Association between health system specialty pharmacy use and health care costs among national sample of Medicare Advantage beneficiaries.

BACKGROUND: Health care expenditures are growing rapidly. There is a growing body of literature showing that health system specialty pharmacy is associated with improvement in clinical outcomes; however, there is a lack of data on its effect on health care costs and utilization. OBJECTIVE: To perform exploratory research assessing the association between health system specialty pharmacy use and health care costs and utilization. METHODS: A retrospective cohort study was conducted examining medical and pharmacy claims from 2018 and 2019 of Medicare Advantage beneficiaries. Optum Advisory Service's proprietary deidentified Normative Health Information database was used, which includes claims, membership, and provider data for 12.6 million Medicare Advantage members. Members who filled a prescription at a health system specialty pharmacy and had a specialty provider participating in the health system specialty pharmacy care model in clinic were assigned to the intervention group. Members who did not use a health system specialty pharmacy but had the same provider (provider benchmark group) or different provider (network benchmark group) were considered as comparisons. The network benchmark group was further refined to match variation in health care cost due to geography. The primary outcome measure was total health care costs (across the medical and pharmacy benefit) on a per-patient per-month basis. Secondary outcomes were selected utilization drivers and cost subcomponents. Cost and utilization metrics were calculated on a risk-adjusted basis using Centers for Medicare & Medicaid Services Hierarchical Condition Categories (CMS-HCC) risk score methodology. Differences were assessed for categorical variables with chi-square tests, and 2-tailed t-tests were used for continuous variables. RESULTS: Of the analytic sample of 9,780 members used in this study, 208 (2.1%) used health system specialty pharmacy services. During the 2018 baseline period, total health care costs and utilization were similar after CMS-HCC risk score adjustment ($9,520 among health system specialty pharmacy users; $8,691 among the provider benchmark group; $9,510 among the network benchmark group) but lower in 2019 ($7,060, $7,683, and $8,152, respectively). The differences in 2019 were primarily driven by savings in pharmacy and free-standing physician-related costs. CONCLUSIONS: Use of a health system specialty pharmacy is associated with a lower health care cost. Further study is required to analyze how drug and disease-specific interactions influence total health care costs and utilization for health system specialty pharmacy populations. DISCLOSURES: This study was funded by Shields Health Solutions and completed with Optum Advisory Services, which provided all analysis and was the sole source of data. University of Massachusetts Medical School investigators were independent context experts, who volunteered their time for this study. Hellems is employed by Optum Advisory Services; Fasching and Smith are employed by Shields Health Solutions; and Soni and McManus are employed by the University of Massachusetts Medical School. Soni received support from the National Institute of General Medical Science (T32GM107000), National Center for Advancing Translational Sciences (TL1-TR001454), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (1F30HD091975-03). McManus's time was supported by R01HL126911, R01HL137734, R01HL137794, R01HL135219, R01HL136660, U54HL143541 from the National Heart, Lung and Blood Institute. McManus has received research support from Bristol Myers Squibb, Care Evolution, Samsung, Apple Computer, Pfizer, Biotronik, Boehringer Ingelheim, Philips Research Institute, Flexcon, Fitbit; has consulted for Bristol Myers Squibb, Pfizer, Philips, Samsung Electronics, Rose Consulting, Boston Biomedical Associates, and FlexCon; and is also a member of the Operations Committee and Steering Committee for the GUARD-AF Study (NCT04126486), sponsored by Bristol Meyers Squibb and Pfizer. The other authors have nothing additional to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The funders played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Secondary immune thrombocytopenia (ITP) as an initial presentation of Whipple's disease.

Immune thrombocytopenia (ITP) is a heterogeneous autoimmune disease characterized by low platelet count that has been associated with a number of chronic infections but rarely described as a manifestation of Whipple's disease (WD). We present a case of Whipple's disease in a patient initially diagnosed with ITP. A 46-year old male in the fifth decade of life presented with presumed idiopathic ITP and was treated with several therapies including corticosteroids, rituximab, and thrombopoietin receptor agonists. Several years later, he developed weight loss and worsening arthralgias. He was found to have evidence of WD in a jejunal lymph node, the duodenum, and the cerebral spinal fluid (CSF). His diagnosis of WD, as a cause of secondary ITP, came a full 8 years after he was discovered to have thrombocytopenia and over 4 years after he was diagnosed with ITP. WD is an uncommon, multiorgan system disease caused by the actinomycete Tropheryma whipplei. Whipple's disease presents a diagnostic challenge due to the wide array of possible presenting clinical manifestations, as well as a prolonged time course with separation of symptoms over many years. While T. whipplei is ubiquitous in the environment, few individuals develop clinical disease, raising the prospect that select immunodeficiencies, both singular or in combination, may play a role in infection. While rare, in the appropriate clinical setting, one should consider infection with T. whipplei in addition to other chronic infections as a cause of secondary ITP regardless of how long ago the diagnosis of ITP was made.

