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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...
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...) CEO Paul Hudson has sharp words for Sanofi's mistakes—and a pointed plan he thinks will fix them 12/10/2019 10:42:24 AM Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab. The company has long been a leader in diabetes and cardiovascular diseases, but it won't be focused there going forward. Instead, it's focusing on rare diseases, cancer, and transformative launches. (Click for more...) Sanofi, Regeneron uncouple on long-standing drug partnership, splitting up Praluent, Kevzara 12/10/2019 10:03:41 AM After more than a decade of working together, Sanofi and Regeneron's drug partnership finally turned a profit recently on the back of strong sales of blockbuster Dupixent. Instead of staying the course, the couple are now reworking their arrangement—and so far it's leaving Regeneron worse for wear. (Click for more...) Fujifilm liposome plant ready to deliver 12/10/2019 9:45:46 AM Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer fighting drugs it is developing. But the Japanese company is not keeping it all to itself. The plant also will make them for other drug developers. (Click for more...) Flu season is off to an early start 12/10/2019 9:15:35 AM Flu season is off to an early start Tue, 12/10/2019 - 09:20 ehaberkorn@aph… Tue, 12/10/2019 - 09:15 The most influenza activity is concentrated in the southern states so far this season. Interestingly, CDC reports heightened activity of the B strain of the influenza virus. Typically, this strain of the virus doesn’t show up until around March or April. Pharmacists and other vaccine providers should continue to tell patients to get vaccinated. (Click for more...) J&J CEO promises talc is asbestos-free, but spurns his chance to tell Congress why 12/10/2019 8:49:27 AM Johnson & Johnson CEO Alex Gorsky has spent years answering safety questions about its under-the-gun talc products, but when it comes to facing Congressional queries, he's not interested. Gorsky has spurned numerous requests to testify, a House subcommittee says, though he's offered to send an expert witness in his place. (Click for more...) SMC green light for rare blood cancer treatment 12/10/2019 2:57:50 AM NHS funding was backed for four medicines (Click for more...) Private clinic launches UK’s first MRIdian radiotherapy machine 12/10/2019 2:57:17 AM NHS patients will be able to access the treatment via clinical trials (Click for more...) Healx, Boehringer link for rare neurological disease therapy 12/10/2019 2:56:46 AM The project will utilise Healx' AI-based drug discovery platform (Click for more...) RCEM’s winter data reveals much worse picture of A&E waits 12/10/2019 2:56:05 AM "We are clearly in the worst state we’ve ever been in as we enter the true winter season", says College president Dr Katherine Henderson. (Click for more...) Progress toward regional measles elimination worldwide, 2000-2018 12/9/2019 11:03:37 PM Progress toward regional measles elimination worldwide, 2000-2018 Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 In 2012, the World Health Assembly endorsed the Global Vaccine Action Plan; countries in all six World Health Organization (WHO) regions have adopted goals to eliminate measles by 2020. During 2000–2018, annual reported measles incidence decreased 66%, and annual estimated measles deaths decreased 73%. Since 2000, measles vaccination has prevented an estimated 23.2 million deaths globally. However, measles incidence increased in five regions during 2016–2018. More than 142,000 people died worldwide from measles last year, compared with 124,000 people dying from the disease in 2017. The recent surge is due to dropping vaccination rates: A 95% coverage rate is required to maintain immunity in communities, but WHO estimates that 86% of children last year received the first dose of the MMR vaccine, and fewer than 70% received the second dose. To achieve regional measles elimination goals, resource commitments are needed to strengthen routine immunization systems, close immunity gaps, and improve case-based surveillance. (Click for more...) Biogen's potential new drug for Alzheimer's disease gets cautiously optimistic review following presentation 12/9/2019 11:03:37 PM Biogen's potential new drug for Alzheimer's disease gets cautiously optimistic review following presentation Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 Following a recent presentation by Biogen about aducanumab, the company's experimental treatment for Alzheimer’s disease, some leading neuroscientists appeared more hopeful about the drug. The presentation was live-streamed at the Clinical Trials on Alzheimer’s Disease conference in San Diego. R. Scott Turner, MD, PhD, director of Georgetown University’s Memory Disorders Program, which partnered in the study, says: "This study proves that we are on the right track to developing more effective, disease-modifying treatments designed to stop or slow memory decline in the earliest disease stage — when patients are still relatively independent in their daily functions." Biogen intends to request FDA approval in early 2020. Aducanumab uses genetically engineered cells that resemble the body's natural disease-fighting processes. The drug's monoclonal antibodies target amyloid beta, a protein associated with the onset of dementia. Samantha Budd Haeberlein, PhD, Biogen's vice president of clinical development, says the company's re-analysis of its data indicated that the rate of deterioration for patients who were given consistently higher doses was slower than those given lower doses over time or compared with placebos, based on cognitive tests and brain scans. The research also indicated that adverse events increased with the higher dosage, including headaches, swelling in the brain, and small hemorrhages, but they were manageable with reductions in dosage. (Click for more...) Association of aspirin use with mortality risk among older adults in the prostate, lung, colorectal, and ovarian cancer screening trial 12/9/2019 11:03:37 PM Association of aspirin use with mortality risk among older adults in the prostate, lung, colorectal, and ovarian cancer screening trial Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 Although aspirin has been shown to reduce cancer mortality, the efficacy of this approach might vary according to biological traits such as age and weight. To investigate whether the strategy lowers the risk of death among older adults, researchers pulled data from individuals aged 65 years and older who participated in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Based on median followup of 12.5 years for 146,152 patients, prophylactic aspirin use does appear to have a mortality benefit in this population. A regimen of 1–3 times per month correlated to a lower risk of all-cause mortality and cancer mortality compared with no use. Taking aspirin at least 3 times a week, meanwhile, curtailed the risk of death from cancer, gastrointestinal cancer, and colorectal cancer as well as all-cause mortality. Stratification by body mass index (BMI), meanwhile, revealed a broader mortality benefit in patients with BMI of 25–29.9 vs. those with BMI of 20–24.9. (Click for more...) Drug helped dementia patients curb their hallucinations and delusions 12/9/2019 11:03:37 PM Drug helped dementia patients curb their hallucinations and delusions Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 The drug pimavanserin (Nuplazid—Acadia Pharmaceuticals), which reduces delusions in Parkinson’s patients, was also effective for people with Alzheimer’s disease and other forms of dementia, according to the results of a clinical trial. If approved by regulators, pimavanserin could become the first drug offered specifically for treating dementia-related psychosis and would be the first new medicine for Alzheimer’s in nearly 20 years. The drug is taken in daily doses to target hallucinations that are frequently linked to anxiety, aggression, and physical and verbal abuse. The results of the trial were announced at an Alzheimer’s conference in San Diego. Pimavanserin was approved for Parkinson’s-related psychosis in 2016, and costs about $3,000 per month. Roughly 8 million Americans have dementia, of whom up to 30% develop psychosis, studies show. Jeffrey Cummings MD, ScD, of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, helped lead the study, which included about 400 people with dementia and psychosis. All were given a low dose of the drug for 3 months, and those who seemed to respond or benefit were then split into two groups. One-half continued on the drug and the others were given a placebo for 6 months or until they had a relapse. Independent monitors halted the study when they saw that those on placebo were more than twice as likely as those on pimavanserin to relapse or worsen — 28% compared with nearly 13%. (Click for more...) CMS Office of the Actuary releases 2018 national health expenditures 12/9/2019 11:03:37 PM CMS Office of the Actuary releases 2018 national health expenditures Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 Total national health care spending in 2018 grew 4.6%, which was slower than the 5.4% overall economic growth, according to a study conducted by the Office of the Actuary at CMS. As a result, the share of the economy devoted to health spending decreased from 17.9% in 2017 to 17.7% in 2018. Growth in overall health care spending has averaged 4.5% for 2016-2018, slower than the 5.5% average growth for 2014-2015, which was affected by expanded Medicaid and private insurance coverage and increased spending for prescription drugs, particularly for drugs used to treat hepatitis C. The growth in total national health care expenditures was approximately 0.4 percentage point higher than the rate in 2017 and reached $3.6 trillion in 2018, or $11,172 per person. Retail prescription drug spending (9% of total health care spending) grew 2.5% in 2018 to $335.0 billion following slower growth of 1.4% in 2017. This faster rate of growth was driven by non-price factors, such as the use and mix of drugs consumed, which more than offset a decline of 1.0% in prices for retail prescription drugs. (Click for more...) Drug overdose medication free at Ohio State pharmacies 12/9/2019 11:03:37 PM Drug overdose medication free at Ohio State pharmacies Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 The Wexner Medical Center at Ohio State University is offering free naloxone (Narcan—Adapt) to help prevent opioid-related overdoses, which took 4,293 lives in Ohio in 2017. The medical center will provide free kits containing two naloxone nasal sprays that can treat overdoses; no prescription is required. The medical center recently received a grant from the Ohio Department of Health to support Narcan distribution across its hospitals and in the community. The program partners with Project Death Avoided With Narcan (DAWN), which began in 2012 and is now present in almost every county in the state. There is not a set restriction, so the hospital can request more kits as people pick them up, and customers are not limited to one kit. Narcan is not harmful if given to someone who isn't experiencing an overdose, and people are protected by the Good Samaritan law when administering the medicine, which provides immunity for minor drug possession and to people who seek medical help for themselves or another person. At the pharmacy, people will fill out paperwork, get educational papers, and participate in a short training session on how to use the product and the kit. (Click for more...) UPS to use sensors that can track medical packages at all times 12/9/2019 11:03:37 PM UPS to use sensors that can track medical packages at all times Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 United Parcel Service Inc. (UPS) plans to launch a service that uses sensors and data analytics to track medical packages' exact location in near-real time. The service, UPS Premier, will prioritize the handling of medical shipments to ensure that packages arrive at exactly the right time and place. Sensors on the packages will let UPS staff know where they are at any given time, instead of relying at a few points throughout the delivery cycle. The sensors interact with electronic readers in sorting and distribution operations to provide information that employees can use to prioritize deliveries and change them as needed. The new service is the latest example of how technology is being used to improve the complex health care supply chain, which often involves packages that are temperature-sensitive and can expire quickly. For example, FedEx Corp. has a health care-focused logistics service called SenseAware that customers can use to monitor location of shipments, as well as keep track of the precise temperature, light exposure, and barometric pressure. The need for precision logistics has increased because of a growing older population and trends toward personalized health, which focuses on predicting and preventing diseases. (Click for more...) Birth rate falls for 4h consecutive year 12/9/2019 11:03:37 PM Birth rate falls for 4h consecutive year Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 CDC reports that U.S. birth rates fell for the 4th year in a row in 2018. There were roughly 3.8 million babies born in the United States in 2018, down 2% from the previous year, marking the lowest number of births in more than 3 decades. The total fertility rate declined to 1,729.5 births per 1,000 women. According to CDC, there would need to be 2,100 births per 1,000 women in order for the population to not decline. The drop is driven by women waiting longer to have children and a decline in the teen birth rate, which fell 7.4% for young women aged 15–19 years. The number of births increased slightly in 2018 for women aged 35–44 years, CDC said. (Click for more...) FDA Is green-lighting drugs at breakneck speed and raising alarm 12/9/2019 11:03:37 PM FDA Is green-lighting drugs at breakneck speed and raising alarm Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 FDA is approving new drugs at a historic pace, sparking alarm among consumer advocates. The breakneck pace has drug companies preparing for green lights months ahead of the scheduled approval dates. Though the average wait for a drug to be approved has traditionally been 10 months, FDA approved five medicines in 8 weeks over this autumn. The agency said it is moving quickly to get potentially life-saving medicine to patients in need. The Trump administration on the whole has focused on reducing regulation across the United States, but FDA first began to pick up its pace back in the Clinton administration. Though some have applauded FDA for its rapid pace, patient-safety advocates have warned that speeding through the approval process may mean regulators miss potentially dangerous adverse events and allow controversial drugs to go to market. Michael Carome, health research group director at the consumer advocacy group Public Citizen, said he feared the country is "allowing drugs come to market sooner, faster without having sufficient information about their safety." (Click for more...) House Republicans will unveil their own drug pricing bill 12/9/2019 11:03:37 PM House Republicans will unveil their own drug pricing bill Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 House GOP leaders plan to unveil their bill to lower drug prices as an alternative to Democratic proposals. The details will be laid out by Way and Means ranking member Rep. Kevin Brady (R-TX), Energy and Commerce ranking member Rep. Greg Walden (R-OR) and Education and Labor ranking member Rep. Virginia Foxx (NC). This House Republican measure will include a first-ever cap on out-of-pocket costs for seniors on Medicare, along with other provisions for which Democrats have previously expressed support. Aides stressed that the proposal, which will be rolled out next week as a 375-page bill, contains no "poison pills" that could prompt Democrats to oppose it. "There are not rock-hard, Republican-only provisions in here," a GOP committee aide told me. "It's a sincere proposal. We would remove things if they want us to." The House GOP bill is a countermove to House Speaker Nancy Pelosi (D-CA), who is teeing up a vote on a drug pricing bill Republicans and the pharmaceutical industry dislike. Pelosi's measure would allow the federal government to directly negotiate lower prices with drug makers in the Medicare program. (Click for more...) Statement from FDA's Janet Woodcock on impurities found in diabetes drugs outside the U.S. 12/9/2019 11:03:37 PM Statement from FDA's Janet Woodcock on impurities found in diabetes drugs outside the U.S. Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, discusses the agency's investigation into the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past 18 months, several drug products including angiotensin II receptor blockers and ranitidine have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. "Based on the information we have available, the levels of NDMA seen outside the United States are within the range that is naturally occurring in some foods and in water," says Woodcock. "While we are aware that some regulatory agencies outside the United States may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time." FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found. (Click for more...) Connecticut bill allowing pharmacists to give kids influenza vaccine at risk 12/9/2019 11:03:37 PM Connecticut bill allowing pharmacists to give kids influenza vaccine at risk Sun, 12/08/2019 - 19:00 cbaker_admin Mon, 12/09/2019 - 23:03 A Connecticut bill that would allow trained pharmacists to administer the influenza vaccine to children age 12 years and older cleared the General Assembly's public Health Committee this year but died on the Senate calendar due to inaction. Nathan Tinker, CEO of the Connecticut Pharmacists Association, said his organization does not plan to push for the bill again in the next legislative session due to fears that conflict around efforts to end a religious exemption for some vaccines will spill over and affect the influenza vaccine bill. The bill has met resistance from parents questioning the necessity of influenza vaccination, and some physicians have questioned whether pharmacists can determine the appropriate vaccine for a pediatric-age patient. Supporters of the influenza vaccination bill argue that allowing parents to drop by a pharmacy will lead to higher influenza vaccination rates. The bill had the support of the state's Department of Public Health, which noted three children in Connecticut died from flu-related complications during the 2017–18 influenza season. Pharmacists and advanced practice registered nurses in Connecticut are currently allowed to vaccinate individuals aged 18 years or older. (Click for more...) Sanofi CEO Hudson backs away from struggling diabetes, cardiovascular areas in strategy unveiling 12/9/2019 6:50:27 PM That didn’t take long. Sanofi CEO Paul Hudson has only been at the reins for a couple months, but on Tuesday, he unveiled a major shakeup. Going forward, the company plans to prioritize its strongest-growing products, like immunology med Dupixent and vaccines, and exit businesses where it’s not performing as well. (Click for more...) ASH: J&J's Darzalex cuts death risk by 40% in new myeloma patients 12/9/2019 4:26:23 PM ORLANDO, FLORIDA—Johnson & Johnson hasn’t had problems convincing physicians to use multiple myeloma med Darzalex, which quickly went blockbuster and beyond on the back of some historic approvals. But new "gold standard" data presented Monday could further increase doctors’ confidence in the med, the company says. (Click for more...) Sanofi CEO offers clues of tomorrow's vision reveal with cancer biotech buy 12/9/2019 10:40:17 AM Sanofi CEO Paul Hudson has been preparing for months to lay out his new strategy for the French drugmaker, with the big unveiling set for Tuesday. But could Monday's cancer deal announcement be a big hint? Analysts think so. (Click for more...) Taking blood pressure meds before bed may reduce CV events 12/9/2019 10:01:19 AM Taking blood pressure meds before bed may reduce CV events Mon, 12/09/2019 - 10:05 caldridgeyoung… Mon, 12/09/2019 - 10:01 The trial randomized almost 20,000 patients in the primary care setting and followed them for an average of 6 years. Patients in one group took their blood pressure medication before bed, while patients in another group took theirs upon waking. The group that took the medication before bed had a 45% reduction in overall cardiovascular events, which included cardiovascular death, myocardial infarction, coronary revascularization, heart failure, and stroke. (Click for more...) Samsung execs face jail for destroying evidence in Biogen JV fraud probe 12/9/2019 9:36:06 AM Samsung BioLogics has fought accusations that it inflated the value of its Biogen biosimilar joint venture Samsung Bioepis, breaking accounting rules in the process. Counter to that defense? The fact that several executives destroyed and hid evidence. And now, three of those execs could face jail time. (Click for more...) FDA slams repackager for unsupported drug expiration dates 12/9/2019 9:30:59 AM The FDA has slapped around a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations. (Click for more...) J&J aims to help Rwanda buffer Ebola's advance with 200,000 vaccine doses 12/9/2019 8:57:03 AM With an Ebola virus outbreak still wreaking havoc in Congo, world health authorities are looking for ways to stop the spread. To prepare the Rwandan border for a potential crisis, Johnson & Johnson is stepping in. (Click for more...) FiercePharmaPolitics—House to vote on Pelosi plan as GOP trots out rival bill 12/9/2019 8:56:20 AM Ready for a drug pricing showdown in the House of Representatives? Democrats plan to vote this week on House Speaker Nancy Pelosi’s cost-cutting bill, while Republicans plan to unveil a rival plan that focuses on Medicare reform and pharma transparency. (Click for more...) Sanofi bulks up cancer offering with Synthorx buy 12/9/2019 6:37:46 AM The French drugmaker is spending around $2.5 billion on the deal (Click for more...) AZ’ Calquence boosts PFS in CLL patients 12/9/2019 5:23:02 AM The drug demonstrates “remarkable efficacy”, says AZ’ José Baselga (Click for more...) Survey reveals ‘critical deficiencies’ in NHS record-keeping 12/9/2019 5:20:53 AM Policymakers must identify fragmented systems and promote better data sharing, study authours say (Click for more...) CAR-T therapies shine at ASH 12/9/2019 5:15:12 AM Janssen's JNJ-4528 and BMS' liso-cel show 100% response rates (Click for more...) ASH: Takeda details Ninlaro's miss in scrapped AL amyloidosis trial 12/9/2019 3:43:37 AM ORLANDO, FLORIDA—Back in June, Takeda scrapped a Ninlaro trial in the rare disease light-chain (AL) amyloidosis. Saturday, it shared the data behind the decision—results execs say they’re excited to get into the public domain. (Click for more...) Bacitracin Ophthalmic Ointment 12/8/2019 7:00:00 PM Drug: Bacitracin Ophthalmic Ointment, Revision Date: Mon, 09 Dec 2019 (Click for more...) Ciprofloxacin Ophthalmic Solution 12/8/2019 7:00:00 PM Drug: Ciprofloxacin Ophthalmic Solution, Revision Date: Mon, 09 Dec 2019 (Click for more...) Docusate Sodium Oral Liquid in Bulk Bottles 12/8/2019 7:00:00 PM Drug: Docusate Sodium Oral Liquid in Bulk Bottles, Revision Date: Mon, 09 Dec 2019 (Click for more...) Erythromycin Lactobionate Injection 12/8/2019 7:00:00 PM Drug: Erythromycin Lactobionate Injection, Revision Date: Mon, 09 Dec 2019 (Click for more...) Latanoprost Ophthalmic Solution 12/8/2019 7:00:00 PM Drug: Latanoprost Ophthalmic Solution, Revision Date: Mon, 09 Dec 2019 (Click for more...) Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution 12/8/2019 7:00:00 PM Drug: Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution, Revision Date: Mon, 09 Dec 2019 (Click for more...) Prednisolone Acetate 1% Ophthalmic Suspension 12/8/2019 7:00:00 PM Drug: Prednisolone Acetate 1% Ophthalmic Suspension, Revision Date: Mon, 09 Dec 2019 (Click for more...) Nystatin Oral Suspension 12/8/2019 7:00:00 PM Drug: Nystatin Oral Suspension, Revision Date: Mon, 09 Dec 2019 (Click for more...) ASH: AbbVie, Roche pad their case for fixed-duration Venclexta use in CLL 12/8/2019 11:19:07 AM ORLANDO, FLORIDA—AbbVie and Roche have been fielding their fair share of questions about how well their fixed-duration regimen of Venclexta and Rituxan can keep chronic lymphocytic leukemia from returning after therapy ends. The companies now think they have some compelling answers. (Click for more...) ASH: AstraZeneca's Calquence posts sky-high survival numbers in previously untreated CLL 12/8/2019 12:06:40 AM ORLANDO, FLORIDA—Over the last couple of weeks, regulators in the U.S., Canada and Australia have all green-lighted AstraZeneca’s Calquence in newly diagnosed chronic lymphocytic leukemia patients. And Saturday, the company unveiled more of the data that convinced them to dole out those approvals. (Click for more...) Cannes Lions Health names heads of judging panels for pharma, health and wellness creativity 12/7/2019 2:41:15 PM Cannes Lions has named two industry leaders to helm the pharma and health and wellness juries. Anne de Schweinitz, FleishmanHillard global managing director for healthcare, will lead the pharma panel of judges, while Tom Richards, chief creative officer and chairman of Havas Health, will marshal the health and wellness judges. (Click for more...) Ubrogepant for the treatment of migraine 12/6/2019 10:30:01 PM Ubrogepant for the treatment of migraine Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 Researchers examined the use of ubrogepant for treatment of single acute migraine attacks in a randomized trial involving 1,672 adults. About one-third of participants were assigned to an initial dose of placebo, with another one-third assigned to 50 mg of the study drug, and the remainder allocated to 100 mg. The investigators were primarily interested in between-group differences in freedom from pain and absence of the most bothersome migraine-related symptom at 2 hours after initial dose. Migraine sufferers who received the higher dose of ubrogepant were most likely to satisfy the first co-primary outcome, while patients who received the lower dose were most likely to achieve the second. The most common adverse events, meanwhile, were nausea, somnolence, and dry mouth; and they occurred most often in patients treated with the higher dose of ubrogepant. While the evidence suggests that ubrogepant is superior to placebo for treatment of acute migraine, the researchers note that additional study is needed to gauge its durability and safety and to compare it with other migraine drugs. (Click for more...) Roche wins FDA approval for immunotherapy cocktail against lung cancer 12/6/2019 10:30:01 PM Roche wins FDA approval for immunotherapy cocktail against lung cancer Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 FDA has approved atezolizumab (Tecentriq—Roche), a cancer immunotherapy drug mixed with chemotherapy, as an initial treatment for a form of lung cancer. The move comes as Roche seeks to establish its alternative to drugs from Merck and Bristol-Myers Squibb. Atezolizumab combines paclitaxel protein-bound particles (Abraxane—Celgene) and carboplatin chemotherapy to treat metastatic non-squamous non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, according to Roche. (Click for more...) Discontinuing buprenorphine too soon 'life-threatening' 12/6/2019 10:30:01 PM Discontinuing buprenorphine too soon 'life-threatening' Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 Given the significant risk of overdose among patients who stop taking buprenorphine to treat an opioid dependency, researchers say continued treatment is imperative. Led by Arthur Robin Williams, MD, of Columbia University, the team tracked outcomes in nearly 9,000 adults who had undergone anywhere from 6 to 18 months of continuous buprenorphine therapy through Medicaid before discontinuing the regimen. Within 6 months of treatment termination, slightly more than 5% were treated for a subsequent opioid overdose—a likely underrepresentation, considering that some individuals experienced multiple episodes and many likely did not seek hospital treatment. Moreover, the estimate included only overdoses billed to Medicaid and only those that were not fatal. "The rate at which individuals relapsed and overdosed after ending treatment was alarmingly high, suggesting that discontinuing buprenorphine is a life-threatening event," said Williams. While overdose rates were similar across the board, the investigators noted that emergency department visits and hospital admissions were fewer among the subset of patients who received treatment for 15–18 months vs. 6–9 months. These patients also were less likely to fill an opioid prescription in the 6 months after ending treatment. While Williams says the findings indicate that "longer is better" in terms of buprenorphine treatment, the optimal duration is still up in the air for now. The research appears in the American Journal of Psychiatry. (Click for more...) Biogen's top scientist nearly dares FDA not to approve Alzheimer's drug 12/6/2019 10:30:01 PM Biogen's top scientist nearly dares FDA not to approve Alzheimer's drug Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 Biogen's chief medical officer is supremely confident in aducanumab, an Alzheimer's treatment that the company claims demonstrated efficacy in a new analysis of trial results previously interpreted as unfavorable. "I don't think the field has ever seen data like this," Al Sandrock, MD, said, practically daring FDA not to grant approval. The company is slated to present the new take on the two large studies during the Clinical Trials on Alzheimer's Disease annual meeting next month. However, it gave FDA officials an early look in June and again in October, at which time regulators agreed that it was "reasonable" to apply for approval. If the agency still fails to give aducanumab the green light, Sandrock warns that "lots more people" would have to cope with Alzheimer's without a drug to help them. (Click for more...) There are now vaping-related lung injury cases in all 50 states 12/6/2019 10:30:01 PM There are now vaping-related lung injury cases in all 50 states Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 A teen from Alaska is the state's first case of vaping-related lung injury, according to the Alaska Department of Health and Social Services, meaning that there have now been cases of e-cigarette, or vaping, product use associated lung injury reported in all 50 states. The department reports the teen is hospitalized but improving. The patient reported regularly vaping nicotine and products containing tetrahydrocannabinol (THC), the main psychoactive substance in cannabis. CDC has recommended that people not use THC-containing e-cigarette or vaping products since it has identified vitamin E acetate, often used as an additive in THC-containing products, as a chemical of concern. Across the United States, there have been 2,290 cases of vaping-related lung injury linked to vaping as of November 20, according to CDC. Until Tuesday, Alaska was the only state without any vaping-related lung injuries reported to CDC. A total of 47 deaths have been confirmed in 25 states and the District of Columbia. (Click for more...) Johnson & Johnson says new tests show no asbestos in Johnson's Baby Powder 12/6/2019 10:30:01 PM Johnson & Johnson says new tests show no asbestos in Johnson's Baby Powder Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 New tests indicate that Johnson’s Baby Powder is free of asbestos, says Johnson & Johnson (J&J). The company says a total of 155 tests were conducted by two different third-party labs using four different testing methods. The tested samples were from the same bottle tested by FDA's contracted lab, according to J&J. In October, FDA officials noted that contaminants are not uniformly dispersed throughout talc and there is no standard test for asbestos in talc. Tests conducted by the third-party labs showed asbestos was not present in the single bottle that FDA's contracted lab had tested, nor was it present in retained samples of the finished lot from which the bottle was produced, J&J said December 2. The company said the results demonstrate that disparities with previously reported results were due to test sample contamination or analyst error at the lab, or both. J&J recalled roughly 33,000 bottles of baby powder nationwide after FDA said it had found trace amounts of asbestos, marking the first time U.S. regulators declared a finding of asbestos in the product. J&J faces more than 15,000 lawsuits from consumers claiming its talc products caused their cancer. (Click for more...) FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria 12/6/2019 10:30:01 PM FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 FDA on December 5 authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed. "Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria," said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health. "FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge." According to CDC, approximately 5% of U.S. hospital patients carry the MRSA bacteria, although many of those that carry the bacteria do not develop infections. MRSA is resistant to many common antibiotics, which means that if infections develop they can be very challenging to treat and control. The use of active screening to detect MRSA colonization and enable implementation of infection control measures has played an important role in reducing the rates of MRSA infection. FDA granted marketing authorization of the cobas vivoDx MRSA test to Roche Molecular Systems Inc. (Click for more...) The most viable drug pricing bill in Congress is getting a makeover 12/6/2019 10:30:01 PM The most viable drug pricing bill in Congress is getting a makeover Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) are poised to unveil an updated version of their Prescription Drug Pricing Reduction Act of 2019, which caps out-of-pocket costs for Medicare enrollees and requires drugmakers to pay rebates if they hike prices faster than inflation. The revisions, which the White House says it supports, are expected to bring further cost relief to seniors, and aides predict the bill could win much-needed support from more Republican lawmakers. "The skeleton is the same, but we do believe it will be much more popular with members and their constituents," an aide working on the legislation told The Health 202. Grassley and Wyden's measure is considered the drug pricing bill with the best chances of passing Congress, but it is unlikely Senate Majority Leader Mitch McConnell will schedule the bill for a floor vote in the remaining days before the holiday break. It is instead expected that parts of the bill could be folded into a larger spending bill. Grassley and Wyden are retaining their bill’s most controversial provision—the mandatory rebates from pharmaceutical makers—which has caused many Republicans to distance themselves from the legislation. (Click for more...) Trump administration unveils program to provide HIV prevention drugs for uninsured 12/6/2019 10:30:01 PM Trump administration unveils program to provide HIV prevention drugs for uninsured Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 The Trump administration has unveiled a new program to provide HIV prevention medication to people without prescription drug coverage as part of its goal to eradicate the virus in America by 2030. The government's Ready, Set, PrEP program will provide about 200,000 uninsured Americans annually with free access to daily pre-exposure prophylaxis, or PrEP, which prevents those exposed to the HIV virus from contracting it. The Trump administration unveiled a new program to provide HIV prevention medication to people without prescription drug coverage as a part of the president's ambitious effort to eradicate the virus in America by 2030. The medications will be donated by Gilead Sciences, which manufactures the only HIV prevention drugs currently approved by the federal government. A 30-day supply of the drugs can cost as much as $2,000 without insurance. To qualify for the program, participants must test negative for HIV, have a valid on-label prescription for PrEP and not have any prescription drug coverage. The introduction of PrEP helped cities like New York, once the at heart of the nation's deadly AIDS crisis, bring new infections to their lowest level on record last year. Researchers say that NYC's success is the result of a three-part plan implemented by the city, which relies heavily on the use of PrEP and antiretroviral drugs that suppress HIV to untransmittable levels. The Center for Disease Control (CDC) reports that than 1.2 million Americans are at risk for HIV, but only about 220,000 had received a prescription for PrEP in 2018. Coverage was especially low among young gay and bisexual people of color who could benefit from PrEP the most. (Click for more...) FDA requires additional testing of ranitidine and nizatadine 12/6/2019 10:30:01 PM FDA requires additional testing of ranitidine and nizatadine Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 FDA on Wednesday reported it has asked manufacturers of ranitidine and nizatidine products to expand their testing for N-nitrosodimethylamine (NDMA) to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use. FDA's scientists have determined ranitidine does not form NDMA in typical stomach conditions. However, the agency says it needs further investigation to fully test how ranitidine and nizatidine behave in the human body. