Preferences for pharmacogenomic testing in polypharmacy patients: a discrete choice experiment.

To elicit preferences for pharmacogenomic (PGx) testing in polypharmacy patients. A face-to-face discrete choice experiment survey was designed and administered to adult polypharmacy patients recruited at a local retail pharmacy in Albuquerque (NM, USA). A total of 128 eligible polypharmacy patients completed the discrete choice experiment survey and significantly preferred a PGx test with lower cost, better confidentiality and higher certainty of identifying best medication/dose and side effects and one that can be used to advocate for their treatment needs (all p < 0.

A case-based learning exercise to increase students' understanding of the pharmacist's role in public health interventions for individual patients.

Introduction: The purpose of this study was to evaluate whether a public health (PH) micro-level case-based learning exercise increased pharmacy students' self-perceived understanding and confidence in their role as PH pharmacists.

Methods: Three PH micro-level case-based learning exercises in community pharmacy settings were developed and integrated into the third professional year PH course. Students enrolled in the PH course from January 2012 - May 2015 completed a pre- and post-activity survey consisting of 22 statements with Likert scale responses.

Comparison of post-marketing surveillance approaches regarding infections related to tumor necrosis factor inhibitors (TNFi's) used in treatment of autoimmune diseases.

: To examine agreement between the FDA Adverse Event Reporting System (FAERS) and observational studies in common infections for tumor necrosis factor inhibitors (TNFi's). : Using MedDRA® preferred terms, all infection cases in FAERS with each TNFi were retrieved using Evidex. Observational studies reporting TNFi-related infections were identified from PubMed (OS-PM) and ClinicalTrials.

Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Union (EU) countries, Japan, and the U.S.

Relationships Between Social/Emotional Support and Quality of Life, Depression and Disability in Patients With Chronic Obstructive Pulmonary Disease: An Analysis Based on Propensity Score Matching.

Background: Patients with chronic obstructive pulmonary diseases (COPD) suffer from impaired Health-Related Quality of Life (HRQoL). Having an adequate social/emotional support may improve the quality of life of COPD patients.

Objective: To study the relationships between social/emotional support and HRQoL, depression and disability among patients with COPD.

The impact of a theory-based web-intervention on the intention to use prescription drugs for non-medical purposes among college students: a randomized controlled trial.

The non-medical use of prescription drugs (NMUPD) among college students is escalating at an alarming rate. A limited number of studies have utilized a theoretical framework to influence this behavior. To utilize the reasoned-action approach theory to design and evaluate a web-based intervention to influence students' attitudes, perceived norms (PNs), perceived behavioral control (PBC) and intentions toward NMUPD.

Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis.

Objective: In a pilot study, our group showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the current study was to compare an internet-based self-management program to a patient-focused educational book developed to assess measures of self-efficacy and other patient-reported outcomes in patients with SSc.

Methods: We conducted a 16-week randomized, controlled trial.

Dietary Intake Among Opioid- and Alcohol-Using Pregnant Women.

Background: Substance abuse in nonpregnant adults has been associated with increased intake in calories and decreased intake of nutrient-dense foods; however, studies examining dietary intake in opioid-using and alcohol-using pregnant women are lacking.

Objective: The objective of this study was to evaluate dietary intake in opioid-using pregnant women with or without concurrent light-to-moderate alcohol use as compared to abstaining controls.

Methods: This prospective birth cohort included 102 pregnant women classified into four study groups: controls (n = 27), medication-assisted treatment (MAT; n = 26), alcohol (ALC; n = 22), and concurrent use of both substances (MAT + ALC; n = 27).

Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions (SONAR).

A 43-year-old female with multiple sclerosis developed urethral melanoma. The only potential risk factor was treatment with natalizumab, a humanized monoclonal antibody against α4 integrins. To investigate the risk-exposure relationship, we reviewed this case, all other published cases, and cases of natalizumab-associated melanoma reported to regulatory agencies.

Influenza vaccination for patients with chronic obstructive pulmonary disease: Implications for pharmacists.

Background: Influenza virus is responsible for substantial morbidity and mortality. Specific populations are at higher risk for exacerbations from influenza virus, such as patients with chronic obstructive pulmonary disease (COPD). Influenza vaccination coverage among COPD patients is low.

