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Purpose of Review: Diabetic neuropathy is a common complication of diabetes mellitus (DM) and can affect up to 50% of DM patients during their lifetime. Patients typically present with numbness, tingling, pain, and loss of sensation in the extremities. Since there is no treatment targeting the underlying mechanism of neuropathy, strategies focus on preventative care and pain management., Recent Findings: Up to 69% of patients with diabetic neuropathy receive pharmacological treatment for neuropathic pain. The United States Food and Drug Administration (FDA) confirmed four drugs for painful diabetic neuropathy (PDN): pregabalin, duloxetine, tapentadol, and the 8% capsaicin patch. Nonpharmacological treatments such as spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS) both show promise in reducing pain in DM patients. Despite the high burden associated with PDN, effective management remains challenging. This update covers the background and management of diabetic neuropathy, including its epidemiology, pathogenesis, preventative care, and current therapeutic strategies., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To report data from the first three years of operation of the RSNA-ACR 3D Printing Registry., Methods: Data from June 2020 to June 2023 was extracted, including demographics, indications, workflow and user assessments. Clinical indications were stratified by 12 organ systems. Imaging modalities, printing technologies and number of parts per case were assessed. Effort data was analyzed, dividing staff into provider and non-provider categories. The opinions of clinical users were evaluated through a Likert-scale questionnaire, and estimates of procedure time saved were collected., Results: A total of 20 sites and 2,637 cases were included, consisting of 1,863 anatomic models and 774 anatomic guides. Mean patient age for models and guides was 42.4 ± 24.5 years and 56.3 ± 18.5 years respectively. Cardiac models were the most common type of models (27.2%), and neurologic guides were the most common type of guides (42.4%). Material jetting, vat photopolymerization and material extrusion were the most common printing technologies used overall (85.6% of all cases). On average, providers spent 92.4 minutes and non-providers spent 335.0 minutes per case. Providers spent most time on consultation (33.6 minutes), while non-providers focused most on segmentation (148.0 minutes). Confidence in treatment plans increased after using 3D printing (p<.001). Estimated procedure time savings for 155 cases was 40.5 ± 26.1 minutes., Conclusion: 3D printing is performed in healthcare facilities for many clinical indications. The registry provides insight into the technologies and workflows used to create anatomic models and guides, and the data shows clinical benefits from 3D printing., (Copyright © 2024. Published by Elsevier Inc.)

Pyogenic (septic) arthritis is a severe joint infection characterized by the invasion of microorganisms into the synovium, causing inflammation and joint destruction. This review article provides a comprehensive overview of pyogenic arthritis, focusing on etiology, pathogenesis, clinical manifestations, diagnosis, and management strategies. This review explores routes of microbial entry into joints, emphasizing the importance of prompt identification and treatment to prevent irreversible joint damage. Clinical manifestations, such as joint pain, swelling, and limited range of motion, are discussed, along with the challenges in differentiating pyogenic arthritis from other joint disorders. Diagnostic approaches, including joint aspiration and imaging modalities, are critically examined for accuracy in confirming diagnosis. This review also addresses the significance of early intervention through antimicrobial therapy and joint drainage, highlighting the role of multidisciplinary collaboration in optimizing patient outcomes. In summary, the present investigation underscores the complexities of pyogenic arthritis and the need for a comprehensive understanding of pathophysiology for timely and effective management to improve patient prognosis and quality of life., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Kaye et al.)

Chronic pruritus is defined as an itch lasting greater than six weeks. It can manifest from a wide variety of etiologies, as many different substances can act as pruritogens, such as steroids, histamine, progesterone, endogenous opioids, and serotonin. In the setting of cholestatic liver disease, increased bile acids play a major role in chronic pruritus. The itching in cholestatic liver disease is worsened in intensity at night and localized frequently to the palms, soles, knees, and other pressure sites. It can be hard to manage, affecting the quality of sleep and causing irritability, poor attention, and, in some cases, depression. One such disease that results from chronic pruritus is progressive familial intrahepatic cholestasis (PFIC), a group of uncommon hereditary disorders that affects the formation of bile and its outflow from the liver. Previously, the drug ursodeoxycholic acid was used to help manage pruritus or surgical procedures, e.g., partial external biliary diversion or partial internal biliary diversion, to help control complications of the disease. This literature review will discuss three clinical studies covering the effectiveness of odevixibat in treating pruritus in patients with PFIC. Odevixibat (Bylvay) is an oral drug that has been FDA-approved to treat pruritus in patients three months of age and older with PFIC. Odevixibat prevents the reabsorption of bile salts in the intestines, resulting in decreased levels of bile salts via their excretion in stool. Several studies have determined that the drug is well tolerated and provides a nonsurgical, pharmacological treatment alternative for those with PFIC., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Flattmann et al.)

Vitamin A deficiency (VAD) or excess in expectant mothers can result in fetal abnormalities such as night blindness, bone anomalies, or epithelial cell problems. In contrast, excessive vitamin A in pregnancy can precipitate fetal central nervous system deformities. During pregnancy, a pregnant woman should monitor her vitamin A intake ensuring she gets the recommended dosage, but also ensuring she doesn't exceed the recommended dosage, because either one can result in teratogenicity in the fetus. The widespread and unregulated use of multivitamins and supplements makes consuming doses greater than the recommended quantity more common in developed countries. While vitamin A excess is more common in developed countries, deficiency is most prevalent in developing countries. With proper maintenance, regulation, and education about VAD and excess, a pregnant mother can diminish potential harm to her fetus and potential teratogenic risks., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Abadie et al.)

Background: The Bureau of Labor Statistics (BLS) uses a single Standard Occupational Classification (SOC) code (29-1051) that reflects a traditional definition of pharmacist job functions. Pharmacists working in nontraditional roles would be categorized under other SOC codes and not included in the BLS pharmacist count. Knowing the magnitude of how many working pharmacists may not be included in the BLS pharmacist count would help determine whether the gap is a minor margin of error or a significant problem affecting pharmacist workforce projections., Objectives: The primary objective of this paper was to estimate the gap between the number of possibly working pharmacists and the BLS pharmacist count in 2019. A secondary objective was to examine BLS pharmacist counts in nontraditional roles and compare with published industry data., Methods: The annual number of individuals receiving their first professional pharmacy degree from 1965 to 2019 (55 graduation cohorts) was adjusted using the expected survival rate to 2019 by age and gender and workforce participation rate in 2019 for pharmacists for each cohort and then summed across cohorts. Data sources included Accreditation Council for Pharmacy Education, U.S. Vital Statistics reports, and American Consumer Survey. One-way and scenario-based sensitivity analyses were conducted to vary professional occupation mortality advantage and pharmacist workforce participation rate assumptions., Results: Based on the number of individuals receiving their first professional pharmacy degree between 1965 and 2019 (442,409), there were 356,998 possibly working pharmacists in 2019. This value indicates 45,798 more pharmacists (15%) may have been working in 2019 than the 311,200 employee pharmacists reported by BLS for 2019. A gap of 8000 to 46,000 more working pharmacists (3%-15%) versus BLS persisted after sensitivity analyses., Conclusion: The magnitude of possibly working pharmacists not included in BLS counts warrants further consideration of current pharmacist job projections, methods, and metrics to improve future projections and monitoring of the pharmacist labor force., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Clinical pharmacist interventions have resulted in optimized diabetes control in complex patients; however, there are no studies examining the durability of achieved outcomes after patients discontinued being seen by the pharmacist. A pharmacist-led comprehensive medication management (CMM) Diabetes Intensive Medication Management (DIMM) “tune up” clinic provided the opportunity to evaluate long-term glycemic control outcomes following clinical discharge. This study used a retrospective cohort study design with a matched primary care provider (PCP) comparison group. Outcomes were compared between the groups at several post-discharge intervals (6, 9, and 12 months) using independent t tests and chi-square tests, where appropriate. DIMM-managed patients achieved an average HbA1c reduction of 3% upon discharge, and maintained an average HbA1c concentration that was significantly lower than PCP-managed patients at 6 months (p < 0.001) and 9 months (p = 0.009) post-discharge. Although DIMM-managed patients had lower HbA1c than PCP-managed patients at 12 months post-discharge, the difference was not significant (p = 0.105). Similar findings were noted for average FPG and LDL across the study time points. No differences in average HDL levels were reported across the time points. A significantly larger proportion of DIMM-managed patients maintained HbA1c < 8% compared to PCP-managed patients at 6 months (67.5% versus 47.2%, p = 0.001) and 9 months (62.6% versus 40.6%, p = 0.040) post-discharge; DIMM-managed patients had a larger, but non-significant, proportion of goal retention compared to PCP-managed patients at 12 months (56.9% versus 47.2%, p = 0.126) post-discharge. Similarly, a significantly larger proportion of DIMM-managed patients sustained HbA1c < 9% compared to PCP-managed patients at 6 months (87.8% versus 66.7%, p < 0.001) and 9 months (82.1% versus 68.3%, p = 0.012) post-discharge; however, there was no significant difference at 12 months. The attenuation of the DIMM-managed metabolic biomarkers suggests that an additional follow-up visit or touchpoint may be helpful. The personalized care of the DIMM “tune up” approach was successful in achieving sustained glycemic control for up to 9 months. Outcomes can help inform future long-term result durability evaluations.

