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Diabetes is a complex, chronic medical condition affecting 29.1 million people in the United States (9.3% of the population) and is projected to affect one in three Americans by 2050 if the current trend continues (1). Diabetes management can be challenging, often requiring multiple therapeutic agents as the disease progresses. Current guidelines recommend metformin as first-line pharmacological therapy for the treatment of type 2 diabetes. Multiple second-line options are available for patients whose A1C goal is not achieved with monotherapy, and selection should be based on patient- and drug-specific factors. Sodium–glucose cotransporter 2 (SGLT2) inhibitors, the newest U.S. Food and Drug Administration (FDA)–approved oral antidiabetic agents, are among these options for patients with type 2 diabetes. Canagliflozin, dapagliflozin, and empagliflozin are the currently available SGLT2 inhibitors in the United States (2,3). Sodium–glucose cotransporter 1 (SGLT1) is predominantly located in the small intestine, but is also expressed in the kidneys, trachea, heart, and colon (4,5). In the kidneys, SGLT1 is primarily located in the S3 segment of the proximal convoluted tubule (PCT) (4). SGLT2 is expressed in the kidneys and primarily located in the S1 and S2 segments of the PCT (4,5). In normoglycemic adults, about 180 g of glucose (Figure 1) is filtered per day in the glomerulus, and most is reabsorbed (4,6). In people with diabetes, reabsorption of glucose is increased compared to people without diabetes (7,8). SGLT1 and SGLT2 are located in the apical membrane and facilitate the transport of glucose with sodium from the renal tubular lumen into the cells (Figure 2) (4). FIGURE 1. Structures of glucose, phlorizin, canagliflozin, dapagliflozin, and empagliflozin. FIGURE 2. Cotransport of glucose and sodium by SGLT1 and SGLT2 in the PCT. Phlorizin (Figure 1), an O -glucose derivative/ O -glycoside, was discovered in …

Latent autoimmune diabetes in adults (LADA) is considered a subgroup of type 1 diabetes and is often misdiagnosed because of a lack of both awareness and standardized diagnostic criteria (1–3). LADA is characterized by adult-onset diabetes and circulating autoimmune antibodies; thus, patients may present clinically with characteristics of both type 1 and type 2 diabetes (2–5). Typically, the clinical features of type 1 diabetes seen in LADA include a lower BMI compared to what is typical in type 2 diabetes and autoimmunity against one or more of the following antibodies: islet cell autoantibodies (ICA), autoantibodies to glutamic acid decarboxylase (GAD), tyrosine phosphatase–related islet antigen 2 (IA-2), and insulin autoantibodies (IAA) (4,5). The characteristics of type 2 diabetes that may present in LADA include older age at onset and insulin resistance or deficiency. Characteristics of LADA tend to include an intermediate level of β-cell dysfunction between those in type 1 and type 2 diabetes, faster decline of C-peptide compared to type 2 diabetes, and a level of insulin resistance that is comparable to type 1 diabetes (4). β-Cell decline is variable in LADA, as measured by C-peptide levels (5–7). Although it has a closer pathophysiological relationship to type 1 diabetes, LADA is often misdiagnosed and treated as type 2 diabetes (2–5). This results in insufficient glycemic control and harm to patients. It is imperative to establish distinct practice guidelines for the diagnosis and treatment of LADA and for providers to recognize this clinical scenario as one that requires special testing to establish a proper diagnosis and thus improve patient safety and treatment efficacy. The similarities between type 1 diabetes, type 2 diabetes, and LADA can make diagnosis difficult (Table 1). There are, however, other characteristics for this population that may …

Idarucizumab (Praxbind), a humanized monoclonal antibody fragment was granted accelerated approval from the Food and Drug Administration in October 2015 as the first agent to reverse the effects of a novel oral anticoagulant. The drug is indicated for dabigatran reversal in patients requiring emergency surgery/urgent procedures or with life-threatening or uncontrolled bleeding. In a randomized study with healthy volunteers, compared with placebo, idarucizumab reduced the clotting times for all tests assays (assessed pre-, end of-, and 24 hours after infusion), while the results for the placebo group remained unchanged. Another randomized clinical trial assessed the safety and efficacy of idarucizumab in patients with either overt bleeding or undergoing emergency surgery where hemostasis was required. This study is ongoing, but preliminary results showed reversal efficacy demonstrated a reasonable safety profile from the time of the infusion to 90 days after. The wholesale acquisition cost of two 2.5 g vials of idarucizumab is currently $3482.50. To treat 10 or 20 patients per year with a single 5 g dose is estimated to cost $34,825 and $69,650, respectively. In the clinical trial described above, approximately 20% of patients required a second dose, which would further increase the cost of use. In this formulary review for a health system's pharmacy and therapeutics committee, idarucizumab clinical trials and medication package insert were summarized and, after consulting with clinical experts from our institutions, practical recommendations for use were generated to ensure appropriate and safe use of this agent.

In recent years, comparative effectiveness tools and methods have evolved to assist health care decision makers in identifying optimal therapies. In-person training programs on comparative effectiveness research may be helpful in understanding and applying this information.To provide a follow-up assessment of the use of comparative effectiveness research (CER) in the pharmacy and therapeutics (PT) committee decision-making process, using information collected from participants 1 year after attending a live continuing education program, in which participants were taught about CER designs and how to access available CER resources through the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care (EHC) Program.A retrospective, cross-sectional questionnaire was developed and mailed to 2 groups of individuals: CER workshop attendees and interested nonattendees (expressing an interest in attending a workshop but did not attend for unknown reasons). The questionnaire asked respondents to indicate personal and organizational use of CER in the decision-making process. Participants were asked to indicate whether their knowledge, ability, and use of CER studies increased since participating in the program. Data were analyzed using nonparametric tests to compare the responses of attendees and nonattendees, as well as overall reliability of the instrument.A total of 164 respondents completed the questionnaire (63 attendees and 101 nonattendees; overall response rate = 44%). The majority of respondents were pharmacists (n = 157, 95.7%) and were affiliated with a hospital (n = 106, 64.6%). Proportions of attendees and nonattendees differed significantly in the use of EHC research reviews/reports (45% and 28%, respectively; P = 0.02) and EHC executive summaries of research reviews/reports (48% and 29%, respectively; P = 0.01). At 1-year follow-up, the majority of attendees reported an increase ("somewhat" or "very much") in knowledge of CER (91.5%), ability to use CER (83.0%), and use of CER studies (58.7%).Health professionals attending a continuing education CER program reported higher use of EHC CER materials compared with nonattendees. Additionally, attendees reported increased use of CER in clinical decision making. A continuing education program such as this may provide an effective avenue for introducing CER methods and resources to the PT committee and clinical decision-making processes.This project was supported by grant number R18HS019220 from the Agency of Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency of Healthcare Research and Quality. Augustine has stock in Pfizer. The authors declared no other potential conflicts of interest associated with this study. Study concept and design were primarily contributed by Malone, along with Warholak, Hines, Brown, Hurwitz, and Taylor. Warholak, Hines, Brown, Hurwitz, and Taylor collected the data, assisted by Malone, Brixner, Cobaugh, and Schlaifer. Data interpretation was performed by Malone and Augustine, with assistance from the other authors. The manuscript was written primarily by Augustine, with assistance from Malone, Sun, Warholak, Hines, Brown, Hurwitz, and Taylor. Malone revised the manuscript, assisted by Warholak, Hines, Brown, Hurwitz, Taylor, Brixner, Cobaugh, and Schlaifer.

Underserved Hispanic patients are particularly vulnerable to problems associated with controlling diabetes. Hispanics not only are more susceptible to developing diabetes, but also have higher A1C values (1) and more severe diabetes-related complications. Hispanic Americans are 2.6 times more likely to start treatment for diabetes-related end-stage renal disease and have a 50% higher mortality rate than non-Hispanic whites (2). According to the Hispanic Community Health Study/Study of Latinos, the prevalence of diabetes in the United States is 10.2% in South Americans, 13.4% in Cubans, 17.7% in Central Americans, 18% in Puerto Ricans and Dominicans, and 18.3% in Mexicans (3). Total yearly costs in 2010 for Hispanics with diabetes totaled $49.8 billion and are estimated to reach $109.9 billion in 2025 because of an expected 111% increase in diabetes cases (4). Many diabetes patients, including Hispanics, are overwhelmed by the high treatment burden of self-care demands (5). A retail pharmacy survey of individuals in five states found that many individuals with diabetes lack a focused management plan and may also be confused about specific health care issues (6). One particular obstacle is nonadherence to diabetes treatments. Hispanic patients have exhibited nonadherence behaviors related to their diabetes treatment, including medication nonadherence (7,8). Nonadherence is very costly (9), and savings of $5 billion annually are possible with improved medication adherence on the part of non-Hispanic and Hispanic patients alike. This could result in 341,000 fewer hospitalizations and 700,000 fewer emergency room visits (10). One tactic to mitigate nonadherence has been to involve pharmacists in diabetes management, particularly in primary care settings, where diabetes is a common diagnosis (11). Studies demonstrating the benefit of pharmacists in diabetes care and of their expertise in medication management highlight their importance as interdisciplinary team members (12–17). Including pharmacists in team-based …