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present. Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods. Consumers may also consider alternative treatments that are approved for the same or similar uses as ranitidine and nizatidine. (Click for more...) Texas law to end surprise medical bills could be 'irrelevant' by Jan. 1 12/6/2019 10:30:01 PM Texas law to end surprise medical bills could be 'irrelevant' by Jan. 1 Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 Texas' bipartisan effort to protect patients from surprise medical bills could be weaker than intended when it takes effect January 1. Earlier this year, lawmakers came together on a new law, known as Senate Bill 1264, to protect people in state-regulated health plans from getting outrageous bills for out-of-network care. The new law creates an arbitration process for insurers and providers to negotiate fair prices in those cases, intending to establish those fair prices without involving patients. One state agency hashing out how the law will work is the Texas Medical Board, which has proposed a rule that would expand the use of a narrow exception in the law and require all out-of-network providers to give patients a waiver with the expectation of paying out-of-network costs. The Texas Medical Board says the proposed rules "require an out-of-network provider to provide written notice and disclosure to a patient no less than 10 business days prior to the date of a nonemergency procedure.” Consumer advocates say that this is essentially a loophole that, if adopted, would curb the effectiveness of SB 1264 by creating a path for any provider that wants to continue sending out-of-network bills and continue to balance-bill. (Click for more...) Analysts predict IPI and Senate bill unlikely to impact drug industry like Pelosi bill 12/6/2019 10:30:01 PM Analysts predict IPI and Senate bill unlikely to impact drug industry like Pelosi bill Thu, 12/05/2019 - 19:00 cbaker_admin Fri, 12/06/2019 - 22:30 A report by analysts at Bernstein concludes that House Speaker Nancy Pelosi's (D-CA) drug pricing measure would have more effect on the biopharma industry than a bill from Sen. Chuck Grassley (R-IA) or the Trump administration's proposed International Pricing Index (IPI). The study estimates the Senate bill would affect approximately 2% of drug sales. Grassley's bill calls for overhauling Medicare Part D by setting a cap for drug price increases above inflation and requiring some manufacturers to pay a penalty for drugs with negative Medicaid prices. Similarly, the IPI for Medicare Part B drugs would likely affect about 3% of sales, say the analysts, who note that it is "uneven in its effects—impacting few companies sharply but having very modest effects on most." The index is expected to face a legal challenge, according to the report. The analysts say Pelosi's bill would allow the government to directly negotiate the price of up to 250 brand name drugs, with the largest price negotiations also made available to commercial payers. The analysts wrote, "Unlike the other plans, it applies to the totality of the U.S. market (including commercial payers). It will also equate U.S. pricing to international pricing AND require 30% discount in the catastrophic payment window of Part D. While the industry will absorb the [Senate Finance Committee] plan without missing a beat and the Trump IPI will do some damage, but is manageable, the Pelosi plan in its current version will be a fundamental change of business model for the drug industry." (Click for more...) Watch out, Keytruda. Ferring's bladder cancer gene therapy rival has new data—and they look competitive 12/6/2019 10:01:28 AM On the heels of an FDA speedy review for Keytruda’s potential use in non-muscle invasive bladder cancer, its close rival, a gene therapy by Ferring Pharmaceuticals spinout FerGene, has posted competitive late-stage data. But Merck has at least one upper hand. (Click for more...) FDA greenlights generics of Novartis' $3B MS star Gilenya amid legal fight 12/6/2019 9:47:41 AM In June, a U.S. district court judge temporarily shielded Novartis’ $3 billion-a-year multiple sclerosis drug Gilenya from generic competition—but that’s not preventing generics makers from lining up at the starting gate. Thursday, the FDA approved the first three generic versions of Gilenya, which will be made by HEC Pharm, Biocon and Sun Pharmaceutical. (Click for more...) Gilead, seeking HIV patent extension, faces 'gamesmanship' claims from patient group 12/6/2019 9:31:47 AM Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients. In a petition to the U.S. Patent & Trademark Office, the group PrEP4All says the drugmaker delayed development of the drug regimen to protect the market for older meds. (Click for more...) Alexion shoots down 'proactive' sale demand from activist investor 12/6/2019 8:58:21 AM Alexion has withstood its fair share of gales in recent years after a wholesale shakeup at the top and now a potential shift toward an M&A-focused strategy underway. Now, despite one activist investor's call for a "proactive" sale, Alexion's board has decided to stay the course. (Click for more...) FiercePharmaAsia—Astellas' $3B gene therapy bet; China's PD-1 coverage; Hanmi-Rapt I-O deal 12/6/2019 5:16:15 AM Astellas buys into gene therapy with $3 billion Audentes Therapeutics takeover. Keytruda and Opdivo lose out in latest China reimbursement talks. Hanmi Pharma expands immuno-oncology footprint with $118 million Rapt Therapeutics deal. And more. (Click for more...) Astellas, Audentes pen $3bn gene therapy deal 12/6/2019 2:07:44 AM Genetic regulation is set to become a fifth primary focus for the Japanese drugmaker, on top of its already existing business lines. (Click for more...) Novartis, Amazon ink deal for ‘smart’ manufacturing 12/6/2019 2:07:12 AM The online retail giant's honed data abilities will help Novartis produce more personalised therapies. (Click for more...) ViiV Healthcare submits HIV drug fostemsavir in the US 12/6/2019 2:06:19 AM The treatment could offer a new option for patients unable to reach viral supression (Click for more...) PharmaTimes unveils winners of MSEA 2019 12/6/2019 1:31:48 AM This year's competition welcomed a fantastic spread of companies as well as a higher number of entrants (Click for more...) Biogen to make case to skeptics for its controversial Alzheimer's drug 12/5/2019 10:05:01 PM Biogen to make case to skeptics for its controversial Alzheimer's drug Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 Biogen on Thursday will present highly anticipated data on its experimental Alzheimer’s drug aducanumab, which the U.S. biotech company had declared a failure earlier this year. Experts say aducanumab still needs to overcome serious questions over Biogen’s new analysis of the trials. "I've never seen it done where a trial has been stopped (for futility) and then they come back and say, 'Hey, we did some more analysis and guess what? It’s better,'" said Laurie Ryan, who heads the dementias of aging branch at the National Institute on Aging. "None of us has seen the raw data. We hope we see that." Biogen's drug had been seen as potentially offering proof of the long-held theory that removing a toxic protein called beta-amyloid from the brain would slow progression of the disease. Those hopes appeared to be dashed in March with an announcement that an interim analysis of two late-stage trials indicated they were likely to fail. In October, however, Biogen said additional data showed a significant benefit in one of the twin trials, and that results for a subset of patients in the second trial support those findings. The company said that after discussions with FDA, the agency encouraged it to file for approval. Biogen will present the additional aducanumab data at the Clinical Trials on Alzheimer’s Disease conference in San Diego. (Click for more...) FDA expands use of insulin glargine to childhood diabetes 12/5/2019 10:05:01 PM FDA expands use of insulin glargine to childhood diabetes Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 FDA expanded the indication for insulin glargine 300 units/mL injection (Toujeo—Sanofi) to include children as young as age 6 years with type 1 diabetes. FDA initially approved the longer lasting insulin glargine injection in 2015 for adults with type 1 and type 2 diabetes. Sanofi reported positive results from the Phase III EDITION JUNIOR trial of insulin glargine in children and adolescents with type 1 diabetes, as presented in November at the International Society for Pediatric and Adolescent Diabetes annual conference in Boston. In the trial, 463 children and adolescents between aged 6-17 years, who were treated for type 1 diabetes for at least 1 year and with blood glucose levels between 7.5% and 11.0% at screening, were randomized to receive either insulin glargine 300 units/mL injection or insulin glargine 100 units/mL. The drugs were administered to participants alongside their current mealtime insulin. The primary endpoint was noninferior reduction in blood glucose after 26 weeks. The researchers found that fewer patients taking insulin glargine 300 units/mL injection experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking insulin glargine 100 units/mL. The company says no unexpected safety concerns were reported based on the established profiles of both products. (Click for more...) Trends in infant pertussis hospitalizations in the United States, 2009-17 12/5/2019 10:05:01 PM Trends in infant pertussis hospitalizations in the United States, 2009-17 Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 Emory University researchers examined the effect Advisory Committee on Immunization Practices (ACIP) recommendation changes in 2012 had on the incidence of pertussis hospitalizations among babies aged 2 months and younger. This pediatric population has not reached vaccination age and, therefore, is especially vulnerable; however, the new ACIP directive targeted mothers in the prenatal period. The panel called for all women to receive the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during pregnancy. While pertussis rates reportedly declined after 2012 in infants aged 1 year and younger, the Emory team was interested in whether the same was true for the youngest subset of those infants. Using a nationwide commercial database of privately insured patients, they singled out infants with birth hospitalization taking place from January 2009 through October 2017. Of nearly 2 million babies who were enrolled in private insurance for at least 2 months, the rate of pertussis hospitalizations declined to 3.3 per 100,000 infants during 2013–17 from 8.4 per 100,000 infants during 2009–12. The finding augments the mounting evidence favoring maternal Tdap vaccination. (Click for more...) Michigan, Ohio and other Midwest states hit with hepatitis A outbreak tied to berries 12/5/2019 10:05:01 PM Michigan, Ohio and other Midwest states hit with hepatitis A outbreak tied to berries Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 FDA is urging consumers in 11 states to discard any blackberries bought from Fresh Thyme grocery stores between September 9 and September 30. CDC has linked the blackberries to 16 cases of hepatitis A in Nebraska, Indiana, Minnesota, Michigan, Missouri and Wisconsin. Fresh Thyme has said it is cooperating with the CDC investigation and working with suppliers to identify the source of the contamination. (Click for more...) Extent of insulin rationing in the U.S. is 'shameful,' say experts 12/5/2019 10:05:01 PM Extent of insulin rationing in the U.S. is 'shameful,' say experts Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 A survey by the nonprofit advocacy group T1International indicates that the practice of insulin rationing as a result of cost by people with type 1 diabetes is significantly more common in the United States than in other high-income countries and even in certain low- and middle-income countries. The findings were presented in Busan, South Korea, at the International Diabetes Federation Congress 2019 by the group's trustee, James Elliott, MMSc, of Toronto. A total of 1,478 respondents from 90 countries completed T1International's online survey in 2018. Approximately 26% of 627 respondents from the United States reported they had rationed insulin because of cost in the previous year, compared with just 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Overall, 18% of respondents reported the practice. The survey revealed that rates of rationing blood glucose testing supplies were even higher. Elliott recommended that clinicians ask patients if they were rationing insulin, noting: "Not everyone is going to be upfront. There's a lot of associated stigmas." He added that the World Health Organization's new insulin prequalification program to broaden access to treatment is a "start," and that T1International wants to extend that beyond human insulins to include analogs. (Click for more...) PBM Abarca inks discount deal for Amgen's Enbrel 12/5/2019 10:05:01 PM PBM Abarca inks discount deal for Amgen's Enbrel Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 Puerto Rico-based PBM Abarca says Amgen agreed to give the PBM's health insurance clients an extra discount on the rheumatoid arthritis drug etanercept (Enbrel), if patients discontinue use after 3 months. The new agreement will enable health insurers to save costs when patients discontinue the drug due to adverse effects or a lack of effectiveness, according to Abarca. The amount of the additional discount was not disclosed. Abarca signed a similar agreement in 2018 with Amgen for its cholesterol drug evolocumab (Repatha) and with Biogen for coverage of its medicines to treat multiple sclerosis. Javier Gonzalez, Abarca's chief operating officer, estimates that etanercept costs the insurance plans it represents between $4,000 and $5,000 per patient per month. The drug has been on the U.S. market since 1998 and is Amgen's best-selling product. (Click for more...) Hospital groups sue to block price-transparency rule 12/5/2019 10:05:01 PM Hospital groups sue to block price-transparency rule Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 Hospital groups on Wednesday sued to block a Trump administration rule forcing them to disclose secret rates. The lawsuit says the rule compelling the hospitals to publish their negotiated rates with insurers violates the First Amendment and goes beyond the statutory intent of the Affordable Care Act. The rule requires hospitals to publicize the rates they negotiate with individual insurers for all services, including drugs, supplies, facility fees, and care by doctors who work for the facility. It is scheduled to take effect in January 2021, with hospitals facing fines up to $300 a day if they do not disclose negotiated rates. "The burden of compliance with the rule is enormous, and way out of line with any projected benefits associated with the rule," according to the suit, which was filed by the American Hospital Association and other industry groups in U.S. District Court in Washington. The groups are asking for an expedited decision, saying hospitals could otherwise spend needless time and resources preparing for a rule that may be invalidated by the court. The legal standoff could complicate other White House initiatives to expand price disclosure throughout the health care industry. (Click for more...) Kroger to pay $225K to settle civil allegations at Charlottesville pharmacy 12/5/2019 10:05:01 PM Kroger to pay $225K to settle civil allegations at Charlottesville pharmacy Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 Kroger Limited Partnership and Kroger Pharmacy have agreed to pay $225,000 to settle civil allegations that it violated the Controlled Substances Act more than a dozen times at a Rio Hill location in Charlottesville, VA, according to a release from the U.S. Attorney's Office for the Western District of Virginia. "Pharmacies are vital partners in our collective efforts to reduce the unlawful diversion and use of dangerous opioid drugs," said U.S. Attorney Thomas T. Cullen. "As this case illustrates, federal prosecutors will utilize all available tools, including civil actions, to ensure that entities and individuals involved in the lawful dispensing of these potentially deadly drugs fully comply with the law." The Kroger's pharmacy was accused of failing to guard against the diversion of such prescription drugs, which means legally prescribed medications were likely transferred to someone other than the person for whom they were prescribed for illicit use. The release says the pharmacy violated the federal law on at least 16 distinct occasions between May 2, 2015 and May 30, 2016. (Click for more...) FDA warns about lack of research, possible risks of CBD 12/5/2019 10:05:01 PM FDA warns about lack of research, possible risks of CBD Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 In a revised consumer update, FDA emphasized that it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. The cannabis compound has been widely touted as a harmless way to treat a slew of ailments without much evidence to back it up. CBD products flooded the market this year after Congress legalized hemp last December. The agency said it cannot conclude that CBD is "generally recognized as safe" (GRAS) by qualified experts for use in human or