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POCT Certificate Program

The University of Charleston School of Pharmacy will host a pharmacist training session on May 11th from 1-5 PM.  The program will provide the “Community Pharmacy-Based Point-of-Care Testing (POCT) Certificate Program” through the NACDS organization.
Specifics from NACDS include:
-Practical, hands-on training in point-of-care testing in four (4) disease states
-20 credit hours of ACPE-accredited continuing education
-Unique dual home study and in-person structure
-Access to and training on the interactive, web-based education platform
The cost will be:
    $400 for pharmacists
    $300 for UC alumni and preceptors
    $250 for any current UCSOP students
Contact Gannett Monk with any questions at gannettmonk@ucwv.edu, or to request the UC alumni/preceptor/student discount code.
To sign up, go to:  http://www.ucwv.edu/POCT/ 


ASHP and ACPE revised guidelines ASHP and the Accreditation Council for Pharmacy Education (ACPE) just released revisions to the Accreditation Standards for Pharmacy Technician Educat (Click for more...)

News from elsewhere...
Novartis' hot new eye drug Beovu tied to potential vision loss: experts 2/24/2020 2:25:33 PM Novartis has touted early success for its new eye drug Beovu, but an alert tying the drug to potential vision loss might cause docs to balk when it comes to prescribing the medicine. The American Society of Retina Specialists issued a note Sunday night to members about 14 cases of retinal vasculitis for Beovu patients, 11 of which were occlusive retinal vasculitis that can lead to vision loss. (Click for more...) Sanofi to create massive standalone API producer by melding six sites in Europe; IPO to come 2/24/2020 11:41:56 AM New CEO Paul Hudson has pledged to squeeze €2 billion out of Sanofi’s annual costs in a couple of years through a mix of methods that leans heavily on clamping down on its manufacturing budgets. It has now announced a plan that it says will not only do that but add to its top line. (Click for more...) Biocon confident of approval for Lantus copy after Malaysia plant inspected by FDA a third time 2/24/2020 10:31:27 AM With a new target date approaching for its competitor to Lantus, Biocon’s insulin manufacturing plant in Malaysia has again been given a once over by the FDA. While the agency nicked it with three observations, the Indian company is confident of getting the product to market this time. (Click for more...) Eli Lilly's Trulicity nabs novel CV approval in patients with or without established disease 2/24/2020 10:27:18 AM Analysts and investors were less than amazed when Eli Lilly revealed cardiovascular outcomes data for its GLP-1 diabetes med Trulicity in late 2018. It wasn't that the study didn't hit its mark, they argued, but that the results weren't impressive enough to move the needle in a competitive field. (Click for more...) Empty AstraZeneca plant sized up by CDMO which may or may not be AGC Biologics 2/24/2020 9:35:47 AM Colorado is making a play for a Japanese CDMO in hopes it will invest about $100 million in an empty AstraZeneca plant in Boulder. It just isn’t saying who it is. (Click for more...) FiercePharmaPolitics—Grassley pushes for Senate drug pricing bill to pass by May 2/24/2020 9:19:57 AM As the Democratic primaries roll on, one Republican senator is making a big push for his legislation. Sen. Chuck Grassley has predicted his Senate Finance Committee bill, introduced with Sen. Ron Wyden, will pass by May. He aims to attract more Republican support, negotiate with House speaker Nancy Pelosi and win the president's endorsement for the bill. (Click for more...) ‘Record high’ two million people at type II diabetes risk 2/24/2020 6:35:49 AM There are 1,969,610 people registered with a GP who have non-diabetic hyperglycaemia, a condition which puts people at high risk of type II. (Click for more...) New AI-created antibiotic can kill many antibiotic-resistant bacteria 2/24/2020 6:29:43 AM The AI system can screen more than a hundred million chemical compounds in a matter of days. (Click for more...) NHS to install ‘LIGHT’ proton therapy 2/24/2020 6:25:53 AM In addition to the launch, Advanced Oncotherapy will work with an NHS Trust on various research and development activities associated with the use of LIGHT to increase the awareness of proton therapy for the treatment of cancer. (Click for more...) Galderma’s investigational prurigo nodularis drug hits Phase II endpoint 2/24/2020 6:13:36 AM Prurigo nodularis is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus. (Click for more...) Discover how drug repurposing is taking on rare disease 2/24/2020 3:30:11 AM This year, February 29 is Rare Disease Day, which is an annual event in which patient organizations around the world raise awareness of rare diseases through activities and special programming such as charity runs, documentary screenings, panel discussions, art contests and much more. Many rare diseases, very few treatments There are approximately 7,000 rare diseases […] (Click for more...) WVU student pharmacists compete in national competition to raise awareness about critical public health issue 2/24/2020 12:00:00 AM During February and March, students at the West Virginia University School of Pharmacy are competing in the 2020 Medication Adherence Team Challenge — a two-month interdisciplinary competition between student health professionals across the country to help raise awareness about the importance of medication adherence. (Click for more...) Office of Interprofessional Education will host March 23 event focusing on substance use disorder 2/24/2020 12:00:00 AM The Office of Interprofessional Education (IPE) will be hosting an event focused on substance use disorder (SUD) and the associated stigma on Monday, March 23, 2020, as part of a year-long interprofessional education curriculum for students at the Health Sciences Center. (Click for more...) WVU Pharmacy Associate Professor named Associate Editor of Journal of the American Pharmacists Association 2/24/2020 12:00:00 AM Dr. Kimberly Kelly, an Associate Professor in the School of Pharmacy, Pharmaceutical Systems & Policy and a member of the WVU Cancer Institute Research Program, has been named an Associate Editor of the Journal of the American Pharmacists Association. (Click for more...) FDA works to ensure smooth regulatory transition of insulin and other biological products 2/21/2020 8:00:02 PM FDA works to ensure smooth regulatory transition of insulin and other biological products Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 FDA on Thursday took additional steps to increase patient access to insulin products, as well as certain other biological products set to transition regulatory pathways in March. The actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients, and health care providers. Beginning on March 23, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act, including applications for insulins and other biological products, will be deemed to be a license for the product under the Public Health Service Act. This will, for the first time, enable submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. As such, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition. The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing costs of insulin products. Thursday's actions include the publication of a final rule and frequently asked questions documents for patients and health care providers explaining more about the transition. (Click for more...) This season's influenza vaccine 45% effective, an improvement over last season's vaccine 2/21/2020 8:00:02 PM This season's influenza vaccine 45% effective, an improvement over last season's vaccine Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 CDC reports that the overall effectiveness of the influenza vaccine in the current influenza season is 45%, based on how well it prevents illness severe enough to send a person to a physician or become hospitalized. This season's vaccine has reduced the number of severe influenza cases by a little less than one-half. Experts note that the overall effectiveness could change because the prime influenza season is still ongoing, and other strains could emerge. The 2018-19 influenza vaccine was poorly matched for that season's circulating viruses, being just 29% effective. The primary reason was a late-season surge of a particularly virulent strain of influenza. This season, two main strains have been circulating: A/H1N1 and B/Victoria. When CDC examined how well the vaccination has been guarding against each strain, investigators found it has been 50% effective against B/Victoria. That surprised CDC because the B strain in the vaccine is actually mismatched against the B strain that is currently circulating. Also surprising is the fact that preliminary data indicates that protection against the A/H1N1 strain is lower, at 37% overall. When CDC looked more closely at the A/H1N1 statistics, it found virtually no protection was offered for adults ages 18-49 years. Brendan Flannery, lead investigator for CDC's influenza vaccine effectiveness network, says: "It's really a mystery as to why we don't see effectiveness against H1N1 in that adult age group." For children and adolescents, meanwhile, the vaccine is 55% effective. (Click for more...) Why the coronavirus seems to hit men harder than women 2/21/2020 8:00:02 PM Why the coronavirus seems to hit men harder than women Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 An analysis of coronavirus cases released by the Chinese Center for Disease Control and Prevention suggests that the virus is particularly harmful to middle-aged and older adults. Researchers also noted that both men and women have been infected in approximately equal numbers, but the death rate among men was 2.8%, compared with 1.7% among women. The difference may be attributed to various biological factors, such as the female hormone estrogen playing a role in immunity. Women also carry two X chromosomes, which contain immune-related genes. Health behaviors that differ by sex in some societies may also play a role in responses to infections. China has 316 million smokers who represent nearly one-third of smokers globally, comprising 40% of worldwide tobacco consumption. Only about 2% of Chinese women smoke, compared with more than one-half of all men. Chinese men also have higher rates of type 2 diabetes and high blood pressure than women in the country, while rates of COPD are almost twice as high among Chinese men as among women. Akiko Iwasaki, a professor of immunology at Yale University who studies why some viruses affect women more severely, points out that men may have a "false sense of security" when it comes to the coronavirus. Sabra Klein, PhD, a researcher at the Johns Hopkins Bloomberg School of Public Health who studies sex differences in viral infections and vaccine responses, says studies indicate that men are less likely to wash their hands or to use soap than women. (Click for more...) Gilead's coronavirus drug trial slowed by lack of eligible recruits 2/21/2020 8:00:02 PM Gilead's coronavirus drug trial slowed by lack of eligible recruits Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 Gilead Sciences' antiviral drug remdesivir is being tested in clinical trials in Wuhan, China, to combat the new coronavirus. The trials seek to test more than 700 patients, but has only recruited 168 patients with severe symptoms and 17 patients with mild and moderate symptoms from 11 medical institutes, according to Zhang Xinmin, an official from China's Ministry of Science and Technology. According to the trials' screening criteria, severely ill patients had to be within 12 days of the illness's onset and not have taken other treatments within the past 30 days to qualify. Potential mild and moderate participants would need to be within 8 days of the illness's onset. All candidates had to have tested positive for the infection. Many candidates in Wuhan were disqualified because they had started taking medication at home, either those recommended by state media or based on online anecdotes. (Click for more...) Trial of nemolizumab in moderate-to-severe prurigo nodularis 2/21/2020 8:00:02 PM Trial of nemolizumab in moderate-to-severe prurigo nodularis Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 Researchers investigated nemolizumab as a potential treatment for the chronic skin disease prurigo nodularis, which is characterized by itchy skin lesions. They selected the monoclonal antibody for their randomized Phase II trial because it targets the interleukin-31 receptor, which is implicated in the pathogenesis of prurigo nodularis. Over a period of 12 weeks, 70 participants with moderate-to-severe disease and severe pruritus received either nemolizumab or placebo at baseline, week 4, and week 8. Baseline pruritus score was 8.4 on the numerical rating scale for each treatment arm, and the main outcome was change in that score at week 4. The peak pruritus score on the numerical rating scale at that interval was down 53% from baseline for the nemolizumab group vs. 20.2% in the control group. While nemolizumab significantly reduced itching and severity of skin lesions compared with placebo in patients with prurigo nodularis, the antibody was associated with adverse events that were gastrointestinal and musculoskeletal in nature. Investigators conclude that larger, long-term studies are warranted to determine the safety and durability of nemolizumab in this setting. (Click for more...) Adverse effects of low-dose methotrexate 2/21/2020 8:00:02 PM Adverse effects of low-dose methotrexate Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 Researchers set out to measure rates of adverse events (AEs) associated with low-dose methotrexate (LD-MTX), the go-to treatment for rheumatoid arthritis (RA). Through secondary analyses of a large North American trial, they compared AE rates, risk, and risk differences of LD-MTX vs. placebo. The National Institutes of Health funded the work, which involved patients with known cardiovascular disease and diabetes or metabolic syndrome—but not RA—who tolerated the study drug during an active run-in period. All 4,786 participants received folic acid, as well as LD-MTX or placebo based on 1:1 randomized assignment. The primary endpoint was risk for AEs. At median followup of 23 months, the overall rate of prespecified AEs was 87% for the LD-MTX group and 81.5% for the control group. In terms of specific AEs, the evidence indicated that patients taking LD-MTX had a small to moderately higher risk for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs compared with placebo recipients. However, renal AEs occurred less frequently in the LD-MTX group than in the control group. (Click for more...) Stimulant overdoses rising in the U.S 2/21/2020 8:00:02 PM Stimulant overdoses rising in the U.S Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 According to a recent report in Addiction, fatal overdoses involving cocaine and other stimulants have been rising in the United States and often coincide with at least one opioid. As of 2016, 27% of cocaine overdoses and 14% of stimulant overdoses in U.S. emergency departments also involved an opioid, while in 2017, almost 75% of overdose deaths involving cocaine and 50% of those involving stimulants also involved at least one opioid. The report looked at data on nonfatal overdoses from 2006 to 2016 and fatal overdoses from 2006 to 2017 involving cocaine, psychostimulants, and opioids. Mortality rates from stimulant overdoses involving opioids rose 29% from 2010 to 2015 and 51% from 2016 to 2017, while stimulant overdoses without opioids increased 23% from 2008 to 2017. Researchers say their findings highlight the escalating nature of the opioid crisis and note that mixing stimulants and opioids may make overdoses more likely. (Click for more...) Without oversight, electronic prescribing can harm patients 2/21/2020 8:00:02 PM Without oversight, electronic prescribing can harm patients Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 The federal government recently won a $145 million civil and criminal settlement against Practice Fusion, a San Francisco-based electronic health record (EHR) company. Practice Fusion admitted to taking payments from a major drug company in exchange for dropdown menus that encouraged physicians to prescribe opioids to their patients. The company internally estimated that the drug company could gain nearly 3,000 new customers and increase opioid sales to more than $11 million by implementing the change. Between 2016 and 2017, more than 700,000 unique "pain care plans" were started because of the alert, and 20%-33% of them involved opioids. The case highlights how health electronic prescribing is intended to make prescribing safer, but unintended harms may occur without adequate oversight, say Jason N. Doctor, , and Liisa T. Laine, at the Schaeffer Center for Health Policy & Economics at the University of Southern California. They and their research team analyzed the effects of e-prescribing in Finland, where a nationwide e-prescribing system was rolled out across several municipalities over 4 years starting in 2010. They found that e-prescribing increased the potentially harmful dispensing of benzodiazepines among younger patients because it facilitated prescription refills. "We believe the federal government should require electronic prescribing safeguards that leverage scientific insights about how prescribers make choices to ensure that these systems improve health, not harm it," the authors assert. (Click for more...) Pharmacists take a bite out of inappropriate dental antibiotics 2/21/2020 8:00:02 PM Pharmacists take a bite out of inappropriate dental antibiotics Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 A study presented at IDWeek 2019 indicated that antibiotics are overprescribed prior to most dental visits. The 2007 American Heart Association prophylaxis criteria only recommend dental prophylaxis for patients with prosthetic valves, previous infective endocarditis, certain congenital cardiac conditions, or cardiac transplant patients with valvulopathy if they undergo manipulation of gingival tissue, periapical region of the teeth, or perforation of oral mucosa. Researchers analyzed the Truven Health MarketScan Commercial Claims and Encounters and Medicare supplemental databases for 2011 to 2015 and found that antibiotic prophylaxis was prescribed for 168,420 dental visits, according to co-investigator Alan E. Gross, PharmD, at the University of Illinois at Chicago (UIC) College of Pharmacy. Researchers also revealed that of those dental visits that received prophylaxis, 90.7% had gingival manipulation, but only 20.9% of visits were by patients with cardiac conditions. This suggests that 80.9% of antibiotic prophylaxis was unnecessary, says co-investigator Katie J. Suda, PharmD, UIC College of Pharmacy. The primary endpoint of the study was the cumulative incidence of any serious adverse events due to antibiotic prophylaxis within 14 days after prescription. Investigators found 5,260 serious adverse events, including 3,912 allergic reactions, 1,568 emergency department visits, and 9 Clostridioides difficile infections. (Click for more...) BCBS responds to physician pushback on mail-order pharmacy plan 2/21/2020 8:00:02 PM BCBS responds to physician pushback on mail-order pharmacy plan Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 Blue Cross Blue Shield (BCBS) of Tennessee has responded in defense of a recent policy change that requires providers to order specialty drugs that have to be administered in-office from select mail-order pharmacies. The defense responds to a February 11 letter from a group of medical societies, led by the American College of Rheumatology, which said the policy would delay patient care, reduce access to much-needed drugs, inflate out-of-pocket costs, and increase drug waste. BCBS noted the change would save Tennessee employers around 20% on specialty drugs and asserted that the groups' claims were "stoking fear." BCBS emphasized that the policy still covers the same drugs, administered by the same physicians at the same facilities, and said that the amount saved for employers would go directly to the employers, not to BCBS or its PBM. The company said, in most instances, specialty drug treatments are scheduled in advance and require prior approval, so the policy should not prove a barrier to access. (Click for more...) FDA to review evidence on associations between genetic information and specific medications 2/21/2020 8:00:02 PM FDA to review evidence on associations between genetic information and specific medications Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 FDA has introduced a collaboration between the agency's Center for Devices and Radiological Health and Center for Drug Evaluation and Research intended to provide FDA's view of the state of the current science in pharmacogenetics. The new web-based resource includes a table that describes some of the gene-drug interactions for which the agency believes there is sufficient scientific evidence to support the described associations between certain genetic variants, or genetic variant-inferred phenotypes, and altered drug metabolism, and in certain cases, differential therapeutic effects, including differences in risks of adverse events. The table includes certain established gene-drug interactions that appear in FDA-approved drug labeling. Recognizing, however, that not all supported gene-drug interactions may be found in current FDA labeling, the table also includes some additional gene-drug interactions that are consistent with the current FDA labeling and for which there is sufficient scientific evidence based on published literature. "It is important to provide clinicians, patients, and test developers with information now while we continue to review the scientific evidence, including the scientific evidence underlying various professional guidelines," FDA states. The agency is also exploring additional approaches for evaluating the evidence underlying gene-drug associations, such as participation in a community-based collaborative approach to the ongoing evaluation of the evolving science. (Click for more...) Kentucky pharmacists hope a new bill will bring financial relief 2/21/2020 8:00:02 PM Kentucky pharmacists hope a new bill will bring financial relief Thu, 02/20/2020 - 19:00 cbaker_admin Fri, 02/21/2020 - 20:00 A bill in the Kentucky State Senate would help local pharmacists by helping them get an adequate reimbursement for the products they dispense. Senate Bill 50, which is currently pending in the Senate rules committee, would limit the influence of PBMs and open up more communication with the state regarding Medicaid plans. Richard Slone of Rx Discount Pharmacy hopes the bill will help keep his doors open by downplaying the effect of PBMs on his business while saving taxpayers money. (Click for more...) Esperion scores FDA nod for cholesterol-buster Nexletol 2/21/2020 5:15:51 PM Esperion has had a rocky road to approval for its LDL-cholesterol-lowering drug Nexletol after a late-stage trial in 2018 threatened to derail its quest. But after backing its drug up with strong safety data, Esperion has the green light to go to market. (Click for more...) Lundbeck's FDA nod for Vyepti piles even more competition on crowded migraine prevention field 2/21/2020 3:29:02 PM A new entrant is joining the migraine prevention race. On Friday, the FDA approved Lundbeck's Vyepti, formerly known as eptinezumab, as the first IV therapy to prevent migraines in adults. (Click for more...) Ensuring products are safe for patients with celiac disease and gluten allergies 2/21/2020 12:25:56 PM Ensuring products are safe for patients with celiac disease and gluten allergies Fri, 02/21/2020 - 12:29 caldridgeyoung… Fri, 02/21/2020 - 12:25 Celiac disease is different from other gluten-related disorders because it’s an inherited autoimmune disorder that affects the small intestine. Nonceliac gluten sensitivity or a gluten intolerance is not the same thing, according to the Celiac Disease Center at University of Chicago Medicine. A gluten or wheat allergy, much like any allergy, causes the immune system to respond to what it thinks is a foreign substance in the body. (Click for more...) 