You are the consulting physiatrist of a busy surgical intensive care unit (ICU) at a large, urban academic medical center. You are part of a Pharmacy and Therapeutics Ad Hoc Subcommittee charged with exploring all “routineeper protocol” use of medications in the ICU. Your charge is to critically assess these types of medications from the perspective of both safety and expense. One of the categories the Subcommittee is charged with reviewing is the routine use of seizure prophylaxis in the first week after traumatic brain injury (TBI). Data provided by the finance department have indicated that there has been a steady trend during the past 3 years to use levetiracetam rather than phenytoin as the prophylactic agent of choice in the first days to weeks after TBI. The financial ramification of this trend has been significant, to the magnitude of $100,000 annually. The chief of trauma surgery and chair of neurosurgery are completely comfortable in designating the less expensive phenytoin as the prophylactic drug of choice in the ICU, citing little evidence base for the use of levetiracetam as a prophylactic agent in persons with TBI. You voice your opposition to the return to phenytoin based on reasonable animal and clinical evidence of a detrimental impact on neurologic recovery. The pharmacist-in-chief for the hospital reminds you that this year’s budget is extremely tight and the potential cost saving of designating phenytoin as the drug of choice is quite significant. Consequently, it will take a great deal of convincing for the chief medical officer to support anything other than a whole-scale return to the use of phenytoin. Much to the surprise of the entire group, the chief of the epilepsy service suggests that the hospital use neither agent and abandon entirely the policy of routine early seizure prophylaxis after TBI. Although the group is surprised by this suggestion, they agree to consider it and table a vote until the next meeting in a week. You spend some time exploring your position on this suggestion. After your research, what position do you take regarding a new hospital policy stating that seizure prophylaxis is not required in the first week after a TBI? Dr Monica Verduzco-Gutierrez will argue that early seizure prophylaxis should be administered after a TBI. Dr Cara Camiolo Reddy will take the position that the use of antiepileptic agents for prevention of early seizures after TBI is not warranted.

Diabetes has been increasing in prevalence over the years, and nearly 30 million Americans (9.3%) now have diabetes (1). This disease burden on the population also translates to increased prevalence rates of diabetes complications. Diabetes is associated with several eye complications, including cataracts and glaucoma (2). However, the most common eye disorder associated with diabetes is diabetic retinopathy (DR), which is the leading cause of blindness among U.S. adults (2,3). During the 2005–2008 time period, >4 million adults ≥40 years of age with diabetes had retinopathy, including diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR), which can lead to vision loss (1). The management of systemic disorders is vital to preventing diabetic eye complications (4). Specifically, the management of diabetes, hypertension, and hyperlipidemia has been associated with reduced or delayed onset and progression of DR (5–11). However, even with adequate control of these metabolic conditions, people with diabetes may still be at risk for developing retinopathy. Adequate eye screening is therefore important for the early detection and treatment of visual complications (4). Screening recommendations call for a dilated, comprehensive eye examination within 5 years after diabetes diagnosis for people with type 1 diabetes and immediately after diagnosis for those with type 2 diabetes (12). Laser therapy has been the mainstay of treatment for DR and DME. Primarily, laser photocoagulation treatment has been used to prevent vision loss and to delay progression of retinopathy (13). The associated adverse effects of laser therapy, including night and peripheral vision loss, are generally preferred to eventual blindness. When laser treatment is not feasible, vitreous surgery becomes an option and has been shown to be beneficial for PDR and DME (4). Research has supported the intravitreal administration of steroids, whose anti-inflammatory and antiangiogenic effects are beneficial in …

There are 29.1 million people in the United States living with diabetes (1). Except in cases with contraindications, annual influenza vaccination is recommended for all people with diabetes to reduce morbidity, mortality, and health care costs associated with influenza illness (2,3). There were 12 influenza vaccines available for the 2016–2017 influenza season. These vaccines were categorized into inactivated or live, quadrivalent or trivalent, and high-dose or standard-dose formulations (2). Common adverse reactions of pain, soreness, fever, muscle aches, fatigue, redness, or swelling may occur after intramuscular vaccine administration (4). Hyperglycemia is not noted as an adverse reaction in vaccine package inserts; however, reports of its occurrence have been documented in the Vaccine Adverse Event Reporting System (VAERS) (5). Since 1991, there have been 946 reports of hyperglycemia with all available vaccines and 361 reports of hyperglycemia with all types of influenza vaccines. When looking specifically at the trivalent influenza vaccine, there have been 235 reported cases, with 70.6% reported during the first 4 days after vaccine administration (5). In light of these reports, a literature search was performed to obtain more information about acute hyperglycemia after vaccine administration. The search was performed with the advanced search option in PubMed using the terms "hyperglycemia,” “blood sugar,” “blood glucose,” “vaccines,” “influenza vaccine,” “diabetes,” and “immunizations.” The search failed to yield any literature reports specifically related to blood glucose …

Background Managing prescription renewal requests is a labor-intensive challenge in ambulatory care. In 2009, Vanderbilt University Medical Center developed clinic-specific standing prescription renewal orders that allowed nurses, under specific conditions, to authorize renewal requests. Formulary and authorization changes made maintaining these documents very challenging. Objective This article aims to review, standardize, and restructure legacy standing prescription renewal orders into a modular, scalable, and easier to manage format for conversion and use in a new electronic health record (EHR). Methods We created an enterprise-wide renewal domain model using modular subgroups within the main institutional standing renewal order policy by extracting metadata, medication group names, medication ingredient names, and renewal criteria from approved legacy standing renewal orders. Instance-based matching compared medication groups in a pairwise manner to calculate a similarity score between medication groups. We grouped and standardized medication groups with high similarity by mapping them to medication classes from a medication terminology vendor and filtering them by intended route (e.g., oral, subcutaneous, inhalation). After standardizing the renewal criteria to a short list of reusable criteria, the Pharmacy and Therapeutics (P&T) committee reviewed and approved candidate medication groups and corresponding renewal criteria. Results Seventy-eight legacy standing prescription renewal orders covered 135 clinics (some applied to multiple clinics). Several standing orders were perfectly congruent, listing identical medications for renewal. We consolidated 870 distinct medication classes to 164 subgroups and assigned renewal criteria. We consolidated 379 distinct legacy renewal criteria to 21 criteria. After approval by the P&T committee, we built subgroups in a structured and consistent format in the new EHR, where they facilitated chart review and standing order adherence by nurses. Additionally, clinicians could search an autogenerated document of the standing order content from the EHR data warehouse. Conclusion We describe a methodology for standardizing and scaling standing prescription renewal orders at an enterprise level while transitioning to a new EHR.

Pharmacy and Therapeutics (P&T) Committees manage programs that provide patients with effective, safe, and financially sound medication treatments. Despite their importance, little research exists into what committee characteristics lead to adoption of its decisions by prescribers. Considered as “teams”, research from the management literature and a qualitative study identified a theoretical model of P&T Committee performance that includes five concepts and a set of four outcome measures. The study aims were to: (1) Describe the variance in P&T Committee functioning and performance in the United States, (2) Quantify drivers of performance within the P&T Committee Performance model and (3) Quantify the relationships between concepts in the P&T Committee model and the effects of these relationships on P&T Committee performance. An on-line and paper cross-sectional survey was sent to 321 Pharmacy Directors, Hospital Administrators/Medical Staff Directors and P&T Committee Chairs at non-university non-specialty hospitals with an ASHP residency. Previously validated measures were used for two concepts, and newly created measures for three concepts. Four dependent variables were used: adoption of formulary medications, medication restrictions, Community-Acquired Pneumonia (CAP) treatment and Deep Vein Thrombosis (DVT) risk assessment protocols. Multivariate regression and path analysis were used with the dependent variables, with five primary variables of interest and five control variables. The response rate was 17.76%. P&T Committee developed processes are successful in leading prescribers to adopting formulary medication decisions (96.02 ± 3.94%), with no differences based on hospital characteristics. They have not been as successful in developing processes for adoption of decisions on medication restrictions (77.02 ± 28.81%) and protocols (63.02 ± 32.76%, 73.02 ± 29.96%). Engaged team members were important in the adoption of all four studied P&T Committee decisions. Influential physicians and implementation activities varied in their importance depending on the decision being made. The presence of influential

Objectives:The aim of this study was to develop and to assess a specific Multi-Criteria Decision Analysis (MCDA) framework to evaluate new drugs in an hospital pharmacy and therapeutics committee (P&TC) setting.Methods:A pilot criteria framework was developed based on the EVIDEM (Evidence and Value: Impact on DEcisionMaking) framework, together with other relevant criteria, and assessed by a group of P&TC's members. The weighting of included criteria was done using a 5-point weighting technique. Two drugs were chosen by evaluation: an orphan-drug for Gaucher disease, and a nonorphan drug for the treatment of inflammatory bowel disease. Evidence matrices were developed, and value contribution of each drug was evaluated by P&TC's members. An agreed final framework was obtained through a discussion between the P&TC's members.Results:After criteria assessment, the pilot framework included eight quantitative criteria: “disease severity,” “unmet needs,” “comparative efficacy/effectiveness,” “comparative safety/tolerability,” “comparative patient-reported outcomes,” “comparative cost consequences-cost of treatment,” “comparative cost consequences-other medical costs,” and “quality of evidence”; and one contextual criterion: “opportunity costs and affordability.” The most valued criteria were: “comparative safety/tolerability,” “disease severity,” and “comparative efficacy/effectiveness.” When assessing the drugs most valued characteristics of the MCDA were the possibility that all team may contribute to drug assessment by means of scoring the matrices and the discussion to reach a consensus in drug positioning and value decision making.Conclusions:The reflective MCDA would integrate quantitative and qualitative criteria relevant for a P&TC setting, allowing reflective discussions based on the criteria weighting score.