Despite numerous challenges in relation to being a recently established school, the University of California, Irvine (UCI) School of Pharmacy and Pharmaceutical Sciences (SPPS), similar to many schools of pharmacy in the United States, was highly committed to supporting the rollout of COVID-19 vaccines. UCI SPPS and our affiliated UCI Medical Center (UCIMC) Pharmacy Department partnered to spearhead the pharmacy element of a large-scale COVID-19 vaccination clinic on campus for both employees and the community. Three key initiatives were established in order to overcome the obstacles we faced in the large-scale roll out of COVID-19 vaccines: (1) forging new collaborations within the pharmacy team, (2) leveraging interprofessional education and practice, and (3) raising awareness of the pharmacists' role. Our response to the COVID-19 vaccines at UCI was a tangible, visible model that demonstrated that, while we continue to embrace our role in team-based, patient-centered care, it is also important for us to step up and lead the profession. Additionally, this vaccine rollout experience is a teachable moment for our communities and our health professional partners as we continue to march forward as one voice to serve the American public.

Diabetes complications remain a leading cause of death, which may be due to poor glycemic control resulting from medication nonadherence. The relationship between adherence status and HbA1c (glycemic control) has not been well-studied for clinical pharmacist interventions. This study evaluated medication adherence, patient satisfaction, and HbA1c, in a collaborative pharmacist-endocrinologist diabetes clinic over 6 months. Of 127 referred, 83 patients met the inclusion criteria. Mean medication adherence scores, considered "good" at baseline, 1.4 ± 1.2, improved by 0.05 points ( p = 0.018), and there was a 26% increase in patients with good adherence. A significant improvement of 0.40 percentage points (95% CI: -0.47, -0.34) was observed in mean HbA1c across the three time points ( p < 0.001). Mean total satisfaction scores were high and increased, with mean 91.3 ± 12.2 at baseline, 94.7 ± 9.6 at 3 months, and 95.7 ± 10.8 at 6 months ( p = 0.009). A multimodal personalized treatment approach from a pharmacist provider significantly and positively impacted glycemic control regardless of self-reported medication adherence, and patient satisfaction remained high despite changing to a clinical pharmacist provider and increased care intensity.

In the United States, pharmacists' scope of practice continues to expand, with increasing opportunities for pharmacists in all practice settings to enhance health in society. In ambulatory care, pharmacists remain integral members on the healthcare team and have demonstrated positive impacts on patient care. Sharing similar characteristics as pharmacists in the community setting, a deeper look into common elements of a successful ambulatory care practice that can be applied in the community pharmacy setting is warranted. Key success factors identified from ambulatory care include (1) maximizing a pharmacist's unique knowledge base and skill set, (2) forming collaborations with physicians and other providers, (3) demonstrating outcomes and value, and (4) maintaining sustainability. Opportunities exist for pharmacists in the community setting to utilize these success factors when developing, implementing, and/or expanding direct patient care services that improve accessibility to quality care and population health.

Objective: Investigate the impact of increased access to new and refilled prescriptions by means of an automated pickup kiosk (Asteres ScriptCenter) on prescription abandonment rates, patient experience, and pharmacist consultations., Design: Nonrandomized, observational study using retrospective, deidentified data from the filling pharmacy, the kiosk, and a pharmacist-completed counseling documentation log over a 35-month study period., Setting and Participants: Hospital employees opting to use a kiosk located in the lobby with 24 hours a day, 7 days a week access for pickups and a telephone pharmacist consultation service compared with employees using the regular counter at the filling pharmacy., Outcome Measures: Return to stock (RTS) rate to assess prescription abandonment, time to prescription pickup, consultation duration, kiosk user assessment, and pharmacist assessment of counseling ability., Results: Approximately 9% of employees (440) enrolled to use the kiosk, with 5062 kiosk pickups recorded for new prescriptions (29%), refill prescriptions (33%), and over-the-counters (38%). The mean kiosk RTS (4.3% ± 3.2) was lower than that at the regular counter (5.6% ± 0.8), P = 0.04, whereas the mean time to pickup was approximately 1 day greater at the kiosk than the regular counter (2.8 ± 0.4 vs. 1.8 ± 0.2, P < 0.001). The average kiosk consultation was approximately 1 minute shorter (2.0 ± 1.4) than that of the regular counter (3.4 ± 1.9, P < 0.001), and fewer patients using the kiosk (15.7%) had additional questions at the end of a consultation session than patients at the regular counter (38.8%, P < 0.001). Most of the kiosk users agreed that their prescription questions were answered and that kiosk convenience was an important reason for using the filling pharmacy. Almost all (>90%) pharmacists indicated that they were able to effectively counsel patients at the kiosk and the regular counter., Conclusion: The kiosk, used by self-selected health care workers located in a hospital workplace setting with 24 hours a day, 7 days a week access, was a convenient, contactless pickup extension of the filling pharmacy with a lower prescription abandonment rate and similar pickup and consultation characteristics as at the regular pharmacy counter., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Introduction: Our objective was to evaluate physicians' perspectives on the clinical utility of pharmacogenetic (PGx) testing in kidney, liver, heart, and lung transplantation (KLHL-Tx)., Methods: A 36-question web-based survey was developed and administered to medical and surgical directors of US KLHL-Tx centers., Results: There were 82 respondents (10% response rate). The majority were men (78%), non-Hispanic whites (70%), medical directors (72%), and kidney transplant physicians (35%). Although 78% of respondents reported having some PGx education, most reported lack of confidence in their PGx knowledge and ability to apply a PGx test. Participants reported mixed views about the clinical utility of PGx testing-most agreed with the efficacy of PGx testing, but not the benefits relative to the risks or standard of care. While 55% reported that testing was available at their institution, only 38% ordered a PGx test in the past year, most commonly thiopurine-S-methyltransferase. Physician-reported barriers to PGx implementation included uncertainty about the clinical value of PGx testing and patient financial burden., Conclusion: Together, our findings suggest prospective PGx research and pilot implementation programs are needed to elucidate the clinical utility and value of PGx in KLHL-Tx. These initiatives should include educational efforts to inform the use of PGx testing., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Previous studies show patients with type 2 diabetes (T2D) and a mental health (MH) disorder exhibit poorer glycemic control compared with those without. Objective: Compare mean change in glycosylated hemoglobin (A1C) after 6 months in the Diabetes Intense Medical Management (DIMM) "Tune Up" Clinic in patients with and without MH disorders. Methods: Retrospective cohort study in T2D patients, with A1C at baseline and 6 months, divided into subgroups of those with ≥1 MH diagnoses and without MH. Primary outcome was mean change in A1C from baseline to 6 months. Secondary outcomes were mean change in other metabolic parameters and proportion achieving A1C and related goals. Results: Of 155 patients meeting inclusion criteria, 66 (42.6%) had at least 1 MH disorder (MH group) and 89 (57.4%) did not (non-MH group). Mean A1C, fasting blood glucose (FBG), and triglycerides (TG) change (improvement) did not differ significantly between MH and non-MH groups at 6 months (eg, A1C reduction: -2.1% [SD = 2.0] vs -2.3% [SD = 2.1]; P = 0.61, respectively). Percentage at A1C goal did not differ significantly between groups, though a higher percentage of the non-MH group achieved FBG and TG goals than the MH group. Conclusion and Relevance: In 6 months, both groups in the DIMM clinic achieved a statistically significant mean A1C reduction (over 2%) with no statistical or clinical difference in the magnitude of change between groups. Patients with T2D benefitted from the DIMM model and personalized visits with a pharmacist regardless of having a MH disorder.