'Boring is good,' Teva CEO Schultz says amid push to hit targets, remove risk 2/21/2020 11:20:50 AM Teva CEO Kåre Schultz has taken the company through a dramatic restructuring aimed at better positioning the company for the future. In an interview with Israel's Calcalist, he shared details of his approach to the turnaround. (Click for more...) Puma Biotech's Nerlynx remains a dud. Will a breast cancer expansion turn things around? 2/21/2020 10:53:21 AM Sales of Puma Biotech’s only commercial product—breast cancer drug Nerlynx—still need improvement, company chief Alan Auerbach acknowledged. But as one analyst sees it, a label expansion may not even be enough to save the struggling med amid increased competition from drugs with impressive data. (Click for more...) Gilead loses again in PrEP patent fight with HHS, sending dispute to federal court 2/21/2020 9:20:43 AM For the second time this month, Gilead has suffered a setback in its public patent dispute with the U.S. government. A patient review board decided against striking up a review of HHS patents on HIV prevention drug Truvada after Gilead argued they were invalid. (Click for more...) Allergan's Botox still a physician favorite for migraine despite CGRP push: analyst 2/21/2020 8:54:15 AM With CGRP drugs on the rise in the preventive migraine market, old stalwarts like Allergan's Botox are feeling the pinch from the new competition. But a new survey says neurologists may not be so quick to give up on Botox––and that could be another win for AbbVie on the eve of its Allergan merger. (Click for more...) FiercePharmaAsia—Coronavirus's impact on AstraZeneca, global drug supply; vadadustat PRV 2/21/2020 7:34:17 AM AstraZeneca braces for COVID-19's impact on its China business as global health regulators monitor for potential disruptions in drug supplies. Akebia Therapeutics will use a priority review voucher on the application for its Otsuka-partnered anemia drug vadadustat. And more. (Click for more...) Opdivo/Yervoy continues to impress in kidney cancer 2/21/2020 6:12:17 AM The results represent the longest follow-up with any immuno-oncology–based therapy in previously untreated RCC patients. (Click for more...) GSK, Immatics team up for cancer cell therapies 2/21/2020 6:04:41 AM Under the terms of the agreement, Immatics will receive an upfront payment of $45m. (Click for more...) NHS staff still face ‘unacceptable’ abuse from public 2/21/2020 5:58:12 AM NHS leaders have confirmed that from April, NHS services will be able to protect staff by barring from non-emergency care any patient or visitor who inflicts discriminatory or harassing behaviour on staff. (Click for more...) Teva’s Austedo flunks in late-stage paediatric Tourette study 2/21/2020 5:54:27 AM Compared to placebo, the drug didn’t achieve significant reduction in motor and phonic tics. (Click for more...) Survey: 20 million Americans have crowdfunded to help pay medical bills 2/20/2020 7:30:01 PM Survey: 20 million Americans have crowdfunded to help pay medical bills Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 Eight million Americans have started crowdfunding campaigns through websites like GoFundMe to pay for medical expenses for themselves or someone in their households, according to the NORC at the University of Chicago survey released Wednesday. Another 12 million Americans said they have started a campaign for someone else, and 20% of Americans said they donated to such campaigns. The proliferation of these online fundraisers to pay for medical bills is a symptom of the increasing costs of health care, even for those who have insurance. The NORC survey found 85% of respondents thought the government should be responsible for providing help when medical care is unaffordable. (Click for more...) New coronavirus spreads more like influenza than SARS: Chinese study 2/20/2020 7:30:01 PM New coronavirus spreads more like influenza than SARS: Chinese study Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 The new coronavirus behaves more like influenza than other closely related viruses, indicating it may spread even more easily than previously predicted, according to researchers in China who studied nose and throat swabs from 18 CoViD-19 cases. In at least in one case, the virus was present despite the patient showing no symptoms, suggesting that asymptomatic patients could be spreading the disease. The preliminary findings, published in the New England Journal of Medicine, offer new evidence that the novel coronavirus is not like other types of closely related coronaviruses. The new coronavirus appears to inhabit both the upper and lower respiratory tracts, while SARS causes infections deeper in the lower respiratory tract. Among the 17 symptomatic patients monitored by researchers in Guangdong province, the team found levels of the virus increased soon after symptoms first appeared, with higher amounts of virus present in the nose than in the throat. The researchers say their findings add to reports that the virus can be transmitted early in the course of the infection and that controlling the virus will require an approach different from what worked with SARS, which primarily involved limiting its spread in a hospital setting. (Click for more...) Stress ulcer prophylaxis with PPIs vs. HR2Bs on mortality among ICU patients receiving invasive mechanical ventilation 2/20/2020 7:30:01 PM Stress ulcer prophylaxis with PPIs vs. HR2Bs on mortality among ICU patients receiving invasive mechanical ventilation Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 The multinational, multisite PEPTIC study compared outcomes using two different strategies for stress ulcer prevention in the intensive care unit (ICU). The final analysis included 26,828 adult ICU patients requiring invasive mechanical ventilation who had been randomly assigned by location to treatment with either proton pump inhibitors (PPIs) or histamine-2 receptor blockers (HR2Bs). The primary endpoint was in-hospital mortality for any reason at 90-day followup, which occurred at a rate of 18.3% for the PPI group and 17.5% for the H2RB group. While the difference was not considered statistically significant, the researchers acknowledge that interpretation of their findings may be limited by crossover in the use of the study medications. They note that 4.1% of patients randomized by site to PPIs actually received H2RBs, while more than 20% of patients who were supposed to receive H2RBs based on their treating facility actually received PPIs. (Click for more...) ART alone vs. ART with a kick and kill approach, on measures of the HIV reservoir in participants with recent HIV infection 2/20/2020 7:30:01 PM ART alone vs. ART with a kick and kill approach, on measures of the HIV reservoir in participants with recent HIV infection Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 U.K. researchers report results from a randomized trial focused on the "kick and kill" approach to HIV treatment. The technique targets the persistent reservoir of latently infected cells in HIV patients, which blocks antiretroviral therapy (ART) from curing the infection. Forcing HIV transcription from those cells, theoretically, should make them vulnerable to elimination. To evaluate the potential of kick and kill, the RIVER study worked with adult males who had recently received an HIV diagnosis and initiated ART shortly thereafter. A total of 30 men were designated to receive ART alone, with another 30 designated to ART plus kick and kill. The main outcome was total HIV DNA isolated from peripheral blood CD4 + T-cells at weeks 16 and 18, which was not significantly different between the two treatment arms. Based on results from this Phase II study, the kick and kill approach did not improve measures of the HIV reservoir any more so than ART only. The investigators do not believe their findings disprove the efficacy of the strategy; rather, they say enhancement of both kick and kill agents are important going forward in new trials. (Click for more...) NIH study supports new approach for treating cerebral malaria 2/20/2020 7:30:01 PM NIH study supports new approach for treating cerebral malaria Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 New research indicates that specific immune cells may play an important role in the effects of cerebral malaria, a form of malaria that mainly affects young children and results in 400,000 deaths annually. The findings, published in the Journal of Clinical Investigation, suggest that drugs targeting T cells may be effective in treating the disease. NIH researchers examined brain tissue from 23 children who died of cerebral malaria and 11 children who died from other causes, using microscopy to explore the presence of cytotoxic lymphocytes (CTLs) in the brain tissue samples. They found an increased accumulation of CTLs along the walls of brain blood vessel in the cerebral malaria tissue samples compared with non-cerebral malaria cases. The CTLs were also shown to contain and release effector molecules, which damage cells. The researchers also found evidence that HIV may worsen cerebral malaria, comparing CTL patterns in the cerebral malaria cases where there was coinfection with HIV and no infection. In the HIV-positive cases, there were more CTLs and they had migrated across the surface to the outside of the vessels, instead of lining up against the inside wall of brain blood vessels as they did in HIV-negative cases. (Click for more...) Shingles vaccine linked to lower stroke risk 2/20/2020 7:30:01 PM Shingles vaccine linked to lower stroke risk Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 At the International Stroke Conference 2020 in Los Angeles, researchers unveiled data about using zoster vaccine live (Zostavax—Merck) for shingles prevention. A large Medicare cohort study suggests that using this treatment can also reduce the risk of subsequent stroke among older adults. Shingles vaccination was associated with a 20% decrease in stroke risk in people younger than age 80 years in the study. Older participants showed a 10% reduced risk. Reductions were seen for both ischemic and hemorrhagic events, according to the data. Quanhe Yang, PhD, lead study author and senior CDC scientist, said: "Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk." Yang and colleagues evaluated the only shingles vaccine available at the time of the study, zoster vaccine live. However, CDC has determined that an adjuvanted, non-live recombinant vaccine (Shingrix—GlaxoSmithKline) is the preferred shingles vaccine for healthy adults aged 50 years and older. Zoster vaccine live can still be used in healthy adults over age 60 years, according to CDC. Yang said a reduction in inflammation may be the mechanism by which stroke risk is reduced. (Click for more...) CRN, CHPA and 2 others warn about coronavirus prevention, treatment claims 2/20/2020 7:30:01 PM CRN, CHPA and 2 others warn about coronavirus prevention, treatment claims Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 The Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, and the United Natural Products Alliance have issued a joint advisory about some dietary supplement makers promoting their products by claiming to treat or prevent coronavirus. The organizations suggest that marketers and retailers should refuse to stock or sell supplements presented as treating, curing, or preventing coronavirus, noting that while research supports the use of certain supplements to promote immune health, there is no research suggesting that a supplement might treat or prevent coronavirus. The groups also pointed out that makers of dietary supplements in the United States are legally prohibited from making disease prevention or treatment claims. (Click for more...) Surescripts' report shows greater demand for Rx price transparency 2/20/2020 7:30:01 PM Surescripts' report shows greater demand for Rx price transparency Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 A survey by Surescripts called Prescription Price Transparency and the Patient Experience suggests that patients want to discuss the price of a prescription with their provider to avoid unpleasant surprises and delays. The survey found that more than one-half of the patients surveyed had not taken a medication due to cost, of whom 94% said they would have been willing to take a lower-cost alternative if their physician or nurse had suggested one. Nearly 3 in 10 patients had not taken medication because of the wait time. Among Millennials, 61% said they had skipped a medication due to the price, while 38% said they did so because it took too long to fill. The survey also found that 56% of patients said they discuss medication costs with their physician or nurse at least some of the time, but 63% of these conversations were initiated by the patient. The survey furthermore indicates that patients believe prescription price transparency at the point of care helps them afford their medications (55%), and raises both their satisfaction with their physician (50%) and the likelihood that they will stay with that provider (50%). Some 41% of patients said they referred other patients to their physician as a result of conversations they had about price and lower-cost alternatives. Meanwhile, PBMs and electronic health records vendors are developing tools to enable health care providers to provide patient-specific, benefits-based cost information at the point of care. (Click for more...) Report tracks highest-cost and most-used prescription drugs in Massachusetts 2/20/2020 7:30:01 PM Report tracks highest-cost and most-used prescription drugs in Massachusetts Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 The Center for Health Information and Analysis (CHIA), an independent state agency in Massachusetts that monitors the performance of the state's health care system, recently released its second report on prescription drug use and spending at the point of purchase by residents who are covered by insurance. The report reveals that 10 treatment categories of drugs represented more than 70% of pharmacy claims from 2015 to 2017. These categories include anti-asthmatic, cardiovascular, and antiviral medications. The 3-year analysis is based on a subset of commercial pharmacy claims in CHIA's All Payer Claims Database that includes the amount paid by a health plan to pharmacies, in addition to patient out-of-pocket costs. The largest portion of spending was for anti-inflammatory tumor necrosis factor inhibiting agents, a class of drugs used to treat difficult-to-manage diseases such as rheumatoid arthritis. The most frequently prescribed drug during the 3-year period was lisinopril, an angiotensin-converting enzyme (ACE) inhibitor that treats high blood pressure and heart failure. The drug ledipasvir/sofosbuvir (Harvoni—Gilead Sciences), used by many patients with chronic hepatitis C, appears as the costliest drug on a list of 20 drugs in terms of cost and prescriptions, with an average cost per prescription at $30,771.60. Dextroamphetamine-amphet er, which is used in the treatment of ADHD, had an average cost per prescription of $139.59 and had the highest number of prescriptions: 127,738. (Click for more...) Report finds that drug rebates drive up consumer costs 2/20/2020 7:30:01 PM Report finds that drug rebates drive up consumer costs Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 Discounts by drug makers to PBMs could be driving up list prices and some consumer costs, according to a new report by researchers at the University of Southern California. They conducted a data analysis that found that for every dollar in discounts drug makers give to PBMs for a brand-name drug, the list price goes up $1.17. The report states, "This suggests that reducing or eliminating rebates could result in lower list prices, thereby decreasing out-of-pocket costs for uninsured patients and for insured patients with deductibles or coinsurance." To ensure that people with insurance are able to purchase their treatments, drug companies offer major discounts to PBMs in order to be included in their formularies. The white paper authors point out, "This dynamic can drive the perverse result in which PBM formularies favor drugs that offer higher rebates over similar drugs with lower net costs and lower rebates." The researchers also found that discounts for drugs with no generic equivalents appeared to drive list prices higher than drugs with generic equivalents. The team based its findings on the use of a data tool that monitors quarterly list prices and estimates the net prices of brand drugs. The researchers caution the tool has not been formally validated but is used "in high-stakes investment decisions by Wall Street banks and in drug value assessments by the Institute for Clinical Effectiveness Research." (Click for more...) Ohio governments working to craft unusual opioid bargain 2/20/2020 7:30:01 PM Ohio governments working to craft unusual opioid bargain Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 Ohio officials are nearing agreement on dividing up proceeds of a potential settlement with the opioid industry that would give local governments much of the control of the purse strings. Communities in Ohio would receive 30% of the money up front—double the 15% reserved for the state, and hold some long-term sway over a network of regional boards reporting to a nonprofit foundation that would manage the remaining 55%. The number of opioid deaths suffered by a community would be among criteria for determining its share. Attorneys are working to address significant divisions that remain after a meeting of the parties last week. Tensions between Ohio's smaller and larger communities—as well as between all the municipalities and the state—prompted requests that the ultimate Ohio deal provide more legal assurances to cities and counties about the 55% share proposed to go to the foundation. No other state has announced plans for dividing settlements over the toll of opioids, and no national opioid settlement has been finalized yet. One with Purdue Pharma is being worked on in bankruptcy court, and a group of three drug distribution companies and two manufacturers are working on a settlement intending to resolve all litigation against them. (Click for more...) Colorado lawmakers aim to add more transparency to prescription costs with set of bills 2/20/2020 7:30:01 PM Colorado lawmakers aim to add more transparency to prescription costs with set of bills Wed, 02/19/2020 - 19:00 cbaker_admin Thu, 02/20/2020 - 19:30 Colorado state lawmakers have introduced legislation to add transparency to prescription medication costs. House Bill 20-1160, known as the Drug Price Transparency Insurance Premium Reductions bill, would require drug manufacturers, insurers, and PBMs to report certain information about their high-cost drugs. This information would be reported to the state Division of Insurance, which would use it to put out a report on its website to help consumers understand which medications are seeing price increases. The agency would also report back to the legislature to help lawmakers understand what is happening with pricing so they can craft legislation to address it. In particular, the bill would look at is how much is spent on marketing some of the most expensive medications versus research and development. HB20-1160 would also require insurers to pass savings on to consumers by lowering premiums based on the rebates they receive from manufacturers. Bill co-sponsor Rep. Dominique Jackson says the bill is just a first step towards understanding the challenges that are driving up prescription drug costs. (Click for more...) Lilly backs athletes going for gold in Tokyo with sponsorship of U.S. Olympic and Paralympic teams 2/20/2020 1:56:51 PM Eli Lilly is joining Team USA as an official partner for the first time, sponsoring Olympic and Paralympic athletes headed to Tokyo this summer. The one-year deal will include a campaign with Team USA athletes engaging as brand ambassadors to raise awareness of conditions such as diabetes, cancer, migraine and psoriasis. (Click for more...) Through Rx-to-OTC switch process, FDA approves three drugs for nonprescription use 2/20/2020 11:11:04 AM Through Rx-to-OTC switch process, FDA approves three drugs for nonprescription use Thu, 02/20/2020 - 11:25 caldridgeyoung… Thu, 02/20/2020 - 11:11 Diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain—GlaxoSmithKline), a NSAID for temporary relief of arthritis pain. (Click for more...) Merck & Co.'s touted chief digital officer bolts for Marriott just 2 years into tenure 2/20/2020 10:52:46 AM In a sign of the times, Merck & Co. mimicked other leading drugmakers in late 2018 by hiring its first chief digital officer—a position tailor-made to bring the company's R&D and marketing into the tech-fueled future. But now, after less than two years, Merck's digital head is moving on. (Click for more...) Teva's Austedo hits a setback with Tourette syndrome trial failures 2/20/2020 10:43:44 AM Facing long-running challenges in generics and following a global scaling back of its operations, Teva has centered its growth ambitions on new launches Austedo and Ajovy. This week, the company’s Austedo expansion aims hit a setback with a trial failure in pediatric patients with Tourette syndrome. (Click for more...) Biotech buying manufacturing know-how for its clinical-stage radiation treatment 2/20/2020 10:11:56 AM A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug is buying all of the know-how for manufacturing the API and will move manufacturing to the U.S. (Click for more...) Merck KGaA selling manufacturing site, allergy drugs to Dermapharm 2/20/2020 9:18:11 AM It's out with the old and in with the new for Merck KGaA. The German drugmaker is selling a manufacturing site and portfolio of older allergy drugs as it focuses on new specialty drugs. (Click for more...) Takeda CEO: It's time to be 'more proactive than reactive' on outbreak prep 2/20/2020 9:03:00 AM After prior outbreaks of Zika, Ebola, MERS and other emerging diseases left thousands dead, experts expected another crisis⁠—it was only a matter of when. Now, amid a hunt for treatments and vaccines against the novel coronavirus, Takeda CEO Cristophe Weber says it's time to prepare for the next outbreak. (Click for more...) Half of GPs skip out ‘vital’ diabetes kidney test 2/20/2020 6:26:46 AM The test, which is used to detect kidney damage that can lead to fatal complications, should be conducted every year. (Click for more...) Roche’s Tecentriq bags Priority Review in US 2/20/2020 5:43:33 AM In a trial, the drug improved overall survival by 7.1 months compared with chemotherapy. (Click for more...) US breakthrough designation granted to Padcev in bladder cancer 2/20/2020 5:38:33 AM The designation was granted based on results from the dose-escalation cohort and expansion cohort A of the EV-103 Phase Ib/II trial. (Click for more...) ‘Transformative’ surgical robot trialled on NHS 2/20/2020 5:33:28 AM The step marks a “pivotal milestone" for Versius. (Click for more...) Dedication to science drives a 20-year relationship between an information expert and a distinguished researcher 2/20/2020 3:30:08 AM With about 600 articles published in major dermatology journals, almost 40 books authored, 70 chapters in various books, and a h-index of 49, Dr. Robert Baran is one of the most knowledgeable dermatologists in the world. He began publishing more than 67 years ago, is invited to many international conferences every year, and his specialty […] (Click for more...) Under the Dome: WVU Legislative Update 2/20/2020 12:00:00 AM The latest edition of Under the Dome — Feb. 20, 2020 — provides an update on a number of high-profile bills and resolutions introduced and debated, including the University's VSIP bill, WV Forward Initiatives, campus carry and higher education exemption bills. (Click for more...) HHS engages Sanofi's recombinant technology for 2019 novel coronavirus vaccine 2/19/2020 7:05:48 PM HHS engages Sanofi's recombinant technology for 2019 novel coronavirus vaccine Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 HHS said Tuesday that it will provide expertise and reallocated funds to Sanofi Pasteur for the development of a vaccine against the 2019 novel coronavirus (COVID-19). Sanofi will use its egg-free, recombinant