A formulary is the product of an evaluative process, the formulary system, conducted by an expert panel that both sanctions and guides the selection, prescription, administration, and monitoring of pharmaceuticals and related items for a given environment. An expert panel, often called the Pharmacy and Therapeutics Committee (P&T), is a group of pharmacists, physicians, nurses, and administrators assembled for the purpose of providing guidance and validation for pharmaceutical utilization in a given organization. Expert panels became prominent because of qualitative and quantitative changes in drug production and marketing strategies employed by industry, the expansion of public health sector medicine, and organized, macro-level drug control systems. It could be argued that, as a clinical instrument, the formulary is predicated on the role pharmacy is perceived to play in actual direct patient care. In this lecture, the concept and defining characteristics of a formulary (the perspective of an expert panel, differences in the environment of application, and interprofessional relationships), the modifiers used to describe a formulary, which modifiers enhance or distract from its meaning, and the outlook for comprehensive and objective evaluation through the formulary mechanism are discussed.

Background Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF) with a considerable economic impact on the hospital’s annual budget. Biosimilar therapies are expected to be less costly for healthcare systems. Purpose The primary endpoint was to analyse treatment costs with etanercept biosimilar (EB) vs etanercept reference product (ERP) as initial treatment and the potential economic impact of switching to EB for maintenance therapy. Material and methods Retrospective observacional study including all patients treated with etanercept from March to September 2017. Data on prescription details, number of prescriptions and costs, were retrieved from the Farmatools ® management tool (outpatients clinical module). The Pharmacy and Therapeutics Committee included EB as a cost-effective alternative and in the light of available scientific data, prescribers agreed with the pharmacy staff to use it as initial therapy. Regarding switching maintenance therapy from ERP to EB, prescribers were responsible for individualising the decision according to patients’ medical records. Results During the study period 190 patients were treated with etanercept. Seventy-eight per cent were rheumatology patients and 22% were dermatology patients. EB was prescribed as initial treatment in 100% of cases (25 new treatments in rheumatology, nine in dermatology). No switching to EB was prescribed in maintenance therapy. A total of 256 doses of EB 50 mg were dispensed, which generated savings of €43.491, when compared to ERP’s best offer. Regarding the potential economic impact of switching maintenance therapy, we estimated that this strategy would mean savings of €339.012 to our centre. No adverse effects or low efficacy data were reported with EB treatments. Conclusion Introducing EB as initial therapy for rheumatology and dermatology patients has resulted in a modest reduction in drug spending in our centre. Potential savings justify the urgent need to implement agreed protocols for switching to EB in maintenance therapy as well. This would mean significant cost savings and improved access for patients to these highly effective therapies. A cross-sectoral collaboration among prescribers, pharmacists and nurses facilitate pharmacovigilance activities, in order to assure the quality, safety and efficacy of EB. No conflict of interest

Objectives: Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore.Methods: A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary.Results: Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists’ proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management.Conclusions: Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

Just a few years shy of a century ago, a group of Canadian researchers discovered a viable method of extracting insulin, filling a large and critical gap in the therapeutic treatment of diabetes (1). Since then, insulin and its associated delivery devices have become an integral part of the care and management of patients living with diabetes. Shortly after the first insulin injection was successfully delivered, vials of insulin became available commercially. At this time, large glass syringes were used to administer insulin, and each injection required sterilization of the syringe, as well as sharpening of the syringe needle with a pumice stone. Through the years, insulin syringes modernized, but it was not until the 1970s that an alternate delivery system—the insulin pump, used in continuous subcutaneous insulin infusion (CSII) regimens—became available. Fifteen years later, the first insulin pen was introduced to the marketplace, providing evidence that, as time progresses, there is no shortage of innovation in the diabetes arena. The first two rapid-acting inhaled insulins on the market—Exubera in 2006 and Afrezza in 2014—represented yet another innovation milestone. In theory, inhaled insulin completely eliminated the psychological barriers associated with subcutaneous insulin delivery, such as needle phobia and incorrect injection technique. However, in October 2007, Pfizer withdrew Exubera from the market, and in January 2016, Sanofi withdrew from a $925 million marketing agreement with MannKind for Afrezza; both removals were due to poor sales volume. Although patients and providers have been searching for years for alternatives to injecting insulin, Exubera has already failed, and Afrezza’s destiny is uncertain. In 2006, Exubera was the first inhaled insulin approved by the U.S. Food and Drug Administration (FDA). It showed noninferiority in efficacy with regard to A1C lowering in both type 1 diabetes (2) and type 2 diabetes (3) compared to mixed regular/NPH …

The growing incidence and prevalence of diabetes has made a significant impact on the development of diabetic kidney disease (DKD) (1). DKD is among the most frequent complications of diabetes; indeed, diabetes accounts for ∼50% of all cases of end-stage renal disease (ESRD) in developed countries (2). Patients often have comorbid diabetes and chronic kidney disease (CKD). Although intensive glycemic management has been shown to delay the onset and progression of increased urinary albumin excretion and reduced estimated glomerular filtration rate (eGFR) in diabetes patients (3), conservative dose selection and adjustment of antidiabetic medications is necessary to balance glycemic control with safety. A1C has limitations related to its precision and interpretation in the CKD population (4), with erythrocyte turnover being a major cause of A1C imprecision in this population. Red blood cell survival times become shorter as eGFR falls, resulting in a reduction in measured A1C. Treatment with erythrocyte-stimulating agents lowers A1C further, perhaps because of changes in hemoglobin concentrations (5,6). Observational data support the notion that higher A1C levels in nondialysis diabetes patients with CKD stages 3–5 (eGFR levels

Purpose A large hospital’s systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described. Summary In 2003 the University of Pittsburgh Medical Center (UPMC)–Presbyterian implemented a policy that created a formal process for the systematic evaluation of formulary requests and drug-utilization patterns indicating or suggesting off-label use. Explicit criteria were developed for differentiating “innovative off-label use” (i.e., use based on a reasonable rationale yet lacking definitive scientific support in the form of fully published randomized controlled trials) from medication use more appropriately classified as clinical research. The UPMC–Presbyterian policy also outlined a process for the development, implementation, and evaluation of guidelines on innovative off-label use, including the collection of efficacy and safety outcomes. As of October 2012, 31 proposals for off-label medication use had been evaluated by the medical center’s pharmacy and therapeutics committee and formulary subcommittee. Thirteen requests resulted in a determination of innovative off-label use and the development of prescribing guidelines, and 10 prompted the extension of an agent’s current formulary status; in 6 cases, proposed off-label uses were determined to constitute clinical research. In some instances, innovative off-label medication use generated safety and outcomes data that led to changes in local standards of care. An algorithm to guide decision-making with regard to requests and proposals for off-label medication use is provided. Conclusion The UPMC–Presbyterian experience indicates that off-label medication use can be effectively managed using evidence-based principles and peer review mechanisms.

