2008. PRACTICE DESCRIPTION: MTM services and training. PRACTICE INNOVATION: A campus-based MTM pharmacy was established for teaching, practice, and collaboration with community pharmacies to provide comprehensive medication reviews (CMRs) and MTM training. MAIN OUTCOME MEASURES: Number of collaborating pharmacies, number of patients contacted, number of CMRs conducted, and estimated cost avoidance (ECA). RESULTS: UW Pharmacy Cares was licensed as a Class A pharmacy (nondispensing) and signed "business associate" agreements with six community pharmacies. During July to December 2008, 10 faculty pharmacists completed training and 5 provided CMR services to 17 patients (5 telephonic and 12 face-to-face interviews). A total of 67 claims (17 CMRs and 50 CMR-generated claims) were submitted for reimbursement of $1,642 ($96.58/CMR case). Total ECA was $54,250, averaging $3,191.19 per patient. Seven student pharmacists gained CMR interview training. CONCLUSION: Interest in collaboration by community pharmacies was lower than expected; however, the campus-community practice model addressed unmet patient care needs, reduced outstanding MTM CMR case loads, increased ECA, and facilitated faculty development and training of student pharmacists.

A web-based team-oriented medical error communication assessment tool: development, preliminary reliability, validity, and user ratings.

BACKGROUND: Multiple-choice exams are not well suited for assessing communication skills. Standardized patient assessments are costly and patient and peer assessments are often biased. Web-based assessment using video content offers the possibility of reliable, valid, and cost-efficient means for measuring complex communication skills, including interprofessional communication. DESCRIPTION: We report development of the Web-based Team-Oriented Medical Error Communication Assessment Tool, which uses videotaped cases for assessing skills in error disclosure and team communication. Steps in development included (a) defining communication behaviors, (b) creating scenarios, (c) developing scripts, (d) filming video with professional actors, and (e) writing assessment questions targeting team communication during planning and error disclosure. EVALUATION: Using valid data from 78 participants in the intervention group, coefficient alpha estimates of internal consistency were calculated based on the Likert-scale questions and ranged from α=.79 to α=.89 for each set of 7 Likert-type discussion/planning items and from α=.70 to α=.86 for each set of 8 Likert-type disclosure items. The preliminary test-retest Pearson correlation based on the scores of the intervention group was r=.59 for discussion/planning and r=.25 for error disclosure sections, respectively. Content validity was established through reliance on empirically driven published principles of effective disclosure as well as integration of expert views across all aspects of the development process. In addition, data from 122 medicine and surgical physicians and nurses showed high ratings for video quality (4.3 of 5.0), acting (4.3), and case content (4.5). CONCLUSIONS: Web assessment of communication skills appears promising. Physicians and nurses across specialties respond favorably to the tool.

The relationship between anticholinergic medications and Mini-Cog scores in older adults receiving home health care.

OBJECTIVES: To describe anticholinergic use patterns in older adult home health recipients and examine their relationship to evidence of cognitive impairment. DESIGN: Retrospective study. SETTING: A home health care agency in Eastern Washington state. PARTICIPANTS: Potential study subjects were 174 recipients of home health services between March 1, 2006, and October 1, 2006, who were 60 years of age or older and had been screened for cognitive impairment by the Mini-Cog assessment test. A random sample of 65 out of 75 patients who scored in the impaired range on the Mini-Cog and a random sample of 65 out of 99 patients who scored in the unimpaired range were included in the study. MAIN OUTCOME MEASURE: prevalence of anticholinergic medication use. RESULTS: The majority of participants (80.0%) were using a medication with anticholinergic effects; however, more participants were using weak anticholinergics (66.1%) than potent agents (33.8%). After controlling for age, caregiver presence, and marital status, participants who scored as cognitively impaired on the Mini-Cog were less likely to be taking a medication with anticholinergic properties (odds ratio 0.34, 95% confidence interval 0.13-0.94). CONCLUSION: Although anticholinergic use was common in this older adult, home health population, the majority of participants were using medications with weak anticholinergic activity, as opposed to potent ones. Participants with cognitive impairment were less likely to be using any medication with anticholinergic properties.

The effects of vaccination forecasts and value-based payment on adult immunizations by community pharmacists.

BACKGROUND: The prevalence of vaccine-preventable diseases in adults remains a significant public health issue in the United States. The objectives of this demonstration project were to increase the number of influenza, pneumococcal, pertussis, and herpes zoster immunizations administered to adults by community pharmacists, evaluate the percentage of immunizations documented in the state immunization information system (IIS), and design and pilot a value-based payment model. METHODS: A one-year prospective, observational demonstration project was conducted in 70 community pharmacies in western Washington State from September 1, 2016 to August 31, 2017. An immunization interface was integrated into workflow at each pharmacy to enable "forecasting" of and proactive recommendation to patients about their vaccine needs and documentation of vaccines administered in the state IIS. Categorical value-based payment models were developed and implemented in a subgroup of 12 community pharmacies from March 1 to November 30, 2017. The change in the number of immunizations administered in comparison to the baseline period and the percentage of immunizations documented in the state IIS during the demonstration period were analyzed using descriptive statistics. RESULTS: There was a 15% total increase in the collective number of influenza, pneumococcal, pertussis, and herpes zoster vaccines administered in the demonstration year in the 70 pharmacies, due to increases in influenza and pertussis vaccinations. Eighty-three percent of the vaccines administered were documented in the state IIS. Pneumococcal, pertussis, and herpes zoster performance appeared to be unaffected by the value-based payment models while influenza performance improved across the 12 pilot pharmacies. CONCLUSIONS: This work demonstrated that community pharmacists contribute to improving adult immunizations through vaccine "forecasting" and proactive recommendation. Meaningful quality measures with both positive and negative incentives could further drive adoption of best immunization practices. Further implementation and outcomes research is needed to fully examine the impact and scalability of these strategies.