DNA platform to produce a candidate vaccine against the virus. The company's technology creates an exact genetic match to proteins of the virus. "Flexibility and scalability are cornerstones of rapid response to an emerging infectious disease," said Rick A. Bright, PhD, director of the Biomedical Advanced Research and Development Authority, a component of HHS' Office of the Assistant Secretary for Preparedness and Response. "Using this proven technology, we can pivot immediately to address this new global health threat." Bright said the aim is to develop "a licensed vaccine to provide long-term health security against this latest virus and prevent future coronavirus outbreaks." (Click for more...) HHS, Janssen collaborate to develop coronavirus therapeutics 2/19/2020 7:05:48 PM HHS, Janssen collaborate to develop coronavirus therapeutics Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 The Biomedical Advanced Research and Development Authority (BARDA), part of HHS' Office of the Assistant Secretary for Preparedness and Response, said Tuesday it is expanding its partnership with Janssen Research & Development to develop treatments for coronavirus infections. BARDA will collaborate with Janssen, which is part of Johnson & Johnson, to identify medications that might be used safely and effectively to reduce the severity of illness and treat coronavirus infections. Additionally, Janssen will identify compounds that have antiviral activity against the 2019 novel coronavirus. "This is the third coronavirus to emerge and cause severe respiratory disease in humans within 18 years, and there are still no proven therapies to treat this disease," said BARDA Director Rick A. Bright, PhD. "In partnering with Janssen, BARDA is breaking this barrier to protect against this, as well as the next, coronavirus outbreak." Products to be screened include approved therapeutics and investigational therapeutics that have completed some clinical trials so that basic safety and pharmacology data are available. (Click for more...) Cardiovascular and safety outcomes of chlorthalidone vs. hydrochlorothiazide to treat hypertension 2/19/2020 7:05:48 PM Cardiovascular and safety outcomes of chlorthalidone vs. hydrochlorothiazide to treat hypertension Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 Chlorthalidone has not been challenged as the first-line thiazide diuretic to treat high blood pressure, prompting researchers to compare its safety and efficacy with that of hydrochlorothiazide. They drew their data from three large databases, ultimately compiling a cohort of 730,255 patients from the period spanning 2001–18. More than 50 safety endpoints were studied, including acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome consisting of the first three outcomes plus sudden cardiac death. Among the sample population, 693,337 patients were prescribed hydrochlorothiazide, with 3,089 composite outcome events recorded. Only 36,918 patients were prescribed chlorthalidone, with 149 composite outcome events documented. The study determined that chlorthalidone does not offer significant cardiovascular benefits over hydrochlorothiazide. The data do suggest that it has a worse safety profile of the two drugs, thanks to an association with elevated risk of hypokalemia, hyponatremia, acute renal failure, chronic kidney disease, and type 2 diabetes. Based on this real-world evidence, investigators believe the status of chlorthalidone as the gold standard for hypertension is not justified. (Click for more...) Empirical anti-MRSA vs. standard antibiotic therapy and risk of mortality in patients with pneumonia 2/19/2020 7:05:48 PM Empirical anti-MRSA vs. standard antibiotic therapy and risk of mortality in patients with pneumonia Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 Yet another study calls into question the value of empirical anti-methicillin-resistant Staphylococcus aureus (MSRA) therapy for patients hospitalized with pneumonia. In this setting, researchers retrospectively examined 30-day mortality among men and women treated for community-onset pneumonia in the Veterans Health Administration health care system from 2008–13. Of 88,605 patients meeting the profile, 33,632 underwent standard pneumonia care plus empirical anti-MSRA therapy. Among them, 13,528 received empirical anti-MRSA therapy plus usual antibiotics and 20,104 received empirical anti-MRSA therapy without standard antibiotics. The remaining 54,973 patients received empirical standard guideline-recommended therapy alone. A total of 8,929 patients met the primary endpoint of 30-day mortality, but investigators determined that anti-MSRA therapy did not correlate to fewer deaths in any group of patients hospitalized with pneumonia—including those with risk factors for MRSA. To the contrary, empirical anti-MRSA treatment was significantly associated with greater 30-day mortality compared with standard therapy alone. Meanwhile, compared with standard therapy alone, empirical anti-MRSA therapy plus standard therapy was significantly associated with an elevated adjusted risk of death, kidney injury, and other unfavorable outcomes. (Click for more...) Vaccines can prevent fatal complications from measles, study affirms 2/19/2020 7:05:48 PM Vaccines can prevent fatal complications from measles, study affirms Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 A study in BMJ Case Reports reveals that nearly a third of all reported cases of measles have such complications as pneumonia, hepatitis, and viral meningitis. The researchers noted that anti-vaccination efforts are a factor in an upsurge in cases among children and adults, and that complications occur most commonly in people younger than age 5 years or older than age 20 years. They wrote, "With the current global outbreak of measles, we emphasize the importance of an immunization history. Urgent efforts are needed to ensure global coverage." The report also noted that full coverage requires both doses of the measles vaccine. In one reported case, the researchers noted that the patient received only a single dose of the two-dose measles vaccine in childhood. In two other cases examined in the study that resulted in appendicitis and viral meningitis, there were no reported histories of measles vaccinations. Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, said people should be particularly cautious because it is currently peak season for influenza. He explained, "This article reinforces how terrible a disease measles is ... and why we need to vaccinate our kids." The reemergence of measles is occurring in the United States and other countries around the world, including Madagascar, Nigeria, and Ukraine. CDC estimates that more than 140,000 people worldwide died from measles in 2018. (Click for more...) FDA anticipates disruptions, shortages as China outbreak plays out 2/19/2020 7:05:48 PM FDA anticipates disruptions, shortages as China outbreak plays out Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 FDA Commissioner Stephen Hahn says the agency has contacted drug and device makers regarding anticipated shortages in medical supplies and drugs as the COVID-19 outbreak widens. FDA notes that to date, supply chain links have not been affected, but it will take all available measures if disruptions appear. FDA also has stopped all plant inspections in China, but says it can rely on facilities' compliance history and other information to determine whether drugs are safe for import. Hahn says, "We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. It's worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China. Raw materials used in manufacturing do come from China and other locations in Southeast Asia, and we are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials." Hahn adds that FDA is in contact with regulators worldwide and has added resources to promptly identify "potential disruptions or shortages." A survey conducted in India, which manufactures roughly 40% of the generic drugs used by U.S. patients, indicates that manufacturers there have about a 2-month supply of ingredients from China. (Click for more...) FDA touts generic drug research in 2019 2/19/2020 7:05:48 PM FDA touts generic drug research in 2019 Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 A new report released by FDA describes scientific research conducted and funded by the agency in fiscal year 2019 to support the development of generic drugs under the Generic Drug User Fee Amendments (GDUFA II). The report covers 13 research areas within FDA's four scientific priorities the agency set for FY2019, including complex drug-device combination products and methodologies for bioequivalence and substitutability evaluation. The research addresses ways to strengthen FDA's assessment of abuse-deterrent formulations, generic dry powder inhalers, and handling the complexity of long-acting injectables and implants, among other areas. FDA's Office of Research and Standards said the agency is using machine learning to predict the time to first submission of abbreviated new drug applications (ANDAs). FDA also awarded 14 new research contracts and three grants in FY2019 and conducted more than 50 research projects using internal resources. Sally Choe, PhD, director of the Office of Generic Drugs, and Michael Kopcha, PhD, RPh, director of the Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research, noted that in FY2019, FDA released 252 new and revised product-specific guidances for generic drugs and received 112 requests for pre-ANDA meetings for complex generic drugs. Choe and Kopcha also credit GDUFA-funded research with helping develop new complex generic drugs, such as fluticasone propionate and salmeterol inhalation powder and acyclovir cream. (Click for more...) New partnership gives pharmacies mHealth tools for diabetes prevention 2/19/2020 7:05:48 PM New partnership gives pharmacies mHealth tools for diabetes prevention Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 Telehealth and mHealth should play key roles in diabetes prevention efforts in underserved communities, according to APhA. The APhA Foundation says it is partnering with The Kroger Company and Tabula Rasa Healthcare to add connected health elements to its CDC-approved National Diabetes Prevention Program, called Project IMPACT: Diabetes Prevention. Launched in 2017, the program's goal is to provide access to health and wellness resources and coaching to at-risk populations nationwide via pharmacies. Benjamin Bluml, the APhA Foundation's senior vice president of Research and Innovation, says: "Our approach is to use community pharmacy-based screenings to identify people who are unaware of their risk and offer them a convenient solution. In doing so we provide a solution at a place they already visit, we use people they already confide in—their community pharmacist—and we make it convenient to learn and be coached to a healthier lifestyle. If someone's schedule is too crazy to attend in-person group classes at their community pharmacy, they can still participate via a telephonic or on-line option." Bluml adds that pharmacies seeking to join Project IMPACT "need to already have demonstrated a commitment to helping their communities improve health, over and above the important medication dispensing services." (Click for more...) Benzer Pharmacy launches at-home medication disposal program 2/19/2020 7:05:48 PM Benzer Pharmacy launches at-home medication disposal program Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 Tampa, FL-based Benzer Pharmacy will soon offer DisposeRx packets designed for safely disposing unused and expired medications at home. The packets will be offered by pharmacists during comprehensive in-person consultations with patients. Tonya Shackelford, Benzer Pharmacy president, says: "Our culture is built on a 'people first' philosophy, and the safety of our patients and their families is paramount. We know that medication disposal is a critical but often overlooked step needed to prevent drug diversion and accidental poisonings. DisposeRx is a simple and cost-effective product with a supporting education program that we can offer to our loyal customers." Benzer has 82 locations across 29 states and is committed to patient wellness and providing the professional support that local pharmacists need to better serve their communities. (Click for more...) Chain pharmacies add CLIA-waived POC blood testing and other preventive health services to their in-store offerings 2/19/2020 7:05:48 PM Chain pharmacies add CLIA-waived POC blood testing and other preventive health services to their in-store offerings Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 A rising number of clinical laboratory companies are offering testing via unconventional delivery systems. For example, Mansfield, TX-based eTrueNorth has partnered with Walmart, Winn-Dixie, Kroger, and other companies to offer employees CLIA-waived point-of-care testing, preventive health services, wellness screenings, and other medical laboratory testing services via its eLabNetwork group of pharmacies. By incorporating point-of-care testing at community pharmacies, eTrueNorth says it can address shortfalls in health care. According to the company, its ePOCT software suite provides the infrastructure for CLIA-waived laboratories to meet all applicable federal, state, and local regulations. Documentation is provided to medical professionals as they monitor compliance with quality-control initiatives for diagnostic devices. Coral May, eTrueNorth's CEO, president, and co-founder, says in the second quarter of 2020, the company will unveil "within several different health plans" the ability "to provide and submit claims for tests that will close quality measures, gaps in care." This indicates that participating insurers would be communicating with their members directly to steer them to eLabNetwork pharmacies where they can receive CLIA-waived testing. Meanwhile, eTrueNorth's Voucher Solution program allows employees who miss onsite wellness screenings or who work remotely to visit a local pharmacy to obtain point-of-care testing and on-site counseling. (Click for more...) Trump Medicaid proposal sparks bipartisan warnings 2/19/2020 7:05:48 PM Trump Medicaid proposal sparks bipartisan warnings Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 The Trump administration's proposal to overhaul the complex payment arrangements states use to raise money for their Medicaid programs has come under criticism from Republicans and Democrats alike. The proposal would allow CMS to limit the extra payments from states to providers serving high numbers of uninsured patients or Medicaid patients. Opponents say such changes could result in providers deciding not to accept Medicaid patients. Hospitals, insurers, patient advocates, and members of both political parties have urged the administration to withdraw the proposal. The administration argues some states use questionable methods of raising funds so they can leverage more money from Washington. One approach used by states consists of taxing providers who stand to benefit from more Medicaid funds flowing into the state. Governors and state Medicaid directors argue those long-standing arrangements are both legal and necessary as states look for ways to keep up with escalating health care costs. Dozens of states wrote public comments to CMS Administrator Seema Verma, urging her to withdraw the proposal, including conservative states that are typically supportive of her work. (Click for more...) FDA takes action with Indian government to stop about 500 shipments through international mail 2/19/2020 7:05:48 PM FDA takes action with Indian government to stop about 500 shipments through international mail Tue, 02/18/2020 - 19:00 cbaker_admin Wed, 02/19/2020 - 19:05 FDA on Tuesday announced that its first bilateral enforcement operation with the government of India stopped approximately 500 shipments of illicit, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January. Operation Broadsword targeted packages entering the United States through an International Mail Facility from January 28 through January 30. The operation was a collaboration between FDA's Office of Regulatory Affairs, Office of Criminal Investigations, Forensic Chemistry Center and Division of Northern Border Imports, along with the Government of India's Central Board of Indirect Taxes and Customs and Directorate of Revenue Intelligence and U.S. Customs and Border Protection. Investigators from both governments examined more than 800 shipments, which identified approximately 50 different FDA-regulated products, including medications intended to treat and or mitigate serious diseases, such as various forms of cancer and HIV. Many of the shipments, which included opioid drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection. (Click for more...) Joint effort of FDA and India intercepts illegally shipped opioids, cancer drugs 2/19/2020 11:34:54 AM India and the FDA has sometimes had a strained relationship given how often the agency has come down on Indian drugmakers for manufacturing lapses. Now, in a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S. (Click for more...) Bluebird, cleared for Zynteglo launch, aims to dose first patients soon 2/19/2020 10:41:55 AM Dogged for months by concerns over manufacturing, Bluebird Bio's ultra-pricey flagship gene therapy Zynteglo was finally cleared for launch in Germany just weeks ago. Now, with a manufacturing green light in hand, Bluebird is hoping to make good on its commercial hopes in the coming months. (Click for more...) J&J offered doctors free services and profit-making advice to boost Remicade scripts: whistleblower suit 2/19/2020 9:39:15 AM Many top drugmakers have faced allegations that they offered free services as kickbacks to doctors, and Johnson & Johnson is among them. A whistleblower lawsuit says J&J's Janssen unit helped doctors set up high-volume "infusion suites" and offered other services to amp up Remicade and Simponi prescriptions. (Click for more...) AbbVie-Allergan deal foes try again to spur an FTC crackdown 2/19/2020 9:16:12 AM AbbVie and Allergan's megamerger is likely in the final stages of review after the pair agreed to offload three drugs, including IL-23 hopeful brazikumab. But a cadre of union and consumer groups say that's not enough—and they're taking another stab at turning regulators against the combo. (Click for more...) Audentes investing $109M in gene therapy manufacturing facility with 200 jobs 2/19/2020 9:13:57 AM With a gene therapy nearing the finish line and $3 billion in hand from its buyout by Astellas, biotech Audentes is ready to start work on its $109 million gene therapy manufacturing facility that will employ 200. (Click for more...) New report highlights ‘toxic’ risk of propranolol 2/19/2020 6:10:58 AM There was a 34% increase in overdose deaths caused by propranolol between 2012 and 2017, and by 2016 nearly 4.7 million prescriptions were issued to patients annually. (Click for more...) Opdivo, cabiralizumab combo falls short in pancreatic cancer 2/19/2020 6:03:36 AM Bristol-Meyers Squibb said that it will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials. (Click for more...) Vyndaqel first treatment approved in Europe for ATTR-CM 2/19/2020 5:58:42 AM The decision was based on results from the Phase III ATTR-ACT study. (Click for more...) 21 states reject $18 billion offer from drug wholesalers to settle opioid litigation 2/18/2020 7:05:01 PM 21 states reject $18 billion offer from drug wholesalers to settle opioid litigation Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 More than 20 state attorneys general have rejected an $18 billion offer from three major drug wholesalers aimed at settling litigation over their alleged role in the opioid crisis. At least 30 states have either sued the distributors or have been involved in talks to resolve claims. Whether they support the $18 billion offer or not, states said they continue to negotiate with the wholesalers to potentially strike some kind of deal. The dissenting states reportedly want a larger total amount, or for the sum to be paid out sooner than the proposed 18 years. Some states are said to be targeting between $22 billion and $32 billion over fewer than 18 years. The rejection is the latest setback in talks to resolve the thousands of lawsuits arising from the opioid crisis. The majority of suits filed against the drug industry have been brought by county and city governments and are consolidated in federal court in Cleveland. State attorneys general have largely pursued cases in their own state courts. The dissenting states' letter signals an agreement is not likely before summer and will probably involve a larger sum than Wall Street anticipated, Evercore ISI analyst Elizabeth Anderson said in a note Friday to investors. (Click for more...) FDA approves three drugs for nonprescription use through prescription-to-OTC switch process 2/18/2020 7:05:01 PM FDA approves three drugs for nonprescription use through prescription-to-OTC switch process Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 FDA approved on February 14 three drugs for nonprescription use through the prescription-to-OTC switch process. The agency approved diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain—GlaxoSmithKline) for the temporary relief of arthritis pain; olopatadine HCl ophthalmic solution/drops, 0.1% (Pataday Twice Daily Relief—Alcon) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander; and olopatadine HCl ophthalmic solution/drops, 0.2% (Pataday Once Daily Relief—Alcon) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use. "As a result of the Rx-to-OTC switch process, many products sold OTC today use ingredients or dosage strengths that were available only by prescription 30 years ago," explained Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in FDA's Center for Drug Evaluation and Research. "Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription." For a drug to switch to nonprescription, or OTC, status, the data must show that the product is safe and effective for use in self-medication as directed in the proposed labeling. The drug manufacturer must demonstrate that users can understand how to take the drug safely and effectively without the supervision of a health care professional. FDA noted that all three drugs will now only be marketed in the United States as nonprescription drugs. Individuals taking them should read and follow the Drug Facts labels for them. Individuals who are currently taking prescription versions of these products and have questions about the Rx-to-OTC switch should talk to their health care professional. (Click for more...) Amid coronavirus fears, a second wave of influenza hits U.S. kids 2/18/2020 7:05:01 PM Amid coronavirus fears, a second wave of influenza hits U.S. kids Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 The U.S. influenza season got underway earlier than usual—with the initial wave starting in October, cresting in late December, and slowing in the early part of the year—but a second wave is now wreaking havoc, especially on children. According to CDC data, about 26 million Americans have fallen ill during the current cycle, with about 250,000 requiring hospitalization and approximately 14,000 dying. Agency sources say those number are not high by historical standards because the viruses driving both the late 2019 and early 2020 surges are not taking as heavy a toll on older adults as normal. Rather, they explain, those strains are particularly hard on children, who are experiencing an alarming rate of influenza-related hospitalization and mortality. Both statistics are at the highest levels at this point in any cycle since 2009–10, with weeks more still to go. Complicating the extended influenza season even more is the emergence of coronavirus, which presents similar symptoms. Although most cases have occurred in China, 15 have been documented in the United States. However, given the potential for confusion over diagnoses, five public health labs that normally test for influenza will also begin screening for coronavirus. (Click for more...) CDC: Influenza surveillance system enlisted in hunt for COVID-19 cases 2/18/2020 7:05:01 PM CDC: Influenza surveillance system enlisted in hunt for COVID-19 cases Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 Federal health officials will use a national influenza surveillance system to identify people who may be infected with the new coronavirus, COVID-19, launching its first phase at public health laboratories that are part of the system in Los Angeles, San Francisco, Seattle, Chicago, and New York City. CDC says that surveillance at those five sites is just a starting point and that COVID-19 surveillance will expand nationally in the coming weeks. All 15 COVID-19 cases in the United States have been connected to Hubei province travelers or their close contacts, but federal health officials want to be prepared in case the pattern changes. CDC has also adjusted how it tests for quarantined evacuees as it learns more about how the virus behaves in people. There are currently about 600 people still in quarantine, and CDC will now limit testing to people with a history of exposure who have symptoms. Nancy Messonnier, MD, director of CDC's National Center for Immunization and Respiratory Diseases, noted Friday that testing too early may result in a negative test that could provide a false sense of security. The concern, she said, is not about false negative readings, but that virus levels have not risen high enough to be detectable. (Click for more...) Largest study of sepsis cases among Medicare beneficiaries finds significant burden 2/18/2020 7:05:01 PM Largest study of sepsis cases among Medicare beneficiaries finds significant burden Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 A landmark study, published in Critical Care Medicine, has identified sepsis—a potentially deadly complication of infection—as a significant burden on the Medicare population and system. Researchers from the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and CMS analyzed data from Medicare beneficiaries from 2012–18, including 9.5 million inpatient hospital admissions. They found that while Medicare enrollment rates went up 22% during the study period, the rate of sepsis-related hospital admissions among beneficiaries surged 40% over the same time span. Although sepsis-related mortality was down overall, the analysis indicated that 10% of patients with non-severe sepsis died while hospitalized or within 1 week of being discharged and that 60% died within 3 years. Those percentages climbed for patients with septic shock, one of the most acute types of sepsis. Also at elevated risk were patients with other chronic health conditions. The study additionally captured the steep cost of treating sepsis, which actually declined on a per-stay basis over the 6 years. However, because the number of patients developing sepsis increased, Medicare's overall spending on the condition jumped to more than $41.5 billion in 2018 from $27.7 billion in 2012. Based on modeling, the study authors anticipate that the cost of care for last year could come in at more than $62 billion. In the meantime, ASPR, CMS, and CDC all continue to work independently and with others on solutions aimed at early detection; awareness, education, and training; and innovation in treating the infections that cause sepsis. (Click for more...) Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer 2/18/2020 7:05:01 PM Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 A multinational team of cancer researchers worked together to determine if tucatinib, as an adjunct to dual therapy with trastuzumab and capecitabine, might improve the prognosis for certain breast cancer patients. The study population included more than 600 women with human epidermal growth factor receptor 2 (HER2)–positive disease who were previously treated with HER2-targeted agents including trastuzumab, pertuzumab, and trastuzumab emtansine. Participants received combination therapy with trastuzumab and capecitabine plus, according to randomization, oral tucatinib or placebo. The primary outcome was progression-free survival in the first 480 patients to undergo randomization. The rate at 1-year followup for patients in the group treated with tucatinib, an investigational highly selective inhibitor of the HER2 tyrosine kinase, was 33.1%. That was more than double the 12.3% logged by the control group. Progression-free survival lasted a median 7.8 and 5.6 months, respectively. Secondary outcomes—including progression-free survival in patients with brain metastasis and overall survival—also favored tucatinib, as assessed in the total study population. However, the researchers noted, patients in the tucatinib arm were more likely to experience diarrhea and elevated aminotransferase levels. (Click for more...) Letter to the Editor: When pharmacists make drug errors 2/18/2020 7:05:01 PM Letter to the Editor: When pharmacists make drug errors Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 APhA CEO Thomas E. Menighan responds to a recent New York Times article on overworked pharmacists by noting the current system sets pharmacists up to fail. "The weight of the potentially dire consequences of filling the wrong prescription or missing dangerous drug interactions is crushing pharmacists, personally and professionally," warns Menighan. He says the solution comes from "taking a hard look at how pharmacies are reimbursed and who profits from inadequate patient care." PBMs make good money, despite no proof that they serve patients. They say they keep prices and premiums down but fight efforts to demystify how they achieve this. "If it's not greedy, let's see how it works. If it really helps patients, tell us how. But they won't. It’s indefensible," concludes Menighan. (Click for more...) Analysis of unregulated sale of life-saving prescription drugs online in the United States 2/18/2020 7:05:01 PM Analysis of unregulated sale of life-saving prescription drugs online in the United States Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 Analog insulins are the most frequently advertised prescription drugs listed on Craigslist, and they are offered at a deep discount, a new study reveals. Although the unregulated sale and purchase of prescription drugs is illegal, the researchers investigated the availability of three drugs—insulin, albuterol, and epinephrine (EpiPen)—on Craigslist, noting that reports in the lay press indicate that some individuals who cannot afford their prescriptions seek out discounted products through online marketplaces. During a 12-day period in June 2019, the cross-sectional analysis of U.S. Craigslist advertisements in all 50 states found 105 ads for albuterol and 327 for insulin. There were no ads for EpiPens. Of the insulin products being sold, analog insulin was the most commonly advertised, with 311 posts. Compared with the price listed on Drugs.com, the average price for an albuterol inhaler was $18.77 more expensive than retail. However, the price per vial of analog and human synthetic insulin were $372.30 and $123.19 less expensive, respectively. A content analysis of the ads revealed a few key themes: the motivation of the sellers, the quality and safety of the products, and sales and shipping details. "Sellers were frequently motivated by altruism and aversion to wasting medication," the researchers report. "The content of many advertisements raised safety concerns about the quality and safety of the medications being sold." The authors note that although there is no way to know if these ads resulted in actual sales, the findings indicate that "patients are seeking and likely finding medication, in particular analog insulin, in unregulated and unmonitored online marketplaces." (Click for more...) CVS Health makes Caremark transformation leadership appointments 2/18/2020 7:05:01 PM CVS Health makes Caremark transformation leadership appointments Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 As part of its growth plan, CVS Health says it is making several executive leadership changes. CVS Health executive vice president Alan Lotvin, who formerly led the company's transformation efforts, will now serve as president of CVS Caremark. He also will oversee CVS Specialty and CVS Kidney Care. Lotvin has considerable experience in the PBM business, including expertise in specialty pharmacy. Jonathan Mayhew was appointed executive vice president of transformation, and will be responsible for the transformation product portfolio. Mayhew most recently served as senior vice president for the Aetna Markets organization. CVS Health says Mayhew's ability to build and grow businesses will help products thrive across the company's open-access platform. Alec Cunningham was named executive vice president and COO for Aetna, and will focus on Medicare Advantage and government programs overall. Cunningham joined CVS Health last year from Concerto Healthcare. Finally, Derica Rice, executive vice president and president, CVS Caremark, will depart CVS Health. Rice will remain with the company through February to help with the transition. (Click for more...) Missouri House approves statewide prescription drug monitoring 2/18/2020 7:05:01 PM Missouri House approves statewide prescription drug monitoring Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 Lawmakers in the Missouri House passed legislation to form a statewide prescription drug monitoring program (PDMP). The program is intended to curb the abuse of opioids. At present, more than 80% of the state's population is covered under St. Louis County's PDMP, and this measure would expand the coverage statewide, with certain added safeguards. State Rep. Holly Rehder (R), who sponsored the measure, explains: "The precautions we put in this bill that is not in the St. Louis County program to address privacy … is that our narcotics control act cannot be used for the sole basis for issue of a warrant. This bill mandates that the search of a PDMP cannot be used as the basis for denying someone access to a firearm." Missouri is the only state that does not have a statewide PDMP. The measure now moves to the Senate. (Click for more...) Colorado wants to let pharmacists write prescriptions for HIV prevention drugs 2/18/2020 7:05:01 PM Colorado wants to let pharmacists write prescriptions for HIV prevention drugs Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 Colorado could be among the first states to allow patients to obtain prescription HIV drugs from the pharmacy. Proposed legislation gathering bipartisan support would allow pharmacists to screen a person for HIV using a blood test and consultation, and then prescribe either the daily prevention drug, called PrEP, or an emergency drug, called PEP, taken within 72 hours of potential exposure to the virus. The measure, introduced by state Reps. Leslie Herod (D) and Alex Valdez (D), also calls for insurance plans to cover the medication and reimburse pharmacists for the consultation. If passed, the legislation would require the state Board of Pharmacy to write training requirements for pharmacists following CDC guidelines on HIV medications. Some GOP lawmakers want to revise the measure to make sure the Colorado Medical Board also is involved. (Click for more...) Walgreens, CVS blame physicians for Florida's opioid crisis 2/18/2020 7:05:01 PM Walgreens, CVS blame physicians for Florida's opioid crisis Mon, 02/17/2020 - 19:00 cbaker_admin Tue, 02/18/2020 - 19:05 In 2018, the state of Florida filed a lawsuit against Walgreens and CVS Health, asserting that the two companies should have realized their opioid orders were inappropriate. Walgreens distributed 2.2 million opioid analgesics to a city of 12,000 people in 2017, while CVS sold 700 million opioid doses in Florida between 2006 and 2014, the lawsuit claims. In response, Walgreens and CVS recently filed a third-party complaint denying liability for the state's opioid crisis and requesting the court focus on the physicians who prescribed the opioids. In January, Walgreens and CVS sued hundreds of Ohio physicians on grounds that physicians and other prescribers should be legally penalized if pharmacies are found liable, because the pharmacies followed the directions of the physicians. (Click for more...) BMS leans on new long-term Opdivo data in crowded kidney cancer field 2/18/2020 11:51:46 AM Bristol-Myers Squibb’s Opdivo-Yervoy combo is competing in an increasingly crowded space when it comes to previously untreated kidney cancer. But the company is leaning on long-term data to help set its regimen apart. More than half of patients treated with the pairing were alive at the 42-month mark, compared with 47% of those taking Pfizer’s Sutent, the New Jersey drugmaker showed over the weekend. (Click for more...) Grassroots effort is aimed at pharmacist action on drug importation 2/18/2020 10:13:24 AM Grassroots effort is aimed at pharmacist action on drug importation Tue, 02/18/2020 - 10:47 caldridgeyoung… Tue, 02/18/2020 - 10:13 U.S. (Click for more...) 55th Van Liere Research Conference set for April 2-3 2/18/2020 12:00:00 AM The 55th Van Liere Research Conference is set for April 2-3, 2020, at WVU Health Sciences Center. (Click for more...) FDA requests the withdrawal of lorcaserin from the market 2/14/2020 6:05:01 PM FDA requests the withdrawal of lorcaserin from the market Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 FDA on Thursday requested that Eisai Inc. voluntarily withdraw its drug lorcaserin (Belviq, Belviq XR) after a safety clinical trial found an increased occurrence of cancer. Eisai has submitted a request to voluntarily withdraw the drug. FDA noted that when the drug was approved 8 years ago, "we required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular problems. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung." Last month, the agency said it was reviewing clinical trial data and cautioned the public about a possible cancer risk linked to the drug based on a preliminary analysis of the information. Patients should stop taking the drug and talk to their health care providers about alternate medications and programs for weight management. Providers should stop prescribing and dispensing lorcaserin to patients. Additionally, they should contact patients currently taking the drug, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the drug. FDA noted that it is not recommending any special screening for people who have used lorcaserin. "As with any individual patient, regardless of prior lorcaserin treatment, standard screening recommendations for cancer should be implemented," the agency said. (Click for more...) CDC confirms 15th case of COVID-19 2/14/2020 6:05:01 PM CDC confirms 15th case of COVID-19 Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 CDC on Thursday confirmed the 15th case of coronavirus disease (COVID-19) infection in the United States. The patient is among a group of individuals under a federal quarantine order at JBSA-Lackland in Texas due to their recent return to the United States on a State Department-chartered flight that arrived on February 7. The individual has been isolated and is receiving medical care at a nearby hospital. CDC noted, "There will likely be additional cases [of COVID-19] in the coming days and weeks, including among other people recently returned from Wuhan." Nearly 200 people were released from quarantine on Tuesday CDC said, but more than 600 others who returned from Wuhan on chartered flights are still under federal quarantine and are being closely monitored in an effort to contain the spread of the new coronavirus. (Click for more...) Plasma exchange and glucocorticoids in severe ANCA-associated vasculitis 2/14/2020 6:05:01 PM Plasma exchange and glucocorticoids in severe ANCA-associated vasculitis Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 In hopes of unlocking a safer and more effective way to treat antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis, a multinational team of scientists tested the use of plasma exchange and glucocorticoids. Participants in the PEXIVAS trial, all of whom had severe disease, were randomly assigned to undergo plasma exchange or no plasma exchange. Additional randomization dictated whether they would take a standard dose of oral glucocorticoids or a lesser amount. The primary endpoint of the trial was all-cause mortality or end-stage kidney disease (ESKD) after 7 years. That outcome was met by 100 of 352 patients (28.4%) in the plasma-exchange group and 109 of 352 patients (31%) in the control group, for a difference that was not considered clinically significant. Among the 325 patients who received a standard dose of glucocorticoids, meanwhile, death from any cause or ESKD occurred in 83 (25.5%). That compared with 92 of 330 patients (27.9%), in the lower-dose group. The absolute risk difference was 2.3 percentage points, which established the lower dose as noninferior to the standard amount. (Click for more...) Effect of reduced exposure to vasopressors on 90-day mortality in older critically ill patients with vasodilatory hypotension 2/14/2020 6:05:01 PM Effect of reduced exposure to vasopressors on 90-day mortality in older critically ill patients with vasodilatory hypotension Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Researchers investigated whether reducing exposure to vasopressors through permissive hypotension would curtail 90-day mortality in critically ill older adults undergoing treatment for vasodilatory hypotension. Vasopressors can help return blood pressure to safe levels, but the approach may be riskier for older patients. With this in mind, the team combed dozens of ICUs in the United Kingdom for patients aged 65 years and older who were receiving vasopressors for vasodilatory hypotension. According to randomized assignment, vasopressor administration was based on permissive hypotension—mean arterial pressure target of 60–65 mm Hg—or determined at the discretion of the treating clinician. The primary outcome, death at 90 days, was assessed in 2,463 study participants. Those in the permissive hypotension group were exposed to vasopressors for a mean 33 hours vs. 38 hours for those who received usual care. The rate of 90-day mortality was 41% and 43.8%, respectively, for an odds ratio of 0.82. Based on the finding, the investigators conclude that reducing exposure to vasopressors through permissive hypotension did not significantly curtail death at 90 days in this patient population. (Click for more...) Drug prices are suppressed overseas, White House study finds 2/14/2020 6:05:01 PM Drug prices are suppressed overseas, White House study finds Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Foreign governments are taking advantage of American drug company research and U.S. consumers by artificially suppressing drug prices abroad, according to a new study from the Trump administration. "Stringent government underpricing in foreign countries has substantially increased foreign free-riding on the United States," said the report from the White House Council of Economic Advisers. "The result is a slower pace of overall innovation, less competition from new entrants, and thus higher prices paid for patented drugs that lack therapeutic competition." The study compared the prices of 200 top-selling branded drugs in the United States and 15 other developed countries. It concluded that European prices on top-selling drugs are approximately 32% of U.S. prices. The findings suggest drug pricing could become another source of friction between the United States and trading partners. Although foreign drugmakers also suffer from underpricing, the cost is borne disproportionately by the United States because it funds roughly half of all global medical research, invests 75% of global medical venture capital, and accounts for 70% of patented pharmaceutical profits, the study said. Challenging the assumptions underlying the study, Patricia Danzon—a professor of health care management at the University of Pennsylvania's Wharton School—attributed the price difference to manufacturers' ability to raise prices in the United States, not governments' ability to keep them down abroad. (Click for more...) Oklahoma pharmacy board investigating chain pharmacies, staffing levels 2/14/2020 6:05:01 PM Oklahoma pharmacy board investigating chain pharmacies, staffing levels Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 The Oklahoma State Board of Pharmacy has confirmed that it is investigating chain pharmacies for inadequate staffing levels and other issues that cause pharmacists to work in a stressful environment. State pharmacy boards and associations in at least 24 states have received complaints from pharmacists about working conditions, according to a recent New York Times report. Pharmacist Greg Clyde says he worked at a chain pharmacy for 10 years before opening his own store. Clyde says, "When I talk to my pharmacist friends who still work in those environments, they describe the workload, they are working on things from a week ago instead of things today." He adds that other factors leading to stress include OTC immunizations, sicker patients, and the rapid turnover of pharmacy technicians. (Click for more...) Ascension VP on shifting priorities for hospital pharmacies, next generation of pharmacists 2/14/2020 6:05:01 PM Ascension VP on shifting priorities for hospital pharmacies, next generation of pharmacists Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Jeff Oliver, vice president of pharmacy for Ascension's Florida division, discusses some of the challenges that leaders in hospital pharmacy are facing. Most pharmacists employed by health systems are focused on the acute care side, but the hospital industry is shifting its focus toward ambulatory care, he says. The challenge lies in figuring out how to align and train staff to deal with that shift, helping pharmacists transition from an acute care background into more of a transition-to-care role. Standardizing pharmacy practices across a health system is also a concern. Most pharmacy jobs available today are for community pharmacy positions, not in hospitals; but the community pharmacy arena is also seeing a lot of change. The opioid crisis has shifted the expectations of hospital pharmacists towards drug diversion and prevention, as well as treatment for patients who have been affected by the crisis. Meanwhile, pharmacists are also much more involved in supply chain logistics and management than they used to be, having more of a role in the full product life-cycle of pharmaceuticals. Oliver predicts that the pharmacy industry will continue to see a shift toward telehealth and implement technology to make care more accessible. "Pharmacy's going to continue to adopt technology both to enhance our reach clinically and also to optimize what we're doing on the operational side," Oliver said. (Click for more...) Federal government to track how private Medicare information gets to marketers 2/14/2020 6:05:01 PM Federal government to track how private Medicare information gets to marketers Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 The HHS inspector general's office plans to launch a nationwide probe into how telemarketers may be getting hold of older adults' personal Medicare information. The audit will follow a narrower probe which found that an electronic system designed for pharmacies to verify Medicare coverage was being used for searches that appeared to have nothing to do with filling prescriptions. A report on that initial probe details how sensitive details can still get to telemarketers when a Medicare beneficiary thinks he or she is dealing with a trustworthy entity such as a pharmacy or doctor's office. Key personal details gleaned from Medicare's files can then be cross-referenced with databases of individual phone numbers, allowing marketers to home in with their calls. The report is being released Friday. The initial audit focused on 30 pharmacies and other service providers that were frequently pinging a Medicare system created for community pharmacies. Pharmacies are able to access coverage data on Medicare recipients by using a special provider number from the government. Investigators found that four of the pharmacies they audited allowed marketing companies to use their provider numbers to ping Medicare. Some pharmacies also used older adults' information to contact doctors treating those beneficiaries to see if they would write prescriptions. (Click for more...) Insulin bill would cap monthly supplies of drug at $50 