Healthcare system conversion to a biosimilar: Trials and tribulations.

PURPOSE: While biologic medications have transformed the care and management of millions of patients, they are a large financial strain on the healthcare system. Biosimilar medications present a great opportunity to improve care affordability. However, despite streamlined approval processes and the potential for cost savings, the acceptance and adoption of biosimilars have been slow. This descriptive report illustrates the preparation for, challenges of, and execution of an enterprise-wide biosimilar conversion within a large healthcare system. The 3 phases of biosimilar conversion utilized at our institution included selection of a biosimilar, pharmacy and therapeutics (P&T) committee approval, and implementation. SUMMARY: When selecting a biosimilar, clinical data, medication safety, cost, institutional cost savings, payer coverage, patient assistance programs, and additional patient services should be taken into consideration to ensure patient care is not affected. Understanding and endorsement of biosimilar use by physician leadership, care managers, and pharmacists are crucial before implementation. P&T committee approval with clear delineation of the patient population (naive vs experienced), disease states, and whether the biosimilar would be the preferred medication should be obtained. Transparent communication of clear expectations to patients and coordination with the information technology (IT), contracting, and supply chain departments are necessary before the go-live date. Contracting and IT implementations should ideally take potential changes in biosimilar adoption into consideration and have enough flexibility to account for these changes. Planned evaluations of patients' experiences with the change to the biosimilar should be incorporated as part of the implementation plan. CONCLUSION: The barriers to biosimilar adoption are plentiful. Careful planning, clear communication, and coordination with all affected disciplines can ensure successful biosimilar conversion.

Descriptive comparison of hospital formulary decisions with published oncology valuation methods.

INTRODUCTION: As cost of cancer therapy continues to increase, several organizations have developed rubrics to ascertain treatment. No studies have evaluated these methods for hospital formulary decision-making. We applied different value measurement tools to formulary decisions from one hospital system to assess their operational utility. METHODS: We evaluated four value systems: National Comprehensive Cancer Network Evidence Blocks, DrugAbacus drug pricing, European Society for Medical Oncology clinical benefit scale, and the American Society of Clinical Oncology net health benefit. Each value score or cost was assessed against our hospital formulary requests between 2012 and 2016. Formulary requests accepted and rejected were compared with respect to their relative numbers of National Comprehensive Cancer Network blocks, difference between DrugAbacus and actual cost, and European Society for Medical Oncology and American Society of Clinical Oncology scores. RESULTS: Twenty-two chemotherapy requests were included, with 20 approvals and 2 rejections. No correlation was observed between number of evidence blocks and formulary acceptance (p = 0.13). Most drugs had a higher actual price than the DrugAbacus suggested cost (p = 0.036). No significant differences were observed in European Society for Medical Oncology (p = 0.90) or American Society of Clinical Oncology (p = 0.70) scores between drugs that were accepted or rejected. When evaluating monthly cost per point of American Society of Clinical Oncology score, a numerical difference between groups was observed (median = $369.7 versus $1256.8 per point, p = 0.61). CONCLUSIONS: Existing oncology value assessment systems only variably inform hospital formulary decisions. The American Society of Clinical Oncology net health benefit score deserves further study as a method to systematically quantify the clinical safety and efficacy of formulary medication addition relative to cost.

Strategies for success in creating an effective multihospital health-system pharmacy and therapeutics committee.

PURPOSE: Lessons learned from the creation of a multihospital health-system formulary management and pharmacy and therapeutics (P&T) committee are described. SUMMARY: A health system can create and implement a multihospital system formulary and P&T committee to provide evidence-based medications for ideal healthcare. The formulary and P&T process should be multidisciplinary and include adequate representation from system hospitals. The aim of a system formulary and P&T committee is standardization; however, the system should allow flexibility for differences. Key points for a successful multihospital system formulary and P&T committee are patience, collaboration, resilience, and communication. When establishing a multihospital health-system formulary and P&T committee, the needs of individual hospitals are crucial. A designated member of the pharmacy department needs to centrally coordinate and manage formulary requests, medication reviews and monographs, meeting agendas and minutes, and a summary of decisions for implementation. It is imperative to create a timeline for formulary reviews to set expectations, as well as a process for formulary appeals. Collaboration across the various hospitals is critical for successful formulary standardization. When implementing a health-system P&T committee or standardizing a formulary system, it is important to be patient and give local sites time to make practice changes. Evidence-based data and rationale must be provided to all sites to support formulary changes. Finally, there must be multidisciplinary collaboration. CONCLUSION: There are several options for formulary structures and P&T committees in a health system. Potential strengths and barriers should be evaluated before selecting a formulary management process.

Institutional care paths: Development, implementation, and evaluation.

