Assessment of legacy and emerging contaminants in an introduced catfish and implications for the fishery.

Since introduction into the Chesapeake Bay watershed in the 1970s, blue catfish (Ictalurus furcatus) populations have increased, impacting native species. One strategy suggested to limit their growing numbers is to expand the existing commercial fishery. However, the promotion of human consumption of this large, omnivorous fish may increase exposure to contaminants of concern (COC). However, there are few published data on contaminants in blue catfish. To evaluate this possibility, we measured COC (PCBs, PBDEs, OCs, Hg) in individual fillets and compared levels to established consumption advisory limits. James River (near Richmond, Virginia) and Upper Potomac River (downstream of Washington DC) fish exhibited higher burdens of most COC than those from the lower James and rural Rappahannock rivers. Fish sex and δ15N values (surrogate for trophic position) did not correlate with COC concentrations. Potomac River fish exhibited greatest δ15N, perhaps related to local wastewater inputs. Despite differences in human population densities among watersheds, fish mercury (Hg) levels were similar. Most fillets surpassed US EPA advisory limits for unrestricted consumption (> 16 meals/month) for Hg and PCBs. Hg and PCB advisories in the region typically restrict consumption to two 220 g meals/month. Hence, individuals who rely on fish for a large portion of their diet may be exposed to unacceptable Hg and PCB concentrations. COC levels typically increased with fish length; in particular, fish > 550 mm often exceeded unrestricted consumption limits for chlordanes and DDTs. PBDEs, pentachloroanisole, hexachlorobenzene, and mirex levels were generally below established advisories. However, because fish advisories are based on the expected consequences from single contaminants and a single or limited number of toxicological endpoints, consumers face greater risks due to cumulative effects from all coincident COCs, as well as additional exposure pathways, such as other food and air. The additional data on contaminant levels reported here will increase the accuracy of forecasted risks. However, it also illustrates the complexity in communicating the risks from multi-contaminant exposure.

Primary Biliary Cholangitis: Medical and Specialty Pharmacy Management Update.

BACKGROUND: Chronic liver disease and cirrhosis are a leading cause of morbidity and mortality in the United States. Primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis and which has been designated an orphan condition, is a chronic autoimmune disease resulting in the destruction of the small bile ducts in the liver. Without effective treatment, disease progression frequently leads to liver failure and death. Until May 2016, the only FDA-approved treatment for PBC was ursodiol (UDCA), an oral hydrophilic bile acid, which can slow progression of liver damage due to PBC. However, 1 out of 3 patients taking UDCA has an inadequate biochemical response, leading to increased risk of disease progression, liver transplantation, and mortality. Given this unmet clinical need, new therapies are in development for the treatment of PBC. To provide pharmacists with an overview of the latest research on the pathophysiology of PBC and potential new treatment options and to highlight medical and specialty pharmacy approaches to managing access to drugs to treat orphan diseases such as PBC, a 2-hour satellite symposium was presented in conjunction with the 2015 Academy of Managed Care Pharmacy (AMCP) Nexus meeting. Although obeticholic acid was approved by the FDA for the treatment of PBC in May 2016, this development occurred after the symposium presentation. The symposium was supported by an independent educational grant from Intercept Pharmaceuticals and was managed by Analysis Group. Robert Navarro, PharmD, moderated the CPE-accredited symposium titled "Medical and Specialty Pharmacy Management Update on Primary Biliary Cirrhosis." Expert panelists included Christopher L. Bowlus, MD; James T. Kenney, RPh, MBA; and Gary Rice, RPh, MS, MBA, CSP. OBJECTIVE: To summarize the educational satellite symposium presentations and discussions. SUMMARY: Autoimmune liver diseases, including PBC, are responsible for 15% of all liver transplants performed and an equal percentage of deaths related to liver disease. UDCA is the only FDA-approved therapy for treatment of PBC and is considered the standard of care. Nevertheless, many patients do not respond to UDCA, creating the need for new therapeutic options to improve clinical outcomes for PBC patients with inadequate response to treatment. While several agents are being studied in combination with UDCA, monotherapy with the novel agent obeticholic acid, a farnesoid X receptor agonist, has also shown promising results. Health plans are anticipated to assign any newly introduced therapy for the treatment of PBC to specialty pharmacy given its orphan disease status. This assignment enables the health plan to receive disease education, which is particularly important when new drugs are indicated for orphan diseases, and assistance with designing appropriate prior authorization criteria. The clinical value of any new therapeutic options that will inform formulary decisions and prior authorization criteria will be assessed based on evidence of efficacy, safety, and tolerability, among other factors, such as the potential to reduce or delay medical resource utilization (e.g., liver transplant). Key considerations for prior authorization of a new therapy will be determining which PBC patients are appropriate candidates for the new therapy and developing criteria for that determination. These are likely to include clinical diagnostic criteria and degree of response to prior treatment with UDCA. Initially, any new therapy would likely be positioned as noncovered until appropriate prior authorization criteria are established. CONCLUSIONS: PBC is a chronic liver disease with significant morbidity and mortality, as well as a significant burden on the health care system if the disease progresses to the point at which a liver transplant is needed. Although UDCA, the current standard of care, has improved outcomes for many patients, others have an inadequate response to this treatment. This symposium discussed these issues and also addressed the overall treatment paradigm for orphan drug therapies, key implications for patient management, and the role of specialty pharmacy management and any associated needs both in general and specifically for new therapeutic options for PBC.