As atividades hospitalares caracterizam-se por um acentuado dinamismo em consequência do surgimento de novas tecnologias em saúde, tais como medicamentos. Uma unidade hospitalar, devido suas características de ensino, pesquisa e atendimentos de alta complexidade, possui maior concentração de diferentes tipos de tecnologias em saúde. O Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto –USP (HCFMRP-USP) é uma instituição hospitalar, de qualidade comprovada, inserido no SUS como referência terciária/quaternária e que conta com a Divisão de Assistência Farmacêutica (DAF) para desenvolvimento das ações de atenção a saúde. A DAF para auxílio da gestão de recursos, seleção e padronização de medicamentos adotou como estratégia a Comissão de Farmácia e Terapêutica (CFT). A CFT é uma instância colegiada, de caráter consultivo e deliberativo, estabelecida pela Organização Mundial de Saúde como ferramenta de estratégia para monitorar e promover a qualidade no uso do medicamento, porém estudos que sobre a atuação das CFTs no Brasil são incipientes. Desta forma, este estudo pretende apresentar a CFT do HCFMRP-USP. Objetivos: apresentar a composição, atribuições e metodologia de trabalho da CFT, bem como desenvolver uma análise crítica de seu atual funcionamento. Metodologia: Foi realizado estudo descritivo e exploratório com o objetivo de descrever o atual funcionamento da CFT do HCFMRP-USP. Foram buscadas portarias, regulamentações internas e foi realizada revisão bibliográfica sobre a CFT. Para Análise crítica do atual funcionamento, foi selecionado dentre os itens padronizados pela comissão aquele que se enquadrasse como pertencente a classificação A e V, após o cruzamento das curvas ABC e VEN, cujo item selecionado foi o medicamento Sevoflurano. Resultados: A CFT foi instituída no ano de 2010 em substituição a extinta comissão de padronização. Desde então, a CFT analisou 134 solicitações e destas 41 foram padronizadas. O medicamento sevoflurano foi incorporado no HCFMRP-USP em 2010 e, a partir deste ano, observa-se um aumento gradativo do consumo do mesmo. Entretanto, após análise das prescrições do referido medicamento no ano de 2012, foi observado que a dispensação do sevoflurano não segue as especificações do perfil de pacientes conforme estabelecido no protocolo instituído no momento da padronização. Conclusões: Portanto, concluímos que a implantação da CFT foi uma estratégia que proporcionou a padronização racional. Entretanto, observa-se que não há controle da dispensação e utilização do medicamento de acordo com o protocolo estabelecido no momento da padronização. Salientamos que o controle do uso do Sevoflurano não é atribuição da CFT devendo esta atribuição ser delegada à área técnica responsável.

Exercise, as part of lifestyle modification, is known to be the first line of therapy for patients with type 2 diabetes (1), and, dating back as far as 1000 AD, Greek physicians prescribed exercise as a way to improve health (2). Regular exercise provides many physiological and psychological benefits, including improvements in glycemic control (in most individuals), insulin sensitivity, blood pressure, lipid profile, muscular strength, and bone mineral density. In addition, exercise reduces total daily insulin requirements in people on insulin therapy, risk for coronary artery disease, body weight, percentage of body fat, stress, and depression and improves individuals’ sense of well-being and quality of life (3–5). Given all the health benefits it provides, exercise truly can be considered “medicine.” Despite being advised to participate in exercise as an essential part of diabetes management, only 39% of adults with diabetes are physically active (6), and many face barriers to becoming and staying physically active. Brazeau et al. (7) found four main barriers to physical activity in patients with type 1 diabetes: fear of hypoglycemia, work schedule, loss of control over diabetes, and low fitness level. Fear of hypoglycemia is the major barrier and biggest challenge for people treated with insulin. Exercise can cause profound changes in glucose homeostasis and may lead to hypoglycemia. Some hypoglycemia symptoms such as sweating and fatigue are similar to the physical sensations of normal exertion, which can make it difficult for patients to distinguish between the two (7). Given that an excessive decrease in blood glucose is a primary clinical concern and barrier to being physically active for people with diabetes, it is important to consider potential interactions between antihyperglycemic medications and exercise to minimize the risk of hypoglycemia. This article provides a brief overview of medication management considerations in people with …

Background Increased longevity and the prevalence of associated pathologies is leading to more hospital admissions involving chronic patients with multiple pathological problems. In orthopedic surgical patients, it is very important to individually evaluate the risk/benefit of maintaining or suppressing chronic medications. For certain medications, there are consensus recommendations, but for others, the available information may be limited or controversial. Objective To develop and validate a new guide for the continuity of care in perioperative medication management in older orthopedic surgical patients. Materials and methods An expert pharmacist developed the guide by systematically reviewing each medication category according to the Anatomical Therapeutic Chemical (ATC) classification system. The Pharmacy and Therapeutics Committee at the Hospital General Universitario de Elche reviewed the guide. After a training course on the guide for pharmacists, the guide was validated by studying the interobserver variability between pharmacists as well as between each pharmacist and the expert pharmacist. Cohen’s kappa index (κ) was applied to determine interrater reliability. Results The guide includes 51 therapeutic groups. Each ATC pharmacological subgroup is structured according to the benefits and risks of continuing therapy. When we compared each pharmacist’s recommendations with those of the expert pharmacist, the kappa value was found to be 0.8 [95% CI (0.7, 0.9)], indicating almost perfect concordance (overall percentage agreement 89.3%). Conclusions We developed a guide for the continuity of care in perioperative medication management to improve the rationalization of medicines in the perioperative environment. After the pharmacists had been trained, the guide was validated by demonstrating a high level of concordance among the pharmacists’ recommendations. Formal training seems to be essential to ensure consistency in medical decisions. Level of evidence IV (Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653).

Introduction: The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used. The findings were converged during the interpretation phase. Expert commentary: Most professionals were represented in the PTCs, with variations across hospitals. Membership of PTCs included a pharmacist, who in the majority of cases was the secretary. PTC activities included dissemination of decisions (100%) and formulary management (89.5%). However, reporting of adverse drug reactions (ADRs) and medication errors was typically poor at all hospital levels. Lack of expertise of pharmacoeconomic analysis and evidence-based decision-making in formulary management was identified as a key challenge in formulary management. In conclusion, future programmes should strengthen PTCs in specialised aspects of formulary management. Further training in the principles of pharmacovigilance is needed to enhance ADR reporting, as well as to ensure compliance with both WHO and provincial guidelines.

Purpose The results of the 2016 ASHP national survey of pharmacy practice in hospital settings are presented. Methods A stratified random sample of pharmacy directors at 1,315 general and children’s medical–surgical hospitals in the United States were surveyed using a mixed-mode method offering a choice of completing a paper survey or an online survey. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS’s hospital database. Results The survey response rate was 29.8%. Drug policy development by pharmacy and therapeutics committees continues to be an important strategy for improving prescribing. Strict formulary systems are maintained in 63.0% of hospitals, and 89.7% of hospitals use clinical practice guidelines that include medications. Pharmacists have the authority to order laboratory tests in 89.9% of hospitals and order medications in 86.8% of hospitals. Therapeutic interchange policies are used in 89.2% of hospitals. Electronic health records (EHRs) have been implemented partially or completely in most hospitals (99.1%). Computerized prescriber-order-entry systems with clinical decision support are used in 95.6% of hospitals, and 92.6% of hospitals have barcode-assisted medication administration systems. Transitions-of-care programs are increasing in number, with 34.6% of hospitals now offering discharge prescription services. Pharmacists practice in 39.5% of hospital ambulatory or primary care clinics. The most common service offered by pharmacists to outpatients is anticoagulation management (26.0%). When pharmacists practice in ambulatory care clinics, 64.5% have prescribing authority through collaborative practice agreements. Conclusion Pharmacists continue to expand their role in improving the prescribing of medications in both hospital and outpatient settings. The adoption of EHRs and medication-use technologies has contributed to this growth.

Pharmacy and therapeutics (PT) committees are responsible for managing drug formularies in numerous health care settings. Although pharmacy practice and health care organizations provide general recommendations of responsibilities and skills for members and nonmember contributors of PT committees, the study investigators hypothesized that there is diversity in the training, responsibilities, and practices of these members and contributors.To describe the training, responsibilities, and practices of members and nonmember contributors of PT committees in a variety of health care settings, using an online survey.In December 2015, an online survey was delivered to clinicians who were considered likely to be involved in PT committee service from hospitals ranked by U.S. NewsWorld Report and a convenience sample of clinicians practicing in managed care settings. The survey instrument was designed to assess various domains and perceptions of PT committee processes.Sixty-nine respondents representing various health care delivery settings in the United States were eligible for and completed the survey. The majority of the respondents were pharmacists (94.2%), and 72.5% of the respondents were PT committee members. The remainder of the respondents were nonmember PT committee contributors. Approximately 60% of the respondents had served in PT committee roles for ≥ 10 years. Specialized postgraduate training incorporating literature evaluation and formulary management was possessed by 21.7% and 17.4% of the respondents, respectively; however, most of the respondents received on-the-job training. Approximately half of the respondents were responsible for preparation of PT committee documents, and 58% reported that nonmember contributors typically write and prepare these documents. Skill in literature evaluation was the most important criterion in selecting authors of PT committee documents, while 10.1% of the respondents indicated that their committees did not use any criteria for author selection. When authoring documents, primary literature was routinely consulted by 89.5% of the respondents. Most of the respondents (84.1%) used an organization-specific document template, while 5.8% of the respondents indicated that they prepared documents with no defined process. The most highly ranked factor that could have a perceived beneficial effect on PT committee functions were guidelines on the authoring and reviewing of PT committee documents.The survey of PT committee members and nonmember contributors used in this study identified current training, responsibilities, and practices that can inform recommendations for standards in these domains. Findings suggest opportunities for improvement in achieving best practice recommendations to ensure evidence-based decision making by PT committees.No outside funding supported this study. At the time of this study, Kelly was employed by Global Account Management Group (GAMG), which provides consulting services to the hospital and health services industry. As an employee of GAMG, Kelly has served on various advisory boards. All fees for consulting work were paid to GAMG and were primarily related to training or the federal market (e.g., Department of Defense or the Department of Veterans Affairs) and have no association with this study. Rodriguez and Moody report no conflicts of interest. All authors contributed to study concept and design. Rodriguez took the lead in data collection, assisted by the other authors. Data interpretation was performed by Rodriguez, along with Kelly and Moody. The manuscript was written and revised primarily by Rodriguez, along with the other authors.