PURPOSE: The Cleveland Clinic experience with care paths, including their creation and implementation, challenges overcome during development and testing, and outcomes of selected care path evaluations, is described. SUMMARY: Care paths are tools to assist healthcare professionals in practicing evidence-based medicine. The Cleveland Clinic health system has implemented or is developing approximately 100 care paths, including care paths designed to optimize management of sepsis and septic shock and to promote timely use of i.v. tissue plasminogen activator and correct dosing of antithrombotics and statins in patients with stroke. Key steps in successful care path initiatives include (1) identifying key stakeholders, (2) achieving stakeholder consensus on a standardized approach to disease or condition management, (3) cultivating provider awareness of care paths, (4) incorporating care path tools into the electronic health record and workflow processes, and (5) securing the resources to develop, implement, and maintain care paths. Electronic health records facilitate the use of and adherence to care paths. After care path implementation, revisions are typically needed due to unexpected issues not initially identified and to optimize care path features and support resources for clinical practice. Ongoing evaluation is required to determine whether an implemented care path is producing the intended patient and quality performance outcomes. CONCLUSION: Care paths provide a standardized approach to treatment or prevention of a disease or condition, reducing unnecessary variability and expense while promoting optimal, cost-effective patient care.

What is new in managing patients with food allergy? Almost everything.

PURPOSE OF REVIEW: This review aims to describe current concepts in managing patients with food allergy. There have been many recent advances in the management of patients with IgE-mediated reactions to food, including diagnosis, prevention, management, and ongoing research in the field. Food allergy is increasing in prevalence and may be life threatening. This review aims to highlight changes in recommended practice when diagnosing and managing patients with food allergy. RECENT FINDINGS: Early introduction of highly allergenic foods, particularly peanut, has been shown to decrease the risk for development of food allergy in patients who are at elevated risk. Avoidance of foods without a clinical history of food allergy may increase the risk of subsequent allergy. Epinephrine remains the first line therapy for anaphylaxis, and patients and families need to be instructed on indications and technique for use. Promising research is ongoing in areas of immunotherapy to food allergens. SUMMARY: Food allergy is a potentially life-threatening condition that may persist throughout adulthood. Practitioners should be aware of changes to recommendations for the diagnosis, prevention, and management of patients with food allergy.

Development of a pharmacy resident rotation to expand decentralized clinical pharmacy services.

PURPOSE: The development of a pharmacy resident rotation to expand decentralized clinical pharmacy services is described. SUMMARY: In an effort to align with the initiatives proposed within the ASHP Practice Advancement Initiative, the department of pharmacy at Cleveland Clinic, a 1,400-bed academic, tertiary acute care medical center in Cleveland, Ohio, established a goal to provide decentralized clinical pharmacy services for 100% of patient care units within the hospital. Patient care units that previously had no decentralized pharmacy services were evaluated to identify opportunities for expansion. Metrics analyzed included number of medication orders verified per hour, number of pharmacy dosing consultations, and number of patient discharge counseling sessions. A pilot study was conducted to assess the feasibility of this service and potential resident learning opportunities. A learning experience description was drafted, and feedback was solicited regarding the development of educational components utilized throughout the rotation. Pharmacists who were providing services to similar patient populations were identified to serve as preceptors. Staff pharmacists were deployed to previously uncovered patient care units, with pharmacy residents providing decentralized services on previously covered areas. A rotating preceptor schedule was developed based on geographic proximity and clinical expertise. An initial postimplementation assessment of this resident-driven service revealed that pharmacy residents provided a comparable level of pharmacy services to that of staff pharmacists. Feedback collected from nurses, physicians, and pharmacy staff also supported residents' ability to operate sufficiently in this role to optimize patient care. CONCLUSION: A learning experience developed for pharmacy residents in a large medical center enabled the expansion of decentralized clinical services without requiring additional pharmacist full-time equivalents.

Liposomal bupivacaine versus continuous infusion bupivacaine via an elastomeric pump for the treatment of postoperative pain.