Clinical Practice Guideline: Safe Medication Use in the ICU.

OBJECTIVE: To provide ICU clinicians with evidence-based guidance on safe medication use practices for the critically ill. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and ISI Web of Science for relevant material to December 2015. STUDY SELECTION: Based on three key components: 1) environment and patients, 2) the medication use process, and 3) the patient safety surveillance system. The committee collectively developed Population, Intervention, Comparator, Outcome questions and quality of evidence statements pertaining to medication errors and adverse drug events addressing the key components. A total of 34 Population, Intervention, Comparator, Outcome questions, five quality of evidence statements, and one commentary on disclosure was developed. DATA EXTRACTION: Subcommittee members were assigned selected Population, Intervention, Comparator, Outcome questions or quality of evidence statements. Subcommittee members completed their Grading of Recommendations Assessment, Development, and Evaluation of the question with his/her quality of evidence assessment and proposed strength of recommendation, then the draft was reviewed by the relevant subcommittee. The subcommittee collectively reviewed the evidence profiles for each question they developed. After the draft was discussed and approved by the entire committee, then the document was circulated among all members for voting on the quality of evidence and strength of recommendation. DATA SYNTHESIS: The committee followed the principles of the Grading of Recommendations Assessment, Development, and Evaluation system to determine quality of evidence and strength of recommendations. CONCLUSIONS: This guideline evaluates the ICU environment as a risk for medication-related events and the environmental changes that are possible to improve safe medication use. Prevention strategies for medication-related events are reviewed by medication use process node (prescribing, distribution, administration, monitoring). Detailed considerations to an active surveillance system that includes reporting, identification, and evaluation are discussed. Also, highlighted is the need for future research for safe medication practices that is specific to critically ill patients.

The Impact of Liver and Renal Dysfunction on the Pharmacokinetics and Pharmacodynamics of Sedative and Analgesic Drugs in Critically Ill Adult Patients.

The use of sedative and analgesic drug therapy is often necessary for the care of critically ill patients. Renal and hepatic dysfunction, which occurs frequently in this patient population, can significantly alter drugs' pharmacokinetic and pharmacodynamics properties. By anticipating how these medications may be affected by liver or kidney dysfunction, health care practitioners may be able to provide tailored dosing regimens that ensure optimal comfort while minimizing the risk of adverse events.

Utilization of buffered vinegar to increase the shelf life of chicken retail cuts packaged in carbon dioxide.

Poultry processors commonly place whole parts of broilers in plastic packages and seal them in an atmosphere of 100% carbon dioxide before shipping them to food service and retail customers. This practice extends the shelf life of retail cuts to approximately 12 d under refrigerated conditions. The objective of this study was to determine the antimicrobial efficacy of vinegar for growth inhibition of mesophilic and lactic acid bacterial counts and enhancement of shelf life in CO2-packaged refrigerated chicken thigh samples. Meat quality, sensory differences, and microbial enumeration were evaluated for chicken thighs that were sprayed with 0, 0.5, or 1.0% vinegar. No differences were observed (P > 0.05) among treatments (control vs. 0.5 and 1.0% vinegar-treated chicken thighs) with respect to pH and Commission Internationale d'Eclairage L*a*b*for both chicken skin and the meat tissue. The difference from the control test indicated that trained panelists were not able to detect a difference (P > 0.05) in flavor between the chicken thigh treatments. The mesophilic and Lactobacillus bacterial counts were enumerated after 0, 4, 8, 12, 16, and 20 d of storage. The mesophilic bacterial load for the 1.0% vinegar treatment was less than all other treatments after 8, 12, 16, and 20 d of storage, whereas the 0.5% vinegar treatment had lower bacterial counts at d 12 than both controls and had an approximate shelf life of 16 d. For lactic acid bacteria, the vinegar 1.0% treatment had lower counts than the control treatments at d 12 and 16. The results from the study indicate that a combination of 1.0% vinegar with CO2 packaging can extend the shelf life from 12 to 20 d for chicken retail cuts without negatively affecting the quality and sensory properties of the broiler meat.

Introduction to drug pharmacokinetics in the critically ill patient.