2/14/2020 6:05:01 PM Insulin bill would cap monthly supplies of drug at $50 Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Lawmakers in Connecticut seeking to address the high cost of prescription drugs in a short legislative session have proposed a bill to cap the monthly cost of insulin at $50. The bill would also limit the price of insulin-related supplies, such as syringes, pumps, and blood sugar meters, to $100 per month. The Health Care Cost Institute estimates that type 1 diabetes patients, who usually must inject themselves daily, paid an average of $5,705 for insulin in 2016, nearly twice as much as what they paid 4 years earlier. The bill is one of several drug-related proposals that the General Assembly will consider this year. State lawmakers are also examining the importation of prescription drugs from Canada, forming a board to regulate drug prices, and prohibiting mid-year changes to drug formularies. Connecticut state Rep. Sean Scanlon (D) worked on the measure with Sen. Matthew Lesser (D). A public hearing on the proposal is scheduled for February 25. (Click for more...) Lilly, Novo Nordisk fight insulin biosimilars with tweaks to FDA draft guidance 2/14/2020 6:05:01 PM Lilly, Novo Nordisk fight insulin biosimilars with tweaks to FDA draft guidance Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Two of the country's three insulin makers are seeking to revise FDA draft guidance that wants to bring more insulin competition to market. In the draft guidance, FDA suggested that insulin biosimilar developers may not need to conduct comparative clinical immunogenicity studies under certain circumstances. In comments submitted on January 28, Novo Nordisk said it "experienced a circumstance of unexpected immunogenicity in response to a new insulin analog which was encountered during its clinical development." The company noted, "As such, we believe caution needs to be applied regarding the broad assumption" found in the draft guidance. Eli Lilly said FDA should overhaul the guidance to explain which biosimilar applications its immunogenicity testing policy would apply to. The company said it "believes that good science dictates some amount of clinical immunogenicity data should be required in order to understand the impact of potential differences in immunogenicity profiles on clinical outcomes." The company also wants FDA to state in its guidance that the agency does not address issues with respect to product biosimilarity and interchangeability of delivery devices and presentations, including connected systems. In addition, Eli Lilly objected to approving insulin biosimilars as interchangeable products, warning that "a patient could be confronted with an unfamiliar presentation without the benefit of prescriber oversight or additional training." (Click for more...) NCPA endorses bill to ban PBM spread pricing tactic 2/14/2020 6:05:01 PM NCPA endorses bill to ban PBM spread pricing tactic Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 A proposed bill, H.R. 5281—the Drug Price Transparency in Medicaid Act, seeks to prohibit spread pricing by PBMs in Medicaid managed care. Under spread pricing, PBMs can overbill Medicaid managed care programs, under-reimburse pharmacies for medications dispensed, and retain the difference. The bipartisan legislation was introduced by Reps. Buddy Carter (R-GA) and Tony Cárdenas (D-CA). The National Community Pharmacists Association (NCPA) is endorsing the bill. Karry La Violette, NCPA's senior vice president of government affairs, says: "Time and time again, PBMs have been caught using tactics like spread pricing to take advantage of the system, lining their pockets while harming patients and the taxpayers they are supposed to serve. We're grateful to Reps. Carter and Cárdenas for recognizing the problem and for their leadership in putting forward a proposal to stop this abuse. We look forward to working with them to advance this bill." (Click for more...) Sen. Schumer urges WNY dollar stores to stop selling topical products with FDA warning 2/14/2020 6:05:01 PM Sen. Schumer urges WNY dollar stores to stop selling topical products with FDA warning Thu, 02/13/2020 - 19:00 cbaker_admin Fri, 02/14/2020 - 18:05 Sen. Chuck Schumer (D-NY) has called on dollar stores in Western New York to stop carrying "potentially dangerous" OTC topical products like ointments and cosmetics. FDA has determined that the makers of these products have shown a pattern of serious violations of federal law, and as a result, the products could cause irritations like rashes and other sickness "or worse," according to Schumer. The senator said he successfully convinced Manhattan Family Dollar and Dollar Tree stores to remove the products in question from their shelves late last year; however, some other parts of the state have not been as compliant. "I'm asking the FDA to come in and look at all of the dollar stores here in Western New York and demand that they take them off, and if they don't, to impose the appropriate fines and other penalties that the law allows them to do," Schumer said. He also wants the FDA to crack down on retailers' ability to obtain products that do not meet U.S. regulations. (Click for more...) Direct-to-consumer genetic testing: Top five things pharmacists should know 2/14/2020 1:23:17 PM Direct-to-consumer genetic testing: Top five things pharmacists should know Fri, 02/14/2020 - 13:26 caldridgeyoung… Fri, 02/14/2020 - 13:23 According to the National Library of Medicine, the most popular tests use genetic variations to make predictions about health, provide information about common traits, and offer clues about a person’s ancestry. Here’s what pharmacists should know. (Click for more...) Adults unintentionally make it easy for young children to eat dangerous meds 2/13/2020 6:04:43 PM Adults unintentionally make it easy for young children to eat dangerous meds Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 New research highlights the need to keep medications in their child-resistant containers. The study—which involved calls to five U.S. poison control centers by researchers from CDC, Emory University School of Medicine, and the Georgia Poison Center—is published in the Journal of Pediatrics. According to the research, more than one-half of the time when children get into prescription medications, the drug had already been removed from the child-resistant packaging by an adult. "These data suggest it may be time to place greater emphasis on encouraging adults to keep medicines in containers with child-resistant features," says the study's senior author, Daniel Budnitz, MD, MPH, of CDC's Division of Healthcare Quality Promotion. "There is an opportunity here for innovative medication container options that promote adult adherence and provide portability and convenience, while maintaining child safety." Four common scenarios identified in the study were that the medication was removed from its original container to take as prescribed, with the medication put into an organizer that was not child-resistant; the medication was removed for ease of travel or transport and put into baggies or other small containers that were not child-resistant; the medication was removed for convenience, with some left on countertops or a bedside table for the patient to take later; and, finally, the medication was removed unintentionally, as some may be accidentally spilled or dropped and then missed when picking them up. The most common scenarios also varied by type of medication. Additionally, while children most often got into their parents' medications, for some prescription drugs that can be very harmful to young children in small amounts—such as cardiac medications—more than one-half belonged to the grandparents, highlighting the importance of reminding them, as well as parents, about keeping medications up and away and out of the reach and sight of children. (Click for more...) Coronavirus test kits sent to states are flawed, CDC says 2/13/2020 6:04:43 PM Coronavirus test kits sent to states are flawed, CDC says Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 CDC reported Wednesday that some of the coronavirus testing kits that were sent to state laboratories are not working correctly. "Obviously, a state wouldn't want to be doing this test and using it to make clinical decisions if it isn't working as well, as perfectly, at the state as it is at CDC," said Nancy Messonnier, MD, director of CDC's National Center for Immunization and Respiratory Diseases, said at a news conference. The agency recommends testing for some individuals who have symptoms such as fever, cough, or shortness of breath, and who, within the past 2 weeks, have traveled to China or have been in close contact with a patient known to be infected with the novel coronavirus. Doctors with patients who fall into that category are supposed to discuss with their state health department whether the individuals should be tested for the coronavirus. According to CDC, testing kits were shipped to every state; however, officials did not indicate how many of the kits were not working right. Messonnier explained that trial runs in some states found that the CDC kits produced "inconclusive" results. The tests did not use samples from potential patients but were conducted as part of standard quality-control procedures. Messonnier said the issue appeared come from one ingredient used in the test, and CDC will make a new supply of that ingredient to send to all the labs. A CDC spokesperson said states that did not have difficulty with the kits could keep using them and would still receive the newly made ingredient from CDC when it was ready. Separately, CDC announced late Wednesday that another Wuhan evacuee quarantined at a California military base had tested positive for coronavirus, bringing the total number of confirmed cases in the United States to 14. (Click for more...) Medtronic recalls MiniMed insulin pumps for incorrect insulin dosing 2/13/2020 6:04:43 PM Medtronic recalls MiniMed insulin pumps for incorrect insulin dosing Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 Medtronic has initiated a recall of some of its insulin pumps after receiving reports that the device was malfunctioning. The Class I recall - the most serious type of recall - includes about 322,000 pumps. The devices affected are the Minimed model 630G ((MMT-1715), all lots before October 2019, and the Minimed model 670G (MMT-1780), all lots before August 2019. According to FDA, "Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death." Medtronic has received 26,421 complaints in which the insulin pumps malfunctioned in this manner. The company is aware of 2,175 related injuries and 1 death. Medtronic first warned of safety problems with the insulin pumps in November. (Click for more...) Effect of standard therapy with vs. without an antistaphylococcal ß-lactam on MRSA bacteremia outcomes 2/13/2020 6:04:43 PM Effect of standard therapy with vs. without an antistaphylococcal ß-lactam on MRSA bacteremia outcomes Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 Researchers wondered if supplementing routine antibiotic therapy with a course of antistaphylococcal ß-lactam might reduce the high mortality rate in cases of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. To answer their question, the multinational team recruited 352 adults hospitalized with MSRA bacteremia for a randomized study. Approximately one-half of the participants received usual care with I.V. vancomycin or daptomycin, while the others received the same therapy plus a 7-day course of I.V. flucloxacillin, cloxacillin, or cefazolin. Although the trial was terminated early due to increased risk of injury in the intervention group, a total of 345 patients completed the protocol. Among them, 35% of those assigned to combination therapy and 39% of those receiving standard treatment met the primary outcome: a 90-day composite of mortality, persistent bacteremia at day 5, microbiological relapse, and microbiological treatment failure. Based on the evidence, the researchers determined that adding antistaphylococcal ß-lactam to standard antibiotic therapy is not significantly better than usual care alone in treating patients with MRSA bacteremia. (Click for more...) Neural signature identifies people likely to respond to antidepressant medication 2/13/2020 6:04:43 PM Neural signature identifies people likely to respond to antidepressant medication Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 Research published in Nature Biotechnology indicates that new machine learning techniques can identify complex patterns in a person's brain activity that correlate with meaningful clinical outcomes. Investigators were able to identify a neural signature that predicts whether individuals with depression are likely to benefit from sertraline, a commonly prescribed antidepressant. Senior author Amit Etkin, MD, PhD, a professor of psychiatry and behavioral sciences at Stanford University and CEO of Alto Neuroscience, observes: "Our findings are exciting because they reflect progress made toward this clinical goal, and they also show the potential of bringing sophisticated data analytic methods to psychiatry." The investigators created a new machine learning algorithm for analyzing electroencephalography (EEG) data called SELSER (Sparse EEG Latent SpacE Regression). SELSER was used to analyze data from the NIMH-funded Establishing Moderators and Biosignatures of Antidepressant Response in Clinic Care study. Investigators applied SELSER to participants' pre-treatment EEG data, assessing whether the machine learning approach could lead to a model that predicted participants' depressive symptoms after treatment. SELSER was able to reliably predict individual patient responses to sertraline based on brain alpha waves. This EEG-based model performed better than standard models that use either EEG data or other types of individual-level data, such as symptom severity and demographic characteristics. (Click for more...) Estimates of medication diversion in hospice 2/13/2020 6:04:43 PM Estimates of medication diversion in hospice Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 To characterize the problem of medication diversion in the hospice setting, where caregivers rely on opioids to keep patients comfortable, researchers surveyed a nationwide sample of 371 agencies. From June–September 2018, respondents reflected on their experiences with medication diversion. The questions covered practices and policies—such as use of prescription drug monitoring programs, staff drug testing, and handling of patients or relatives with substance abuse addiction—as well as data on confirmed and suspected cases of diversion. One or more case of confirmed diversion was reported in 31% of the participating hospices during the previous 90 days. The research also identified family caregivers, other relatives, and patients themselves as the primary culprits, in that order. Diversion was much more likely with smaller agencies than with medium or large ones, and the risk also increased with hospices that deliver the bulk of care in the patient's own home. Confirmed plus suspected diversion was even more common, with 58% of hospices surveyed reporting at least one case. This trend also was associated with smaller agencies and predominantly at-home care, as well as with use of a prescription drug monitoring program. Additional study is required, the University of Maryland, Baltimore team concludes, to determine how hospices can minimize diversion while effectively managing patient pain. (Click for more...) 'Flip the Pharmacy' campaign helps to enhance patient care beyond prescriptions 2/13/2020 6:04:43 PM 'Flip the Pharmacy' campaign helps to enhance patient care beyond prescriptions Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 A group of 44 independently owned community pharmacies in Nebraska hopes to find ways to enhance patient care beyond filling prescriptions. The group is launching a campaign called "Flip the Pharmacy" to achieve a more long term approach to providing better health care. Staci Hubert, Nebraska Enhanced Services Pharmacy Network Lead Luminary, says pharmacies wants to provide more of a value-based care system for their patients. She explains, "It's basically looking more as a teamwork with your physician trying to keep information flowing. We do see patients probably 35 times a year, where they see their physicians maybe 3." Pharmacists also will focus on curbing medical-related costs. Chris Watts, pharmacist at Valley Pharmacy, notes: "So, we're trying to leverage that relationship to improve patient outcomes," asking "how can we effect what they're doing with the treatments with the doctor and enhancing that instead of just giving them the prescription and saying goodbye." Watts says he hopes the new campaign will demonstrate to his patients and insurance companies how dedicated pharmacists are to improving the overall health and wellness of their patients. (Click for more...) New Surescripts service aims to speed process for prescribing specialty meds 2/13/2020 6:04:43 PM New Surescripts service aims to speed process for prescribing specialty meds Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 Surescripts is offering a new service, called Specialty Patient Enrollment, to automate the specialty prescribing process. Current processes require physicians to fill out paper forms and often involve faxes and phone calls to manage prior authorization requests and approvals. Through the Specialty Patient Enrollment service, information can be automatically populated using data already in providers' electronic health record systems. Combined with access to patient-specific prescription price information and the ability to process prior authorizations electronically, the new service is expected to reduce administrative delays and help patients get medications more quickly. Patient solution organizations also play a role, leveraging data and serving as a point of contact for patients and providers to help manage patient populations and increase access to specialty drugs. A number electronic health records and specialty pharmacies have already signed up for the new service. (Click for more...) Mass. AG Healey sues Juul over youth vaping epidemic 2/13/2020 6:04:43 PM Mass. AG Healey sues Juul over youth vaping epidemic Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 Juul has been sued by Massachusetts Attorney General Maura Healey, who claims the company intentionally marketed and sold its e-cigarettes to young people, creating a youth vaping epidemic. The lawsuit, filed in Suffolk Superior Court, asserts Juul illegally advertised and sold nicotine products to underage youth. In the complaint, Healey alleges that Juul intentionally used young-looking models in its ads, recruited celebrities and social media influencers with young followings to promote its products, put ads on youth websites such as Nickelodeon, sold and shipped thousands of e-cigarettes to underage kids in the state, and told underage customers how to get around local age restriction laws, among other claims. The lawsuit seeks damages and penalties for the company's conduct. Healey says more than one-half of high school students in Massachusetts report using e-cigarettes, while 1 in 3 high school students in the state say they have vaped in the last month. Healey began investigating Juul in 2018 to determine in the company was intentionally marketing to minors, and whether it tracks underage use of its products. Juul is also facing lawsuits from school districts, public health organizations, and other states. Healey has already sued eight online e-cigarette sellers that her office determined were violating the state's prohibition on flavored tobacco products. (Click for more...) Proposal designed to help Maine small pharmacies moves forward in state legislature 2/13/2020 6:04:43 PM Proposal designed to help Maine small pharmacies moves forward in state legislature Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 A Maine legislative committee has passed a bill that aims to protect small pharmacies in the state. The proposal is meant to stop insurance carriers from charging pharmacies certain fees, such as those that are not apparent at the time the insurer processed the claim. State Sen. Nate Libby (D-Lewiston) said the change would help local and independent pharmacies stay in business. The proposal passed by a 5-4 vote on Thursday in the legislature's Health Care, Insurance, and Financial Services Committee and now faces a vote before the full legislature. (Click for more...) Tracking and tracing drugs and vaccines: WHO drafts new policy 2/13/2020 6:04:43 PM Tracking and tracing drugs and vaccines: WHO drafts new policy Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 A draft policy from the World Health Organization (WHO) seeks to assist regulators with creating systems to monitor and trace pharmaceuticals and vaccines through their supply chains, using international harmonized standards. WHO is requesting feedback on the draft policy by the end of February. The policy is part of a wider initiative to help regulators reduce the risk of substandard and falsified medical products, shortages, and expired products. The policy includes seven traceability features, such as batch-level traceability and unit-level serialization. WHO points out that some countries already mandate data aggregation, while others require the capture of data by the manufacturer or repackager, such as the European Union and United States. The draft notes that forming voluntary pilots to test draft regulations before finalizing them can help to identify unanticipated complexities. WHO stated, "Whilst this policy brief aims to outline the features of existing traceability features and providing guidance on developing workable regulation, this remains only a starting point." This draft policy is not applicable to medical devices, but WHO notes there are significant differences among regulations and supply chains for pharmaceuticals and devices, so a situation analysis is provided in the first appendix. (Click for more...) FDA releases guidance for rare disease known as Sanfilippo Syndrome 2/13/2020 6:04:43 PM FDA releases guidance for rare disease known as Sanfilippo Syndrome Wed, 02/12/2020 - 19:00 cbaker_admin Thu, 02/13/2020 - 18:04 FDA has issued new draft guidance that provides recommendations to industry on supporting a robust program for developing therapies for Mucopolysaccharidosis Type III (MPS III), also known as Sanfilippo Syndrome. MPS III is a rare and serious disorder, often appearing in children, in which the body does not have enough enzymes to break down long chains of sugar molecules called glycosaminoglycans (GAG). The buildup of GAGs can lead to cell damage and progressive organ dysfunction, primarily involving the central nervous system. Children with MPS III at birth appear healthy until initial symptoms start to manifest between the ages of 2 and 6 years, often in the form of mild developmental delays. (Click for more...) Life science community shares research to combat coronavirus 2/13/2020 3:30:25 AM After weeks of rising concern about the rapid spread of the coronavirus in China’s Wuhan province, on January 31 the World Health Organization (WHO) declared it a global health emergency. But the story of the coronavirus outbreak is about more than a health scare – it is a terribly sad human tragedy. Already (as of […] (Click for more...) WVU announces music and health degree 2/13/2020 12:00:00 AM Students who have a passion for music but also want a career in healthcare can now study both disciplines with a new degree program at West Virginia University. WVU will be one of the first universities in the nation with a music and health undergraduate program. (Click for more...) The illness now has a name, CoViD-19 2/12/2020 6:00:01 PM The illness now has a name, CoViD-19 Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 The World Health Organization (WHO) has given a name to the illness caused by the new coronavirus: CoViD-19. The name stands for coronavirus disease 2019, the year when the illness was first detected. Tedros Adhanom Ghebrevesus, MD, director-general of the WHO, stressed that, in order to avoid any stigma, the new name makes no reference to