PURPOSE: The duration of analgesia and comparative efficacy of liposomal bupivacaine and an elastomeric bupivacaine pump in a diverse surgical population were determined. METHODS: A retrospective cohort study was conducted to evaluate patient outcomes following liposomal bupivacaine and elastomeric bupivacaine pump use from January through June 2013. The primary objective of the study was to evaluate 24-hour postoperative opioid use (in morphine equivalents). RESULTS: Sixty-seven liposomal bupivacaine and 262 elastomeric bupivacaine pump patients were included. Significant between-group differences were seen in American Society of Anesthesiologists physical status, patient-controlled analgesia use, postoperative nonopioid use, and surgical procedure. On univariate analysis, liposomal bupivacaine-in comparison with elastomeric bupivacaine pump -was associated with reduced median (interquartile range, IQR) 24-hour postoperative opioid use (33.0 mg morphine equivalents [IQR, 19.0-80.4 mg morphine equivalents] versus 70.4 mg morphine equivalents [IQR, 37.1-115.4 mg morphine equivalents], p < 0.001) and median 72-hour postoperative opioid use (61.3 mg morphine equivalents [IQR, 28.7-142.8 mg morphine equivalents] versus 115.9 mg morphine equivalents [IQR, 69.9-175.4 mg morphine equivalents], p < 0.001). However, after adjustment for potential confounders with linear regression analysis, study medication was not associated with a decrease in 24-hour (ß coefficient for elastomeric bupivacaine pump: 10.26; 95% confidence interval [CI]: -8.42 to 28.95; p = 0.281) or 72-hour postoperative opioid use (ß coefficient for elastomeric bupivacaine pump: 2.23; 95% CI: -29.88 to 34.34; p = 0.891). CONCLUSION: No difference was found between patients who received liposomal bupivacaine compared with elastomeric continuous infusion bupivacaine from a traditional pump in 24- or 72-hour postoperative opioid utilization after adjustment for baseline differences.

Cleveland Clinic's Center for personalized healthcare: setting the stage for value-based care.

Cleveland Clinic (OH, USA) launched the Center for Personalized Healthcare in 2011 to establish an evidence-based system for individualizing care by incorporating unique patient characteristics, including but not limited to genetic and family health history information, into the standard medical decision-making process. Using MyFamily, a web-based tool integrated into our electronic health record, a patient's family health history is used as a surrogate for genetic, environmental and behavioral risks to identify those with an elevated probability of developing disease. Complementing MyFamily, the Personalized Medication Program was created for the purpose of identifying gene-drug pairs for integration into clinical practice and developing the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. We have successfully implemented the gene-drug pairs HLA-B*57:01-abacavir and TPMT-thiopurines into patient care. Our efforts to establish personalized medical care at Cleveland Clinic may serve as a model for large-scale integration of personalized healthcare.

Curcumin for inflammatory bowel disease: a review of human studies.

OBJECTIVE: To evaluate the use of curcumin in inflammatory bowel disease. DATA SOURCES: ALTMEDEX, Comprehensive Database of Natural Medicines, MEDLINE/PubMed were searched from January 1980 through May 2009 using the terms curcumin, turmeric, ulcerative colitis, Crohn's disease, Curcuma longa, Curcuma domestica, Indian saffron, inflammatory bowel disease. Data was limited to human trials. References of identified articles were reviewed. DATA SYNTHESIS: Data evaluating the use of curcumin in inflammatory bowel disease (including ulcerative colitis and Crohn's disease) is limited to two studies comprising data for only 99 patients. Curcumin in conjunction with mainstream therapy, consisting of sulfasalazine (SZ) or mesalamine (5-aminosalicylic acid [5-ASA] derivatives) or corticosteroids was shown to improve patient symptoms and allow for a decrease in the dosage of corticosteroids or 5-ASA derivatives. In one small study of 10 patients, some patients even stopped taking corticosteroids or 5-ASA. CONCLUSIONS: Although two small studies have shown promising results, all authors conclude that larger-scale, double-blind trials need to be conducted to establish a role for curcumin in the treatment of ulcerative colitis. In addition to improving results when used in conjunction with conventional medications for UC, curcumin may pose a less-expensive alternative.

Coenzyme Q10: a therapy for hypertension and statin-induced myalgia?

Some small clinical trials seem to show that coenzyme Q10 supplements can be used to lower blood pressure and to treat or prevent myalgia caused by hydroxymethylglutaryl coenzyme A reductase inhibitors (statins). However, larger trials are needed to determine if they are truly effective for these purposes. The authors examine the evidence and also discuss issues such as bioavailability, elimination, safety, and cost.

Acetaminophen: old drug, new warnings.

The US Food and Drug Administration (FDA), concerned about the incidence of acute liver failure due to acetaminophen (Tylenol) overdose, has mandated new labeling on acetaminophen packaging. It is also considering (but has not enacted) reducing the maximum daily dose from 4 g (possibly to 3,250 mg), banning acetaminophen-narcotic combination products, and changing the current maximum single dose of 1 g to prescription status, making 650 mg the highest recommended nonprescription dose. We review the epidemiology, toxicology, and management of acetaminophen overdose and steps the FDA and physicians can take to prevent it.

Potentially inappropriate medications and adverse drug effects in elders in the ED.