Objective. To examine perceived stress, coping strategies, and health-related quality of life in Doctor of Pharmacy students across the first three years (pre-clinical portion) of the curriculum. Methods. Three instruments, the Perceived Stress Scale, Brief COPE, and Short Form-36, were administered to students three times a year over a five-year period. Median annual scores were compared using Skillings-Mack tests and correlations were assessed using Spearman correlation. Results. One hundred forty-five students (approximately 46% of the school's enrollment) participated. A significant increase in scores on the PSS, increase in students' maladaptive coping behaviors, and worsening mental health-related quality of life were detected in students across the first three years of the pre-clinical curriculum. The PSS scores of first- and second-year pharmacy students had a moderate to large positive correlation with maladaptive coping behaviors (rho = 0.43 and 0.58, respectively) and PSS scores exhibited a large negative correlation with maladaptive coping behaviors in all three years of the pre-clinical curriculum (rho ranged from -0.69 to -0.78). Conclusion. Increasing levels of stress, increasing use of maladaptive coping strategies, and declining mental health-related quality of life among pharmacy students across the first three years of the four-year curriculum were very similar to findings in the cohort of pharmacy students observed in the preceding five years., (© 2020 American Association of Colleges of Pharmacy.)

Aims: To assess stakeholder perspectives regarding the clinical utility of pharmacogenomic (PGx) testing following kidney, liver, and heart transplantation. Methods: We conducted individual semi-structured interviews and focus groups with kidney, liver, and heart transplantation patients and providers. We analyzed the qualitative data to identify salient themes. Results: The study enrolled 36 patients and 24 providers. Patients lacked an understanding about PGx, but expressed interest in PGx testing. Providers expressed willingness to use PGx testing, but reported barriers to implementation, such as lack of knowledge, lack of evidence demonstrating clinical utility, and patient healthcare burden. Conclusion: Patient and provider educational efforts, including foundational knowledge, clinical evidence, and applications to patient care beyond just immunosuppression, may be useful to facilitate the use of PGx testing in transplant medicine.

Introduction: The scope of pharmacy practice has evolved over the last few decades to focus on the optimization of medication therapy. Despite this positive impact, the lack of reimbursement remains a significant barrier to the implementation of innovative pharmacist practice models., Summary: We describe the successful development, implementation and outcomes of three types of pharmacist collaborative care models: (1) a pharmacist with physician oversight, (2) pharmacist-interprofessional teams and (3) physician-pharmacist teams. The outcome measurement of these pharmacist care models varied from the design phase to patient volume measurement and to comprehensive quality dashboards. All of these practice models have been successfully funded by affiliated health systems or grants., Conclusions: The expansion of pharmacist services delivered by clinical faculty has several benefits to affiliated health systems: (1) significant improvements in patient care quality, (2) access to experts in specialty areas, and (3) the dissemination of outcomes with national and international recognition, increasing the visibility of the health system., Competing Interests: The authors declare no conflict of interest.

Objectives: To develop a pharmacist patient care services intervention reporting checklist to be used in conjunction with existing primary reporting tools. The tool should enhance consistent reporting of pharmacist patient care interventions. Tool use in pharmacist-patient care intervention reporting may increase: (1) likelihood for inclusion in higher order analyses and (2) successful replication., Methods: Adhering to principles of the Equator Network, a modified Delphi approach was used. An expert group identified guidance need, conducted a thorough literature search confirming need, developed a comprehensive list of potential elements, refined the list via multiple rounds, finalized language and structure, and published the checklist. Multiple rounds of iterative input were completed face to face, in conference calls, and during public comment periods. The finalized list of elements was organized into a logical flow with the use of clear and concise language and then transformed into an intuitive checklist., Results: The core task force identified 9 critical components over a 4-year period Collectively, the input represented more than 200 stakeholders. Stakeholders overwhelmingly supported the inclusion (89%; n = 29) and clarity (91%; n = 26) of each element. The final 9 elements were organized into a checklist to enhance pharmacist patient care intervention reporting (PaCIR). Accompanying each element is a specific explanation justifying its inclusion. An appendix containing published and created examples of how authors may satisfactorily meet each element is provided., Conclusion: Use of the PaCIR checklist will enhance the quality of reporting of pharmacist patient care intervention studies. This enhanced quality can support replication of the studies and increase the likelihood these studies will be considered for inclusion in systematic reviews and meta-analyses. Researchers are urged to consider use of reporting guides such as PaCIR during the project design phase., (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Objective: Numerous barriers prevent patients with type 2 diabetes (T2D) from completing a diabetes self-management program. We investigated whether patients with T2D exhibited improved clinical outcomes after attending a relatively short, interactive diabetes self-management program conducted by pharmacist diabetes educators, compared to a physician's usual care., Results: We retrospectively analyzed the data of adults with T2D who attended a diabetes self-management program (≥ 1 group meeting or individual appointment followed by a telephone interview from a pharmacist diabetes educator between May 2010 and Dec. 2012; n = 513) and compared their outcomes with those of T2D patients who received only their physician's usual care (n = 857). Each patient's A1C was assessed at baseline, 3 months, and 6 months post-intervention. The mean [SD] reduction in A1C percentage points in the T2D patients was significantly greater in the diabetes self-management program group compared to the physician's usual care group at both 3 months (- 0.8% [1.5] vs. - 0.2% [0.9], p < 0.001) and 6 months post-intervention (- 0.6% [1.3] vs. - 0.2% [1.1], p < 0.001). T2D patients significantly improved their glycemic control within 3-6 months of attending the diabetes self-management program compared to patients who only received their physician's usual care.

Background: Gaining glycemic control in patients with type 2 diabetes (T2D) usually requires more complicated medication regimens. Increased medication regimen complexity (MRC) negatively impacts adherence and clinical outcomes., Objective: Compare MRC change in patients with uncontrolled T2D referred to a collaborative pharmacist-endocrinologist Diabetes Intense Medical Management (DIMM) clinic "tune up" model versus similar patients receiving usual primary care provider (PCP) care over 6 months., Methods: Retrospective, observational, comparative cohort study compared MRC of complex DIMM clinic patients to a similar group (adults with T2D, glycosylated hemoglobin [A1C] ≥8%), continuing to receive usual care from their PCPs. The MRC Index (MRCI) was used to quantify MRC., Results: Both DIMM (n=99) and PCP (n=56) groups were similar, with high baseline mean MRC scores as measured by number of medications and MRCI (12.0 [SD=5.7] vs 13.7 [SD = 5.6], and 32.7 [SD=17.0] vs 38 [SD=16.5]), respectively. Mean MRC change over 6 months was not significantly different between groups, although mean A1C reduction was significantly greater in the DIMM versus PCP group (-2.4% [SD=2.1] vs -0.8% [SD=1.7], P<0.001, respectively)., Conclusions and Relevance: Outcomes represent the first report demonstrating how treating patients with an innovative DIMM model can help complex T2D patients achieve glycemic control without increasing the MRC to more than a comparator group. With the growing prevalence of T2D and associated elevated treatment costs, identifying effective means for achieving glycemic control without increasing complexity is needed. Application of this model may be considered by other health systems to aid in achieving outcome measures.

Background: Public attention and recent US Congressional activity has intensified focus on escalating medication prices. However, the actual cost of medication use extends beyond the up-front cost of purchasing medicines. It also encompasses the additional medical costs of morbidity and mortality resulting from nonoptimized medication regimens, including medication nonadherence., Objectives: Applying the most current nationally representative data sources, our goal was to estimate the cost of prescription drug-related morbidity and mortality in the United States., Methods: Total costs of nonoptimized prescription drug use and average pathway costs for a patient who experienced a treatment failure (TF), a new medical problem (NMP), or a TF and NMP were modeled in Microsoft Excel (Microsoft Corporation, Redmond, WA) and TreeAge Pro Healthcare, v2014 (TreeAge Software, Inc, Williamstown, MA), respectively., Results: The estimated annual cost of prescription drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion in 2016 US dollars, with a plausible range of $495.3 billion to $672.7 billion. The average cost of an individual experiencing TF, NMP, or TF and NMP after initial prescription use were $2481 (range: $2233, $2742), $2610 (range: $2374, $2848) and $2572 (range: $2408, $2751), respectively., Conclusions: The estimated annual cost of drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion, equivalent to 16% of total US health care expenditures in 2016. We propose expansion of comprehensive medication management programs by clinical pharmacists in collaborative practices with physicians and other prescribers as an effective and scalable approach to mitigate these avoidable costs and improve patient outcomes.