animal food. FDA noted that CBD products marketed for therapeutic uses have not been approved and their claims and safety remain uncertain. "We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by FDA and determined to be safe, or that trying CBD 'can't hurt,'" said Amy Abernethy, principal deputy commissioner for FDA. "Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by FDA, and we want to be clear that a number of questions remain regarding CBD's safety, including reports of products containing contaminants, such as pesticides and heavy metals." Abernethy leads a working group at FDA tasked with crafting regulations to bring legal CBD products to market. (Click for more...) Maine pharmacists say prescription drug shortage threatens patient safety 12/5/2019 10:05:01 PM Maine pharmacists say prescription drug shortage threatens patient safety Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 When Wayne Davis of Topsham, ME, underwent three surgeries for bladder cancer, his physicians began a regimen of immunotherapy to prevent a recurrence. However, the treatment was halted when a shortage of the immunotherapy serum meant it had to be rationed. Brian Marden, PharmD, the chief pharmacy officer at MaineHealth, says: "We're managing today about 40 different drug shortages across MaineHealth." Karen Philbrick, the pharmacy director at LincolnHealth, says shortages have extended to emergency syringes, which are filled with drugs like epinephrine and used in ambulances and emergency rooms. Pharmacists now have to create kits of the medication themselves when an emergency arises, says Philbrick. Such a situation makes errors more likely, asserts Tom Moniz, PharmD, pharmacy operations manager for Northern Light Eastern Maine Medical Center. An FDA report released in October found that most drugs in short supply are generic injectables. FDA has recommended financial incentives for manufacturers to produce less-profitable drugs. Legislation recently introduced by Sen. Susan Collins (R-ME) calls for drug manufacturers to report the cause and expected duration of shortages and to make contingency response plans. (Click for more...) CHPA petitions FDA to establish path for CBD in supplements 12/5/2019 10:05:01 PM CHPA petitions FDA to establish path for CBD in supplements Wed, 12/04/2019 - 19:00 cbaker_admin Thu, 12/05/2019 - 22:05 The Consumer Health Care Products Association (CHPA) is petitioning FDA to issue regulations establishing a clear pathway for the inclusion of CBD in dietary supplements. Under CHPA's proposal, FDA would require manufacturers of CBD-containing dietary supplements to submit new dietary ingredient (NDI) notifications for each product and comply with other relevant laws. The NDI notifications would give FDA with data about CBD, particularly given the agency's need for evidence establishing a reasonable expectation of safety when used under the suggested conditions on the product's label. The CHPA citizen petition also urges FDA to issue guidance on enforcement discretion for manufacturers to take certain quality-related steps during the notice-and-comment rulemaking period. (Click for more...) Hydroxyzine Pamoate Oral Capsules 12/5/2019 7:00:00 PM Drug: Hydroxyzine Pamoate Oral Capsules, Revision Date: Fri, 06 Dec 2019 (Click for more...) Lidocaine Injection 12/5/2019 7:00:00 PM Drug: Lidocaine Injection, Revision Date: Fri, 06 Dec 2019 (Click for more...) Midazolam Injection 12/5/2019 7:00:00 PM Drug: Midazolam Injection, Revision Date: Fri, 06 Dec 2019 (Click for more...) Potassium Acetate Injection 12/5/2019 7:00:00 PM Drug: Potassium Acetate Injection, Revision Date: Fri, 06 Dec 2019 (Click for more...) Ropivacaine Injection 12/5/2019 7:00:00 PM Drug: Ropivacaine Injection, Revision Date: Fri, 06 Dec 2019 (Click for more...) Venlafaxine Hydrochloride Extended-Release Capsules 12/5/2019 7:00:00 PM Drug: Venlafaxine Hydrochloride Extended-Release Capsules, Revision Date: Fri, 06 Dec 2019 (Click for more...) Following Merck approval, Gavi authorizes $178M to build Ebola vaccine stockpile 12/5/2019 2:37:04 PM Merck just last month won the world's first licensure for an Ebola vaccine. Now, an international vaccine group has authorized funding to establish a global stockpile of 500,000 doses. Amid an ongoing outbreak in Congo, officials have used about 250,000 doses. (Click for more...) Acadia's Nuplazid could hit blockbuster heights after strong psychosis data: analyst 12/5/2019 11:24:18 AM When Acadia trumpeted news that it would end a late-stage trial for its Nuplazid in dementia-related psychosis (DRP) early, it represented a big win for a drugmaker still stinging from a major schizophrenia flop. Now, data from that trial are giving some analysts hope that Nuplazid could hit blockbuster heights—with or without schizophrenia. (Click for more...) Novartis, after 5 blockbuster nods in 2019, hopes for 25 more in the coming years 12/5/2019 11:05:01 AM Novartis had a "breakthrough" year in 2019 with five new blockbuster approvals, CEO Vas Narasimhan said in conjunction with a Thursday R&D event. While those launches get underway, the company is planning 80 major drug submissions in key markets over the next three years, and 25 of those could be blockbuster opportunities. (Click for more...) Gilead, HHS kick off program to provide PrEP drugs Truvada, Descovy for free 12/5/2019 9:24:42 AM Gilead and HHS have had a busy year in PrEP, including a patent lawsuit, but now they're starting a program to provide HIV prevention meds to those who can benefit for free. Under the program, HHS is paying Gilead $200 per bottle of medication to cover distribution costs. (Click for more...) After Zantac scare, FDA targets generic metformin for carcinogen tests 12/5/2019 8:50:01 AM After a global scare over carcinogen contamination in heartburn med Zantac, regulators are growing increasingly wary about other drugs that may have flown under the radar. Now, generic metformin, a Type 2 diabetes medication, could be next in the FDA's firing line. (Click for more...) INTCR 2020 Executive Steering Group Chair shares insight into this ever-growing competition 12/5/2019 4:27:49 AM Flying the flag for clinical research for over 20 years, this competition continues to grow and develop year after year. (Click for more...) Late-stage Ibsrela success for Ardelyx 12/5/2019 4:18:25 AM If approved, the drug will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis. (Click for more...) EMA to review Amarin’s Vascepa filing 12/5/2019 4:14:13 AM The fish oil-derived therapy is already approved in the US for patients with severe hypertriglyceridaemia. (Click for more...) 200,000 uninsured Americans to get free HIV prevention drugs 12/4/2019 10:03:53 PM 200,000 uninsured Americans to get free HIV prevention drugs Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 HHS launched on Tuesday a program that will provide HIV prevention medications free of charge to 200,000 people without insurance. In an announcement, HHS Secretary Alex M. Azar described how the government plans to distribute the pre-exposure prophylaxis (PrEP) drugs for the Ready, Set, PrEP program. Gilead, manufacturer of emtricitabine and tenofovir disoproxil fumarate (Truvada) and emtricitabine & tenofovir alafenamide (Descovy), announced in May that it would donate Truvada. Under the new program, the federal government will for the first time supply PrEP to individuals not enrolled in Medicaid, the Veterans Health Administration, or any other federal health program. Any patient without health insurance, who has had a recent negative HIV test, and has a prescription for PrEP will be able to call 855-447-8410 or sign onto a government website, getyourprep.com, to apply for the free HIV drugs. Azar noted that people can also apply in person, through participating health care providers, such as a community clinic. Azar said that until March 30, the government will pay Gilead $200 per bottle to cover the cost of moving donated drugs from factories through the supply chain to patients. After that time, Walgreens, Rite Aid, and CVS Health will donate dispensing services and provide counseling to patients, and the government will investigate less expensive ways to get the drugs from the manufacturer to those chains. (Click for more...) HIV testing, treatment, prevention not reaching enough Americans 12/4/2019 10:03:53 PM HIV testing, treatment, prevention not reaching enough Americans Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 A new CDC report shows that too many Americans with HIV are unaware that they are infected, too few have the virus under control with effective treatment, and too few are taking HIV preexposure prophylaxis (PrEP). The Vital Signs report said that increasing HIV testing, treatment, and prevention is key to stopping HIV transmission in the United States. "The time is now to end HIV in America. We have the right tools, the right data and the right leadership to get this done," said CDC Director Robert R. Redfield, MD. "Those living with HIV are our best teachers. They are key to helping us reach people where they are so that we can better diagnose and link patients to care." In 2017, according to the report, approximately 154,000 people living with HIV were not aware of their status, and only 63% of those who knew they had HIV had the virus under control via effective treatment. In 2018, only about 18% of the 1.2 million individuals who could benefit from HIV PrEP had received a prescription for the drug. From 2013 to 2017, CDC found that new HIV infections held relatively steady, at about 38,000 annually. The new initiative will focus first on 50 local areas that account for more than 50% of new HIV diagnoses and seven states with a substantial rural burden. If additional resources become available, the program will eventually expand throughout the country. (Click for more...) Survey: 37% of Americans plan to skip influenza vaccine this season 12/4/2019 10:03:53 PM Survey: 37% of Americans plan to skip influenza vaccine this season Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 More than a third of U.S. adults say they do not plan to get vaccinated against influenza this year, a new survey shows. According to the survey from NORC at the University of Chicago, these individuals expressed concern about adverse effects from the vaccine or believe it does not work very well. "Widespread misconceptions exist regarding the safety and efficacy of flu shots," said Caitlin Oppenheimer, senior vice president of Public Health Research at NORC at the University of Chicago. She noted, however, that "because of the way the flu spreads in a community, failing to get a vaccination not only puts you at risk but also others for whom the consequences of the flu can be severe." Data from early November show that 44% of adults said they had been vaccinated against influenza and 18% more said they still plan to get vaccinated. CDC notes that influenza vaccines are the best protection against the virus, which takes the lives of thousands of Americans every year. (Click for more...) Asthma control is critical during pregnancy 12/4/2019 10:03:53 PM Asthma control is critical during pregnancy Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 An observational study by Canadian researchers indicates that pregnant women with asthma should take particular care to keep their asthma under control to protect both themselves and their child. The study in the European Respiratory Journal used data on more than 103,000 pregnancies in women with asthma. Complications such as shortness of breath, wheezing, coughing, or chest tightness that required medical attention occurred in 4,455 of the pregnancies. After adjusting for other factors, compared with women who had no such complications, those who had asthma-related exacerbations had a higher relative risk for pre-eclampsia, preterm birth, having a low birth-weight baby, and having a baby with a congenital malformation. Asthma attacks in mothers were also associated with prolonged consequences for offspring. Compared with the children of mothers who had no asthma exacerbations, the children of mothers who did had a 22% increased risk for asthma and a 12% increased risk for pneumonia through age 5 years. Kawsari Abdullah, lead study author and a postdoctoral researcher at the Children's Hospital of Eastern Ontario, says: "Based on this research, I can't say whether women should take medication or not. The important thing is that they need to control their symptoms and follow the guidelines their physicians provide." (Click for more...) Drug recall in U.S. causes hypoparathyroid patients extreme hardship 12/4/2019 10:03:53 PM Drug recall in U.S. causes hypoparathyroid patients extreme hardship Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 Patients nationwide with severe hypoparathyroidism are under considerable stress amid a U.S. recall of injectable recombinant parathyroid hormone (PTH) (Natpara—Takeda). FDA issued the recall for Natpara in September due to concern that rubber particulate matter from the drug's cartridge might be contaminating the product. Aliya Khan, MD, a professor of clinical medicine at McMaster University in Ontario, Canada, is the lead author of recent guidelines on the treatment of hypoparathyroidism, and has received research funding from Takeda and Ascendis Pharma, both of which make injectable PTH. Khan says, "Firstly, endocrinologists need to be aware that when you stop PTH treatment suddenly, patients' need for calcium supplements and calcitriol may be as high as two times what they were on before they started PTH therapy." Physicians must monitor patients' calcium, vitamin D, phosphate, and magnesium levels almost daily, Khan says. She adds that patients may be transitioned from PTH to teriparatide (Forteo—Eli Lilly), another recombinant form of PTH that is licensed for use in osteoporosis. However, teriparatide must be used off-label in the United States, and once injected, it does not last long. As a result, patients may need to use up to four needles per day to stabilize calcium levels, according to Khan. If teriparatide is prescribed, subcutaneous injections given in the thigh are recommended for the treatment of hypoparathyroidism, according to a joint statement from the Endocrine Society and American Society for Bone and Mineral Research. (Click for more...) Vaping crisis: CDC study identifies vitamin E as possible culprit in lung injuries, deaths 12/4/2019 10:03:53 PM Vaping crisis: CDC study identifies vitamin E as possible culprit in lung injuries, deaths Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 A new report by the Minnesota Department of Health, which focused on vaping products containing THC, found that 20 vaping products seized in the state by law enforcement this year tested positive for vitamin E acetate, an additive used in THC oil. In contrast, testing revealed that none of 10 products recovered a year ago contained the substance. Earlier in November, CDC identified vitamin E acetate in the lungs of patients hospitalized with vaping-related illnesses. The substance is sometimes used as an additive or thickening agent in vaping products containing THC, a marijuana compound. CDC says among 29 lung tissue samples from 10 states tested for the additive, all contained vitamin E acetate. Although the Minnesota study strengthens the connection between vitamin E acetate and vaping-related illness, Ruth Lynfield, MD, a Minnesota Department of Health epidemiologist and medical director, points out that the study was small, analyzed samples from a single state, and does not prove the substance causes lung illness. She says researchers need to complete "some additional work to understand the mechanism of the injury and the role of vitamin E." She says they also need to assess whether other chemicals may have contributed to the outbreak. (Click for more...) CVS Health completes rollout of time delay safes in all of its NC pharmacies 12/4/2019 10:03:53 PM CVS Health completes rollout of time delay safes in all of its NC pharmacies Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 Time-delay safes have been rolled out to all 375 CVS Pharmacy locations in North Carolina, including pharmacies within Target stores. The safes are expected to help prevent pharmacy thefts and the diversion of controlled substances. The safes electronically delay the time it takes for pharmacy employees to be able to open them. CVS Pharmacy first implemented time-delay safes in Indianapolis in 2015, resulting in a 70% reduction in pharmacy thefts among those stores. All CVS Pharmacy locations with time-delay safes have visible signage warning they are in use. CVS Health has also extended its Safe Medication Disposal Program in North Carolina by completing the installation of 65 drug disposal kiosks in select CVS Pharmacy locations in communities statewide, adding to the 42 units previously donated to local law enforcement. (Click for more...) Potential Medicare savings on inhaler prescriptions through the use of negotiated prices and a defined formulary 12/4/2019 10:03:53 PM Potential Medicare savings on inhaler prescriptions through the use of negotiated prices and a defined formulary Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 Some of the greatest outlays under Medicare, which is barred from directly negotiating drug prices with manufacturers, are for inhalers. However, researchers at Brigham and Women's Hospital in Boston argue that the system could save big on the devices if only allowed to negotiate and establish a defined formulary—as the Department of Veterans Affairs (VA) is already permitted to do. William B. Feldman, MD, Jerry Avorn, MD, and Aaron S. Kesselheim, MD, JD, MPH used publicly available, deidentified data from 2017 to illustrate the potential costs savings. Medicare Part D reported pre-rebate expenditures of $10.3 billion for 31 different inhalers that year. The total likely came down to $7.3 billion, they calculated, assuming a discount of 28.7% based on overall mean 2017 rebates. If Medicare was privy to VA-negotiated prices, the authors estimate, that would have shaved off another $1.4 billion. Finally, if Medicare had also adopted the VA formulary, the total outlay would have fallen to $3.1 billion. Although precise numbers could not be generated due to the confidentiality surrounding Medicare and VA rebates, the authors believe their findings are a fair representation. Federal legislation allowing Medicare to negotiate directly with drugmakers, they conclude, "has the potential to reduce spending on inhalers without compromising the quality of patient care." (Click for more...) Effectiveness of a self-determination theory-based cessation intervention for smokers at EDs in Hong Kong 12/4/2019 10:03:53 PM Effectiveness of a self-determination theory-based cessation intervention for smokers at EDs in Hong Kong Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 Researchers assessed the efficacy of a smoking-cessation intervention delivered to emergency department (ED) patients at four Hong Kong hospitals. Adult smokers, who sought care at the EDs between July 2015 and March 2017, were randomly assigned to one of two treatment arms. The 787 patients who made up the intervention group received about a minute's worth of advice and were permitted to select an immediate or progressive quit schedule for themselves. The 784 control patients received literature on smoking cessation. The primary endpoint was biochemically confirmed abstinence at 6 months, which occurred at a rate of 6.7% in the intervention group compared with 2.8% in the control group. The finding suggests that this intervention, which is based on self-determination theory, could provide an effective quit pathway for smokers with little time and cost investment. (Click for more...) Senate panel approves Hahn as FDA head 12/4/2019 10:03:53 PM Senate panel approves Hahn as FDA head Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 The Senate Health, Education, Labor, and Pensions Committee on Tuesday advanced the nomination of Stephen Hahn, a noted oncologist and cancer researcher, to lead FDA. Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, was nominated by President Trump last month to replace Scott Gottlieb, who left the job in April. The vote was 18 to 5. Committee Chairman Lamar Alexander (R-TN) said before the vote that Hahn is "exactly the type of nominee" that should lead the FDA, citing his management and research experience. But Sen. Patty Murray (D-WA), the panel's ranking Democrat, voted against Hahn, saying during his confirmation hearing last month he had "refused to commit to implementing a strong policy to clear nontobacco e-cigarettes" from the market. Other Democrats split, with some voting for Hahn's confirmation and others voting against him. Alexander has said he hoped Hahn would be confirmed by the end of the year. (Click for more...) Labor unions team up with drug makers to defeat drug-price proposals 12/4/2019 10:03:53 PM Labor unions team up with drug makers to defeat drug-price proposals Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 The Pharmaceutical Industry Labor-Management Association (Pilma) is trying to defeat drug-pricing proposals in statehouses across the nation as well as in Congress. A wave of Facebook ads that ran this fall targeted 15 recently elected Democrats in Congress, warning that the bill "threatens thousands of good-paying jobs and restricts access to lifesaving medication." The group, a coalition that includes major drug manufacturers as well as large construction-industry unions whose members help build pharmaceutical plants and research labs, has been buying print advertisements in local newspapers, mailing fliers to voters in vulnerable Democratic districts, and hiring former labor officials and well-known union lobbyists to deliver their message. Tim Dickson, the executive director of Pilma, says the group's position is aimed at creating jobs for union workers. “We place a premium on the partnership that yields jobs,” he said. "And we have a longstanding position that we’ve held for quite some time that certain policies, such as price controls, will have a negative effect on union construction jobs." (Click for more...) Commentary: Protect patient access to drug infusions administered in physician offices 12/4/2019 10:03:53 PM Commentary: Protect patient access to drug infusions administered in physician offices Tue, 12/03/2019 - 19:00 cbaker_admin Wed, 12/04/2019 - 22:03 Gastroenterologists Rajalakshmi Iyer, MD, and James Regan, MD, warn that the Senate Finance Committee's drug pricing bill "could make it difficult—and potentially impossible—for us to provide" infusions of medications to treat patients with challenging disorders like Crohn’s disease and ulcerative colitis. The specific provision concerning the gastroenterologists would include the value of coupons that pharmaceutical companies provide to patients in determining how Medicare calculates a drug's average sales price, which is used to determine how much physicians are reimbursed for administering the drug. They note many patients rely on coupon programs to afford and stay on their course of treatment. The Senate Finance bill would include these coupons as if they were part of the negotiated price between the insurer and the pharmaceutical company. "Doing this would reduce Medicare’s reimbursement to physician practices like ours by lowering the average sales price payment calculation," conclude Iyer and Regan. "But our costs for acquiring those products would not change, making it difficult for physician practices like ours to provide these important drugs." (Click for more...) 50% Dextrose Injection 12/4/2019 7:00:00 PM Drug: 50% Dextrose Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Acyclovir Injection 12/4/2019 7:00:00 PM Drug: Acyclovir Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Bupivacaine Injection 12/4/2019 7:00:00 PM Drug: Bupivacaine Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Calcium Acetate Oral Capsules and Tablets 12/4/2019 7:00:00 PM Drug: Calcium Acetate Oral Capsules and Tablets, Revision Date: Thu, 05 Dec 2019 (Click for more...) Cefoxitin Sodium Injection 12/4/2019 7:00:00 PM Drug: Cefoxitin Sodium Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Dobutamine Injection 12/4/2019 7:00:00 PM Drug: Dobutamine Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Enoxaparin Sodium Injection 12/4/2019 7:00:00 PM Drug: Enoxaparin Sodium Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Fentanyl Citrate Injection 12/4/2019 7:00:00 PM Drug: Fentanyl Citrate Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Hydromorphone Hydrochloride Injection 12/4/2019 7:00:00 PM Drug: Hydromorphone Hydrochloride Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Leuprolide Acetate Long-Acting Suspension for Intramuscular Injection 12/4/2019 7:00:00 PM Drug: Leuprolide Acetate Long-Acting Suspension for Intramuscular Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Melphalan Injection 12/4/2019 7:00:00 PM Drug: Melphalan Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Morphine Injection 12/4/2019 7:00:00 PM Drug: Morphine Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Sodium Bicarbonate Injection 12/4/2019 7:00:00 PM Drug: Sodium Bicarbonate Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Sufentanil Injection 12/4/2019 7:00:00 PM Drug: Sufentanil Injection, Revision Date: Thu, 05 Dec 2019 (Click for more...) Verapamil Extended-Release Tablets 12/4/2019 7:00:00 PM Drug: Verapamil Extended-Release Tablets, Revision Date: Thu, 05 Dec 2019 (Click for more...) AAP updates ADHD treatment guidelines 12/4/2019 12:37:18 PM AAP updates ADHD treatment guidelines Wed, 12/04/2019 - 00:46 caldridgeyoung… Wed, 12/04/2019 - 12:37 The updated guidelines are based on the most recent ADHD research and the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. According to the guideline authors, their review of this literature “did not support making dramatic changes to the previous recommendations … [and] only incremental updates have been made in this guideline revision.” (Click for more...) 1 in 5 adolescents and 1 in 4 young adults now living with prediabetes 12/3/2019 10:00:01 PM 1 in 5 adolescents and 1 in 4 young adults now living with prediabetes Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 The prevalence of prediabetes among adolescents and young adults in the United States is high, new research shows. The report, published Monday in JAMA Pediatrics, found that 18% of adolescents aged 12-18 years and 24% of young adults aged 19-34 years have the condition in which blood glucose levels that are higher than normal but are not yet high enough to be diagnosed as type 2 diabetes. For the study, CDC researchers used data from the National Health and Nutrition Examination Survey from 2005-16. According to the data, the percentage of adolescents and young adults living with prediabetes was higher among males and those with obesity. Additionally, adolescents and young adults with prediabetes had much higher cholesterol levels, systolic blood pressure, abdominal fat, and lower insulin sensitivity compared with those who have normal glucose tolerance. To help counter this trend, parents can encourage healthy eating and increased physical activity. States and communities, meanwhile, can support mothers who choose to breastfeed; work with early care and education centers and schools to improve healthy food and beverage options and opportunities for physical activity for children; increase access to healthy and affordable foods; and make it easier and safer to walk and bike where families are. (Click for more...) Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment 12/3/2019 10:00:01 PM Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 ICON8, a multinational clinical trial, compared the effects of weekly dose-dense chemotherapy for epithelian ovarian cancer vs. the standard first-line approach that consists of treatment every 3 weeks. The study population included more than 1,500 newly diagnosed women, predominantly European, who were enrolled immediately following primary surgery or before neoadjuvant chemotherapy with subsequent planned delayed primary surgery. Based on randomized assignment, patients received both carboplatin and paclitaxel either every 3 weeks, carboplatin every 3 weeks plus paclitaxel every week, or both carboplatin and paclitaxel on a weekly basis. Progression-free and overall survival were specified as the co-primary outcomes. The trial results demonstrated dose-dense chemotherapy as a viable first-line therapy for epithelial ovarian cancer; however, they did not point to any significant improvement in progression-free survival compared with the standard. On the other hand, weekly treatment was associated with a higher rate of grade 3 or 4 toxic effects; however, these effects were mostly uncomplicated. (Click for more...) A randomized, controlled trial of Ebola virus disease therapeutics 12/3/2019 10:00:01 PM A randomized, controlled trial of Ebola virus disease therapeutics Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 The PALM Consortium study evaluated the safety and efficacy of four investigational therapies for Ebola virus disease (EVD). Enrollment opened in November 2018 in the Democratic Republic of Congo, 3 months after the onset of an EVD outbreak there. Anyone testing positive for Ebola virus RNA was entered into the study population and randomized to one of four treatment arms. They included the antiviral agent remdesivir, the single monoclonal antibody MAb114, and the triple monoclonal antibody REGN-EB3. Meanwhile, participants assigned to ZMapp, another triple monoclonal antibody, served as the control group. The main outcome was 28-day mortality, which occurred at a higher rate among patients receiving ZMapp or remdesivir vs. MAb114 or REGN-EB3. The research, highlighting the efficacy of these two new investigational treatments, demonstrates how scientifically and ethically sound clinical studies can be done in the midst of disease outbreaks and help shape response. (Click for more...) Passive measles immunity wanes quickly in infants 12/3/2019 10:00:01 PM Passive measles immunity wanes quickly in infants Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 New research indicates that newborns' immunity to measles from the transference of antibodies from the mother is temporary. A study published in Pediatrics found that among 92% of babies aged 3 months, antibody levels were no longer high enough to protect them from measles, and by 6 months, that percentage rose to 100%. Study author Michelle Science, MD, of the Hospital for Sick Children in Toronto, and colleagues, wrote: "The widening gap between loss of maternal antibodies and measles vaccination described in our study leaves infants vulnerable to measles for much of their infancy and highlights the need for further research to support public health policy." Walter Orenstein, MD, of Emory University School of Medicine, Atlanta, GA, who was not involved in the study but co-wrote an accompanying commentary, noted that before measles was eliminated, most mothers developed their immunity by being infected by wild-type virus, which produces stronger immunity compared with a vaccination. Mothers also experienced repeated exposure to the virus, which provided a natural immune boost. After the measles virus was eliminated in the 1990s in the United States and Canada, most mothers gained their immunity through vaccination, so their infants likely started out with lower antibody levels. Orenstein says instead of reducing the age of vaccination, the best strategy for protecting very young infants is encouraging vaccine uptake and preventing measles exposure from local or traveler-linked outbreaks. (Click for more...) Scientists find promising drug combination against lethal childhood brain cancers 12/3/2019 10:00:01 PM Scientists find promising drug combination against lethal childhood brain cancers Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 Researchers have devised a new plan of attack against a group of deadly childhood brain cancers collectively called diffuse midline gliomas (DMG), including diffuse intrinsic pontine glioma (DIPG), thalamic glioma, and spinal cord glioma. Scientists at NIH, Stanford University, and Dana-Farber Cancer Institute identified a drug pair that worked together to both kill cancer cells and counter the effects of a genetic mutation that causes the diseases. The researchers showed that combining the two drugs—panobinostat and marizomib—was more effective than either drug by itself in killing DMG patient cells grown in the laboratory and in animal models. Their studies also uncovered a previously unrecognized vulnerability in the cancer cells that scientists may be able to exploit to develop new strategies against the cancer and related diseases. The team focused on the combination of histone deacetylase inhibitors (like panobinostat) with drugs called proteasome inhibitors (such as marizomib). Proteasome inhibitors block cells’ normal protein recycling processes. The panobinostat-marizomib combination was highly toxic to DIPG cells in several models, including DIPG tumor cell cultures that represented the main genetic subtypes of the disease and mice with cells transplanted from patient tumors. The combination also reduced tumor size in mice and increased their survival. A similar response was found in spinal cord and thalamic DMG models developed from cells grown in culture from patient cells. Plans are underway for clinical trials of the drug combination and of marizomib alone. (Click for more...) CVS Health to buy Illinois insurance unit 12/3/2019 10:00:01 PM CVS Health to buy Illinois insurance unit Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 Centene is selling its Illinois Medicaid and Medicare Advantage business lines to CVS Health in order to facilitate its more than $15 billion purchase of WellCare Health Plans. The Centene unit is one of six private insurers awarded contracts to administer Medicaid benefits in Illinois under a managed care program intended to improve care and save money. The proposed merger of Centene and WellCare follows WellCare's 2018 purchase of Meridian, another participant in the state's Medicaid managed care program. IlliniCare has 16% of the state's Medicaid managed care market, and WellCare's Meridian has 36%, according to the latest data from the Illinois Department of Healthcare & Family Services, which oversees Medicaid. "Expanding our Medicaid and Medicare Advantage presence in Illinois will allow us to serve more members with our proven holistic approach that addresses physical, behavioral and social determinants of care," said Karen Lynch, executive vice president of CVS Health and president of Aetna. (Click for more...) A glitch in diabetes monitors serves as a cautionary tale for health tech 12/3/2019 10:00:01 PM A glitch in diabetes monitors serves as a cautionary tale for health tech Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 Dexcom, a company that makes sensors used by people with diabetes to measure their blood-glucose levels, has been one of the biggest success stories in applying technology to health. Sales of its continuous glucose monitors climbed to $396 million in the third quarter of 2019, up 49% from a year ago. However, a key feature of Dexcom's devices recently failed. One of the selling points of the monitors is that they allow people other than the person with diabetes to receive alerts when the patient's blood sugar drops too low. But those alerts, a feature called Dexcom Follow, stopped working. Worse, parents who were using it to help monitor their children with type 1 diabetes did not realize that the system had stopped working. Parents went public with stories of how the 2-day technical glitch was making it harder to manage their children's conditions. James McIntosh, a spokesman for Dexcom, said that company became aware of the issue early on November 30. The company did not release any updates or changes to cause the issue, he said, but it appears a server overload occurred due "to an unexpected system issue that generated a massive backlog." (Click for more...) Medicare patients in deadly 'donut hole' struggle to pay for medication 12/3/2019 10:00:01 PM Medicare patients in deadly 'donut hole' struggle to pay for medication Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 After Medicare patients pay $3,820 on covered drugs, they reach the so-called donut hole, and subsequently must pay 25% of their plan's cost for covered brand-name prescription drugs and 37% for generics. Leigh Purvis, director of Health Services Research in AARP's Public Policy Institute, says this coverage gap has been slowly closing, but people are reaching the gap sooner as a result of rising drug prices. Purvis recommends that patients contact their physician to consider less expensive alternatives and explore state or federal assistance programs. More than 5 million older adults nationwide without low-income subsidies where affected by the donut hole in 2016, according to a Kaiser Family Foundation study. Alex Sheff, co-director of policy and government relations at Massachusetts-based Health Care for All, says the group is calling for a wider-ranging and more transparent strategy to curb drug pricing in the state. (Click for more...) CVS Health encourages families to get influenza vaccinations 12/3/2019 10:00:01 PM CVS Health encourages families to get influenza vaccinations Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 CVS Health is reminding people that they can still get influenza vaccinations to protect themselves and their family members from influenza. New CDC data indicate that seasonal influenza activity is increasing, with cases rising week over week and cases reported in most states. "Flu levels typically peak between December and February, but trends this year seem to be hinting at an early start to the flu season," said Kevin Hourican, CVS Pharmacy president. "As the flu shot takes a couple of weeks to become fully effective, now is a good time to get vaccinated so that you have a better chance of remaining healthy throughout the holiday season, when families and friends gather and the flu typically begins to spread." National Influenza Immunization Week—held this week, from December 1 through December 7—was established in 2005 to draw attention to the importance of continued vaccination through the busy holiday season and into the New Year, when influenza activity is usually at its peak. "As the most effective way to prevent people from contracting the flu, a flu shot should be a priority at this time of year," added Angela Patterson, chief nurse practitioner officer, MinuteClinic. "But we also want to remind people that if they do end up getting sick and think they have the flu, they should see a health care provider as soon as symptoms develop to be able to take advantage of available prescription and OTC medications that can help them feel better or reduce the duration of their illness." (Click for more...) U.S. considers easing drug protections to break logjam over trade pact 12/3/2019 10:00:01 PM U.S. considers easing drug protections to break logjam over trade pact Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 The Trump administration is reportedly considering scaling back intellectual-property protections for drug manufacturers to help win Democratic support for the U.S.