Jasmine D. Gonzalvo

Saxagliptin: A Clinical Review in the Treatment of Type 2 Diabetes Mellitus

BACKGROUND Some conventional therapies for type 2 diabetes mellitus (T2DM) fail to address the progressive nature of the disease, and as a result, they may become ineffective in maintaining normoglycemia. Antihyperglycemic agents have been developed to target incretin hormones, specifically glucagon-like peptide (GLP)-1. Incretin analogues and agents that delay GLP-1 degradation, the dipeptidyl peptidase (DPP)-4 inhibitors, offer mechanisms of action that may improve T2DM management. Saxagliptin was approved by the US Food and Drug Administration in July 2009 and by the European Medicines Evaluation Agency in October 2009 for use as monotherapy or in combination regimens for the treatment of T2DM. OBJECTIVE The aim of this article was to review the mechanism of action, pharmacology, clinical efficacy, and tolerability associated with the use of saxagliptin in patients with T2DM. METHODS MEDLINE, BIOSIS, International Pharmaceutical Abstracts, and Google Scholar were searched for English-only clinical trials and therapeutic reviews published between 1966 and June 15, 2011 (search term: saxagliptin). Additional trials and reviews were identified from the reference lists of published articles. RESULTS Findings on efficacy and tolerability were obtained from 11 completed Phase III clinical trials. In trials in saxagliptin-naive patients, changes from baseline in glycosylated hemoglobin (HbA(1c)) ranged from -0.72% to -0.90% in the saxagliptin treatment arms compared with -0.27% with placebo (all, P < 0.007). When saxagliptin was used in combination with metformin for 24 weeks, the adjusted mean reductions from baseline in HbA(1c) and the proportions of patients achieving target HbA(1c) (<7.0%) were significantly greater with saxagliptin + metformin compared with monotherapy with either drug (all, P ≤ 0.0001). When saxagliptin was used in combination with a sulfonylurea or a thiazolidinedione, the changes in HbA(1c) ranged from -0.54% to -0.64% and -0.66% to -0.94%, respectively, in a dose-dependent manner (P ≤ 0.0007 vs monotherapies). Based on changes in HbA(1c), saxagliptin + metformin was reported to be noninferior to sitagliptin + metformin (-0.52% and -0.62%, respectively; difference, 0.09% [95% CI, -0.01% to 0.20%]). Saxagliptin was reported to have been well tolerated, with the most common adverse events being upper respiratory infection, urinary tract infection, headache, and nasopharyngitis. A systematic review of cardiovascular events in pooled trial results of saxagliptin use reported no increased cardiovascular risk compared with metformin, glyburide, or placebo (relative risk, 0.24 [0.09-0.63]). CONCLUSIONS Saxagliptin, used as monotherapy and in combination regimens, has been associated with significant reductions in HbA(1c) and significant increases in the rate of achieving target HbA(1c) in patients with T2DM. It has been reported to be well tolerated compared with other oral antihyperglycemic agents. Based on the findings from the studies in this review, the primary role of saxagliptin is expected to be in combination therapy with other antihyperglycemic agents.

Redesign of a statewide teaching certificate program for pharmacy residents.

Objectives. To identify and assess changes made to the Indiana Pharmacy Resident Teaching Certificate program over 10 years to adapt to the growing number and changing needs of pharmacy educators in the next generation. Design. In 2011, all resident program participants and directors were sent an electronic survey instrument designed to assess the perceived value of each program component. Assessment. Since 2003, the number of program participants has tripled, and the program has expanded to include additional core requirements and continuing education. Participants generally agreed that the speakers, seminar topics, seminar video recordings, and seminar offerings during the fall semester were program strengths. The program redesign included availability of online registration; a 2-day conference format; retention of those seminars perceived to be most important, according to survey results; implementation of a registration fee; electronic teaching portfolio submission; and establishment of teaching mentors. Conclusion. With the growing number of residents and residency programs, pharmacy teaching certificate programs must accommodate more participants while continuing to provide quality instruction, faculty mentorship, and opportunities for classroom presentations and student precepting. The Indiana Pharmacy Resident Teaching Certificate program has successfully evolved over the last 10 years to meet these challenges by implementing successful programmatic changes in response to residency program director and past program participant feedback.