In Mexico the technical and scientific information about the Pharmacy and Therapeutics Committees (CFT) is quite limited and in Nayarit it is more so. However, in 2009 there were important events related to the topic of hospital pharmacy, since the NATIONAL MODEL OF HOSPITAL PHARMACY is published, which is a watershed for the development of the committees of pharmacy and therapeutics in the country. This guide contains a section called "Supply of supplies and management of pharmacy" in which, in addition to proposing schemes to subrogate the supply of medicines, the model of intra-hospital pharmacy service was proposed for the High Specialty Regional Hospitals (HRAE), this section consists of the following elements: a) pharmacy and therapeutics committee, b) clinical file, c) prescription control system, d) pharmacy service, e) prescription management, and f) distribution mechanisms to patients/kits. En México la información técnica y científica sobre los Comités de Farmacia y Terapéutica (CFT) es bastante limitada y en Nayarit lo es más. Sin embargo en el año 2009 hubo importantes acontecimientos referentes al tema de farmacia hospitalaria, pues se publica el MODELO NACIONAL DE FARMACIA HOSPITALARIA, el cual es un parteaguas para el desarrollo de los comités de farmacia y terapéutica en el país. Esta guía contiene un apartado denominado "Abasto de insumos y gestión de farmacia" en el que, ademas de proponer esquemas para subrogar el suministro de medicamentos, se planteó el modelo del servicio de farmacia intra-hospitalaria para los Hospitales Regionales de Alta Especialidad (HRAE), este apartado consta de los siguientes elementos: a) comité de farmacia y terapéutica, b) expediente clínico, c) sistema de control de recetas, d) servicio de farmacia, e) gestión de la prescripción, y f) mecanismos de distribución a pacientes/botiquines.

Background The introduction of PCSK9 inhibitors in the treatment of hypercholesterolaemia marks a breakthrough for patients unresponsive to traditional treatment. However, in our country, 44.9% of adults have high LDL-C levels (≥ 130 mg/dL or under treatment), so inadequate use of these innovative drugs might have a strong impact on efficiency and safety. The national atherosclerosis association published a document regarding the restricted indications for use of the PCSK9 inhibitors, and we adapted it to our centre. Purpose We evaluated compliance with the protocol for prescription of PCSK9 inhibitors in our centre. Material and methods In March 2016, the pharmacy and therapeutics committee created their own protocol together with internal medicine, cardiology and endocrinology services. It turned out to be more restrictive than the national guidelines, with higher LDL-C levels required. Based on the available evidence and taking into account criteria of efficacy and safety, four indications were included: (1) HoFH: homozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (2) HeFH: heterozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (3) previous cardiovascular event (pCVE) with LDL-C >100 mg/dL with the maximum tolerated dose of statin and ezetimibe; and (4) any of the above with LDL-C >120 mg/dL in patients who are statin intolerant, or for whom a statin is contraindicated. We evaluated the compliance with our protocol for prescribing PCSK9 inhibitors from March to September 2016, based on computerised medical records. Results We received 26 prescriptions, 20 from the internal medicine service, 3 from the endocrinology service and 3 from the cardiology service. All complied with the protocol, except for 1 that was approved by the committee for the treatment of hyperlipoproteinaemia. The following patients were treated: 18 HeFH, 6 pCVE and 1 pCVE who was statin intolerant. Conclusion In our centre, there was high compliance with the protocol for the prescription of PCSK9 inhibitors. Due to the major economic impact of these new drugs, continuous follow-up would be required to ensure that every prescription meets the requirements of the protocol in the treatment of hypercholesterolaemia with PCSK9 inhibitors. No conflict of interest

Purpose The development, implementation, and pilot testing of a discharge medication reconciliation service managed by pharmacists with offsite telepharmacy support are described. Summary Hospitals’ efforts to prepare legible, complete, and accurate medication lists to patients prior to discharge continue to be complicated by staffing and time constraints and suboptimal information technology. To address these challenges, the pharmacy department at a 324-bed community hospital initiated a quality-improvement project to optimize patients’ discharge medication lists while addressing problems that often resulted in confusing, incomplete, or inaccurate lists. A subcommittee of the hospital’s pharmacy and therapeutics committee led the development of a revised medication reconciliation process designed to streamline and improve the accuracy and utility of discharge medication documents, with subsequent implementation of a new service model encompassing both onsite and remote pharmacists. The new process and service were evaluated on selected patient care units in a 19-month pilot project requiring collaboration by physicians, nurses, case managers, pharmacists, and an outpatient prescription drug database vendor. During the pilot testing period, 6402 comprehensive reconciled discharge medication lists were prepared; 634 documented discrepancies or medication errors were detected. The majority of identified problems were in three categories: unreconciled medication orders (31%), order clarification (25%), and duplicate orders (12%). The most problematic medications were the opioids, cardiovascular agents, and anticoagulants. Conclusion A pharmacist-managed medication reconciliation service including onsite pharmacists and telepharmacy support was successful in improving the final discharge lists and documentation received by patients.

A seleção é um processo qualificado que produz uma Lista de Medicamentos Essenciais (LME) e dá racionalidade à gestão da Assistência Farmacêutica (AF). O artigo apresenta a seleção de medicamentos em estados e municípios brasileiros, discute a percepção de gestores da AF com relação ao conceito de Medicamentos Essenciais (ME) e às estratégias adotadas na gestão, além de investigar se e de que forma a Relação Nacional de Medicamentos Essenciais (RENAME) foi adotada e está apoiando as ações locais de AF. O estudo de âmbito nacional foi realizado com base no referencial teórico-metodológico da pesquisa qualitativa em saúde. Foram entrevistados gestores de estados e municípios das cinco regiões brasileiras. Os resultados indicam fragilidades no processo de seleção e na utilização da RENAME. Foram identificadas barreiras como a falta de formalização da AF nas esferas subnacionais, as dificuldades em se compor e manter uma comissão de farmácia e terapêutica e a incorporação acrítica de medicamentos na LME. Estados e Municípios apresentam distorções que afastam a LME do conceito de ME. The selection of medicines is a skilled process that produces an essential medicines list (EML) and substantiates rational management of pharmaceutical services. This paper presents the selection of essential medicines in Brazilian states and municipalities. It discusses the perception of pharmaceutical services managers regarding the concept of essential medicines and strategies adopted for their implementation, in addition to investigating how the National Essential Medicines List was adopted and is supporting local pharmaceutical services actions. A nationwide study was carried out adopting a qualitative methodological approach in health. State and municipal managers from the five Brazilian regions were interviewed. The findings point to weaknesses in local selection procedures and in the use of the National Essential Medicines List (Rename). Barriers such as lack of formalization of pharmaceutical services at regional levels, difficulties in drafting and maintaining a pharmacy and therapeutics committee and the acritical incorporation of drugs on the EML were identified. States and municipalities have distortions that exclude the EML form the concept of essential medicines.

The association between inpatient hyperglycemia and adverse patient outcomes is well documented.1–7 Thus, focus on inpatient glycemic control has increased in the past decade. However, optimal glycemic targets remain controversial, and significant barriers to optimal glycemic control persist. After publication of the initial van den Berghe trial in surgical intensive care patients,1 several professional organizations published guidelines supporting near-normal glycemic targets.8,9 Subsequent trials documented an increased risk for hypoglycemia with tight glycemic control, suggesting that more modest glycemic targets may be optimal.10–13 The Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study,14 a large, randomized trial involving > 6,100 medical and surgical patients, documented higher 90-day mortality rates in patients managed with tight glycemic control than in those receiving conventional glucose management. Although hypoglycemia was more common among patients in the intensive treatment group, the association of hypoglycemia with an increased hazard ratio for death was similar in the two groups, suggesting that hypoglycemia contributed to the excess mortality in the intensively treated group.15 The increased risk for hypoglycemia and mortality with tight glycemic control does not justify ignoring glycemic control, but it does justify setting more moderate targets. The American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the Surviving Sepsis Campaign, and the Institute for Healthcare Improvement all updated their guidelines for glycemic control in 2009 in response to data from NICE-SUGAR.16–18 All four sets of guidelines recommend initiating insulin therapy in patients with persistent hyperglycemia (blood glucose > 180 mg/dl). After insulin is initiated, the target blood glucose range should be 140–180 mg/dl for the majority of patients. However, a more stringent goal of 110–140 mg/dl may be appropriate for certain patients, provided it can be achieved without …

Rationale, aims and objectives Non-communicable diseases have become an increasing problem in the Pacific Island countries (PICs). With the medical supply system often attached to hospitals in PICs, the training of hospital pharmacy staff has become increasingly important. This study aimed to explore hospital pharmacy services in the PICs using these validated surveys (BS26–27 and BS28–31 surveys) focusing upon hospital pharmacists' influence on prescribing and quality use of medicines. Method The BS26–27 and BS28–31 surveys were distributed online to pharmacy directors in hospitals in the PICs in 2011 and 2013, respectively. Surveys were made available in both English and French. Results In total, data from 55 hospitals were received (77% of the hospital sample in PICs) for either the BS26–27 or BS28–31 survey. From the responses received, 97% (36/37) of hospitals had a formulary, with 81% (26/32) of hospitals having a Pharmacy and Therapeutics (P&T) committee. Furthermore, 67% (24/36) of respondents stated that they provided some sort of clinical pharmacy service. On average, hospitals had two pharmacists involved in clinical pharmacy services. In BS28–31, over 75% (n = 27) of respondents believed having a strong relationship with other health care professionals, having effective communication skills and taking professional responsibility for the medicines prescribed as ‘mostly’ or ‘strongly’ facilitating clinical services. Conclusions Hospital pharmacists' participation on P&T committee and clinical services is common in the PICs. Such services enhance medication selection and reduce wastage. Although there are still too few hospital pharmacists in PICs, additional support aimed at enhancing their team building and communication skills will allow them to expand their roles and continue to improve patient health outcomes.