The objective of this study was to examine the prevalence of potentially inappropriate medications (PIMs) and potential adverse drug effects (ADEs) in older adults presenting to the emergency department (ED). This was a prospective observational study of a convenience sample of adults 65 years and older presenting to the ED at an urban, tertiary care hospital. Potentially inappropriate medications were defined according to 2003 Beers criteria. Potential ADEs were defined as either (1) a potential drug-drug interaction, (2) alternative medication likely to cause toxicity or drug interactions, or (3) toxic doses of vitamins or minerals. Of 174 eligible patients, 124 were enrolled. The mean number of medications used per patient was 8.6 (range, 0-20). Thirty six patients (29%, 95% confidence interval, 27%-37%) presented to the ED with at least one PIM. Eight PIMs were prescribed in the ED, representing 16% of all prescriptions in the ED. Potential ADEs meeting the defined criteria were found in 26.6% of patients. A subanalysis of a random sample of charts revealed significant discordance between medication lists obtained by the research assistants and that of the health care providers. Older ED patients are at high risk for use of potentially inappropriate medications and ADEs. This problem may be magnified by inaccurate medication lists obtained by ED providers. A larger multicenter study may help to better define the scope of this problem.

Acute stroke with high-dose intravenous immune globulin.

PURPOSE: A case of acute stroke in a patient who was receiving high-dose intravenous immune globulin (IVIG) for dermatomyositis is reported. SUMMARY: A 43-year-old woman presented with overwhelming proximal weakness and myalgias, swelling in her hands, facial and knee rash, generalized fatigue, numbness in her left arm, and lower-back pain. Physical examination revealed that she had symptoms consistent with dermatomyositis. The patient was initially treated with prednisone but developed a severe adverse drug reaction to the medication. The prednisone was discontinued, and the patient was admitted to the hospital for a first-time dose of IVIG therapy. During the infusion, the patient was found to have a facial droop, left-sided hemiplegia, and an increase in restlessness. A large, significant right internal carotid artery occlusion was discovered and initially treated mechanically and then with drugs in an attempt to establish revascularization. A subsequent computed tomography scan of the brain demonstrated a large right-middle cerebral distribution infarct with slight hemorrhage into the basal ganglia. IVIG is increasingly being used for many approved and non-approved indications. Although rare, stroke associated with thrombosis caused by the administration of IVIG has been reported in the literature. On the basis of the Naranjo probability scale, this adverse drug event was calculated as a probable reaction due to the administration of IVIG. CONCLUSION: A patient had an acute stroke after receiving a high dose of IVIG for dermatomyositis. Patients should be given a slower rate of infusion and smaller dosages of IVIG, and they should be closely monitored for potential stroke associated with thrombosis during IVIG therapy.

Clinical and economic outcomes in thrombolytic treatment of peripheral arterial occlusive disease and deep venous thrombosis.

PURPOSE: Over the past 2 decades the use of thrombolytic therapy in the management of peripheral occlusive diseases, most notably peripheral arterial occlusion (PAO) and deep venous thrombosis (DVT), has become an accepted and potentially preferable alternative to surgery. We examined the period when urokinase was in short supply and subsequently unavailable, to explore potential differences in clinical outcome and economic effect between urokinase and recombinant tissue plasminogen activator (rt-PA). MATERIAL AND METHODS: Data were obtained from the Premier Perspective Database, a broad clinical database that contains information on inpatient medical practices and resource use. The study population included all patients hospitalized in 1999 and 2000 with a primary or secondary diagnosis of PAO or DVT. Incidence was calculated for common adverse events, including bleeding complications, intracranial hemorrhage, amputation, and death. Cost data were also abstracted from the database, and are expressed as mean +/- SD. RESULTS: Demographic variables were similar in the urokinase and rt-PA groups. The rate of bleeding complications was similar in the urokinase and rt-PA groups. There were no intracranial hemorrhages in the urokinase group, compared with a rate of 1.5% in the rt-PA PAO group (P = .087) and 1.9% in the rt-PA DVT group (P = .175). The in-hospital mortality rate was lower in the urokinase-treated PAO subgroup (3.6% vs 8.5%; P = .026), but a similar finding in the DVT subgroup did not achieve statistical significance (4% vs 9.8%; P = .069). While pharmacy costs were greater in the urokinase-treated group (US 5472 dollars +/- US 5579 dollars vs US 3644 dollars +/- US 6009 dollars, P < .001; PAO subgroup, US 11,070 dollars +/- US 15,409 dollars vs US 6150 dollars +/- US 12,398 dollars, P = .003), overall hospital costs did not differ significantly between the 2 groups. This finding appears to be explained by a shorter hospital stay and reduced room and board costs in the urokinase-treated group. CONCLUSION: There were significant differences in outcome in patients with PAO and DVT who received treatment with urokinase and rt-PA. While pharmacy costs were significantly greater when urokinase was used, reduction in length of stay accounted for similar total hospital costs compared with rt-PA. These findings must be considered in the context of the retrospective nature of the analysis and the potential to use dosing regimens that differ from those in this study.