Access to prescription medications is critical as the U.S. population ages. Escalating drug costs have garnered mounting attention from the public with increasing federal scrutiny. The Medicare Part D program will increasingly be relied upon to support the health of our nation's older people. We reviewed the publically available Medicare Part D usage data from 2011 to 2015 to quantify the cost of the 10 costliest medications for Part D, evaluated the number of beneficiaries treated with these medications, and measured beneficiaries' out-of-pocket costs. We observed over the analysis period, an increase in spending for these medications, a reduction in number of patients that received them, with increased out-of-pocket costs for the patient. In 2015 U.S. dollars, the amount Medicare Part D spent on the 10 costliest medications increased from $21.5 billion in 2011 to $28.4 billion in 2015-a 32% increase. The number of beneficiaries who received 1 of the 10 costliest medications fell from 12,913,003 in 2011 to 8,818,471-a 32% drop, with an average annual decrease of 7.9%. Out of pocket spending by patients that use these medications increased over the study period. For beneficiaries without the low-income subsidy, the average out-of-pocket cost share for 1 of the 10 costliest medications increased from $375 in 2011 to $1,366 in 2015-a 264% increase overall and an average 66% increase per year. Specialty medications are a growing portion of the costliest medications. As medication costs continue to escalate, and specialty medications become more common, the U.S. will be increasingly challenged with devising mechanisms to access sustainable, affordable medications for all older adults., (© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.)

Diabetes and its various comorbidities are responsible for a substantial societal financial burden. Healthcare and managed care providers must take responsibility for and address the high healthcare costs attributed to diabetes care. They can work together to improve diabetes-related patient care and reduce costs. Newer therapeutic agents and those used as combination therapy may decrease direct costs by improving glycemic control and preventing negative outcomes associated with diabetes comorbidities. Additional diabetes education, increased time to review medication adherence and diabetes monitoring, and having affordable care are all necessary to improve the care of individuals with diabetes.

Diabetes accounts for the second largest amount of avoidable healthcare costs in the United States-an estimated $24.6 billion in wasteful and avoidable spending. Diabetes is a lifelong disease that is highly dependent on patient self-management. Unfortunately, studies demonstrate that almost 50% of patients with diabetes fail to reach the glycemic goal of glycated hemoglobin <7%. Patient nonadherence poses a significant barrier to effective management of diabetes and can place a significant burden on the patient and the healthcare system, resulting in even greater increases in costs, morbidity, and mortality. Therefore, effective treatment and long-term management of diabetes requires a patient-centered collaborative model of care with an understanding of the factors associated with nonadherence. This may help develop patient-, provider-, and system-focused strategies to help increase the rates of medication adherence, reduce complications associated with uncontrolled diabetes, and lower the overall cost of management.

Purpose: The primary aim of this study was to explore changes in knowledge level, perceived importance and apprehension of immunizations by first year pharmacy students pre- vs. post-immunization education and training., Educational Activity: First year pharmacy students at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (UC San Diego SSPPS) completed a pre- and post-immunization training course questionnaire. Knowledge base and perceived importance level of immunizations including hepatitis B, influenza, measles, mumps, rubella (MMR), varicella, tetanus, diphtheria, pertussis (Tdap), meningococcal and human papilloma virus (HPV) were assessed. In addition, apprehension of needle administration and fears regarding safety and efficacy were evaluated., Findings: Of 120 students, 85 (71%) completed pre- and post-course questionnaires for this study. Mean knowledge test scores increased from 56% pre-course to 83% post-course. Pre-course, 73% of participants considered immunizations as very important in preventing future disease outbreaks. Post-course, this percentage climbed to 94%. Prior to taking the course, 52% of students were apprehensive about administering injections; however, after completing the course this percentage declined to 33%. The majority of students who had been fearful prior to the course retained their fears of receiving needle injections. The proportion of students believing immunizations should be a personal choice, not mandatory, did not significantly change from pre-course (49%) to post-course (44%)., Summary: The UC San Diego SSPPS immunization course increased student knowledge of immunization facts and the perceived importance of immunizations. However, a substantial portion of students retained apprehension about administering and receiving needle injections and the proportion believing immunizations should be a personal choice, almost half, did not change appreciably., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Adverse drug events (ADE) are a leading cause of mortality in the United States. Recent studies have demonstrated a high level of complex medication regimens in institutionalized residents. Evidence of the relationship between medication regimen complexity (MRC) and ADE-related rehospitalizations or emergency department (ED) visits is evolving. Therefore, there is a demand for better characterization and study of MRC as an objective identifier to quickly screen and prioritize high-risk patients for follow-up medication management therapy. This manuscript will serve as a brief summary review of the current findings regarding the relationship between MRC and hospital readmission and ED usage and provide strategies for pharmacists to more efficiently evaluate complex medication regimens and optimize therapies.

Background: In 2012 U.S. diabetes costs were estimated to be $245 billion, with $176 billion related to direct diabetes treatment and associated complications. Although a few studies have reported positive glycemic and economic benefits for diabetes patients treated under primary care physician (PCP)-pharmacist collaborative practice models, no studies have evaluated the cost-effectiveness of an endocrinologist-pharmacist collaborative practice model treating complex diabetes patients versus usual PCP care for similar patients., Objective: To estimate the cost-effectiveness and cost benefit of a collaborative endocrinologist-pharmacist Diabetes Intense Medical Management (DIMM) "Tune-Up" clinic for complex diabetes patients versus usual PCP care from 3 perspectives (clinic, health system, payer) and time frames., Methods: Data from a retrospective cohort study of adult patients with type 2 diabetes mellitus (T2DM) and glycosylated hemoglobin A1c (A1c) ≥ 8% who were referred to the DIMM clinic at the Veterans Affairs San Diego Health System were used for cost analyses against a comparator group of PCP patients meeting the same criteria. The DIMM clinic took more time with patients, compared with usual PCP visits. It provided personalized care in three 60-minute visits over 6 months, combining medication therapy management with patient-specific diabetes education, to achieve A1c treatment goals before discharge back to the PCP. Data for DIMM versus PCP patients were used to evaluate cost-effectiveness and cost benefit. Analyses included incremental cost-effectiveness ratios (ICERs) at 6 months, 3-year estimated total medical costs avoided and return on investment (ROI), absolute risk reduction of complications, resultant medical costs, and quality-adjusted life-years (QALYs) over 10 years., Results: Base case ICER results indicated that from the clinic perspective, the DIMM clinic costs $21 per additional percentage point of A1c improvement and $115-$164 per additional patient at target A1c goal level compared with the PCP group. From the health system perspective, medical cost avoidance due to improved A1c was $8,793 per DIMM patient versus $3,506 per PCP patient (P = 0.009), resulting in an ROI of $9.01 per dollar spent. From the payer perspective, DIMM patients had estimated lower total medical costs, a greater number of QALYs gained, and appreciable risk reductions for diabetes-related complications over 2-, 5- and 10-year time frames, indicating that the DIMM clinic was dominant. Sensitivity analyses indicated results were robust, and overall conclusions did not change appreciably when key parameters (including DIMM clinic effectiveness and cost) were varied within plausible ranges., Conclusions: The DIMM clinic endocrinologist-pharmacist collaborative practice model, in which the pharmacist spent more time providing personalized care, improved glycemic control at a minimal cost per additional A1c benefit gained and produced greater cost avoidance, appreciable ROI, reduction in long-term complication risk, and lower cost for a greater gain in QALYs. Overall, the DIMM clinic represents an advanced pharmacy practice model with proven clinical and economic benefits from multiple perspectives for patients with T2DM and high medication and comorbidity complexity., Disclosures: No outside funding supported this study. The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Preliminary versions of the study data were presented in abstract form at the American Pharmacists Association Annual Meeting & Exposition; March 27, 2015; San Diego, California, and the Academy of Managed Care Pharmacy Annual Meeting; April 21, 2016; San Francisco, California. Study concept and design were contributed by Hirsch, Bounthavong, and Edelman, along with Morello and Morreale. Arjmand, Ourth, Ha, Cadiz, and Zimmerman collected the data. Data interpretation was performed by Ha, Morreale, and Morello, along with Cadiz, Ourth, and Hirsch. The manuscript was written primarily by Hirsch and Zimmerman, along with Arjamand, Ourth, and Morello, and was revised by Hirsch and Cadiz, along with Bounthavong, Ha, Morreale, and Morello.