Potential New Treatments for Diabetic Kidney Disease

Antifibrotic agents, antioxidant agents, ET-a receptor antagonists, and a few other agents with nonspecific or multifaceted mechanisms of action have been evaluated and progressed to small clinical studies in human subjects. Although there are limited data at the present time, these early evaluations have produced some favorable results that at least warrant further investigation. There is certainly not enough compelling evidence to justify the routine use of any of these products specifically for DKD at the moment; however, more well-controlled and adequately powered studies in several hundred patients will help determine which of these may have a place in the DKD treatment armamentarium of the future.

Pharmaceutical Role Expansion and Developments in Pharmacist-Physician Communication

Expanded clinical pharmacist professional roles in the team-based patient-centered medical home (PCMH) primary care environment require cooperative and collaborative relationships among pharmacists and primary care physicians (PCPs), but many PCPs have not previously worked in such a direct fashion with pharmacists. Additional roles, including formulary control, add further elements of complexity to the clinical pharmacist–PCP relationship that are not well described. Our objective was to characterize the nature of clinical pharmacist–PCP interprofessional collaboration across seven federally funded hospitals and associated primary care clinics, following pharmacist placement in primary care clinics and incorporation of expanded pharmacist roles. In-depth and semistructured interviews were conducted with 25 practicing clinical pharmacists and 17 PCPs. Qualitative thematic analysis revealed three major themes: (1) the complexities of electronic communication (particularly electronic nonformulary requests) as contributing to interprofessional tensions or misunderstandings for both groups, (2) the navigation of new roles and traditional hierarchy, with pharmacists using indirect communication to prevent PCP defensiveness to recommendations, and (3) a preference for onsite colocation for enhanced communication and professional relationships. Clinical pharmacists’ indirect communication practices may hold important implications for patient safety in the context of medication use, and it is important to foster effective communication skills and an environment where all team members across hierarchies can feel comfortable speaking up to reduce error when problems are suspected. Also, the lack of institutional communication about managing drug formulary issues and related electronic nonformulary request processes was apparent in this study and merits further attention for both researchers and practitioners.

Accuracy of automated community pharmacy-based blood pressure devices.

OBJECTIVES To estimate accuracy and reliability of pharmacy-based fixed-location automated blood pressure devices (ABPDs) and to test the hypothesis that an ABPD is less accurate with more variable results than a home blood pressure device (HBPD). METHODS Randomized study comparing 99 ABPDs with an Omron Digital HBPD in Indiana pharmacies. Each site was visited by one of five study investigators. A questionnaire was used to collect information about ABPDs. To test the ABPD against the HBPD, investigators measured their own blood pressure with each device three times in random order. RESULTS No significant differences were observed between HBPD and ABPD diastolic readings, whereas a statistically significant difference between HBPD and ABPD systolic readings was found. ABPD measurements are as reliable as HBPD measurements when comparing single measurements from each, but reliability differs with more than one reading. CONCLUSION Compared with a valid HBPD, the ABPD produces inaccurate systolic blood pressure values but similar reliability. Regular blood pressure measurement by health professionals remains optimal for managing hypertensive individuals.

Teaching Certificate Program Participants’ Perceptions of Mentor-Mentee Relationships

Objective. To assess teaching certificate program (TCP) participants’ perceptions of mentor-mentee relationships. Methods. A 15-item survey instrument was administered to all 2014-2015 participants of the Indiana Pharmacy Teaching Certificate (IPTeC) program. Results. One hundred percent of IPTeC program participants (83/83) responded to the survey. The majority of participants indicated that having a professional mentor was either very important (52%) or important (47%) to their professional development and preferred to choose their own professional mentor (53%). Mentor characteristics rated as highly important by mentees included having similar clinical practice interests (82%), having similar research interests (66%), and being available to meet face-to-face (90%). Age, race, and gender of the mentor were not rated by mentees as important. Conclusion. Teaching certificate program participants place high importance on having a professional mentor. Mentorship of pharmacists completing TCPs should be a priority for current pharmacy faculty members so adequate guidance is available to future pharmacy educators.

Language Concordance as a Determinant of Patient Outcomes in a Pharmacist-Managed Cardiovascular Risk Reduction Clinic.