Hepatotoxicity with Vismodegib: An MD Anderson Cancer Center and Research on Adverse Drug Events and Reports Project.

Background: On 30 January 2012, the US FDA approved vismodegib (Erivedge, Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma.

Objective: Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers.

Methods: FAERS was searched for reports dated 1 January 2009 through 31 December 2015 using terms including hedgehog pathway and vismodegib and hepatic-related terms such as liver, jaundice, and hepatitis, among others.

Generic oncology drugs: are they all safe?

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel).

Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.

Objective: To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval.

Data Sources: MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009.

Study Selection And Data Extraction: The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses).

Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA's adverse event reporting system.

Objective: To identify and summarize FDA's Adverse Event Reporting System (FAERS) cases of progressive multifocal leukoencephalopathy (PML) associated with biological and targeted cancer therapies (BTCT) that were approved between 2009 and 2015.

Methods: FAERS was searched using each BTCT name as primary or secondary suspect drug and the adverse reaction of PML. Among BTCTs with >2 case reports of PML, proportional reporting ratios (PRR) and 95% confidence intervals (CI) were calculated.

Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network.

Background: The 3 fluoroquinolone (FQ) antibiotics - ciprofoxacin, levofoxacin, and moxifoxacin - are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration's adverse event reporting system.

Objective: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDA's Adverse Event Reporting System (FAERS).

Methods: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95% confidence intervals (CI).

Severe COPD Exacerbation Risk and Long-Acting Bronchodilator Treatments: Comparison of Three Observational Data Analysis Methods.

Objective: Results from three observational methods for assessing effectiveness of long-acting bronchodilator therapies for reducing severe exacerbations of chronic obstructive pulmonary disease (COPD) were compared: intent-to-treat (ITT), as protocol (AP), and an as-treated analysis that utilized a marginal structural model (MSM) incorporating time-varying covariates related to treatment adherence and moderate exacerbations.

Study Design And Setting: Severe exacerbation risk was assessed over a 2-year period using claims data for patients aged ≥40 years who initiated long-acting muscarinic antagonist (LAMA), inhaled corticosteroid/long-acting beta-agonist (ICS/LABA), or triple therapy (LAMA + ICS/LABA).

Results: A total of 5475 COPD patients met inclusion criteria.

Improving the effectiveness of pharmacist-assisted tobacco cessation: a study of participant- and pharmacy-specific differences in quit rates.

Background: The New Mexico Pharmaceutical Care Foundation provided a pharmacist-assisted tobacco cessation program from 2004 to 2010. In evaluating the program, discrepant 6-month quit rates were observed between pharmacies.

Objective: To identify participant- and pharmacy-specific factors associated with improved quit rates.

Assessing disparities in the receipt of inhaled corticosteroid prescriptions for asthma by Hispanic and non-Hispanic white patients.

Rationale: Inhaled corticosteroids (ICS) are widely used in the management of asthma. Prior research suggests that access to ICS among patients with asthma may vary by ethnicity.

Objectives: Study objectives were to determine if there is a difference in the proportion of Hispanic and non-Hispanic white patients with asthma in the receipt of an ICS prescription and to determine independent predictors for the receipt of an ICS prescription for asthma.

Regulatory and clinical considerations for biosimilar oncology drugs.

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces.

Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report.

Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.

Methods: The Research on Adverse Drug events And Reports methodology was used for assessment-the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.

Predictors for mortality in hospitalized patients with chronic obstructive pulmonary disease.

Background: Chronic obstructive pulmonary disease (COPD) has been the only leading cause of death associated with a continuously increasing trend in the US over the past 30 years.

Objectives: The aim of this research was to identify predictors for all-cause in-hospital mortality for COPD patients.

Methods: We conducted a cross-sectional study of patients with the discharge diagnosis of COPD, utilizing the 2007 Premier Perspective database.

Quitting patterns and predictors of success among participants in a tobacco cessation program provided by pharmacists in New Mexico.

Background: Tobacco use causes hundreds of thousands of deaths in the United States each year. Pharmacists are available in the community to provide tobacco cessation interventions. Between 2004 and 2010, the New Mexico Pharmaceutical Care Foundation (NMPCF) provided a pharmacist-led tobacco cessation program to residents in New Mexico.