Despite regular use of drugs for critically ill patients, overall data are limited regarding the impact of critical illness on pharmacokinetics (PK). Designing safe and effective drug regimens for patients with critical illness requires an understanding of PK. This article reviews general principles of PK, including absorption, distribution, metabolism, and elimination, and how critical illness can influence these parameters. In the area of drug absorption, we discuss the impact of vasopressor use, delayed gastric emptying and feeding tubes, and nutrient interactions. On the topic of drug distribution, we review fluid resuscitation, alterations in plasma protein binding, and tissue perfusion. With drug metabolism, we discuss hepatic enzyme activity, protein binding, and hepatic blood flow. Finally, we review drug elimination in the critically ill patient and discuss the impact of augmented renal clearance and acute kidney injury on drug therapies. In each section, we highlight select literature reviewing the PK impact of these conditions on a drug PK profile and, where appropriate, provide general suggestions for clinicians on how to modify drug regimens to manage PK challenges.

Potassium acetate and potassium lactate enhance the microbiological and physical properties of marinated catfish fillets.

Sodium or potassium salts such as lactate and acetate can be used to inhibit the growth of spoilage bacteria and food-borne pathogens, and thereby prolong the shelf-life of refrigerated seafood. However, minimal information is available regarding the combined effects of potassium salts (acetate and lactate) with an agglomerated phosphate blend on the quality and safety of refrigerated catfish fillets. The objective of this study was to determine the microbiological and quality characteristics of marinated catfish fillets treated with organic acid salts. Catfish fillets were vacuum-tumbled with a brine solution with and without the added organic acid salts, at 10% over initial, raw weight prior to tray-packing and storage at 4 °C for 14 d. Fillets were evaluated for yields, color, pH, tenderness, consumer acceptability, and shelf-life. No differences (P > 0.05) existed among the treated and untreated fillets with regards to solution pick-up and pH, but all treated fillets increased (P < 0.05) cooking yields and Intl. Commission on Illumination (CIE) a* values, and decreased (P < 0.05) CIE L* and b* values in the catfish fillets when compared to the untreated fillets. The fillets treated with a combination of potassium acetate and potassium lactate had lower (P < 0.05) psychrotrophic plate counts and lower spoilage scores than the control treatments on days 7, 10, and 14. In addition, consumers preferred (P < 0.05) treated catfish fillets (fried) with respect to appearance, flavor, and overall acceptability over the negative control. In conclusion, the combination of potassium acetate and potassium lactate enhanced sensory quality and extended the shelf-life of refrigerated catfish fillets.

Drug dosing considerations for the critically ill patient with liver disease.

Hepatic dysfunction in the critically ill patient presents a unique challenge to clinicians when designing pharmacotherapeutic treatment plans. Overall, the literature regarding drug dosing in critically ill patients with hepatic dysfunction is incomplete and current tools available to bedside clinicians have limitations. Despite these challenges, rational drug regimens can be implemented by critical care nurses who consider the potential impact of hepatic dysfunction on drug pharmacokinetics. This information can be applied clinically and careful monitoring plans can be implemented to assess a drug for efficacy and safety. This article reviews the pharmacokinetic changes that can occur in hepatic failure, identifies practical ways to quantify the severity of dysfunction, and discusses general drug dosing strategies in this patient population.

Pilot comparison of three cardiopulmonary resuscitation medication dosing strategies in overweight children.

OBJECTIVES: Dose calculations using three variations of patient weight estimates (actual body weight [ABW], ideal body weight [IBW], and the Broselow Pediatric Emergency Tape [BPET, a length-based weight estimation tool]) were compared to administered doses of cardiopulmonary resuscitation medications in overweight and obese children to assess for differences in dose. METHODS: This retrospective cohort analysis included 54 consecutive pediatric patients who underwent emergency resuscitation at UMass Memorial Medical Center between January 2000 and October 2008. Patients were identified using ICD-9 codes related to cardiopulmonary resuscitation. Patients were included if they were overweight or obese, less than 12 years of age, less than 146 centimeters in length, and received emergency resuscitation medication(s). Doses of administered medications were recorded and compared to potential doses calculated based on ABW, IBW and the dose recommended by the BPET. Dose differences greater than 10% were considered clinically significant and dose differences greater than 20% were considered to be potential medication errors. RESULTS: Out of 54 possible patients, four overweight patients were included; none were obese. Ten total medication doses were assessed (minimum two per patient). In all patients, at least one comparator dose varied by greater than 20% from the administered dose. Four out of 10 doses calculated according to ABW, eight out of 10 doses calculated with IBW, and eight out of 10 doses recommended by the BPET all differed by greater than 20% from the administered dose. CONCLUSIONS: Dosing variations were observed when the dose received was compared to dosing using three variants of patient weight estimates. The largest dosing differences were observed upon comparison of the administered dose versus the dose recommended by the BPET.

Pharmacist-conducted medication reconciliation in an emergency department.