Background: Conductive hearing loss due to ossicular abnormalities occurs from many causes, including trauma, infection, cholesteatoma, surgery and congenital anomalies. Surgical reconstruction of the ossicular chain is a well-established procedure for repair of ossicular defects, but is still plagued by high failure rates. Underlying disease and proper sizing of prostheses are two challenges that lead to component failure. Three-dimensional (3D) printing has been used successfully to solve a number of medical prosthesis problems. Custom 3D printing an individualized ossicular prosthesis would be a potential solution for the wide range of anatomic variation encountered in the pathological middle ear, and could decrease the rate of post-operative prosthesis displacement by increasing the likelihood of a proper fit, in addition to decreasing surgical time.In this study, the incus was removed from three formalin-fixed cadaveric human temporal bones with no macro- or microscopic evidence of pathology. Imaging of the cadaveric bone was obtained using a standard temporal bone CT protocol. A custom prosthesis for each cadaveric human temporal bone was designed using the Mimics Innovation Suite software (Materialise, Belgium) and fabricated on a Form2 3D printer (FormLabs, Somerville, Massachusetts). Four surgeons then performed insertion of each prosthesis into each middle ear, blinded to the bone from and for which each was designed. The surgeons were asked to match each prosthesis to its correct parent bone., Results: Each prosthesis had unique measurements. Each of the four surgeons was able to correctly match the prosthesis model to its intended temporal bone. The chances of this occurring randomly are 1:1296., Conclusions: A custom 3D printed ossicular prosthesis is a viable solution for conductive hearing loss due to ossicular chain defects. Commercially available CT scanners can detect significant anatomic differences in normal human middle ear ossicles. These differences can be accurately represented with current 3D printing technology and, more significantly, surgeons can detect these differences., Competing Interests: Included on Title page.This study was subject to University of Maryland, Baltimore IRB review (Re: HP-00070402). Their determination after review was that oversight was not required for this study.Not applicable.The authors (JH and DE) declare a financial competing interest. We are seeking legal protection of our intellectual property and have a patent pending (US Provisional Patent Application Number: 62/490,276).Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Heart failure (HF) hospitalization is associated with multiple medication modifications. These modifications often increase medication regimen complexity and may increase the risk of readmission and/or emergency department (ED) visit., Objectives: To determine the association between changes in medication regimen complexity (MRC) during hospitalization of patients with heart failure and the risk of readmission or ED visit at 90 days. Secondary objectives include examining the association between changes in MRC and time to readmission as well as the relationship between number of medications and MRC., Methods: This was a retrospective cohort study that included U.S. Veterans hospitalized with heart failure. MRC was quantified using the medication regimen complexity index (MRCI). The change in MRCI was the difference between admission MRCI and discharge MRCI recorded during the index hospitalization. Demographic and clinical data were collected to characterize the study population. Patient data for up to one year after discharge was recorded to identify hospital readmissions and ED visits., Results: A total of 174 patients were included in the analysis. Sixty-two patients (36%) were readmitted or had an ED visit at 90 days from the index hospitalization. The mean change (SD) in MRCI during the index hospitalization among the cohort was 4.7 (8.3). After multivariate logistic regression analysis, each unit increase in MRCI score was associated with a 4% lower odds of readmission or ED visit at 90 days but this finding was not statistically significant (OR 0.955; 95% CI 0.911-1.001). In the cox proportional hazard model, the median time to hospital readmission or ED visit was 214 days. Each unit increase in MRCI score was associated with a modest but non-significant increase in probability of survival from readmission or ED visit (HR 0.978; 95% CI 0.955, 1.001)., Conclusion: Changes in medication regimen complexity that occur during hospitalization may also be associated with optimization of medical therapy and do not necessarily portend worse outcomes in patients with HF., (Published by Elsevier Inc.)

Background: No previous studies exist examining the impact of a short-term pharmacist-endocrinologist collaborative practice model on glycemic control in complex patients., Objective: Evaluate outcomes associated with a PharmD-Endocrinologist Diabetes Intense Medical Management (DIMM) "tune up" clinic for complex patients., Methods: A retrospective cohort study of 99 patients referred to DIMM clinic versus a comparator group of 56 primary care provider (PCP) patients meeting the same criteria (adult type 2 diabetes patients, glycosylated hemoglobin [A1C] ≥ 8%, follow-up visit within 6 months) in a Veterans Affairs Medical Center. DIMM clinic used a short-term model that coupled personalized clinical care with real-time, patient-specific diabetes education during two to four 60-minute visits over 6 months. PCP patients received usual care. Primary outcome was mean A1C change after 6 months. Secondary measures included fasting blood glucose, lipids, blood pressure, weight, body mass index, and percentage of patients meeting goals., Results: Patients in each group had an average of 8 and were taking 12 to 14 medications daily. Mean A1C (%) improvement in DIMM group was significantly greater at 6 months (-2.4 [SD = 2.1] vs -0.8 [SD = 1.7]; P < 0.001), than PCP group. Percentage meeting A1C goal levels (<7%, <8%, and <9%) was significantly greater at 3 and 6 months compared with baseline in the DIMM group (P < 0.001) versus (only <8%) at 3 and 6 months compared with baseline in PCP group., Conclusions: The DIMM clinic "tune up" model demonstrates a successful collaborative practice which helped complex diabetes patients achieve glycemic control in a 6-month period., (© The Author(s) 2015.)

The Digital Imaging and Communications in Medicine (DICOM) standard is the universal format for interoperability in medical imaging. In addition to imaging data, DICOM has evolved to support a wide range of imaging metadata including contrast administration data that is readily available from many modern contrast injectors. Contrast agent, route of administration, start and stop time, volume, flow rate, and duration can be recorded using DICOM attributes [1]. While this information is sparsely and inconsistently recorded in routine clinical practice, it could potentially be of significant diagnostic value. This work will describe parameters recorded by automatic contrast injectors, summarize the DICOM mechanisms available for tracking contrast injection data, and discuss the role of such data in clinical radiology.