Background For beta-lactams, the parameter that best predicts bacterial killing is the length of time the antibiotic concentration exceeds the minimum inhibitory concentration (MIC). Studies have demonstrated improved outcomes with extended infusion (4-hour) piperacillin-tazobactam (P-TZ) compared with traditional immediate infusions. Objectives To describe how one institution made the conversion from immediate infusion of P-TZ to a 4-hour extended infusion utilizing an approved automatic therapeutic substitution, staff education, and smart pump technology, and to examine the impact of this conversion on patient length of stay and pharmacy costs. Methods With approval from the Pharmacy and Therapeutics (P&T), Antimicrobial Stewardship, and Medical Executive Committees, the decision was made to automatically convert all P-TZ orders to a standardized 4-hour infusion given every 8 to 12 hours depending on renal function. The medical records of all adult patients receiving P-TZ during 12 months pre implementation and 24 months post implementation of a 4-hour extended infusion of P-TZ were retrospectively analyzed for length of stay and mortality. The cost of P-TZ was also assessed during these time periods. Results With the help of smart pump technology, our institution successfully completed a conversion to 4-hour extended infusion P-TZ. Through this conversion, pharmacy expenditure of P-TZ was reduced by 38%; the total cost savings was $387,980.62 for the 24-month postintervention phase. Extended infusion P-TZ reduced hospital length of stay by 0.6 days ( P < .05), resulting in an additional cost savings of $1,689,480 for the 24-month postintervention phase. A conservative estimate of total cost savings to the hospital in the first 24 months, including the reduction in P-TZ expenditures, was $2,077,460.

The introduction of biosimilars represents an important mechanism by which health care organizations can manage the increasing expense of pharmaceuticals. While intended to occupy a position similar to that of generic versions of small-molecule medications, biosimilars will be governed by a unique regulatory mechanism, given the size, complexity, and variability of the originator biologic drugs. Therefore, the processes by which biosimilars will be evaluated for formulary inclusion and clinical use will be different as well. The biosimilar market is still in the early stages of development and requires further maturation. Therefore, pharmacists can seize the intervening time to assume leadership positions in preparing their organizations and clinical colleagues, including physicians, for the continued development of this new product class. Pharmacists must ensure that an appropriate clinical infrastructure is in place to allow for the safe and effective prescribing, administration, and monitoring of biosimilars. They must also be prepared to differentiate between state regulatory actions concerning biosimilars and the conflicting marketing messages that originator and biosimilar manufacturers are likely to issue. This article provides an introduction to the key formulary considerations required for biosimilar evaluation and use.

Background Fidaxomicin (fidax) is approved for treatment of Clostridioides difficile infection. In February 2018 IDSA/SHEA released updated guidelines suggesting expanded use of fidax, recommending it or oral vancomycin (po vanc) in severe or non-severe initial episodes or for most recurrences. In April 2018, University of Pittsburgh Medical Center (UPMC) relaxed system-wide guidelines to allow for fidax use in the first recurrence of C. difficile or later, with earlier use allowed by ID or GI specialists or with local Pharmacy and Therapeutics Chair approval. Hospitals could continue to be more restrictive if desired. We reviewed changes in fidax, po vanc, and IV/PO metronidazole (metro) use at UPMC hospitals after guideline changes. Methods For the reviewed antibiotics, hospital-level usage was evaluated at 15 UPMC hospitals before/after system-level changes. Usage was measured as days of therapy per 1,000 patient-days (DOT/1,000 PD). Sites were further grouped by the level of restrictions: Standard (following new system guidelines) or more restrictive (additional restrictions remained in place locally). Hospitals were also grouped by type of local stewardship programs (ASP): Robust (included an Infectious Diseases trained clinical pharmacist or ID physician with specific time dedicated to antibiotic review) or Non-Robust. Results Figure 1 shows before/after changes in usage at all hospitals. Figure 2 shows changes in Standard vs. More Restrictive hospitals, and Figure 3 shows changes in Robust vs. Non-Robust hospitals. Conclusion Fidax use remained low, but an increase was seen after the release of the guidelines and relaxation of system restrictions, mainly in hospitals without additional restrictions in place. PO vanc also increased across the system, possibly indicating better adherence to updated guidelines regarding less metro use for C. difficile treatment. Although minimal decrease, if any, was seen with metro itself. This could have been compounded by the recent fluid shortage as well as other common uses for metro. Dissemination of new guidelines to providers should be a key function of ASPs as well as monitoring for changes in usage after implementation of local changes. Further studies are needed to define any differences in practice patterns and clinical outcomes related to changes in guidelines. Disclosures All authors: No reported disclosures.

Objective Determine effectiveness of pharmacy-driven medical staff training regarding proton-pump inhibitor (PPI) therapy. Design This study was performed in two parts. Part I evaluated baseline PPI usage within the hospital. Part II evaluated the effect of pharmacy-driven medical staff education on PPI prescribing patterns. Data were collected retrospectively via electronic chart review. Setting Passavant Area Hospital in Jacksonville, Illinois, is a 99-bed community hospital. Participants Patients' profiles were selected if administration of at least one PPI was electronically charted during their hospital stay. Patients discharged from the emergency department were not included in the study. There were a total of 1,089 charts reviewed (Part I: N=565; Part II: N=524). The average patient age was 66.5 years. Interventions Part I results were presented to the pharmacy and therapeutics (P&T) committee and medical staff. A series of three educational presentations were subsequently given to medical staff. Part II results were reported to the P&T committee, with further interventions to be determined after consulting with hospital administration and medical staff. Main outcome measure Improvement of appropriate acute PPI therapy. Secondary outcome measures included duration of acute therapy and continuation of chronic therapy. Results There was improvement in the appropriate usage of PPI for stress ulcer prophylaxis (SUP) (P=0.1216), decreased chronic PPI therapy (P=0.0054), and increased documentation of PPI indication (P=0.0365). A decrease of appropriate acute duration of PPI for SUP was also observed (P Conclusions Appropriate initiation of acute and continuation of chronic PPI therapies improved. Appropriate duration of use declined in SUP patients. Pharmacy interventions have an overall positive impact on appropriate use of PPI therapy.

Purpose The use of formulary systems and pharmacy and therapeutics (P&T) committees in the Western Pacific Region (WPR) and the factors associated with their use were explored. Methods Minor additions were made to a previously validated survey and reviewed by a WPR advisory committee. The Basel Statements 26 and 27 survey was made available in eight languages and sent electronically to 1989 hospital pharmacy directors through respective hospital pharmacy associations in the WPR. Results A total of 797 responses (40%) from 34 nations were received. Of these responses, 87% of hospitals (691 of 797) used a formulary. Also, 93% of respondents (619 of 664) indicated that their hospital had a P&T committee. However, only 44% of respondents (274 of 626) reported that more than half of their formulary medicines were linked to standard treatment guidelines. Furthermore, only 41% of hospitals (247 of 601) had a policy for off-label medication use. The pharmacy directors’ perceived benefits of formularies were correlated with having more formulary medicines linked to standard treatment guidelines, basing their use on the best available evidence, and having a policy for the use of off-label medicines. Conclusion A large proportion of hospitals in the WPR have implemented formularies and P&T committees. Although formularies are commonly used, their effectiveness may be limited, as formularies are often not linked to standard treatment guidelines or the best available evidence.