PURPOSE: The effect of pharmacist conducted medication reconciliation on compliance with a hospital's medication reconciliation policy was studied. METHODS: In this eight-week pilot study, one pharmacist worked in the emergency department (ED) to facilitate the safe and accurate transfer of medication histories for admitted patients. During the first four weeks, retrospective chart review was performed for 100 patients in March 2006 to determine the compliance rate to the hospital's medication reconciliation policy (medication reconciliation completed for every patient using the hospital-approved form). Over the next four weeks, the same pharmacist prospectively obtained medication histories from consecutive patients in April 2006; these patients comprised the study group. The pharmacist completed the medication reconciliation form and identified and corrected all discrepancies. Unpaired t tests and Fisher's exact test were used to determine significant differences between groups. RESULTS: The hospital-approved medication form was used for 78% of patients in the control group (78 of 100) and 100% of patients in the study group (60 of 60). The mean +/- S.D. number of errors per form was significantly higher in the control group than in the study group, and the percentage of forms containing at least one error was significantly higher in the control group (p = 0.001 for both comparisons). Allergy documentation was recorded for 62 patients in the study group versus all 60 in the study group (p = 0.001). CONCLUSION: Pharmacist-conducted medication reconciliation in the ED increased compliance to the institution's medication reconciliation policy for admitted patients. Pharmacist-acquired medication histories had significantly fewer errors in documentation and had more documentation of patient allergies.

Effect of additive selection on calculated aluminum content of parenteral nutrient solutions.

PURPOSE: The quantity of aluminum in common ingredients used to compound parenteral nutrient (PN) solutions was calculated to quantify the actual aluminum content, and opportunities to modify the aluminum content by changing the manufacturer of the ingredients were explored. METHODS: A retrospective evaluation of a random sample of 10 neonatal, 10 pediatric, and 10 adult patients who received PN solutions was performed to quantify the aluminum content in these solutions on the basis of the ingredients used at the authors' institution. A recalculation was performed using the lowest aluminumcontaining ingredients to determine the potential for aluminum minimization in each PN solution. RESULTS: Various manufacturers produce each ingredient required to make PN solutions. Significant variation exists among manufacturers, vial size, and concentrations. Statistically significant differences in the mean aluminum content of PN solutions before and after aluminum minimization were found to exist within each sample of patients. Among the neonatal PN solutions, aluminum content was significantly reduced from a mean +/- S.D. of 84.16 +/- 47.61 to 33.6 +/- 16.69 mug/kg/day. The pediatric PN solutions had a significant decline in aluminum content from a mean +/- S.D. of 16.24 +/- 3.66 to 6.84 +/- 2.66 mug/kg/day. Aluminum content in the high-risk adult PN solutions significantly decreased from a mean +/- S.D. of 4.58 +/- 2.06 to 2.31 +/- 0.63 mug/kg/day. CONCLUSION: There is wide variability in the aluminum concentration of injectable products used in the compounding of PN solutions. Selecting products with low aluminum concentration may substantially reduce the amount of the element administered to patients.

The effects of liver and renal dysfunction on the pharmacokinetics of sedatives and analgesics in the critically ill patient.

In critically ill patients, the duration of effect and dose-response relationship of sedative and analgesic drugs can be significantly affected by the presence of renal or hepatic dysfunction. Alterations in pharmacokinetics and pharmacodynamics vary according to the degree of organ impairment and presence of comorbid illnesses. This article reviews the principals that govern the absorption, distribution, metabolism, and elimination of sedatives and analgesics during renal and hepatic impairment. By anticipating changes in pharmacokinetics, and by routinely assessing the clinical response to therapy, unintended adverse consequences of sedative and analgesic drug therapy may be avoided.

Management of delirium tremens.

Delirium tremens is recognized as a potentially fatal and debilitating complication of ethanol withdrawal. Research thus far has primarily focused on the prevention of delirium tremens.

Antifactor Xa levels in four patients with burn injuries who received enoxaparin to prevent venous thromboembolism.

Four patients with severe burn injuries received enoxaparin 40 mg twice/day subcutaneously for the prophylaxis of venous thromboembolism (VTE). Peak antifactor Xa levels were measured 4 hours after administration of a dose, and trough antifactor Xa levels were measured 30 minutes before the next scheduled dose. Ultrasonography was performed once/week to assess the presence of VTE. Any occurrence of major bleeding was documented in the patients' charts. All patients had trough antifactor Xa levels below 0.1 U/ml. Enoxaparin dosages were subsequently adjusted to achieve trough antifactor Xa levels of 0.1-0.2 U/ml. This required dosages higher than those typically recommended for VTE prophylaxis (40 mg every 24 hrs or 30 mg every 12 hrs). One patient needed more than 60 mg every 12 hours. No patient had a venous thromboembolic event or major bleeding. The low antifactor Xa levels that were observed suggest that a reduced dose-response relationship may exist between subcutaneously administered enoxaparin and antifactor Xa activity in patients with severe burn injuries. Prospective studies should be performed to further investigate this relationship.