Background: The extant literature reveals a lack of psychometrically validated tools measuring patient satisfaction with pharmacist clinical services. The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) was developed to address this need using a mixed methods approach., Objective: To assess the psychometric properties of the PSPSQ 2.0, an instrument developed to measure patient satisfaction with clinical services provided by pharmacists., Methods: Validation studies were conducted in two Veterans Affairs (VA)-based and two community-based (diabetes and psychiatric care) disease management/medication therapy management clinics. The PSPSQ 2.0 consisted of 22-items related to three domains identified as quality of care, patient-pharmacist relationship and overall satisfaction using a 4-point, Likert-type scale. It was administered to participants following their session with a pharmacist at the clinics. Collected data were analyzed for descriptive statistics, internal consistency, and validity using exploratory factor analysis., Results: A total of 149 patients completed the survey. Patients from VA clinics were on average 61 years old, mostly white (63%), and predominantly male (95%). Patients from non-VA clinics were on average 47 years old, mostly White (47%) and male (53%). Non-VA patients mostly had Medicaid (42%) and commercial health insurance (31%), whereas VA patients retained benefits with the US Department of Veterans Affairs. Reliability of the scale using internal consistency metrics revealed a Cronbach's alpha of 0.98, 0.98 and 0.95 for VA, diabetes, and psychiatric care clinics, respectively, whereas the Cronbach's alpha for the pooled sample was 0.96. Factor analyses resulted in a three-factor solution accounting for 91% and 69% variance for diabetes and psychiatric care clinics, respectively; however, VA clinics and pooled sample yielded only 2-factor solution with 80% and 66% variance, respectively, with more items loading on patient-pharmacist relationship domain., Conclusions: The results suggest that the PSPSQ 2.0 can serve as a reliable and valid tool for measuring patient satisfaction with pharmacists providing clinical services in VA- and non-VA settings upon further validation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: TV accounts for more than half of pharmaceutical direct-to-consumer advertising (DTCA) spending in the U.S. The purpose of this study is to quantify average household exposure to branded and non-branded (help-seeking) televised prescription drug advertisements and describe variation over time and according to medication indication and geography., Methods: In 2013, Nielsen TV ratings were compiled for prescription pharmaceutical advertising that aired between 2003 and 2011 for the top 75 U.S. media markets. All advertisements were coded as branded or help-seeking. Advertisements were further coded for one of eight prevalent indications (allergies, arthritis, asthma, erectile dysfunction, high cholesterol, smoking cessation, depression, and sleep disorder) or as "other.", Results: Televised DTCA exposure increased from 2003 to 2007 and then declined 43% by 2011, to 111 monthly prescription drug advertisements per household. The examined indications were associated with varying amounts and patterns of exposure, with greatest declines among medications for allergies and sleep disorders. Help-seeking advertisements comprised 10% of total exposure, with substantial variation by indication., Conclusions: Considerations of DTCA's effects on health care should take into account the shifting concentration of advertising across indications., (Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Aim: Canakinumab (CAN), a selective, fully human, anti-IL-1β monoclonal antibody, has demonstrated long-term benefits in gouty arthritis (GA) patients, who have contraindications for, or are unresponsive or intolerant of, non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine (two trials:β-RELIEVED [n = 228]; β-RELIEVED II [n = 226]). The trials collected different responses, including patient-reported outcomes (PRO). A composite response end-point (CRE) was used to interpret each patient's overall response to treatment., Methods: Data from β-RELIEVED trials were pooled for this retrospective analysis. The CRE representing overall change in GA-related health outcomes, from baseline to 12 weeks, included clinical markers; PROs from the Gout Impact Scale (GIS); and the SF-36 bodily pain scale. Response to each variable (i.e. markedly important difference) was determined a priori. Variable values [1 (responder) or 0 (non-responder)] were summed to create a CRE score for each patient., Results: For eight of 12 variables measured, the percentage of CAN responders was significantly greater than for TA (p < 0.05). On average, patients receiving CAN met a higher percentage of response criteria (65%) than patients receiving triamcinolone acetonide (TA) (49%), p < 0.001. Mean CRE scores were significantly higher for CAN vs. TA (mean [SD]; 4.7 [2.7] vs. 3.7 [2.4], p < 0.001). Treatment differences remained even after serially removing individual responder variables and domains from the composite end-point, indicating that the differences between CAN and TA were robust., Conclusion: CAN was superior to TA across multiple health-outcome variables comprising clinical markers and PRO over 12 weeks in patients contraindicated, intolerant or unresponsive to NSAIDs and/or colchicine., (© 2014 John Wiley & Sons Ltd.)

Purpose: Polypharmacy and medication adherence are well known challenges facing older adults. Medication regimen complexity increases the demands of self-care in the home. Some medication regimens may be more complex than others, especially when dosage form, frequency of dosing, and additional usage directions are included in complexity along with the number of medications In older adults with depression, it is unknown what features of their medications most influence their medication regimen complexity., Methods: A sample cohort of 100 adults ≥65 years old with a diagnosis of depression was randomly selected from electronic medical records (EMR) in ambulatory clinics at the University of Colorado (CU) and University of San Diego (SD). Demographic, medical history, and medication-related information was extracted from the EMR. Complexity was determined using the Medication Regimen Complexity Index (MRCI). IRB approval was obtained., Findings: The cohort mean age was 74.3 years (SD) and 79.7 years (CU). The mean unweighted Charlson comorbidity index for 1.0 (SD) and 1.8 (CU). The mean number of medications was 7.1 and 8.0, with 1.1 and 1.2 depression meds, 5.4 and 4.3 non-depression prescription meds, and 0.6 and 2.4 OTC meds for the SD and CU cohorts, respectively. 66% of SD adults and 70% of CU adults took six or more meds. Individual MRCI scores were on average 17.62 (SD) and 19.36 (CU). Dosing frequency contributed to 57-58% of the MRCI score, with patients facing an average of 7-8 unique dosing frequencies in their regimen. In both cohorts, there was an average of 3 additional directions added to the regimens to clarify dosing., Implications: As expected, in our older adult cohorts with depression the majority of patients took multiple medications. Using a standardized instrument, we characterized the regimen complexity and found that it was increasingly complex due to numerous dosing forms, frequencies and additional directions for use. Patient-level medication regimen complexity should go beyond depression medication to encompass the patient's entire regimen for opportunities to reduce complexity and improve ease of self-care., (Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.)

Purpose: A collaborative pharmacist-primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensive patients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic., Methods: This randomized, pragmatic clinical trial was conducted in hypertensive patients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥ 18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥ 140/≥ 90 mm Hg (≥ 130/≥ 80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol., Findings: A total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (-7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (-5.2 [16.9] vs -1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001)., Implications: A PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556., (Published by Elsevier Inc.)

Background: Patients with HIV often have multiple medications besides antiretrovirals (ARV). Medication regimen complexity-formulations, dosing frequencies, and additional directions-expands pill burden by considering self-care demands. Studies show an inverse association between ARV adherence and medication complexity for ARVs only. Patient-level medication regimen complexity beyond ARV complexity is unknown., Objective: To measure and characterize Patient-level Medication Regimen Complexity Index (pMRCI) and Antiretroviral Medication Regimen Complexity Index (ARCI) for patients in 2 HIV clinics. We hypothesized that an all-medication complexity metric will exceed disease-state-defined complexity metrics; for ARVs only, the pMRCI score will be smaller than the ARCI score by capturing fewer features of regimens. Associations between complexity and adherence were not assessed., Method: Electronic records supplied a retrospective, random sample of adult patients with HIV; medication lists were used to code the pMRCI (n=200). A random subsample (n=66) was coded using ARCI for ARV regimens only., Result: Medication counts ranged from 1 to 27; pMRCI scores ranged from 2 to 67.5. ARVs contributed roughly 25% to the pMRCI; other prescriptions contributed about 66%. Dosing frequency made the largest contribution of all components (62%) to the pMRCI. For ARVs, pMRCI and ARCI scores did not differ statistically., Conclusion: Unique dosing frequencies raised complexity and may provide opportunities for intervention. Other prescriptions drove pMRCI scores, suggesting that HIV management programs should review all medications. A patient-level approach added value to understanding the role of medications in patient complexity; future work can assess association of pMRCI with adherence and patient outcomes., (© The Author(s) 2014.)

Background: The Medication Regimen Complexity Index (MRCI) is a 65-item instrument that can be used to quantify medication regimen complexity at the patient level, capturing all prescribed and over-the-counter medications. Although the MRCI has been used in several studies, the narrow scope of the initial validation limits application at a population or clinical practice level., Purpose: To conduct a MRCI validation pertinent to the desired clinical use to identify patients for medication therapy management interventions., Methods: An expert panel of clinical pharmacists ranked medication regimen complexity for two samples of cases: a single-disease cohort (diabetes mellitus) and a multiple-disease cohort (diabetes mellitus, hypertension, human immunodeficiency virus infection, geriatric depression). Cases for expert panel review were selected from 400 ambulatory clinic patients, and each case description included data that were available via claims or electronic medical records (EMRs). Construct validity was assessed using patient-level MRCI scores, medication count, and additional patient data. Concordance was evaluated using weighted κ agreement statistic, and correlations were determined using Spearman rank-order correlation coefficient (ρ) or Kendall τ., Results: Moderate to good concordance between patient-level MRCI scores and expert medication regimen complexity ranking was observed (claims data, consensus ranking: single-disease cohort 0.55, multiple disease cohort 0.63). In contrast, only fair to moderate concordance was observed for medication count (single-disease cohort 0.33, multiple-disease cohort 0.48). Adding more-detailed administration directions from EMR data did not improve concordance. MRCI convergent validity was supported by strong correlations with medication count (all cohorts 0.90) and moderate correlations with morbidity measures (e.g., all cohorts; number of comorbidities 0.46, Chronic Disease Score 0.46). Nonsignificant correlation of MRCI scores with age and gender (all cohorts 0.08 and 0.06, respectively) supported MRCI divergent validity., Limitations: This study used cross-sectional, retrospective patient data for a small number of patients and clinical pharmacists from only two universities; therefore, results may have limited generalizability., Conclusions: The patient-level MRCI is a valid tool for assessing medication regimen complexity that can be applied by using data commonly found in claims and EMR databases and could be useful to identify patients who may benefit from medication therapy management., (© 2014 The Authors Pharmacotherapy published by Wiley Periodicals, Inc. on behalf of Pharmacotherapy Publications, Inc.)