Purpose An initiative to optimize the treatment of malignant hyperthermia in surgical patients through a dantrolene product conversion program is described. Summary A large health system’s formulary evaluation of a new dantrolene sodium product indicated that despite a higher cost per treatment course, the product could offer key advantages over older formulations of dantrolene in terms of preparation and administration time, product content, and storage requirements. A work group, consisting of pharmacy personnel, an anesthesiologist, a nurse anesthetist, and a representative of the health system’s group purchasing organization, determined that a switch to the new dantrolene product would offer both patient care benefits and process benefits. With the approval of the health system’s pharmacy and therapeutics committee, the new product was added to the formulary as the preferred dosage form of dantrolene, and existing dantrolene product stock was converted to the new formulation. Key implementation steps included (1) concurrent replacement of dantrolene stock on all “malignant hyperthermia carts” across the 15-hospital health system, (2) development of educational materials to raise awareness of the conversion and revised product preparation procedures, (3) anesthesiology provider and pharmacy staff education, (4) revision of dantrolene listings in each hospital’s computerized prescriber-order-entry system, and (5) redistribution of returned dantrolene product stock. The dantrolene product conversion occurred over a four-month period. Conclusion A multifacility health system was successful in converting an existing stock of dantrolene to a newly available formulation.

BackgroundAll Department of Veterans Affairs Medical Centers (VAMCs) operate under a single national drug formulary, yet substantial variation in prescribing and spending exists across facilities. Local management of the national formulary may differ across VAMCs and may be one cause of this variation.ObjectiveTo characterize variation in the management of nonformulary medication requests and pharmacy and therapeutics (P&T) committee member perceptions of the formulary environment at VAMCs nationwide.MethodsWe performed an online survey of the chief of pharmacy and an additional staff pharmacist and physician on the P&T committee at all VAMCs. Respondents were asked questions regarding criteria for use for nonformulary medications, specific procedures for ordering nonformulary medications in general and specific lipid-lowering and diabetes agents, the appeals process, and the formulary environment at their VAMCs. We compared responses across facilities and between chiefs of pharmacy, pharmacists, and physicians.ResultsA total of 212 chief pharmacists (n = 80), staff pharmacists (n = 78), and physicians (n = 54) responded, for an overall response rate of 49%. In total, 107/143 (75%) different VAMCs were represented. The majority of VAMCs reported adhering to national criteria for use, with 38 (36%) being very adherent and 69 (65%) being mostly adherent. There was substantial variation between VAMCs regarding how nonformulary drugs were ordered, evaluated, and appealed. The nonformulary lipid-lowering drugs ezetimibe, rosuvastatin, and atorvastatin were viewable to providers in the order entry screen at 67 (63%), 67 (63%), and 64 (60%) VAMCs, respectively. The nonformulary diabetes medication pioglitazone was only viewable at 58 (55%) VAMCs. In the remaining VAMCs, providers could not order these nonformulary drugs through the normal order-entry process. For questions about the formulary environment, physician respondent perceptions differed from those of staff pharmacists and chief pharmacists. Compared with pharmacy chiefs and staff pharmacists, physicians were less likely to agree that providers at their VAMC prescribed too many nonformulary medications (47% and 44% vs. 12%, P < 0.001), more likely to agree that providers must jump through too many hoops to prescribe nonformulary medication (5% and 3% vs. 25%, P < 0.001), and more likely to agree that providers make an effort to convert new patients from nonformulary to formulary lipid-lowering (65% and 73% vs. 94%, P

The pharmacy and therapeutics (P&T) committee or its equivalent has been a long-standing committee of the medical staff in almost every institution. The P&T committee is typically defined as the body that recommends policy to the medical staff and the administration of the organization on matters related to the safe and therapeutic use of medications as well as other matters relating to medication use. The Food and Drug Administration definition of a drug includes blood and blood components, and the American Society of Health-System Pharmacists guidelines suggest including blood derivatives in their definition of a drug. Clinicians and other health care providers have needed to become more familiar with blood and blood component therapy as more prescription blood products have become available. As such, the P&T committee could work collaboratively with blood bank personnel, who are experts in this area, to help ensure that blood derivative products undergo the same evidence-based formulary review process as other medications.

Purpose The implementation of an innovative ambulatory care pharmacy residency program at a Veterans Affairs (VA) outpatient clinic is described. Summary Community-based outpatient clinics (CBOCs) are a largely underutilized resource for pharmacy residency training. Through a collaboration of the University of Georgia College of Pharmacy in Athens and Charlie Norwood VA Medical Center in Augusta, a postgraduate year 2 (PGY2) pharmacy residency program was established at the CBOC in Athens. The program graduated its first resident in 2009; components of training included (1) disease state management at an anticoagulation clinic and a newly created disease state-focused pharmacotherapy clinic, (2) participation in the planning and implementation of a new lipid management service, (3) a variety of didactic, laboratory, and experiential teaching activities at the college of pharmacy, and (4) management experiences such as completing requests for nonformulary medications, management of drug shortages, adverse drug reaction reporting, and participation in meetings of local and regional VA pharmacy and therapeutics committees. The demonstrated value of the ongoing program led to position upgrades for two CBOC clinical pharmacists and the addition of a clinical faculty member, enabling the program to offer additional learning experiences and preceptorship opportunities. Conclusion A PGY2 ambulatory care residency program established in a CBOC provided a novel practice setting for the resident, helped improve patient care and pharmacy student education, and assisted in the professional development of preceptors and providers at the training site.

This is a review of key factors for pharmacy and therapeutics committees to consider when developing a therapeutic interchange (TI) program for venous thromboembolism (VTE) prophylaxis. Recent patient safety initiatives aimed at reducing the incidence of hospital-acquired VTE may increase the prescribing of thromboprophylactic agents recommended in VTE management guidelines. As a result, more pharmacy and therapeutics committees may consider TI programs for parenteral anticoagulants. However, the TI of anticoagulants appears challenging at this time. Firstly, the therapeutic equivalence of the commonly prescribed parenteral anticoagulants, enoxaparin, dalteparin and fondaparinux, has not been established. Secondly, because of the wide range of clinical indications for these anticoagulants, a blanket agent-specific TI program could lead to off-label use. Use of an indication-specific TI program could be difficult to manage administratively, and may cause prescribing confusion and errors. Thirdly, careful dosing and contraindications of certain parenteral anticoagulants in special patient populations, such as those with renal impairment, further impact the suitability of these agents for inclusion in TI programs. Finally, although TI may appear to offer lower drug-acquisition costs, it is important to determine its effect on all cost parameters and ultimately ensure that the care of patients requiring VTE prophylaxis is not compromised.

Objective To quantify the Spanish Pharmacy and Therapeutics Commission (P&TC) activity with regard to assessing and selecting drugs and describing variability in decisions made to include them. Method Descriptive, cross-sectional study based on a questionnaire aimed at 513 hospitals with more than 75 beds. We included questions referring to the P&TC resolutions, the therapeutic positioning and assessment reports. Recruitment was carried out between November 2007 and January 2008. Variability among P&TC conclusions was presented in five categories or levels of coincidence. Results One hundred and seventy-five hospitals participated, with a response rate of 34% (54% of beds). The mean number of drug-indications assessed per hospital was 10.35 (7.45). The proportion of assessments that conclude with drug inclusion or rejection was 75.3% and 21.4%, respectively. 16.2% concluded with therapeutic equivalence. Conditions for use were established for 64% of them, and 33% were included in a clinical guide. With regard to variability, 81.0% of assessments coincided with the conclusion to include or reject the drug. A contradictory decision was made for 19.0%. Conclusions Drug assessment and selection in hospitals are considerable. The proportion of drugs approved is similar in different types of hospitals. There is extensive variability as regards deciding upon inclusion and is similar to studies conducted in other countries. They indicate that a standardising methodology would be recommendable.

Objective: To design a therapeutic exchange protocol for antidepressants and clinically assess variables, such as compliance level, frequency of cases with clinically significant increase on the Udvalg-fur-Kliniske-Undersogelser (UKU) psychopharmacological scale, adverse effects analysis, overall analysis of UKU rating development and patients’ level of acceptance. Secondary objectives were to correlate psychopharmacological treatment aspects with the pharmacological morbidity level, and evaluate the clinical impact of pharmacotherapeutic optimisation measures. Method: The protocol is designed in accordance with a bibliographical review, which was approved by the Pharmacy and Therapeutics Commission. Sequential study was carried out with a sample of 30 patients. Three measurements were taken (base line, at 48---72 h and at 1---3 weeks) to calculate the pharmacotherapeutic morbidity with the UKU rating scale and the Global Clinical Impression. Pharmacotherapeutic optimisation measures were used for those patients with high pharmacotherapeutic morbidity levels. Results: The compliance level was 73.3%. One patient experienced ≥25% increase on the UKU rating scale and another patient suffered from an adverse effect. The final UKU rating reached statistical significance compared with the measurements taken at 48---72 h (P=.032) and with the base line measurement (P=.007). Patient acceptance was 90%. The impact of optimisation measurements on the pharmacotherapeutic morbidity level was clinically and statistically significant (P

Objective: To design a therapeutic exchange protocol for antidepressants and clinically assess variables, such as: compliance level, frequency of cases with clinically significant increase on the Udvalg-fur-Kliniske-Undersogelser (UKU) psychopharmacological scale, adverse effects analysis, overall analysis of UKU rating development and patients’ level of acceptance. Secondary objectives were to correlate psychopharmacological treatment aspects with the pharmacological morbidity level, and evaluate the clinical impact of pharmacotherapeutic optimisation measures. Method: The protocol is designed in accordance with a bibliographical review, which was approved by the Pharmacy and Therapeutics Commission. Sequential study was carried out with a sample of 30 patients. Three measurements were taken (base line, at 48-72 hours and at 1-3 weeks) to calculate the pharmacotherapeutic morbidity with the UKU rating scale and the Global Clinical Impression. Pharmacotherapeutic optimisation measures were used for those patients with high pharmacotherapeutic morbidity levels. Results: The compliance level was 73.3%. One patient experienced ≥25% increase on the UKU rating scale and another patient suffered from an adverse effect. The final UKU rating reached statistical significance compared with the measurements taken at 48-72 hours (P = .032) and with the base line measurement (P = .007). Patient acceptance was 90%. The impact of optimisation measurements on the pharmacotherapeutic morbidity level was clinically and statistically significant (P < .001). Conclusions: The proposed protocol has been widely accepted and it is quite certain that it is to be introduced in at a general hospital level.