A retrospective study of direct cost to patients associated with the use of oral oncology medications for the treatment of multiple myeloma.

OBJECTIVE: To examine direct cost to patients associated with oral oncolytics for the management of multiple myeloma (MM) both before and after financial assistance, and assess the effect on adherence. METHODS: In this retrospective study, pharmacy claims were analyzed for those patients with a diagnosis of MM who received thalidomide, lenalidomide, or pomalidomide from a large specialty pharmacy in the US between January 1, 2011, and December 31, 2013. Average direct cost to patients, per prescription, was analyzed both before and after financial assistance. Adherence was assessed through an analysis of medication possession ratio (MPR) for those patients who filled a prescription ≥2 times throughout the 3-year time period. RESULTS: A total of 77,821 prescriptions for thalidomide, lenalidomide, and pomalidomide were filled by 6731 unique patients between January 1, 2011, and, December 31, 2013. The average direct cost to patients, per prescription, for any of these three agents was $227.23 prior to financial assistance and $80.11 after financial assistance, representing an average patient savings of $147.14 per prescription. Prior to financial assistance, the average direct cost to patients was ≤$50 for 57.6% of all prescriptions. After financial assistance, 86.2% of patients had a direct cost of ≤$50 per prescription. Adherence, as assessed by MPR, did not vary significantly based on direct cost to the patient. LIMITATIONS: This study included patients receiving therapy from a single specialty pharmacy for a single indication. There may be patients included in the analysis who received prescriptions from other pharmacies prior to or after the prescriptions available for analysis. Most of the prescriptions included in the analysis were for lenalidomide. CONCLUSIONS: This retrospective study demonstrated that the specialty pharmacy helped patients significantly reduce their direct cost expenditures by securing funding and co-pay assistance.

Evolving strategies for the management of multiple myeloma: a managed care perspective.

Current challenges in the management of multiple myeloma (MM) include the changing treatment landscape and the need for better care coordination and improved communication. A roundtable meeting involving key stakeholders (physicians, nurses, pharmacists, managed care professionals, pharmaceutical industry professionals, and patient care advocates) was held to discuss challenges in the management of MM and evolving strategies to address these challenges and improve quality of care for patients with MM. Interventions discussed included the use of a treatment pathway to standardize treatment, decrease costs, and possibly increase efficacy by encouraging adherence to treatment guidelines whenever possible, and the use of an oncology medical home (OMH) to facilitate communication among treatment providers. Challenges to the successful implementation of treatment pathways include the rapid introduction of new therapies and the need to balance efficacy and value. It was stressed that treatment pathways must not prioritize profits over the health and welfare of the patient. Considerations related to the implementation of the OMH include the identification of appropriate measures to evaluate quality, value, and outcomes, and the provider implementation costs related to the OMH model.

Asthma management guidelines: updates, advances, and new options.

BACKGROUND: Asthma still poses a substantial and unacceptable health and economic burden. The National Asthma Education and Prevention Program (NAEPP) guidelines for the management of asthma continue to evolve based on emerging clinical data, improving the understanding of asthma and approaches to its management. OBJECTIVE: To examine the clinical implications of current NAEPP guidelines for the diagnosis and treatment of asthma and the potential impact of the proposed 2007 guidelines update on asthma management. To examine the role of managed care organizations in fostering evidence-based asthma management. SUMMARY: Current NAEPP guidelines recognize symptom control as the chief therapeutic target in the management of asthma. The proposed update to NAEPP guidelines places greater emphasis on symptom control by expanding its definition to not only include measures of impairment but also the risk for deteriorating pulmonary function, asthma exacerbations, and controller medication side effects. Although inhaled corticosteroids remain central to achieving long-term asthma control in both current and proposed guidelines, the latter offers greater treatment flexibility and recognizes combination therapy as a preferred choice for achieving control in many patients with moderate persistent asthma. Managed care organizations, primarily using disease management programs, provide impetus for the widespread adoption of evidence-based asthma treatment guidelines. CONCLUSION: Widespread adoption of evidence-based asthma management programs offers the opportunity for achieving and maintaining asthma control.