Barriers to medication adherence in poorly controlled diabetes mellitus.

PURPOSE: The purpose of this study is to characterize the adherence and medication management barriers for adults with poorly controlled type 2 diabetes mellitus (DM) (those with A1c 9% or above) and to identify specific adherence characteristics associated with poor diabetes control. METHODS: This was a cross-sectional analysis of baseline data from a randomized, controlled diabetes intervention conducted in University of Washington (UW) Medicine Clinics in the greater Seattle, Washington, area. The goal of the original study was to evaluate the effect of a pharmacist intervention on improving diabetes control over 12 months. Evaluation measures for medication adherence included self-reported adherence and medication management challenges using the Morisky question format and difficulty with taking medications for each diabetes medication based on the Brief Medication Questionnaire. Specific adherence characteristics associated with poor diabetes control (A1c >9%) were identified using multivariate regression analysis. RESULTS: Seventy-seven subjects (mean A1c, 10.4%; mean duration of DM, 7 years) were studied. The most common adherence challenges included paying for medications (34%), remembering doses (31%), reading prescription labels (21%), and obtaining refills (21%). Taking more than 2 doses of DM medication daily (beta = .78, SE = 0.32, P = .02) and difficulty reading the DM medication prescription label (beta = .76, SE = 0.37, P = .04) were significantly associated with higher hemoglobin A1c. Self-reported adherence was not related to A1c control. CONCLUSIONS: In this study, we identified 2 factors that were associated with poorer A1c control. These findings highlight the importance of identifying potential challenges to medication adherence for those with DM and providing support to minimize or resolve these barriers to control.

Looking to the future: focus on DPP-4 inhibitors for the treatment of type 2 diabetes and emerging therapies.

Strong evidence exists demonstrating the benefits of tight glycemic control in type 1 and type 2 diabetes mellitus patients, but glycemic goals are not adequately achieved for many patients. Advancement in the knowledge surrounding the physiology of endogenous glucoregulatory peptide hormones, such as glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, has led to new therapeutic targets for the treatment of type 2 diabetes mellitus. Dipeptidyl peptidase-4 (DPP-4) inhibitors provide practitioners with a novel mechanism of action to use for combination therapies for the treatment of type 2 diabetes mellitus. This article, part 3 of a 3-part series, reviews the new class of medications known as DPP-4 inhibitors as well as discusses a future buccal insulin formulation, Oral-Lyn, on the horizon for the treatment of diabetes mellitus.

Inhaled dry powder insulin for the treatment of diabetes mellitus.

BACKGROUND: Inhaled dry powder insulin (IDPI) is the first inhaled insulin approved for the treatment of type 1 and type 2 diabetes mellitus (DM). OBJECTIVE: This article reviews available information on IDPI, focusing on its clinical pharmacokinetics, comparative efficacy, tolerability, adverse events, dosage and administration, and cost. METHODS: MEDLINE (1966-July 2006) and Web of Science (1995-July 2006) were searched for original research and review articles published in English. The search terms used were inhaled insulin, inhaled human insulin, rDNA origin inhalation powder, inbaled dry powder insulin, and IDPI. All published comparative efficacy studies were included in the review, as well as selected information from the package insert for IDPI. RESULTS: IDPI is an inhaled dry powder form of regular human insulin (RHI) that is used as a premeal insulin to improve glycemic control by reducing postprandial glucose excursions. The literature search identified 5 efficacy trials comparing reductions in glycosylated hemoglobin (HbA(1c)) in a total of 582 patients with type 1 DM who received either premeal IDPI plus neutral protamine Hagedorn (NPH) or Ultralente insulin or injectable RHI plus NPH or Ultralente insulin. The search identified 5 comparative efficacy studies of IDPI monotherapy or the addition of IDPI to the current regimen in a total of 1413 patients with type 2 DM that was uncontrolled with diet and exercise, metformin, a sulfonylurea, metformin and a sulfonylurea, or a secretagogue plus an insulin sensitizer. The use of IDPI as a mealtime insulin in these studies was associated with absolute changes in HbA(1c) ranging from -0.6% to +0.1% in patients with type 1 DM and from -1.4% to -2.9% in patients with type 2 DM. HbA(1c) values <7% were achieved in 16.9% to 28.2% of patients with type 1 DM and 16.7% to 44.0% of patients with type 2 DM. The most common nonrespiratory adverse event noted during clinical trials of IDPI was hypoglycemia (type 1 DM: 8.6-9.3 episodes/subject-month; type 2 DM: 0.3-1.4 episodes/subject-month), and the most common adverse event involving the pulmonary system was cough (21.9%-29.5%). CONCLUSIONS: IDPI is the first available inhaled insulin. It provides an additional option for the achievement of HbA(1c) goals with a premeal insulin.