Objective: To summarize a standard formulary decision process and provide recommendations for the integration of pharmacogenomic (PGx) information within the formulary decision-making process. Data Sources: With use of MEDLINE (1920-March 2010). the terms “formularies, hospital” and “pharmacogenetics” were searched in the MeSH database, yielding no results. The MeSH terms were then searched separately in addition to searching for “rational drug therapy” and “essential medicines list” through the main PubMed database. Study Selection and Data Extraction: Articles deemed relevant to both terms were assessed, interpreted, and incorporated as key pieces to the review of formularies and the integration of PGx information as a part of the formulary review process. The articles referenced were deemed appropriate and categorized into 5 areas: formulary management systems and pharmacy and therapeutics (P&T) committees, international formularies, formulary decision-making. PGx evidence, and recommendations regarding integrating PGx into formulary decision-making. Data Synthesis: The field of PGx is rapidly evolving as the evidence supporting genetically guided individualized therapy continues to grow. To bring this evidence from the bench to the bedside, institutions will need to evaluate PGx data to integrate individualized therapy into practice. Few standardized methods exist to analyze and apply clinical PGx data and incorporate the information into drug evaluation at the formulary level. Several online sites provide resources to aid in formulary review and can be used when incorporating clinically relevant PGx information into a formulary decision. In addition, there are key questions that organizations can ask as they evaluate the PGx information in each step of the decision-making process. Conclusions: P&T committees should formulate a plan to integrate a search for pharmacogenomic data with each drug evaluation and integrate the results into the formulary decision process to enhance the appraisal of drug efficacy, safety, and cost.

To the Editor: The recent article, “Bupivacaine Liposomal Versus Bupivacaine: Comparative Review,” by Noviasky et al [Hosp Pharm. 2014;49(6):539-543] is a valiant effort to review this topic. However, the authors have made a critical oversight in their attempt to interpret analgesic efficacy based solely on pain intensity. As per Schmidt’s study,1 analgesic efficacy must be evaluated using not only the pain intensity score, but also other outcome measures such as the postsurgical consumption of rescue medication, subject-reported results from validated outcomes instruments such as the Brief Pain Inventory (BPI), and subject satisfaction with postsurgical analgesia (to name just a few). If one were to study pain intensity scores alone, it would be incorrectly assumed that the analgesic effects of liposomal bupivacaine would last for only 12 to 24 hours. When combined with the other outcome measures, such as the use of postsurgical opioid rescue medications and assessments of patient functionality and satisfaction, it was clear that the analgesic effect lasted throughout the 72-hour study period. Although the pain scores normalized within the first day, they did so because the placebo patients were receiving statistically significantly more narcotic rescue pain medication than the liposomal bupivacaine patients (of course, it would be unethical to study a patient’s pain response without rescue medication being available). Other outcome metrics, such as patient satisfaction and quality of life measures from the BPI, also showed statistically significant advantages to liposomal bupivacaine throughout the entire 72-hour period – not just the first 12 to 24 hours. Most of the data presented in the Noviasky article comes from studies used in the submission to the US Food and Drug Administration (FDA) for approval of liposomal bupivacaine (Exparel; bupivacaine liposome injectable suspension). Subsequent studies such as the Improve trials for colorectal surgery and the orthopedic data presented at the most recent American Academy for Orthopedic Surgery (AAOS) were completely ignored and unaddressed. In the first Improve trial, Cohen2 demonstrated that a liposomal bupivacaine–based multimodal regimen resulted in statistically significantly less opioid consumption, lower hospital costs, and a shorter length of stay than a standard opioid-based analgesic regimen for postsurgical pain in patients undergoing open colectomy compared to his institution’s standard of care (opioid-based patient-controlled analgesia [PCA]). These results have been replicated in several other trials and surgical models (Marcet,3 Candiotti4). In fact, a very recent pooled analysis of these similarly designed studies by Cohen et al5 showed statistically significant reductions in postsurgical opioid consumption, reductions in hospital median length of stay by 1.4 days, and reductions in mean per-patient hospitalization costs by $2,455. This decrease by 60% of total narcotic consumption was accompanied by a 67% reduction in opioidrelated adverse events. Turning to the orthopedic study at the March 2014 meeting of the AAOS, Barrington and Emerson6 compared their last 1,000 total joint arthroplasties (TJA) without liposomal bupivacaine to their first 1,000 TJAs with liposomal bupivacaine; their study demonstrated pain relief for 72 hours compared to bupivacaine HCl, which lasted only 6 to 8 hours, as well as a decreased number of falls (from 10 to 2) and a savings of $1,246 per patient. The value of liposomal bupivacaine as an analgesic adjuvant must be considered as a multidimensional concept, including efficacy, safety, and pharmacoeconomics. Because liposomal bupivacaine typically affects the pharmacy budget, pharmacy directors tend to focus on that feature while not observing the hospitalwide savings that may be achieved. As a former hospital pharmacy director for many years, I know this only too well. But while working in the group purchasing organization industry, I realized that by integrating quality measures and patient outcomes with pharmacy data, a better, fuller evaluation is realized.7 In June 2010, the American Society of Health-System Pharmacists (ASHP) and Society of Hospital Medicine (SHM) reported on survey results8 in which directors of pharmacy or members of ASHP’s Pharmacy Practice Managers Section reported that only 13% of formulary system decisions made by their Pharmacy and Therapeutics (P&T) Committees in hospitals were influenced by pharmacoeconomic methods, even though 87% of respondents felt that pharmacoeconomic methods should be used. Additionally, more than 9 out of 10 survey respondents reported having pharmacoeconomic analysis available during their most recent P&T Committee discussion, but only 26% rated the available information as extremely helpful and 71% desired additional pharmacoeconomic information. Hospital pharmacy departments are not financial silos, and perhaps now is the time for hospital pharmacists to again embrace this joint SHM/ASHP statement. Given that liposomal bupivacaine provides pain relief and patient satisfaction over several days while still improving hospital pharmacoeconomics (despite pharmacy budgets being impacted), why aren’t we as pharmacists leading the charge to this therapeutic victory?

In hospital, sick elderly patients often receive many drugs concomitantly and are at high risk of adverse drug events. Pharmacy and therapeutics committees provide many services supporting appropriate medication management, but geriatricians are rarely mentioned in the list of specialists working in drug and therapeutics committees. This narrative review describes the activities, structure and functions of a medication use committee active for the past 12 years in a large Swiss university-affiliated geriatric in-hospital department.

The Regence Group is a Blue Cross, Blue Shield plan in the Pacific Northwest that covers approximately two and a half million people resident in the states of Washington, Oregon, Idaho, and Utah. The Pharmacy Department at Regence is responsible for reviewing all drugs that are ultimately placed on their formulary and also for drug policy. The evolution of the use of medication reviews in managed care plans, how evidence is used to make formulary decisions, and the role of the Pharmacy and Therapeutics Committee in the decision-making process, are discussed.

Several centres were visited in North America to identify strategies that could improve the processes used by Australian hospitals when evaluating new medicines for clinical and economic benefits. The centres visited included hospitals, a managed care organisation and the Canadian Agency for Drugs and Technologies in Health. All of the hospitals visited used a formulary to manage medicines and took a similar approach to evaluating new medicines for formulary listing and monitoring decisions. The institutional pharmacy and therapeutics committees were responsible for decision-making and were guided by detailed drug monographs prepared by pharmacy staff. There was limited use of pharmacoeconomic data in decision-making. Resources used to guide decision-making included standard guidelines for formulary submission, comparative effectiveness reviews and a checklist. A more consistent and rigorous approach to assessing medicines and determining cost-effectiveness could be achieved in Australian hospitals by using a standard format for submissions. Australian drug and therapeutics committees' members need to be educated about the utility of pharmacoeconomic studies in the evaluation of new medicines.

Objective: The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs. Material and methods: All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocio between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). Results: Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%). Conclusions: There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.