-Mexico-Canada Agreement. Many Democrats are calling on the administration to reduce the length of time that leading biologic drugs would be protected from generic imitators in the trade pact, which currently protects these drugs for 10 years. That compares with 12 years under U.S. law. The Trump administration is considering easing the standard, according to people familiar with the matter. Pharmaceutical companies want the longest-possible protection period for their drugs so that producers of biosimilars cannot quickly take advantage of data from their medical trials to market their own products. They see trade agreements as a way to set a blueprint for intellectual property protection for biologic drugs, similar to the patent protection enshrined in trade pacts. Mexico and Canada would have to agree to any changes to the three-way accord they signed a year ago. (Click for more...) Pharmacy chains sue Bausch Health, other drugmakers for overcharging for diabetes drug 12/3/2019 10:00:01 PM Pharmacy chains sue Bausch Health, other drugmakers for overcharging for diabetes drug Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 A new lawsuit claims that two drug companies struck a deal with a third to delay the entry of their generic versions of a diabetes drug. The suit, filed by three pharmacy chains, including Walgreens Boots Alliance, alleges that Assertio Therapeutics and Lupin Ltd. made a deal with Bausch units to postpone the entry of their version of metformin HCl (Glumetza—Bausch). This deal, they say, enabled the companies to "maintain a monopoly" on the sale of the branded drug and its generic versions. (Click for more...) Vermont to submit in-process drug importation plan to feds 12/3/2019 10:00:01 PM Vermont to submit in-process drug importation plan to feds Mon, 12/02/2019 - 19:00 cbaker_admin Tue, 12/03/2019 - 22:00 To curb the cost of pharmaceuticals, state and federal officials are considering allowing Americans to import drugs from Canada. The Trump administration is developing a way for states to import prescription drugs from Canada at a discounted rate. State health care officials in Vermont and Gov. Phil Scott hope to submit an application to the federal government in the summer of 2020 that could potentially serve as a model for the rest of the nation. If the proposal is approved, people in the state would be able to import such drugs as insulin at a discounted price. Scott says: "While Vermont is small and our ability to impact pharmaceutical drug prices may be limited, I think it's important to do what we can and do it in a public way because our small size cuts both ways. It also allows us to be nimble and, coupled with our close proximity to Canada, allows us to be a leader on this policy." Florida is working on a similar effort, but in Vermont, any Medicaid or commercial payer would be able to participate. (Click for more...) 25% Dextrose Injection 12/3/2019 7:00:00 PM Drug: 25% Dextrose Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Argatroban Injection 12/3/2019 7:00:00 PM Drug: Argatroban Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Aspirin Suppositories 12/3/2019 7:00:00 PM Drug: Aspirin Suppositories, Revision Date: Wed, 04 Dec 2019 (Click for more...) Bupivacaine with Epinephrine Injection 12/3/2019 7:00:00 PM Drug: Bupivacaine with Epinephrine Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Buspirone Tablets 12/3/2019 7:00:00 PM Drug: Buspirone Tablets, Revision Date: Wed, 04 Dec 2019 (Click for more...) Calcium Chloride Injection 12/3/2019 7:00:00 PM Drug: Calcium Chloride Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Doxorubicin Injection 12/3/2019 7:00:00 PM Drug: Doxorubicin Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Famotidine Tablets 12/3/2019 7:00:00 PM Drug: Famotidine Tablets, Revision Date: Wed, 04 Dec 2019 (Click for more...) Lidocaine with Epinephrine Injection 12/3/2019 7:00:00 PM Drug: Lidocaine with Epinephrine Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Losartan and Hydrochlorothiazide Tablets 12/3/2019 7:00:00 PM Drug: Losartan and Hydrochlorothiazide Tablets, Revision Date: Wed, 04 Dec 2019 (Click for more...) Methotrexate Injection 12/3/2019 7:00:00 PM Drug: Methotrexate Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Nimodipine Oral Solution 12/3/2019 7:00:00 PM Drug: Nimodipine Oral Solution, Revision Date: Wed, 04 Dec 2019 (Click for more...) Octreotide Injection 12/3/2019 7:00:00 PM Drug: Octreotide Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Oxytocin Injection 12/3/2019 7:00:00 PM Drug: Oxytocin Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Sterile Water for Injection - Small Volume Vials 12/3/2019 7:00:00 PM Drug: Sterile Water for Injection - Small Volume Vials, Revision Date: Wed, 04 Dec 2019 (Click for more...) Ulipristal Acetate 12/3/2019 7:00:00 PM Drug: Ulipristal Acetate, Revision Date: Wed, 04 Dec 2019 (Click for more...) Vancomycin Hydrochloride Injection 12/3/2019 7:00:00 PM Drug: Vancomycin Hydrochloride Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Hydroxocobalamin Injection 12/3/2019 7:00:00 PM Drug: Hydroxocobalamin Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Orphenadrine Citrate Injection 12/3/2019 7:00:00 PM Drug: Orphenadrine Citrate Injection, Revision Date: Wed, 04 Dec 2019 (Click for more...) Potassium Iodide and Iodine (Lugol's Solution or Strong Iodine Solution) 14 mL bottles 12/3/2019 7:00:00 PM Drug: Potassium Iodide and Iodine (Lugol's Solution or Strong Iodine Solution) 14 mL bottles, Revision Date: Wed, 04 Dec 2019 (Click for more...) Pharmacogenomic testing could benefit children who need PPIs 12/3/2019 10:48:29 AM Pharmacogenomic testing could benefit children who need PPIs Tue, 12/03/2019 - 10:54 caldridgeyoung… Tue, 12/03/2019 - 10:48 The study looked at use of PPIs in children. These medications are commonly used for pediatric patients to treat GI disorders. However, more adverse infection events have been reported with their use, according to the study authors. (Click for more...) FDA collaborates with Elsevier on drug-induced liver injury (DILI) tool 12/3/2019 3:30:00 AM A leading cause of attrition of compounds in drug development, drug-induced liver injury (DILI) is also one of the top causes of drug withdrawals, restrictions and project terminations. DILI results when reactive metabolites – formed when certain orally administered drugs are metabolized in the liver – end up binding to cellular proteins and damaging liver […] (Click for more...) Massachusetts enacts U.S.'s toughest flavored-tobacco ban 12/2/2019 8:30:01 PM Massachusetts enacts U.S.'s toughest flavored-tobacco ban Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Gov. Charlie Baker of Massachusetts has signed into law the nation's toughest prohibition on flavored tobacco, including a ban on menthol cigarettes. The new restrictions will put the state at the forefront of a national crackdown on flavored tobacco in an effort to stop young people from developing tobacco habits. A ban on flavored vaping products is slated to start immediately. Menthol cigarettes will be banned starting June 1. The bill adds an excise tax for unflavored vaping products, which are still allowed under the law but face new sales restrictions based on nicotine content, and expands access to smoking-cessation help. The flavor ban does not apply to places like cigar bars where people consume tobacco on site. The Vapor Technology Association claimed the Massachusetts law will not protect youth but will make life harder for adults trying to quit smoking. (Click for more...) New strawberry-flavored HIV drugs for babies are offered at $1 a day 12/2/2019 8:30:01 PM New strawberry-flavored HIV drugs for babies are offered at $1 a day Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Cipla, an Indian generic drug manufacturer, announced on Friday a new strawberry-flavored formulation of the combination HIV medication ritonavir–lopinavir–abacavir–lamivudine (Quadrimune). The drug comes in the form of granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. The granules are first coated in a polymer that does not melt until it reaches the stomach and has a sweet, fruity flavoring. "This is excellent news for all children living with HIV," said Winnie Byanyima, the new executive director of UNAIDS. "We have been eagerly waiting for child-friendly medicines that are easy to use and good to taste." Many pediatric formulations of HIV drugs are very hard and cannot be crushed or are in bitter syrups that are hard for the child to keep down. The new pediatric formulation will be priced at $1 a day. The announcement, made by Cipla and the Drugs for Neglected Diseases Initiative, an offshoot of Doctors Without Borders, was made in advance of World AIDS Day, which is held on December 1 every year. (Click for more...) Head-to-head comparison finds three anti-seizure drugs equally effective for severe form of epilepsy 12/2/2019 8:30:01 PM Head-to-head comparison finds three anti-seizure drugs equally effective for severe form of epilepsy Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 There are three treatment options commonly used by doctors in the emergency room to treat patients with refractory status epilepticus, severe seizures that continue even after benzodiazepine medications, which are effective in controlling seizures in more than two-thirds of patients. New findings published in the New England Journal of Medicine reveal that the three drugs—levetiracetam, fosphenytoin, and valproate—are equally safe and effective in treating patients with this condition. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS). "Doctors can be confident that the particular treatment they choose for their patients with status epilepticus is safe and effective and may help them avoid the need to intubate the patient as well as stays in the intensive care unit," said Robin Conwit, MD, NINDS program director and an author of the study. "This was a truly collaborative, multidisciplinary study that involved pediatricians, emergency medicine doctors, neurologists, pharmacologists, and biostatisticians all contributing their expertise." (Click for more...) Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC 12/2/2019 8:30:01 PM Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Researchers conducted a Phase III trial to compare first-line osimertinib with other epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in patients with EGFR mutation–positive advanced non–small-cell lung cancer (NSCLC). The trial indicated longer progression-free survival with osimertinib than with comparator EGFR-TKIs. For the study, researchers randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily, or erlotinib at a dose of 150 mg once daily; patients received these drugs combined in a single comparator group). The median overall survival was 38.6 months in the osimertinib group and 31.8 months in the comparator group. At 3 years, 28% of 279 patients in the osimertinib group and 9% of 277 patients in the comparator group were continuing to receive a trial regimen. The median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group. Researchers found that among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. (Click for more...) Alnylam's rare genetic disorder drug priced at $575,000 per year 12/2/2019 8:30:01 PM Alnylam's rare genetic disorder drug priced at $575,000 per year Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Alnylam Pharmaceuticals has priced its gene silencing drug givosiran (Givlaari) to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval on Wednesday. The drug uses RNA interference to target and "silence" specific genetic material and is the second such drug to be approved by FDA. The injection, which is dosed based on patient weight, will be available after discounts at $442,000 per year and is approved for acute hepatic porphyria (AHP), a rare disorder that can lead to severe pain and paralysis, respiratory failure, and seizures. The population of AHP patients with diagnosed, active disease in the United States and Europe is estimated to be approximately 3,000, but the time to diagnosis can be as long as 15 years due to the broad, non-specific range of symptoms. Alnylam said givosiran will be subjected to an additional feature that will trigger rebates or discounts to insurers if the number of diagnosed patients they cover exceeds current estimates. (Click for more...) Amazon launches medication management features for Alexa 12/2/2019 8:30:01 PM Amazon launches medication management features for Alexa Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Customers of Giant Eagle Pharmacy, a regional retailer in the Midwest and East Coast, will soon be able use Amazon's Alexa to set up medication reminders and request refills via voice. These features appear poised for integration with both Amazon's Care pilot health care service and PillPack prescription ordering service. Amazon says it turned to Omnicell, a medication management solution and adherence tool provider, to create the new features. Customers will need to create an Alexa voice profile and a personal passcode to ensure security. Amazon notes that it had already rolled out a way for developers to build HIPAA-compliant skills using its platform, which can also redact users' interactions with the skill from the Alexa app. Amazon also recently added a way for customers to view and delete recordings at any time, including from the Privacy Settings page, in the Alexa app, or by voice. Commands that customers can say include "Alexa, manage my medication," "Alexa, what medication am I supposed to take right now?" and "Alexa, refill my prescription." Rachel Jiang, head of Alexa Health & Wellness, says: "We believe this new Alexa feature will help simplify the way people manage their medication by removing the need to continuously think about what medications they've taken that day or what they need to take." (Click for more...) Walgreens opens first VillageMD site 12/2/2019 8:30:01 PM Walgreens opens first VillageMD site Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 On November 20, primary care company VillageMD opened its first primary care clinic at a Walgreens store in Houston. The clinic, called Village Medical at Walgreens, is the first of five sites to open in Houston, the rest of which will open in 2020. The Village Medical clinics are located next to Walgreens stores and offer a variety of services through same-day, walk-in appointments, as well as house calls and virtual visits. The opening comes weeks after Walgreens announced it would close nearly 160 in-store health clinics, citing the fact that profits dipped 55% in the first quarter of 2019. Walgreens plans to shift its strategy for walk-in clinics to focus more on chronic care management than treating minor illnesses. As part of this plan, Walgreens kept 220 clinics run by local health systems and will continue to look to outside partners to provide in-store medical services. (Click for more...) Trump administration's drug importation plan faces resistance in U.S., Canada 12/2/2019 8:30:01 PM Trump administration's drug importation plan faces resistance in U.S., Canada Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 The Trump administration's proposal to import less expensive prescription drugs from Canada faces significant opposition from U.S. pharmaceutical companies and the Canadian government. Canadian officials warn their country is too small to supply their neighbors to the south with prescription drugs. FDA expects to release the proposal in January, according to the fall regulatory agenda published last week. Under the plan, state governments could seek permission from HHS to import cheaper prescription drugs from