Objective: To introduce a teaching tool that can be used to assess the complexity of medication therapy management (MTM) patients, prioritize appropriate interventions, and design patient-centered care plans for each encounter., Summary: MTM patients are complex as a result of multiple comorbidities, medications, and socioeconomic and behavioral issues. Pharmacists who provide MTM services are required to synthesize a plethora of information (medical and nonmedical), evaluate and prioritize the clinical problems, and design a comprehensive patient-centered care plan. The MTM Spider Web is a visual tool to facilitate this process. A description is provided regarding how to build the MTM Spider Web using case-based scenarios. This model can be used to teach pharmacists, health professional students, and patients., Conclusion: The MTM Spider Web is an innovative teaching tool that can be used to teach pharmacists and students how to assess complex patients and design a patient-centered care plan to deliver the most appropriate medication therapy.

Objectives: To compare medication regimen complexity (MRC) for patients with uncontrolled hypertension, uncontrolled diabetes, or both, to examine the contribution of complexity components (dosage form, frequency, additional directions) to total MRC index (MRCI) score, and to explore the relationship of MRC with patient characteristics and medication regimen cost., Methods: This cross-sectional retrospective study used electronic medical record data for patients' most recent visit to a university internal medicine clinic during 2009. MRCI scores (disease specific and patient level [medications for all conditions]) were calculated for adults with uncontrolled hypertension, diabetes, or both (i.e., not at recommended treatment goals)., Results: 206 patients (85 with hypertension, 60 with diabetes, and 61 with both) were included. The median (range) disease-specific MRCI was significantly greater for diabetes (8.0 [3-21]) than for hypertension (3.0 [2-11], P < 0.001), though the median number of disease-specific medications was identical (2). The majority of hypertension MRC was the result of dosage frequency (62.1%), while diabetes MRC was distributed among dosage form (38.3%), frequency (39.1%), and additional directions (27.6%). The median patient-level MRCI scores for each group were 11 to 15 points higher than the disease-specific MRCI scores. Higher MRCI scores were associated with higher regimen cost, comorbidity burden, and female gender., Conclusion: The magnitude of MRCI scores varied across the three disease groups, increased dramatically when all medications were considered, and revealed greater complexity than a simple count of prescribed medications. The MRCI may be a useful tool for targeting patients for whom medication therapy management services would be most beneficial and cost effective.

Background: Expected treatment effectiveness from medications can be diminished due to suboptimal adherence. Medication nonadherence has been linked to pill burden from the quantity of medications; however, medication regimens with similar quantities of medications vary in complexity due to multiple dosage forms, frequency of dosing, and additional usage directions. Thus, a simple medication count ignores medication regimen complexity, especially as it pertains to a patient-level perspective that includes prescription and over-the-counter medications. A gap exists in the study of a patient-level medication regimen complexity metric across disease-specific populations., Objective: The goal of this study was to implement the quantitative Medication Regimen Complexity Index (MRCI) at the patient level in defined populations with chronic disease (geriatric depression, HIV, diabetes mellitus, and hypertension). Patient-level medication regimen complexity included all prescribed medications and over-the-counter medications documented in the electronic medication list., Methods: Using electronic medical records at the University of Colorado Hospital ambulatory clinics, we sampled 4 retrospective cohorts of adult patients in active care in 2011 with a qualifying medical diagnosis and prescribed disease-specific medication. Samples were randomly selected from all qualifying patients; de-identified information was coded using the MRCI., Results: Cohort-defining disease-specific prescription medications (eg, antidepressants for the depression-defined cohort) contributed <20% to the total patient-level complexity MRCI score; the MRCI score was dominated by complexity associated with all other prescription medications. Within disease-specific cohorts, MRCI scores differentiated patients with the highest and lowest medication counts, comorbidity counts, and the Charlson comorbidity index scores. For example, geriatric depression patients had a highest quartile mean MRCI score of 41 and a lowest quartile mean MRCI score of 13. Between disease-specific cohorts, high and low MRCI scores differed because each cohort had its own MRCI ranges. For example, highest quartile MRCI scores varied from a mean MRCI score of 41 (geriatric depression) to 30 (hypertension); lowest quartile scores ranged from a mean MRCI score of 7 (hypertension and HIV) to 13 (geriatric depression)., Conclusions: MRCI components of dosing frequency and prescribed medications outside of the cohort-defining disease medications contributed the most to the patient-level scores. Thus, chronic disease management programs may want to consider all medications that patients are taking and examine ways to reduce complexity, such as reducing multiple dosing frequencies when possible. MRCI scores differentiated high and low patient-level complexity measures, representing possible utility as a prospective tool to identify target patients for intervention. Future work includes simplifying the MRCI and enhancing the scores with medication risk factors, as well as explicitly linking to adherence and health services., (Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.)

Background: In recent years waterpipe smoking has become a popular practice amongst young adults in eastern Mediterranean countries, including Iran. The aim of this study was to assess waterpipe smoking perceptions and practices among first-year health sciences university students in Iran and to identify factors associated with the initiation and maintenance of waterpipe use in this population., Results: Out of 371 first-year health sciences students surveyed, 358 eight students completed a self-administered questionnaire in the classrooms describing their use and perceptions towards waterpipe smoking. Two hundred and ninety six responders met study inclusion criteria. Waterpipe smoking was common among first-year health sciences university students, with 51% of students indicating they were current waterpipe smokers. Women were smoking waterpipes almost as frequently as men (48% versus 52%, respectively). The majority of waterpipe smokers (75.5%) indicated that the fun and social aspect of waterpipe use was the main motivating factor for them to continue smoking. Of waterpipe smokers, 55.3% were occasional smokers, using waterpipes once a month or less, while 44.7% were frequent smokers, using waterpipes more than once a month. A large number of frequent waterpipe smokers perceived that waterpipe smoking was a healthier way to use tobacco (40.6%) while only 20.6% thought it was addictive. Compared to occasional smokers, significantly more frequent smokers reported waterpipe smoking was relaxing (62.5% vs. 26.2%, p = 0.002), energizing (48.5% vs. 11.4%, p = 0.001), a part of their culture (58.8% vs. 34.1%, p = 0.04), and the healthiest way to use tobacco (40.6% vs. 11.1%, p = 0.005)., Conclusions: Social and recreational use of waterpipes is widespread among first-year health sciences university students in Iran. Women and men were almost equally likely to be current waterpipe users. Public health initiatives to combat the increasing use of waterpipes among university students in Iran must consider the equal gender distribution and its perception by many waterpipe smokers as being a healthier and non-addictive way to use tobacco.

Objective: The Gout Impact Scale (GIS) is a gout-specific quality of life instrument that assesses impact of gout during an attack and impact of overall gout. The GIS has five scales and each is scored from 0 to 100 (worse health). Our objective was to assess minimally important differences (MIDs) for the GIS administered in a randomized controlled trial (RCT) assessing rilonacept vs placebo for prevention of gout flares during initiation of allopurinol therapy., Methods: Trial subjects (n = 83) included those with two or more gout flares (self-reported) in the past year. Of these, 73 had data for Weeks 8 vs 4 and formed the MID analysis group and were analysed irrespective of the treatment assignment. Subjects completed the GIS and seven patient-reported anchors. Subjects with a one-step change (e.g. from very poor to poor) were considered as the MID group for each anchor. The mean change in GIS scores and effect size (ES) was calculated for each anchor's MID group. The average of these created the overall summary MID statistics for each GIS. An ES of 0.2-0.5 was considered to represent MID estimates. Results. Trial subjects (n = 73) were males (96.0%), White (90.4%), with mean age of 50.5 years and serum uric acid of 9.0 mg/dl. The mean change score for the MID improvement group for scales ranged from -5.24 to -7.61 (0-100 scale). The ES for the MID improvement group for the four scales ranged from 0.22 to 0.38., Conclusion: The MID estimates for GIS scales are between 5 and 8 points (0-100 scale). This information can aid in interpreting the GIS results in future gout RCTs. Trial Registration. Clinicaltrials.gov, www.clinicaltrials.gov, NCT00610363.