any of the people, places, or animals that have been linked to the coronavirus. Under international guidelines, the WHO "had to find a name that did not refer to a geographical location, an animal, an individual or group of people, and which is also pronounceable and related to the disease," he explained. More than 44,000 confirmed cases of the new virus have been reported worldwide, including 393 outside of China, in two dozen countries. "With 99% of cases in China, this remains very much an emergency for that country, but one that holds a very grave threat for the rest of the world," Tedros said. (Click for more...) HHS, Janssen join forces on coronavirus vaccine 2/12/2020 6:00:01 PM HHS, Janssen join forces on coronavirus vaccine Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR) said Tuesday that it will expand an existing partnership with Janssen Research & Development to expedite development of vaccines that protect against the new coronavirus, CoViD-19. Under the agreement, Janssen and ASPR's Biomedical Advanced Research and Development Authority (BARDA) will share research and development costs and expertise to help speed Janssen's investigational novel coronavirus vaccine into clinical evaluation. BARDA director Rick A. Bright said, "With emerging infectious diseases such as CoViD-19, speed is crucial to saving lives and reducing further spread of the virus. Janssen is a proven partner with a flexible, rapid, vaccine platform which gives us an edge in the race to protect people in the U.S. and worldwide from the health security threat posed by this novel coronavirus." Additionally, Janssen will also work on the scale-up of production and manufacturing needed to manufacture the candidate vaccine. (Click for more...) Addition of maraviroc vs. placebo to standard ART for initial treatment of advanced HIV infection 2/12/2020 6:00:01 PM Addition of maraviroc vs. placebo to standard ART for initial treatment of advanced HIV infection Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 A European study investigated the effect of adding maraviroc to routine treatment for patients with advanced HIV at the time of diagnosis. Starting combined antiretroviral therapy (c-ART) alone usually does not improve their poor prognosis, but researchers hypothesized that supplementing the regimen with maraviroc—an antiretroviral drug with immunologic properties—might. The randomized controlled trial was carried out at 50 clinical facilities in France, Spain, and Italy, with a sample population of approximately 400 HIV-positive, antiretroviral-naive adults with low CD4 counts and/or a previous AIDS-defining event (ADE). About one-half of the participants received twice-daily maraviroc in addition to c-ART, while the remainder received c-ART plus placebo. At 72-week followup, the incidence of severe morbidity—as defined by new ADE and other markers, including death—was not significantly different between the two treatment arms. The rate of adverse events rated 2 or higher also was similar. Based on these outcomes, the researchers find that adjuvant maraviroc with c-ART does not improve the outlook for HIV patients initiating therapy for advanced disease. (Click for more...) Poxvirus vectored cytomegalovirus vaccine to prevent cytomegalovirus viremia in transplant recipients 2/12/2020 6:00:01 PM Poxvirus vectored cytomegalovirus vaccine to prevent cytomegalovirus viremia in transplant recipients Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 In a Phase II trial funded in part by the National Cancer Institute, researchers sought to evaluate the safety and efficacy of the Triplex vaccine in hematopoietic stem cell transplant (HCT) recipients. The recombinant attenuated poxvirus, which expresses immunodominant cytomegalovirus (CMV) antigens, was developed to enhance CMV–specific T cells and prevent CMV reactivation post-transplantation. The multisite study included 102 CMV-seropositive HCT patients with elevated risk for CMV reactivation, all of whom received Triplex vaccination on day 28 after their procedure. A total of 46 study participants received Triplex again on day 56 after transplant, while placebo was given to 45. CMV reactivation was documented in 5 of the Triplex recipients and 10 of the placebo recipients through day 100 post-transplant. While the unexpectedly low rate of CMV events in the placebo group reduced the power of the trial, the investigators report that Triplex elicited and boosted CMV-specific immune responses. With no Triplex-vaccinated participants dying of nonrelapse causes or developing serious adverse events, and with a rate of severe acute graft-versus-host disease that was no worse than with placebo, the researchers found no safety concerns with Triplex. (Click for more...) Teen drug use might drop as U.S. youth smoke less 2/12/2020 6:00:01 PM Teen drug use might drop as U.S. youth smoke less Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 Two recent studies suggest that young people in the United States are smoking less than in the past, which could be helping to reduce teen drug use as well. One study, published in Pediatrics, looked at survey data on tobacco use among middle school and high school students between 2011 and 2018 and found a decline in the proportion of youth who smoke and a drop in the number of daily cigarettes used by current smokers. Overall, the proportion of current smokers who were daily cigarette users dropped from 27% in 2011 to 18% in 2018, while the proportion who smoked at least 10 days a month declined from 50% to 38%. However, the proportion of youth who vaped daily increased from 9% to 22%. A separate study in Tobacco Control tracked teen smoking from 2000 and 2018 and found that the proportion of high school seniors who had never smoked rose from 39% in 2001 to 76% in 2018. Moreover, teens who had tried smoking were much more likely to try amphetamines and opioids than non-smokers. Researchers note that teens who smoke are more likely to become friends with other smokers, who may then introduce them to other drugs. In addition, teens who try nicotine may experience changes in their brain that make them more receptive to using other drugs. (Click for more...) CVS Health reports fourth quarter and full-year 2019 results 2/12/2020 6:00:01 PM CVS Health reports fourth quarter and full-year 2019 results Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 CVS Health reported Wednesday fourth-quarter and full-year 2019 results. For the fourth quarter of 2019, total revenues rose 22.9% to $66.9 billion. GAAP operating income rose to $3 billion, while adjusted operating income rose 1.3% to $3.8 billion. For overall 2019, CVS reported that total revenues increased 32% to $256.8 billion. GAAP operating income rose to $12 billion, and adjusted operating income jumped 36.2% to $15.3 billion. For 2020, CVS said it expects GAAP operating income ranging from $12.8 billion-$13 billion. In addition, it expects adjusted operating income ranging from $15.5 billion-$15.8 billion. GAAP diluted EPS from continuing operations are expected to be $5.47-$5.60, while adjusted EPS is expected to range from $7.04-$7.17. Cash flow from operations is forecast at $10.5 billion-$11 billion. "Our fourth quarter and full-year financial results reflect strong financial and operational execution and a successful first year of integrating the Aetna business," said CVS Health president and CEO Larry Merlo. "We're using our unmatched capabilities to create a higher-quality, simpler and more affordable health care experience, which benefits patients, clients and consumers and positions the company for continued success." He added, "As a result of the significant progress we made in 2019, and meeting or exceeding our expectations for the year, we raised our outlook for 2020. Client, patient and consumer reception to our innovative product and service offerings, including our HealthHUB locations, has been positive." (Click for more...) WBA issues 2019 global sustainability report 2/12/2020 6:00:01 PM WBA issues 2019 global sustainability report Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 The "Corporate Social Responsibility Report 2019" released by Walgreens Boots Alliance (WBA) outlines the company's global sustainability initiatives, including initiatives to enhance access to quality health care. The report notes WBA's expansion of in-store support for people with cancer. Following the U.K. in-store model, in March 2019 Walgreens unveiled "Feel More Like You" that features trained beauty consultants and pharmacists who advise and support people with cancer at more than 3,000 U.S. locations. As part of another initiative launched 6 years ago, Walgreens and nonprofit Vitamin Angels collaborated to enhance maternal and child health by providing vitamins to more than 200 million women and children worldwide. For every customer purchase of vitamins from selected suppliers, Walgreens donates 1% of sales to Vitamin Angels' outreach efforts across the United States and globally. Additionally, for the past 2 years, Walgreens' Quarter Drive customer donation campaign in January has raised more than $3 million for the Vitamin Angels mission. WBA's new report also describes efforts across WBA businesses to reduce energy consumption, slash landfill waste, and encourage employees and customers to adopt environmentally friendly actions. (Click for more...) Kroger, Hy-Vee and other supermarket pharmacies extend health care reach 2/12/2020 6:00:01 PM Kroger, Hy-Vee and other supermarket pharmacies extend health care reach Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 Pharmacists at Kroger Health, the health care arm of Kroger Co., have begun prescribing and supplying smoking cessation products at 114 Kroger in-store pharmacies in Indiana and 15 pharmacies in Fred Meyer and Smith’s stores in Idaho. The program comes after recent legislative changes in both states allowed pharmacists to prescribe tobacco cessation medications to patients looking to quit smoking. Kroger Health announced the smoking cessation program just a week after launching rapid testing for strep throat and flu at pharmacies in Michigan and Idaho. Hy-Vee also is promoting preventive care, focusing on cardiovascular health, with free biometric screenings across its eight-state Midwestern market. Working out of Hy-Vee Healthy You Mobile RVs, Hy-Vee dietitians will perform the screenings at 91 stores during February on a first-come, first-served basis. Meanwhile, Food Lion has launched a new mobile pharmacy app to enable remote management of prescriptions and health and wellness. Finally, Publix Super Markets plans to open its 13th in-hospital pharmacy at the Halifax Health Medical Center in Daytona Beach, FL. The pharmacy will provide prescription and OTC medications, and is expected to open in August. (Click for more...) Charlie's Law brings together Garden State Pharmacy Owners, DisposeRx 2/12/2020 6:00:01 PM Charlie's Law brings together Garden State Pharmacy Owners, DisposeRx Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 Garden State Pharmacy Owners (GSPO), the association of New Jersey independent pharmacies, is designating DisposeRx as the preferred vendor of at-home disposal products. GSPO executive director Marty Miller notes that the partnership was prompted by the recent passage of Charlie's Law, a new state law that requires pharmacists to provide written and oral information on medication disposal as well as a safe disposal method. DisposeRx at-home medication disposal packets are made of FDA-approved materials and provide a simple, effective solution for the disposal of unused or expired medication. Patients can use the product with a medications that take the form of tablets, capsules, liquids, and powders, and the vial is safe to dispose of in the household trash. (Click for more...) House panel advances bipartisan surprise billing legislation despite divisions 2/12/2020 6:00:01 PM House panel advances bipartisan surprise billing legislation despite divisions Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 Proposed legislation to safeguard patients from excessive "surprise” medical bills was approved by the House Education and Labor Committee on February 11. Under the approach, which is also supported by the House Energy and Commerce Committee and the Senate Health Committee, payment rates would be based on the median amount paid for a particular service in the geographic area, with the option of going to arbitration for certain higher-cost bills. In contrast, an approach proposed by the Ways and Means Committee, which is backed by doctor and hospital groups, would allow payment decisions to be made by an outside arbiter. Unions and consumer group have backed the Education and Labor approach, saying the Ways and Means proposal would further raise health care costs that would be passed on to consumers in the form of higher premiums. The vote now goes to the full House. (Click for more...) Colorado House OKs bill aimed at lowering costs at pharmacies 2/12/2020 6:00:01 PM Colorado House OKs bill aimed at lowering costs at pharmacies Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 The Colorado House has approved a bill that would give pharmacies some protection from direct and indirect remuneration fees (DIR fees). Sponsors of House Bill 1078 say the problem is that these fees are often charged to pharmacies long after a patient fills a prescription, but pharmacies do not know what they will be, putting their businesses at risk. "Last year we started hearing reports about these fees that were being charged to rural pharmacists and community pharmacists, and we realized that these fees were being charged 60 or 90 days after the prescriptions were being filled," said Rep. Sonya Jaquez Lewis, who is a pharmacist. "These fees put many pharmacies at risk of going out of business. They now are amounting in tens of thousands of dollars, if not hundreds of thousands of dollars." The bill, which now heads to the Colorado Senate, would cap the rates that PBMs can charge and would prohibit retroactively reducing payments on uncontested claims except under certain circumstances. (Click for more...) GAO report raises questions about reauthorizing two PRV programs 2/12/2020 6:00:01 PM GAO report raises questions about reauthorizing two PRV programs Tue, 02/11/2020 - 19:00 cbaker_admin Wed, 02/12/2020 - 18:00 The Government Accountability Office (GAO) has released a new report on the successes and challenges of three priority review voucher (PRV) programs. The PRV programs incentivize companies to develop new rare pediatric disease, tropical disease, and medical countermeasure drugs by providing companies with a voucher, which can be sold or used to speed the approval of another drug, when a new treatment is approved. From fiscal year 2009, when the first PRV was awarded, through last September, FDA has awarded 31 PRVs, mostly for rare pediatric disease treatments. Seventeen of these PRVs were sold to another sponsor for prices ranging from about $67 million to $350 million. Although FDA brought in almost $44 million in PRV user fees for the 16 redeemed PRVs, the agency told GAO that it "cannot anticipate the therapeutic area for which a PRV will be redeemed, so PRV user fees may not ameliorate the effect of PRV redemptions on the review divisions." Drug sponsors, researchers, and other stakeholders reported "mixed views" to GAO on the reauthorizations. While drug sponsors "generally indicated support for their reauthorizations", one researcher supported the expiration of the rare pediatric disease and medical countermeasure programs, saying that such decisions could ultimately raise the potential revenue from the sale of an available PRV and also make the tropical disease PRV program more popular. Stakeholders suggested tweaking the programs by requiring innovation for and guaranteed access to PRV-eligible drugs, among other changes. GAO also said that the few studies it found on the PRV programs suggested that they had little or no effect on drug development. (Click for more...) The evidence-based approach to traditional medicine: An interview with Dr. Iveta Petrova 2/12/2020 3:30:22 AM A fruitful collaboration between Elsevier and Beijing University of Chinese Medicine (BUCM) resulted in Embase adding a new Traditional Chinese Medicine (TCM) taxonomy to its thesaurus tool Emtree in January 2020. At the same time as the release, BUCM held an evidence-based medicine training and seminar in Beijing to help promote the concept of evidence-based […] (Click for more...) Health Sciences Library to host opening reception for "Health Sciences Professionals Create!" exhibit 2/11/2020 12:00:00 AM The West Virginia University Health Sciences Library will host an opening reception for "Health Sciences Professionals Create!", an exhibit of art and craft by Health Sciences students, staff and faculty, on Feb. 26 from noon to 1 p.m. at the Health Sciences Center Pylons. (Click for more...) FDA report shows 2019 was a strong year for innovation 2/10/2020 3:30:12 AM On January 2, 2020, the FDA released the CDER annual report, stating that 2019 was “another strong year for innovation and advances.” The FDA cleared 48 new drugs for market, making it the second most productive year in the last decade (2018 approved 59 drugs). But given the fact that the total number of submissions […] (Click for more...) HSC community invited to learn more about Advancing Excellence in Gender Affirmative Care 2/6/2020 12:00:00 AM In collaboration with WVU Medicine, the Health Sciences Center is working to better understand and be more mindful of patients' gender affirmations. (Click for more...) Webinar: Using machine learning to identify adverse events from scientific literature 2/5/2020 1:25:42 PM The “vigilance” aspect of the pharmacovigilance process can be very challenging. Always being on guard and knowing all of the places to look can be difficult. In a sea of information, it can even seem like a nearly impossible task to maintain awareness of all adverse events (AE). That is why there has been a […] (Click for more...) Skype is being retired March 3; WVU recommends Microsoft Teams as alternative 2/5/2020 12:00:00 AM Skype for Business will no longer be available to WVU employees as of Tuesday, March 3, and ITS is recommending the use of Microsoft Teams as a powerful replacement for collaboration and communication. (Click for more...) WVU Police programs set for Health Sciences Center in February 2/4/2020 12:00:00 AM A member of the West Virginia University Police Department will offer two active shooter trainings — Thursday, Feb. 20 from 1 to 2 p.m. at Health Sciences, North, Room 1909, and Friday, Feb. 21, from 9 to 10 a.m. at Health Sciences, Addition Room G17. (Click for more...) Under the Dome: WVU Legislative Update 2/4/2020 12:00:00 AM Under the Dome delivers a review of the issues being considered by state government and the 84th West Virginia Legislature of West Virginia. It provides information on matters that affect WVU and higher education. (Click for more...) Bridging information silos the FAIR way 2/3/2020 3:30:09 AM We are living in a unique time, when the combination of computational power, expertise in knowledge engineering, and the data generation rate are all aligned to enable the aggregating and analyzing of data from different sources and types in order to better understand life science systems. The incredibly data-rich workflows that result from this alignment […] (Click for more...) Intersectional Health Fair set for Feb. 16 2/3/2020 12:00:00 AM The West Virginia University Multicultural Association of Students in Healthcare (MASH) is hosting an Intersectional Health Fair on Sunday, Feb. 16. (Click for more...) A message on the novel coronavirus from WVU Medicine Chief Operating Officer Ron Pellegrino, MD 2/1/2020 12:00:00 AM A message on the novel coronavirus from WVU Medicine Chief Operating Officer Ron Pellegrino, MD. (Click for more...) Elsevier supports Amsterdam’s AI initiatives 1/29/2020 3:30:23 AM Amsterdam, a vibrant and renowned cultural destination, has also been enlarging its reputation as an innovative scientific hub. A series of big new national initiatives, including the corporate Kickstart AI program and the academia-driven AI Technology for People initiative (which is making “AI for Health” one of its main priorities), have put the focus squarely […] (Click for more...) Limited scholarships available for tobacco treatment training course 1/29/2020 12:00:00 AM A limited number of scholarships remain for the May 20-22, 2020 continuing education course at the West Virginia University School of Dentistry. (Click for more...) Pharma execs discuss drug pricing at JPM2020 1/27/2020 3:30:18 AM I’ve found lately that drug and treatment pricing pressure is an absolutely unavoidable topic in the industry. It has been highlighted even more recently due to the fact that this pressing issue is often mentioned by the candidates currently running for president in our upcoming election here in the United States. Knowing how important healthcare […] (Click for more...) Nominations now being accepted for Vice President's Awards 1/27/2020 12:00:00 AM The annual Vice President's Awards Committee is now accepting nominations. The awards are an opportunity to honor and recognize employees at the WVU Health Sciences Center. (Click for more...) Student Opportunities in Rural Health Fair 1/27/2020 12:00:00 AM The WVU Institute for Community and Rural Health is hosting an information fair on Wednesday, February 5, 2020 in the Pylons Lobby at the WVU Health Sciences Center from 10am to 1pm. There will be a full range of opportunities for undergraduate and graduate health professions students interested in practicing in rural and under-served areas to explore. Come with questions and get answers (and snacks and giveaways too)! (Click for more...) New book illustrating disease pathways released 1/23/2020 3:30:18 AM Pathway models are critical to drug discovery and personalized medicine, as they help with analyzing the massive amounts of data and information that confront pharma researchers in today’s data-rich world. That’s why it’s more important than ever to gain a better understanding of molecular signaling biology and disease pathways. To that end, Elsevier has just […] (Click for more...) Which Wich to open soon at The Market @ WVU 1/22/2020 12:00:00 AM Which Wich, featuring sandwiches, salads and wraps, will open Jan. 27 at the Market @ WVU. (Click for more...) Under the Dome: WVU Legislative Update 1/22/2020 12:00:00 AM The latest edition of Under the Dome highlights the Soft Drinks Tax, Campus Carry, Needle Exchange Program and more. (Click for more...) International Advanced Pharmacy Practice Experience (APPE) Rotation in South Africa Celebrates 10 Year Anniversary 1/16/2020 12:00:00 AM The International Advanced Pharmacy Practice Experience (APPE) rotation in South Africa celebrates its 10-year anniversary. (Click for more...) Registration now open for Faculty Engagement Event 1/15/2020 12:00:00 AM Registration is now open for the 5th Annual Faculty Engagement Event, set for March 20 at the Erickson Alumni Center. The event is open to all Health Sciences faculty on all campuses. (Click for more...) WVU student pharmacists participate in rural health immersion 1/14/2020 12:00:00 AM Fifty of West Virginia's 55 counties have a shortage of health professionals or are medically underserved. The West Virginia Area Health Education Centers (AHEC) is attempting to address the issue by providing scholarships for students who are studying healthcare in the Mountain State. (Click for more...) President Gordon Gee joins Clay Marsh's latest podcast 1/14/2020 12:00:00 AM WVU President Gordon Gee joins Dr. Clay Marsh, vice president of Health Sciences and executive dean of the School of Medicine, for the latest episode of "Health Connections with Clay Marsh, MD." The episode is free to download and is available now on all major podcasting platforms. (Click for more...) WVU Institute for Community and Rural Health student program focuses on outreach and creating community ties 1/13/2020 12:00:00 AM MORGANTOWN, W.VA. – Capitalizing on the success of two outreach trips to southern West Virginia during academic breaks in 2019, a group of students majoring in Health Sciences disciplines at