Background: Published literature reveals that health care disparities exist due to race, gender, and language, although this has not been confirmed in a pharmacist-managed patient population. Objective: The objective of this study is to examine the association of language concordance and clinical outcomes in a comparison of English-speaking (ES) and Spanish-speaking (SS) patients in a pharmacist-managed cardiovascular risk reduction clinic (CVRRC). Methods: A retrospective chart review was undertaken to collect hemoglobin A1C, blood pressure, and low-density lipoprotein cholesterol (LDL-C) for patients enrolled in the CVRRC from July 2010 and August 2012. A 2-sample t-test was utilized to compare these outcomes between ES and SS patients. Results: A total of 9 SS patients and 62 ES patients were included. No statistically significant differences were found between ES and SS patients in this language-concordant, pharmacist-managed clinic setting. Conclusions: These results suggest that similar clinical outcomes between ES and SS patients may be achieved with the ability of pharmacists to speak the same language as their patients.

Implementing mentoring into a pharmacy teaching and learning curriculum

Recent recommendations for standardization of postgraduate pharmacy experiences in education include the implementation of a mentoring program.[1][1],[2][2] The Indiana Pharmacy Teaching Certificate (IPTeC) program emphasizes the importance of the mentor–mentee relationship in developing

Perceptions of Spanish-speaking clientele of patient care services in a community pharmacy.

BACKGROUND A paucity of studies exists that have assessed community pharmacy preferences of Spanish-speaking patients living in areas of the U.S. with rapidly growing Hispanic populations. The qualitative approach to this research affords a unique opportunity to further explore perceptions of the Spanish-speaking population. OBJECTIVES To identify perceptions of Spanish-speaking patients living in the U.S. with a focus on the care provided in community pharmacies, as well as to determine their satisfaction with community pharmacies. METHODS Participants were recruited after weekly Spanish-speaking church services for approximately one month. Qualitative, semi-structured individual interviews to identify perceived unmet patient care needs were conducted in Spanish and transcribed/translated verbatim. Qualitative thematic analysis was used to summarize findings. A written questionnaire was administered to collect patient satisfaction and demographic information, summarized using descriptive statistics. RESULTS Twelve interviews were conducted by the principal investigator. Primary themes included lack of insurance coupled with high medical care costs serving as a barrier for acquisition of health care, difficulty accessing timely and convenient primary care, perceived negative attitudes from pharmacy personnel, lack of Spanish-speaking health care providers, and the provision of verbal and written medication information in English. CONCLUSIONS The results of this study suggest a great need for health care providers, including pharmacists, to expand outreach services to the Spanish-speaking community. Some examples derived from the interview process include increasing marketing efforts of available services in the Spanish language, hiring Spanish-speaking personnel, and offering medical terminology education classes to Spanish-speaking patients.

Survey of pharmacist-managed primary care clinics using healthcare failure mode and effect analysis

Objective The primary objective was to expand upon results of a previously piloted patient perception survey with Healthcare Failure Mode and Effect Analysis (HFMEA), to identify areas within pharmacist-managed clinics needing improvement. Methods The survey was adapted for use in pharmacist-managed clinics. Patients completed the survey following regularly scheduled pharmacist appointments. Data were analyzed with a method adapted from HFMEA. Product scores could range from five to 25. A product of five indicates that pharmacists are doing a good job on the items that patients place the most value on, while a product score of 25 indicates that pharmacists are doing a poor job. A score greater than or equal to ten was used to identify areas for improvement. Results Seventy-one patients completed surveys. Thirteen components were assessed and no item achieved a mean product greater than or equal to ten. The survey item with the highest mean product pertained to discussion of potential medication side effects (mean: 7.06; interquartile range: 5-10). Analysis of each survey item found that all survey items had multiple individual responses that provided a product score of greater than or equal to ten. The survey items most frequently listed in the overall population as being most valued were “Told you the name of each of your medicines and what they are used for”, “Answered your questions fully,” and “Explained what your medicines do”. Conclusions Educational components provided during pharmacist-managed clinic appointments are aligned with patients’ needs and are successfully incorporating the components that patients value highly in a patient-healthcare provider interaction. The HFMEA model can be an important teaching tool to identify specific processes in need of improvement and to help enhance pharmacists’ self-efficacy, which may further improve patient care.