Objective: To study health care utilization patterns in patients with gout., Methods: In a gout population from primary care and rheumatology clinics in 3 U.S. metropolitan cities, we collected data on gout-related utilization (primary care, rheumatology, urgent care, emergency room, and other) in the past year. We evaluated the association of comorbidities, age, gender, gout characteristics (time since last gout attack and tophi), and gout severity ratings (mean of serum uric acid, patient-rated, and physician-rated gout severity) and with emergency/urgent care and primary care utilization using regression and correlation analyses., Results: Of the 296 patients who reported visiting at least 1 type of health practitioner for gout in the past year, the percentage of patients utilizing the service at least once and annual utilization rates among utilizers were as follows: primary care physician, 60%, 3.0 ± 3.4; nurse practitioner/physician assistant, 26%, 2.7 ± 2.5; rheumatologist, 51%, 3.7 ± 5.7; urgent care, 23%, 2.1 ± 2.2; emergency room, 20%, 2.0 ± 1.7; and hospitalization, 7%, 2.1 ± 1.4. Higher overall gout severity was associated with greater use of each resource type and with overall gout-related utilization. Nonemergency/nonurgent care utilization (primary care physician, nurse practitioner, physician's assistant, and rheumatologist for gout) was the strongest predictor of gout-related emergency/urgent care utilization. Patients with more comorbidities had greater gout-related primary care utilization., Conclusions: Overall gout severity was associated with all types of gout-related utilization. This may help to screen high utilizers for targeted behavioral and therapeutic interventions. Having a higher number of comorbid conditions was a risk factor for higher gout-related primary care utilization., (Published by Elsevier Inc.)

Background: The types of pharmacist-provided medication therapy management (MTM) services provided to patients with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and the effects of MTM on medication adherence and patient outcomes have only recently begun to be studied. Although available studies suggest that patients receiving MTM services have better antiretroviral therapy (ART) adherence and outcomes, only 1 study has examined a large group of patients with HIV/AIDS, and none has examined adherence or outcomes for more than 1 year. A pilot program conducted by the California Department of Health Care Services (DHCS) and Medi-Cal (California's Medicaid program) provided an opportunity to examine ART adherence and outcomes in a large patient population receiving MTM services in community pharmacies over 3 years., Objectives: To examine an HIV/AIDS pharmacy MTM compensation pilot program over a 3-year period (2005- 2007) in a sample of Medi-Cal beneficiaries by describing the associations between use of pilot pharmacies and (a) adherence to ART regimens; (b) medication utilization, including number and type of ART medication regimens and use of contraindicated ART regimens; (c) occurrence of opportunistic infections; and (d) all-cause pharmacy and medical costs., Methods: This was a cohort study examining Medi-Cal pharmacy and medical claims data (2005-2007) for patients with HIV/AIDS who were served by pilot pharmacies versus other (nonpilot) pharmacies. The study groups, pilot and nonpilot pharmacy patients with HIV/AIDS, consisted of Medi-Cal beneficiaries aged 18 years or older as of January 1, 2005, who were continuously enrolled from January 1, 2004, through December 31, 2007, and who received both a diagnosis of HIV/AIDS and at least 1 ART pharmacy claim during both the index period (2004) and the study period (January 1, 2005, through December 31, 2007). Pilot pharmacy patients were identified as having filled 50% or more of their ART prescriptions each year at 1 of the 10 pilot pharmacies. Patients for whom comprehensive medication data were not available, including those enrolled in managed care plans and/or Medicare, were excluded. Adherence was defined as a medication possession ratio (MPR) of 80%-120% and excess medication fills as MPR greater than 120%. Logistic regression was used to investigate the factors associated with adherence. Comparisons were made between groups using bivariate statistics (Pearson chi-square for categorical variables and t-tests for continuous variables). For comparisons of costs, generalized linear models were used including predictor variables for age, gender, and race/ethnicity. RESEARCH RESULTS: The study sample consisted of 2,234 patients meeting the study inclusion criteria. The proportion of study patients receiving the majority of their prescription medications (ART plus non-ART) at pilot pharmacies was 19.7% in 2005 and increased to 27.6% in 2006 and 28.1% in 2007. The demographic profile of pilot pharmacy patients was similar to that of patients receiving medications at nonpilot pharmacies, except that pilot pharmacies had a higher proportion of Latino patients (e.g., 19.7% vs. 14.9% in 2007, respectively, P = 0.006). A greater percentage of pilot than nonpilot pharmacy patients were adherent to their ART medication regimens (e.g., 2007: 69.4% vs. 47.3%, respectively, P < 0.001). After controlling for age, gender, and ethnicity/race in logistic regression analysis, use of a pilot pharmacy (odds ratio [OR] = 2.74, 95% CI = 2.44-3.10) was the most important factor associated with likelihood of adherence. Each year, pilot pharmacy patients were more likely than nonpilot pharmacy patients to remain on a single type of ART regimen (e.g., 2007: 71.7% vs. 49.1%, respectively, P < 0.001) and less likely to have excess fills (e.g., 2007: 12.9% vs. 35.5%, respectively, P < 0.001) and to use contraindicated regimens (e.g., 2007: 8.9% vs. 12.2%, respectively, P = 0.027). The percentages of patients experiencing opportunistic infections were similar between groups each year, approximately 35% (P = 0.809-0.945). In the generalized linear model analyses, the between-group differences in predicted mean (standard error [SE]) total health care costs per patient were not significantly different in any year (e.g., 2007: $38,983 [$1,023] vs. $38,856 [$633], respectively, P = 0.915). In each year, predicted non- ART medication costs were approximately 30%-40% greater in the pilot pharmacy than nonpilot pharmacy group (e.g., 2007: $10,815 [$538] vs. $8,190 [$252], respectively, P < 0.001); however, predicted expenditures for inpatient services were significantly lower (e.g., 2007: $3,083 [$293] vs. $5,186 [$300], respectively, P < 0.001). Payment from the DHCS Medi-Cal program for MTM services was approximately $1,000 per pilot pharmacy patient per year., Conclusions: Over a 3-year period, patients at pilot pharmacies consistently had higher medication adherence rates, were more likely to remain on a single type of ART regimen throughout the year, had fewer excess fills, and used fewer contraindicated regimens than nonpilot pharmacy patients. There were no significant differences in mean total cost per patient per group, and the additional MTM services payment added less than 3% to the total cost.

Background: Published studies assessing specific methods that patients with diabetes and their caregivers perceive as helpful means of increasing medication adherence are lacking., Objective: To determine methods that patients with diabetes and their caregivers have used to improve medication adherence, investigate the perceived helpfulness of these methods, and identify motivating factors and medication characteristics that may positively influence adherence., Methods: A cross-sectional survey was distributed to patients with diabetes and caregivers of patients with diabetes at the 11th annual Taking Control of Your Diabetes conference in October 2005 at the San Diego Convention Center. Outcome measures were self-reported medication adherence, perceived helpfulness of methods employed to improve adherence, motivating factors that may improve adherence, and medication characteristics that may improve adherence., Results: A total of 524 (40.5% response rate) questionnaires were included in the final analysis, 357 from patients with diabetes and 167 from caregivers. Taking medications as part of a daily routine and using pill boxes were the most frequently reported helpful methods for improving medication adherence. The 3 motivating factors most commonly identified as improving medication adherence were: knowing that diabetes medications work effectively to lower blood glucose, knowing how to manage medication adverse effects, and understanding medication benefits. Many participants thought that newer injectable diabetes medications resulting in weight loss or no additional blood glucose monitoring would be helpful in optimizing adherence., Conclusions: Participants in this study identified medication education as a key factor in improving adherence. To empower patients to overcome medication adherence barriers, pharmacists could perform more proactive and thorough counseling sessions that include education on indication, mechanism of action, and therapeutic effects of drugs. They could recommend that patients take medications concurrently with a daily routine and use a pill box, as these actions were reported to be likely to improve medication adherence. However, our results also remind us that motivating factors and tools that may improve adherence may be very patient specific and that pharmacists should incorporate an assessment of this variance in their counseling sessions., (© 2011 SAGE Publications.)