Canadian suppliers that meet stringent requirements. Florida, Colorado, Vermont, and Maine are in the process of drafting such proposals. However, it remains uncertain if Canada will be a willing partner to such an effort. "It is important to recognize that Canada's market for pharmaceuticals is too small to have any real impact on U.S. drug prices," Canada's acting Ambassador to the United States Kirsten Hillman said in a statement following her meeting earlier this month with Joe Grogan, President Trump's domestic policy chief. Another big obstacle is the U.S. pharmaceutical industry. "We believe that it's critical for U.S. policymakers to hear the perspectives of health care and law enforcement experts, as well as patient advocates from Canada regarding proposals to allow importation of certain medicines," says Shabbir Safdar, executive director of the industry group Partnership for Safe Medicines. (Click for more...) MA bill would allow pharmacists to supply emergency insulin supply 12/2/2019 8:30:01 PM MA bill would allow pharmacists to supply emergency insulin supply Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 Newly proposed legislation in Massachusetts would permit pharmacists to dispense a 72-hour supply of insulin to a patient in an emergency. Filed by state Sen. Dean Tran (R-Fitchburg), the bill defines "emergency situation" as an event in which a physician's authorization for dispensing the drug cannot be readily obtained. The Senate recently passed with a unanimous vote pharmaceutical pricing legislation that would cap copays at $25 a month and would exclude insulin from deductibles. Prior to passing the bill, lawmakers agreed to an amendment from Tran that called for state officials to estimate the costs associated with allowing pharmacists to dispense insulin in emergency situations. The Senate referred Tran's bill to the Public Health Committee for review. The House agreed with that referral. Tran noted that 20 states have passed emergency insulin access laws in the past 5 years. In 2014, an Ohio man died of diabetic ketoacidosis after he ran out of insulin over a holiday and could not obtain a refill. (Click for more...) FDA comes down hard against CBD-infused food and beverage, ending months of silence 12/2/2019 8:30:01 PM FDA comes down hard against CBD-infused food and beverage, ending months of silence Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 The federal government has not concluded that global cannabidiol (CBD) is "generally recognized as safe" (GRAS) for use in human or animal food, meaning CBD in food and drink is still illegal. FDA has issued warning letters to 15 companies for illegally selling products containing CBD, saying they had violated the Federal Food, Drug and Cosmetic Act. FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. At the same time, FDA published a revised Consumer Update detailing broad safety concerns about CBD products. Companies that have been full-speed-ahead on developing and marketing CBD-infused food and drink say they have been waiting for direction from FDA on how to label and market products and are increasingly frustrated with the agency's lack of clear regulations. Brands including Ben & Jerry’s, Unilever, and Anheuser-Busch have announced CBD products in development, and community pharmacies such as Walgreens and CVS have vowed to sell them. (Click for more...) FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms 12/2/2019 8:30:01 PM FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 FDA recently sent a warning letter to a New Mexico company for marketing and selling unapproved and misbranded drugs. The products include a treatment for opioid withdrawal symptoms. According to FDA, the company, EPH Technologies Inc., is also promoting a number of other products with unproven claims that they can treat various medical conditions, including migraines and dizziness. "When products are allowed to make unsubstantiated medical claims, consumers might forgo or delay FDA-approved treatments and take an alternative product instead," said Donald D. Ashley, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "We need manufacturers and distributors to understand that they are responsible for evaluating their products prior to marketing, including the labeling, to ensure that they meet all federal requirements." The agency noted that it continues to encourage the development of additional and safe products to treat opioid withdrawal symptoms, and last year it approved lofexidine hydrochloride (Lucemyra–US WorldMeds), the first non-opioid treatment for the mitigation of withdrawal symptoms associated with abrupt discontinuation of opioids. (Click for more...) FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection 12/2/2019 8:30:01 PM FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection Sun, 12/01/2019 - 19:00 cbaker_admin Mon, 12/02/2019 - 20:30 FDA on Monday approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) System is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum. "Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia. As millions of children suffer from ear infections every year, it is important to have safe and effective treatments available to this susceptible patient population," said Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health. "This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort." While health care professionals frequently prescribe antibiotics as a treatment for ear infections, a doctor may eventually recommend a surgical procedure to place a small tube in the eardrum. The Tula System enables the delivery of an ear tube to patients under local anesthesia in a physician’s office setting, therefore avoiding the administration of general anesthesia. (Click for more...) 0.9% Sodium Chloride Small Volume Bags (< 150 mL) 12/2/2019 7:00:00 PM Drug: 0.9% Sodium Chloride Small Volume Bags (< 150 mL), Revision Date: Tue, 03 Dec 2019 (Click for more...) Aminophylline Injection 12/2/2019 7:00:00 PM Drug: Aminophylline Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Dopamine Hydrochloride Injection 12/2/2019 7:00:00 PM Drug: Dopamine Hydrochloride Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Doxycycline Hyclate Injection 12/2/2019 7:00:00 PM Drug: Doxycycline Hyclate Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Epinephrine Injection 12/2/2019 7:00:00 PM Drug: Epinephrine Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Hyoscyamine Sulfate Injection 12/2/2019 7:00:00 PM Drug: Hyoscyamine Sulfate Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Labetalol Injection 12/2/2019 7:00:00 PM Drug: Labetalol Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Lorazepam Injection 12/2/2019 7:00:00 PM Drug: Lorazepam Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Norepinephrine Bitartrate Injection 12/2/2019 7:00:00 PM Drug: Norepinephrine Bitartrate Injection, Revision Date: Tue, 03 Dec 2019 (Click for more...) Prednisone Oral Tablets 12/2/2019 7:00:00 PM Drug: Prednisone Oral Tablets, Revision Date: Tue, 03 Dec 2019 (Click for more...) Promethazine Injection 12/2/2019 7:00:00 PM Drug: Promethazine Injection, Revision Date: Tue, 03 Dec 2019 (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...) Asthma management just got a little more precise and personalized 12/2/2019 10:39:09 AM Asthma management just got a little more precise and personalized Mon, 12/02/2019 - 10:49 caldridgeyoung… Mon, 12/02/2019 - 10:39 “As such, there is an opportunity to personalize asthma management,” Martirosov said. From updated guidelines and recommendations, to new biologic therapies and diagnostic tools, treating and managing asthma is an evolving practice. Recently published studies and guidelines reflect current information on treating intermittent mild asthma; the role of triple therapy in severe, uncontrolled asthma; and better approaches to therapy for black patients. (Click for more...) New study suggests caution when combining fracture-associated medications for older adults 12/2/2019 9:46:15 AM New study suggests caution when combining fracture-associated medications for older adults Mon, 12/02/2019 - 10:12 caldridgeyoung… Mon, 12/02/2019 - 09:46 A new study published in JAMA Open Network found a strong association between the number of fracture-associated medications taken by older adults and their risk of fracture. The research showed that on average, taking any one of these drugs doubled a person’s risk, taking any two almost tripled it, and taking three or more increased fracture risk four-fold. (Click for more...) Levetiracetam Immediate-Release Tablets 12/1/2019 7:00:00 PM Drug: Levetiracetam Immediate-Release Tablets, Revision Date: Mon, 02 Dec 2019 (Click for more...) Atropine Sulfate Injection 11/26/2019 7:00:00 PM Drug: Atropine Sulfate Injection, Revision Date: Wed, 27 Nov 2019 (Click for more...) Heparin Sodium Premixed Bags 11/26/2019 7:00:00 PM Drug: Heparin Sodium Premixed Bags, Revision Date: Wed, 27 Nov 2019 (Click for more...) Hydroxyethyl Starch in Sodium Chloride Injection 11/26/2019 7:00:00 PM Drug: Hydroxyethyl Starch in Sodium Chloride Injection, Revision Date: Wed, 27 Nov 2019 (Click for more...) Metronidazole Hydrochloride Injection 11/26/2019 7:00:00 PM Drug: Metronidazole Hydrochloride Injection, Revision Date: Wed, 27 Nov 2019 (Click for more...) Rocuronium Injection 11/26/2019 7:00:00 PM Drug: Rocuronium Injection, Revision Date: Wed, 27 Nov 2019 (Click for more...) Valsartan Tablets 11/26/2019 7:00:00 PM Drug: Valsartan Tablets, Revision Date: Wed, 27 Nov 2019 (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...) 5% Lidocaine and 7.5% Dextrose Injection 11/25/2019 7:00:00 PM Drug: 5% Lidocaine and 7.5% Dextrose Injection, Revision Date: Tue, 26 Nov 2019 (Click for more...) Chlorothiazide Oral Tablets and Suspension 11/25/2019 7:00:00 PM Drug: Chlorothiazide Oral Tablets and Suspension, Revision Date: Tue, 26 Nov 2019 (Click for more...) Cyclosporine Oral Solution 11/25/2019 7:00:00 PM Drug: Cyclosporine Oral Solution, Revision Date: Tue, 26 Nov 2019 (Click for more...) Fluticasone and Salmeterol Powder for Inhalation 11/25/2019 7:00:00 PM Drug: Fluticasone and Salmeterol Powder for Inhalation, Revision Date: Tue, 26 Nov 2019 (Click for more...) Telmisartan Tablets 11/25/2019 7:00:00 PM Drug: Telmisartan Tablets, Revision Date: Tue, 26 Nov 2019 (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...) Acalabrutinib now approved for treatment of adults with CLL, SLL 11/25/2019 2:46:29 PM Generic Name: AcalabrutinibTrade Name: CalquenceCompany: AstraZenecaNotes: As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA approved a new indication for acalabrutinib to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as an initial or subsequent therapy. The supplemental approval of acalabrutinib for patients with CLL or SLL was based on two randomized clinical trials that compared acalabrutinib to other standard treatments. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving acalabrutinib had a longer progression-free survival compared with patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving acalabrutinib also had a longer progression-free survival than patients receiving other standard treatments. The most common adverse effects were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmias. Patients may experience serious infections and should be monitored and treated promptly. Patients should also be monitored for bleeding and managed appropriately. Patients may also experience low blood counts and should have blood work monitored regularly. Patients should be advised to use sun protection as other malignancies, such as skin cancers and other solid tumors, have occurred in patients taking the drug. FDA advises health professionals to tell females of reproductive age to use effective contraception during treatment. Women who are pregnant or breastfeeding should not take acalabrutinib because it may cause harm to a developing fetus or newborn baby or cause delivery complications. Medication Monitor Categories: Supplemental Approvals (Click for more...) Adalimumab-afzb, biosimilar to Humira, approved for multiple inflammatory conditions 11/25/2019 2:29:35 PM Generic Name: Adalimumab-afzbTrade Name: AbriladaCompany: PfizerNotes: On November 18, 2019, Pfizer announced FDA approval of adalimumab-afzb, a tumor necrosis factor (TNF) blocker and biosimilar to adalimumab (Humira), to treat certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis. FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of adalimumab-afzb to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety, and immunogenicity of adalimumab-afzb and found no clinically meaningful differences compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.3 The labeling carries a boxed warning that patients treated with adalimumab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. The drug should be discontinued if a patient develops a serious infection or sepsis. The most common adverse reactions in clinical trials were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. Medication Monitor Categories: Supplemental Approvals (Click for more...) Amphetamine Mixed Salts, Immediate-Release Tablets 11/24/2019 7:00:00 PM Drug: Amphetamine Mixed Salts, Immediate-Release Tablets, Revision Date: Mon, 25 Nov 2019 (Click for more...) Azithromycin Injection 11/24/2019 7:00:00 PM Drug: Azithromycin Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Cefuroxime Sodium Injection 11/24/2019 7:00:00 PM Drug: Cefuroxime Sodium Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Clindamycin Phosphate Injection 11/24/2019 7:00:00 PM Drug: Clindamycin Phosphate Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Haloperidol Tablets 11/24/2019 7:00:00 PM Drug: Haloperidol Tablets, Revision Date: Mon, 25 Nov 2019 (Click for more...) Hydralazine injection 11/24/2019 7:00:00 PM Drug: Hydralazine injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Ketorolac Injection 11/24/2019 7:00:00 PM Drug: Ketorolac Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Levetiracetam Injection 11/24/2019 7:00:00 PM Drug: Levetiracetam Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Loxapine Tablets 11/24/2019 7:00:00 PM Drug: Loxapine Tablets, Revision Date: Mon, 25 Nov 2019 (Click for more...) Nitrofurantoin Oral Suspension 11/24/2019 7:00:00 PM Drug: Nitrofurantoin Oral Suspension, Revision Date: Mon, 25 Nov 2019 (Click for more...) Thrombin Topical Solution (Bovine) 11/24/2019 7:00:00 PM Drug: Thrombin Topical Solution (Bovine), Revision Date: Mon, 25 Nov 2019 (Click for more...) Vinblastine Sulfate Injection 11/24/2019 7:00:00 PM Drug: Vinblastine Sulfate Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Vincristine Sulfate Injection 11/24/2019 7:00:00 PM Drug: Vincristine Sulfate Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Chorionic Gonadotropin (Human) for Injection 11/24/2019 7:00:00 PM Drug: Chorionic Gonadotropin (Human) for Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) Ciprofloxacin Oral Suspension 11/24/2019 7:00:00 PM Drug: Ciprofloxacin Oral Suspension, Revision Date: Mon, 25 Nov 2019 (Click for more...) Copper Chloride Injection 11/24/2019 7:00:00 PM Drug: Copper Chloride Injection, Revision Date: Mon, 25 Nov 2019 (Click for more...) 23.4% Sodium Chloride Injection 11/21/2019 7:00:00 PM Drug: 23.4% Sodium Chloride Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Amiodarone Injection 11/21/2019 7:00:00 PM Drug: Amiodarone Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Diltiazem Hydrochloride Injection 11/21/2019 7:00:00 PM Drug: Diltiazem Hydrochloride Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Droperidol Injection 11/21/2019 7:00:00 PM Drug: Droperidol Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Epinephrine Auto-Injectors 11/21/2019 7:00:00 PM Drug: Epinephrine Auto-Injectors, Revision Date: Fri, 22 Nov 2019 (Click for more...) Furosemide Injection 11/21/2019 7:00:00 PM Drug: Furosemide Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Melphalan Tablets 11/21/2019 7:00:00 PM Drug: Melphalan Tablets, Revision Date: Fri, 22 Nov 2019 (Click for more...) Tacrolimus Capsules 11/21/2019 7:00:00 PM Drug: Tacrolimus Capsules, Revision Date: Fri, 22 Nov 2019 (Click for more...) Thiamine Injection 11/21/2019 7:00:00 PM Drug: Thiamine Injection, Revision Date: Fri, 22 Nov 2019 (Click for more...) Tuberculin 11/21/2019 7:00:00 PM Drug: Tuberculin, Revision Date: Fri, 22 Nov 2019 (Click for more...) Cyclosporine Capsules 11/21/2019 7:00:00 PM Drug: Cyclosporine Capsules, Revision Date: Fri, 22 Nov 2019 (Click for more...) Disulfiram Tablets 11/20/2019 7:00:00 PM Drug: Disulfiram Tablets, Revision Date: Thu, 21 Nov 2019 (Click for more...) Amyl Nitrite Inhalation 11/19/2019 7:00:00 PM Drug: Amyl Nitrite Inhalation, Revision Date: Wed, 20 Nov 2019 (Click for more...) Chlordiazepoxide Capsules 11/19/2019 7:00:00 PM Drug: Chlordiazepoxide Capsules, Revision Date: Wed, 20 Nov 2019 (Click for more...) Daptomycin Injection 11/19/2019 7:00:00 PM Drug: Daptomycin Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Deferoxamine Injection 11/19/2019 7:00:00 PM Drug: Deferoxamine Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution 11/19/2019 7:00:00 PM Drug: Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution, Revision Date: Wed, 20 Nov 2019 (Click for more...) Fluorometholone Ophthalmic Ointment 11/19/2019 7:00:00 PM Drug: Fluorometholone Ophthalmic Ointment, Revision Date: Wed, 20 Nov 2019 (Click for more...) Griseofulvin Oral Presentations 11/19/2019 7:00:00 PM Drug: Griseofulvin Oral Presentations, Revision Date: Wed, 20 Nov 2019 (Click for more...) Immune Globulin, Intravenous or Subcutaneous (Human) 11/19/2019 7:00:00 PM Drug: Immune Globulin, Intravenous or Subcutaneous (Human), Revision Date: Wed, 20 Nov 2019 (Click for more...) Iopamidol Injection 11/19/2019 7:00:00 PM Drug: Iopamidol Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Isocarboxazid Tablets 11/19/2019 7:00:00 PM Drug: Isocarboxazid Tablets, Revision Date: Wed, 20 Nov 2019 (Click for more...) Lorazepam Tablets 11/19/2019 7:00:00 PM Drug: Lorazepam Tablets, Revision Date: Wed, 20 Nov 2019 (Click for more...) Mupirocin Calcium 2% Cream 11/19/2019 7:00:00 PM Drug: Mupirocin Calcium 2% Cream, Revision Date: Wed, 20 Nov 2019 (Click for more...) Mupirocin Calcium 2% Nasal Ointment 11/19/2019 7:00:00 PM Drug: Mupirocin Calcium 2% Nasal Ointment, Revision Date: Wed, 20 Nov 2019 (Click for more...) Mycophenolate Mofetil Capsules and Tablets 11/19/2019 7:00:00 PM Drug: Mycophenolate Mofetil Capsules and Tablets, Revision Date: Wed, 20 Nov 2019 (Click for more...) Nicardipine Hydrochloride Injection 11/19/2019 7:00:00 PM Drug: Nicardipine Hydrochloride Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Ondansetron Hydrochloride Injection 11/19/2019 7:00:00 PM Drug: Ondansetron Hydrochloride Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Rabies Vaccine 11/19/2019 7:00:00 PM Drug: Rabies Vaccine, Revision Date: Wed, 20 Nov 2019 (Click for more...) Dorzolamide Ophthalmic Solution 11/19/2019 7:00:00 PM Drug: Dorzolamide Ophthalmic Solution, Revision Date: Wed, 20 Nov 2019 (Click for more...) Scopolamine Transdermal System 11/19/2019 7:00:00 PM Drug: Scopolamine Transdermal System, Revision Date: Wed, 20 Nov 2019 (Click for more...) Sincalide Injection 11/19/2019 7:00:00 PM Drug: Sincalide Injection, Revision Date: Wed, 20 Nov 2019 (Click for more...) Trifluoperazine Tablets 11/19/2019 7:00:00 PM Drug: Trifluoperazine Tablets, Revision Date: Wed, 20 Nov 2019 (Click for more...) Ketamine Injection 11/18/2019 7:00:00 PM Drug: Ketamine Injection, Revision Date: Tue, 19 Nov 2019 (Click for more...) Pantoprazole Injection 11/18/2019 7:00:00 PM Drug: Pantoprazole Injection, Revision Date: Tue, 19 Nov 2019 (Click for more...) Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment 11/18/2019 7:00:00 PM Drug: Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment, Revision Date: Tue, 19 Nov 2019 (Click for more...) Mannitol Injection 11/18/2019 7:00:00 PM Drug: Mannitol Injection, Revision Date: Tue, 19 Nov 2019 (Click for more...) BCG Live Intravesical 11/17/2019 7:00:00 PM Drug: BCG Live Intravesical, Revision Date: Mon, 18 Nov 2019 (Click for more...) Carbidopa and Levodopa Extended-Release Tablets 11/17/2019 7:00:00 PM Drug: Carbidopa and Levodopa Extended-Release Tablets, Revision Date: Mon, 18 Nov 2019 (Click for more...) Carisoprodol Tablets 11/17/2019 7:00:00 PM Drug: Carisoprodol Tablets, Revision Date: Mon, 18 Nov 2019 (Click for more...) Cefepime Injection 11/17/2019 7:00:00 PM Drug: Cefepime Injection, Revision Date: Mon, 18 Nov 2019 (Click for more...) Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection 11/17/2019 7:00:00 PM Drug: Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection, Revision Date: Mon, 18 Nov 2019 (Click for more...) PCA Sterile Empty Vials and Injector 11/17/2019 7:00:00 PM Drug: PCA Sterile Empty Vials and Injector, Revision Date: Mon, 18 Nov 2019 (Click for more...) Piperacillin and Tazobactam Injection 11/17/2019 7:00:00 PM Drug: Piperacillin and Tazobactam Injection, Revision Date: Mon, 18 Nov 2019 (Click for more...) Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection 11/17/2019 7:00:00 PM Drug: Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection, Revision Date: Mon, 18 Nov 2019 (Click for more...) Ampicillin Sodium and Sulbactam Sodium Injection 11/14/2019 7:00:00 PM Drug: Ampicillin Sodium and Sulbactam Sodium Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Anagrelide Hydrochloride Capsules 11/14/2019 7:00:00 PM Drug: Anagrelide Hydrochloride Capsules, Revision Date: Fri, 15 Nov 2019 (Click for more...) Enalaprilat Injection 11/14/2019 7:00:00 PM Drug: Enalaprilat Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Magnesium Sulfate Injection 11/14/2019 7:00:00 PM Drug: Magnesium Sulfate Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Mepivacaine Injection 11/14/2019 7:00:00 PM Drug: Mepivacaine Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Metoprolol Injection 11/14/2019 7:00:00 PM Drug: Metoprolol Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Sodium Acetate Injection 11/14/2019 7:00:00 PM Drug: Sodium Acetate Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Temazepam Capsules 11/14/2019 7:00:00 PM Drug: Temazepam Capsules, Revision Date: Fri, 15 Nov 2019 (Click for more...) Progesterone Injection 11/14/2019 7:00:00 PM Drug: Progesterone Injection, Revision Date: Fri, 15 Nov 2019 (Click for more...) Cefazolin Injection 11/13/2019 7:00:00 PM Drug: Cefazolin Injection, Revision Date: Thu, 14 Nov 2019 (Click for more...) Dexamethasone Sodium Phosphate Injection 11/13/2019 7:00:00 PM Drug: Dexamethasone Sodium Phosphate Injection, Revision Date: Thu, 14 Nov 2019 (Click for more...) Leucovorin Calcium Injection 11/13/2019 7:00:00 PM Drug: Leucovorin Calcium Injection, Revision Date: Thu, 14 Nov 2019 (Click for more...) Rabies Immune Globulin 11/13/2019 7:00:00 PM Drug: Rabies Immune Globulin, Revision Date: Thu, 14 Nov 2019 (Click for more...) Mitoxantrone Hydrochloride Injection 11/13/2019 7:00:00 PM Drug: Mitoxantrone Hydrochloride Injection, Revision Date: Thu, 14 Nov 2019 (Click for more...) Ceftazidime Injection 11/12/2019 7:00:00 PM Drug: Ceftazidime Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Dexrazoxane Injection 11/12/2019 7:00:00 PM Drug: Dexrazoxane Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Heparin Injection 11/12/2019 7:00:00 PM Drug: Heparin Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Hydroxyprogesterone Caproate Injection 11/12/2019 7:00:00 PM Drug: Hydroxyprogesterone Caproate Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Meropenem Injection 11/12/2019 7:00:00 PM Drug: Meropenem Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Ranitidine Injection 11/12/2019 7:00:00 PM Drug: Ranitidine Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Ceftriaxone Sodium Injection 11/12/2019 7:00:00 PM Drug: Ceftriaxone Sodium Injection, Revision Date: Wed, 13 Nov 2019 (Click for more...) Penicillamine 11/12/2019 7:00:00 PM Drug: Penicillamine, Revision Date: Wed, 13 Nov 2019 (Click for more...) Busulfan Injection 11/11/2019 7:00:00 PM Drug: Busulfan Injection, Revision Date: Tue, 12 Nov 2019 (Click for more...) Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution 11/11/2019 7:00:00 PM Drug: Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, Revision Date: Tue, 12 Nov 2019 (Click for more...) Methocarbamol Tablets 11/11/2019 7:00:00 PM Drug: Methocarbamol Tablets, Revision Date: Tue, 12 Nov 2019 (Click for more...) Recombinant Zoster Vaccine (Shingrix) 11/11/2019 7:00:00 PM Drug: Recombinant Zoster Vaccine (Shingrix), Revision Date: Tue, 12 Nov 2019 (Click for more...) Tacrolimus Injection 11/11/2019 7:00:00 PM Drug: Tacrolimus Injection, Revision Date: Tue, 12 Nov 2019 (Click for more...) Asparaginase Erwinia chrysanthemi 11/10/2019 7:00:00 PM Drug: Asparaginase Erwinia chrysanthemi, Revision Date: Mon, 11 Nov 2019 (Click for more...) Buprenorphine Hydrochloride Injection 11/10/2019 7:00:00 PM Drug: Buprenorphine Hydrochloride Injection, Revision Date: Mon, 11 Nov 2019 (Click for more...) Cefotaxime Sodium Injection 11/10/2019 7:00:00 PM Drug: Cefotaxime Sodium Injection, Revision Date: Mon, 11 Nov 2019 (Click for more...) Yellow Fever Vaccine 11/10/2019 7:00:00 PM Drug: Yellow Fever Vaccine, Revision Date: Mon, 11 Nov 2019 (Click for more...) Atropine Ophthalmic Solution 11/7/2019 7:00:00 PM Drug: Atropine Ophthalmic Solution, Revision Date: Fri, 08 Nov 2019 (Click for more...) Benztropine Mesylate Injection 11/7/2019 7:00:00 PM Drug: Benztropine Mesylate Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Bisacodyl Suppositories 11/7/2019 7:00:00 PM Drug: Bisacodyl Suppositories, Revision Date: Fri, 08 Nov 2019 (Click for more...) Erythromycin Ophthalmic Ointment 11/7/2019 7:00:00 PM Drug: Erythromycin Ophthalmic Ointment, Revision Date: Fri, 08 Nov 2019 (Click for more...) Etomidate Injection 11/7/2019 7:00:00 PM Drug: Etomidate Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Fluconazole Injection 11/7/2019 7:00:00 PM Drug: Fluconazole Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Fluorescein Sodium Ophthalmic Strips 11/7/2019 7:00:00 PM Drug: Fluorescein Sodium Ophthalmic Strips, Revision Date: Fri, 08 Nov 2019 (Click for more...) Levetiracetam Extended-Release Tablets 11/7/2019 7:00:00 PM Drug: Levetiracetam Extended-Release Tablets, Revision Date: Fri, 08 Nov 2019 (Click for more...) Nalbuphine Injection 11/7/2019 7:00:00 PM Drug: Nalbuphine Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Tacrolimus Extended-Release Capsules and Tablets 11/7/2019 7:00:00 PM Drug: Tacrolimus Extended-Release Capsules and Tablets, Revision Date: Fri, 08 Nov 2019 (Click for more...) Tropicamide 1% Ophthalmic Solution 11/7/2019 7:00:00 PM Drug: Tropicamide 1% Ophthalmic Solution, Revision Date: Fri, 08 Nov 2019 (Click for more...) Calcitriol Injection 11/7/2019 7:00:00 PM Drug: Calcitriol Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Physostigmine Salicylate Injection 11/7/2019 7:00:00 PM Drug: Physostigmine Salicylate Injection, Revision Date: Fri, 08 Nov 2019 (Click for more...) Elsevier uses machine learning to benefit pharmacovigilance 11/7/2019 3:30:28 AM Monitoring the scientific literature for adverse drug reactions (ADRs) is critical to maintaining drug safety, and there is no room for error. As regulations tighten, pharmacovigilance teams are seeking better strategies and methods for ensuring that all ADRs are identified in the most effective and efficient way possible. Elsevier is providing leadership in this area […] (Click for more...) Acetylcysteine Oral and Inhalation Solution 11/6/2019 7:00:00 PM Drug: Acetylcysteine Oral and Inhalation Solution, Revision Date: Thu, 07 Nov 2019 (Click for more...) Meperidine Hydrochloride Injection 11/6/2019 7:00:00 PM Drug: Meperidine Hydrochloride Injection, Revision Date: Thu, 07 Nov 2019 (Click for more...) Secobarbital Capsules 11/6/2019 7:00:00 PM Drug: Secobarbital Capsules, Revision Date: Thu, 07 Nov 2019 (Click for more...) Vecuronium Bromide Injection 11/6/2019 7:00:00 PM Drug: Vecuronium Bromide Injection, Revision Date: Thu, 07 Nov 2019 (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...) 5% Dextrose Injection (PVC-free and DEHP-free) 11/5/2019 7:00:00 PM Drug: 5% Dextrose Injection (PVC-free and DEHP-free), Revision Date: Wed, 06 Nov 2019 (Click for more...) Alprostadil Urethral Suppositories 11/5/2019 7:00:00 PM Drug: Alprostadil Urethral Suppositories, Revision Date: Wed, 06 Nov 2019 (Click for more...) Desiccated Thyroid Tablets 11/5/2019 7:00:00 PM Drug: Desiccated Thyroid Tablets, Revision Date: Wed, 06 Nov 2019 (Click for more...) Diclofenac Potassium Tablets 11/5/2019 7:00:00 PM Drug: Diclofenac Potassium Tablets, Revision Date: Wed, 06 Nov 2019 (Click for more...) Dicyclomine Oral Presentations 11/5/2019 7:00:00 PM Drug: Dicyclomine Oral Presentations, Revision Date: Wed, 06 Nov 2019 (Click for more...) Fluvastatin Capsules 11/5/2019 7:00:00 PM Drug: Fluvastatin Capsules, Revision Date: Wed, 06 Nov 2019 (Click for more...) Guanfacine Hydrochloride Tablets 11/5/2019 7:00:00 PM Drug: Guanfacine Hydrochloride Tablets, Revision Date: Wed, 06 Nov 2019 (Click for more...) 14.6% Sodium Chloride Concentrated Solution for Injection 11/4/2019 7:00:00 PM Drug: 14.6% Sodium Chloride Concentrated Solution for Injection, Revision Date: Tue, 05 Nov 2019 (Click for more...) Olanzapine Intramuscular Injection 11/4/2019 7:00:00 PM Drug: Olanzapine Intramuscular Injection, Revision Date: Tue, 05 Nov 2019 (Click for more...) Sodium Phosphate Injection 11/4/2019 7:00:00 PM Drug: Sodium Phosphate Injection, Revision Date: Tue, 05 Nov 2019 (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...) RimabotulintoxinB Intramuscular Injection 10/31/2019 8:00:00 PM Drug: RimabotulintoxinB Intramuscular Injection, Revision Date: Fri, 01 Nov 2019 (Click for more...) Bisoprolol Fumarate Tablets 10/29/2019 8:00:00 PM Drug: Bisoprolol Fumarate Tablets, Revision Date: Wed, 30 Oct 2019 (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...) Cyclosporine Injection 10/28/2019 8:00:00 PM Drug: Cyclosporine Injection, Revision Date: Tue, 29 Oct 2019 (Click for more...) Thrombin Topical Powder (Recombinant) 10/24/2019 8:00:00 PM Drug: Thrombin Topical Powder (Recombinant), Revision Date: Fri, 25 Oct 2019 (Click for more...) Tirofiban Hydrochloride Injection 10/24/2019 8:00:00 PM Drug: Tirofiban Hydrochloride Injection, Revision Date: Fri, 25 Oct 2019 (Click for more...) Bivalirudin Injection 10/23/2019 8:00:00 PM Drug: Bivalirudin Injection, Revision Date: Thu, 24 Oct 2019 (Click for more...) Bumetanide Injection 10/23/2019 8:00:00 PM Drug: Bumetanide Injection, Revision Date: Thu, 24 Oct 2019 (Click for more...) Mineral Oil and Petrolatum Ophthalmic Ointment 10/23/2019 8:00:00 PM Drug: Mineral Oil and Petrolatum Ophthalmic Ointment, Revision Date: Thu, 24 Oct 2019 (Click for more...) Atropine Sulfate Ophthalmic Ointment 10/22/2019 8:00:00 PM Drug: Atropine Sulfate Ophthalmic Ointment, Revision Date: Wed, 23 Oct 2019 (Click for more...) Losartan Tablets 10/22/2019 8:00:00 PM Drug: Losartan Tablets, Revision Date: Wed, 23 Oct 2019 (Click for more...) Fludrocortisone Acetate Tablets 10/22/2019 8:00:00 PM Drug: Fludrocortisone Acetate Tablets, Revision Date: Wed, 23 Oct 2019 (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...) Acetazolamide Injection 10/21/2019 8:00:00 PM Drug: Acetazolamide Injection, Revision Date: Tue, 22 Oct 2019 (Click for more...) Sterile Talc 10/21/2019 8:00:00 PM Drug: Sterile Talc, Revision Date: Tue, 22 Oct 2019 (Click for more...) Valsartan and Hydrochlorothiazide Tablets 10/21/2019 8:00:00 PM Drug: Valsartan and Hydrochlorothiazide Tablets, Revision Date: Tue, 22 Oct 2019 (Click for more...) Nelarabine Injection 10/21/2019 8:00:00 PM Drug: Nelarabine Injection, Revision Date: Tue, 22 Oct 2019 (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...) Furosemide Tablets 10/20/2019 8:00:00 PM Drug: Furosemide Tablets, Revision Date: Mon, 21 Oct 2019 (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...) Amobarbital Sodium Injection 10/17/2019 8:00:00 PM Drug: Amobarbital Sodium Injection, Revision Date: Fri, 18 Oct 2019 (Click for more...) Amino Acid Products 10/16/2019 8:00:00 PM Drug: Amino Acid Products, Revision Date: Thu, 17 Oct 2019 (Click for more...) Diphenhydramine Injection 10/16/2019 8:00:00 PM Drug: Diphenhydramine Injection, Revision Date: Thu, 17 Oct 2019 (Click for more...) Sodium Polystyrene Sulfonate Oral or Rectal Suspension 10/16/2019 8:00:00 PM Drug: Sodium Polystyrene Sulfonate Oral or Rectal Suspension, Revision Date: Thu, 17 Oct 2019 (Click for more...) Sodium Polystyrene Sulfonate Powder 10/16/2019 8:00:00 PM Drug: Sodium Polystyrene Sulfonate Powder, Revision Date: Thu, 17 Oct 2019 (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...) Clotrimazole Lozenges (Clotrimazole Troches) 10/10/2019 8:00:00 PM Drug: Clotrimazole Lozenges (Clotrimazole Troches), Revision Date: Fri, 11 Oct 2019 (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...) Midodrine Tablets 10/8/2019 8:00:00 PM Drug: Midodrine Tablets, Revision Date: Wed, 09 Oct 2019 (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...) Albuterol Inhalation Solution 10/3/2019 8:00:00 PM Drug: Albuterol Inhalation Solution, Revision Date: Fri, 04 Oct 2019 (Click for more...) Irbesartan Tablets 10/2/2019 8:00:00 PM Drug: Irbesartan Tablets, Revision Date: Thu, 03 Oct 2019 (Click for more...) Flurazepam Capsules 10/1/2019 8:00:00 PM Drug: Flurazepam Capsules, Revision Date: Wed, 02 Oct 2019 (Click for more...) Hypromellose Ophthalmic Solution 10/1/2019 8:00:00 PM Drug: Hypromellose Ophthalmic Solution, Revision Date: Wed, 02 Oct 2019 (Click for more...) Letermovir Injection 10/1/2019 8:00:00 PM Drug: Letermovir Injection, Revision Date: Wed, 02 Oct 2019 (Click for more...) Morphine PCA Vials 10/1/2019 8:00:00 PM Drug: Morphine PCA Vials, Revision Date: Wed, 02 Oct 2019 (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...) Diazepam Injection 9/30/2019 8:00:00 PM Drug: Diazepam Injection, Revision Date: Tue, 01 Oct 2019 (Click for more...) Gentamicin Sulfate Ophthalmic Ointment 9/29/2019 8:00:00 PM Drug: Gentamicin Sulfate Ophthalmic Ointment, Revision Date: Mon, 30 Sep 2019 (Click for more...) Methyldopa Tablets 9/26/2019 8:00:00 PM Drug: Methyldopa Tablets, Revision Date: Fri, 27 Sep 2019 (Click for more...) Multiple Vitamins for Infusion 9/26/2019 8:00:00 PM Drug: Multiple Vitamins for Infusion, Revision Date: Fri, 27 Sep 2019 (Click for more...) Prochlorperazine Maleate Tablets 9/26/2019 8:00:00 PM Drug: Prochlorperazine Maleate Tablets, Revision Date: Fri, 27 Sep 2019 (Click for more...) Triamcinolone Acetonide Intravitreal Injection 9/26/2019 8:00:00 PM Drug: Triamcinolone Acetonide Intravitreal Injection, Revision Date: Fri, 27 Sep 2019 (Click for more...) WVU Pharmacy alumna and colleagues honored by APhA Foundation 9/25/2019 12:00:00 AM The American Pharmacists Association (APhA) Foundation is recognizing a West Virginia School of Pharmacy alumna for making childhood vaccinations a priority in her state. (Click for more...) Metoclopramide Injection 9/23/2019 8:00:00 PM Drug: Metoclopramide Injection, Revision Date: Tue, 24 Sep 2019 (Click for more...) Cosyntropin Injection 9/22/2019 8:00:00 PM Drug: Cosyntropin Injection, Revision Date: Mon, 23 Sep 2019 (Click for more...) Pentamidine Isethionate 9/22/2019 8:00:00 PM Drug: Pentamidine Isethionate, Revision Date: Mon, 23 Sep 2019 (Click for more...) Testosterone Enanthate Intramuscular Injection 9/22/2019 8:00:00 PM Drug: Testosterone Enanthate Intramuscular Injection, Revision Date: Mon, 23 Sep 2019 (Click for more...) Erythromycin Lactobionate Injection 9/22/2019 8:00:00 PM Drug: Erythromycin Lactobionate Injection, Revision Date: Mon, 23 Sep 2019 (Click for more...) Morphine Sulfate Immediate-Release Tablets 9/22/2019 8:00:00 PM Drug: Morphine Sulfate Immediate-Release Tablets, Revision Date: Mon, 23 Sep 2019 (Click for more...) Potassium Phosphate Injection 9/22/2019 8:00:00 PM Drug: Potassium Phosphate Injection, Revision Date: Mon, 23 Sep 2019 (Click for more...) Protamine Sulfate Injection 9/22/2019 8:00:00 PM Drug: Protamine Sulfate Injection, Revision Date: Mon, 23 Sep 2019 (Click for more...) WVU Health Sciences Center Faculty Development Program Noon Hour Sessions 9/19/2019 12:00:00 AM WVU Health Sciences Center Faculty Development Program will host a series of sessions at noon on Sept. 26. (Click for more...) WVU pharmacy student finds purpose through courageous battle with childhood cancer 9/18/2019 12:00:00 AM September is Childhood Cancer Awareness Month. Statistics show more than 10,000 children in the United States under the age of 15 will be diagnosed with some form of cancer in 2019. (Click for more...) WVU Pharmacy stude