West Virginia University will return to the southern part of the state for spring break in April 2020. (Click for more...) TEDxWVU seeking speakers for third annual event March 28 1/6/2020 12:00:00 AM TEDxWVU is seeking speakers to present talks that will spark deep discussion and connection surrounding the "Say it Loud" theme. Speaker applications close Jan. 13. (Click for more...) Deadline extended for Colloquium for Underrepresented Aspiring Doctoral Candidates 1/6/2020 12:00:00 AM The deadline to apply for the March 22-24 Colloquium for Underrepresented Aspiring Doctoral Candidates has been extended to Feb. 15. (Click for more...) Train to become a certified tobacco treatment specialist 12/18/2019 12:00:00 AM This course is for professionals in the fields of medicine, dentistry, nursing, pharmacy, public health, social work, respiratory therapy and addiction counseling. (Click for more...) Large study shows bedtime administration of antihypertensive drugs reduces CV events 12/17/2019 12:02:31 PM Primary Category: CardiologyKey point: Administration of antihypertensive medications at bedtime resulted in improved nighttime blood pressure (BP) readings and resulted in a greater reduction in cardiovascular (CV) events compared with administration in the morning, according to results of a study published in European Heart Journal. Finer points: Some data have suggested that bedtime dosing of antihypertensives may result in improved outcomes compared with morning dosing. However, the available data are based on small studies, and additional research is needed to confirm these findings. The Hygia Chronotherapy trial was a large-scale study conducted in 19,084 patients from Spain with hypertension to determine if bedtime versus morning dosing of antihypertensives impacted BP and CV outcomes. The study included 10,614 men and 8,470 women (mean age 60.5 y) who had an office-measured BP of 149.4/86.1 mm Hg. A total of 9,552 patients were randomized to morning administration of their antihypertensives (mean number of medications 1.8; 53.1% ARB, 25.3% ACE inhibitor [ACEI], 32.7% calcium channel blocker [CCB], 22.0% beta-blocker, and 46.5% diuretic) and 9,532 were randomized to bedtime administration (mean number of medications 1.7; 53.1% ARB, 23.4% ACEI, 36.8% CCB, 17.5% beta-blocker, and 39.5% diuretic). After a median follow-up of 6.3 years, 1,752 patients experienced the primary composite CV outcome of CV death, myocardial infarction [MI], coronary revascularization, heart failure, or stroke. The results showed that bedtime administration of antihypertensives resulted in a lower risk of the primary CV composite outcome compared with morning administration (hazard ratio [HR] = 0.55 [95% CI 0.50–0.61]). Individual components of the primary outcome were also significantly lower with bedtime dosing, including CVD death (0.44, 0.34–0.56), MI (0.66, 0.52–0.84), coronary revascularization (0.60, 0.47–0.75), heart failure (0.58, 0.49–0.70), and stroke (0.51, 0.41–0.63). Regarding BP, bedtime dosing was associated with lower nighttime readings, greater sleep-time relative BP decline, and lower prevalence of nondipping. There were no significant differences in the prevalence of adverse events among the two groups. What you need to know: The results of the Hygia trial suggest that once-daily antihypertensive drugs are more effective in reducing CV events when taken at bedtime. The researchers noted that the 45% relative reduction in the primary CV outcome with bedtime dosing could be partially attributed to improved targeting of underlying circadian rhythm–organized biological mechanisms. They wrote that the peak activity of the renin-angiotensin-aldosterone system (RAAS) occurs during sleep, suggesting that administration of medications such as the ARBs and ACEIs may be best at bedtime. An accompanying editorial notes the strengths and weaknesses of this well-controlled study. Strengths include the large size and the consistency of the beneficial effects of bedtime administration. As the editorialists noted, however, this study was done only in white patients in Spain. The study did not examine the potential confounding of “dippers” (i.e., higher BP in the early morning and a decline late in the evening and while sleeping) and “nondippers” on the benefits of bedtime administration. Further, regimens containing diuretics may not be as well tolerated at night, which could lead to lower adherence to bedtime administration of diuretics. Also, past studies evaluating chronotherapy of BP medication have shown no differences in CV outcomes. Current antihypertensive guidelines and prescribing information for antihypertensive medications do not indicate a preference for morning or bedtime dosing. Many patients take their antihypertensives in the morning, along with other medications; however, the results of the Hygia trial may encourage some clinicians to recommend bedtime dosing for their patients. Confirmatory studies are needed to assess if bedtime administration of BP medications results in improved BP control and reduces CV outcomes in more diverse patients when controlling for other potential confounders (e.g., “dippers” and category of antihypertensive). What your patients need to know: Inform patients with hypertension that results from a new study suggest that administration of antihypertensive medications at bedtime may result in better BP control and a reduction in CV events compared with taking the medications in the morning. Encourage patients to discuss these findings with their providers to determine the best antihypertensive dosing regimen for them. Sources: Hermida RC, et al. Bedtime hypertension treatment improves cardiovascular risk reduction: The Hygia Chronotherapy Trial. Eur Heart J. 2019;[Epub ahead of print]. Mathur P, et al. Chronotherapy for hypertension: Improvement in patient outcomes with bedtime administration of antihypertensive drugs. Eur Heart J. 2019;[Epub ahead of print]. Primary Section Advisor: Eric MacLaughlin (Click for more...) Nintedanib shown to slow lung function decline in patients with systemic sclerosis lung disease 12/17/2019 11:58:20 AM Primary Category: RespiratoryKey point: Treatment with nintedanib (Ofev—Boehringer Ingelheim) slowed the rate of decline in pulmonary function in adults with interstitial lung disease (ILD) associated with systemic sclerosis, according to a study published in the New England Journal of Medicine. Finer points: Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and anti-inflammatory effects in preclinical models of systemic sclerosis and ILD. The drug was first approved in 2014 to treat adults with idiopathic pulmonary fibrosis. In September 2019, on the basis of efficacy and safety data from the SENSCIS trial, it was approved to treat adults with systemic sclerosis–associated ILD. The SENSCIS trial and other recent studies represent a significant advance by showing antifibrotic agents are useful in other ILDs. Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. The condition is estimated to affect about 100,000 people in the United States and 2.5 million worldwide. Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs. ILD, one of the most frequent disease manifestations, can be debilitating and may become life-threatening. Approximately 25% percent of patients develop significant lung involvement within 3 years of diagnosis. Distler and colleagues conducted a Phase III, randomized, double-blind, placebo-controlled trial (SENSCIS) to investigate the efficacy and safety of nintedanib in 576 patients (aged 20–79) with ILD associated with systemic sclerosis from 194 trial sites across 32 countries. Patients were randomly assigned to receive 150 mg of nintedanib administered orally twice daily or placebo for 52 weeks. The primary efficacy endpoint was the annual rate of decline in forced vital capacity (FVC). Key secondary endpoints were absolute changes from baseline in the modified Rodnan skin score and the total score on the St. George’s Respiratory Questionnaire (SGRQ) at week 52. Results showed that nintedanib slowed the loss of pulmonary function by 44% (41 mL/y [95% CI 2.9–79.0 mL/y]; P = 0.04) in patients who received nintedanib compared with those who received placebo. The change from baseline in the modified Rodnan skin score and the total SGRQ score at week 52 did not differ significantly between the trial groups, with differences of −0.21 (95% CI −0.94 to 0.53; P = 0.58) and 1.69 (95% CI −0.73 to 4.12 [not adjusted for multiple comparisons]), respectively. No clinical benefit of nintedanib was observed for other manifestations of systemic sclerosis. What you need to know: Results of the SENSCIS trial showed that nintedanib has a beneficial effect by reducing FVC decline in patients with ILD associated with systemic sclerosis over 1 year. However, the researchers noted that “the lower rate of decline in FVC in the nintedanib group was not accompanied by a benefit with respect to health-related quality of life.” Also, they stated, “the results do not support nintedanib as a disease-modifying agent for systemic sclerosis as a whole (i.e., nintedanib does not address other organ complications).” Diarrhea, commonly reported in this study, can be managed by dose modifications and antidiarrheal agents. What your patients need to know: Inform patients with systemic sclerosis–associated ILD that results of a new study suggest that use of nintedanib slows the rate of decline in pulmonary function. Tell patients the most common adverse effect is diarrhea and that the prescribing information includes warnings for patients with liver impairment and GI disorders. Encourage patients interested in this treatment to discuss the benefits and risks with their providers. Sources: Distler O, et al. Nintedanib for systemic sclerosis–associated interstitial lung disease. N Engl J Med. 2019;380(26):2518–28. Primary Section Advisor: Roy A. Pleasants, II (Click for more...) Office of Interprofessional Education seeking applications for inaugural awards 12/13/2019 12:00:00 AM The Office of Interprofessional Education will kick off an award program for faculty/staff and students in 2020. Faculty, staff and students from the Health Sciences campus are welcome to attend the inaugural awards luncheon April 17, the final day of Interprofessional Education Week. (Click for more...) Study shows statin dose may affect the risk of osteoporosis 12/10/2019 11:25:12 AM Primary Category: Focus on Lipids CareKey point: Patients on higher doses of statins were at an increased risk of osteoporosis compared with controls, whereas those on lower doses of statins had a decreased risk of osteoporosis, according to results of a retrospective, observational study published in Annals of the Rheumatic Diseases. Finer points: The literature discussing statin use and the risk of osteoporosis has been conflicting, with some publications suggesting that statins have a positive effect on bone mineral density (BMD) and fracture risk, and other publications questioning whether statins may have negative effects. Leutner and colleagues conducted a retrospective review of medical claims data of all Austrians from January 2006 to December 2007 to identify patients who used statin therapy at various doses and those with a diagnosis of osteoporosis. The cohort consisted of 353,502 patients treated with statins, of which 11,701 were diagnosed with osteoporosis. A control group that did not use statin therapy consisted of 7,543,947 patients, of which 68,699 patients were diagnosed with osteoporosis. The analysis showed that a diagnosis of osteoporosis was more common in patients treated with statins compared with the control group of those who were not treated with statins (odds ratio [OR] 3.62 [95% CI 3.55–3.69]). When researchers assessed the effects of different doses of statins, they observed that the risk of osteoporosis was lower with low-dose statin treatment (i.e., 0–10 mg/d) compared with controls. The ORs for osteoporosis for low doses of the following statins were 0.70 (0.56–0.86) for simvastatin, 0.39 (0.18–0.84) for lovastatin, 0.68 (0.52–0.89) for pravastatin, and 0.69 (0.55–0.87) for rosuvastatin. Low-dose atorvastatin use was not associated with a lower risk (i.e., OR 1.04, 0.86–1.25). A reversal in this trend was observed for higher doses of statin therapy, with an increased risk of osteoporosis compared with controls. The ORs for osteoporosis for higher doses of the following statins were 1.64 (1.31–2.07) for exceeding the 40 mg threshold of simvastatin and 1.78 (1.41–2.23) and 2.04 (1.31–3.18) for exceeding the 20 mg threshold of both atorvastatin and rosuvastatin, respectively. What you need to know: Statins are widely used because of their potent lipid-lowering effects and cardiovascular (CV) benefits. In recent years, however, potential risks of statin therapy have come to light, such as cognitive adverse effects (e.g., memory loss, confusion) and reports of increased glucose and A1C levels. These risks are somewhat controversial, and FDA and other organizations continue to advocate that the benefits of statins outweigh the potential risks. The current analysis suggests that higher doses of statins may increase the risk of osteoporosis. This is the first study to suggest a dose-dependent effect of statins on diagnosis of osteoporosis. In contrast, other data have suggested a benefit of statins on BMD and fracture risk, which makes interpretation and application of the current results challenging. The researchers provide potential explanations for their findings, noting that higher doses of statins may inhibit the synthesis of sex hormones, which may harm BMD. They concluded that larger, prospective studies are needed to determine how different doses of statins affect osteoporosis. In the meantime, however, they noted that monitoring of high-risk patients (e.g., postmenopausal women) using higher doses of statins might be useful to offer individualized therapy to prevent or treat osteoporosis. What your patients need to know: If patients who are currently taking statins ask about this new analysis, state that these data are controversial. Explain to patients that further well-designed studies are needed to determine if these associations are real. Discuss with patients the known benefit profile of statins (e.g., CV risk reduction) so they can make informed treatment decisions. Sources: Leutner M, et al., Diagnosis of osteoporosis in statin-treated patients is dose-dependent. Ann Rheum Dis. 2019;[Epub ahead of print]. Primary Section Advisor: Amber L. Briggs (Click for more...) Response to step-up therapy in asthma may differ in black children compared with black adolescents and adults 12/10/2019 11:07:08 AM Primary Category: Focus on Asthma CareKey point: Black children with uncontrolled asthma responded equally well to either an increased dose of their inhaled corticosteroid (ICS) or to the addition of a long-acting beta-agonist (LABA) to low-dose ICS. However, black adolescents and adults were more likely to experience improved asthma control with the addition of a LABA to a low-dose ICS compared with increasing their dose of inhaled ICS, according to results of two trials published in the New England Journal of Medicine. Finer points: Asthma guidelines recommend the addition of LABAs to ICS for those with poorly controlled asthma. These recommendations are based primarily on studies that included few patients who identify themselves as black. The Best African American Response to Asthma Drugs (BARD) trials were conducted to determine the best “step-up” strategy for children, adolescents, and adults with uncontrolled asthma while taking low-dose fluticasone, who have at least one grandparent who identified as black. The two studies were both prospective, randomized, double-blind, four-period, crossover trials, with one conducted in children aged 5 to 11 years (n = 280, mean age 8.5 y) and the other in those aged 12 years and older (n = 294, mean age 37.3 y). In the trial with children, the four regimens included doubling the dose of fluticasone to 100 mcg given twice daily; doubling the dose of fluticasone to 100 mcg and adding salmeterol 50 mcg; quintupling the dose of fluticasone to 250 mcg; or quintupling the dose of fluticasone to 250 mcg and adding salmeterol 50 mcg. For adolescents and adults, the four regimens included adding twice-daily salmeterol 50 mcg to baseline twice-daily administration of fluticasone 100 mcg; increasing the dose of fluticasone by a factor of 2.5 to 250 mcg; quintupling the dose of fluticasone to 500 mcg; or increasing the dose of fluticasone by a factor of 2.5 to 250 mcg and adding salmeterol 50 mcg. Each treatment lasted 14 weeks, with the first 2 weeks considered to be the washout period for the previous regimen and the wash-in period for the new regimen. The treatment regimens were compared on the basis of a composite of asthma exacerbations, asthma-control days, and lung function. The trial results showed that an equal number of children had a better response when the fluticasone dose was increased five-fold or when the fluticasone dose was doubled and salmeterol was added (46% of children in both groups, P = 0.99). In contrast, adolescents and adults had a better response when salmeterol was added compared with increasing the dose of fluticasone. Specifically, in children, a superior response occurred in 46% with quintupling the fluticasone dose and in 46% with doubling the fluticasone dose and adding on salmeterol. In adolescents and adults, a superior response was observed with the addition of salmeterol compared with medium- and high-doses of fluticasone (i.e., salmeterol–low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003] and salmeterol–medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). What you need to know: The results of the BARD trials suggest that data cannot be extrapolated from clinical trials involving mixed populations to specific subgroups of patients (e.g., age, race). These trials indicate that black children may respond equally well to step-up therapy that focuses on increasing the ICS dose rather than adding a LABA. In contrast, the results for adolescents and adults are consistent with current guidelines derived primarily from white patient populations that recommend the addition of a LABA to ICS to help control asthma. The researcher did note that adrenal axis suppression was seen in children who received the highest ICS dose, but that the trial was not powered to assess how this may have impacted growth. They concluded, “A larger, more simplified trial should be undertaken to determine the best treatment approach for black children with poorly controlled asthma despite the use of standard doses of an inhaled glucocorticoid.” What your patients need to know: Inform parents and caregivers that asthma therapy for young, black children (i.e., 5–11 y) may need to be individualized and may not conform to current guidelines. Educate all patients on proper inhalation dosage, administration, and technique, and provide them with written asthma educational resources when available. Sources: Wechsler ME, et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019;381(13):1227–39. Primary Section Advisor: Devra K. Dang (Click for more...) Submissions sought for Robert E. Stitzel Award for Student-Generated Educational Media in Pharmacology 12/10/2019 12:00:00 AM The Stitzel Award Competition is soliciting submissions of pharmacology educational media from students in any health professional or graduate program within the WVU Health Sciences Center. (Click for more...) FDA approves voxelotor for sickle cell disease 12/2/2019 12:48:51 PM Generic Name: VoxelotorTrade Name: OxbrytaCompany: Global Blood TherapeuticsNotes: FDA granted accelerated approval to voxelotor, a hemoglobin S polymerization inhibitor for adults and children ages 12 years and older with sickle cell disease. Efficacy was evaluated in 274 patients with sickle cell disease in HOPE, a randomized, double-blind, placebo-controlled, multicenter trial. The primary efficacy outcome measure was hemoglobin (Hb) response rate, defined as an Hb increase of > 1 g/dL from baseline to week 24. The response rate for voxelotor was 51.1% (46/90) compared with 6.5% (6/92) in the placebo group (P The most common adverse reactions to voxelotor are headache, diarrhea, abdominal pain, nausea, rash, fatigue, and pyrexia. Product information includes a warning for hypersensitivity and potential laboratory interference. Voxelotor may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography. The recommended voxelotor dose is 1,500 mg orally once daily with or without food. Recommended dosage for patients with severe hepatic impairment (Child Pugh C) is 1,000 mg orally once daily. Medication Monitor Categories: New Drug Approvals (Click for more...) As-needed corticosteroid–beta-agonist inhalers for adults with mild to moderate asthma? 12/2/2019 11:55:30 AM Primary Category: Focus on Asthma CareKey point: As-needed use of a combination inhaler containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a fast-onset long-acting beta-agonist (LABA) for quick relief reduced severe asthma exacerbations compared with low-dose ICS (budesonide) maintenance plus an as-needed short-acting beta-agonist (SABA; terbutaline) inhaler, according to a recent study published in the Lancet. Finer points: Treatment of mild persistent asthma has included maintenance with low-dose ICS and as-needed inhaled SABA to minimize symptoms and prevent exacerbations. The 2019 Global Initiative for Asthma (GINA) update included as-needed ICS–formoterol therapy as a strategy for mild asthma. However, the relative efficacy and safety of ICS–formoterol compared with maintenance corticosteroid plus as-needed SABA has been uncertain. The Personalized Asthma Combination Therapy with Inhaled Corticosteroid and Fast-Acting Beta-Agonist (PRACTICAL) study compared the effects of a combination of inhaled budesonide plus formoterol with a maintenance budesonide inhaler plus an as-needed terbutaline inhaler on severe asthma exacerbations in adult patients with mild to moderate asthma aged 18 to 75 years in an open-label, randomized controlled trial set in real-world environments. Researchers in New Zealand assigned 437 patients to budesonide–formoterol (200 mcg, 6 mcg; one inhalation as needed for symptom relief) and 448 patients to maintenance budesonide (200 mcg, one inhalation twice daily) plus terbutaline (250 mcg, two inhalations as needed). Researchers followed patients from May 4, 2016, to December 22, 2017, looking primarily at the number of severe asthma exacerbations each patient had during the study. Severe exacerbations were defined as the use of systemic corticosteroids for at least 3 days, hospital admission, or an emergency department (ED) visit due to asthma. There were few severe exacerbations in either group; however, patients who took budesonide–formoterol as needed had fewer severe asthma exacerbations per patient per year than those who took maintenance budesonide plus terbutaline as needed (0.119 vs. 0.172, relative rate 0.69 [95% CI 0.48–1.00], P = 0.049). The budesonide–formoterol group had fewer ED visits (5 vs. 7) and hospital admissions (0 vs. 2) than the maintenance budesonide plus terbutaline group. What you need to know: While ICS taken daily reduces the risk of exacerbations in patients with mild to moderate asthma, many patients do not adhere well to the regimen because of the intermittent nature of their symptoms. These patients end up with SABA-only therapy, which has been shown to increase the risk of exacerbations with frequent use. An alternative is to use an ICS with formoterol as needed. This study revealed that in adult patients with mild to moderate asthma, using the combination therapy budesonide–formoterol as needed for symptom relief was more effective at preventing severe exacerbations than using maintenance budesonide plus terbutaline as needed. Most studies looking at ICS–LABA as-needed therapy have been with budesonide–formoterol and not with other ICS–LABA combination inhalers available in the United States. As needed ICS–LABA therapy with salmeterol is not appropriate because of its much slower onset of action. While this strategy has been incorporated into the 2019 GINA update, it is uncertain whether it will be recommended when the new U.S. asthma guideline is published. An accompanying editorial suggests that there may be select patients in whom as-needed ICS–LABA therapy may not be ideal (e.g., patients with eosinophilic inflammation). The editorialists noted, “Establishment of biomarkers for mild asthma responsive to intermittent therapy might be just as important as biomarkers for biological therapy in patients with severe asthma.” Also, the cost of fixed combinations of ICS–LABA may limit the adoption of this option. Further, there are limitations to this study. The dry powder budesonide–formoterol inhaler used in this study is not available in the United States. The available budesonide–formoterol inhaler ([Symbicort—AstraZeneca] in a metered-dose formulation) contains less of each active ingredient (160 vs. 200 mcg budesonide and 4.5 vs. 6 mcg formoterol) compared with the budesonide–formoterol inhaler used in the study. What your patients need to know: Inform patients with mild to moderate asthma that using budesonide–formoterol as needed for symptom relief reduced the risk of severe exacerbations more than maintenance therapy in a recent study, but the differences were modest. Patients with mild to moderate asthma already receiving maintenance therapy may talk to their providers about switching to as-needed budesonide–formoterol, especially if they are poorly adherent to their ICS maintenance regimen. However, budesonide–formoterol might be expensive and not covered by their insurance. Sources: Hardy J, et al. Budesonide–formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): A 52-week, open-label, multicenter, superiority, randomized controlled trial. Lancet. 2019;394(10202):919–28. Gauthier M, et al. As-needed β agonist–inhaled corticosteroid in mild asthma. Lancet. 2019;394(10202):897–8. Global Initiative for Asthma. Global strategy for asthma management and prevention. Updated 2019. Accessed November 20, 2019. Primary Section Advisor: Devra K. Dang (Click for more...) Survey suggests overuse of aspirin for primary prevention of CVD 12/2/2019 11:33:24 AM Primary Category: CardiologyKey point: Data from the National Health Interview Survey published in the Annals of Internal Medicine suggest that approximately 29 million Americans are taking daily aspirin for primary prevention of cardiovascular disease (CVD), including those in which use is not recommended, such as older people and those with bleeding risk factors. Finer points: Over the past decade, numerous guidelines have supported the use of aspirin for primary prevention of CVD. However, more recent data from well-designed, prospective, randomized outcomes trials demonstrated that the net benefits of aspirin use for primary prevention of CVD were low and even harmful in some people. Researchers from Harvard used data from the 2017 National Health Interview Survey of Health and Disability among U.S. adults to estimate the number of Americans using aspirin for primary prevention of CVD. In their analysis of 14,328 adults (mean age 57.5 y, 54% women, 33% nonwhite), they found that 23.4% of patients aged 40 years or older—approximately 29 million U.S. adults—were taking aspirin for primary prevention of CVD. Of the analyzed survey respondents, 22.8% took aspirin without their physicians’ recommendation, nearly one-half of the adults aged 70 years or older without CVD took aspirin, and numerous people with bleeding risk factors (e.g., history of peptic ulcer disease) also used aspirin for primary prevention. What you need to know: The current analysis highlights the prevalence of aspirin use for primary prevention of CVD and that many people are using OTC aspirin without their physician’s recommendation. This can be problematic, as recent data have shown that the risks of aspirin outweigh the benefits in those with bleeding risk factors and in older adults (i.e., >70 y). The 2019 American College of Cardiology/American Heart Association (ACC/AHA) guideline on primary prevention of CVD noted that aspirin should be used infrequently for primary prevention because of the lack of net benefit. Specifically, these organizations recommended avoiding it for primary prevention of CVD in patients older than 70 years or in those of any age who are at an increased risk of bleeding. ACC/AHA recommend that use of low-dose aspirin for primary prevention be considered only for adults aged 40 to 70 years who have a higher CV risk and who do not have an increased bleeding risk. The results suggest that clinicians should inquire about aspirin use. Pharmacists are well positioned to obtain this medication history. In the community setting, people may be purchasing low-dose aspirin at the pharmacy, which is a perfect opportunity to ask about aspirin use, assess both CVD and bleeding risk factors, and educate patients on the recent recommendations for primary prevention of CVD. What your patients need to know: If patients are interested in using low-dose aspirin for primary prevention of CVD, assess their CV risk factors and bleeding risks. Inform them that the current data do not support routine use of aspirin for primary prevention unless patients are at an elevated risk of CV events. If patients are appropriate candidates for aspirin therapy, educate them on proper dosing and administration, drug–drug interactions, and potential adverse effects. Sources: O’Brien CW, et al. Prevalence of aspirin use for primary prevention of cardiovascular disease in the United States: Results from the 2017 National Health Interview Survey. Ann Intern Med. 2019;171(8):596–8. Arnett DK, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;74(10):1376–1414. Primary Section Advisor: Eric MacLaughlinSecondary Category: OTC Medicines Corner (Click for more...) Triple therapy in a single inhaler improves asthma symptoms and control, studies show 11/26/2019 10:12:45 AM Primary Category: Focus on Asthma CareKey point: Addition of a long-acting muscarinic antagonist (LAMA) to inhaled corticosteroid (ICS) plus long-acting beta-2-agonist (LABA) therapy improved lung function and reduced exacerbations in adults with uncontrolled asthma, according to an analysis of two clinical trials published in the Lancet. Finer points: Many patients with asthma can achieve good control, especially with a combination of an ICS plus LABA. However, until recently, few options were available for patients who could not achieve control with such combinations. Researchers reviewed the first studies to assess single­-inhaler triple therapy: TRIMARAN and TRIGGER, two parallel-group, double-blind, randomized, controlled, Phase III trials that compared the single-inhaler combination of beclomethasone dipropionate (BDP), an ICS; formoterol fumarate (FF), a LABA; and glycopyrronium (G), a LAMA, to the combination of BDP and FF. Trial participants were aged 18 to 75 years and from 171 sites across 16 countries for TRIMARAN, and 221 sites across 17 countries for TRIGGER; 126 sites participated in both studies. Eligible patients had a documented history of asthma for at least 1 year, had one or more exacerbations in the previous year, were diagnosed before age 40, and had prebronchodilator forced expiratory volume in 1 second (FEV1) of less than 80% predicted normal value and a change in FEV1 of more than 12% and over 200 mL at 10 to 15 min after inhaling albuterol 400 µg. The main difference between the studies was the ICS dose received before and during the study, with patients in TRIMARAN receiving a medium dose and patients in TRIGGER receiving a high dose. Improvement of the lung-function (predose FEV1) coprimary endpoint was met in both studies, with a slightly larger effect size in TRIGGER. The rate of moderate and severe exacerbations coprimary endpoint was met in TRIMARAN, with a significant 15% reduction for BDP/FF/G versus BDP/FF, and although a similar effect size was seen in TRIGGER, with a 12% reduction, it was not significant. In the key secondary endpoint analysis of data pooled from the two studies, triple therapy reduced the rate of the more clinically relevant severe exacerbations by 23%. For the other secondary exacerbation endpoints, in the pooled analyses, triple therapy reduced the rate of moderate exacerbations by 12% and combined moderate and severe exacerbations by 14%. The time to first moderate or severe exacerbation, first moderate exacerbation, and first severe exacerbation was longer with BDP/FF/G than with BDP/FF. What you need to know: These studies showed that in adults with uncontrolled asthma who were treated with a medium to high dose of ICS plus a LABA, addition of a LAMA in a single inhaler, BDP/FF/G triple therapy improved lung function with an associated positive effect on severe exacerbations and some benefit in asthma symptoms and control. The authors noted that “interpreting the clinical relevance of results when assessing the additive effect of a therapy on top of therapies that are known to be effective is challenging. The differences that we observed between the BDP/FF/G group and BDP/FF group for some of the endpoints could be argued to be numerically small (with the differences in predose FEV1 at week 26 and morning [peak expiratory flow] over 26 weeks being lower than those included in the powering assumptions), and indicate only a moderate effect of triple therapy.” However, they pointed out the population studied has few treatment options available, and uncontrolled asthma is associated with a substantial economic and health burden, so even “moderate incremental” improvements can be valuable. They also noted that the treatments were well tolerated. The only single-inhaler triple therapy product currently available in the United States contains fluticasone/vilanterol/umeclidinium and is approved for COPD. Tiotropium, in the Respimat inhaler formulation, was FDA approved in 2015 for maintenance treatment of asthma and can be added to the usual ICS/LABA combination inhalers in selected patients who require additional treatment for asthma, but this requires two inhalers and two inhalation techniques. What your patients need to know: Inform patients with uncontrolled asthma that new studies show that single-inhaler triple therapy improved lung function and reduced exacerbations. Tell them that this triple-drug inhaler has not been approved in the United States. Educate patients on proper inhaler technique, potential adverse effects, and the importance of being adherent to their long-term asthma controller medications, which may require using more than one inhaler. Sources: Virchow JC, et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): Two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet 2019;394(10210):1737–49. Primary Section Advisor: Devra K. Dang (Click for more...) Analysis suggests OTC oral contraceptives may improve access, reduce unintended pregnancies 11/26/2019 9:56:39 AM Primary Category: OTC Medicines CornerKey point: Women who were able to obtain oral contraceptives OTC without a prescription had higher rates of OTC continuation over time, according to the results of a systematic review published in BMJ Global Health. Finer points: Oral contraceptives require a prescription in the United States, which may hinder access for some patients, especially those who lack access to health care. A 2015 review of oral contraceptive access in 147 countries found 102 countries had oral contraceptives available without a prescription. Kennedy and colleagues conducted a systematic review of the literature to assess the impact of OTC oral contraceptives on patient care (e.g., adherence, adverse effects) and on patient and provider values and preferences. Data from four studies involving 5,197 patients compared either full OTC availability or pharmacist-prescribing (i.e., behind-the-counter) with prescription-only availability. Also, data from 23 value and preference studies assessed patient and provider views on OTC access to oral contraceptives. For the four studies assessing impact on patient care, two studies conducted in the 2000s examined women who obtained OTC oral contraceptives in Mexico and compared them with women who received them from providers in Mexico or the United States. The other two studies were older and compared first contraceptive users who obtained oral contraceptives OTC from a pharmacy drug store or a provider. Data from one of these studies showed that OTC users had higher oral contraceptive continuation rates over 9 months, and data from another study noted that OTC users were more likely to have a contraindication to therapy. However, data on adverse effects showed that similar rates were observed for the OTC and provider-prescribed groups. For the value and preference studies, most women expressed high interest in the hypothetical availability of OTC oral contraceptives. The reasons for this were ease of access, convenience, privacy, and time saved from clinician visits for prescriptions. However, some providers were concerned about costs, continued use of the provider for other preventive services such as pelvic and breast exams and screening for STDs, and the safety of such access, especially for first-time users. Providers were generally in support of having OTC access to progestin-only products compared with combination oral contraceptives, which contain estrogens. What you need to know: Organizations such as Planned Parenthood, the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG) have all released statements supporting OTC availability of oral contraceptives. These organizations note that women can use self-screening tools to determine their eligibility for hormonal contraceptive use. ACOG wrote that pharmacist-provided contraception might be a necessary intermediate step to increase access to contraception, but OTC access to hormonal contraception should be the goal. Although providers are concerned about how the availability of OTC contraceptives may affect other necessary health services, these concerns should not be the primary reasons to restrict access to these medications. Clinicians have noted that patients with health disparities who lack adequate access to health care and adolescent girls who may have barriers to getting a prescription for oral contraceptives would likely benefit the most. While combined oral contraceptives are generally more popular, the estrogen component of these products has more serious precautions that need to be considered (e.g., risk of thromboembolism, use in those who smoke or have a history of cardiovascular disease). Therefore, some have noted that the availability of progestin-only products seems more reasonable, as progestin-only emergency contraceptives (e.g., Plan B One-Step—Foundation Consumer Healthcare) have been available OTC for years. What your patients need to know: Inform patients that oral contraceptives are currently available only by prescription in most states. A few states have adopted laws that allow pharmacists to provide contraceptives without a prescription, and efforts have been undertaken to try and move these products OTC. Educate patients on other forms of contraception that are available OTC, such as condoms, spermicides, and levonorgestrel-containing emergency contraception, if needed. Also, direct those who are interested in oral contraceptives to nearby providers who can help them. Sources: Kennedy CE, et al. Should oral contraceptive pills be available without a prescription? A systematic review of over-the-counter and pharmacy access availability. BMJ Glob Health. 2019;4(3):e001402. Planned Parenthood. Congress moves to make birth control more accessible. Accessed November 12, 2019. American Academy of Family Physicians. Over-the-counter oral contraceptives. Accessed November 12, 2019. American College of Obstetricians and Gynecologists. Over-the-counter access to hormonal contraception. Accessed November 12, 2019. Primary Section Advisor: Tara Whetsel (Click for more...) Riluzole oral film approved for patients with ALS 11/25/2019 3:33:01 PM Generic Name: Riluzole oral filmTrade Name: ExservanCompany: Aquestive TherapeuticsNotes: Aquestive Therapeutics announced FDA approval of riluzole oral film for treatment of amyotrophic lateral sclerosis (ALS). It can be administered without water to patients with ALS who have trouble swallowing. According to Aquestive, studies have demonstrated riluzole's pharmacokinetic bioequivalence to the reference listed drug, Rilutek. The recommended dosage is 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal. Common adverse reactions are oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. Medication Monitor Categories: Supplemental Approvals (Click for more...) "Evening of Science" set for Tuesday, Nov. 12 11/6/2019 12:00:00 AM The West Virginia University Office of Research and Graduate Education will host an "Evening of Science" Tuesday, Nov. 12 from 4 to 6 p.m. on the 4th floor at Evansdale Crossing. (Click for more...) Alumni supporting alumni 11/6/2019 12:00:00 AM In the Class Notes section of the new WVU Alumni Magazine there is a photo of WVU School of Pharmacy alumna Kylea Goff (PharmD,'10) who greeted WVU School of Medicine alumnus and Men's Co-Champion John Logar (MD, '01) at the finish line for the Iditarod Trail Invitational in Nome, Alaska!! Goff is assistant director of pharmacy at Norton Sound Health Corporation in Nome. (Click for more...) Important Accessibility Information for Faculty 11/6/2019 12:00:00 AM WVU's Office of Accessibility Services' new database Student Accommodation Management for Mountaineers (SAMM) is now available online, providing faculty members with easier access to information about the disability accommodations authorized in their classes. (Click for more...) WVU Pharmacy students can expect an enhanced learning facility in 2020 11/6/2019 12:00:00 AM A new Pharmacy Skills Development Center, designed to prepare student pharmacists for an evolving role in health care, will open in 2020 at the West Virginia University School of Pharmacy in Morgantown. (Click for more...) Free MAT waiver training course 11/4/2019 12:00:00 AM A free course is available Jan. 8, 2020, for area healthcare workers, social workers, pharmacists, physicians, physician assistants and nurse practitioners battling the opioid epidemic. (Click for more...) WVU Cancer Institute Annual Meeting and Hardesty Lecture 11/1/2019 12:00:00 AM The WVU Cancer Institute (WVUCI) is sponsoring the second Annual WVUCI Scientific Meeting on Nov. 22, 2019, at the Erickson Alumni Center. This is a half-day event with scientific sessions that include outside speakers, as well as reports from selected WVUCI faculty members highlighting their basic, clinical and population research. (Click for more...) WVU researchers awarded joint Small Business Technology Transfer Grant for treatment of acute arthritis 10/29/2019 12:00:00 AM The National Institutes of Health has just awarded a new Small Business Technology Transfer (STTR) grant jointly to a small West Virginia-based business ExesaLibero Pharma and WVU, as its primary academic partner. This grant is awarded in two separate phases, Phase 1 is for six months and after satisfying specified milestones, Phase 2 is awarded for an additional two years. These grants are awarded to the small business company that then subcontracts with WVU and other entities to conduct portions of the research work. (Click for more...) WVU School of Pharmacy alumni earn awards at WVPA annual convention 10/22/2019 12:00:00 AM The 112th Annual West Virginia Pharmacists Association (WVPA) Convention was held in Charleston, West Virginia, October 19-20 and two West Virginia University School of Pharmacy Alumni received awards. (Click for more...) Student pharmacists wear pink for breast cancer awareness 10/22/2019 12:00:00 AM October is breast cancer awareness month, and student pharmacists are doing their part to increase visibility of the annual campaign. On Monday, a group of students wore pink and gathered for a photo in the Pylons area of the Health Sciences Center. The photo was organized by the American Pharmacists Association - Academy of Student Pharmacists Operation Women's Health. (Click for more...) LGBTQ+ Health Week at WVU Health Sciences 10/21/2019 12:00:00 AM To help students and healthcare professionals better understand health issues impacting the LGBTQ+ community, Student Healthcare Alliance for Promoting Equality (SHAPE) is hosting its third annual LGBTQ+ Health Week, Nov. 1-8. (Click for more...) Inaugural WVU Health Sciences Lab Open House 10/18/2019 12:00:00 AM WVU Health Sciences faculty and students from more than 20 laboratories will host the inaugural WVU Health Sciences Lab Open House Tuesday, Oct. 22, from 1 to 3 p.m. in the Pylons/Learning Center Commons. (Click for more...) Don't miss the game Saturday - come join our watch party at The Market! 10/18/2019 12:00:00 AM Making time for a Mountaineer game on the weekend can be stressful - especially if you're working, or studying, at Ruby Memorial or Health Sciences Morgantown. (Click for more...) Ready for Work Clothing Drive Oct. 14-25 10/14/2019 12:00:00 AM VISTA Collaborative at WVU's Center for Service and Learning is partnering with WV Women Moving Forward to host a Ready for Work Clothing Drive from October 14-25. The drop-off location at the Health Sciences Center is located on the first floor behind Cavanaugh's (Pylons Area). Solid color scrubs in all sizes are needed. (Click for more...) Vandalia - Con Steampunk Convention to benefit Bonnie's Bus coming Oct. 18-20th to Morgantown 10/11/2019 12:00:00 AM Vandalia-Con (Click for more...) The Academy of Excellence in Teaching and Learning induction ceremony is on October 15 10/11/2019 12:00:00 AM WVU Health Sciences Center Faculty Development Program will host its Academy of Excellence in Teaching and Learning induction ceremony on Oct. (Click for more...) WVU SoP hosts Homecoming Weekend 2019 10/10/2019 12:00:00 AM The School of Pharmacy hosted Homecoming Weekend 2019 Oct. 4 and 5. Activities included a Homecoming Parade watch party at the Iron Horse Tavern on High Street Friday night and a tailgate in the Light Blue Lot at Milan Puskar Stadium Saturday afternoon. Also on Friday, the School's Leadership Council met provide feedback and insight to Dean Petros and SoP faculty. (Click for more...) Pharmacy students shed light on mental health 10/10/2019 12:00:00 AM Members of WVU's American Pharmacists Association-Academy of Student Pharmacists (APhA-ASP) Operation Mental Health were in the Pylons October 9 to provide some stress relief. (Click for more...) APhA CEO returns to his alma mater to share his professional experiences 10/10/2019 12:00:00 AM Executive Vice President and CEO of the American Pharmacists Association Tom Menighan (BSPharm, '74) returned to his alma mater on October 3 for a question and answer style session with WVU School of Pharmacy students. The president of WVU's American Pharmacists Association - Academy of Student Pharmacists (APhA-ASP) Maxwell DeNora moderated the talk. They discussed Menighan's time at WVU, his multifaceted career as a pharmacist and the future of pharmacy among other topics. The presentation, "Your Future Through My Rear View Mirror," was presented by the School's Dean's Hour and was organized by APhA-ASP. Photos of the event can be viewed at https://lnkd.in/eSkJk4u (Click for more...) Take Back the Night 10/8/2019 12:00:00 AM This year, WVU will join hundreds of college campuses in holding a Take Back the Night event. (Click for more...) WVCTSI Clinical Trials Center of Excellence opens at WVU 10/7/2019 12:00:00 AM MORGANTOWN, W.Va. – To help further cement its status as a top research institution, the West Virginia Clinical and Translational Science Institute has announced the formation of the Clinical Trials Center of Excellence at West Virginia University. (Click for more...) Dr. Otis Brawley will present the Annual Hardesty Lecture 10/4/2019 12:00:00 AM Dr. Otis Brawley will present the Annual Hardesty Lecture Nov. 22 at 4 p.m. in the Erickson Alumni Center. (Click for more...) Health Sciences to sponsor WVU Global Health Week 10/1/2019 12:00:00 AM The Global Health Program at WVU Health Sciences will sponsor WVU Global Health Week Oct. 14-18 at noon in room 1905 Health Sciences North. Lunch is provided to those who RSVP by Oct. 7. (Click for more...)
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